In the Matter of the Complaint Against ATHENA PRODUCTS, LTD. at the following addresses: Box 81371 Atlanta, GA 30366 1551 Dunwoody Village Pkwy. P. O. Box 888653 Dunwoody, GA 30338 3545 Broad Street P. O. Box 81112 Chamblee, GA 30366 5999 New Peachtree Rd. P. O. Box 48392 Doraville, GA 30362 3545 Broad Street P. O. Box 80783 Atlanta, GA 30366 780 Morosgo Dr., N.E. P. O. Box 13321 Atlanta, GA 30324 3104 Briarcliff Rd., N.E. P. O. Box 29501 Atlanta, GA 30359 780 Morosgo Dr., N.E. P. O. Box 29501 Atlanta, GA 30324 3176 Marjan Dr. Atlanta, GA 30340 520 W. Ponce deLeon Ave. P. O. Box 757 Decatur, GA 30030 P. O. Box 311 15 Franklin St. Avondale Estates, GA 30002 P. O. Box 893 3328 E. Ponce deLeon Ave. Scottsdale, GA 30079 P. O. Box 95294 4 Executive Park Dr., N.E. Atlanta, GA 30347 and P. O. Box 98377 3104 Briarcliff Rd., N.E. Atlanta, GA P.S. Docket Nos. 10/127 through 10/141 07/31/81 APPEARANCE FOR COMPLAINANT: Daniel E. Lewis, Esq. Consumer Protection Division, Law Department, United States Postal Service, Washington, D.C. 20260-1100 APPEARANCE FOR RESPONDENT: Tom Benham, Esq. Benham & Cohen, 6600 Powers Ferry Road, NW, Suite 210, Atlanta, GA 30339
Each of the above-styled proceedings was initiated on February 25, 1981, when the Consumer Protection Division, Law Department, United States Postal Service (Complainant) filed a Complaint in which it is charged that Athena Products, Ltd. (Respondent), in the sale of a specified product, is engaged in conducting a scheme or device for obtaining money through the mail by means of false representations within the meaning of 39 U. S. Code 3005. By agreement of the parties, all of these cases were tried in a consolidated proceeding. The cases fall into one of three broad categories under general headings of (1) weight loss and figure modification (Docket Nos. 10/127, 10/134 and 10/135; (2) rejuvenation, or supplements to prolong youth (Docket Nos. 10/136, 10/137, and 10/138); and (3) vitaming and mineral supplement products (Docket Nos. 10/128 through 10/133 and 10/139 through 10/141). Each docket number in a particular group and the product involved therein will be separately identified and considered.
The cases in the first group to be considered have been described as relating to vitaming and mineral supplement products. They involve eight products and one combination of products as follows: Chromill-GTF (10/128); Natural Calm (10/129); Athena Nutrition for Women (10/130); META-E (10/131); Food for Thought (10/132); Ex-Sel (10/133); Power Tabs (10/139); The Athena Stay Young Program (10/140); and Euzinc-D (10/141).
The substance of the Complaint in 10/128 is that by means of direct mail solicitations and by means of advertisements which are calculated to induce readers thereof to remit money through the mails for its product Chromill-GTF, Respondent makes the following representations which are alleged to be materially false (Complaint, PP 3 and 4):
a. Chromill-GTF can prevent diabetes.
b. Chromill-GTF will retard aging.
When, hereinafter, alleged representations are stated, it will be understood that they appear in paragraph 3 of the appropriate Complaint. The allegation that the representations are materially false is made in paragraph 4 of each Complaint
The Complaint in 10/129 describes a similar method of soliciting remittances of money through the mail for the product Natural Calm on the basis of the following representations which, likewise, are alleged to be materially false:
a. Natural Calm is an effective sleep aid.
b. Natural Calm is effective in the cure of nervousness.
c. Natural Calm is effective in the relief of daytime tension.
d. Natural Calm is effective in the cure of insomnia.
The Complaint in 10/130 describes a similar method of soliciting remittances of money through the mail for the product Athena Nutrition for Women on the basis of the following representations, which are alleged to be materially false:
a. Athena Nutrition for Women retards the aging process.
b. Athena Nutrition for Women is effective in the prevention of such conditions as:
1. fatigue
2. facial pallor
3. brittle, dull fingernails
4. figure-distorting bloating and water retention
5. hormone imbalance
6. dry, cracked lips
c. Athena Nutrition for Women is effective for:
1. improving the appearance of hair, skin and nails.
2. reducing hair loss and thinning.
The Complaint in 10/131 describes a similar method of soliciting remittances of money through the mail for the product META E on the basis of the following representations, which are alleged to be materially false:
a. Meta E helps your body's cells utilize oxygen more efficiently so that the aging process is slowed down inside and out.
b. Meta E breaks down fats and cholesterol in blood vessels.
c. Vitamin E, by improving hormone production has a healthy effect on sexuality and potency.
d. Meta E will effectively:
1. promote the lungs self cleaning mechanism.
2. bolster the body's immunity response to bacteria and infections.
3. protect skin from environment pollution.
The Complaint in 10/132 describes a similar method of soliciting remittances of money through the mail for the product Food for Thought on the basis of the following representations, which are alleged to be materially false:
a. Food for Thought is an effective brain stimulant.
b. Food for Thought is an effective remedy for:
1. forgetfulness
2. low I.Q.
3. lack of concentration
4. poor coordination
5. reduced alertness
6. cloudy thinking
c. Ingested tablets with RNA can alter cell function.
d. L-glutamine can measurably raise intelligence and thinking abilities.
The Complaint in 10/133 describes a similar method of soliciting remittances of money through the mail for the product EX-SEL on the basis of the following representations, which are alleged to be materially false:
a. Selenium deficiency is commonplace in the diet of U. S. population.
b. Increased levels of selenium are desirable and safe.
c. Ex-Se; retards the aging process.
d. Ex-Sel prevents oxidation from weakening the heart.
e. Ex-Sel is effective in the prevention of:
1. aging
2. heart disease
3. sterility
4. internal deterioration
The Complaint in 10/139 describes a similar method of soliciting remittances of money through the mail for the product Power Tabs on the basis of the following representations, which are alleged to be materially false:
a. Power Tabs is an effective energy booster.
b. Power Tabs provides instant energy.
c. Bee pollen, fructose and methionine are energy-supplying nutrients.
The Complaint in 10/140 describes a similar method of soliciting remittances of money through the mail for the product The Athena Stay Young Program on the basis of the following representations, which are alleged to be materially false:
a. The Athena Stay Young Program retards the effects of aging.
b. The Athena Stay Young Program will result in:
1. moist and soft skin
2. higher energy levels
3. sharp memory
4. better alertness
5. renewed sexual abilities
c. The Athena Stay Young Program is an effective remedy for:
1. line, wrinkles and age spots
2. abnormal memory and thinking process
3. fatigue
d. RNA ingested is an effective anti-aging supplement.
e. Meta-E slows down "the process which accelerates aging."
f. Ex-Sel retards the aging process.
g. Chromiss-GTF retards the aging process.
The Complaint in 10/141 describes a similar method of soliciting remittances of money through the mail for the product Euzinc-D on the basis of the following representations, which are alleged to be materially false:
a. Euzinc-D is an effective sexual stimulant.
b. Euzinc-D is an effective remedy for such maladies as:
1. impotency
2. sterility
3. low sperm count
4. prostatitis
5. diminishing sex drive
c. Zinc deficiency is commonplace in diet of U.S. population.
d. Damiana root is a powerful sexual rejuvenator.
e. Oriental ginseng root is a powerful sexual rejuvenator.
1. Athena Products, Ltd. (hereinafter sometimes Respondent or Athena) in its advertising solicits the remittance of money through the mail in the sale of RNA, RX for Aging, Euzinc-D, Cellulite PM, Cellulite TR3, Ex-Sel, Food for Thought, META-E, Natural Calm, Athena Nutrition for Women, Chromill-GTF, Power Tabs, Athena Stay Young Program, Yough Factor, and In-Trim (formerly Control). (Strip., Tr. 428-429)
2. Respondent has directed that orders for the fifteen products which are the subjects of this proceeding be sent to some or all of the following addresses:
Box 81371, Atlanta, Georgia 30366;
1551 Dunwood Village Parkway, P.O. Box 888653, Dunwoody, Georgia 30338
3545 Broad Street, P.O. Box 81112, Chamblee, Georgia 30366;
5999 New Peachtree Road, P.O. Box 48392, Doraville, Georgia 30362;
3545 Broad Street, P.O. Box 80783, Atlanta, Georgia 30366;
780 Morosgo Drive, N.E., P.O. Box 13312, Atlanta, Georgia 30324;
3104 Briarcliff Road, N.E., P.O. Box 29501, Atlanta, Georgia 30359;
780 Morosgo Drive, N.E., P.O. Box 14152, Atlanta, Georgia 30324;
3176 Marjan Drive, Atlanta, Georgia 30340;
P.O. Box 757, 520 West Ponce deLeon Avenue, Decatur, Georgia 30030;
P.O. Box 311, 15 Franklin Street, Avondale Estates, Georgia 30002;
P.O. Box 893, 3328 East Ponce deLeon Avenue, Scottsdale, Georgia 30079;
P.O. Box 95294, 4 Executive Park Drive, N.E., Atlanta, Georgia 30347; and P.O. Box 98377, 3104 Briarcliff Road, N.E., Atlanta, Georgia. (Stip., Tr. 429-430)
3. Respondent has not previously solicited, and as of the time of the hearing did not then solicit, the remittance of money for any of the aforementioned fifteen products to the following address:
P.O. Box 277, 977 Montreal Road, Clarkston, Georgia 30021.
(Stip., Tr. 430)
The Complaint was dismissed as to this address. (Tr. 447)
4. There were received in evidence the following exhibits which are true and correct copies of letters ordering the fifteen products from Respondent in test purchases by the Special Investigations Division of the United States Postal Service Exhibit numbers 3, 22, 42, 62, 82, 102, 122, 142, 162, 182, 202, 222, 242, 262, and 282. (Stip., Tr. 430, 431)
5. There were received in evidence the following exhibits which are true and correct copies of money orders, with dates of issue as shown, mailed to Respondent by Complainant's representatives for the purchase of the fifteen products named in Finding of Fact (F.F.) 1:03,12,40,17$DExhibit No.Product and Docket No.Date of Issue4RNA (10/137)June 4, 198023RX for Aging (10/136)June 4, 198043Euzinc D (10/141)June 5, 198063Cellulite PM (10/135)October 17, 198083Cellulite TR3 (10/134)June 10, 1980103Ex Sel (10/133)June 5, 1980123Food for Thought (10/132)June 4, 1980143META E (10/131)June 3, 1980163Natural Calm (10/129)June 4, 1980183Athena Nutrition forAugust 18, 1980 Women (10/130)203Chromill-GTF (10/128)June 9, 1980223Power Tabs (10/139)June 4, 1980243Athena Stay Young ProgramJune 4, 1980 (10/140)263Youth Factor (10/138)June 5, 1980283In-Trim or Control (10/127)April 7, 1980 (Stip., Tr. 432)
6. There were received in evidence the following exhibits which are true and correct copies of the envelopes in which the fifteen test purchase products were contained and which were received by Complainant's representatives:02,15,50$D$GExhibit No.Product and Docket No.$G5RNA (10/137)$G$G24RX for Aging (10/136)$G44Euzinc D (10/141)$G64Cellulite PM (10/135)$G84Cellulite TR3 (10/134)$G104Ex Sel (10/133)$G124Food for Thought (10/132)$G144META-E (10/131)$G164Natural Calm (10/129)$G184Athena Nutrition for Women (10/130)$G204Chromill-GTF (10/128)$G224Power Tabs (10/139)$G244Athena Stay Young Program (10/140)$G264Youth Factor (10/127)$G284In-Trim or Control (10/127)$G (Stip., Tr. 432)
7. In its advertisements Respondent makes the representations alleged in each Complaint as indicated below. Each representation is set forth under the name of the product and the docket number of the Complaint related to that product. Advertising language on which the representation may be based is copied underneath each alleged representation.
Within the respective groups of cases throughout this decision, the language quoted from Respondent's advertisements is illustrative and not exclusive. Language other than that quoted will also serve to support the holding that Respondent makes the alleged representations.
a. Chromill-GTF can prevent diabetes.
"Unfortunately, as we get older, we tend to absorb less of the mineral. This is further aggravated by the fact that chromium has also become noticeably deficient from our foods. Without sufficient chromium, your body will be deprived of the energy it needs and will be subject to unhealthy fluctuations in blood sugar levels that can lead to hypoglycemia, hyperglycemia and diabetes.
"Chromium deficiencies affect many people, but most frequently those in middle-age and older. The increasing majority of these deficiencies has led to the discovery that the naturally occuring state of chromium, so vital to blood sugar regulation and energy production, can be duplicated. This is the Glucose Tolerance Factor molecule, or GTF.
"Chromill-GTF exactly duplicates the natural chromium GTF molecule and provides you with the most effective and potent source of chromium you can get." (CX 210)
b. Chromill-GTF will retard aging.
"Sure, it's only natural that we get older. But, who says we have to look and feel older and resign ourselves to less energy and activity. Take Chromill GTF today. It contains the scientifically developed mineral formulation that will let you, too, recapture the vigor of youth." (CX 206)
"With CHROMILL GTF you'll be participating in all the fun-filled activities you love. Now, there is no reason not to feel as young as you want as long as you want. When you supplement your diet with CHROMILL GTF, you'll have all the energy you need to stay active, enthusiastic and full of vitality. CHROMILL GTF gives you energy to stay young." (CX 207)
a. Natural Calm is an effective sleep aid.
"NATURAL CALM lets you get the sleep you need safely and naturally." (CX-161)
b. Natural Calm is effective in the cure of nervousness.
"Natural Calm is the natural, safe solution to the problem of sleeplessness and nervousness." (CX-161)
c. Natural Calm is effective in the relief of daytime tension.
"And Natural Calm works with your natural body processes to calm you down during even the most tension-filled days without drowsiness and disorientation." (CX 167)
d. Natural Calm is effective in the cure of insomnia.
"And Natural Calm is a natural solution to sleeplessnes and nervousness. Natural Calm contains tryptophan and other natural ingredients shown to provide a calming, relaxing effect on your brain and central nervous system, the areas that control tension and are responsible for sleep.
Even insomniacs are able to enjoy a normal night's sleep with Natural Calm." (CX 166)
a. Athena Nutrition for Women retards the aging process.
(See quotation under "c" below.)
b. Athena Nutrition for Women is effective in the prevention of such conditions as:
1. fatigue
2. facial pallor
3. brittle, dull fingernails
4. figure-distorting bloating and water retention
5. hormone imbalance
6. dry, cracked lips
(See quotation under "c" below.)
c. Athena Nutrition for Women is effective for:
1. improving the appearance of hair, skin and nails.
2. reducing hair loss and thinning.
"Athena contains these nutrients in large enough doses to assure they will help resolve deficiency symptoms. The unique formula can prevent such problems as fatigue, facial pallor and brittle, dull fingernails. In addition, Athena helps improve the appearance of hair, skin and nails, and reduces the hair loss and thinning that accompanies growing older. Then too, Athena aids in the prevention of figure-distorting bloating and water retention, hormone imbalance, and the dry, cracked lips that plague all women as they age.
"No other supplement contains all of the health protecting, age retarding benefits that are found in the exclusive Athena formula." (CX 181; See, also CX 188)
a. Meta E helps your body's cells utilize oxygen more efficiently so that the aging process is slowed down inside and out.
(See quotation under "d" below.)
b. Meta E breaks down fats and cholesterol in blood vessels.
(See quotation under "d" below.)
c. Vitamin E, by improving hormone production has a healthy effect on sexuality and potency.
(See quotation under "d" below.)
d. Meta E will effectively:
1. promote the lungs self cleaning mechanism.
2. bolster the body's immunity response to bacteria and infections.
3. protects skin from environmental pollution.
"Meta E is a powerful, nutritional supplement made up of vitamin E and its natural partner lecithin. Vitamin E is one of nature's most dynamic and versatile life support systems. It helps your body's cells utilize oxygen more efficiently so that the aging process is slowed down inside and out. Vitamin E soothes, moisturizes and protects your skin from environmental pollution. And, vitamin E is also vital to proper heart and lung functioning--it actually promoted the lung's self-cleaning mechanism. Plus, researchers have recently found that vitamin E speeds healing, reduces scarring and bolster's the body's immunity response to bacteria and infections. It has also been shown that by improving hormone production in men and women, vitamin E has a healthy effect on sexuality and potency.
"Lecithin works closely with vitamin E to fight internal pollution. It breaks down fats and cholesterol in your blood vessels, thereby relieving the strain on your heart and arteries." (CX 141, See also CX 147, 148)
a. Foor for Thought is an effective brain stimulant.
"FOOD FOR THOUGHT will sharpen your thinking and improve your memory." (CX 125)
b. Food for Thought is an effective remedy for:
1. forgetfulness
2. low I.Q.
3. lack of concentration
4. poor coordination
5. reduced alertness
6. cloudy thinking
"Forgetfulness, lack of concentration, reduced alertness, poor coordination, cloudy thinking, and even lowered intelligence are, in many instances, symptoms of a poorly nourished brain. Like every other body part, the brain needs its own special nutritional supplies. But, feeding your brain isn't easy] Only a few nutrients are capable of crossing the blood/brain barrier to feed and fuel brain cells.
"The most important of the brain nou ishing nutrients are L-glutamine, choline and lecithin. In laboratory tests, L-glutamine has been shown to improve the ability to remember and to increase I.Q. Choline and lecithen also have been reported to improve memory as well as promote clearer thinking and better concentration. These nutrients along with others that are crucial to brain cell health can be found in the unique Food for Though nutritional supplement." (CX 127)
c. Ingested tablets with RNA can alter cell function.
"RNA not only improves memory, but appears to be effective in preventing the onset of senility and extending the lives of brain cells. By nourishing your brain cells and improving their efficiency, Food For Though can greatly improve the function of your mind." (CX 125)
d. L-glutamine can measurably raise intelligence and thinking abilities.
"The key nutrient in Food for Thought is the amino acid L-glutamine. It penetrates the blood/brain barrier to supply your brain cells with the fuel they need to function properly. In actual tests, L-glatamine has been shown to measurably raise intelligence and memory. Food for Thought also features choline which improves communication between nerve cells, heightening your sensory perceptions, improving your coordination and making you more alert;***". (CX 121)
a. Selenium deficiency is commonplace in the diet of U.S. population.
"And few people get enough selenium, the most important of the antioxident nutrients.
* * *
"Yet *** selenium deficiencies are still extremely common in humans." (CX 107)
b. Increased levels of selenium are desirable and safe.
"For all its importance, however, selenium is one of the most difficult minerals to get enough of in our diets. Only four states in the country have soil rich in this mineral. And, whatever little selenium is found in most foods is refined away. Nutritionists estimate that most Americans get less than half the selenium they should have each day. That's why we offer you Ex-Sel." (CX 105)
c. Ex-Sel retards the aging process.
"EXSEL--helps slow down the aging process." (CX 108)
d. Ex-Sel prevents oxidation from weakening the heart.
"***Ex-Sel can prevent the corrosive effect of oxidation from weakening your heart***." (CX 101)
e. Ex-Sel is effective in the prevention of:
1. aging
2. heart disease
3. sterility
4. internal deterioration
"The youth preserving antioxidant power of Ex-Sel can prevent the corrosive effects of oxidation from weakening your heart, muscles and other vital organs. So, provide yourself with the best possible protection against the ravages of human corrosion. Include new increased strength Ex-Sel in your diet every day, and keep the effects of radiation, oxidation and internal deterioration in check." (CX 101)
"Include Ex-Sel every day in your diet and protect yourself afainst the ravages of aging, heart disease, sterility, and other health problems that a selenium deficiency can cause." (CX 105)
a. Power Tabs is an effective energy booster.
"Too often, a lack of energy will take the spontaneity and joy our of these special evening moments. Not only may you yourself be too tired to get the most out of your nights, but your fatigue and consequent lack of interest can really disappoint those loved ones around you. It's times like these that your body needs a sudden burst of energy to get you going again. This boost can be found in the power-packed, all natural formula of Power Tabs." (CX 230)
b. Power Tabs provides instant energy.
"Power Tabs is a high-potency, quick energy supplement that works with your body's own metabolism to revitalize you and give you the instant energy you need, the instant you need it]" (CX 230)
c. Bee pollen, fructose and methionine are energy-supplying nutrients.
"Each tablet contains important natural energy boosters like methionine, bee pollen, and fructose to recharge your body's energy at the cellular level." (CX 226)
a. The Athena Stay Young Program retards the effects of aging.
"The forces of aging are at work in your body now and they accelerate as you grow older. That's why the Athena Stay Young Program is for those people who want to delay the onset of the effects of aging, as well as those people who want to reduce existing age symptoms." (CX 241)
b. The Athena Stay Young Program will result in:
1. moist and soft skin
2. higher energy levels
3. sharp memory
4. better alertness
5. renewed sexual abilities
"The Athena Stay-Young Program is an aggressive anti-aging nutritional package that combines our current knowledge on the mechanisms of aging with our ability to produce specific nutrients which counter the effects of aging. Regular use of the program should result in skin that is soft, moist and young looking; higher energy levels; and memory and reasoning abilities that remain keen and alert years longer. By retarding aging, the Stay-Young Program will help you look young, feel younger, and enjoy work, sports, hobbies and sex for many more years to come." (CX 245)
c. The Athena Stay Young Program is an effective remedy for:
1. lines, wrinkles and age spots
2. abnormal, memory and thinking process
3. fatigue
"Daily RNA [part of the Stay Young Program] will help eliminate wrinkles and age spots; improve memory and thinking processes; and reduce fatigue." (CX 248)
d. RNA ingested is an effective anti-aging supplement.
"RNA: The anti-aging supplement." (CX 249)
e. Meta-E slows down "the process which accelerates aging."
"Vitamin E allows your cells to use oxygen more efficiently, thus slowing down the process which accelerates aging." (CX 250)
f. Ex-Sel retards the aging process.
"Selenium preserves tissue elasticity and protects your body from harmful radiation which speeds the aging process ***." (CX 245)
g. Chromill-GTF retards the aging process.
"Chromill-GTF helps control improper sugar metabolism and glucose production --both of which accelerate aging and lead to such life-threatening diseases as hypoglycemia and diabetes." (CX 250)
a. Euzinc-D is an effective sexual stimulant.
"If you feel that your sexual relationship isn't all it should be--or could be]--then you need Euzinc D. EuZinc D can bring back all the pleasure and excitement that make personal relationships so rewarding and enjoyable. Don't be surprised if, after taking Euzinc D, your sex life becomes everything you ever hoped for]
EuZinc-D
'The High-Performance
Supplement'" (CX 41)
b. Euzinc-D is an effective remedy for such maladies as:
1. impotency
2. sterility
3. low sperm count
4. prostatitis
5. diminishing sex drive
"Zinc is vital to proper sexual development and it remains important to sexual health throughout life. The continued proper functioning of the male testes and the female ovaries are dependent on sufficient zinc. A shortage of this mineral can lead to impotence, sterility, low sperm count, prostatitis and diminishing sex drive in both men and women. Zinc is important to your personal appearance, too. Without sufficient zinc, hair won't grow and look healthy, and attractive skin and fingernails are impossible.
"Unfortunately, as we grow order, it becomes increasingly difficult for our bodies to metabolize and store enough zinc --even if we could get enough in our often zinc-deficient diets. This is why Euzinc-D could be just what is needed to make the most of our intimate moments." (CX 56)
c. Zinc deficiency is commonplace in diet of U.S. population.
"The body loses its ability to absorb and store this crucial mineral, plus our diets are zinc deficient." (CX 48)
d. Damiana root is a powerful sexual rejuvenator.
e. Oriental ginseng root is a powerful sexual rejuvenator.
"Euzinc D combines chelated zinc with Damiana and Oriental Ginseng root, two powerful and natural sexual rejuvenators." (CX 41)
8. The following exhibits were received in evidence as true and correct copies of transcripts of product labels showing the ingredients and the dosage of each of the products involved in the instant case. (Each product label carries the notation "DISTRIBUTED BY: Athena Products, Ltd., Atlanta, GA 30304" which does not appear below. Also omitted from some label transcripts below is the "CAUTION: Keep out of children's reach." The docket numbers of the cases have been added in ( ) on the copies of the transcripts of the product labels for identification purposes.)03,20,49,11$DCHROMILL(10/128)GTF50 TABLETSDirections:Adults take one to two tablets daily asa supplemental source of chromium and manganese. Contents:Each sugar free coated tablet provides:Chromium 50 mcg. (As it naturally occurs in chromiumyeast complex containing the essential glucose tolerance factor)Manganese 9 mg. (as manganese amino acid chelate)Plus a specially processed all-naturalcompound providing:Licorice Root Powder 20 mg.(CX 216)Natural(10/129)Calmmade fromL-Tryptophan and Dolomite 50 CAPSULESDirections:One or two capsules daily as a dietarysupplement or as directed by aphysician.Contents:Each capsule contains:L-Tryptophan100 mg.Dolomite250 mg.Valerian Root25 mg.Scullcap25 mg.Pantothenic Acid20 mg.(CX 176)ATHENA(10/130)NUTRITIONFORWOMEN50 TabletsDIRECTIONS:Take one or two tablets daily as adietary supplement.CONTENTS:Each tablet contains:% RDAB2200 mg11,765Folic Acid800 mcg.200B6200 mg.10,000B121000 mcg.16,667Iron30 mg.167(CX 194)META(10/131)NATURAL VITAMIN EWITH WHEAT GERM OILAND LECITHIN50 CAPSULESDirections:One or two capsules daily as a dietarysupplement or as directed by aphysician.Contents:Each capsule contains;Vitamin E* 400 I.U.** Wheat Germ Oil100 mg.*** Lecithin100 mg.*** * d-alpha Tocopheryl Acetate from natural sources. ** 1333% of U. S. Recommended Daily Allowance *** Need in human nutrition not established.(CX 156)Food(10/132)forThoughtNUTRITION TO IMPROVE YOUR MIND50 TabletsDirections:Take one or two tablets as a dietarysupplement.Contents:Each tablet contains:L-Glutamine300 mg.Lecithin100 mg.Choline Bitartrate50 mg.Vitamin B-12100 mcg.RNA50 mg.DL-Methionine50 mg.Inositol50 mg.(CX 136)NATURAL SELENIUM YEAST(10/133)EX SEL*2*75 mcg (from amino acid chelate)50 CAPSULESDirections:Adults take one to two capsules dailyas a dietary supplement.Contents:Each capsule provides:Selenium75 mcg.*2* (as selenium amino acid chelate*)Vitamin E25 I.U.*2* (d-alpha Tocopheryl Acetate)Golden Seal Root Powder20 mg.Plus a specially processed all naturalbase containing comfrey root powder andalfalfa powder. *derived from hydrolyzed primary dried yeast(CX 116)POWER TABS(10/139)50 TABLETSDirections:Adults take one tablet daily as adietary supplement.Contents:Each sugar free coated tablet provides:d1-methionine (an essential amino acid)500 mg.Natural Bee Pollen100 mg.Fructose (Natural fruit energy source)250 mg.Jamaican Ginger Root Powder25 mg.Peppermint Leaves Powder10 mg.Vitamin B1 (Thiamine Mononitrate51 mg.Vitamin B5 (Panthothenic Acid)23 mg.Magnesium100 mg. (as magnesium oxide naturally derived from dolomite)Phosporus (as Calcium Phosphate)50 mg.Calcium (as Calcium Phosphate)65 mg.Iron (from ferrous fumerate)18 mg.Plus a specially processed all natural compoundcontaining Vitamin B12, dessicated stomachsubstance, wheat germ and primary dried yeast.Provides:Vitamin B12 (stabilized-- absorbed on resin*)250 mcg.Stomach substance** 10 mg. *specially processed to enhance stability andprevent degradation in the stomach's acidenvironment and to allow maximum assimilationin the duodenum and small intestines. **dessicated stomach substance contains the intrinsic factor needed for B12 absorption.(CX 236)
Athena Stay young Program: (10/140) This program consists of four containers of 50 capsules, each, containing, respectively, the following products the ingredients of which have been listed above: Chromill-GTF (10/128); META-E (10/131); Ex-Sel (10/133); and RNA (10/137); see CX 254, pp. 1 and 2.03,20,51,09$DNATURAL CHELATED ZINC(10/141)EUZINC-D60 mg. (from amino acid chelate)50 TABLETSDirections:Adults take one tablet daily as a dietarysupplement.Contents:Each sugar-free coated tablet provides:Zinc60 mg.* (as zinc amino acid chelate)Damiana Powder25 mg.In a specially processed all natural compoundcontaining Oriental Ginseng Root Powder,Parsley leaves, Prostate substance and Royal Jelly. *400% of U.S. GovernmentRecommended Daily Allowance of zinc for adultsand children 12 or more years of age.(CX-56)
9. At the request of Respondent the hearing was held in Atlanta, Georgia, on May 27, 28, 29 and June 1, 1981. Counsel for the parties participated in the examination and cross-examination of the witnesses. On July 6, 1981, proposed findings of fact, conclusions of law and supporting argument were filed on behalf of each party.
10. a. Each party presented a number of expert witnesses. The first witness for Complainant was Dr. Sorell L. Schwartz. Dr. Schwartz graduated from the University of Maryland in 1959 with a bachelor's degree, majoring in pharmacy. In 1963, he received his Ph.D. in pharmacology at the Medical College of Virginia. From 1963 to 1966 he served as a U.S. Naval Officer, Naval Medical Research Center, National Naval Medical Center, Bethesda, Maryland. He remained, as a civilian, at the Naval Medical Research Institute until 1968 as head of the Pharmacology Division. In 1968, he was appointed Associate Professor, Department of Pharmacology, at Georgetown University Schools of Medicine and Dentistry, Washington, D.C., where, in 1976, he was made a full Professor, which is his present capacity. (Tr. 10-11; CX 300)
Pharmacology, Dr. Schwartz said, is most easily defined by translation from the Greek as study of drugs. As a field of study, it involves the study of the mechanism of the actions of drugs, both their therapeutic actions and their toxic actions. It deals with matters in isolated cells and entire clinical human populations.
He has been involved for quite a number of years in the design, evaluation and rish assessment of clinical trials. A clinical trial, with regard to drugs, is a study done, generally, in humans in order to determine if a material has a therapeutic efficacy and in what dose that efficacy is manifested and what undesirable side effects are observed. A therapeutic claim can be assumed to be the same as a claim of efficacy. A therapeutic claim or a claim of efficacy is that if one administers a particular agent, a drug in this case, one sees an effect and one relates the effect observed to the biological activity of the substance administered.
Placebo effects are those responses to therapeutic measures which are as a result of the intervention of a therapeutic procedure itself as opposed to the inherent biological activity of the material administered. The controlled clinical trial is the procedure accepted by the medical or scientific community that can weed out the placebo effect from a biological effect.
Essentially the study is designed such that one group receives the material which is being tested and another group called the control group receives similar treatment, something that looks like the material, but actually the active ingredient is not present. And then the responses are measured in the group that received the active ingredient versus the group that did not receive the active ingredient and they are compared statistically for significant difference in the response between the treated group and the control group. The material that the control group received is what is referred to as the placebo and the response that the control group has is what we call the placebo effect. The control group is used to provide information as to the background effect, the placebo effect, that might be occurring in the treated group.
There is a role for controlled clinical trials in the claims for efficacy of any therapeutic agent. There are always placebo effects, 100% of the time, even in cases where durgs are bing studies for their effect on blood sugar diabetes, you get placebo effects. One would be very hard pressed to find a study in which placebo effects are not observed. The percentage of participants in a controlled clinical trial who react with a placebo effect determines whether or not that particular product is efficacious. In a study of a drug to relieve pain the placebo response expected is quite high and it therefore becomes quite a significant task to determine the therapeutic efficacy of an analgesic agent, even though it can, and has been, and is done. On the other hand, there are such matters as diabetes where there are placebo effects which might be observed but where the incidence of placebo effects is expected to be much less. Depending on the end point of the study, the placebo effect may or may not be very large.
To determine the validity of a controlled clinical test one evaluates the measures used in its design. There are numbers of steps involved in its design that involve the selection of the individuals, the imposition of observers, statistical methods to be used, the number of subjects to be used, the parameterization of a selection, and the end points to be examined. For example, one has to be certain that the end point he is examining is related to the condition he is trying to treat.
In reading a report of an allegedly valid controlled clinical test, in many cases it can be determined from the reading of the test data whether it is valid if enough information is given. When studies are reported however, there are certain elements of the tests which often are not given in the lieterature for the sake of saving space. To do a complete evaluation, one needs to look at the complete records.
In determining the value of a study and the value of information, consideration is given to the journal which is publishing it because of its editorial policies. Papers published in certain journals are given more weight than those in other journals because certain journals have much stricter editorial policies than others.
Results of controlled clinical trials are regularly published in medical and scientific journals. Dr. Schwartz regularly reviews medical journals and other scientific reports with respect to new developments in the medical and pharmacologic fields. There are numbers of bibliographic retrieval systems, many of them are keyed to the National Library of Medicine's INDEX MEDICUS. The INDEX MEDICUS is a publication put out by the Department of Health and Human Services, in general, the National Library of Medicine, in specific, in which thousands of journals from all countries and all parts of the world are indexed and indexes are published monthly in a hard form. There is, also, access to these indexes, many years of them, by computer reviews. (Tr. 13-20)
b. Complainant's next witness was Dr. Sara M. Hunt. Dr. Hunt is Professor and Chairman of Community Nutrition at Georgia State University. Dr. Hunt received a bachelor's degree in General Home Economics in 1942, at Lambuth College, Jackson, Tennessee; a bachelor's degree in Foods and Institutional Management in 1945 at the University of Tennessee; a master's degree in Community Health Nutrition and Biochemistry in 1963 at the University of Tennessee; and a certificate in Dietetics in 1946 at the medical College of Virginia. Dr. Hunt has been employed at various times in the capacities of dietician, research nutritionist, teacher, and public health nutritionist. (Tr. 89, 90; CX 302)
c. Dr. William Ayers was called by Complainant to testify in this proceeding. Dr. Ayers was graduated from Georgetown University, Washington, D.C., in 1957 with a bachelor of science degree, majoring in biology. He received his M.D. from the same institution in 1961, following which he served a medical internship at Grady Memorial Hospital, Atlanta, Georgia, 1961-62. From 1962-64 he was a Research Fellow in Cardiovascular Medicine at Albany Medical College, Albany, New York; from 1964-66, he was a resident in Medicine at the Veterans Administration Hospital, Washington, D.C.; and a Fellow in Pulmonary Disease at the last institution in 1967; he was Pulmonary Project Officer, and later Chief of the Medical Systems Development Laboratory, National Center for Health Services, Research and Development, H.E.W., 1967-69; Instructor in Medicine at Georgetown and George Washington Universities, 1967-70; he was associated with the Department of Clinical Engineering at both of the latter institutions during the period 1970-72; he was Associate Professor, Departments of Medicine and Pediatrics, Georgetown University School of Medicine 1972-79. He has been associated with Georgetown University School of Medicine primarily since 1972 as Assistant Dean for Curriculum, Medical Director of the Georgetown Diet Management Program, and Director of Introduction to Clinical Sciences Course.
The Georgetown Diet Management Program, of which Dr. Ayers is the Director, includes nutritionists, biochemists, psychological counseling and medical input in an attempt to control and aid people in weight reduction, primarily, but also, in more general nutritional problems such as the opposite of the obesity problem which is anorexia nervosa, and in nutritional states associated with some specific diseases, in particular, cancer. (Tr. 324-326; CX 301) Dr. Ayers is active on the teaching faculty of the School of Medicine. As the director of the Introduction to Clinical Science course for the medical students he lectures in the clinical nutrients portion of that overall course.
11. a. The first witness called to testify by Respondent was Dr. Richard S. Lord, of Marietta, Georgia. Dr. Lord graduated from Georgia State University in 1965 with a bachelor's degree, majoring in chemistry. He received his Ph.D. degree in Biochemistry from the University of Texas, Austin, Texas, in 1970. He next did approximately a year of work at the Clayton Foundation of the National Institutes of Health (N.I.H.), Bethesda, Maryland, and then moved to the University of Arizona, Tucson, Arizona, where he worked for approximately two years as an N.I.H. post-doctoral fellow. While in Tucson he worked on the properties of the hormone insulin and its cell-association chemical properties. He next went to N.I.H. as a staff fellow for one year. Here, he worked on aspects of human thyroid function, specifically isolation characterization of protein from human blood, human thyroxine binding globulin. For the next three years he was with a corporation in Illinois working on a then new test offered on a routine basis to doctors for testing of trace elements in human hair for detection of imbalances, deficiencies and excesses. With this corporation Dr. Lord directed the operations of a company called Doctors Data and acted as a consultant to physicians in various parts of the country with regard to interpretation of what was then relatively new data. In 1968, he started his own laboratory in Marietta where hair was tested for trace elements. For the past year and a half his laboratory has been expanded to a full clinical laboratory for routine blood and urine analyses. In 1980 he accepted a position as Associate Professor of Biochemistry at Life Chiropractic College, Marietta, Georgia.
At the laboratory he provides services for all specialties of physicians including those in general medical practice, preventive medicine, diagnostic medicine, ophthalmology and the entire range of medicine. (Tr. 452-455)
The most often requested hair analysis is one for 21 elements, including a panel of five major elements --calcium, magnesium, phosphorous, sodium and potassium; a group of essential trace elements --zinc, iron, copper, managanese, chromium, cobalt, molybdenum and selenium; and finally a group of non-essential trace elements --lead, cadmium, nickel, aluminum, boron, barium, strontium and mercury. There is no direct indication of vitamin deficiency from the hair sample. With respect to the percentage of the population he would say are deficient in one or more vitamins or mineral substances, he feels it is necessary to clarify what a deficiency is. His testimony on this subject is as follows:
"The classical definition of a deficiency involves a symptom of the group of sumptoms involved with what is called a frank nutritional deficiency which can be overcome by low levels of vitamins or minerals. Other definitions, however, include simply ones which show laboratory measurements that are out of the normal range. For example, an iron deficiency might be detected from an hematocrit or hemoglobin level or a blood sample even though the individual may not be suffering from overt signs of frank iron deficiency at the time, so on the basis of the latter which is where most of my effort is directed looking at the laboratory data there is, considering the 21 elements that I'm talking about in the hair, probably about half of those have one or more of those elements out of range indicating a deficiency state, and when those are included with other blood testing then that number would be even greater. "In other words, the more tests that we do on an individual the more likely we are to find an indication of increased need of a given nutrient for that individual, and if we tested all of the forty-odd nutrients which is almost never done, then my opinion is we would find a very high percentage of the population which could be called deficient in that sense." (Tr. 457)
Most physicians are not actively involved in testing for these nutritional deficiencies on hair samples. Most physicians are actively involved in checking the ones that have long been established like iron in blood samples, but as far as looking for specific nutritional deficiencies other than that one which of course has been taught for a long time in the medical schools, most doctors do not.
There definitely is a growing number of doctors who are doing the testing as they become aware. He said the basic reason that more testing is not done is because nutrition is really not emphasized in medical schools and dental schools for the good reason that the curriculum just does not allow it for one thing. Some of the testing methods are relatively new, and as the doctors become aware of the tests they are beginning to use them. As a result, they detect the occurrence of nutritional deficiencies. This is true not only for hair but for the newer blood testing methods. There is a wide variety of blood tests that are becoming available, many of which have implications for nutrition. One that has a very direct implication is one that is called H.D.L. Cholesterol which is essentially replacing the measurements that have been done for a long time on total cholesterol in blood and has been demonstrated to be a good indicator of heart disease risk factor and which responds to nutritional therapies both in terms of gross dietary components, fiver and carbohydrate, and micronutrients such as vitamins. This is a test, because it is based on blood which is a traditionally accepted tissue, that doctors have accepted fairly rapidly across the board and are applying to assessing that aspect of health which relates to nutrition.
As to whether the RDA's apply to all individuals as an absolute guideline, here again, the comment must be made in the framework of the definitions of what are nutritional deficiencies. Given one definition that a nutritional deficiency is one which results in the classical signs of vitamin B1 or B2 or calcium or iron deficiency, then the RDA's are a pretty good guideline. On the other hand, based on measurements in Dr. Lord's laboratory, there is no question that there are nutritional deficiencies detected in cases where simple dietary intake appears acceptable. In that respect Dr. Lord said that the occurrence of nutritional deficiencies again is widespread and it goes undetected. He said that there are people who appear to be having the "recommended daily allowance" of vitamin or mineral supplements, who, when subjected to testing, show deficiencies. He said that the RDA's provide a guideline that we should all work towards, but, in his opinion, it is incorrect to assume that everyone will have optimal health if we get the RDA level on an average on a monthly period.
Soil content, growing conditions, transportation of food products, processing methods, things of this nature have various effects on the vitamin and mineral levels in foods which are, he thinks, well documented. The soil content of minerals particularly is reflected in the plant content of minerals. The fact that many vegetables and fruits are grown now out of necessity to give a product that can be transported without spoilage leads to giving optimal nutritional qualities sometimes secondary emphasis. The storage of nutrients both in the store or in the commercial houses and in the home in general results in depletion of vitamins in that case, not of minerals, because vitamins are chemically unstable. The cooking in the home results in rapid depletion of any vitamins, and, depending on the method, loss of large amounts of minerals. It is very difficult for an individual to determine the actual amount of vitamins they are receiving in foods, virtually impossible. (Tr. 456-461)
b. Respondent also called Barry William Gushleff, D.O. as a witness. Dr. Gushleff graduated from Central Methodist College, Fayette, Missouri, in 1960 with a bachelor's degree, majoring in chemistry and mathematics. He received a master of science degree in Biochemistry from Washington University, St. Louis, Missouri, in 1963; and he received a Doctor of Osteopathy degree in 1967 from Kirksville (Missouri) College of Osteopathic Medicine. He has a residency in Family Practice at the University of Missouri Medical Center and he is Board Certified by the American College of Family Practice. After he completed his residency, his professional work has been in the fields of family practice and general practice. He also assists patients in the field of weight reduction. (Tr. 568-569)
c. Lloyd A. Grumbles, M.D., Philadelphia, Pennsylvania, was the next witness called by Respondent. Dr. Grumbles testified that he received his college degree from Texas A & M, College Station, Texas (no year stated); and his medical degree from Baylor College of Medicine, Houston, Texas, in 1948. He interned in Fitzsimmons General Hospital, Denver, Colorado; had a residency in neurology and psychiatry at the University of Colorado; was staff psychiatrist at Valley Forge Army Hospital; was chief of psychiatry and director of the Mental Hygiene Clinic at Fort Rucker, Alabama; was Senior Physician at Warner State Hospital; and then he became Director of Special Therapies at The Friends Hospital in Philadelphia. He was Board Certified in psychiatry and neurology in 1954. Dr. Grumbles stated that he had analytic training and that he began private practice of psychiatry in 1957. He was in practice of fairly standard orthodox psychotherapy with a very busy practice for about ten years until he became involved with some of the pioneers of orthomolecular psychiatry, such as Abram Hoffer and Humphrey Osmond and John W. Canterra. Shortly thereafter he increasingly studied all his patients from a metabolic point of view and found that the response was much more effective in a large percentage of the patients than from just psychotherapy alone or the usual drugs alone. Dr. Grumbles testified that orthomolecular pshychiatry has to do with the treatment of mental disorders as disturbances in metabolism, nutrition, and the adjustment of the normal substances in the body to achieve normal mental state. Increasingly his practice has become more widespread than just psychiatry he now devotes about a third of his time to psychiatry and about two-thirds to general medical nutritional work. In his fifteen years of orthomolecular psychiatry he has been increasingly impressed that nutritional deficiencies are very widespread. Based on the study of his patients he finds some deficiency in at least 80 per cent of the people. (Tr. 619-622)
He once was, but no longer is, a member of the AMA. He does not belong to the American Psychiatric Association because to do so one must belong to the AMA.
Orthomolecular medicine, in the practice of which he is presently engaged in connection with his psychiatric practice, was once called mega-vitamin therapy. It was Linus Pauling who coined the term "orthomolecular," meaning the right molecule in the right quantity at the right time. He extrapolated from that the idea that this would be a very good concept to use for the psychiatric type of treatment that he was doing. Dr. Grumbles was in that type of psychiatry before Linus Pauling wrote that paper, and so orthomolecular psychiatry was the first branch that used the term and it has been extended to the Orthomolecular Medical Society as well as the Orthomolecular Psychiatric Society.
The products which are the subjects of this case involve nutritional supplements as opposed to natural foods. By natural foods Dr. Grumbles refers to, when possible, foods that are grown without the use of pecticides, in meats and eggs and so on, without use of hormonal substances and antibiotic substances. He refers, also, to the utilization of whole grains, fresh vegetables, fresh fruits and these things as opposed to the processed foods that most of our population consumes, almost being forced to. He uses the term "health food store" generically because most pharmacies do not carry the preparations in the quantities and varieties that he often recommends to his patients, whereas the health food stores usually do.
Dr. Grumbles' method of treating neurotic and psychotic patients differs widely from the usual therapeutic measures adopted by psychiatrists as a whole, but not from the therapeutic measures employed by psychiatrists of the orthomolecular school. He departs from the usual therapeutic measures used by general medical practitioners only in the sense that he studies nutrition in his general medical patients much more intensely than the average physician does, and he is much more aware of the nutritional factors. Simply by being alert to them and pursuing this, he finds that nutrition often is effective where prescription medication is merely palliative, but his peers do not claim to have any miracles in that either.
As a propylactic matter, or as insurance, he believes, generally speaking, that it is good for the population in the United States to take these vitamins and minerals and other nutrients, if any, in order to compensate for any possibility of a deficiency that is not discernible.
d. Respondent next called Murray R. Susser, M.D., as a witness. Dr. Susser received a bachelor's degree, majoring in English Writing and Pre-medical studies, at the University of Pittsburgh, from which institution he received the M.D. degree in 1966. In 1966-67 he did his internship at St. Martin's Memorial Hospital, in Pittsburgh. He began the general practice of medicine in 1967 and he practiced general and family practice until about 1968 when he began to evolve into a nutritional practice. He limited his practice solely to nutrition in about 1974, but he also employed other family practice modalities. He described his change to new medical beliefs and practices as follows:
"What happened was I was disappointed in orthodox medicine. I went into it very enthusiastically and by the time I finished by internship I was well grounded in it, I had a good education in orthodox medicine and I went into a partnership with two excellent orthodox physicians in 1967, and I loved it except that a lot of things didn't work, a lot of people didn't get better, chronic, non-specific kinds of diseases often didn't get better, people seemed to react badly to drugs and I tried everything I could to get people better and they often didn't get better. So I tried psychiatry and that didn't work satisfactorily, I tried all the best consultants and that didn't work any better --they didn't do any better than I did. I tried using drugs in an unusual way, like a lot of people would use drugs like Dilantin, drugs in unorthodox fashions and that certainly didn't work at all. And one of the things --finally, very reluctantly some friends prevailed on me to try vitamins and that was the first thing that I felt worked.
"And I had some miraculous successes early on with vitamins and that piqued my curiosity and I kept using more and more vitamins and eventually I started to have --you known, the results were really incredible.
* * * *
"It was very painful and frightening for me to use vitamins because I was taught in medical school that anyone who used vitamins was a quack and a fraud and I thought that was what I was getting into, and it was a scary thing for me to go against my teachings. And I did it very cautiously, when I first used Vitamin E, I studied the pharmacology of it so intensely that I was amazed at its safety, even though there was so little evidence of any danger in it, I still was frightened the first time I prescribed it for a patient." (Tr. 731-733)
e. The last witness to be called by Respondent was Emanuel L. Golden, M.D., of Boca Raton, Florida. Dr. Golden received his Bachelor of Arts degree at New York University in 1947. Then he took one year of post graduate training in pharmacological research at the Department of Endocrinology at New York University Medical School. From 1948 to 1952 he went to the University of Chicago Medical School, where he received the M.D. degree. This was followed by an internship in The Jewish Hospital of Brooklyn and then three years of residency at the Bronx Veterans Administration Hospital. Dr. Golden related the nature of his experience as being that of clinical medicine with emphasis on rheumatology in the last fifteen years, and some clinical research. He has written two papers and he has been a director of at least three or four different arthritis clinics, medical director of several geriatric institutions in New York, and consultant to Mr. Sinai Hospital, New York, in arthritis. He has also done some pharmacological work for Thompson Medical Company. He described his present practice as a general internal medicine practice, but, based on his own personal belief, the emphasis is on nutrition in helping with general medical care of his patients and his arthritic patients. (Tr. 825-827)
Dr. Golden is, and for several years has been, a contributing editor to SOMA magazine. This is a magazine by which Respondent circulates its advertising for various products that are the subject of this litigation. He writes articles on nutrition and health which are published in that magazine and for which he is compensated. Dr. Golden thinks the AMA is "primarily a socioeconomic group, political group and have very little to do with research. It is not their province to comment or direct research. That is another, that is under the National Institute of Health or some other federal agency. The AMA is involved with ethical behavior of physicians, supporting various bills in Congress, educating the public and if you are talking about their role in educating the public, I think they have been deficient in commenting on nutrition. That is my personal opinion."
He does not think that the observations that he makes in his clinical practice are more reliable with respect to nutritional deficiencies than is the research that may be going across the country in all areas and reported by doctors, nutritionists in the Recommended Dietary Allowances. He feels that the research that the AMA may encourage on discovering the effects of various nutrients on deficiency states is very important, but pellagra and beriberi have already been cured and scurvy has been cured. He said the important current questions are those that involve such matters as the pharmaceutical use of various nutrients in higher than the RDA allowances, the use of ascorbic acid and pyridoxine and Vitamin E and various metals in treatment of hietherto unknown diseases which may be existing but are in a latent form. And only through serendipity can we discover a lot of things. Not everything good that we have now is discovered through scientific efforts. A lot of things have been discovered through simple clinical observation. (Tr. 840-844)
12. The first group of cases to be considered is the one that is for convenience described as relating to eight (8) vitamin and mineral supplement products, and one product consisting of a combination of four of the eight individual products.
THE TESTIMONY
A Chromill-GTF --(10/128) - For Diabetes and Aging
1. Dr. Schwartz was the first witness to testify concerning this product. Referring to a note in parentheses on the label uncer "Chromium" which reads "(as it naturally occurs in chromium yeast complex containing the essential glucose tolerance factor)" he said this means that the chromium is inorganic chromium which was extracted from yeast which was originally in yeast as a chromium complex. It is not his conclusion or interpretation that this represents chromium that is complexed with glucose tolerance factor (sometimes hereinafter GTF) as much as it is chromium that was derived from a situation where it was the original GTF. Part of this interpretation is based on the fact that he is unaware that chromium containing GTF is commercially available. There is nothing on the label that leads him to believe that this product does in fact contain GTF.
2. There are indications that certain chromium deficiencies occur in certain populations in this country. There is a theory that GTF is impaired by deficiency in chromium - primarily in older persons. In the absence of chromium deficiency Dr. Schwartz is aware of no valid studies that show that chromium supplementation will prevent diabetes. In his opinion, this product will not prevent diabetes or retard aging. In people who are not deficient in chromium there is no need for chromium supplementation. (Tr. 276-279)
3. On cross-examination Dr. Schwartz said that his statement that there is adequate chromium in the diet of the American people is not based on proof derived by a valid, conclusive, scientific study, but, rather, it is based upon his understanding of nutrition. In nutrition one does not prove that there are adequate levels so much as one looks for inadequacy in levels. While he would not say that it has been proven that there is adequate chromium in the diet of American people in general, there is nothing to lead to the belief that there is not. In experiments with animals chromium deficiency adversely affects glucose tolerance, but it will not mimic diabetes in other respects. In diabetics, older individuals, and mal-nourished children chromium supplementation will improve glucose tolerance and there is some reason to believe that chromium enhances the effect of insulin. There are animal studies in which the effect of the diabetes as reflected in glucose intolerance is mimicked in animals and in which chromium deficiency in animals has accelerated atherosclerosis. He has never personally observed or conducted any experiment with chromium GTF to determine whether the claims of Respondent in regard to this product are true or false, nor is he aware of any experiment or clinically controlled study conducted by any other person which demonstrates the truth or falsity of Respondent's claims for this product. (Tr. 299-304)
4. Dr. Hunt was called to testify next by Complainant. There are two nutritional ingredients in this product - chromium and manganese. If there is no chromium deficiency there is no need for supplementation. Sources of chromium include: meat and, especially, seafood, whole grain cereals, cheese and liver. Chromium deficiency has been reported in children with protein malnutrition and it is thought that perhaps it may exist in people past 70 years. The last is a possibility, but it has not been pinpointed as existing. Glucose tolerance factor is an organic molecule that contains the chromium and it has lecithinic acid, cysteine and glycine. It is chromium that is active in the body. The product could not prevent diabetes because diabetes itself is inherited genetically and it is an interaction between a genetic predisposition and the environment. It will not retard aging. (Tr. 133-135)
5. Dr. Hunt believes there are possible chromium deficiencies, but she does not think that the general population has chromium deficiency. She would not be able to compare the chromium content of blood levels of people in U.S. population against populations in other countries. This product is not necessary for everybody because not everybody has a chromium deficiency. To determine whether someone has chromium deficiency one of the best ways it by a glucose tolerance test which a physician must administer. Chromium is a matter in which there presently is great interest. Walter Mertz, of the United States Department of Agriculture, has been doing a lot of research in all trace metals, and chromium is one of his favorites. He discovered the GTF and he is the one who showed that trivalent chromium in this molecule is what is affected. He believes that people do need to be more careful about intake and not eat too many refined cereals, but he is not urging people to take chromium supplements.
6. A review entitled "Chromium Nutrition in Man" (RX 3) in the May 1974 American Journal of Clinical Nutrition (p. 505) contains a statement to the effect that relatively large sections of the population may be at risk from at least a marginal deficiency of trivalent chromium. It is also stated in the review that a more severe degree of chromium deficiency "leads to a syndrome indistinguishable from mild diabetes mellitus, including glycosuria and fasting hyperglycemia." (id.) Dr. Hunt did not disagree with the last statement. For people who are deficient there is a possibility that chromium may potentiate the activity of insulin and thereby be beneficial. Chromium could well help improve the glucose tolerance in elderly people, but it can not prevent diabetes. If people have a deficiency in chromium and an accompanying decreased secretion of insulin, chromium supplementation might improve the efficiency of insulin and thereby improve their condition, but it would not prevent the disease itself. (Tr. 160-167)
7. On redirect examination Dr. Hunt described the American Journal of Clinical Nutrition as a respected journal which she regularly reads. She recalls having read, and is familiar with the article, "Losses of Vitamins and Trace Minerals Resulting from Processing and Preservation of Foods" in the May 1971 issue. (RX10) In this article the author reports sizable losses in various nutrients due to processing and preservation of foods. Dr. Hunt pointed out, however, that with respect to vitamin B6 most of this vitamin comes not from vegetables but from animal foods. The author has reported accurately his findings, she said, but unless one is familiar with the sources of the various vitamins and minerals, he may draw a wrong conclusions from the statements in the article. Fruits and vegetables do not provide the bulk of pyridoxine, for example; it comes from animal products.
8. Concerning the author's statement that "chromium deficiency is probably a factor in atherosclerosis" (RX 10, p. 571), Dr. Hunt says that by the use of the word "probably" the author is saying, in effect, "I don't really know for sure, I sort of feel like that it might have some influence, but I can't say that there is a cause and effect relationship." Dr. Hunt was troubled by the fact that conclusions in the report were based on one study, even though the study was said to have involved more than 300 schools.
9. The use of supplementation with chromium of a diabetic who had normal chromium levels would not be effective. Supplementation is not effective in cases in which there is no deficiency. In the right-hand column, 2nd complete paragraph, p. 571 of RX 10, the author states that despite the statement that deficiencies exist in the tissues of many persons in the United States, and that such deficiency increases with age, nevertheless - "At this time, replacement or supplementation would have little effect, for inorganic chromium salts are poorly absorbed and their action may be slight." This is the area in which Dr. Mertz is now working. (Tr. 232-247)
10. The next witness, Dr. Ayers, said that if people eat anywhere near a balanced diet, chromium deficiency is not a common problem among United States citizens. If a person has no deficiency, there is no need in human nutrition for supplementation of chromium. The above statement is true with respect to all vitamins and minerals.
11. A glucose tolerance test is the sequence of events that takes place after ingestion of a measured amount of glucose and note is taken of the rapidity with which it is removed from the blood stream after ingestion. There is some evidence, particularly in animals and to a lesser extent in humans, that the slope or shape of the curve of removal of glucose from its peak value over time can be altered in some individuals by taking chromium. The shape of the curve is what is altered and it is highly variable within the same individual.
12. Dr. Ayers defined glucose tolerance factor as chromium in its absorbable form. Concerning the language on the product label, "Chromium (as it naturally occurs in chromium yeast complex containing the essential glucose tolerance factor)", the witness is not sure what the quote means because he does not think that the essential GTF is an isolated factor. He presumes it means the chromium that is there that is absorbed when taken in this form, and the chromium itself has some interaction with insulin in the removal of sugar from the blood at the cell membrane level. Thus, he presumes that what Respondent means by glucose tolerance factor in the quoted language is that the chromium in the product is the absorbable form of chromium. There is nothing else in the product that would indicate to Dr. Ayers that it contains the GTF as he defined it because he does not know what GTF is.
13. Dr. Ayers is not aware of any valid clinical trials that support the proposition that chromium supplementation will prevent diabetes. Diabetes is a disease, it is not an abnormal glucose tolerance. There are very classical changes in diabetes that are seen under the microscope in certain cell membranes and cell linings throughout the body that are hallmarks of the disease diabetes. Glucose tolerance may be abnormal for a variety of reasons, not all of which are related to diabetes. There is, therefore, no evidence of which he is aware that chromium supplementation prevents diabetes mellitus, the disease.
14. The witness stated that Chromill GTF, as a complete product, will not prevent diabetes and it will not retard aging. (Tr. 361-365)
15. On cross-examination Dr. Ayers said that he takes at face value the statement on p. 571, RX 10, that chromium deficiency exists in tissues of many persons in the United States. He has done no tests or studies to determine the effects of chromium supplementation in nutrition. He knows of some published reports of studies of others, but not all of them meet the strict criteria of controlled studies. He knows of no reports that indicate chromium supplementation definitely will or will not be helpful to persons who have a tendency toward diabetes, or may suffer from diabetes in the event that they have a chromium deficiency. (Tr. 402-403)
16. Dr. Lord's opinion is that there definitely are chromium deficiencies and that this fact has been established quite a bit more clearly than in the case of something like molybdenum, for example. He said that it is known that there is one very prevalent disease --adult onset diabetes --which responds to chromium therapy.
17. To explain how diabetes responds to chromium he gave an explanation of the biochemical role of chromium, of which the most widely understood role is that it is required at the cell membrane where the binding site for the insulin molecule occurs. People who do not have adequate chromium, even though they may be producing insulin in sufficient quantities, do not get the glucose response of insulin because the insulin, when it reaches the type cell which would be like a fat cell, or a liver, or a muscle cell, causes no response. By simple replacement of the proper form of chromium through supplements, diabetics have shown vast improvement. In some cases, insulin requirements for exogenous insulin have been greatly reduced and eliminated.
18. In explaining the effect of the foregoing events on aging, Dr. Lord said that one of the most prevalent conditions resulting in aging is the loss of blood sugar control in general. Here again, [the class of diabetics in] only in the most most extreme class of diabetics is that loss obvious and they are dependent on exogenous insulin. He continued as follows: "We know from fairly recent accumulated data at least the effects of loss of blood sugar control are very widespread resulting in the attachment of glucose of sugar molecules to virtually all protein. Any time or period in which the glucose level goes up there is a clinical lab test based on this fact which is one of the more rapidly growing tests, because of its power in showing glucose control, which would measure a compound called glycohemoglobin which is a fraction of the hemoglobin circulating in the blood which has glucose molecules attached to it. The control of the diabetic can be monitored very accurately by measuring the levels of the blood, and we know the effects of blood sugar control are the basis and would result in what we call aging being accelerated." (Tr. 501-503)
19. On cross-examination, Dr. Lord said that adult onset diabetes can be caused by chromium deficiency, because it responds to chromium treatment. Not every case of adult onset diabetes, however, is attributable to chromium deficiency. He could cite no authority for his opinion, based on the fact that chromium supplementation can treat the disease, that diabetes is caused in part by chromium deficiency.
20. An adult who has any condition without a chromium deficiency will not benefit from extra chromium. His definition of chromium deficiency is any level of chromium in any tissue that is below optimal, and optimal can not be defined. It simply must be said that there is evidence that diets, first of all, are deficient in chromium and that that deficiency leads to a very pervasive chromic disease condition. A moment later he said: "My definition of chromium deficiency would be that amount of dietary intake below which the person exhibits chromium depletion signs." (Tr. 523)
21. He has seen chromium deficiencies that complied with his definition of deficiency. He said that when he has seen it, the levels of chromium are in excess of the RDA recommendations and in some cases the same as the RDA. An intake of chromium at the RDA level is probably sufficient for a lot of people. That leaves a lot of people, however, as he said are found from laboratory measurements, who are depleted in chromium and who would then exhibit, eventually, signs of chromium deficiency.
Therefore, he does not disagree with the RDA, the guidelines, he is just saying that there are individuals who do not fall into those guidelines, and those individuals are not an extreme rarity.
22. He mentioned, without citation, studies of pregnancies in which chromium tends to go down first of all during a pregnancy, and chromium levels in neonates, or the newborn, correspond to chromium levels in mothers, and females who have multiple pregnancies show lower and lower chromium levels, so the burden of the pregnancy results in a total depletion of the body chromium. He said that these instances, together with the known fact that our dietary intake of chromium in many cases is depleted because of specific individual food choices, gives us evidence that there is need for chromium in a lot of people.
23. With reference to the statement that a balanced varied diet supplies adequate amounts of trace elements he said that if it implies that the average diet consumed in America is a balanced and varied diet, he disagrees. If it implies a diet that contains a daily intake of various green and yellow vegetables, milk products, of whole grain foods, of nuts and seeds, then yes, that is the way we would want to get the vitamins and minerals that we need. Unless there is a very specific metabolic lesion that a doctor should detect, his contention is that the diet of a great number of people in this country is not anywhere near what it should be to supply the balance of minerals that is needed for optimal health or even for nominal health as he would define it, which just means living your seventy years free of chromic degenerative diseases and mental conditions, emotional conditions, disorders.
24. As far as absorption being impaired by minerals is concerned, one definitely can have too much of these. He said that the levels that would result in impairment of absorption, however, unless someone is already impaired, in which case it is a moot question. That occurs only in very rare instances.
25. Dr. Lord again redefined deficiency of a given nutrient as an intake of that nutrient which is below the total demand for an individual at the time that it is consumed. It was agreed that the foregoing definition would be used for purposes of all the questions to be asked of this witness during the remainder of the day.
26. Based on the last-stated definition, the product Chromill GTF, absent a chromium deficiency will not retard aging.
27. For a person suffering from adult onset diabetes, if that person did not have a chromium deficiency, supplementation of chromium would have no beneficial effect. (Tr. 532-535)
28. Dr. Grumbles, the next witness, stated that the primary ingredient of Chromill GTF is the GTF factor naturally occurring in yeast, and it is the trident chromium that has been found to be the biologically active form of chromium as indicated by the initials GTF meaning glucose tolerance factor chromium. In his opinion the entire American population would be benefited by supplemental chromium. Previously it had to be taken in the form of brewer's yeast which no one argued with as a recommended supplementation, primarily for the micronutrients, and especially for the chromium which was the only source of it until the GTF had been isolated. The benefit to be derived from taking a product of this nature is that it is a matter of insurance in view of what he considers to be our borderline nutritional status where micronutrients are concerned, that it does play a definite role in the body's utilization of insulin and the basic insulin glucose cell membrane reaction where it is actively utilized.
29. Chromium has been found to be deficient in arteriosclerotic arteries. Dr. Grumbles said that there has been a report, the reference to which he could not cite, or a study in Europe in which deceased Americans' small capillaries were taken and put under pressure and compared with Europeans', especially Eastern Europeans' where similar capillaries were put under pressure. The Americanbred capillaries tended to break at about less than 300 millimeters of mercury, where those from Eastern Europe can go to a much higher level of pressure before being found to be fragile. To him, this is perhaps good evidence that chromium is needed as a general factor in the American diet. He also fins this from his own practice. The particular population that this was done on was from an area where the chromium source was very high, and that is the chief point of the experiment: that a deficiency in chromium creates the capillary fragility, and the adequate chromium intake seems to insure the increased elasticity in the case of blood vessels.
30. He said that without question many diabetics are able to function on a much more stable level with a given dose of insulin. In many instances the does of insulin can be lowered and the oral hypoglycemia agents can be reduced or eliminated when chromium has been administered. The role between sugar and the need of chromium is indicated in his experience by the patients who have a history of extremely high refined carbohydrate intake, sugars, starches, things of this sort. With that history he said he can predict, without any problems at all, that they are going to be very low in chromium and manganese on hair analysis.
31. When patients have inadequate insulin that they produced themselves the insulin must be supplied from outside. If the insulin is not utilized properly, very often the diabetic may have a serum level of insulin that is not too far from normal produced by their own pancreas, but it simply is not being utilized properly. In such a case the chromium does help very much in utilization of the insulin and the carbohydrate metabolism, glucose metabolism.
32. The benefits this product has in regard to aging derive from the fact that chromium is found to be very deficient with increasing age, very deficient with arteries for example that are found to be artereosclerotic and analyzed for chromium content, and a number of the processes that have to do with aging, and the fact that the diabetic ages much more rapidly in all the concomitants of aging than the so-called nondiabetic population.
33. It is the opinion of Dr. Grumbles that the product Chromill GTF in the doses of the ingredients that are shown on the transcript of the product label is an excellent dosage for general supplementation. There is nothing in the product that could cause anyone any potential harm. (Tr. 650-656)
34. Concerning the definition of diabetes, he said that, originally, diabetes was thought to be a deficiency of insulin produced by the pancreas causing an increase in blood sugar, spilling sugar in the urine, excessive thirst, excessive urination. It is now known that there are many different kinds of conditions that may lead to hyperglycemia.
35. For purposes of this hearing, it would be correct to state simply that diabetes is a relative or absolute deficiency of insulin activity being effective at the cellular membrane level.
36. His understanding of the term glucose tolerance factor is that it is a compound relative to chromium that is the effective agent in the body for facilitating the utilization of insulin at the cell membrance level. A trident chromium which was a chromium compound isolated from yeast seems to fulfill this bill. It has not been synthesized, and there may be factors involving this we do not know yet, but it is generally acceptable that the compound extracted as GTF, glucose tolerance factor, from yeast is representative of the use of this chromium mechanism.
37. He said that he knows of support in medicine or science for the use of the glucose tolerance factor in diet as opposed to just the theory that it exists. He was able to cite no supporting references. He does not know if Dr. Mertz, the developer of the theory, endorses the use of his theory for glucose tolerance factor in commercial products today.
38. He said that, hypothetically, in some diabetics, the hyperglycemic agents, whether oral or insulin, can be reduced or even eliminated by the administration of chromium along with a total nutritional program, and that he would assume that if these people had been on such a program initially they would not have developed the "clinical" diabetes later. Dr. Grumbles does not know what percent of diabetics have responded to chromium therapy but he thinks it would be a low percent. There is no real evidence that it will work as effectively in cases of the adolescent or juvenile diabetic, and there might be some cases of it of such people with extreme chromium deficiency that it would be helped by it. Dr. Grumbles said he has had no experience with that type of diabetes.
39. The other claim for this product is that use of it will retard aging. Dr. Grumbles stated that he is in agreement with that claim. He spoke of the fragility of capillaries from populations, Americans, specifically, as opposed to certain high chromiumconsumption European population, and that the low chromium capillaries were much more fragile. He could cite no specific report of a study supporting his belief, but he thinks it was published in the past year.
40. He provides oral supplementation of chromium to patients in his medical practice. For his adult diabetics he routinely supplements them with chromium just on the possibility it may help. It is a fairly inexpensive element and it is one for which no known toxic level has ever been found. He also gives it to people who show low chromium on hair analysis, accompanied by a dietary history of tremendous intake of refined sugars, et cetera.
41. He could not say that everyone should take chromium supplementation. He can say it would do them no harm and there may be some possibility of benefit. The dosage he uses is anywhere from 50 to 200 micrograms. (Tr. 691-700)
42. Upon examining the ingredients listed on CX 216, Dr. Susser said he knows of no harm that could come from this product to persons by whom it is ingested as directed. He has a definite opinion, from what he has heard and read, that there seems to be a lot of evidence that there is widespread chromium deficiency in this country. He thinks the ingesting of Chromill GTF tablets could very well be beneficial.
43. It is shown in the work of Mertz that chromium is a part of the glucose tolerance factor, and he spoke of his own experience which he said shows that several patients have had their diabetic symptomatology improved very, very much from chromium supplementation, GTF. He cited the case of one lady who was on 20 units of insulin a day, but who no longer requires that because her blood sugar is lower on chromium and the other supplements than it was on insulin.
44. It is "pretty possible" that supplements of chromium have benefits in limiting diabetes for people who might have chromium deficiencies that would ultimately go into a diabetic state. He arrived at this conclusion by reasoning that any time you can improve a condition like diabetes by giving supplements to somebody who already has it, the chances are you will keep that diabetes from returning in that person and that means to him that there are probably other people out there who, if they took chromium supplements, would therefore not develop diabetes.
45. In regard to the effects supplements of chromium have in regard to overall aging, he said that chromium has been shown to have effects in two areas of the body, in the glucose tolerance and in the vascular system. If the vascular system gets brittle, then obviously people age quicker. The studies for which no citation was given, but which were said to have been done in the Balkan countries with the blood vessels, in which they took blood vessels of American cadavers and from European cadavers, and blew them up with air, they found that the American cadavers ruptured ar around 250 to 300 millimeters of mercury, whereas the European counterparts sustained pressures up some 500 to 3000 millimeters of mercury and the only difference they could find in these blood vessels was that the European specimens had mor chromium.
46. He thinks one or two tablets of 50 micrograms of Chromill could provide a substantial benefit. (Tr. 767-769)
47. In his opinion, supplementation of chromium will prevent diabetes in some people, but he really does not know. In his opinion, supplementation of chromium could retard aging. The support for this belief is only the fact that it probably prevents diabetes and that it does have an effect on blood vessel disease, so that having adequate chromium will evidently prevent diabetes in some people, retard arteriosclerosis in others and therefore, the retardation process in both these conditions would retard aging.
48. He has no evidence that people who are not diabetics and who do not have arteriosclerosis will receive any benefit from taking Chromill GTF. Chromium supplementation will not cure all types of diabetes, but it will have a beneficial effect on most. He has never had experience in treating children with diabetes, so he does not know what effects it would have on them, but it has a beneficial effect on adults. (Tr. 782-785)
49. Dr. Golden stated that there is definitely a need for vitamin and mineral supplementation, especially in our environment where we have fad diets and processed foods and additives, junk foods, toxic pollutants in the air and water and soil. He said the average American diet, even though people may be obese, is inadequate in many respects.
50. In his opinion the oral supplementation of this product by people in this country would not have any potential harmful effect. Chromium in the diet, specifically of the adult, plus manganese, is helpful in utilizing glucose without the stress on the pancreatic release of insulin. It has an insulin-sparing effect and for many of our American people who are latent or potential diabetics, there is a good preventative factor in adding chromium and manganese which is a metal that is included in many metallic enzymes in our intermediary metabolism of carbohydrates, fats and proteins, so both of these elements have a definite therapeutic value. Licorice powder probably just makes it palatable and it is a good carminative for the bowel.
51. As to whether this product would be helpful as a supplement so far as aging might be concerned, Dr. Golden said that it would be if we can prevent diabetes in our diabetes prone population, but that is a big question mark. We do not know who is diabetic prone except by hereditary or epidemiological investigation, or family genetic follow-up or doing glucose tolerance tests. This product is a good preventive for diabetes, and with arteriosclerosis cutting off the blood supply to the brain, to the heart, to our vital organs, it can have a salutary effect on preventing aging or premature aging. (Tr. 827-829)
52. Dr. Golden testified that Chromill GTF can prevent diabetes, but in conjunction with good diet and in conjunction with good nutrition, not by use of the pill alone. He continued by saying that in preventing diabetes, you prevent hardening of the arteries and the neuropathy that involves and the weakness of the connective tissue which is part of the diabetic situation. Therefore, if you can stop that or retard it then you can, in so doing, retard the aging process or delay its onset.
53. Dr. Golden did not really answer the question as to whether, in the absence of diabetes, this product would provide any benefit with regard to retarding aging. The closest he came to answering the question was when he said that "In a potential diabetic or an obese person or a person with poor nutrition it can have a preventive effect in aging, yes, if you want to stretch that point." (Tr. 845-846)
54. Referring to the case of a hypothetical potential diabetic in which the witness had described the ingredients in RNA, META-E, Ex-Sel and Chromill-GTF as being most beneficial for persons who have no discernible or detectable problem, Dr. Golden was asked whether they would be adequate to be taken as insurance against the development of some unwanted condition. Dr. Golden replied as follows:
"Put it this way, if he was on a low caloric, low fat diet and he was a potential diabetic and I omitted chromium from that diet and then gave him a diet with the chromium I think his chances of avoiding the eventual evolution of diabetes, true diabetes mellitus is greater, diet for diet, but not in and by itself. i mean, I believe in the entire holistic entity. I don't like to zero in on one thing. We know that chromium is an essential part of the glucose tolerance factor, we know that a deficiency of this can cause a premature onset of diabetes in laboratory animals and we know that it has a salutary effect in preventing diabetes in potential diabetics. Now that has been written up in books on metabolism, I have another book over there, and it has been proven that it is an essential metal involved in upswings and down swings of sugar level in the blood stream. So I say if a person is a potential diabetic and he adds chromium or GTF to his diet, he will have a better effect than if he omitted it."
55. Dr. Golden was reminded that he had said that he might change the patient's diet and in the course of doing that he would add some chromium. He was then asked whether the administration of 50 micrograms per day or 100nmicrograms per day would be adequate to accomplish the desired objective of preventing diabetes. He answered:
"That particular amount I don't know whether it is, certainly it doesn't appear to be too great, it may not be totally adequate in certain people but I feel that in the sense that we understand the GTF, it appears that amount of chromium would be adequate. It acts through very minute amounts and the excess is excreted. It is not a toxic metal in that amount so the body takes what it needs and excretes the rest with just the exception of the fat soluble vitamins. The body is wise in its needs, it takes from the food and nutrients that we put into it and takes from it and then excretes the rest. So in that sense it many."
56. In such a situation as was just described, Dr. Golden seemed clearly to suggest that the 100 micrograms might not be adequate. On this point, he commented:
"I don't know the quantitative --I don't think there ever has been a quantitative determination of how much chromium is necessary, I think they take a safe dose and they say that if your body is deficient in it this will correct the deficiency and certainly the amount in the GTF, that 50 milligrams or 100 milligrams would be adequate to correct the hypoglycemic and hyperglycemic swings of people with low sugar condtions. And it has been used in hypoglycemia in women with good results where they have a very low swing and it has helped to stabilize it in conjunction with the nutrition."
57. He agreed that human beings are individuals and, that as such, their shortages and over-abundances of various nutrients vary from time to time, from individual to individual. His opinion was then asked as to the desirability of providing a product that has a standard, uniform level of beneficial ingredients for the entirety of the public, to which he said:
"Just in the preventive sense, Your Honor, that there are so many obese people in this country, and with the fad diets and refinement of food that we have, there is more and more possibilities for deficiencies of these metals, which have been hitherto unknown and haven't been described, so it is a new subject and I don't think all the answers are in. We're groping, I don't think the NIH has the answers. I don't think the AMA has the answers. I think what we're trying to do is say if you are obese or you're a potential diabetic, space you food correctly, try to get lean, avoid excessive refined carbohydrates and other factors and add something that we know is beneficial in saving the pancrease from being depleted, that has been shown in laboratory animals to be a safe and efficacious way or preventing hypoglycemia, which is often a prodrome of true diabetes mellitus."
Dr. Golden said that in his opinion it would be fair to state with respect to these products that for some individuals the amount of the various ingredients would be adequate, for other individuals the amounts of the ingredients would be inadequate, and for the third group of individuals it would be more than adequate, but not toxic because the excess is excreted.
60. The same thing is true with an antibiotic. He said that he can not tell that, judging from a person's height and weight, he is going to give the optimium amount of an antibiotic because he does not know what the person's absorption power is, he does not know what his or her plasma proteins are, so he shoots for a range that he thinks would be adequate for an adult of an estimated weight, and that is purely an empiric determination. He said that it is like the RDA, it is a range, and the range has been increased with each successive redetermination of various vitamins and metals as they have been discovered. He said: "I don't know the agency --it is called the National Research Council of America --determines that Vitamin C is required in greater amounts now than in 1979 or 1980. For some reason they gelt that it should be increased because we know that the refinements of the foods and the other toxins that we have in our environment and pollutants determine that we need more Vitamin C for stress, needed in the adrenal glands and it certainly produces the most expensive urine in the world, but as has been said in other research articles, it does good where it's needed."
61. It was suggested that there has to be some yardstick which is applied to these various ingredients that are needed by the human race, and he was asked whether he thinks it is logical to accept at any given time what is then currently known to be acceptable and useful in terms of the needs of our bodies. Dr. Golden replied:
"Well I think doctors should become more involved in nutrition and more flexible and advise the patient and get involved in this and do --and more research should be determined toward saying well the 60 milligrams or 120 milligrams are needed or more. The only thing these manufacturers have done is shy away from a potentially toxic level because they don't want to produce any harm and reasonably so, but I think we've got to do more research and that's what the thrust of this whole thing with the NIH is, that we are in an infant type of science here."
62. Despite all of the foregoing testimony Dr. Golden said that he does not see any problems with individuals deciding for themselves whether or not they will take vitamins in the doses found in the products involved in this proceeding without actually going to a physician before they make a decision that they want to take vitamin supplements.
B. Natural Calm --(10/129) --Sleep Aid, Relief of
Nervousness, Tension, and Insomnia
1. Dr. Schwartz testified that tryptophan is an amino acid. There have been animal studies with regard to sleep in animals and with regard to biological changes induced by large dose of tryptophan. There have been clinical studies in humans with large doses, gram doses, which have involved measurements of sleep latency (delay in going to sleep) and sleep duration in certain classes of individuals. The dosage of L-tryptophan in Natural Calm is 100 milligrams (mg.) or 1/10 of a gram (gm.). In the studies with the large dose it is suggested that there is a decrease in sleep latency time and, in some cases, increases of sleep duration in certain types of individuals. There was one report that a dose as low as 1 gm. may have worked, but generally the dose ranged from 5 to 10 or 15 gms. and even higher. Pharmacologically there is no other ingredient in this product that would be effective in aiding sleep or curing nervousness, in providing relief of daytime tension or curing insomnia. (Tr. 279-280)
2. On cross-examination, Dr. Schwartz stated that he had never personally observed or conducted any experiments with Natural Calm to determine whether Respondent's claims for it are false, and he knows of no study done by anyone that would show that Respondent's claims for this product are either true or false. He would not conclude that if the product contained 1 gm. of tryptophan rather than 1/10 of 1 gm. that there had been a sufficient experimental study to show that it would have some benefit with regard to sleep and perhaps relaxation, nor would he agree that others have reached that conclusion. He would agree that there are others who have made the observation that 1 gm. of tryptophan had some effect and the same investigators also found that 1 gm. of tryptophan had no effect. He, therefore, said that the consensus of the data, even among those who have been interested in the project, would be that 1 gm. of tryptophan would be inadequate for the general population. The data showed that probably somewhere there are some people who would respsond in terms of sleep latency to 1 gm. of tryptophan. (Tr. 305-306)
3. Dr. Schwartz, on redirect examination said in reply to a question as to whether there is any problem relative to toxicity arising from the ingestion of large dose of L-tryptophan:
"That is an interesting question. I was thinking about that when I was reviewing some of the studies in which large doses are given. There is a derivative of tryptophan, which has been shown to be a potent cocarcinogenic in concert with other materials, carcinogenic in the blood, in fact it has been used as a prototype co-carcinogen. The question comes to mind, bladder cancer is something that develops after long term exposure, I mean years, it is not something that occurs from taking a single dose of something. There is a question of what would happen if people took let us say ten grams of tryptophan a night to go to sleep for fifteen years. I believe it would be very important to do metabolic studies in order to determine whether or not the potential of bladder carcinogen is there. If the potential is there, it would be an absolute requirement, so other than that, I am not aware of any other particular toxicity, though that is enough." (Tr. 320)
4. Dr. Hunt identified the nutritional ingredients of the product as tryptophan and pantothenic acid. Tryptophan has been used in experiments in dosages from 5 to 10 gms. to effect sleep. It causes the reduction of serontin, a sleep inhibitor. The smallest amount that she has ever seen used was 1 gm. The dosage of L-tryptophan in this product is 1/10 of 1 gm. (100 mgs.) Dr. Hunt stated that 100 mgs. of tryptophan would in no way be effective as sleep aid. Tryptophan has been used in experimental studies to alleviate nervousness, but it is in a highly experimental stage, and she does not see how it could be effective in the cure of nervousness. The product would have no effect at all on daytime tension and it would not be an effective cure for insomnia. (Tr. 135-136)
5. On cross-examination, Dr. Hunt said that one tenth of a gram, 100 mg of L-tryptophan, is not large enough to cause relaxation or sleep. She knows of no study by others, or herself, that indicate that 100 mg. would not be effective as a sleep aid, to cure nervousness, or relieve daytime tension. Tryptophan is so highly experimental that she would not recommend that it be taken at all for those purposes. (Tr. 167-169)
6. Dr. Ayers testified he is familiar with the ingredients in Natural Calm except for valerian root and scullcap. He is also familiar with studies concerning the use of L-tryptophan as an aid to sleep. This substance is usually given in doses of several (4 to 8) gms. whereas the dosage in this product is 100 milligrams. The amount in this product is incapable of being an effective sleep aid, and nothing else in the product would relieve such incapability. The product is not effective in the cure of nervousness or the relief of daytime tension if Respondent means that the product is a sedative. The term "daytime tension" is too nebulous to convey a specific meaning, but if this product were offered for relief of that condition, he would not believe the claim. The product is not an effective cure for insomnia. (Tr. 366-367)
7. Dr. Ayers, on cross-examination, said that L-tryptophan could be a sleep aid if given in 5-8 gm. doses. He has read reports of studies to that effect. He has, however, seen no reports of studies showing that L-tryptophan is effective as a sleep aid when given in doses of less than 1 gm.
8. His previous statement, "more is not necessarily better" was made in respect to vitamins and minerals. Tryptophan is an amino acid and the above statement would not apply. Fr. Ayers could not categorically state where the cut-off point is at which L-tryptophan begins or ends being effective as a sleep aid. People have used the higher doses graduated, showing that there is a dose-related response. Studies have been done where the dose of L-tryptophan has been multiplied within a range higher than the amount in this product. There seems to be a dose-related response. There is no reason to believe that less would be better.
9. Dr. Ayers knows of no experiments or clinically controlled studies that demonstrate that Respondent's claims for Natural Calm are false. (Tr. 403-406)
10. Tryptophan has been repeatedly demonstrated to have effects on the central nervous system resulting in quiescence of the central nervous system which, or course, is required for sleep. Large doses of tryptophan have been used with very routine success in producing sleep. Here again, there is evidence that a large portion of the population has occasional trouble at least in getting to sleep, and a smaller percentage has fairly chronic trouble sleeping. There is in all of those cases the very rel possibility that they have at least a borderline condition which would respond to additional tryptophan. Of course, it should be taken shortly before the sleep period.
11. Another component, dolomite, is a source of calcium and magnesium, but the calcium specifically has the effects of achieving a quiescent state in the nervous system. There is, also, widespread evidence of at least a segment of the population being calcium deficient for a variety of reasons. If a person has a sleep problem, there is a high potential for benefit from thata product.
12. The third component, pantothenic acid, is a vitamin or a vitamin precursor that is required in all cells, as the name implies. But specifically, the nerve cells have a particular demand for pantothenic acid and the vitamin itself has been studied on an individual basis and has been shown to have beneficial effect on nerve function. It acts simply in a very key position in metabolism to allow a smooth flow of energy in cells.
13. For someone who has sleep problems this product has evidence of a potential benefit. It would help people who have daytime tension or nervousness to be more relaxed. It is very frequent that such nervousness would result from a lack of sleep and even when they sleep, sometimes they feel like there has been a sleep period but the sleep did not include the proper kind of rest, then nervousness, anxiety and tension seem to be increased in the individual. Of course, aside from tryptophan, dolomite and pantothenic acid have their effects at all times on the smooth functioning of the nervous system. (Tr. 503-505)
14. The dosages of L-tryptophan in the studies of the people who had chronic insomnia were up to four or five times the amount in this product, possibly five hundred to a thousand milligrams, at bedtime. There had been other studies of simple food intake, foods which are high in tryptophan showing that a concentration of adelptomine in the brain and blood is increased by simple food intake of less than a hundred milligrams, so there are effects at this level also. He could give no citation to any authority that leads to the conclusion that L-tryptophan in any dosage below a gram is effective as a sleep aid.
15. He is not aware of any clinical studies in which a dosage of 100 milligrams of L-tryptophan was actually used that support the proposition that L-tryptophan was actually used that support the proposition that L-tryptophan in this dosage is effective for persons who are seeking a sleep aid.
16. Dr. Lord testified that in the sense that Natural Calm replaces calcium and magnesium through the dolomite it is effective in the prevention of osteoporosis. Natural Calm taken as directed would be probably equivalent to a glass of milk.
17. Absent a deficiency of the ingredients which are listed in the product label for Natural Calm, this product would not be an effective sleep aid. That statement would be true with claims that this product is an effective sleep aid, effective in the cure of nervousness, effective in the relief of daytime tension, or any other claims. If there is no deficiency, there is no need for it.(Tr. 535-538).
18. Dr. Grumbles' opinion as to whether or not supplements of the product Natural Calm can have benefits to the population in the United States in regard to those who need or potentially need a product that would aid them in relaxation and sleep and related areas is that in Natural Calm the tryptophan has a very definite effect on the nerve transmission to the brain. It has been shown on the electroencephalogram to have a calming effect. He uses it in patients who are depressed and have sleep loss, using it both during the day time and evening.
19. He pointed out that neither the tryptophan nor any of the other components of this product is a sedative in the sense that it produces sleep. In an reasonable quantity they do facilitate and allow the onset of normal sleep. Dolomite, with the magnesium and calcium both having a calming effect upon the nervous system, a balancing effect actually between the two of them, is conducive to sleep. The well known glass of milk might provide approximately the same minerals and a lot more calories, and I think the dolomite is an excellent supplement in that regard.
20. The valerian root, in the days when Dr. Grumbles was in medical school, was still being prescribed as one of the forms of treatment for hypertension. It is no longer prescribed in general for that, but it certainly does have a calming effect. In this dosage, or even much higher dosage, it would have no harmful effect, and again would be something that might facilitate the natural sleep without producting direct sedation. He could not say a thing about scullcap.
21. Pantothenic acid, he said, is another of the vitamin supplements that is ubiquitously needed in all the cells of the body for the utilization of the energy sources, the whole enzyme system. Without going into any specific discussion, that particular vitamin is useful.
22. As regards using a sedative as opposed to a natural product such as this for people who need some assistance in obtaining sleep, he does not like sedatives. He has had problems with patients over the years who have gone to the store and bought some of the cross-the-counter things that are available that have various alkalines in them, and so on, that can be potentially toxic. He does not find anything in this that can be toxic, and he thinks it might well facilitate sleep without putting anybody to sleep.
23. It must be acknowledged first that Natural Calm might have a placebo effect, but also the ingredients in it have a definite calming effect on the central nervous system, a reduction in irritability, the diminished excessive electrical activity of the brain that accompanies the waking state, and the agitated waking state can be relieved somewhat by these preparations or by these components of this preparation. This is not a sedative in any sense that it will put someone to sleep; it does facilitate or allow natural sleep to occur more easily perhaps by reducing the period between trying to fall asleep and actually being asleep.
24. In his opinion there is nothing in this product that could cause anyone any potential harm. Dr. Grumbles said that Natural Calm will help some people to be able to drift into sleep by reducing cerebral activity, but it is not certain that it is going to aid with everyone, but this is true with any sedative. (Tr. 653-657)
25. Dr. Grumbles said that the dosage of tryptophan that affects brain function, as determined by EEG testing, varies from 500 milligrams to two, three, four grams in some cases. He uses tryptophan or recommends it for persons with symptoms of depression or sleeping problems. The lowest dosage that he knew was available was 500 milligrams, and that is the dosage he uses for these purposes. To patients for whom he prescribes or suggests tryptophan, if it is strictly for sleep, he tells them to try one tablet for a few days. If that does not seem to be beneficial, to try two, and if two do not help, then go give up as far as tryptophan being effective for them is concerned.
26. Any preparation that is taken with the thought of sleeping certainly has a very high placebo effect in some people. He tells his patients exactly what he is giving them and something about the nature or properties of it. If somebody comes to him saying they have trouble sleeping, and he gives them tryptophan and says "This will help you sleep," the placebo effect then would be that they know they are getting a sleeping formula or capsule and, therefore, it may have some beneficial effect. He sincerely hopes that it will have some placebo effect in helping them sleep as well.
27. He has no support in published medical literature for the effectiveness of Natural Calm as a remedy for nervousness, daytime tension, or insomnia. He said that his practice would lead him to believe that Natural Calm has "some possibility" of providing help for such conditions. (Tr. 700-705)
28. After examining the list of ingredients of Natural Calm, Dr. Susser said it was his opinion that the ingestion of this product in the amounts specified by the transcript of product label would be safe for a human being, with the single exception of the ingredient "scullcap" and he has had no experience with that. He uses four of the ingredients of Natural Calm fairly frequently: tryptophan, dolomite, and pantothenic acid on a wide number of people, and valerian root on a few. Tryptophan, dolomite and pantothenic acid have all had effective benefit, in some people. He uses larger dose of tryptophan, but he has used similar doses of the dolomite and pantothenic acid and they have benefited those persons. (Tr. 769-770)
29. With his patients he uses between 500 and 2000 milligrams of tryptophan. He is not aware of any studies or scientific reports that indicate that the administration by mouth of 100 milligrams of L-tryptophan or 200 milligrams, if taken twice day, would have any beneficial effect in aiding sleep. He knows of studies which would show that some of the substances in Natural Calm do have a calming effect. The calcium in dolomite and the magnesium in dolomite, for example, definitely have a calming effect, and there are studies to substantiate that, but he has never seen studies concerning these specific ingredients combined. In his opinion the ingredients in Natural Calm could be effective in the cure of nervousness in the dosage indicated in many cases. He qualified that by saying that when one is dealing with nutrients such as tryptophan it is not a sleeping pill, it does not make a normal person sleepy. If, however, the person needs tryptophan and needs calcium magnesium and has been under stress so that pantothenic acid would be useful for him, this combination could bery well decrease nervousness and improve sleeping. All of these substances have, in certain people, been very effective in promoting sleep and relaxation. He has never used as small a dose of tryptophan, as is found in Natural Calm (100 mg.), but he usually looks for quick results so he would say that if people took it for a fairly prolonged period of time, like weeks, it could very well be beneficial.
30. In his opinion pantothenic acid in the dosage of 20 milligrams for one capsule or 40 milligrams if taken twice a day, could have some effect in the cure of nervousness. he is not aware of any studies or other scientific papers that support the last statement, but he said he knows there are some.
31. In his opinion, whether this product would be effective in curing insomnia would depend on the cause of insomnia, but it could in some people. The situation would be the same with respect to the claim that it is effective in the relief of daytime tension. If there are some people who need tryptophan, calcium and magnesium, pantothenic acid, et cetera, those people will very often respond to this type program. The way to determine if any individual needs this type of program is by therapeutic trial. There is no scientific test for it. The need would vary on an individual basis. When it was pointed out to Dr. Susser that the AMA is of the view that there are no spontaneously occurring clinical deficiencies of pantothenic acid, his response was:
"A. Yeah, I really don't care what the AMA feels about deficiencies. I really think that they are primitive in their thinking as the Royal Navy was in there approach to James Lynn's discovery of the cure of scurvy. They are doing exactly the same think now that happened 200 years ago." (Tr. 786-789)
C. Athena Nutrition for Women --(10/130) - For Improved Appearance, and Retarding the Signs and Symptoms of Aging
1. Dr. Schwartz said that it is not likely that this product would be an effective supplement for vitamin B-12 since effective B-12 therapy is by parenteral administration. There is no need to supplement riboflavin (B2) in the amount of 11,765 per cent of the RDA. For B2, or folic acid, or B6, this product would probably be an effective supplement if there was a deficiency of one of these nutrients. In the case of iron, since the dosage calls for one or two tablets daily, taking of two tablets might provide an adequate supplement, but the iron in this product generally is lower than the iron available in most of the commercially available iron preparations.
2. The product does not retard the aging process and, in the absence of a vitamin or iron deficiency, it will not prevent fatigue, prevent facial pallor, dull or brittle fingernails, figure-distorting bloating, water retention, hormone imbalance, dry cracked lips, and it will not, again in the absence of a deficiency of one or more of the ingredients, improve the appearance of hair, skin and nails or reduce hair loss or thinning. (Tr. 281-283)
3. On cross-examination, Dr. Schwartz stated that so far as any vitamin/mineral supplement is concerned, he is not aware of any study that would indicate that the general population of the United States receives a sufficient amount of vitamins and minerals in their diet. With regard to Athena Nutrition for Women, and all products sold by Respondent, he is aware of no studies made of the products, per se. He is aware, however, of studies of various components of the different products. (Tr. 306-308)
4. Dr. Hunt examined the transcript of the label of this product (CX 194) and she said that she is familiar with the ingredients. All of the ingredients are nutrients. She is surprised that the amounts are so much greater for everything other than folic acid and iron, which are the two nutrients that would be most indicated in any deficiencies in women --with iron deficiency being the most likely. In pregnancy, folic acid is a nutrient that is often a problem. Pregnant and menstruating women require iron supplementation. The product contains 30 mg. of iron per tablet. With such women the starting dose is 60 milligrams. The directions say to take 1 or 2 tablets as a dietary supplement.
5. The content of Vitamin B2 (Riboflavin) is 11,765 per cent of RDA. Dr. Hunt said that she can not imagine why that amount is used. Most of that amount would be excreted in the urine. The product will not retard the aging process or prevent fatigue unless they are due to a deficiency in one or more of the ingredients and this would probably be determined by blood chemistry. At this time the level at which water soluble vitamins become harmful has not been identified. There is always the potential for toxicity when one takes 10,000 - 11,000 times the RDA. The RDA is designed to cover all but possibly 2 1/2 per cent of the total U. S. population. People who advocate the "more is better" school of vitamin supplementation do not take into account the people who do not need anything like the amounts included in the RDA and extra large doses of nutrients can put those people at risk. (Tr. 137-141)
6. On cross-examination Dr. Hunt testified that she previously had expressed concern about the amounts of certain water soluble vitamins in this product which were greatly in excess of the RDA's. She is not aware of any study or incident that shows that anyone has ever been harmed from taking the water soluble vitamins in this product. Menstrual losses cause anemia in women, hence women need more iron than men do. Diagnosis of anemia is made by looking at the type of red blood cells. If anemia is due to deficiency of folic acid, there will be large, immature blood cells and appropriate supplementation is recommended. There is no practical way for the average person to determine nutritional deficiencies and, therefore, there would not be anything wrong or harmful in taking supplements for prophylactic reasons --if they were identified as being needed. Some deficiencies are difficult to identify and others are not so difficult, while gross deficiencies may cause obvious symptoms. People who have a marginal deficiency would, or might, not be able to recognize it, but people ought not to treat themselves, because their feeling less than normal may be caused by something entirely different than nutritional deficiency. If one asks his physician for an analysis of whether he has a nutritional deficiency, he will get such an analysis.
7. Generally, people do not eat the proper foods to get a well balanced diet, but people are becoming more aware now of eating properly and they are more interested in nutrition. About 15 to 20% of the students in the institution of which Dr. Hunt is a Professor of Nutrition and the Head of that Department take a course in nutrition. Also, while people do not select their foods as wisely as they should, this fact is recognized by many food industries and the foods are fortified with vitamins and minerals.
8. Dr. Hunt is not aware that Nutrition for Women has been tested, and, therefore, she does not know of any experiments or clinical studies that indicate that Respondent's claims for this product are false. (Tr. 171-183)
9. Dr. Ayers stated that he is familiar with the ingredients, which are the vitamin B's, iron and folic acid. He said that the product would not retard the aging process. With respect to the ability of the product to help prevent fatigue, it would not do so unless the person had a deficiency of one of the ingredients. The use of this product would help to cure the condition. In the absence of such deficiency the use of the product would be of no help. The same is true with respect to facial pallor, brittle and dull fingernails, figure-distorting bloating and water retention.
10. Of all the vitamins and minerals discussed, the one of which women are most likely to be deficient is iron because menstruating women have continued blood loss. He doubts that iron is used premenstrually. It is used for the anemia that comes from excessive bleeding. If women are not eating a diet that is adequate in iron, they do need supplementation. Sixty milligrams of iron, as permitted by the label, might be enough if taken in a preventive way. It is insufficient to treat iron deficiency, for which much larger doses are used. For instance, facial pallor is a sign of anemia. Sixty milligrams per day would not be the proper treatment for iron deficiency anemia. It would possibly be used in the prevention of it if the person was iron deficient.
11. Unless a person were deficient in the ingredients of this product, the taking of the product would not prevent hormone imbalance, and dry, cracked lips. In the absence of a deficiency in one or more of the ingredients of the product, it would not be effective in improving the appearance of the hair, skin, and nails and it would not reduce hair loss and thinning. (Tr. 367-370)
12. On cross-examination Dr. Ayers stated that it is his opinion that, in general, the United States population is not deficient in Vitamin B2. It is difficult to become deficient in Vitamin B2 if one eats a normal diet, but it has been pointed out in nutritional surveys that segments of the population may not achieve that status. The situation would be substantially the same with respect to folic acid. If one is not eating a balanced diet a deficiency can occur. Also, people in a low soci-economic level and alcoholics can become folic acid deficient. There are distinguishing features in respected to the adequacy of the amounts of different nutrients and they do not lend themselves to statements of general applicability. The answer would be generally the same in regard to Vitamins B6 and B12. Vitamin B12 is a fat soluble vitamin and it is difficult to develop a B12 deficiency without a disease process. There is a recommended dosage for a particular disease, and for iron deficiency anemia the initial recommendation is 500 milligrams and upward to replace the body stores.
13. When asked whether he knows of any studies that demonstrate that the claims made by Respondent for Athena Nutrition for Women are false the witness said that there are many statements in standard textbooks that would indicate for vitamins and minerals that, unless there is a deficiency, giving them will not improve any symptoms regarding them. There are lots of authorities that would agree with that. The claims made are symptoms of deficiency states where a deficiency state means a clinical disease. Unless it is known that that symptom or finding is due to a deficiency of that particular ingredient, it may or may not have effect, and usually the amounts in these products, with the exception of these with the thousand, ten thousand per cent of RDA, are not what are usually used to treat a deficiency state.
14. In regard to treating a subclinical deficiency state the witness said, in substance, that subclinical is, by its name, hard to come by. If it is subclinical, whether it is there is not certain. For prevention of those signs and symptoms he has no problem in the case of people who are not eating a regular well balanced diet, with giving them nutritional supplements as long as it is understood that it is being done in a preventive way. Once they have those symptoms, it is a different ball game. (Tr. 407-411)
15. Dr. Lord characterized Athena Nutrition for Women by saying that it would be beneficial for women and for some men. Women have a greater need in many cases for some of these vitamins and, for a variety of reasons, frequently do tend to be low in them. Some of the national surveys have shown a statistical finding, and on an individual case by case finding, there are reports from doctors indicating a great benefit from these vitamins. The levels are quite high. In this case, the patients get both replenishment of a nutritional deficiency and the effect of not only building up a pool but achieving a direct effect of the vitamin at a high level.
16. He would not be at all concerned about the excessive intake of these nutrients. There are all fairly high levels but he is not aware that it has ever been shown that those particular levels of those vitamins in humans would create any trouble. Deficiencies or inadequate amounts of these particular vitamins and minerals would produce examples of fatigue, facial pallor, and brittle, dull nails, cracked lips, hormone imbalance, figure-distorting bloating and water retention. Thus, supplements of these nutrients in people with those conditions would be helpful in eliminating those conditions. This also would apply to improving the appearance of hair, skin, nails and things of that nature for women, and also to general degenerative conditions if there were deficiencies. (Tr. 505-507)
17. Absent a deficiency of the ingredients stated on the label, this product would have no beneficial effects and that statement applies across the board for all the ingredients of all the nutrient products under consideration in this proceeding.
18. If a woman suffered from a condition known as iron deficiency anemia, two tablets a day of Athena Nutrition for Women would be effective or would provide beneficial effects. The intake of 60 milligrams by two capsules would be enough iron to relieve the sumptoms in a condition of iron deficiency anemia, depending on how severe the deficiency is. In the case of the population that he supposes this product is used by, which may include some frank deficiency iron states but includes a lot of borderline states that we know exist, this product would be just right. You would not want to use too much iron. This product would definitely benefit the frank deficiency state. Of course, in that case one would hop that they would go to a doctor. There are all sorts of personalities out there. A lot of people just say I am not going to go to a docto and I think I've got anemia, I don't feel too good, so I'll take some iron and they frequently benefit from it. Geritol has been doing that for a long time. If one of those persons asked Dr. Lord's opinion if he should just buy the product or go see a doctor for rion deficiency anemia, Dr. Lord would advise him to see a doctor by all means. (Tr. 538-540)
19. It is Dr. Grumbles' opinion that without question there is a need for supplements for women in particular in this country of the ingredients in Athena Nutrition for Women. He was asked if the ingredients will have benefits to women in the area of eliminating fatigue, facial pallor, brittle, dull nails, figure-distorting bloating and water retention, hormone imbalance, and dry cracked lips. He replied:
"Well, certainly the fatigue factor would be helped. The facial pallor is something I guess we don't look at as closely as people once did. I don't usually see facial pallor in women, most of them have makeup on to disguise it, so I can't really express an opinion about that.
"The matter of water retention, vitamin B6 has been reported to have some very definite beneficial effects in eliminating excess water retention.
"The B2 is beneficial in the epidermal products such as hair, nails, skin.
"B12 is notoriously deficient, and iron is a component of every vitamin and mineral supplement that I know of for women from Geritol on down in approximately this dosage."
20. As to whether there is a reasonably high percentage of women in this country who suffer from deficiencies in these ingredients, he said:
[In] A study from Rutgers University on folic acid a number of patients who were admitted to the hospital for nonchronic illnesses or for elective surgery, things that would not deplete their vitamin supplies, were tested for a large range of vitamins as a part of a federally-funded research project, and among this group about sixty percent of them had a highly significant deficiency in folic acid, and these were 'healthy' people from the vitamin standpoint as far as anyone knew.
"I think B6 is one of the most beneficial vitamins that can be taken, and, along with some of the other micronutrients, would be a boon to the health of anyone in our culture.
"Maybe I should make a comment about the very large percent RDA's listed here. I'll start with iron, which is 167 percent of the RDA according to these figures --I haven't checked them. Iron is not likely to be absorbed more than about thirty percent, so you would probably not get as much in one tablet or even two tablets as a woman might need in an active menstrual period of her life.
"B12 is something that is very frequently --I would say in probably from five to ten percent of the healthy populations, is low, and I have already indicated folic acid as being low, and B6 I think is one of the most ubiquitously needed vitamins in our present knowledge of nutrition, and B2 in this instance will certainly support nutritional needs without doing any harm whatever."
21. There is nothing in this product that he would not recommend that any member of his family take without hesitation in the recommended dosage or even greater. (Tr. 657-660)
22. Dr. Grumbles agreed that it would be correct to categorize this product, based on the ingredients listed in the product label, as a vitamin mixture. In his opinion this product will provide benefits based on the claims for the product such as retarding the aging process, affecting conditions such as fatigue, facial pallor, brittle, dull fingernails, figure-distorting bloating, water retention, hormone imbalance, dry cracked lips, improving the appearance of hair, skin, and nails, reducing hair loss and thinning. He thinks that the product could very well provide the benefit in some of these ingredients even if there is no deficiency of any of the listed ingredients.
23. Dr. Grumbles disagrees with the following statement from AMA Drug Evaluations, 4th Ed., CX 313, p. 839, under the subheading "Mixtures":
"Clinically apparent vitamin deficiencies are rare in the United States, and subclinical deficiencies are difficult to detect. Excessive use of one or more vitamins may cause relative deficiencies of other essential micronutrients, and large doses of all minerals are toxic. Also, multivitamin preparations used by adequately nourished individuals may exceed nutrient needs by several hundred percent and represent needless expense."
In stating his disagreement with the foregoing statement he said (Tr. 707):
"Let me start by saying that after about 25 years as a member of the AMA I am no longer a member of the AMA along with two-thirds of my colleagues who are not members of the AMA and who don't consider the AMA as being the final word in most matters, and I, specifically, have very often objected to many of the statements that they have made in this particular publication in various editions of it from the first one, the idea being in the statement you just read that if you eat a well balanced American diet with a variety of foods available off the supermarket shelf you won't need vitamins, and I think that is about the most preposterous claim that any supposedly responsible body of people have ever made."
24. Dr. Grumbles also disagrees with the RDA, 1980, published by the National Research Counsel. He considers the RDA as suggestion, not authoritative by any means, because he does not consider it was deribed in a very scientific manner. He feels that, based on the ingredients listed, women need this product more than men do because iron supplementation is specifically unique in the menstrually active woman more than men. The monthly hormone changes in each menstrual cycle of women certainly increases the amount of stress and at various times of the cycle there are cases when a total nutritional supplement is needed. (Tr. 705-710)
25. Dr. Susser stated that it is his opinion that the contents of Athena Nutrition for Women are generally safe when ingested by women of the United States. He said that there is a great need for supplements of this nature in the United States. His experience is that women in the United States have many complaints about their menstrual periods and that almost a hundred percent of the women resolved the complaints by nutrition. He has used many of these supplements in addition to others, and he has found that complaints such as sore breasts, painful periods, heavy bleeding, swelling, fluid retention during periods, and emotional crisis during and around menstrual periods are almost all entirely attributable to nutrition.
26. Dr. Susser commented as follows on certain symptoms listed in paragraph 3 (b) of the Complaint:
"Fatigue, facial pallor is one that I don't really look at. People I guess do look better when their nutrition improves. Fingernails do often get stronger. I get that report a lot. Bloating and water retention is something that is highly curable, avoidable during periods and, like the hormonal imbalance, I don't measure that but that is what all of these problems are ascribed to, so that is probably one of the reasons why [what] they are getting would be the balancing of their hormones, *** dry cracked lips are a classic sign of vitamin B2 deficiency, so I would think that very often that problem is cleared up by the riboflavin or B2."
He agreed that deficiencies of these ingredients would be the types of things that might give somebody the appearance of aging more rapidly. (Tr. 770-772)
27. It is correct to characterize this product as a vitamin mixture. Dr. Susser disagrees entirely with the view of the American Medical Association that vitamin deficiencies are not common. He has no problems with regard to the combination of these vitamins in a single product. The folic acid content of one capsule is 200% of the RDA. According to the directions on the label one can take two capsules which would be 400% of the RDA.
28. On page 839 of the publication AMA Drug Evaluation (CX 313) under the subheading "Mixtures," there is the statement: "Quantities of folic acid should not exceed the RDA because, although excessive amounts produce a satisfactory hematologic response in pernicious anemia, the neurologic symptoms of this disorder worsen." The witness commented that the quoted statement only applies "if you don't give adequate B-12 with the folic acid and if you have pernicious anemia."
29. Dr. Susser is aware that folic acid in high dosage will mask the ability of a physician to detect B-12 deficiency if he does not have an index for suspicion for it. That is standard medical knowledge, and any physician treating or suspecting megaloblastic anemia, should suspect B-12 deficiency and ask about folic acid because that is one of the things that is widely taught in medical school and widely reported.
30. Dr. Susser does not know that a person with a B-12 deficiency who takes this product will suffer progressive neurologic impairment. If a person with B-12 deficiency, which is really rare by the way in the pernicious anemia assumed in this situation, which requires injectable B-12, but if he took this dose of folic acid, 800 micrograms, which is really only twice the recommended allowance, the witness doubts very much if that dose would mask the B-12 deficiency, although it is possible. He has seen one case of original pernicious anemia in 14 years in a very busy practice, and he has seen a lot of benefits from folic acid. Sometimes one has to balance the risks. This is not a great risk, even to a person who has pernicious anemia.
31. The following further cautionary statement was read from page 829 of the same exhibit.
"Except during pregnancy and lactation, folic acid should not be given in therapeutic doses greater than 0.4 milligrams daily until pernicious anemia has been ruled out. Patients with pernicious anemia receiving more than 0.4 milligrams of folic acid daily who are inadequately treated with Vitamin B-12 may show reversion of the hematologic parameters to normal, but neurologic manifestations due to Vitamin B-12 deficiency will progress. Doses of folic acid exceeding the RDA should not be included in multivitamin preparations; if therapeutic amounts are necessary, folic acid should be given separately."
Based on the above discussion of pernicious anemia and B-12 deficiencies, Dr. Susser stated that conceivably there could be a health hazard or problem in rare cases related to use of this product, two tablets a day, with the folic acid content thereby being about 1600 micrograms.
32. The witness said that in the absence of a deficiency state of any of the ingredients of the product Nutrition for Women, this product has no beneficial effect in retarding aging or preventing conditions such as fatigue, facial pallor, brittle, dull fingernails, figure-distorting bloating, water retention, hormone imbalance, dry cracked lips, and with respect to improving the appearance of the hair, skin and nails and reducing hair loss and thinning. He reiterated his view, however, that his definition of deficiency is different from the AMA's and that he thinks this deficiency is widespread among women. (Tr. 789-798)
D. META-E --(10/131) - To Retard the Aging Process,Break Down Fats and Cholesterol, Improve Hormone Production, Sexuality, Potency, etc.
1. Dr. Schwartz stated that it may later be established that increased amounts of selenium and Vitamin E may provide some benefit in improving the level of free radicals, but to date there is no clinical evidence of this projection. (Tr. 286-287) Aside from this possibility, however, in the absence of a Vitamin E deficiency there is no need for Vitamin E supplementation. In the absence of a deficiency of Vitamin E, this product would not (a) help the body cells utilize oxygen more efficiently so that the aging process is slowed down; (b) break down fats and cholesterol in blood vessels; (c) have a healthy effect on sterility by improving hormone production. In the absence of Vitamin E deficiency this product will not promote the lungs' self-healing mechanism, bolster the body's immunity response to bacteria and infections, or protect skin from environmental pollution. (Tr. 293-297)
2. He is not aware of any study that would indicate that the general population of the United States receives a sufficient amount of vitamins and minerals in their diet. He is, thus, not aware of whether the average American receives sufficient amounts of each and every vitamin available. There are studies of various components of the products, but not of the individual products in toto. There is current thinking that if someone takes supplemental selenium and supplemental Vitamin E, he may be helped in terms of getting rid of exogenously ingested or inhaled free radicals. He is not aware of any toxicity in human beings from taking oral supplements of Vitamin E. (Tr. 307-310)
3. Dr. Hunt reviewed list of ingredients and said that it contains two nutritional ingredients: Vitamin E, and the choline that is in lecithin, but latter is not a nutrient. In the absence of a known Vitamin E deficiency, no supplementation with Vitamin E is needed. Vitamin E is very widely distributed in nature and it is derived from, among others, the following sources: plant oils like safflower, sunflower seed, and cottonseed oil and wheat germ. Instead of 1333% of RDA as stated on the label, by the 1980 RDA the content of Vitamin E is 4000% of RDA. One or two capsules daily may yield as much as 8000% of RDA. This could have implications of toxicity. The product will not help body cells utilize oxygen more efficiently and slow down aging. The product will not help break down fats and cholesterol in blood vessels. Only Dr. Shute in Canada says it will. U. S. clinicians have never been able to replicate Shute's results.
4. It has not been shown that Vitamin E has a healthy effect on sexuality, potency, and hormone production. The theory is based on studies with rats, but no one has been able to demonstrate it in humans. Vitamin E is extremely important in protection of the lungs, but if there is no deficiency, no supplementation is needed. The product will not, in the absence of a deficiency, bolster the body's immunity responses to bacteria and infections. The product will not protect the skin from environmental pollution. (Tr. 141-143).
5. On cross-examination Dr. Hunt said she does not think there is much interest in Vitamin E as a supplement in the field of nutrition today. Vitamin E is still under research, but people have just about given up on it because it has never been demonstrated that Vitamin E could have the effects in humans that it has in animals, and, furthermore, it is almost impossible to get a deficiency of Vitamin E unless there is a malfunction syndrome. Recently there was work done trying to show that Vitamin E could be effective in preventing the aging of cells. The researcher, a Dr. Tappel, eventually, four or five years ago, gave up, saying it was a dead-end street. Dr. Hunt agrees with the statement that "A powerful new method for the direct measurement of lipid peroxidation in the living animal has been discovered. This method showed that lipid peroxidation occurs in vivo in consequence of Vitamin E and selenium deficiency, and strongly supports the hypothesis that Vitamin E functions biochemically as an antioxidant." (appearing at top of p. 84, RX 4, extract from Nutrition Reviews, March 1978).
6. Commenting on RX 5, an article entitled "Nutritional Influences on the Toxicity of Environmental Pollutants" in Archives of Environmental Health, Feb. 1974, the witness stated that she has heard of the publication, but does not see it often. She did not know the author, but she said that he has taken information obtained by experimental work with rats and extrapolated it to humans, which is a very dangerous thing to do.
7. RX 6 was identified as an excerpt from the August 7, 1970, issue of Science Magazine, which Dr. Hunt said is a reputable publication. The excerpt is an abstract by Dr. Bernanrd D. Goldstein, Dept. of Medicine, New York University Medical Center, Goldwater Memorial Hospital, New York, NY, and Raymond D. Buckley, Ramon Cardenas and Oscar J. Balchum, Departments of Medicine and Biochemistry, University of Southern California School of Medicine, Los Angeles, California. The head-note says:
"Abstract. Vitamin E deficiency in rats is associated with a greater susceptibility to lethal levels of ozone. Exposure of rats to sublethal ozone concentrations produces an accelerated decline in serum vitamin E levels. These findings are consistent with the possibility that lipid peroxidation is a mechanism of ozone toxicity."
Dr. Hunt agrees that Vitamin E is very healthful in preventing peroxidation. She would not disagree with any part of the article. This item is, as indicated, an abstract of a report of a study, or studies, of experiments with rats. She has never conducted or observed experiments with Vitamin E to determine whether Respondent's claims for META-E are true or false. (Tr. 183-205)
9. Dr. Ayers testified that vitamin E is so ubiquitous in what we eat that to create a deficiency of Vitamin E you have to work at it. Under some conditions Vitamin E may be deficient, but they are extreme conditions. This product will not help body cells utilize oxygen more efficiently so that the aging process is slowed down inside and out. Vitamin E has been implicated in the transport system for some of the lipoproteins, the fat substances. In that settling it is one of several things that may affect the development of atherosclerosis. It is very unlikely that this product would have any effect on established atherosclerosis. In the absence of a Vitamin E deficiency, META-E will not: have a healthy effect on sexuality and potency; promote the self-cleaning mechanism of the lungs; bolster the body's immunity response to bacteria infections; or protect skin from environmental pollution. (Tr. 370-371)
10. Because it is very prevalent and because it is fat soluble, it is very difficult to get a deficiency of Vitamin E. He knows of no one who has experienced a toxic effect from taking oral supplements of Vitamin E. It is generally agreed that it is a scavenger of free radicals.
11. Vitamin E, of all these vitamins and minerals, is the one about which there is most uncertainty. There are people who very strongly believe that taking that particular vitamin does things; there are certainly those whose views are to the contrary. It is, of all the ingredients discussed in this proceeding, the one concerning which there is most controversy. Among scientists working in the field there is dispute.
12. Commenting on Respondent's claims that META-E breaks down fats and cholesterol in blood vessels, the witness said:
"I think that one is pretty well put in the category that the original research didn't pan out, and I think that we could find, although I can't cite them chapter and verse to you, that that particular area is not one which even the people working in the field claim any more."
13. With regard to the remainder of the alleged representations set forth in the Complaint, the witness commented as follows:
"'Meta-E helps your body cells utilize oxygen more efficiently so that the aging process is slowed down inside and out.' I categorically disagree with that.
* * *
"'Vitamin E by improving hormone production has a healthy effect on sexuality and potency.' That one I don't believe --that one I disagree with, but I know there are people who would argue the opposite.
"That 'Meta-E will effectively promote the lungs' self-cleaning mechanism.' I disagree with.
"That 'Meta-E will effectively bolster the body's immunity response to bacteria and infections.' Again I disagree with all in this setting unless they are deficient in Vitamin E.
"And finally to 'protect the skin from environmental pollution.' I categorically disagree with the same qualification--unless they are deficient."
14. There are people who feel that Vitamin E is particularly important in providing protection from environmental pollution. Dr. Ayers would accept the argument as scientific controversy, but he does not accept the stated conclusion. In reviewing such claims it is important to look at when they were made relative to the intense work that has been done with this vitamin over many years. Reports even as recent as five or six years ago have subsequently been proved not to be so. It is an active area of research, there is active controversy, and some original claims, although they are in print, have not been substantiated. (Tr. 411-415)
15. Referring to the ingredients of META-E Dr. Lord said that this is simply a vitamin and essential nutrient. There have been some very well known benefits of these nutrients, but for these there is not so clear a picture of what they do, so far as the specific biochemical role is concerned, but certainly they exert a protective role in providing an essential substance at least in vitamin E, and in the wheat germ oil. The lecithin is one of those components which the body can produce, but any animal you take completely off lecithin, or deplete it to a large degree, will exhibit deficiency symptoms for the essential fats. This is basically what the product contains.
16. As to the product's capability of helping the body cells utilize oxygen more efficiently so that the aging process is slowed down, Dr. Lord testified that this is where the specific role of vitamin E is thought to exist; that vitamin E can absorb or remove peroxides and epoxides and any kind of free radicals from the cell and prevent cell damage.
17. There have been reports that Vitamin E benefits athero sclerosis. One of the problems in atherosclerosis is the fact that normally the arterial walls degenerate as a result of lack of oxygen. What Vitamin E is thought to do is benefit the body in both the control and turnover of cholesterol as one of the fat components of membranes and all tissues.
18. In its role as a scavenger of free radicals, it helps promote the lungs' self-cleaning mechanism, bolsters the body's immunity response to bacteria and infections, and protects skin from environmental pollution. He said that those are all ways of stating the end product of any derangement involving free radical accumulation or fatty acid oxidation. All of those can be the result of that process, and Vitamin E helps prevent that from occurring. (Tr. 507-509)
19. Dr. Lord understands that supplementation with Vitamin E is effective for a person suffering from arteriosclerosis. This understanding is based on some of the articles he has read. Although he can not give citations on those articles he has read. Although he can not give citations on those articles either, there have been a number of studies of Vitamin E in arteriosclerosis and, although the findings were positive, they were not strongly positive and have been contested. But there is some evidence that it is effective. Hebelieves that Shute ( a Canadian doctor) is one of the names that is most often mentioned.
20. He has read that levels of Vitamin E generally ranging from 200 International Units up to 1200 are effective in cases of heart disease both in decreasing arterial lesions and in improving heart function directly, by improvement in muscle function. He stated that he has seen those reports from more than one researcher. He added that there are some limits on the total amount of Vitamin E intake. The dietary intake of Vitamin E can range tremendously up to 2000 Units per day without much trouble. You can easily consume that much in the diet. So, it depends on that factor also. One could postulate that if someone is taking in 2000 Units in their diet and they get 800 to 1200 Units additionally, they should not do that more than two or three months. That would be a peculiar diet that they should not continue anyway. Assuming the kind of diet that is commonly consumed in this country, we are talking about not the people that are going to get themselves in trouble from using the wrong kind of dietary supplements. But for people who just are not paying much attention to diet, he does not know of any evidence that the inclusion of 400 to 800 units a day has a detrimental effect over years of use. (Tr. 540-543)
21. Insofar as Dr. Grumbles is concerned, the only ingredient in META-E that has any potential for being harmful to anyone is Lecithin, if someone happens to be allergic.
22. In his opinion there is a need in the population of the people of the United States for supplements of the ingredients contained in the product, META-E. He said that the benefits of Vitamin E are almost too numerous to try to enumerate. It has been very well established as having the effect of allowing the body cells to utilize oxygen more efficiently. It has been demonstrated to have an antioxidant or free radical eliminating property, especially along with other micro-nutrients. It has also the property of, in a number of instances in his experience, helping to significantly lower the blood cholesterol. He would have no hesitation in suggesting that along with the element selenium, with which it is almost interchangeable at times, it facilitates the cells. Each has a synergistic effect to the other, to help eliminate the pollutants from the air we breathe daily, especially in our large metropolitan areas like the northeast or wherever else we might be, even in the lovely sunshine of California, the smog, and on the basis od reducing the oxidant, it does have some possibility definitely of slowing the aging process. (It is not clear whether Dr. Grumbles made the last statement in contemplation with selenium. Selenium is not shown to be an ingredient of META-E.)
23. It is his opinion that META-E helps break down fats and cholesterol in the blood vessels. It is his opinion, also, that the product helps improve hormone production, and thus has a healthy effect on sexuality. He said that there have been numerous experiments showing the relationship between Vitamin E and sexual maturity and the sexual functions. It also provides some of the substance for the production of hormones. He feels that META-E will effectively promote the lungs' self-celaning mechanism, bolster the body's immunity response to bacteria and infections and protect the skin from environmental pollution. (Tr. 661-663)
24. Dr. Grumbles cited the work of Dr. Wilfred Shute of Canada as supporting the claims made by Athena products for META-E. That work, according to Dr. Grumbles, supported Vitamin E's effectiveness, first, in sperm mobility and, along with that, use of it in heart disease. He also referred to Dr. Alvin Oschner, who was professor of surgery at Tulane University for 35 years and who founded Oschner Nutritional Clinic. He said that Dr. Oschner wrote at least two papers in 1954 and 1955 in which he described Vitamin E as being the preparation of choice in the treatment of angitis or thrombo phlebitis.
25. It is Dr. Grumbles' opinion that the dosage of Vitamin E contained in this product, one or two capsules of 400 International Units, each, is sufficient to help the body's cells utilize oxygen more efficiently so that the aging process is slowed down inside and out. He regards 400 units as an effective dose, but he often uses as much as 2000 units, usually 800 to 1200. In the dosage he uses in his practice he has not detected any adverse effects as the result of administering those high doses, and he observes his patients carefully. He said there is some report that Vitamin E may tend toward increased hypertension. When he has a patient with indications toward hypertension, he gives smaller Vitamin E and builds up to larger doses. He has never had a patient show any slight elevated blood pressure.
26. He said that Dr. Shute reported that rheumatic heart disease did not respond well, and, in fact, may respond adversely to Vitamin E. He repeated that he has not observed the so-called toxic symptoms of Vitamin E, and he said that he has used very large doses of it over a long period of time.
27. The following opinion on Vitamin E is from the AMA Drug Evaluations (CX 313, p. 826):
"Excessive use of Vitamin E may deplete vitamin A stores, although doses if 300 to 400 IU daily may be taken for prolonged periods without adverse effects. However, the long-term use of 400 to 800 IU daily have been reported to produce nausea, muscular weakness, fatigue, headache, and blurred vision in a few patients and, excessive large doses" [indicated here to be 2,000 to 12,000 IU daily] "have been reported to cause gonadal dysfunction, creatinuria and gastrointestinal upset." Cited in Hayes and Hegsted, 1973. In the next sentence it is stated: "Symptoms disappeared within a few weeks when excessive doses were discontinued."
Commenting with respect to the foregoing quotation, Dr. Grumbles said he does not give single supplements in large doses without a total nutritional program, including whatever supplements are necessary. He makes sure his patients have enough Vitamin A, for example, and he has never had any of these symptoms, except in a very rare person who happend to be allergic to wheat, and this produces all sorts of symptoms. He suspected that in in the AMA reported studies such factors as wheat intolerance were not investigated and these may have caused some of the symptoms the patients had, rather than the actual Vitamin E. He said that is his opinion, but he could not say that it represents what actually occurred. He would regard it as dangerous to use this product for his patients without any Vitamin A content. (Tr. 717)
28. The witness said that evidence has been advanced to show that Vitamin E does provide some protection against environmental pollutants that tend to increase the amount of free radical excesses in the body.
29. Dr. Grumbles disagreed with the following statement from the AMA Drug Evaluations (CX 313, p. 826):
"There is no evidence to support the efficacy of Vitamin E in the numerous conditions for which it is popularly used. Large doses do not protect against arteriosclerosis, cancer, pulmonary damge from air pollution, or deterioration from aging and Vitamin E is ineffective in flammatory skin disorders, habitual abortion, heart disease, menopausal syndrome, infertility, peptic ulcer, burns, porphyria, and neuromuscular disorders." (Tr. 713-718)
30. In regard to the safety of taking, as directed, a product consisting of the ingredients of META-E, Dr. Susser thinks there is a very small likelihood of harm. (Tr. 772) There have been reports of Vitamin E causing hypertensive problems in people who already have excessive hypertension, but he has not had that problem with thousands of people he has put on Vitamin E doses like this. There is the possibility of allergy because a lot of people are allergic to wheat and soy, which is caused from the oil from which Vitamin E is made. There are generally not serious allergies, there are generally warning allergies.
31. In his opinion supplements of META-E would be beneficial within the United States. He cited three instances, including the following two. First, he gave one patient Vitamin E for a heart condition and the patient's potency improved. Dr. Susser did not know that he had a potency problem, and he did not know that Vitamin E was legendary for potency. Secondly, he takes Vitamin E himself. He has been taking 2400 units of Vitamin E a day for about nine years, and he started taking that almost accidentally. Prior to that time he had been taking 800 units of Vitamin E a day, and, one day, he twisted his knee. It swelled up and he wanted to play tennis the next weekend, and important game, and so he moved his Vitamin E to 2400 units a day. A chronic back problem that he had had for years suddenly got better on 2400 units a day. Every time he started to decrease his Vitamin E to less than 2400 units a day his back would start to stiffen up again. He did not take it for his back in the first place and now, some nine years later, if he does not take Vitamin E for three or four days, his back starts to stiffen up again. He stated that he has used this information on many patients with similar kinds of results.
32. As to whether Vitamin E would help the body cells utilize oxygen more efficiently so that the aging process would be slowed down, he does not know the mechanism of whether it is through oxygen or what, but he thinks that Vitamin E is an anti-aging factor. He said that he does not know whether META-E breaks down fats and cholesterol in blood vessels, but he speculated that is very well coud. On the question of whether Vitamin E helps protect from environmental pollution, he thinks it does because Vitamin E is a known antioxidant factor. Free radical formations, which are oxidizers, are formed through environmental pollution, through toxicity and through radiation. (Tr. 772-774)
33. Dr. Susser stated that he knows of support in medical science supporting his conclusion that META-E can help the body cells utilize oxygen more efficiently so that the aging process is slowed down inside and out. He said that there are literally thousands of studies on Vitamin E supporting this proposition at a biochemical level. He referred to studies of Leonard Haffleck, Richard Passwater, Wilfred Shute and Linus Pauling which he said indicate that Vitamin E supplementation increases life expectancy. He was not aware, however, of any valid controlled clinicals trials in humans that would support his opinion with regard to the stated claims.
34. He could not state with any reasonable medical certainty that this product, META-E can break down fats and cholesterol in blood vessels. He said he knows there are studies that show it has an effect on blood vessels, and the fats and cholesterol in blood vessels, but he can not recall the studies, or any studies involving humans.
35. With regard to the claim that Vitamin E, by improving hormone production, has a healthy effect on sexuality and potency, Dr. Susser said there is a study done at Johns Hopkins just recently which showed that Vitamin E in women improved cystic breast disease. That study was just published recently and that would mean improvement in hormonal function of these women. He does not know if there was a direct response in sexuality but it was certainly a secondary sexual organ that was affect by it. He did not know whether in the study that he just referred to hormone levels were measured.
36. With respect to the remaining claims for META-E, he was not aware of any controlled clinical studies that would support the claim that this product will effectively promote the lungs' self-cleaning mechanism, bolster the body's immunity response to bacteria and infections and protect skin from the effects of environmental pollution. He did say, however, that any study he has seen has flaws in it. He is aware that the specific claims for META-E just read are contrary to the opinions of the American Medical Association. He reviewed the last paragraph that starts in the left-hand column, on page 826 of AMA Drug Evaluations (CX 313 which reads: "There is no evidence to support the efficacy of Vitamin E in the numerous conditions for which it is popularly used. Large doses do not protect against aretiosclerosis, cancer, pulmonary damage from air pollution, or deterioration from aging, and vitamin E is ineffective in inflammatory skin disorders, habitual abortion, heart disease, menopausal syndrome, infertility, peptic ulcer, burns, porphyria, and neuromuscular disorders."
He then said:
"I disagree with many of these claims. I have had good results in many women with menopausal syndrome, I have had superb results with burns, I've had some good effects with neuromuscular disorders, I've had some effect with infertility, I've had some effect with arteriosclerosis. So many of these things --and porphyria does respond to Vitamin E, so I think this paragraph is suspect."
37. He is aware that the dosage of this product, two capsuls being 800 International Units combined, of Vitamin E, is in excess of what the American Medical Association views as a safe dosage for Vitamin E. He said, however, that he takes 2400 units a day and has done so for nine years. He routinely puts patients on doses in this range and has done so for about ten years without seeing any adverse effects from it. He knows of hundreds of other physicians who practice similarly and although that does not constitute a controlled study, it is certainly a very wide experience. (Tr. 798-803)
38. Dr. Golden said that he thinks Vitamin E can make many people live to 87 (which is construed to mean that he thinks oral supplementation of Vitamin E is safe). There is scientific proof that Vitamin E acts as an anti-prostaglandin, or has an anti-inflammatory effect. It has reduced intermittent claudication in people with peripheral vascular disease because it acts to increase the good prostaglandins which diminish platelet aggregation and offset the bad prostaglandins. It improves our peripheral circulation and, while he can canot quote or cite articles on it, he is sure there is enough written about them. Vitamin E is an anti-oxidant and it also helps to offset the effect of pollutants in our air that we breathe, pollutants and chemicals that we take into our body, so it has that good effect. The other ingredient is lecithin, which is converted into choline and choline has been used excessively in Alzheimer's disease, with excellent results in some, but good results in many, and certainly no harmful effects in any. Dr. Golden said that wheat germ has the complete B complex group, so he thinks this is an excellent formula, he sees nothing wrong with it, and he sees nothing harmful in it.
39. It is his opinion that there probably are deficiencies in Vitamin E in particular in the American population. There must be deficiencies because Vitamin E is a fat soluble vitamin. As we get older, we may not have enough bile coming out to digest the foods containing fatty substances and absorb them into our system. Older people do not eat well. Kids eat fad diets, so conceivably, we do not get enough Vitamin E, and there is no way of making Vitamin E in our body. He said it is empirical that Vitamin E is needed because there is a definite therapeutic response to Vitamin E in many patients.
40. In his opinion META-E definitely helps the body cells utilize oxygen more efficiently so that the aging process, itself, is slowed down and inhibited. He said that Vitamin E has been shown to decrease cholesterol lipids and it has a lipidatrophic factor, together with other substances such as C, possibly selenium, possibly other minerals and vitamins. It is not only one vitamin that can do this. It is really everything working in synergy with other vitamins and metals because the metals work as co-enzymes with the vitamins.
41. It is his opinion that Vitamin E is beneficial in improving hormone production; in protecting the skin from environmental pollutants, bolstering the body's immunity response to bacteria, and promoting the lungs' self-cleaning mechanism. (Tr. 829-833)
E. Food for Thought --(10/132) - As An Aid to Memory Coordination, Alertness, Intelligence, and to Alter Cell function
1. Dr. Schwartz is familiar with the ingredients of Food for Thought and he said that while particular ingredients of the product are normal constituents in the body of nerve, nerve membrane, and nerve transmitted systems, the exogenous administration of these ingredients would not affect brain function. The body syntheisizes its own L-glutamine and there is no need for supplementation of this substance. There is no support in the scientific literature that L-glutamine is capable of increasing intelligence. The product would not be an effective brain stimulant. It would not be, and it is not, an effective remedy for forgetfulness, low I.Q., lack of concentration, poor coordination, reduced alertness, or cloudy thinking. Ingested RNA will not alter cell function and ingested L-glutamine, as presented in this product, can not measurably raise intelligence abilities. (Tr. 284)
2. Dr. Hunt said that the nutritional ingredients in this product are L-glutamine, a non-essential amino acid which does not really have to be taken in from food, but it is considered a nutrient, the choline (B12) that is in lecithin, methionine and whether inositol is a nutrient is "sort of questionable." There is absolutely no known deficiency of L-glutamine, which is really gluconic acid with an extra amine group added to it. Glutamine is not incorporated into many proteins but it is a way that the body has of handling excess ammonia, among other things. L-glutamine supplementation would have no effect on the brain function of people who are normally able to convert gluconic acid to glutamine. The product would not be an effective brain stimulant because the central nervous system depends almost totally on glucose for nourishment. The product would not be an effective remedy for forgetfulness or for low I.Q. except for mentally defective children who have an enzyme defect that prevents gluconic acid from being converted to glutamine. The product is not a remedy for lack of concentration, poor coordination, reduced alertness, or cloudy thinking. Ingested tablets of RNA can not alter cell function and L-glutamine can not measurably raise intelligence abilities. (Tr. 144-147)
3. On cross-examination there was identified as RX 8, a paper entitled "Effect of Glutamine on IQ Scores of Mentally Deficient Children" given before the symposium on Physiologically Active Trace Substances, 11th Southwest Regional Meeting, American Chemical Society, Houston, TX, Dec. 1, 1955. Dr. Hunt has never seen any experiments with the use of glutamine with people who were not classified as mentally deficient because glutamine is not an essential amino acid. The witness was asked whether, since mentally deficient children were helped with glutamine supplementation, isn't it likely that some of the benefits could be realized by people who are not deficient. The reply was that the given conclusion would not follow from the stated premise because if people not mentally deficient had been helped, much would have been reported about it in the literature since 1955, and this has not been the case. To determine whether glutamine would be helpful to someone who was not mentally deficient would require a controlled experiment --people with substantially the same I.Q. in a double blind study so no one would know who was getting the placebo, and then the change in I.Q. would have to be measured for both groups. Dr. Hunt has not observed or conducted any experiment, and is not aware of any experiments or clinically controlled studies conducted by other persons, to determine, or which demonstrate, that Respondent's claims for Food for Thought are false. (Tr. 207-213)
4. Dr. Ayers stated that the body synthesizes its own L-glutamine in such quantity that there is no need for supplementation of L-glutamine. In normal people who are not in some mal-nourished or otherwise abnormal state, L-glutamine is not capable of increasing intelligence. It is not an effective brain stimulant. Food for Thought is not an effective remedy for forgetfulness, low I.Q., lack of concentration, poor coordination, reduced alertness, or cloudy thinking. The RNA content in this product would not be capable of altering cell function. L-glutamine can not effectively raise intelligence and thinking abilities.
5. If a person were deficient in vitamin B12, supplements of vitamin B12 alone, would not help improve memory. This is so because the process of absorption of that factor requires other coactive products. There is an intrinsic factor from the stomach lining, and so on, so that unless it were given by injection, as opposed to ingestion, it may or may not be effective. The ingredients in Food for Thought were not studies in these nutritional surveys previously mentioned because, with the exception of methionine and vitamin B12, the body makes them all itself and they are not considered essential.
6. On cross-examination Dr. Ayers said that he has seen studies with the lipotrophic agents inositol, choline and lecithin which show that they have no known effect for humans as opposed to rats, and there have been studies where people have given these in an attempt to improve fat metabolism, particularly, and they have been shown to be of no benefit. (Tr. 415-418)
7. Dr. Lord testified that Food for Thought could be beneficial as an oral diet supplement. Some of the components are simply recognized vitamins or essential amino acids and the inclusion of the nutrients that are in this product in the proportions that they are used is apparently aimed at improving nerve function or, at least, sustaining the support of nerve function. Glutamine is a compound that is recognized as being able to penetrate the blood-brain barrier, although it is not an essential amino acid because the body can make it, so here again we are talking about, in those individuals who have evidence of neurologicial impairment, glutamine is one dietary component that can be beneficial just by assuring that the supply of primarily the amine groups which glutamine is integrated into is sufficient. Methionine, similarly being a methyldonor, is required for protein production. Inositol is a nutrient that occurs specifically in nerve cells in high concentration and is found in not any other tissues. Lecithin presumably is included here because of the requirement for an intact membrane function in nerve cells. Lecithin is a vi‚l component of membranes.
8. For the individual who is depleted of any of the nutrients, (yes,) this product will be of benefit specifically in brain function. The nervous system is frequently in the nutritional segment one of the first tissues to show response in terms of simple aggressive behavior in the study animal for example, hyperkinesis in human children, and so on, so (yes,) these nutrients are all known to have supportive roles in nerve function within the brain function, with neurological consequences.
9. The vitamin methionine is one that tends to be limited in the diet, and with respect to the lecithin amino acid, and vitamin B-12, there is evidence of their importance to the population's energy level. Anyone who is on a vegetarian diet, which is quite a fad these days, probably would need the benefit of extra B-12. Lecithin is not established as an essential component in the diet, but a diet that is deficient in lecithin leads to nervous system impairment.
10. The dosage of L-glutamine is going to be a healthy or a small dosage, depending on the diet. Some diets would supply fairly limited quantities of amine precursors and in that case, L-glutamine would benefit. After a meal is consumed a supplement like this could be taken. There is a period of elevated blood level of both glutamine and glutamic acid, and it is elevated more with this product included than it would if it were not there. Therefore, it would be beneficial. (Tr. 509-512)
11. On cross-examination, the witness said that there have been some studies on improvement in mental function when glutamine was added, comparing a study group to a control group, but he was unable to give names and references. he said that when the body synthesizes cell nutrients, it uses exogenous lecithin and, also, it makes its own. Exogenous lecithin greatly enhances the intestinal uptake of all fats and, therefore, one could say that the exogenous lecithin is needed, or certainly beneficial, in the body's building up of its own membranes. (Tr. 547-549)
12. Examining CX 136, Dr. Grumbles stated that there is nothing in the product, Food for Thought, that has any potential harmful effect by consumption in oral tablets as directed. In his opinion there is need in the American population for the supplementation of the ingredients listed on this exhibit. They would be helpful to many people, but he could not say there is a universal need for it.
13. He listed some benefits which he said would be derived from the consumption of this type of product. He does not think it can be said that L-glutamine is going to make everyone smarter, but with people who happen to be a little dull or retarded, it might make them smarter. It would not increase the population's I.Q. by giving them L-glutamine, but he thinks it can serve a very useful purpose.
14. He discussed Lecithin and choline bitartrate together. Lecithin is an excellent source of choline, itself, for the fossil acids that are very essential to nerve functions and a major component of the covering sheaths of the nerve cells and nerve fibers. A more specific usefulness of this product that has been demonstrated is that choline has been found and has been documented to have an effect in preventing and benefiting a condition known as cardiokinesia, an enormous amount of which "we psychiatrists have been guilty of creating by giving the anti-psychotic drugs." The choline in the product has particular usefulness in providing the actual choline which is probably the most important single nerve transmitted in the body.
15. He referred to his discussion of RNA found in paragraphs A 35 through A 66.
16. The DL-methionine and inositol are very important lipotrophic factors which have to do with the body's utilization of fat and actually supporting liver metabolism.
The methionine happens to have a substance that is an antagonist to several of the metals that we refer to our industrial civilization, among which are cadmium and mercury, and this substance is so highly radical that it attaches to these heavy metal molecules or substances in order to eliminate them from the body. He referred to his discussion of Vitamin B-12 in connection with Athena Nutrition for Women (supra, Par. C. 20).
17. He commented that this combination, Food for Thought, could very well be a nice insurance factor without saying it is going to make everybody a genius. He feels that there are people who could have a need for supplements of these types of ingredients. He feels that, generally speaking, supplements of these types of ingredients to those people are going to aid the brain function. One of the most important things in any study of nutrition, nutritional supplements, micro-nutrients, must be the very real appreciation of the fact that when we discuss nutrition, there is no way we can discuss any single nutritional substance as being the essential product for any particular process in the body. It is, rather, the total, all-inclusive, symphonic organization of all of these nutritional substances for the body working together that facilitates any one single function of the body. The more of them we have working harmoniously together at any one time, the more likely you will have beneficial effects.
18. If a patient has a diet from which he generally is receiving sufficient quantities of almost all vitamin and mineral nutrients, but has a deficiency of maybe one or two or three, he may, nevertheless, get the overall beneficial effects of having a complete nutritional diet. All people need all substances but not all supplements. If there is a particular patient who is experiencing forgetfulness and memory loss, something of this nature, the doctor would not necessarily prescribe to him every vitamin in the world, but he might selectively determine which vitamin or mineral supplements he needed because of a particular deficiency. (Tr. 663-669)
19. Dr. Grumbles is aware of studies, published articles, that support his view that Food for Thought, being a product containing all of the ingredients listed on CX 1 36, would be effective for the claims made. He said that in his direct testimony he went over each ingredient specifically and "I did not cite literature, I can do so, not at the moment, I don't have it at my thumb, I don't really study these things to be able to cite literature on them at the moment, but Glutamine I mentioned, the studies on choline and lecithin are very well supported in literature." He said that he discussed RNA. DL-methionine and Inositol are both important, he said, because they have a lot to do with metabolism of the brain and, oddly enough, that is one of the highest lipid contents of the body.
20. Dr. Grumbles testified that he reads a lot of material published in book form, which is always a few days out of date. He also reads publications in the field of nutrition in a number of the journals, such as NUTRITION, the AMA, TIME magazine. READERS DIGEST and LADIES JOURNAL. He said he is very serious about those last three because they are often ahead of the medical journals. He said that he did not do any particular research in preparing his testimony for this hearing and that, as a matter of fact, he felt quite derelict that he didn't because he knew that if asked these questions he could have answered.
21. He feels that the dosages of the various ingredients are adequate to give some degree of insurance against deficiency. He preferred to say the dosages provide a greater possibility of achieving optimum nutritional balance. (Tr. 710-713)
22. Dr. Susser examined the list of ingredients of Food for Thought shown on CX 136 and said that he saw nothing that could be harmful. All of these substances in one way or another have been reported to have some benefit for brain processes. A large part of the brain substance is made up of choline, and lecithin has choline in it in a somewhat different form. Certainly B12 is necessary for proper brain function. Glutamine has been reported to have an effect on thinking, and he related an experience in which he gave glutamic acid hydrochloride to a lady as a digestive aid, and she cam back and told him how it had cleared up her thinking. This experience gave him a lot of incentive to use glutamic acid more and more. He said that he has a lot of low-energy, cloudy-thinking people coming to him, and that glutamine has been very effective with these patients. (Tr. 775-777)
23. Dr. Susser's replies to questions on direct examination in which he said that he is aware of some beneficial effects from the ingestion of Food for Thought in terms of its being an effective brain stimulant, effective remedy for forgetfulness, low I.Q., lack of concerntration, poor coordination, reduced alertness, cloudy thinking were supported by "mostly personal experience." He referred to studies out of MIT which showed the effectiveness of choline and lecithing and there have been reports, the citations to which he could not recall, that glutamine have an effect on mentality. He said that he personally has seen RNA have an effect on mentality.
24. When he sees improvement in some cases when people take supplementation of L-glutamine, to him that means they need it. He gives many products in a group. When something is not working well, if some other problems come up or the problem does not get better, he will add things one at a time and, in a sense, that isolates the product. He has had good response to L-glutamine in that kind of isolation.
25. L-glutamine, 300 milligrams, or taken twice a day --600 milligrams, would not to his knowledge, in any way, based on any valid controlled clinical trials or authoritative scientific publications, be capable of measurably raising intelligence and thinking abilities. (Tr. 803-804)
F. Ex-Sel --(10/133) --To Overcome Selenium, Deficiency, Retard Aging, Prevent Oxidation, Prevent Aging, Heart Diseases, Sterility and Internal Deterioration.
1. Dr. Schwartz is familiar with the ingredients listed for Ex-Sel in CX 116 and he stated that selenium deficiency is not a common problem in the United States population. In the absence of a deficiency, there is no need for supplementation of selenium in diet. Excess selenium has a potential toxic hazard. Increased levels of selenium should not be considered safe unless there is some limitation as to the particular increased level. He said:
"As to the matter of desirability, I think we get into the same question with selenium as we get into with Vitamin E, and that is that there is some evidence in experimental animals indicating the ability of these working together to affect free radical levels, and so there is some projection that an increased level might possibly have a beneficial effect, but until the toxicity is carefully worked out one has to make sure that there is a definition of what increased level is.
* * * * *
"Now, as a statement that increased levels of selenium are desirable, the statement is unsubstantiated thus far, but I think that further research may show, if animal studies are any indication, may show that as a scavenger of free radicals increased levels of selenium and Vitamin E may have some benefit."
In the absence of deficiency, this product will not retard the aging process, prevent oxidation from weakening the heart, prevent aging, heart disease, sterility, or internal deterioration. (Tr. 285-288)
3. He is not sure that a particular deficiency in selenium can be recognized in man. In animals, deficiency is usually reflected in the nerves of the muscles and various problems with muscular function. Also, in animals, his recollection is that there have been lesions in the kidney and the liver as a result of enforced deficiency of selenium, but this matter is subject to checking. Selenium deficiency produces a gamut of effects in the tissues of the muscles, liver, heart, kidney and in the general breakdown of tissue. In discussion selenium, the witness spoke of free radicals and he said:
" Well, a free radical I think is for the purposes of this discussion, a highly reactive chemical substance, so highly reactive it is unstable. The reason we are concerned about them is because they are so reactive they can react to proteins, nucleic acid, and various critical acellular elements and a consequence, it is important that we individualize.
"Free radicals *** are produced by air pollution, they are produced many a time by a number of chemicals processes, by photo-oxidated processes and it is believed that the carcinogenicity of substances, both air pollution and even for that matter food additives and so forth, are through their transformation with free radicals.
* * * *
"I think that in the body the potential role [of selenium and Vitamin E] in the body probably does in fact relate to [the elimination of the problem of free radicals], both in the structure of the cell membranes and in normal metabolic products. Now there is concurrent thinking that indicates that if someone took supplemental selenium and supplemental Vitamin E that it may help with exogenously ingested or inhaled free radicals."
4. Dr. Schwartz is not aware of any documented cases of toxicity in human beings caused by taking oral supplements of selenium or Vitamin E. (Tr. 308-310)
5. Dr. Hunt reviewed the list of ingredients (CX 116) and identified the nutritional ingredients to be selenium and Vitamin E. A deficiency of selenium is not common in the diet of the United States population. Soil in some parts of the country is deficient in selenium, but since food is shipped to and from various parts of the country very few people are likely to have a selenium deficiency. If there is no deficiency of selenium and Vitamin E, there is no need for supplementation. In RDA (1980 ed.) at Table 10, p. 78, it is suggested that daily intakes ranging from 50 to 200 micrograms of selenium have been estimated as being safe and adequate for adolescents and adults. In the table for "Trace Elements", where the selenium range is stated, footnote "b" cautions that "since the toxic levels for many trace elements may be only several times usual intake, the upper levels for the trace elements given in this table should not be habitually exeeded." The product would not prevent oxidation from weakening the heart in the absence of a deficiency and the same would be true with respect to aging, heart disease, sterility or internal deterioration. (Tr 147-153)
6. RX 9 is a copy of a document entitled "Antioxidants and Cancer," Part VI. Selenium and Age-Adjusted Human Cancer Mortality. The abstract or head-note reads as follows:
"The possible epidemiologic relationship between selenium occurrence and cancer mortality was studied in cities and states located in areas with different levels of selenium bioavailability. Statistically significant differences were found in age-specific cancer death rates among states with high, medium and low selenium levels. The death rates for specific types of cancer showed a larger difference in males than in females in the states with high selenium levels. The greater difference between males and females may be related to sex differences or to the fact that males arer heavier smokers and are also more likely to be exposed to industrial pollution. In the states with high selenium levels, there was significantly lower mortality in both males and females from several types of cancer, particularly the environmental problem indicators, such as gastrointestinal and urogenital types of cancer."
7. The witness's evaluation of this article is as follows (Tr. 217):
"I think that it is saying that there is a correlation between those things, but that is not a cause and effect necessarily. I think this is one of the things you have to be sure of, that you can correlate the number of automobiles to the incidence of cancer, you would not say that just because there are a lot of automobiles, that that is the reason cancer occurs, and I do not really think that you can draw those conclusions, this is just a correlation between the two."
8. Dr. Hunt has never personally observed or conducted, and knows of no one else who has, any experiments or clinically controlled studies which demonstrate that Respondent's claims for Ex-Sel are false. (Tr. 216-223)
9. Dr. Ayers is familiar with the ingredients of Ex-Sel with the exception of Golden Seal Root Powder. When asked whether deficiency of selenium is commonplace in the United States, Dr. Ayers replied:
"I will have to categorize that. There are some areas in this country where selenium in the soil is less than it is in others. Some products grown in those areas will have less selenium than in other areas. ***One reason for this, of course, would be that products are shipped widely from one area to another. You may live in an area where there is a soil deficiency but you may not eat necessarily from that area, so that the problems of selenium deficiency in some of the growing areas is a factor in some of the parts of this country. That there are people with low selenium in their bodies is virtually unheard of in this country, [among] peope who eat a normal balanced diet, and furthermore, selenium deficiency disease states in this country are not seen in people who eat normal balanced diets period.
"There is an interesting experiment that has been done for us in Australia in the fields where the levels are terribly low in the soil and in the food product and where the blood levels are lower than in this country, no clinical disease has been identified that goes along with that in those people.
****just because you measure low levels does not mean that there is a deficiency state necessarily as part of it."
10. Ex-Sel will not retard the aging process. Unless there were a very extreme situation this product will not prevent oxidation from weakening the heart. Unless there is a deficiency of the appropriate substance, this product will not be effective in preventing aging, heart disease, sterility and internal deterioration. This answer is applicable to heart disease defined as that which is associated with atherosclerosis, and common heart disease in this country.
11. Increased levels of selenium in the body are not desirable and safe. The witness stated:
"There is no RDA in selenium. The National Research Counsel has not promulgated one. They have given one based on certain studies performed that there is a range considered to be safe, at both a low and a high level and the reason they put a cap of a high level on it is to prevent what they consider to be potential toxicity and they must be a real concern with the National Research Council's Nutrition Handbook that you can get too much of it and so they put a level on what should be considered a safe amount to take in. It is 200 micrograms daily."
If a person who ingests a normal diet should take 2 capsules of Ex-Sel daily, it is likely that such person would exceed the 200 mcg. level recommended as a maximum by The National Research Council. (Tr. 376-379)
12. In RX 9, the authors are indicating that there may be some correlation between different selenium levels in certain groups of people and a higher incidence of cancer in those groups of people. Concerning this article, Dr. Ayers said:
"There is apparently a different incidence of cancer in areas with high and low selenium in --I'm not sure whether it's just in the foods or in the soil or what, but they have taken the human cancer mortality rates and compared them to areas of high or low selenium content, and I think it's in the soil, but I'm not sure. I would have to read it closer. ***What I think it is saying is that where there is lower selenium in the soil there are different attack rates. i don't think you can extrapolate from that and say therefore their selenium blood levels are lower. ***What I'm getting at is that I have already agreed there are differences in selenium in the different parts of the country. I would certainly agree to that.
"There are differences in blood level of people, I would agree to that. That this has been shown to be more than an association as opposed to a cause of cancer, I would categorically deny, and I would like to refer you to a more recent article than this which reviews the topic and concludes that there is no truth.***
"***What I think would be a fair statement which would be the one I would make is that in the United States population there is no known deficiency, in people who eat a reasonable balanced diet, of selenium [to which] can be attributed***any disease state." (Tr. 418-421)
13. As to whether there would be benefits from oral dietary supplementation with the product Ex-Sel, Dr. Lord stated that simply looking at the products with respect to the first two listed ingredients, selenium and Vitamin E, which are clearly nutritionally required components, there are people who would benefit from additional amounts. He feels that there are selenium deficiencies that are commonplace in the diet of the U.S. population. In fact in certain areas of the country there is evidence of soil depletion compared to other areas, and this is reflected in the begetables grown in the soil.
14. Both selenium and Vitamin E relate to the process of free radical scavenging and in that respect, it would have a benefit on the aging process. And they would thus be effective in treating other degenerative conditions such as heart disease and things of that nature. The heart is potentially exposed to free radicals more than any other tissue so it is reational then to assume that Vitamin E would have protective effects especially on the heart. (Tr. 512-513)
15. Dr. Lord said that if people who live in soil selenium-deficient areas eat foods that are arriving from all areas of the country, one would nevertheless expect to find higher levels of selenium deficiency in their diet. He said this is so because selenium in water supplies and from the local component, whatever it is, will range from the majority of the diet to a small percentage of the diet. Taking into consideration the total population, the component of selenium from locally grown and raised foods could be very significant.
16. Selenium is such a newly recognized essential trace element that there has been no human population that has been put on a selenium deficient diet and no documentation of the effects of that deficiency and there probably never will be. Also, because selenium is present in small amounts in many foods and because we do not need very much of it, the demonstration of deficiency will be difficult. However, experimental animals, which are the sources of the best information at this point, give us great indication and evidence which leads to my opinion that there are humans deficient in selenium because on a relative scale experimental animals show deficiency symptoms when you deplete the diet of selenium.
17. His testimony is that he supports the idea that people eat proper diets, selecting foods first of all that are reach in selenium, which is the other problem, selenium is stripped from many foods. If everyone ate the proper diet, just a good balanced diet, now this is one nutrient where you could argue that we really would have little need as far as the evidence now of supplementation. However, people do not do that and we know that diets are routinely eaten that are stripped, largely depleted of selenium, various foodstuffs. In those cases selenium must be there and so it is a wise idea to supply it in a supplement if the person is not going to change his diet. In short, if people would eat the right foods, they would not have to take any capsules for supplementation. He pointed out that his definition of the right foods is not what we would get if we looked at the average American diet, certainly not if we looked at the lower half. If you take an average, half above and half below, the lower half of that average is going to be very low in many of these trace elements and vitamins.
18. If the term "varied diet" includes foods that are high in selenium, he agrees with the following statement from page 163, 1980 RDA:
"Detailed food composition data for this element (selenium) are not yet available but it appears from several studies that the consumption of a varied diet in the United States, balanced with regard to the major nutrients, results in a selenium intake that is adequate and safe." (Tr. 549-553)
19. Considering the ingredients of Ex-Sel and the dosages of each ingredient contained in the product, as shown in CX 116, Dr. Grumbles sees nothing that could have any possible harmful effect.
20. With the anemic chain of food supplies in this country, there is a great possibility of deficiency of selenium as an essential mechanism. He said that in some people in the United States there seems to be definitely a selenium deficiency. Also industrial pollutant factors around us seemed to be very much related to the need for higher selenium.
21. Because of its oxidant properties, the protection against the effects of environmental pollution, and insofar as there has been some seemingly definite, protective effect in reducing certain types of cancer, he believes he would be safe in making the statement that Ex-Sel will help retard the aging process.
22. He feels that the ingredients in the product, Ex-Sel, help prevent oxidation from weakening the heart. He added that this depends upon serum cellular selenium, laboratory tests of which are almost impossible to get done with any degree of efficiency. He said that then you have to rely on the hair test, which is notably unsatisfactory but it seems to be the best we have, and we do find that people who are subjected to a lot of industrial pollutants and things of this sort seem to have consistently lower hair selenium and, in this case, I do supplement. The one thing that requires that doctors be very careful about in documenting hair selenium is that certain dandruff products have selenium as an active ingredient and in that case, you think the patient is utterly toxic from selenium which happens to be really on the hair itself, so it does not indicate toxicity. He very rarely finds a case of high seleniun, but he very often finds a case of low selenium. (Tr. 669-672)
23. Dr. Grumbles said that deficiencies of selenium are commonplace in humans in the United States, but not so commonplace as with zinc. It is his opinion that persons do not get enough selenium content in their food and therefore require supplementation. He did not say that it is fair or rational to extrapolate from studies of animals getting selenium supplementation to say that supplementation is necessary or effective for the normal human population, but he did say that is how most nutrition research is done.
24. He is not aware of any symptoms of deficiencies of selenium in humans. He said that selenium supplementation in animals has not been known to result in any toxic effects, but there have been toxic effects in certin animals grown on land that was extremely high in selenium and there are toxic effects in the industrial selenium. It is hypothetically possible to get toxic effects from excessive nutritional supplementation from selenium, and one industrial use of selenium that is not heard of very often is by our radiologists and technicians doing breast xerogrophy. Everytime they use of these tubes, they send out a whole spray of selenium into the room that they inhale and there is a great possibility of toxicity there. It is possible, also, to have toxicity in man as a result of nutritional excess. (Tr. 718-720)
25. Dr. Susser said that Ex-Sel compounded of the ingredients shown on CX 116 and in that dosage, would not have any harmful effects. In response to the question "Do you know if there are deficiencies in selenium in the United States?", Dr. Susser replied: "I feel that there are lots of deficiencies in the United States ", but he did not say that selenium deficiency is one of them. He feels that people would benefit from ingesting Ex-Sel so far as eliminating part of the deficiency problem is concerned. Selenium is an antioxidant factor, he said, and it works with Vitamin E and there is a lot of evidence in his mind that Vitamin E slows down the aging process. Furthermore, selenium has been shown by several studies to decrease the incidence of cancer and heart disease by approximately 20 percent of the people who take adequate doses of it and that would slow down the aging process. He considers selenium to be a free radical scavenger; thus, in terms of overall deterioration, it would slow the aging process in that regard. There are a lot of elements in the aging process, but that is one of them. (Tr. 776-777)
26. When, on direct examination, he indicated that there is a deficiency in the United States of selenium he intended to indicate that there is a deficiency in the soil and also in humans. He has treated patients with selenium who had symptoms that got better. He said they did not have classic selenium deficiency, "whatever that is." He said that a new work that has come out within the past year has indicated that cystic fibrosis may turn out to be attributable to selenium deficiency. He could not remember the author's name, but he said the report was issued by the International Academy of Preventive Medicine about a year and a half ago. He does not know what the follow up has been on that. He doubts that selenium supplementation as therapy for cystic fibrosis would be approved by the National Cystic Fibrosis Foundation. It later (Tr. 818) developed that the report of selenium therapy for cystic fibrosis was written by a veterinarian. The statement from the Recommended Dietary Allowance, Ninth Edition, 1980, under selenium on page 162 that --
"Disease states attributable to selenium deficiency or excess have not yet been described in human subjects, even though large population groups are living in areas where selenium deficiency and excess have resulted in severe disease and loss of life." does not change his view that cystic fibrosis may be attributable to selenium deficiency. He believes it could be. He does not think the final answer is in, but he thinks there is enough early information to make it very suggestive.
27. He has no information based on controlled clinical trials in humans that Ex-Sel would have any effect on retarding the aging process. He also has no evidence based on valid controlled clinical trials in humans that permits him to state with any reasonable medical certainity that Ex-Sel is effective in the prevention of aging, heart disease, sterility and internal deterioration. (Tr. 804-808)
28. Dr. Golden stated that, in the doses given in this capsule, there is no possibility of harm from taking this product. In his opinion selenium deficiencies are commonplace in the diet of the United States population in any area in which there is a low selenium content in the soil and water. Processing foods and refining our wheqt, flour, and adding additives, chemicals, and other flavoring agents to our food definitely decreased the content of these essential nutrients contained in Ex-Sel and therefore the addition of these nutrients is helpful.
29. Dr. Golden testified that supplements of the product Ex-Sel will have a beneficial effect on retarding the aging process and preventing oxidation from weakening the heart. It is his opinion that the product is effective in regard to heart disease and internal deterioration, but he is not sure that it is effective treatment for sterility. (Tr. 833-835)
G. Power Tabs --(10/139) --As An Energy Booster, To Provide Instant Energy and Energy Supplying Nutrients.
1. Dr. Schwartz is familiar with the ingredients of Power Tabs listed on CX 236. There is no ingredient in the product that will, when taken orally, provide the body with instant energy. In the absence of a vitamin deficiency, the vitamin ingredients will not provide a person who takes the product with any benefits. It is not really a very good multivitamin product and its vitamin content is limited. Even in the presence of vitamin deficiency, unless there were specific deficiencies in thiamine and B5, it would not be a very effect product.
2. There are about 4 1/2 calories per gram of fructose and there would be, therefore, about 1.125 calories, or slightly over one calorie, in the fructose per tablet. This amount is approximately equal to the calories count in a bottle of diet soda. Bee pollen and fructose in the amounts shown on the label would not be effective energy-supplying nutrients. Methionine is an essential amino acid. If there is no methionine deficiency there is no benefit to be derived from the ingestion of the product. (Tr. 288-290)
3. Dr. Hunt reviewed the list of ingredients and identified the nutritional ingredients as methionine, fructose, vitamin B1, panthothenic acid, magnesium, phosphorus, calcium, iron, and vitamin B-12. Her assessment of the product is that it contains nothing that could provide instant energy. The thiamine, pantothenic acid, as well as magnesium, iron and phosphorous are essential for transfer of energy and are important, but they are not going to be instantaneous in action. Fructose and the small quantity of methionine are the only two nutrients to provide any energy whatsoever. There is only 1/4 gram of fructose, which would mean one calorie, and 1/2 gram of methionine, or about 2 calories. Fructose is absorbed at a much slower rate than the other ingredients of the product. The glucose from the average candy bar, which provides from 175 to 250 calories, would get into the blood and provide energy much faster than any benefit in terms of energy could be realized from this point --in which there really is no source of energy. If a person were deficient in magnesium and iron and took this product, there could be no quick energy available, because all of the ingredients must be absorbed and transported before they can be utilized. Whether a person is deficient or not in the ingredients of this product, the taking of the product by such person will not provide effective or instant energy. (Tr. 153-155)
4. Dr. Ayers testified that in a context in which "instant energy" means "high calories within a matter of minutes" there is nothing in this product that would provide the body with instant energy. There is nothing in the product that is of high caloric value and, again, the vitamins that are in the product are subject to all the comments made by vitamins, namely, that unless one is deficient in them the addition of more will not have any effect. Therefore, the product does not give one increased calories to burn for productive energy in a matter of minutes for any activity. (Tr. 379-380)
5. Commenting on whether Power Tabs will have a beneficial effect upon supplying energy Respondent's first witness, Dr. Lord said that supplying energy is a fairly nebulous area as far as the effects of nutrients are concerned because the purpose of every nutrient is to supply energy. Therefore, they would all help to supply energy to the cells and in specific ways they do that. For someone who is on a vigorous exercise program, or who is borderline in the amino acid methionine, in that case the mentionine is considered a methyldonor amino acid and the proteins that make up muscles, actin and miacin, have a specific amino acid that must be formed in the body, requiring methyldonors, so in that case the simple building of muscle mass would be benefited by that nutrient.
6. The bee pollen simply is a good source of trace elements without having a extremely high concentration, but there is a fairly good mix of essential trace elements in bee pollen. The vitamin B1 and pantothenic acid are simply B vitamins that are required every time a cell generates an energy.
7. Iron must be included. At least a large number of these nutrients can be related specifically to energy requirements.
8. One has to have calories to get energy but that does not say much. It does not grasp the reason for taking in these kind of nutrients at all. The course, we all have to have calories and we get those in many ways. The question is what happens to calories? How difficulty is it for us to begin to extract muscle energy, let's say or transport energy for ingestion or the nerve function from the calories that are available and that would be what this would help us do. In other words, calories are not going to have any benefits either unless they have these nutrients. (Tr. 514-515)
9. The first question Dr. Lord was asked on cross-examination was: "With respect to the product Power Tabs and specifically the ingredients listed in the product label, without a source of calories, where would the instant energy in this product come from." Dr. Lord replied:
"The energy that would be supplies by taking a product such as this would simply come from the nutrients that are acquired in the energy pathways that would be supplied. The energy source is constantly available, of course, to the cell in the form of glucose and glycogen but those sources hadve to be metabolized, which requires Vitamin B-1, B-5, iron, calcium, phosphorous and specifically they are and can be quickly assimilated into the co-enzyme form and make energy available. The fact that --lack of energy in general is not ever, at least in our population, a caloric restriction. Lack of energy is rather failure of ability to extract usable energy in the cells, which depends on the presence of these micro-nutrients."
10. He assumes that the caloric intake is adequate to provide energy sources. There is a small amount of fructose in Power Tabs, 250 milligrams, that is an energy source, although it is not an amount that will supply very many calories. Thus, a person taking this product, in order to have instant energy, would have to have enough calories in the diet to supply carbohydrates precursors, at least.
11. He continued by saying that the only instant effect would be from the small amount of fructose in the tablet that could very rapidly - in a period of minutes - be appropriated by the cells for energy. Meanwhile the vitamins have to be converted into the co-enzyme form. Once again, if there is no need, then this product would not do any good, as for all the others, if there is no need for a vitamin. However, "assuming there is a need," then the body can rapidly assimilate thiamine, for example, into the co-enzyme form, which all that it has to do is phosphorylate a single enzymatic step and that vitamin is ready to go to work.
12. In the case of pantothenic acid, there are a few steps involved, but there again, an individual who is "depleted and has a need for this vitamin" can, he "would imagine," in a matter of half an hour, convert the pantothenic acid even into co-enzyme A. As far as the iron, that can be rapidly assimilated into hemoglobin "assuming" that the hemopoietic mechanism is working properly. The calcium also is used directly as the calcium that can be used immediately.
13. Dr. Lord concluded his testimony concerning this product by saying, "a candy bar or a piece of bread, anything will supply a lot more energy sources than anything in this product, but they will not supply the things that you must have to use the energy." (Tr. 554-557)
14. After examining the transcript of product lable and noting the ingredients, he said that it his opinion that this product would be beneficial to people in the American population and that it is a good nutritional supplement. All of these ingredients are essential parts of energy chain in a way. All of the vitamins and minerals are part of the enzyme reactions which generate energy in the metabolic process. He said that he does not think of Natural Bee Pollen, as a magic property but he thinks it is a good source of a number of micro-nutrients, a number of minerals. He sees nothing in this product that would be significantly harmful to anyone. (Tr. 672-673)
15. Dr. Gumbles said that he can not imagine any paper and literature that has been done based on Power Tabs. He does not know of anyone other than Athena that does this exact formula.
16. When asked whether Power Tabs would be an instant supply of energy, he said that he wonders about the word "instant," and he was not sure what it is meant to imply. He does not interpret it to mean that if one takes one of these pills he will go around jumping up and down, full of energy all the time. There is enough fructose that it might give a little bit of energy boost, but that is not a terribly good source of energy. The boost of energy is provided by supplying these essential nutrients which facilitate production of energy in normal quantities in people who might have some deficiency in some of these things.
17. If someone who is on a normal diet is tired, they probably have a deficiency somewhere in their metabolism. When someone has complaints of fatigue for which they are going to need to take something that gives them energy, not including amphetamines and the like, but they want to produce normal energy in the course of their daily metabolism, they are likely to have some deficiency if fatigue and tiredness are the major symptoms they have. If there is no deficiency this product would provide no benefit. (Tr. 720-723)
18. Aside from a personal dislike of fructose as a supplement Dr. Susser does not feel that the ingestion of Power Tabs is harmful. He feels that there are deficiencies of some or all of the ingredients that are in this product, except Jamaican ginger root powder, so that people need supplementation of this type of product.
19. These vitamins are some of those that are generally associated wih responsibility for providing energy to the body. People are not only very sexy, but people have enormous energy when they are healthy person. When somebody is going to take a pill for energy it is probably because he does not feel he has enough energy and in most cases, that is because they have an inappropriate fatigue, or fatigue due to mental or emotional stress or to a nutritional deficiency. When he gets a patient with low energy, he prescribes vitamin programs which are similar to this one. The energy often increases dramatically over a period of anywhere from several days to several weeks. Some cases take as long as five months but for the typical patient, it is a couple of weeks. (Tr. 777-779).
H. Athena Stay Young program --(10/140) --A Combination of the Products Sold Under the Name RNA, META-E, Ex-Sel and Chromill GFT
1. Dr. Schwartz is acquainted with and has testified concerning the contents of the four products comprising this product CX 254. Dr. Schwartz's opinion with regard to the efficacy of these four products would be no different if a person took one or more of the products as opposed to just one.
2. The opinions expressed in this proceeding by Dr. Schwartz represent the view of the majority of scientists in this country who are informed about the areas discussed in this proceeding. (Tr. 298)
3. Dr. Hunt has reviewed the list of ingredients of components of Athena Stay Young Program (CX 254). Products in the program are: Ex-Sel, RNA, META-E, and Chromill GTF. In absence of a deficiency, these products taken together in a nutritional program would not provide any nutritional benefit at all. The opinions she expressed earlier regarding each of the products individually are the same with respect to a program in which all four products are taken (Tr. 158-159)
4. The testimony of Dr. Ayers with respect to the efficacy of these products would be no different if a person took two or more of the products together, rather than taking just one such product singly. If a person took all four products, they would not be able to retard the effects of aging. In the absence of skin moisturizer the taking of all four of the products would not cause the user to have moist and soft skin. In the absence of a deficiency of the ingredients of the four components of the programs, the taking of the four products would not result in higher energy levels, sharp memory, mental alertness or renewed sexual abilities. In the absence of a moisturizing effect and if a person has no deficiency of the ingredients of the four components of the program, the taking of the four products would not be an effective remedy for lines, wrinkles, age spots, abnormal memory and thinking processes or fatigue.
5. The opinions expressed in his testimony in this proceeding are consistent with the consensus of informed medical and scientific opinion on the subjects discussed. (Tr. 384)
6. Dr. Lord adopted the same statements that he previously made to regard to RNA, META-E, Ex-Sel and Chromill GTF so far as it applies to the combination of the products. He said Respondent is reaching a broader segment of probable need in his opinion in this combination because you are just combining additional ingredients. (Tr. 520)
7. It is Dr. Grumbles' opinion that the combination of the products in the Athena Stay Young Program will be beneficial to the extent that he described in discussing the individual products (Ex-Sel, RNA, Chromill-GTF and META-E). (Tr. 680-681)
8. With respect to this four-part program, Dr. Grumbles said that his opinion with respect to each of the components would be more affirmative with all these products than with each single one. He believes that, as well as anything he knows of, these products will support the claims that are made for them. (Tr. 725-729)
9. Dr. Grumbles definition of deficiency refers to the absence of sufficient amount of material to promote the optimum health of the individual. He said that there are pwople who respond to supplementation of various nutrients dramatically from the psychiatric point of view, although they do not have a deficiency of a particular nutrient. Clinical symptoms need not be present for his definition of deficiency. He said that there do not have to be physical symptoms of a specific deficiency present in order for him to determine that supplementation is advisable.
10. The majority of the people in his general practice are in the Medicare age and they come in because they have hypertension, heart disease, arthritis, skin conditions, asthma, bronchitis, emphysima, callouses on their feet, neuritis, some of them have epilepsy. It is the general run of a medical practice. The patients who come to see him do not usually have severe deficiencies of the vitamins and minerals that are present in these products. Occasionally patients come in obviously very everely deficient, but it usually takes a bit of detective work in terms of their dietary history as well as all the clinical examinatins and the physical examination to try to figure out what type of supplementation, what type of diet they need. It is very difficult to do. It requires taking a case history.
11. With respect to some of the deficiencies it requires serum testing, or hair analysis, and urine testing. Fortunately, many people who suffer from a deficiency of vitamins or minerals are able to provide self-treatment without coming into the office or a practitioner of medicine or nutrition.
12. When asked if he does not know what the problem is until he takes a case history, does serum testing, urinalysis, and hair analysis, how would a patient be able to treat themselves without these tests, he said that he does not think the patients should treat themselves for frank disease or frank clinical deficiencies. He later said that he is very pleased when soemone comes into his office and tells him that they take what he considers to be a very adequate nutritional supplement, one that contains all the essential vitamins and minerals in adequate quantitites to act as an insurance policy for them. He thinks this is a lot cheaper than paying medical bills and being sick, and he encourages this practice.
13. He advocates the use of high dose combination multi-vitamin and minerals for almost everyone, but he does not dispense them. He gives people a basic formula and suggests that they get to a health food store or a pharmacy that carries such things, and buy them. It is basically his philosophy that one can take any vitamin and mineral supplements so long as they do not do any harm. He thinks that when a person says he follows "the well-balanced American diet," he is implying that he does that. Dr. Grumbles said his definition of well-balanced diet would be the food one eats and the supplements one takes.
14. If a person is trying to retard the effects of aging, if he came to Dr. Grumbles, he would follow the normal procedure of testing to determine just what it is that might best benefit the individual. He agreed that if the people who read Respondent's advertisements decided to self-treat with these products, they would not know whether the deficiencies that may be related to retarding the effects of aging are due to deficiencies of ribo-nucleic acid, selenium, Vitamin E, riboflavin, folic acid, rion, chromium or superoxide dismustase.
15. He would not give the same dose of a vitamin or group of vitamins to treat a deficiency that he would to supplement normal nutrition. He gives the doses for the individual person which one can do in ones office, with all the procedure discussed so far as studying the patient is concerned. He sees the patient to evaluate the progress of therapy, he repeats testing and sees what it is necessary to modify, so it is a continual effort in trying to find the proper treatment. People with different deficiencies require different sized of doses. People with apparently the same laboratory evidence and even physical evidence may very definitely require different amounts of the same supplement. He advocates the use of high-does multivitamin therapy. In the doses he recommends he thinks it is a safe bit of insurance for everybody.
16. This practice is not generally accepted by the medical and scientific community. He says that is is only accepted by physicians who have some expertise in the field of nutrition, and that is by no means the majority of the medical profession. (Tr. 681-691)
17. With respect to the Athena Stay Young program, Dr. Susser said that taking these products in combination would be very beneficial. He would like to have some Vitamin C in there and maybe a few other things which he would prescribe, but this would be a good combination of nutrients that would be useful. Complaints from patients involving aging, skin problems, low energy, dull memory, lack of alertness, declining sexual ability, wrinkles, abnormal thinking process, and fatigue, have been reveresed very often with supplements such as these.
18. Dr. Susser's testimony on this group of products strongly represents the thinking of physicians such as himself and others in various organizations. (Tr. 780-782)
19. In the absence of a deficiency of any of these products, there really would not be the malady, so to speak, that these products claim to benefit. Therefore, there would be nothing to treat, and his position is that the way to determine deficiency is by a therapeutic trial. There is not available at this time the chemical testing needed to determine the deficiency. He said that one hears many physicians say "I just give my patients vitamins because they say they feel better." He has heard this time and time again, and he has seen it happen in such a way that, in his opinion, the possibility or the likelihood of it being a placebo is almost impossible.
20. The witness's experience has been that people do better when they take supplements, no matter even if they design the combinations themselves. He has seen a lot of people who have designed very nice programs for themselves. When he designs a program for a patient he is dependent to some extent on what the patient tells him. In other words, in order to make a determination of what is a good vitamin regimen one has to really know how the person feels and only person can explain that. Actually, the patient's history is by far the most important test; he gets much more information from that than he does from the blood test or from the hair test, which are useful also, and out of that information he designs a program which he said has had a very high success rate in correcting symptoms. (Tr. 814-816)
21. In Dr. Susser's opinion the benefits derived with respect to any of the claims for any one of the four products in the Stay Young Program would be changed with respect to benefits derived by use of all four products. He said this is his opinion because his experience is that nutritional products work in synergy. Sometimes one product's effect will be markedly increased by adding other nutrients to it. His expeirence is that the more balanced the program, the wider the nutritional supplementation program in scope, generally the better people do. He has no medical studies that will substantiate that opinion.
22. One thing that the use of all four of these products would do that a balanced diet cannot do is to provide nutrients in a form and a dose that could not be obtained from an American diet. For example, one could not get 800 units a day of Vitamin E from any diet so far as he knows. The other substances probably could be provided by a superb diet if somebody had it available, but he is really not sure of the exact quantities of these ingredients. He does diet analyses on patients, and most of them come in at much lower figures than shown on the product labels in their ordinary intake even when they are on relatively good diets.
23. If Respondent had a product consisting of all the products concerning which he testified in this proceeding, it seemed to him that the one thing lacking was Vitamin C and may Vitamin A. He does not think it would be a complete product from his point of view, but he thinks one could take all these products together and do well. It is Dr. Susser's opinion that most people in this country need supplementation, and that it is impossible to get an ideal diet in this country. (Tr. 811-814)
24. Dr. Susser thinks the statements or claims that are represented in the advertising for these products are fair representations of the current state of nutritional theory concerning the beneficial effects of these particular products, but he has "a little feeling of discomfort" because they are stated so strongly. He said he does not know if they are exaggerated. These advertising statements make claims which he feels are valid, and yet he says he is just uncomfortable with any kind of medical advertising.
25. While there is no valid scientific support in terms of double blind studies for some of the statements he made with respect to his belief in the efficacy of these products, he thinks there is valid scientific information based on therapeutic trial, on the theory of try something, trying something that is safe. The fact that the efficacy can not be proved, or has not yet been proved, does not mean it is not true, or that it is not false. At one point he stated that there are 15,000 chemicals within the human body, related to the chemicals that have so far been identified in biochemical literature. He later said that the figure 15,000 is an estimate he read by a biochemist some time ago. He could recall neither the name of the biochemist nor the name of the publication in which the report appeared. (Tr. 822-823)
I. Euzinc-D --(10/141) --A Sex Stimulant, Sexual Rejuvenator, for Relief of Zinc Deficiency, Impotency, Sterility, Low Sperm Count, Prostatitis and Diminishing Sex Drive
1. Dr. Schwartz is familiar with the ingredients of Euzinc-D shown on CX 56. Zinc deficiency is not, to his knowledge, common in the diet of the United States population. If one ingests too much zinc it is possible to get zinc toxicity, as is the base with any metal. In the absence of a deficiency of zinc, there is no need in human nutrition for supplementation of zinc. Large amounts of zinc have been used to aid in the healing of wounds. In some preparations for external use the results are inconclusive, but large amounts of zinc have been used as exigents to wound healing. With respect to this product, it is not an effective sexual stimulant or remedy for impotency. In the absence of a deficiency this product would not be an effective remedy for low sperm count, prostatitis, or diminishing sex drive. Damiana root and Oriental ginseng root are not powerful sex rejuvenators.
2. Even if there was a case of deficiency of zinc in a male, supplementation of the diet with zinc would not help the problem of impotency, except in cases of mal-development. Potency was defined as the ability to perform the sex act, and fertility was defined as the ability to reproduce. (Tr. 290-292, 295)
3. Dr. Schwartz is not aware of tests which show either that zinc deficiency is common in the United States diet of that persons in this country receive adequate amounts of zinc in their diet. There is a Dr. Robert Heckley at Georgetown University in Washington, D.C., who has established a taste and smell clinic. He studies and treats not only absence of taste and smell but also distortion of these sense. His work has dealt with deficiencies of zinc as they reflect the deficiencies of certain zinc-containing proteins whcih are involved in the neuro transmission of the taste and smell process as opposed to a blanket zinc deficiency. Dr. Schwartz is not sure, but he believes that Dr. Heckley treats his patients with zinc supplement. Dr. Schwartz is not aware of any toxicity that has occurred from the taking of zinc supplementation as administered for the purpose of which it is used by Dr. Heckley, although he knows of toxicity caused by ingestion of zinc.
4. Commenting on impotency, Dr. Schwartz said that there are physiologic aspects of it. For example, there is a belief that atherosclerosis may contribute to impotence, and it has been observed that certain drugs used for hypertension also contribute to it. The same is said of alcohol. These people do not complain of lack of desire, but is the lack of ability to perform. On the other hand, the psychological aspect is all in and around the libido and it is the view of psychiatrists whom Dr. Schwartz encounters and who deal with the problem that, absent the identifiable drug-related or pathology-related situation such as atherosclerosis, the overwhelming amount of impotence is psychological.
5. There are physicians who prescribe or recommend vitamin and mineral supplements for patients who are under a great deal of stress of who are on a highly calorie-restricted diet. There are those who recommend especially Vitamin C supplementation for smokers and those who recommend vitamin supplements for alcoholics, and there are others who will say "if they make you feel better, take them." If he had a patient who was impotent, he would eliminate all the physical problems and nutritional deficiencies, and if he found nothing in these areas he would send the patient to a psychiatrist.
6. He stated that he could not at all say that all human beings have certain sub-clinical dietary problems that are not showing up as gross diseases. (Tr. 310-317)
7. Dr. Hunt stated that the only nutritional ingredient of the product is zinc. A deficiency of zinc in the United States diet is not commonplace, although marginal deficiency has been identified in children in the Denver area. It is suspected that it may exist elsewhere, but it has been shown nowhere else. If no deficiency is shown to be present, there is absolutely no need for supplementation of zinc in the amount of 60 milligrams per day, which the label shows to be 400% of the amount recommended by RDA. When one supplements with one particular mineral, it may cause a deficiency of another. For example, excess of zinc may cause deficiency of copper, and it can happen with other nutrients. When one amino acid is used as a supplement, a deficiency in another area can be caused. This product is not an effective sexual stimulant, or remedy for impotency. Even if there were a deficiency there is no gurantee that this product would help. It is not an effective remedy for sterility and it can not be guaranteed to remedy low sperm count. It would not be a remedy for prostatis. Zinc levels in the prostate are higher than in other parts of the body. There is no good evidence that the higher zinc content of the prostate has anything to do with the need for supplementation. If there is no zinc deficiency, supplementation with this product would not be an effective remedy for diminishing sex drive. (Tr. 156-158)
8. Marginal zinc deficiencies occur in the United States among people who are true vegetarians; there is a possibility of not getting enough zinc. The most obvious test for real deficiency of zinc is in depressed growth rates in children. The test for adults would be to test the activity of various enzymes that need zinc as an activator. It is not a terribly complicaed test. Zinc deficiency was found in Egypt and Iran. The children did not grow or develop sexually. They were young adults 20-25 years old, but they were about the size, and had attained the physical development of nine- or ten-year-olds. There were extremely zinc deficient. Practicing physicians today do not routinely test for zinc deficiency unless they think there is some reason to do so or unless their patients request it be done.
9. Dr. Hunt has never, and she knows of no one who has, personally observed or conducted experiements or clinically controlled studies to determin, or which demonstrate, that Respondent's claims for this product are false.
10. Hair analysis can be used as an indicator of a possible zinc deficiency. It can not be relied on as absolute because so many other things interfere with trace minerals in the hair, such as pollutants in air, or anything one might use on his hair. Chemical analysis is more effective in determining zinc levels in the body. (Tr. 224-230, 248)
11. Dr. Ayers stated that zinc deficiency is not a common problem in the United States population. Only in those not having a balanced diet for some reason such as food fadism, lack of funds, low socio-economic status, would a zinc deficiency be found. Euzinc-D is not an effective sexual stimulant. This product is not, in the absence of zinc deficiency, an effective remedy for impotency, sterility, low sperm count, prostatitis, or diminishing sex drive. Damiana root and oriental ginseng root are not powerful sexual rejuvenators. (Tr. 381-383)
12. Dr. Lord said that there is no question in his mind about the existence of zinc deficiency, not only in certain study populations where it has been clearly demonstated, but also in the American population, he said that he has evidence there, not just the fact that that is one of the elements that he measures and it is an accurate reflection of the zinc status. He stated that in his laboratory probably on the order between five and ten percent of the cases show zinc levels below normal range, and this indicates they would benefit from additional zinc.
13. In addition to those inputs, he also sees specific cases and discusses with doctors that know case histories in which the zinc levels as measured in hair tests are low. There is an abundance of evidence that there is zinc deficiency and metabolic problems involving the need for extra zinc. The level of 60 milligrams as in this tablet will overcome most of those deficiencies or, at least, the product will provide a great benefit to replenishing zinc stored and supplied on a daily adequate level. The indications are that not only does it rqise the zinc in hair, for example, but the symptoms are also improved.
14. The relationship of zinc supplementation to sexuality is drawn from some of the early studies that have now been repeated in more than one case showing that one of the effects of zinc insufficiency is the failure to grow and failure for secondary sexual characteristics to develop in populations where they are zinc deficient. Give them zinc and they begin to grow and to develop their secondary sex characteristics, which includes the onset of sperm formation. One of the tissues that has the highest concentration, and thereby would include the highest demand for zinc, is the prostate gland. There have been various studies that he said he recalls reading of the specific effect of zinc being related to sperm production. He cited no such study.
15. The biochemical role of zinc is involved in the level of DN replication, because DNA molecules or cells build up that have to be unwound, we call it an unzippering effect of zinc. Without zinc it can not be unwound and produced in the cells, and that is what sperm production is. It is the very critical distinct way of producing new cells by precursors, so all of these evidences point to the fact that zinc benefits sperm formation that is needed in that process continually. Related matters such as in impotence, sterility, prostatis, and diminished sex drive all revolve around either sperm formation or prostate gland function. Both of those are specific areas where we know zinc is required to develop those functions and to maintain them. (Tr. 516-520)
16. Dr. Lord perceives as a greater problem among people in the American population, those who have inadequate nutrition from their diets and do not supplement their diets with taking any type of vitamin or mineral supplement, rather than those who take vitamin and mineral supplements to the extent that it would cause them some particular health problem. He has never seen or heard of a person who had a problem s a result of taking excess zinc supplements. As a general proposition, even though people are not aware of any deficiency of these nutrients that they might have, Dr. Lord regards it as a good idea, jsut as a matter of insurance, to take supplements such as these to prevent developing deficiencies.
17. That position is modified by his view that there are many symptoms that people are aware of such as insomnia, lack of energy, family history of heart disease, which usually the individual will know if he has, and which are in Dr. Lord's opinion nutritionally related diseases. Those are symptoms that people are aware of and they are aware that doing something with their diet would improve their chances of avoiding those diseases. (Tr. 563-567)
18. Dr. Lord does not know offhand what the incidence of impotence is. Knowing the prevalence, however, of zinc depleted individuals, his opinion would be that anyone who has that clinical problem should consicer a zinc deficiency as the cause of the problem. They should have it checked, ideally, have a laboratory check because that is very simple and easy to do. If they do not want to do that, and at the same time are made aware of the fact that zinc is a probable cause, they should take the supplement.
19. Dr. Lord can cite no studies where low zinc in fully grown adults leads to impotence. It is his opinion that high levels of zinc in the prostate indicate that it has a special demand and that when we know that there is an incidence of zinc deficiency, we should suspect prostate trouble for that reason. That is one of the specific large demands for zinc. zinc is required in every tissue, but the prostate is particularly susceptible to a zinc deficiency and, therefore, those two things are linked, zinc and prostate.
20. One can have too much zinc as is true for any nutrient in the broadest sense, and the trace elements have a narrower range of safe level. Luckily one has to really work at it to get it up into the high ranges from diet, and so a supplement that is properly formulated and does not have excessive levels is going to have no safety precautions.
21. If a person took this product which contains, according to the label, 60 milligrams of zinc, on a daily basis, zinc toxicity is possible. It is a possibility for any mineral. A person could take iron, could take Geritol or any product that has a mineral and overdo it. In fact there is evidence that iron is overdone in some cases. So zinc toxicity is a possibility. If the very special case arises in which people have an unusual diet, put themselves on a diet that is nothing but flax seed, or any of the unusual foods that could be used, then there can be an imbalance and they should not be using any additional product that supplies those trace elements. But that is a very rare case. There is a much more common case that is very well established and known that where people have a need for zinc and even ones who have an adequate diet of zinc would have no problem with an extra 60 milligrams taken indefinitely. There are people who could get in danger by taking it, but they have other indications that should indicate that they have problems. They have indications that they should just not be trying to treat themselves. On the other hand, most readers of Soma Magazine, in reading ads for this product, Euzinc-D, probably do not know whether or not they are zinc deficient.
22. Dr. Lord does not think that a person who was not zinc deficient who read this advertisement in Soma Magazine, ordered the product through the mail, received Euzinc-D, and took the 60 milligrams a day until the carton was empty, which is 50 days, would be at risk. Unless there is a special case, it would be hard to imagine in 50 days any case having a difficulty with that much zinc. They may have a zinc related health problem to begin with, if they are borderline it could be a matter of two weeks. In general, though, they could use this amount of zinc for certainly three or four months innocuously.
23. Dr. Lord disagreed with the 1980 RDA recommendation that not more than 15 milligrams of zinc a day be ingested without medical supervision, but he agrees that it is possible that excessive intakes of zinc may aggravate marginal copper deficiencies. (Tr. 557-562)
24. After having examined the list of ingredients, Dr. Grumbles said that in his opinion the chance of any harmful effect from ingesting Euzinc-D as directed would be astronomically infinitestimal. In his opinion, also, zinc is probably the most common mineral deficiency we have in this country.
25. Zinc, he said, is one of the most useful products, and one that is used more often by him than any other, especially in his work as a psychiatrist and work with schizophrenics. He related the case history of a young schizophrenic patient who was restored to health and mental stability 90 days after he had put her on a program consisting of 60 mg. per day of zinc, 1000 mg. per day of vitamin B-6, and a few general supportive nutrients that were not quite so specific.
26. Concerning the need for zinc supplementation, he referred to some original work from Iran about 1961, by Prasad and somebody else, in which they studies 18 twenty-one year old dwarfs all of whom were found to be extremely zinc deficient. There was another population of 17 dwarfs who were studied. All of the people in both populations had hypogonadism. They divided the second group into two populations. To one group they gave zinc supplementation and to the other they gave standard hospital food. In a period of six months, the ones on zinc supplementation had grown an average of something like 10.6 centimeters, the genitals had developed, the potency had developed and they were normally sexually active people. The ones on the standard hospital diet had grown, approximately, from 3 to 4 centimeters and they took considerably longer even to start developing sexual normality.
27. Continuing relative to the need for zinc supplementation, he said that there have been very carefully done studies which demonstrate that the young woman with menstrual irregularities will start skipping and begin have other menstrual problems. He reported that in his office many such women have all the earmarks of zinc deficiency, show up as zinc deficient on the testing and respond, among other things, with a return of menstrual cycle to normal, a development of the secondary sexual characteristics, et cetera. As to the connection between zinc and libido, he said that we do not have the answer to that yet, but that zinc is a very important component of all the sexual functions. Birth control pills are given sometimes for contraception and sometimes to try to regulate menstrual cycles, we increase the copper level of the body tremendously, thereby decreasing the zinc level and this leads to a lot of the mental side effects of the birth control pill. There have been definite indications that zinc increases sperm motility. There are definite indications that it does help treat impotency. Zinc has a definite bactericidal effect, it promotes healing as well which would have to do with prostatitis, but it also specifically tends to return the prostate size to normal in benign prostatism, to help facilitate the healing of supposedly bacterial prostatitis and the return of the prostatic secretions to normal. (Tr. 673-680)
28. In Dr. Grumbles' opinion severe zinc deficiency is common in this country.
29. He stated that he disagreed "amost totally" with the following quotation from AMA Drug Evaluations (CX 313, p. 838):
"The amount of zinc may be insufficient in those with an inadequate diet, in institutionalized patients, or during periods of increased requirement (for example, growing children, pregnancy, lactation) but severe deficiency in this country probably occurs only secondary to malabsorption syndromes."
30. In addition to the known zinc deficiency states in dwarfs in Iran, other situtations that may cause zinc deficiencies are (1) every time you get a severe infection that begins to deplete your body of zinc; and (2) any time you are under severe emotional stress there can be a zinc deficiency. It is something that is constantly fluctuating. He thinks the basic zinc level is borderline at best in most of us.
31. He would have trouble with the word "stimulant," but he would say that Euzinc-D facilitates the normal processes of the sexual functions in numerous ways.
32. His views on this product are that it would support the other claims mentioned in the discussion. (Tr. 723-725)
33. Dr. Susser expressed the opinion that this product is safe for ingestion as directed by this product label. He does not know anything about Damiana Powder, and he does not usually use 60 milligram doses of zinc for prolonged periods of time. He does not usually prescribe that dosage, although he does use much greater doses, 150 to 200 milligrams, for short periods of time. He has had a number of patients who were treating themselves with zinc over years and years taking doses like this with no difficulty. He thinks zinc deficiency is commonplace in his experience and he feels that supplements such as Euzinc-D will be beneficial to people who have deficiencies.
34. The conditions in which he has seen the best results from treating with zinc have been prostate conditions, prostatitis and prostatosis. When this condition clears up, other things such as low sperm count, sterility and diminishing sex drive often follow. There is a fair amount of thinking and evidence in the nutritional circles that the prostate needs a lot of zinc and when the prostate is having problems, taking zinc will very often correct it. (Tr. 779-780)
35. Absend a condition of prostatitis, or prostatosis, he knows of no evidence based on controlled clinical trials that Euzinc-D would have any beneficial effect, or that it would be an effective remedy for such maladies as impotency, sterility, low sperm count or diminishing sex drive. In the absence of zinc deficiency, as defined by this witness, he said that this product will not correct any of these problems.
36. He uses a dosage of 30 milligrams a day as opposed to the 60 milligrams contained in this product. He does vary the dosage but, usually, he has not found it necessary to use higher doses. (Tr. 809-811)
37. Dr. Golden gave it as his opinion that the taking of this supplement in its indicated formulation will cause no harm to the American population. He feels that zinc is an essential ingredient of hundreds of enzymes in the carbohydrate metabolism and he feels that with our American diet there is a condition that may be called dis-nutrition rather than malnutrition. The people have taken their RDA's and MDR's and everything is right according to the AMA, but he still feels that the population is not getting enough of certain ingredients for certain conditions. He has patients take much greater doses of zinc in treatment of rheumatoid arthritis because zinc happens to work in a very excellent way with an amino acid called histafine that is in the blood stream to decrease the amount of inflammation. He said this has been proven by Peter Simken and him on the West Coast, and it has been repeatedly reported at the American Rheumatism meetings. In our diet it is conceivable that there could be a deficiency of zinc and there also is a therapeutic need for zinc in some people. Now who these people are, we still do not know because in preventive medicine the whole idea as we go in medicine is to prevent things before they happen through periodic checkups and follow-uo of the patient, preventing hypertension with strokes and heart disease, and preventing these nutrition diseases by giving these supplements that are versatile, have no harm, and in many cases are of therapeutic value.
38. Dr. Golden gave a long answer, that was marked by a lack of the clarity of which he obviously is capable, to a request for an opinion as to whether or not supplements of Zinc are beneficial in regard to secuality, meaning conditions such as impotency, sterility, low sperm count, prostatitis, diminished sex drive, things of that nature. It is believed that a reasonabl interpretation of his answer would be that if the impotence, sterility, low sperm count, and diminished sex drive were caused by prostatitis or prostatosis, oral supplementation with zinc could be beneficial. If the conditions mentioned arose from other cause, there is no reliable evidence that oral zinc supplementation would effectively remedy the situation. The last few lines of his answer which suggest the foregoing interpretation read as follows:
"but certainly if you have a deficiency in your diet and it is needed there for whatever metabolic need, it behooves us to try to give the patient the supplementary metal which may produce a shrinking of the prostate which is trying to produce semenal fluid."
39. Dr. Golden is a member of the American Medical Association. He is not in complete agreement with the position of the American Medical Association so far as supplements of vitamins and minerals are concerned. He said that every few years the AMA comes out with higher recommended daily allowances or minimal daily dietary requirements, and they have upgraded their vitamin C and they have upgraded other metals. Other metals and minerals were totally unknown years ago, and then we have a host of metals that we are discovering now and I think nutrition is in its infancy, and we should allow it to develop. He said that whatever the AMA* says in that is not the gospel truth. Whatever they say in that synopsis, five years from now, or one year from now, may prove to be outdated, outmoded and totally ridiculous, and some of the stuff we are talking about now as being contested may be proven, so only time will tell, not double blind control studies. (Tr. 835-840)
*From his testimony, Dr. Golden appears to confuse the AMA Drug Evaluations (CX 313) with the Ninth Edition (1980) of the Recommended Dietary Allowances published by the National Research Council. Both sources were frequently referred to and cited during the hearing. Dr. Golden appeared to be unfamiliar with both publications. (Tr. 841-842)
40. Although he suggested that he had with him some authoritative sources such as valid controlled clinical sciences or treatises or articles from peer review journals that would support his testimony with regard to the effectiveness of the claims made for META-E, Ex-Sel, and Euzinc-D, he was not able to cite any of them. (Tr. 846-847) He said that the use of zinc supplementation for benign prostatic hypertrophy is controversial, but it has been accepted by many urologists who hae used it and have found good results, not in all, but in some cases, but the bottom line is if you use something and you are not doing any harm, and you can help 20 to 30% or a certain subdivision of these people who may be zinc deficient, and these people do get better, then he says try it, use it, because we do not know everything in medicine. (Tr. 846)
13. The products in the next group to be considered have been categorized as those relating to weight loss and figure modification. These products are the subjects of the cases designated by the following docket numbers: In-Trim (formerly Control) ((10/127); Cellulite TR3 (10/134); and Cellulite PM (10/135)
14. The substance of the Complaint in 10/127 is that by no means of direct mail solicitations and by means of advertisements which are calculated to induce readers thereof to remit money through the mail for its product In-Trim (which was foremerly known as Control), Respondent makes the following representations which are alleged to be materially false. (PP 3 and 4):
a. In-Trim (formerly Control) is an effective long term appetite suppressant.
b. In-Trim (formerly Control) is completely safe for all dieters.
c. In-Trim maintains its effectiveness throughtout your diet.
d. In-Trim (formerly Control) will enable you to lose as much weight as you want.
15. The Complaint in 10/134 describes a similar method of soliciting remittances of money through the mail for the product Cellulite TR3 on the basis of the following representations which, likewise, are alleged to be materially false (PP 3 and 4):
a. Cellulite TR3 is effective in eliminating cellulite.
b. Cellulite TR3 inhibits the formation of cellulite.
c. Cellulite differs from ordinary body fat.
d. Celluite is a circulation and elimination problem.
e. Niacin in Cellulite TR3 will cause every blood vessel and capillary to open up and flush itself out with fresh cleaning blood.
16. The Complaint in 10/135 outlines a similar method of doing business through the mail in the sale of a product called Cellulite PM. The alleged representations set forth above from 10/134 as (a), (b) and (c) are repeated in 10/135 as (a), (b) and (d), respectively, together with the following representation, all four of which are alleged to be materially false (PP 3 and 4):
c. Cellulite PM accelerates the burning of foods which keep new fatty tissues from being formed and absorbed.
17. Respondent makes the representations alleged in each Complaint in this group as indicated in the language quoted below each such representation set forth in the respective Complaint.
a. In-Trim (formerly Control) is an effective long term appetite suppressant.
"No matter how hard they try, many people just can't stay on a diet. They lack the motivation or the will power to face long days and weeks of deprivation and hunger. Indeed, the urge to eat is one of the strongest biological impulses in the human body, and hunger is the biggest problem that most dieters face.
That's usually why, if you're like most dieters, you need special help to control your hunger in order to successfully loss weight. You need something to suppress your appetite so you can cut down on the fat-producing foods that keep you from achieving your weight loss goals. You'll find that special help you need in In-Trim." (CX 287)
b. In-Trim (formerly Control) is completely safe for all dieters.
"And, unlike many prescription diet pills, In-Trim is completely safe, totally non-habit-forming and causes absolutely no adverse side effects." (CX 287)
The In-Trim formula is unique. And, best of all it is proven effective and completely safe." (CX 288)
c. In-Trim maintains its effectiveness throughout your diet.
"***In-Trim maintains its effectiveness throughout your diet***." (CX 290)
d. In-Trim (formerly Control) will enable you to lose as much weight as you want.
"Only In-Trim contains PPH-751, the time-release ingredient that provides you with enough hunger suppressing activity to insure that you lose as much weight as you want --without going hungry."
a. Cellulite TR3 is effective in eliminating cellulite.
"Cellulite TR3 dissolves the myth that you can't get rid of cellulite." (CX 81)
b. Cellulite TR3 inhibits the formation of cellulite.
"Thus the most effective way to rid yourself of cellulite is to improve and stimulate your circulation to open and flush out these hard-to-reach deposits. Fortunately, new research has uncovered a method of doing this and preventing the return of those bumps and bulges. The essence of this research is available in Cellulite TR3." (CX 85)
"TR3 helps you get rid of cellulite once and for all." (CX 87)
c. Cellulite differs from ordinary body fat.
"While cellulite may look like ordinary fat, those lumpy, gelatinous deposits are actually accumulations of excess water, toxic wastes and fat cells that get trapped in your connective tissues as a result of sluggish circulation." (CX 81)
d. Cellulite is a circulation and elimination problem.
"Once niacin gets the cellulite tissue revitalized with freshly circulated blood, TR3' herbal diuretics and natural detoxificants can pick up the cellulite wastes, excess water and debris and move them out of the body." (CX 86)
e. Niacin in Cellulite TR3 will cause every blood vessel and capillary to open up and flush itself out with fresh cleansing blood.
"Cellulite TR3 is a time-release, continuous action anti-cellulite compound that contains the necessary nutrients to dissolve and remove cellulite. Its main ingredient is niacin, a highly effective vasodilator that causes every blood vessel to open up and flush itself out with fresh, cleansing blood. Niacin can open up even the tiniest capillaries in cellulite-choked tissues by its ability to provided a purifying circulatory increase that even the most strenuous exercise and massage can't duplicate." (CX 86)
a. Cellulite PM is effective in eliminating cellulite.
b. Cellulite PM inhibits the formation of cellulite.
"During the day you can fight cellulite by using nutritional technique, massage and specific exercise. But at night when cellulite is most prone to develop, what can you do? The answer is an exclusive all natural formulation called CELLULITE PM that workrd while you sleep to fight cellulite formation while it gently loosens old cellulite." (CX 65)
c. Cellulite PM accelerates the burning of foods which keeps new fatty tissues from being formed and absorbed.
"Cellulite PM incorporates gentle naturAl laxatives and herbs that keep you elimination processes working as productively at night as they do during the day. These ingredients also help to accelerate the burning of foods which keeps new fatty tissues from being formed and absorbed." (CX 61)
d. Cellulite differs from ordinary body fat.
"There has been a lot of discussion about what cellulite is and exactly what causes this distressing beauty problem. Some "esperts" even insist that there is no such thin as cellulite. They say that it is just ordinary fat.
Well, the ugly ripples and lumps that characterize cellulite certainly do exist. The main cause is not exess weight but rather a complex health problem --poor circulation." (CX 68)
18. There were received in evidence the following exhibits which are true and correct copies of transcripts of the product labels showing the ingredients and directions for taking each of the products involved in the instant case. (Each product label carries the notation "distributed by: Athena Products, Ltd., Atlanta, GA 30340" which does not appear below. Also omitted from some label transcripts below is the "CAUTION: Keep out of children's reach." The docket numbers of the cases have been added in ( ) for identification purposes.)03,21,50,09$D*2*IN-TRIM (formerly CONTROL)(10/127)Appetite ControllingDiet Planwith PPH-75140 capsulesDIRECTIONS:Take one capsule at 10:00 A.M. or atany other time during the day.CONTENTS:Each capsule contains:Benzocaine9 mg.Sodium Carboxy- methycellulose100 mg.Buchu Extract20 mg.PPH-751(Specially processed timing compoundcontaining potassium chloride and phenylpropanolamine hydrochloride,formulated to release - over aprolonged period of time:Potassium35 mg.Phenylpropanolamine hydrochloride75 mg.WARNING:Discontinue use if rapid pulse, dizziness orpalpitations occur. Persons with high bloodpressure, heart, kidney, thyroid disease ordiabetes should consult with a physicianbefore using. Consult with physician beforeexceeding recommended dosage. (CX 296)CELLULITE TR3(10/134)50 TabletsDIRECTIONS:Adults take 1-2 tablets daily.CONTENTS:Each specially formulated tabletcontains:Kelp59 mg.Parsley Root9 mg.UVA URSI13 mg.Buchu65 mg.Juniper Berries11 mg.Plus TR3, a unique time releasecompound which provides over aprolonged period of time:Niacin500 mg.In a base of Golden Seal Root, GingerRoot, and Corn Silk. (CX 95)$G$G * * *CELLULITE PM(10/135)50 TabletsDIRECTIONS:Adults take one or two tablets dailywith or after the evening meal withfull glass of fluid.CONTENTS:Each specially formulated tabletcontains:Potassium99 mg.Psyllium Husk100 mg.Microcrystalline Cellulose200 mg.Methylcellulose50 mg.Dill Herb75 mg.Fennel25 mg.Dandelion65 mg.Apple Pectin85 mg.Garlic Powder29 mg.In a base containing Lettuce Powder, PeasPowder, Grapefruit Powder, Kelp and Yeast. (CX 72)
1. This product contains 75 milligrams of phenylpropanolamine hydrochloride (PPA), a drug which has been primarily used heretofore as a decongestant. It is included in this product as an anorexic agent or appetite suppressant. Dr. Schwartz had currently researched the studies with respect to the use of PPA as an appetite suppressant, and it is his opinion that the use of PPA in weight loss programs has extremely limited therapeutic benefit, if it has any at all. That is on the therapeutic side. PPA is used as a decongestant, and the reason is that it causes a shrinkage or a constriction of the blood vessels in the mucuous membranes of the nasal pharynx and therefore reduces the swelling. This property of constricting blood vessels is also translated to other parts of the body and from current studies, it is believd now that individuals who have high blood pressure should not use this product. The potential therapeutic benefits of it are so limited, if there are any at all, that there is doubt that the risk to individuals with high blood pressure is in any way offset by any potential therapeutic value.
2. The Food and Drug Administration empanelled a number of committees who deal with the safety and efficacy of over-the-counter (OTC) preparations. One of these panels dealt with the use of PPA as an outpatient preference. That panel determined that there was enough clinical data available to indicate that the drug had some effect in aiding an individual who was on a calorie restricted diet. Now, it is quite clear that any anorexic agent does not cause a loss of weight. An anorexic agent does cause a depression of appetite and, therefore, allows better compliance with the diet. Between two individuals who follow a diet exactly to the last calorie, no difference can be perceived between the one who takes an appetite suppressant and the one who does not, other factors being equal. The appetite suppressant only helps the individual who tends toward non-compliance.
3. The OTC panel report evaluated and gave credibility to the studies in which there was an overall increase in weight loss in groups that took phenylpropanolamine, but the difference in the group was limited to a few pounds per month and there was quite a large distribution among the two groups. In fact, in one of the studies, the largest weight loss occurred in an individual who did not take PPA, which means the individual was probably complying with the diet. The panel determined that the claim made for PPA was calid by virtue of the statisticals in the studies.
That report has not been accepted by the Food and Drug Administration. In fact, it is the general practice of the Food and Drug Administration, upon receipt of such reports, to publish in the FEDERAL REGISTER, its own comments, its own intended interpretations and action and it asks for public comments. The Food and Drug Administration has not done that with this report, even though it is about three or four years old.
4. Dr. Schwartz referred to CX 315 and said that Chapter 13 of that exhibit reflects his opinion. The last complete paragraph on page 221 of that exhibit represents exactly what is being taught to medical students in the course of pharmacology with regard to anorexic agents. There are amphetamine-like reactions with respect to the blood pressure. With regard to the anorexic activity associated there are studies, controlled studies which indicate that in the conclusions of the authors there is some anorexic activity associated with PPA, albeit limited. There are also other clinical studies which indicate it does not. There is a specific clinical trial which indicates that a PPA-treated group has as a group an increase in weight loss over a period of time, although this weight loss was limited. There are, also, other clincial studies in which such activity was not observed. Thus, with respect to amphetamine-like activity, the major activity of PPA is that of increasing the blood pressure.
5. Other ingredients listed in the label for Control besides PPA are benzocaine, sodium, carboxymethylcellulose, buchu extrqct and potassium. In Dr. Schwartz's opinion none of these ingredients, individually or in combination with other ingredients, serves to act as a long-term appetite suppressant. It is also his opinion based on his pharmacological knowledge and his understanding of the ingredients from the transcript of the label, that In-Trim, or Control as it formerly was known, would not be an effective long-term appetite suppressant. In-Trim or Control, in his opinion, absolutely would not be completely safe for all dieters. The basis for his concern for the safety of PPA is, primarily, its effects on blood pressure which have been reported in the literature. Warning individuals with high blood pressure not to use PPA-containing compounds is like warning a child who can not read to beware of the dog. The fact is that there are numbrs of people who have high blood pressure, possibly even the majority ofpeople in the country who have high blood pressure and do not know they have it; therefore, they do not assume that the warning refers to them, and if there is added to that the fact that the affected population is overweight, the likelihood is increased that these silent hypertensives will constitute a high percentage of the group.
6. Any effectiveness PPA has is going to be of short term because persons who take these phenylamines generally develop tolerance for them fairly rapidly, so any appetite suppressant of that group, whether it is initially shown to be very effective or not, is going to have an effect for a very limited period of time. In some individuals it may be measured in days, otheres in a few weeks, but certainly not beyond that. What would be necessary in order that someone would be enabled to lose as much weight as he or she wants is compliance with a diet, and PPA and the rest of the components of this preparation would not aid in compliance with the diet in any significant degree. (Tr. 20-38)
7. On cross-examination Dr. Schwartz stated that he was testifying based upon his viewpoint as a scientist who has a Ph.D. in pharmacology and his background and experience as a pharmacologist. He said that he accepts no claim for therapeutic efficacy of a product until such claim has been subjected to testing by means of a controlled clinical trial, including a double-blind study. He then detailed the various steps that must be taken to set up and conduct such a trial. (Tr. 46-51)
8. He was next asked whether his standard of proof as to the efficacy of the products involved in the proceeding is the standard that is used by the Food and Drug Administration. He replied: "absolutely not. I'm hoping that the FDA is using standards that we use", although he said that the FDA's standards and those he follows are similar. (Tr. 53)
9. Dr. Schwartz has spent about an equal maount of time during his career in research, teaching and advisory activities. He has lectured on anorexic agents, on over-the-counter preparations, on PPA specifically, as well as on other appetite suppressants --prescription and non-prescription. He has discussed various subjects involving components of some of the Respondent's products, such as nucleic acid, heavy metals in relation to toxicity and the effects of Vitamin E.
10. Dr. Schwartz stated that a treating physician's view on a medical matter would be more valuable than his. Conversely, it would be presumed that on many, if not most, pharmacological matters, Dr. Schwartz's observations would be more valuable than a physician's. Such is one of the objectives of specialized education, training and experience. (Tr. 56-58)
11. Dr. Schwartz differs with the statement on p. 222 of CX 315 that the issuance by the FDCA of a report of an advisory committee in which it found PPA to be a safe and effective anorectic agent when used for up to about 12 weeks as an adjunct in weight reduction constituted a reversal of previous opinions voiced by the agency. (Tr. 59) The statement with which Dr. Schwartz disagreed appeared in CX 35, published by the American Pharmaceutical Association. He stated that this publication is not a primary source medical journal. (Tr. 60)
12. Dr. Schwartz has written no articles in the field of weight loss. He has conducted no clinical trials relating to weight loss or weight control but he has designed, evaluated, or modified many such tests some of which have involved anorexic agents. He is, in fact, aware of specific medical problems that show a weight reduction benefit by using PPA. He would expect that the product, Control or In-Trim, would behave in clinical tests very much as PPA, alone, behaved. The study showed that there would be group differences between groups which used PPA in a caloric restricted diet and groups which did not. There may have been some other differences but he was not certain as to the exact nature of these differences. The findings of the study to which Dr. Schwartz referred are reported in CX 320. The Medical Letter, dated August 10, 1979. Most of the known major toxic effects have been developed from clinical experience with the drug, and not through some type of trial for the toxicity. (Tr. 67-71)
13. Dr. Ayers identified PPA as a member of a group of chemical products or items (phenyl-amines) that have a certain action with respect to inhibiting some enzyme systems in the body.
14. Experience and studies have shown a relationship between hypertension and weight. There are numerous studies that indicate that for each degree of upgrading of weight, there is a very high percentage of increase in both systolic and diastolic blood pressure. These studies have been repeated in a variety of populations so that in the overweight population, depending on whether white or black, male or female, for each degree of increased weight, there are increased degrees of high blood pressure, both systolic and diastolic. Taking all of those groups together, somewhere between a third to a half of people that are more than 15% overweight will have some degree of hypertension. The group of drugs of which PPA is a member is, as a group, so constructed chemically that it has as one of its activities appetite suppression. (Tr. 329)
15. An appetite suppressant containing PPA would not be safe for people with high blood pressure. It is more than potentially harmful, it is really harmful. There are studies that show that PPA has raised blood pressure in people, particularly those who seem to have whatever the conglomerate of complexity is that leads to high blood pressure. Particularly in situations in which the prevalence of high blood pressure is an overweight group is very significant, the use of a product that has that potential is very dangerous for the individual.
16. The medical risks for persons suffering from high blood pressure include various vascular accidents in which the blood vessels, either in the brain or eye or elsewhere are changed, and stroke and heart attack are seen in people with high blood pressure when their blood pressure is too high or is not controlled.
17. The Diet Management Program which he supervises has never used anorexic agents as a group. The appetite suppression activity of this group is short term, does not have a lasting effect, and individuals develop a tolerance to that specific aspect of it, appetite suppression. The characteristic of these drugs for suppression of appetite is that after a while the initial dose no longer has an effect. People sometimes take more of the drug to get the effect they used to have. The point is that not all of the end points of the use of that drug proceed at the same rate with respect to the degree of the develpment of this tolerance. So that in taking more of the drug to suppress appetite, they could be doing more harm to the blood vessel problem, high blood pressure problem.
18. Relative to the representations set forth in the Complaint, Dr. Ayers said that In-Trim, formerly Control, is by no means an effective, long term appetite suppressant. It is not safe for all dieters; it will not enable one to lose as much weight as he wants; and it will not maintain its effectiveness throughtout the diet. (Tr. 331-334)
19. There are many medical doctors who would use PPA as a product that would be helpful in curbing appetite in a weight reduction program, but he does not know whether these M.D.'s generally feel that it is safe. It has not been conclusively proved that PPA has appetite suppressant ability, but on the other hand, there are other people who feel it has that characteristic. Potassium plays a part in the metabolism of fats, but Dr. Ayers is not aware that potassium deficiencies can be caused by the consumption of coffee. He has not used In-Trim or any other product that contains PPA. (Tr. 339-343)
20. Dr. Gushleff testified that PPA is an accepted appetite suppressant in the presence of a good proper diet for weight reduction. It has been used for years, it is a very popular, well accepted product. He has used PPA routinely for over ten years in numbers and numbers and numbers of unit doses.
21. Based upon his experience, he would not expect any difference in the use of the product In-Trim or Control from the PPA containing product that he has with his patients. He has used this type of PPA product on probably several thousand patients.
22. He has never personally seen any serious problems or reactions in patients to the use of PPA. He noted that the label transcript says that rapid pulse, dizziness, palpitations may occur, and that persons with high blood pressure, kidney, heart, thyroid and diabetes should consult a physician before using. He said that is on all of the package inserts for PPA. He has seen some people who had a mild increase in their pulse rate, and he has seen more people who have had a dryness of the mouth with it which either remained while they took it, or, after they had been on the medication for a week or ten days, the dryness of the mouth went away. He has never seen any very serious problems with it. He estimated that he has pescribed better than a quarter of a million individual doses of PPA in ten years.
23. He said that PPA that he uses for appetite suppression is only 75 milligrams a day, and he has found it to be very sage in this low dosage.
24. Dr. Gushleff feels that the product is as effective in a diet as any of these products can be. This product, or any other appetite suppressant product, are all measured against a criteria of dextroamphetamine sulphate, which is regarded as being the best. He has found it to work in 75, maybe 80 percent of the people who use it.
25. He has kept people on it for four, five and six months. After a period of time it loses its effectiveness but not entirely, because they will discontinue using the product and some of them will come back and say they would like to use it again for another month or two because they have regained their appetite now.
26. Sometimes it is difficult to determine the difference between a placebo effct and the effectiveness of a drug. He said that one of the product warning labels on a product containing PPA when it was used as a nasal decongestant was anorexia, although it was not used so much as an anorectic agent. He has seen patients that he put on a particular diet to help them lose weight without the medication, and he has seen the same patients that he has put on PPA and it has increased the effectiveness of the diet in their weight reduction.
27. This product will, in the presence of a good diet, assist patients to lose as much weight as they might want or need to lose. Obviously if you are consuming some horrendous amount of calories, this product is not going to be of help. (Tr. 569-575)
28. On cross-examination (TR. 579-611) Dr. Gushleff said that PPA was accepted as an appetite suppressant approved by a council appointed in 1979 by the Food and Drug Administration. He said he thinks that this council came to the conclusion after their research that there were two products that were accepted as appetite suppressant as safe, of which one was benzocaine and the other was phenylpropanolamine.
29. When Dr. Gushleff used the word "accepted" he meant that if it were harmful and a dangerous product, he does not think it would be sold on television, radio, and over the counter in drug stores and supermarkets. He does not think it would be allowed if it were not accepted.
30. Dr. Gushleff stated that 75 milligrams of phenylpropanolamine in a time release capsule has not been shown to be significant in elevating diastolic or systolic blood pressure in patients. Most patients who are overweight and who are recognized as having hypertension are on antihypertensive drugs and the patients have been put on 75 milligrams of PPA in a time-disintegrating capsule, it has not been shown in his clinical evidence to elevate systolic or diastolic blood pressure to any significant degree. Also, the use of PPA and a good diet in helping patients lose weight also aids their hypertension significantly.
31. For people who have uncontrolled hypertension, or for people who have hypertension that is not treated, he would state that PPA is contraindicated, but he thinks if one were going to put this patient on medication that the patient would have the symptom first. If they had not seen their physician or if they were on the medication and did have hypertension, the physician would probably check their blood pressure, but he has not seen any of this happen.
32. If a patient was severely hypertensive Dr. Gushleff would not give it to him until he either saw a cardiologist or got his hypertension under control. He also had one patient who got extremely dry in the mouth and got vertigo from one tablet, so he just stopped taking it. There are some people who are allergic to anything, but he has given over a quarte-million doses of PPA and has had maybe twenty reactions or twenty bad effects. He does not think that is bad, and he says that is average in the Physician's Desk Reference (PDR). For all prescriptions he thinks the average number of adverse side effects is about seven to eleven percent, even of those that are considered not to have side effects. Amphetamine-like reactions he is aware of include insommia and increased motor activity. He used no other ingredient in combination with PPA.
33. When asked what effect, if any, 9 milligrams of benzocaine would have with respect to the use of PPA, he said:
"I don't know. I thought it was a topical anesthetic." He is aware that if the amount of carboxymethylcellulose in a product exceeds a certain small amount it becomes a laxative. It is his opinion that the presence of sodium carboxymethlycellulose in this product in its present amount adds to the capability of the product to serve as an appetite suppressant. He has no idea as to the amount of bulk that would be formed in a stomach by 100 milligrams of sodium carboxymethylcellulose.
34. He said that he would recommend that a person who has not had a blood pressure test go on a diet regimen or a reducing regimen that would incorporate PPA.
35. Dr. Gushleff said that there is a controversy among people who use PPA in weight loss programs with respect to its effectiveness as a long term appetite suppressant. He thinks long-term use of any of these products is controversial because a tolerance builds up for the product over a long period of time, which he would define as longer than six months.
36. He has not performed any valid controlled clinical trials of a double-blind study to determine the difference between people who are taking PPA and a diet as opposed to the control group or the other group which only has diet. He says, however, that he has seen significant evidence that in people who do not take PPA the appetite is not suppressed and they are not able to control their appetite. He described them as foodaholics, which is presumed to mean that they are compulsive eaters. He prescribes PPA by its generic name in dosages of 75 milligrams, once daily at mid-morning.
B. Cellulite TR3 - To Eliminate and Inhibit Formation of Cellulite, Which Differs from Ordinary Body Fat; Cellulite is a Circulation and Elimination Problem.
1. One representation in the Complaint based on the advertising is that niacin in Cellulite TR3 will cause every blood vessel and capillary to open up and flush itself out with fresh cleansing blood. With respect to this point Dr. Schwartz testified that that implies that somewhere along the line there is stale dirtying blood. Niacin, which is a B complex vitamin, in some individuals causes a dilation of blood vessels and has been used rather unsuccessfully to increase blood flow in certain conditions that are called peripheral vascular diseases. These are diseases in which the hands get cold, and the patients get what is called Reynaud's Phenomenon in which the blood vessels shut down and the person gets cold and blue. Niacin has been used in these cases to try to dilate these blood vessels to increase the blood flow. It is apparently effective in some individuals, but not in others. In general, it is not considered particularly efficacious for this purpose, but it is possible that in some individuals and in certain locations that niacin in large enough doses will cause a dilation of blood vessels. If you have a dilation of blood vessels, generally you increase the blood flow. It depends upon the tissue, but, generally, you increase the blood flow in the particular area. The increase of the blood flow, or flushing effect, induced by niacin would have no relationship at all to the removal of fat cells from the body. From a pharmacological point of view, there is no biological effect that niacin would have in removing cellulite from the body. This product would not be effective in eliminating cellulite since there is no evidence of the existence of cellulite, and, secondly, it would not eliminate he mottling effect since that requires essentially, weight reduction.
2. Of the papers on cellulite in the medical profession which the witness has seen, one refers to the mottling of the skin and the cause of it, and there have been some publications to re-emphasize the fact that there is no such thing as a substance called cellulite. With respect, generally, to diagnoses, cellulite is not considered a disease or a disfunction term. It is a term which has grown up outside of the medical profession. The medical profession in scientific areas has dealt with it only because of public awareness of the term, and most of that has been to discount the fact that there is something building up in there that can be taken out. It is, in fact, a structural change, but it is the same as any structural change might be so far as dealing with cells and connective tissue is concerned, but there is no such substance involved. When a dermatologist refers to cellulite now he is referring to the patient's own description of indurations or mottling of the skin and certainly not to some substance that is there. (Tr. 42-46)
3. Dr. Hunt identified the nutritional ingredients of Cellulite TR3 as niacin, which is a vitamin, and kelp, which is not itself a nutrient but it contains some iodine. Niacin was used to reduce serum cholesterol, but not so much used now because it is believed that it can cause some liver problems. It does cause reddening (flushing) of the skin, it causes the blood vessels to dilate and it had the effect of reducing serum cholesterol, but no one knew what happened to the cholesterol when it left the serum. Dr. Hunt said that cholesterol is different from the fat cells that constitute cellulite, as that term is used in this proceeding. A flushing effect in the blood system would have nothing to do with the removal of cellulite from the body. that can be done only by creating a deficit of calories by means of reducing food intake, increasing exercise, or by simultaneously emplying both of these measures. This product will neither inhibit the formation of, or eliminate, cellulite. Cellulite is not a circulation or an elimination problem. This product will not take poisons out of the body. (Tr. 89-97)
4. Dr. Hunt does not use the term "cellulite", rather, she says "fat deposit." Women have "fat deposits" naturally more than men. It begins with adolescence and they continue to have more fat deposits. As one gets older the skin becomes less elastic, and there are areas in which the body stores more fat, where it shows up more (moe apparent). There are exercises that are designed for specific parts of the body, which when coupled with reduction of caloric intake, will get rid of those fat deposits. (Tr. 97-100)
5. Dr. Ayers stated that there is nothing in this product, Cellulite TR3 which would inhibit the formation of cellulite, or that would be effective in eliminating cellulite. This product, unlike Cellulite PM, has niacin in it. Niacin is a very weak vasodilator of people with normal blood vessels, not diseased blood vessesls. He is aware that some individuals have claimed that the accumulation of so-called cellulite is a circulatory problem and that by dilating blood vessels you enhance the removal of this material. That is not so, that is not what so-called cellulite is, it is not a circulatory problem. The effect of niacin in the blood stream, whatever effect that is, would have no effect on removing cellulite. Cellulite is not an elimination problem. (Tr. 337-338)
C. Cellulite PM - For Same Purposes As Cellulite TR3
1. Dr. Schwartz said that his understanding of the word cellulite is that it refers to the mottled appearance of the skin, generally due to structural changes in so-called fat cells. There are others who refer to cellulite as a substance that for some reason collects in the skin and causes this effect. So far as he is concerned, cellulite as a substance is a fantasy. There is nothing in this product, based on the ingredients listed in the product label, that from a pharmacological point of view would permit Cellulite PM to be effective in eliminating cellulite. The only way to accomplish this result is by a weight reduction program and an exercise program. Similarly, there is nothing in the product Cellulite PM that would be able to inhibit the formation of cellulite from the viewpoint of appearance. Cellulite is an unscientific word used to meand ordinary body fat in the upper legs, thigh and buttocks, and there is nothing that would result in this product accelerating the burning of foods and keeping new fatty tissues from being formed and absorbed.
2. With respect to the definition of cellulite, the witness said that there is no difference in the component of the fat. The structure under the skin and the connective tissue might be different, but there is no difference in the nature of the fat itself. (Tr. 38-41)
3. Dr. Schwartz has never been involved with, or for that matter seen anybody else involved with, or seen any results of any study which dealt with these ingredients for the treatment of cellulite. He has, therefore, never seen a study demonstrating whether the claims made for Cellulite PM or Cellulite TR3 are false or true. If cellulite involves a chemical structural change of fat cells and connective tissues, then this would mean that celulite is something different from ordinary body fat.
4. Insofar as attempting to prove the negative is concerned, Dr. Schwartz is not aware of any such study nor will any such study ever be done. There can be 500 studies of Cellulite PM, none of them showing any effects on the skin, and they will never probe the negative; they will only give a high degree of confidence that there is no effect. (Tr. 76-80)
5. Dr. Hunt defined nutrition, generally, as the science of feeding the body well. This involves ingestion, digestion, absorption, transport and utilization of nutrients. The only nutrient listed as an ingredient of Cellulite PM is potassium. Potassium is found widely distributed in foods and there is no need for supplementation of potassium in the diet. If people are taking diuretics, the body may be depleted of potassium and supplementation would be necessary. Dr. Hunt has heard the term "cellulite" used. It is stored energy, it is fat. There may be a little laxative effect from taking the tablets, but other than this there is nothing in Cellulite PM that would enable a woman to rid herself of cellulite. Cellulite differs from ordinary fat only in the place where it is located. It really is only fat. To get rid ot it requires specifically designed exercises for the particular part of the body, and reduced caloric intake. There is no nutritional supplement that can rid the body of cellulite; it will not inhibit the formation of cellulite; and it will not accelerate the burning of foods and thereby keep new fatty tissue from being formed and absorbed. (Tr. 91-95)
6. On cross-examination Dr. Hunt said that she avoids the use of the term "cellulite", and, instaed, shw says fat deposits. It may be possible to identify cellulite as discussed here, but what is generally called cellulite is fat deposits around the hips, and this is fat. Fat deposits that men have around their hips seem to look exactly the same, but the subject is fat appearance. She has noticed this on women, but not very often on women who are thin. As women get older they are much more likely to have this than they are when they are younger. This condition occurs more frequently in women than in men because women just naturally have larger fat deposits. It begin with adolescence and they continue to have more fat deposits. It just so happens as you get older the skin becomes less elastic, and those are the areas of the body where more fat is stored, and it shows up more. Whether or not it looks the same on women and men, it is still fat, and they only way you can get rid of it is by exercising that particular part of the body where it is deposited and getting a deficit in calories. (Tr. 97-102)
7. Dr. Ayers, when asked for a definition of "cellulite", said:
"I don't accept the term "cellulite", to begin with. Right from the beginning I want to make clear that I don't believe a specific substance that somebody called cellulite exists other than it is a form of subcutaneous fat accumulation. So I may refer to it as so-called cellulite and I believe that cellulite is purported by some to have a distinct difference from normal or usual fat. I categorically deny that, Cellulite, in my mind, is an appearance, not an ingredient or a substance and refers to a particular mottling or dimpling of the skin seen usually in females, usually in the lower abdomen, buttocks and thighs and is due to the accumulation under the skin of deposits of fat or increased fat. And the relationship of thata overlying skin to the deeper subcutaneous tissues in the female is different than in the male. The strands of connective tissue, the fibrous tissue that holds the skin in place to the deeper structures has a particular pattern that allows for the accumulation of excess fat between those strands in cells or compartments or a protrusion of the fat above the normal level causing a dome or an extrusion and the skin is held down in other places by these fibrous connective tissue strands that holds the skin down, so you get this pattern that ppears as alternating domes and depressions in the skin in thos particular areas of women. It is, as far as I'm concerned, to summarize, cellulite is an appearance of an excess accumulation of subcutaneous fat, predominatly in women."
8. Cellulite may occur in males but rarely so. Males have a different kind of structure of skin relative to subcutaneous tissue and the firbrous strands in the male have a different pattern that there is in the female. When men become hormonally more like women, through medication, operation, injury or otherwise, they become more like females, and there does develop a pattern in the flesh that is similar to that which is commonly seen in females.
9. For women who wish to get rid of the so-called cellulite, the witness had this to say:
"The central fact is they need to lose weight. The usual way that we accomplish this, that most people accomplish this, as far as I'm concerned the only way to acomplish reduction in weight, is to reduce the calories taken in below what the needs of the body are, so that the body is forced to burn its fat stores for energy and in that way remove the fat that is stored and thus lose weight, and in this setting, then, I'm talking about the reduction of weight due to the removal of fat."
10. There is nothing in Cellulite PM that would be effective in eliminating cellulite, as that term is used in this proceeding. There is nothing in the product that would enable the user to inhibit the formation of cellulite, or that would accelerate the burning of foods and thereby keep new fatty tissues from being formed and absorbed. (Tr. 334-337)
11. Dr. Ayers has done no experimentation with Cellulite PM or Cellulite TR3 or any other product with a similar combination of ingredients. He is not aware of any experiment or controlled study, and he ha conducted none, which would demonstrate that Respondent's claims for Cellulite PM and Cellulite TR3 are false. There are studies in the field of non-absorbable fibers (methylcellulose, for example, in Cellulite PM) in which they have been used, not by themselves but in conjunction with diet and other portions of a weight management progrqm, and the investigators have been unable to isolate any effect due just to those ingredients. (Tr. 344-345). For persons on a 10000 or less calorie per day diet, supplementation with vitamins and minerals, of which potassium is one, is required. Otherwise, potassium is readily available if people are eating anywhere near a normal diet, and supplementation is unnecessary. (Tr. 346)
12. On the subject of the need for potassium and its availability to the adult population of the United States, the following pertinent comment is taken from pages 173-4 of the 1980 edition of the Recommended Dietary Allowances, supra:
* * *
"Potassium is widely distributed in foods, meat, fluid milk, and many fruits are good sources. The usual adult intake is between 1950 and 5900 mg (50-150 mEq/day (Wilde, 1962). Under ordinary circumstances, the healthy adult can maintain potassium balance with an intake nearly as low as the infant's minimal requirement [90 mg per day] even though the kidney is not able to estrict potassium loss so efficiently as sodium excretion can be curtailed with low sodium intake. On the other hand, concentration of potassium in sweat is low (generally less than 390 mg (10 mEq)/-liter) compared with that of sodium (25-30 mEq/-liter). Potassium deficiency usually occurs only when there is excessive loss of potassium through diarrhea, in diabetic acidosis, or in association with use of certain diuretics and laxatives.***"
13. Dr. Gushleff had a patient to come in who brought Cellulite PM and Cellulite TR3 into the office to show them to himand ask if they were any good. She had purchased these through the mail. He said he really did not know, he had not idea whether they worked or not. She came back later and said that she had gotten good results from them and so he wrote this company and asked them to send some to him. He has used these on patients with "cellulite" and he has gotten good results. He has used them for six months. More than half of his patients have had very excellent results, with a dramatic decrease in the dimpling and also in the size of their calves, but it did not entirely remove it all.
14. Dr. Gushleff does not think there is such a thing as cellulite. Cellulite is fat, a fat deposition under the skin. It has become a very popular name. It is a layman's common term now meaning excess fat and the dimpling of the skin in the upper legs and the buttocks region, and some women even want to call the fat in their upper arm "cellulite"
15. Every time he has used one of the Cellulite products he has used the other, used them both at the same time, one in the evening and one in the morning. In addition, everybody for whom he has prescribed Cellulite PM and Cellulite TR3 he has also put on a reducing diet. When asked how he knows whether the results are being achieved from this product as opposed to being achieved from diet along, he replied:
"I don't think this product would work if you had someone gorging themselves with booze and carbohydrates. It would be like an antibiotic and injecting them with bacteria every day. I don't think it is going to work unless you use the proper diet is what am saying."
He later added:
"Yes, in the presence of exercise, proper diet and using this medication, yes, they seem to have gotten much better results than just putting them on a diet and giving them exercise, and I don't know why either." (Tr. 575-579)
16. For people ith "cellulite" Dr. Gushleff prescribes exercise, high protein diet, and Cellulite PM and Cellulite TR3. He has tried it and he has had some good results with it. He has no way of knowing whether the results are from the diet and exercise as opposed to the use of Cellulite TR3 or Cellulite PM except that he said the patients did not seem to take the cellulite off before they were taking the medication. He has had no control group set up to try to find out whether it is the product or the diet.
17. At the time of a patient's first visit, after the interview, it is usual to take a SMA, which is a blood test, and a blood count to make sure that the patient is not anemic and does not have diabetes. Then the patient is given a diet sheet to follow, and he asks them such questions as "Are you a big eater? Are you a snacker?" Sometimes they keep a record, a diary of what they eat. Sometimes it helps them if everything they put in their mouth they write down. The patient makes just the first two visits to the Doctor, and after that, is on a monthly basis. In the meantime it is acceptable for them to call him and ask for his advice or get reassurance or anything of that sort that they need. That does occur, but it is very seldom. They do come back regularly for their monthly visits for a period of, usually, about six months. It depends on how obese they are but, unless they are just extremely large, most women in six months on proper diet and a little exercise can lost a dress size or two, and that is all most women are concerned with.
18. He is aware that this product is sold through the mails, that the person who is taking the product has seen the advertisements and then placed the order for the product, and, having the product in hand, the person takes the product according to the directions so far as he knows. This entire series of events may occur, and undoubtedly does occur, without reference to a doctor.
19. As to which person --the one who is the mail order customer or the one who receives the advice qn reassurances of her doctor --has the better chance of stqying on the diet and losing weight, he thinks there are some people who need the reassurance and the coaching and the patting on the back, and some people that really do not need it.
20. If a person who previously has consulted with a physician about a weight problem sees Respondent's advertisement, orders and receives Respondent's products, Dr. Gushleff doubts that such a person will then go back to the doctor after he has receied the products in the mail. However, if this person should go to see the doctor, that fact would help him to maintain the program including the diet, the PPA and exercise. In other words, persons who attempt, as a program of self-treatment, to initiate and maintain a weight loss program involving PPA, diet and exercise have less chance of succeeding then do other persons following the same regimen but who have the added advantage of reinforcement by professional counseling. (Tr. 611-617)
19. The cases in the last group have been described as relating to rejuvenation or supplements to prolong youth. They involve three products as follows: RX for Aging (10/136); RNA (10/137), and Youth Factor (10/138).
20. The substance of the Complaint in 10/136 is that by means of direct mail solicitations and by means of advertisements which are calculated to induce readers thereof to remit money through the mails for its product RX for Aging, Respondent makes the following representations which are alleged to be materially false (PP 3 and 4):
a. RX for Aging will retard and reverse the effects of aging on skin.
b. The RN content of RX for Aging encourages new growth of health and firm skin cells.
c. RX for Agins is an effective remedy for such aging conditions as:
1. wrinkles
2. age spots crow's feet
d. RX for Aging gives "Almost immediately visible results."
e. RX for Aging is capable of altering the cell's genetic make-up
f. RX for Aging is more effective than a moisturizer.
21. The Complaint in 10/137 describes a similar method of soliciting remittances of money through the mail for the product RNA on the basis of the following representations which, likewise, are alleged to be materially false (PP 3 and 4):
a. RNA Supplement retards the aging process.
b. RNA Supplement will replace the cell's ribonucleic acid (RNA).
c. RNA Supplement is capable of altering the cell' genetic make-up.
d. RNA Supplement can effectively
1. fade age spots
2. smooth complexion
3. soften or eliminate wrinkles and lines
4. increase energy and sex drive
5. greatly improve memory and coordination.
22. The Complaint in 10/138 outlines a similar method of doing business through the mail in the sale of a product called Youth Factor on the basis of the following representations which are alleged to be materially false (PP 3 and 4):
a. Youth Factor slows the aging process.
b. Ingested Superoxide Dismutase (SOD) Supplement Supplement inhibits and neutralizes free radicals.
c. Ingested RNA supplement can replace the cell's ribonucleic acid.
d. Youth Factor is an effective remedy for such conditions as
1. arthritis
2. senility
3. deterioration of the senses.
e. Placenta supplement can reverse "Many of the outward signs of aging.
f. Dr. Benjamin Frank is a famous anti-aging researcher.$23. respondentmakes the representations alleged in each Complaint as indicated in the language quoted below each such representation set forth in the respective Complaint.
a. RX for Aging will retard and reverse the effects of aging on skin.
"RX for Aging is not like other skin care products. it can actually help prevent and reverse the damage age does to skin." (CX 21)
b. The RNA content of RX for Aging encourages new growth of healthy and firm skin cells.
"RX for Aging is able to slow down the visible signs of aging in your face because it encourages the renewed growth of firm, healthy skin tissue." (CX 21) (See, also, language supported charge "d".)
c. RX for Aging is an effective remedy for such aging conditions as:
1. wrinkles
2. age spots
3. crow's feet
"Supplemental RNA has been shown to significantly slow down the skin's aging process, and diminish wrinkles, age spots, crow's feet and sagging skin. RNA and the other RX for Aging ingredients will help your skin retain moisture better, and immediately begins working to eliminate wrinkles and other lines while giving elasticity and firmness to sagging skin. RX for aging is particularly effective in those sensitive areas around the eyes, the back of your hands and your neck." (CX 25)
d. RX for Aging gives "Almost immediately visible results."
"RX for Aging can give you almost immediately visible results as it softens tiny lines and imparts a dewy freshness to your face. With regular RX for Aging use, the results will become even more dramatic because this rejuvenating skin cream actually encourages the new growth of healthy and firm skin cells." (CX 27)
e. RX for aging is capable of altering the cell's genetic make-up.
"RNA is a vital nucleic acid needed by all of your cells to grow, reproduce and function properly. When cellular RNA wears out, the signs of aging begin to show. Supplemental RNA has been shown to significantly slow down the skin's aging process, and diminish wrinkles, age spots, crow's feet and sagging skin." (CX 25)
f. RX for aging is more effective than a moisturizer.
"There has been little you could do in the past to repair and rejuvenate older-looking skin. Despite claims of mysterious ingredients, most skin creams just moiturize or temporarily swell the skin so wrinkles aren't as noticeable. But now, there's RX FOR AGING, a facial cream that can help bring about restorative wonders for all types of skin." (CX 29)
a. RN Supplement retards the aging process.
"RNA helps slow the aging process before it stops you from enjoying life." (CX 2)
b. RNA Supplement will replace the cell's ribonucleic acid (RNA).
"The discovery that faulty RNA can be a primary cause of aging, enabled scientists to make an important break-through in the first fight agains aging --the replacement of dead or decaying RNA with supplemental RNA to rejuvenate cell growth and prolong youth." (CX 2)
"Doctors and scientists, have found that by replacing worn out RNA through supplementation you can renew your cells and prolong your youth." (CX 8)
c. RNA Supplement is capable of altering the cell's genetic make-up.
"This [the fact that some people are aging more quickly than others] is due to the deterioration of the cells' genetic material, ribonucleic acid, or RNA. Faulty RNA means that healthy, firm skin cells won't be able to continue to reproduce. This can lead to wrinkled, spotted and age-damaged skin. And, this same deterioration can occur in every kind of cell in your body --hair cells, organ cells, muscle cells, brain cells --due to a deficiency of healthy RNA.
However, the knowledge that faulty RNA is a primary cause of aging has enabled scientists to make an important breakthrough in the fight against aging --the replacement of unhealthy RNA with fresh supplemental RNA to rejuvenate cell growth and prolong youth." (CX 11)
d. RNA Supplement can effectively
1. fade age spots
2. smooth complexion
3. soften or eliminate wrinkles and lines
4. increase energy and sex drive
5. greatly improve memory and coordination.
"With supplemental RNA age spots faded, complexions became smoother, wrinkles were softened, energy and sex drive increased, and memory and coordination have been greatly increased." (CX 8)
a. Youth Factor slows the aging process.
"The Youth Factor has been designed and formulated to exclusively offer these anit-aging ingredients that researchers such as Dr. Frank feel are responsible for people being able to look and feel younger longer than they ever dreamed possible." (CX 261)
b. Ingested Superoxide Dismutase (SOD) Supplement inhibits and neutralizes free radicals.
"Fortunately there is a natural cellular defense that resists aging by inhibiting and neutralizing free radicals. This remarkable agent is called superoxide dismutase, or SOD, and can actually help stop aging before it starts--if the body has enough of it. However, as we grow older, our body's natural SOD resources dwindle. Until recently, there was no known way to replace diminished levels of this important enzyme. But now, manufactureres have found a way to replenish diminished SOD levels. This technology has led to the development of the Youth Factor, the revolutionary anti-aging supplement." (CX 265)
c. Ingested RNA supplement can replace the cell's ribonucleic acid.
"All of the major anti-aging breakthroughs have been included in the Youth Factor. The revolutionary formula contains: RNA, the life-sustaining cellular substance that is responsible for maintaining cell performance and keeping you young. (CX 266)
d. Youth Factor is an effective remedy for such conditions as
1. arthritis
2. senility
3. deterioration of the senses
"Youth Factor provides the SOD your body needs to stop the cellular destruction that causes damaged skin, age-associated diseases like arthritis and senility, and the deterioration of the senses. (CX 265)
e. Placenta supplement can reverse "Many of the outward signs of aging."
"Youth Factor also contains placenta, the key ingredient in live cell therapy. Placenta has been credited with reversing many of the outward signs of aging as well as restoring diminished internal organs to more vigorous function." (CX 265)
f. Dr. Benjamin Frank is a famour anti-aging researcher.
"Dr. Benjamin Frank, famous anti-aging researcher spent many years formulating a nutritional program to retard the aging process."
The following exhibits were received in evidence as true and correct copies of transcripts of product labels showing the ingredients and the dosage of each of the products involved in the instant case (each product label carries the notation "DISTRIBUTED BY: Athena Products, Ltd., Atlanta, GA 30340" which does not appear below. Also omitted from some label transcripts below is the "CAUTION: Keep out of children's reach." The docket numbers of the cases have been added in ( ) on the product labels for identification purposes.03,21,50,09$DRegular(10/136)RX for AgingSkin Crean with RNA2 ouncesDIRECTIONS:Use RX for Aging each day as needed tomoisturize and soften dry skin. The cream is absorbed into the skin almostimmediately but does not leave a stickyor greasy feeling. RX for Aging can alsobe used as a night cream. Apply it fromyour neck to your forehead and rub itsmoothly into the skin.CONTENTS:Water, Mineral Oil, Autolyzed Yeast (NaturalSource of RNA). Emulsifying Wax NF, StearylAlcohol, Lecithin, Glycerine, GlycerylStearate, Lanolin Alcohol, PEG 100 Stearate,Panthenol, Zinc Hydrolized Protein Chelate,Collagen, Triethanolamine, Dimethicone,Carbomer-934, Methylparaben, Propylparaben,Stearic Hydrazide, 2-Bromo-2-Nitropropane-1,3-Diol, Rose scented cream also containfragrance and FD&C Red #40. (CX 36) * * *RNA(10/137)*2*Ribo Nucleic Acid Complex50 CAPSULESDirections:One capsule daily as a source of RiboNucleic Acid.Contents:Each capsule contains:Ribo Nucleic Acid (Yeast source)250 mg.Dried Brewer's Yeast400 mg.The need for Ribo Nucleic Acid in humannutrition has not been established.Caution:Keep tightly closed in a dry place. Do notexpose to excessive heat. (CX 17) * * *THE YOUTH FACTOR(10/138)40 CAPSULESDirections:Adults take one capsule daily.Contents:Each capsule contains a uniquely processedblend which provides:Superoxide Dismutase50 mcg.Placenta300 mg.Linoleic Acid150 mg.In a specially prepared base containing RNA,DNA, ginseng, mixed Tocopherols andselenium. (CX 274)
A. RNA --(10/137) To Retard Aging; to Replace the Cellular RNA; to Alter the Genetic Make-up of the Cells; to Fade Age Spots, Smooth Complexion; to Soften or Eliminate Wrinkles and Lines; to Increase Energy and Sex Drive and to Improve Memory Coordination.
1. Although the first product listed in this group is RX for Aging, the parties elected to take up first, the product RNA. The following is a summary of the direct testimony of Dr. Schwartz with respect to the product RNA.
2. Ribonucleic acid (RNA) is essentially part of the genetic messenger system of the cell; it carries a signal from the genetic material DNA to the rest of the cellular machinery. There would be no clinical pharmacological action caused by ingestion of RNA. The body synthesizes its own. RNA, when ingested, is not directly absorbed into the cells of the body, but the component digestive products would be. Even if orally ingested RNA were able to survive digestion and to be absorbed, the yeast source of this product could not replace or supplement human RNA. Dr. Schwartz testified that the product RNA will not do any of the things which Respondent in its advertising material represents that RNA will do. (Tr. 251-253)
3. On cross-examination Dr. Schwartz said the claims of efficacy are false when such claims are unsubstantiated by any scientific information. He is not aware of any experiment that demonstrates that the claims made for the product RNA are false.
4. it is scientifically inadvisable to attempt to prove a negative. It is very difficult, time-consuming and costly to double-blind products. Dr. Schwartz is not aware of any experiment or clinically controlled study, and has conducted or performed none, that demonstrate that claims for RNA and RX for Aging are false. (Tr. 262-265)
5. Dr. Hunt has seen a list of ingredients of RNA. There is no actual nutrient included but yeast is a good source of various nutrients; ribonucleic acid contains phosphorus which is a nutrient, but there is not any real nutrient, as such, shown on the list of ingredients. There are no effects or benefits to be derived from oral administration of the product. RNA, taken orally, can not be absorbed intact --it is digested and broken down into its component parts. Yeast RNA would not supplement or duplicate human RNA because what human RNA will be is governed by the deoxyribonucleic acid (DNA). The product will not retard the aging process, replace the cells' ribonucleic acid, alter cells' genetic make-up, and, when taken orally, will not fade age spots, smooth the complexion, soften or eliminate lines and wrinkles, increase energy and sex drive, or improve memory or coordination. If taken by mouth, this product will have no effect. She has no quarrel with the taking of vitamin and mineral supplements by people who do not eat properly, and she feels that they need to have a sort of insurance and take supplements in amounts set forth in the RDA. People with deficiencies need supplementation. For people without deficiencies to take supplementation is wasteful and it creates very expensive urine.
6. On cross-examination Dr. Hunt stated that her testimony is predicated on basic facts of the sciences of physiology and biochemistry. Dr. Hunt has done no particular research into oral supplementation of RNA. There have been changes in various aspects of physiology, but the matters concerning which the witness testified are recognized as being accurate as demonstrated in clinical trials that have been conducted. Dr. Hunt was questioned about an article entitled "Effecs of Ribonucleic Acid on Memory" by D. Ewen Cameron, M.D., and Leslie Solyom, M.D., published in the February, 1961, issue ofthe journal Geriatrics (RX 1) in which the writers reported favorable results in improvement of memory in aged patients upon oral administratin of ribonucleic acid. Dr. Hunt pointed out that the article was 20 years old and asked if there were not something on the subject that is more recent. She said that if the author had achieved such success it is surprising they did not follow up this particular article with a series. Respondent's counsel referred to a later (1963) article by Dr. Cameron in the British Journal of Psychiatry, but the subject of the larter article was not stated and the article was not offered into evidence. With respect to RX 1, the witness said that if the results of the test had been so dramatic as the article indicated, there would have been a tremendous amount of information in other journals. The article indicates that the authors get favorable results from oral administration of RNA, but the authors did not indicate what kind of RNA they used and the procedure followed appears to be very casual. With such dramatic results, it would be expected that the authors would be very specific as to exactly how they did it, and that there would have been numerous replications of the study. Dr. Hunt has seen no studies of this kind reported in the medical literature which would tend to prove or disprove the validity of the results reported by Drs. Cameron and Solyom. (Tr. 115-128)
7. Dr. Ayers, testified that ribonucleic acid (RNA) is one of the nucleic acids, a constituent of the cell that is ubiquitous or widely distributed throughout the body systems. It is important to the genetic make-up of individual cells, and it is essential to human life. Each cell has its own genetic pattern for it, and like all nucleic acids in the human system it is manufactured by the cell from its constituent parts, the amino acids and so on that go in to make it and join together to form its own cell's specific species, specific kinds of nucleic acid, RNA being just one.
8. If a capsule containing RNA were to be digestedm tgat RNA would not be absorbed intact into the cell. When ingested it is subjected to the digestive process, which means that is is broken down to its constituent parts, its building blocks, its amino acids. They are absorbed and enter into what might be called the pool of amino acids that the body has. The body uses those amino acids to build proteins, a variety of different kinds of proteins so that there is no guarantee in any way that the ingested RNA would wind up in RNA in the body, but more importantly because species have specific characteristics of RNA.
9. It just does not follow that if you take somebody else's RNA it would in any way affect you own genetic cellularRNA. Hence, even if yeast RNA could pass through the digestive system and not be broken down into component parts, and if it were to be absorbed, it still could not replace or duplicate the human RNA. It is true, as indicated on the label that "The need for Ribo Nucleic Acid in human nutrition has not been established." RNA supplement does not retard the aging process; it does not replace the cells' ribonucleic acid; it can not alter the cells' genetic make-up; and it can not effectively fade age spots, smooth complexion, soften or eliminate wrinkles and lines, increase energy and sex drive; or greatly improve memory and coordination. (Tr. 349-352)
10. On cross-examination Dr. Ayers stated he has done no studies in the area of RNA. He has researched the literature concerning the work of others. He has seen RNA on drug store shelves. Dr. Ayers did not research Index Medicus to prepare to testify in this case. He read some articles that were given him at various time. He is aware of studies that indicate that orally administered RNA is not absorbed as such, therefore he interpolates from that finding that Respondent's claims for RNA Supplement would not be reasonable. (Tr. 358-359)
11. With respect to the product RNA, it was Dr. Lord's testimony that supplements of RNA in general would have value only for individuals who are consuming diets that are low in the nucleic and ribonucleic acid which is what RNA is. Those compounds are contained in virtually all foods in some amounts; however, the amount in the high carbohydrate foods which are consumed by large sections of the population in deference to high protein foods is fairly low. The high protein foods are the one which contain RNA, and so if high protein foods are not consumed in adequate amounts, then the RNA in the diet will be relatively low. The other aspect of the problem is the one of the assimulation of the nutrients in the diet which tends to be low in many individuals. Either one of those conditions then, low protein diet or low assimilation of nutrients, would make the addition of the RNA product, to supply the precursors for building of the nucleic acids in the person's body, a possible benefit.
12. Reference was made to previous testimony in this case to the effect that the value of taking oral RNA is questionable because of the fact that the product itself is digested in the stomach and broken down into its component parts and, therefore, it would not have any value nutritionally to the human RNA in the body itself. So far as he knows, it is true that the RNA would be largely broken down into the nucleotide or nucleoside building blocks for the RNA. Those will be absorbed and used by the body, and the fact that the body can produce those is the reason they are not considered a vitamin. He said there is evidence, however, that cells lose their ability to produce enough RNA to keep up the replication process, to make new cells. he thinks it is universally accepted that aging is somehow the failure of the ability of the body to reproduce the cells that make up the tissues. Thus, if someone is supplied with the precursors that would allow these processes to be maintained, then they would benefit from the RNA by being able to build their own RNA and DNA, and thereby continue to build fresh cells. This process is a universal aspect of aging. From this rationalization process he concludes that use of RNA supplement, or improvement of the diet, whatever it takes to increase the level of the nucleoside precursors to make DNA and RNA in the cell, would support better regeneration of the tissues, and help retard the aging process.
13. The administrative complaint in this case talks about whether or not RNA is helpful in fading age spots, smoothing complexion, softening or eliminating wrinkles, increased energy and sex drive, improved memory and coordination. Those are definitely all processes involved in aging, and anything that will retard those processes will slow down the aging process.
14. A product containing the ingredients of RNA as listed on CX 17 is what he had in mind, and the benefits that he mentioned would be in people where that need existed. Since the statment that the need in nutrition has not been established he said that someone buying the product would know it is not a dietary essential component and that the benefit would like in their own response to the product. (Tr. 461-465)
15. Dr. Lord has never served as a full time faculty member of a medical or dental school. He bases his statement that medical and dental school curricula do not allow for teaching nutrition on the fact that they do not teach nutrition. That's what, on inquiry, he is told routinely --one of the reasons that it is not taught is because they have so many other courses to teach that it cannot be put in.
16. He said that the source, from which he gleaned this information, was from physicians, first of all those to whom he talks who routinely use his laboratory. He asks them why nutrition is not taught and that is the information they give him. Educators in medical schools and dental schools give him the same kind of reason.
17. About sixty percent of the doctors for whom his laboratory does work request hair analysis and forty percent other types. He does hair analysis to determine zinc levels and he has done serum analysis for zinc levels, but he does not do those routinely in his lab. In his opinion hair analysis for zinc is a more reliable test than serum analysis. He said that, generally, the levels that one finds in the analysis of the hair would be consistent with the analysis that is found as a result of serum testing --not for all minerals, but for some, definitely. Zinc is one of those minerals for which hair analysis more accurately reflects tissue levels of zinc than does serum analysis.
18. Dr. Lord recognizes that there is some difference of opinion in the scientific community with regard to the use of hair analysis to establish levels of zinc. When asked whether it is true that the view that he had expressed, that hair analysis for zinc is more effective than serum analysis, is a minority view in the medical and scientific community, he said:
"Of course it is. Not many doctors even know about hair analysis."
19. Dr. Lord was asked, based on his scientific expertise whether he had an opinion as to whether one would be able to find traces of zinc levels in an exhumed body that had been interred for a hundred years. In reply, he stated that he would guess that one should find zinc. When asked whether it would reflect the current nutritional state of the individual, Dr. Lord replied that he was not sure what it would reflect.
20. Dr. Lord was cautious --to the point of evasiveness and lack of clarity --when he was asked whether his view with regard to the amount of vitamin supplementation that is necessary in human health are consistent with the views expressed in the 1980 edition of Recommended Daily Allowances published by the National Research Council. He did say that the attempt is made in those recommendations to take into consideration the loss of vitamins and minerals that result from transportation, storage and other factors. He said that a person who followed the recommendations in the RDA would have no assurance that he would be able to maintain what he calls optimal health.
21. When asked what would be required in addition to the recommended daily allowances to obtain optimal health, he replied:
"That's a good question. We don't know what would be required, certainly not in any individual. We know, though that there are individuals that exceed those amounts by twofold, for example, just a rough figure, that benefit greatly from having at least twofold if not tenfold times the RDA level if you want to talk about an individual response. Individual responses to greatly increased levels above the RDA levels have been demonstrated countless times."
He repeated, however, that he was not disagreeing that the RDA publication is a useful guideline; he said that is all it is intended to be.
22. Dr. Lord testified with respect to the percentage of the United States population that is in a sub-optimal condition of health. He put the estimate at close to one hundred percent. He said that he could not name an individual in his experience that is as healthy as he could possibly be under ideal conditions.
23. Dr. Lord testified that RNA as ribonucleic acid taken by mouth in the capsule supplement cannot be absorbed in large quantities into the cell; but various minute percentages can be so absorbed. Dr. Lord said the best-understood process that occurs when a person digests a capsule with yeast RNA is simple hydrolysis of the RNA into nucleotide and nucleoside molecules that make up the RNA and the absorption into the blood. He then agreed that it is not the RNA that gets to the cell, but that it is the product from the RNA, the nucleotide and nucleoside.
24. Explaining how a nucleotide or nucleoside differs from the food we eat Dr. Lord indicated that the RNA, first of all, is in all foods, and so the concept that may not have been made clear is that the same nucleotides or nucleosides are required for human cells as re required for any organiam, including the plants and animals that we eat. Those that are broken down from the foods or from the tablets can be assimilated directly back into our own cellular RNA without further changing, thus sparing ourselves a great deal of energy expenditure in having to make those products.
25. Nucleotides and nucleosides can be synthesized in the human body. In this case, however, we have to distinguish evidence of the biochemical role of the nucleosides and nucleotides from clinical levels. Here we have to look simply at the evidence which has been presented which is admittedly limited, but is at the same time encouraging with respect to the ability of ingested nucleic acids to benefit certain clinical conditions such as aging, which is the main one it has been applied to.
26. The biochemical rationale of how such things can be useful when they are not an essential nutrient is simply that, first of all, it is widely accepted scientific doma that the reason for aging is because we lose the ability to replenish fresh new cells. That is why an old person is not like a baby. Biochemically the only difference is he has old cells, old tissues that are not replenishing themselves.
27. To replenish means you have to build within the cell RNA and DNA. To do that the cell has to create a vast amount of cellular machinery --enzymes have to be produced. Old cells lose that ability. Why? Probably because --and this, he said, is once again published and discussed widely --of the presence of free radicals such as superoxide. The effect of those free radicals is to diminish the cell's ability to both preform nucleosides and to assimilate them into DNA, so if we are supplying them then the cell is simply spared that effort, and that is the biochemical rationale explaining why a nutrient such as a nuceloside, which is not an essential nutrient, can benefit a cell which is having trouble in that particular function.
28. Dr. Lord has heard there is supposed to be a limit to the total number of replication cycles of new cells, but no one knows. As far as the limit invivo, it is not at all well demonstrated. In vitro, in cell culture, there seems to be a limit, although even there, there are cell cultures that have been reproducing themselves for many, many years through vast numbers of generations of cells.
29. Based upon his general knowledge, tissue cultures themselves are quite different from cells in vivo. Some experiments with tissue cultures have been carried to the point where we do not know how much they can replicate. Ever since they were isolated they are still replicating. These ae the ones called pila cells which are cancer cells taken from a cancer patient, they are very special cells, but again it just points out the fact that no one knows that there is a limit to the replication of human cells. Certainly we know they can replicate far beyond the seventy or so years that we are expected tolive in this country by looking at simple populations in which people live to be 120 years old, so how can we say we are limited in replication. No one knows.
30. Dr. Lord testified that RNA will retard the aging process in many individual who is in need of nucleic acid precursors, an example of whom would be an old person who is living off a starchy diet.
31. There are types of person or conditions of people that would require the use of an RNA supplement such as this in addition to older people on high starch diets. There are people who go throughout life, or for periods of weeks or months sometimes, on very inadequate diets. The alcoholic, for example, is a clear case where the diet goes for a long period of time lacking in these specific nutrients and they would benefit from these products.
32. An older person on a starchy diet is incapable of synthesizing nucleic acid at times. There is evidence that, in fact, that is what old age is all about, you lose the ability to replicate and make fresh new cells.
33. In Dr. Lord's opinion this product can exten that cell replication process in an older person with progressive symptoms of aging and it can retard the aging process. He said it is well documented in Geriatric Cases that there is a big benefit from all sorts of nutritional improvements in the diet, and simply adding protein foods is one of them. One of the reasons for this result is because of what these foods contain, these types of precursors. (Tr. 482-488)
34. On redirect examination Dr. Lord said that, anyone, including young people, can benefit from additional supplements of RNA, assuming that they are individuals who have episodes of idetary restriction of those compounds. In the case of young people, it is not as clear because they do not have the overt signs of lack of ability to reproduce cells, in general, as a class. He sees young people who experience extended periods of diet which are low in high quality RNA, and that simply means that they are not in the very high carbohydrate foods, as well. In the case of other young persons they are synthesizing their own and apparently have adequate quantities, so it would be just simply assuring to the diet that that component is present. (Tr. 495)
35. Commenting on the general question as to whether vitamin and mineral supplements are needed at all for the diet of the people in the United States today, Dr. Grumbles said:
"In my fifteen years of this type of work, working primarily in this field, I have been increasingly impressed that nutritional deficiencies are very widespread. This based on the study of my patients from the standpoint of very careful histories, physical examinations, the standard blood tests, very specialized blood tests which include the micronutrients, zinc, copper, manganese, iron and the toxic minerals, lead in the blood and serum and also the use of hair analysis routinely for the past five years at least, and treating patients with a program very specifically aimed at correcting these problems that I find to be wrong by those testings, and I would say that the --again, speaking from my own experience I find some deficiency in at least eighty percent of the people that I see as confirmed by testing or by direct physical examination."
36. It is his opinion that benefits can be obtained from the oral supplementation of the diet product RNA. RNA derived from yeast is something that he has used extensively with his patients since 1970. The RNA that he has used is a yeast-derived RNA, which this product states it is also.
37. In his experience and from several years of fairly close friendship and working relationship with Dr. Benjamin Frank who did do a lot of work with RNA, one of the specific things that the witness has used it for has been actual memory problems, and he says this is substantiated by the work of Dr. D. N. Cameron, of Toronto, Canada. There is a definite improvement over a perid of time with RNA in various dosages administered orally depending upon the individual.
38. Another particular effect that he has noted is that patients with emphysema seem to become able to tolerate more exercise, more walking, walking up steps better, and some patients with mild angina have been able to stop their nitroglycerin with the use of RNA and to a large extent are exercise tolerant. These are the chief ways in which he has used it.
39. It is his opinion that these are suggetive that it is curing or relieving to some degree some of the symptoms of old age, but if he is asked whether it does retard aging, he can not answer that question. He does not think anyone can scientifically answer it; it would be purely an opinion.
40. As to the benefits he thinks supplements of RNA have withe regard to the overall aging process, he thinks if we retired, if we relieved some of the symptoms of aging we can postulate then perhaps RNA extends aging. He said that Benjamin Frank was very much convinced of this, but he was never completely convinced of it as an aging retardant, but he has no hesitation in giving it to elderly people who want to keep in good shape.
41. Dr. Grumbles identified Dr. Benjamin Frank as a Swiss physician who practiced in New York for many years, and wrote a book to the '60's called RNA and Aging. Dr. Frank has written one since called the Anti-Aging Diet in which he advocates the use of very high RNA-rich foods. Dr. Frank, himself, died of diabetes. (Tr. 619-626)
42. On cross-examination, he said that his education in the field of nutrition is based on the fact that he studied with the people that he considered most apt and most advanced in the field but not in the way of formal courses. He has studied with them through professional meetings, private meetings, listening to copious numbers of papers at various organization meetings, as well as extensive reading over the past 15 years.
43. About one-third of his clinical practice currently consists of psychiatric patients and the others are people who are referred for nutrition problems.
44. The hair analyses on which he relies are reports that he receives from others. He does not have a hair analysis laboratory. If he is interested in the zinc content of a particular patient and he wants to have the lab do an analysis, he requests both a serum analysis and a hair analysis, but not both from the same laboratory. He uses in his nutritional practice a similar yeast-derived RNA product.
45. His understanding of the mechanisms that take place in the body when one takes yeast-derived RNA by mouth is that the RNA molecule is broken down into its smallest sub-units of nucleotides, nucleosides, which go across the intestinal barrier into the blood stream, and the raw materials for the reassimilation seem to enhanve or facilitate the body's own formation of RNA.
46. He does not try to measure the exact success of this particular mechanism. He simply tries to judge it clinically and he said that is the only explanation that makes any sense. He said he has observed the clinical effect, it has been observed in elderly people by Dr. D. N. Cameron, and he measured the effects in their intermediate memory and by administering it both parenterally and orally and he found responses in both, the better response parenterally but a definite response orally.
47. Assuming that yeast derived RNA were administered parenterally, it is his opinion, that this RNA with yeast would not be capable of duplicating or supplementing RNA cells in the body, but that it would facilitate the body's formation of its own specific RNA. In other words, he is not saying that the yeast RNA now becomes part of the RNA in the body, just the sub-units.
48. With respect to RNA administered exogenously by mouth, his testimony is that it is broken up by the digestive system and the surviving nucleotides and nucleosides will assist the body in the formation of RNA. This is the only way it seems to make sense to him.
49. Referring to Dr. Frank, Dr. Grumbles is aware of controversy with respect to this findings concerning the use of supplemental RNA to retard aging. He would say that Dr. Frank's theories represent the minority view with respect to that argument, but he does not consider scientific evidence or fact to be something that requires a majority vote.
50. Dr. Grumbles repeated that he will give an RNA product to older people although he is not sure it has any benefit, but it might be helpful to them if they want it. It is his view that the results that may come about as a result of an older person taking this would not be in the nature of a placebo effect. He said that people with memory failure do not respond to placebo effect very well, if they do it is for a very short time.
51. He recommends at least from 400 to 1000 milligrams twice a day. On occasion,he has recommended as much as three to four grams a day but that is not the usual dosage. The clinical benefits that he has seen in his use of RNA wereusually in patients whose dosage was about a gram a day. With respect to the clinical results that he personally observed by giving gram doses of RNA, he would not expect to occur in only 250 milligrams on a daily basis. He said that there is a possibility of some results but he finds the larger dose more effective.
52. Insofar as retarding the aging process of users is concerned he thinks it is quite possible that this 250 milligrams of RNA might do so, but he can not unequivocally state scientifically that it can. He rated it as better than nothing. Initially, Dr. Frank, and then in the work he was doing, small dosages were used and he soon became impressed that a larger dosage gave more benefit and was quite safe to give.
53. Dr. Grumbles has no real opinion as to whether this product of Respondent's will extend life span.
54. This product will be capable of replacing the cells' ribonucleic acid in the manner that he described earlier, namely, not by replacing the cells but by providing the substrate material for production of RNA.
55. This product, taken in the dosage indicated, may be of some help in retarding the defenerative process of aging, but it is not the dosage that he would recommend.
56. Based on his understanding of RNA and how it is absorbed, he does not have an opinion as to whether RNA that is not administered parenterally or exogenously administered by mouth, but topically in a cream form on the skin, can be absorbed into the cells. (Tr. 629-639)
57. In addition to nutritional work he also does psychotherapy with patients when indicated along with the nutritional work. He also does a lot of neurological consultations, and he is the neurological consultant to the Philadelphia Institute for Pain and Trauma where he spends a half a day each week. This involves evaluation of patients with pain from a neurological standpoint as well as psychiatric standpoint and making recommendations for controlling or relieving the pain situation. He prescribes whatever medication is indicated for the condition. He has no opposition to the sandard prescriptions.
58. It is his opinion that the RNA and The Youth Factor products in the dosages that are contained in the transcript of the product label, will provide the benefits that he has previously described. He gives the larger doses of RNA simply because he thinks that it is possible under medical supervision, and the smaller doses would be more in keeping with the patient's self-administration.
59. It is Dr. Susser's opinion based upon his experience that there is a need for vitamin and ineral supplementation in general in the population in the United States. His experience is that the United States population is widely deficient, perhaps unifromly deficient, in many nutrients and that most people should take vitamin and mineral supplementation, but he does not think it is as good for them as getting what would be a natural diet.
60. He says that people who maintain that vitamin supplements should be reserved for use in the even of some gross clinical deficiency such as scurvy or beriberi are clinging to an archaic idea and that it is his opinion that people need nutrient supplements before they have, and to prevent, a gross clinical deficiency. He said that up to a few years ago a person could die in a modern hospital and have had all the blood tests done, he could die of beriberi and every blood test would be normal five minutes before he died. So basing vitamin deficiencies on blood tests is kind of nonsensical. Now there are newer tests that have come out and some exotic tests like measuring certain enzymes, which changed that somewhat.
61. Referring to the ingredients of RNA he said that he knows of no harm that could come from taking that supplement. In his opinion there is a need for this supplement by people within the United States population. His experience is that a lot of his patients have done very well taking this type of supplementation.
62. It is also his opinion that supplements of RNA are helpful in regard to retarding the aging process. He has used it with that thought in mind, except after reading Dr. Frank's work he was kind of aware of it but it is difficult for him, as a practitioner, to evaluate how the aging process is being retarded. He has used RNA for other purposes like memory and cold temperature and improving the immune system and he has seen it to be beneficial in those situations, and he thinks it prevents disease. He thinks it corrects certain diseases, and in his mind the aging process is sped up by disease, so if a person has more disease he will generally die faster. Because of that he feels that RNA probably does, in some ways, retard the aging process.
63. He expressed the opinion that RNA supplements can help in certain manifestations of aging such as complexion, wrinkles and things of this nature. Many of his patients take RNA, and, generally, they report having people tell them how much younger they look. His impression is that people who are on this kind of program, including RNA, and he can not acribe it directly to RNA in many cases, but people generally do look younger on this complete program. He has used RNA on himself and he has used it on many patients with memory problems. A significant portion of them report good results in memory; they feel they can remember things a lot better. He did not say whether he believes that the use of RNA restored or improved his own memory.
64. He feels that there is a good possibility that this product is beneficial in aiding the body's own RNA in their replication process. He said that if pancreas cells are injected into a animal, the pancreas cells would all wind up in the pancreas, so he would suspect very likely that the RNA does go to the RNA substance in the human body.
65. He said that although the RNA would be involved in the normal digestive process it would not be digested normally. In the past when he was in medical school, and even many physicians today, he said, are taught that the RNA will not be absorbed intact in the body. Now, however, the work of Joeffrey Bland has shown that RNA and many protein enzymes are in fact absorbed intact through the intestinal wall by the process of pinocytosis, and so therefore it could get into, and in his opinion it does get into the body, some portion of its gets into the body in the metabolic system intact.
66. He thinks that benefits such as he described can occur as a result of taking this product in the dosage that is shown on the product transcript label. He uses doses similar to those shown on CX 17. (Tr. 735-741)
67. Dr. Susser is aware of a publication known as Recommended Dietary Allowances published by the National Research Council and he said that his opinions probably are not consistent with the opinions contained in that publication. He defined deficiency as not getting enough of a nutrient in the diet, and therefore having some measurable lack of that nutrient in the body. After some intermediate remarks, he said that his definition of deficiency includes dependency. It is not determined by blood tests, it is determined by patient response. The definition of deficiency would differ from patient to patient. If he is told that a product would provide some relief to prevent a deficiency, it would make a difference who was going to use that product because deficiency differs from person to person.
68. In his opinion, because the definition of deficiency differs from person to person, whether doses of vitamins should be administered on an individual basis rather than through mass distribution would depend on the severity of the problem. His opinion is that most people in this country need vitamins, and they would do better by taking some vitamins than to take nothing at all.
69. Dr. Susser does not know enough about Dr. Frank's work to have any opinion as to whether it is a reputable source on the anti-aging effects of RNA. He has never read Dr. Frank's studies except for excerpts of them.
70. Dr. Susser's references to a Joeffry Bland are based on his recollection of a taped lecture called The Use of Glandular Substances, and Bland did not do the original work, he quoted another worker who had done it. This other worker is said to have shown that protein substances are in fact absorbed intact through the intestinal wall.
71. When the statement was made to the witness that in CX 313 it is indicated that the AMA's opinion is that vitamin and mineral deficiencies are not common in the United States, he said he would disagree vigorously with that opinion. When the statement was made that the AMA position is also that, in the absence of deficiency, vitamin supplements are not necessary, he said that whether he would agree or disagree with that statement would depend on the context of it. In the context of his definition of a deficiency it is true that in the absence of a deficiency supplements are not necessary. He feels, however, that his definition of deficiency is very different from that of the AMA. In regard to the opinion of the American Medical Association that high-dose combinations of vitamins and minerals are not recommende without medical supervision, he thinks the problem is the determination of what is a high-dose.
72. He thinks the National Research Council's RDA is a very nearly worthless concept. The RDA is determined by intake and output studies. he said that, for example, the RDA of calcium is 800 milligrams a day. The way that was determined as he understands it was by taking a large group of the population, finding out how much calcium they ingest a day and how much calcium they excrete every day, and that came to a range of 250 to 2000 milligrams a day, that was the range of the average American --that was the range of this whole group. The average American came out 800 milligrams a day, so if the RDA is 800 milligrams a day and one person is taking 2000 a day and another person is taking 250 a day, what does 800 milligrams a day mean?
73. Other than the work of Frank and Bland he knows there have been studies done with animals that have shown definite retardation of the aging process with laboratory animals, but he does not know that any definitive studies have been done on humans.
74. He is not aware of any studies or scientific reports other than the work of Bland that he had mentioned that stand for the proposition that any part of an exogenously administered supplement of RNA by mouth is capable of being absorbed in the cell. However, there are studies that show that enzymes, for example, taken by mouth do have anti-inflammatory effect.
75. Bland's study stands for the proposition that the RNA can be absorbed from the intestinal tract into the body fluids, into the blood. He does not know if anuthing has ever been proven in regard to absorption from the blood to the cell. The source of this RNA in the product RNA is yeast RNA. If this product could be absorbed into the cell, there is a very stong possibility that it would be capable of sublimating or altering human RNA. Animal studies were done in which yeast RNA was injected into animals, and the animals showed marked effect in their aging process, their life span was nearly doubled.
76. DNA controls the whole makeup of the cell, of everything in the body. Everything supposedly comes from the master template of DNA. RNA acts as a messenger. One of RNA's major functions is to carry the genetic information from the DNA to other parts of the body. A yeast RNA very well could carry the message of yeast because a lot of these things are tissue specific rather than species specific, and the cell therapy work in Europe has shown that these cellular tissues are tissue specific. Thus, even though they use sheep cells on a human being, the pancreas function is changed and all the sheep cell tissue goes to the pancreas, all the sheep cell liver tissue goes to the liver, and the mesenchymal tissue goes to the mesenchyma.
77. He is not aware of any scientific reports or evidence of any other type that would stand for the proposition that use of a product such as this RNA product in humans would replace the cells' ribonucleic acid.
78. Other than the studies he has mentioned, his answer would be the same with regard to RNA supplements being capable of altering the cell's genetic makeup.
79. While conceding that his inability to recall a single case in which use of the product RNA has effectively faded age spots may well indicate that perhaps it is not an effective remedy, he said that it is his feeling that it very well could be. His answer would be the same with regard to the effectiveness of this product to smooth complexion and also to soften or eliminate wrinkles and lines.
80. He thinks that the ingestion of RNA supplement by humans could effectively increase energy and sex drive or greatly improve memory and coordination. The reason he thinks so is that when those things are diminished it is very often apparently from a vitamin deficiency or dependency. For example, a healthy human being is a very sexual animal, and as such if he is fully nourished and fully healthy, then his sexuality will be very high. He was not aware while he was testifying of any studies of writings that would establish that those four effects would in fact relate to RNA administration in humans. (TR. 744-758)
B. RX for Aging --(10/136)
1. Dr. Schwartz said that he is familiar with all of the ingredients of RX for Aging and that the product, when topically applied, can not be absorbed and enter the skin. Topically applied yeast RNA can not be absorbed and enter the skin. The product is basically a moisturizing ointment or cream base. It will not perform as represented, but if an area has been injured, the use of a moisturizing agent may help the shedding of dead skin which would, perhaps, hasten the development of new skin. The judgment, however, is speculative. The product probably would have the effect of softening the appearance of wrinkles and crow's feet for a fleeting period of time. It would provide no internal cellular benefit, and would not alter the genetic make up of the cells. No biological effect would result from topically applied yeast RNA. (Tr. 254-265)
2. On cross-examination Dr. Schwartz stated he knows of no study that proves that claims made for this product are false. (Tr. 265)
3. Dr. Huntreviewed a copy of the list of ingredients in CX 36. The nutrients in the product are water, and yeast and lecithin are sources for nutrients. The product also contains RNA, which contains the nutrient phosphorus. There is no nutritional ingredient in products which, when topically applied, can be absorbed through the skin into the cells. The cell membrane is very selective as to what will go through it. RNA is not a fat soluble substance, and it is a very large molecule which will not go through the skin. Yeast is the source of the RNA in the product, and topically applied yeast can not be absorbed into the cell. The mineral oil in the product might have a moisturizing effect and make the skin feel softer, but that would be about the only benefit to be derived from the use of the product. It will not retard or reverse the effects of aging on skin, encourage new growth of healthy and firm skin cells, be an effective long-term remedy for aging conditions such as wrinkles and crow's feet, and it will not be an effective remedy for age spots. The product is no more effective than a moisturizer and this effect will last only a short time. It will not alter the genetic make-up of the cells. (Tr. 107-109)
4. Dr. Ayers is not familiar with all ingredients, but is familiar with RNA. He stated that when RNA is topically applied it would not be absorbed through the skin; it is not fat soluble, it does not have the solubility characteristics that would permit it to be able to get into the skin. The source of the RNA in this product is yeast. Topically applied RNA derived from yeast, even if it could be absorbed, which it can not be, could not duplicate or supplement human RNA.
5. The product RX for Aging will not retard and reverse the effect of aging on skin; or encourage new growth of healthy and firm skin cells; or be anything more than a temporary and local remedy for such conditions as wrinkles and crow's feet; or be an effective remedy for age spots; or be able to alter the cells' genetic make-up. This product is no more effective than a moisturizer, and this would be only a short-term effect. (Tr. 352-354)
6. On cross-examination Dr. Ayers said crow's feet are just ordinary wrinkles that are located at the corners of the eyes. He is aware of studies that indicate that orally administered RNA is not absorbed as such. (Tr. 358)
7. Respondent's witnesses either did not testify in regard to this product or, when asked about it, expressed no opinion. (Grumbles, Tr. 639)
C. Youth Factor --(10/138)
1. The following is a summary of the testimony of Dr. Schwartz with respect to superoxide dismutase (SOD). Superoxide dismutase is an enzyme synthesized in the cells which is effective in inhibiting and neutralizing free radicals. Superoxide dismutase is a protein taken orally it will be digested (like a piece of steak). If ingested it will not inihibit or neutralize free radicals. Ingested RNA can not replace the RNA in the cells. The product will not perform as represented. Placenta cells in the product are dead because the environment in which they are presented will not sustain life.
2. Dr. Schwartz says that Dr. Frank is probably a famous anti-aging researcher, but that he certainly is not recognized as one by scientists. (Tr. 256-259)
3. On cross-examination Dr. Schwartz said that he has done no studies with supplemental RNA taken orally. He says that it is his opinion that until such time as RX for Aging undergoes scientific studies showing its efficacy , he would conclude that any claims for such efficacy are false. It is his opinion that claims of efficacy are false when such claims are unsubstantiated by any scientific information. He has never personally conducted any experiments with superoxide dismutase taken in oral form. Current scientific knowledge is that to state that it is possible to orally ingest, absorb, transport and get SOD into the cells of the body is not a tenable proposition. He knows of no study that shows that claims made for Youth Factor are false. (Tr. 260-266)
4. Dr. Hunt reviewed list of ingredients (CX 274) prior to testimony. Linoleic acid, an essential fatty acid, is a nutritional ingredient of this product. Superoxide dismutase is a very important enzyme in the body. She added that all enzymes are proteins. If one has a deficiency in zinc he might have a deficiency in the activity of that enzyme, but this has never been shown. It has been shown with experimental animals under experimental conditions that SOD is dependent on zinc for activity. Orally administered SOD can not be absorbed because it is a protein and will be digested in the digestive tract. When protein is ingested there are in the stomach what are called proteases, which are enzymes, that begin to break down the protein. It goes into the small intestine and it can not survive in tact there because all of the enzymes that come from the pancreas go the small intestine where there are also the enzymes in the epithelial cells of the GI tract where the protein is being absorbed. It can be absorbed as diapedides to some extent, but it is certain that no intact protein is going to be absorbed. If foreign protein could be absorbed, the results would be fatal. The way the body protects us is that foreign proteins can be ingested and they can be broken down into individual amino acids and absorbed as such. If, contrary to fact, ingested SOD other than human SOD could survive digestion and remain intact, it would not in any way supplement or substitute for the SOD in the human body because the proteins are specific for the species.
5. Youth Factor will not slow the aging process; inhibit or neutralize free radicals; replace the cells' RNA; and it is not an effective remedy for arthritis, senility as deterioration of the senses. The placenta component of this product can not possibly be live cells, but whether live or dead, it can not reverse the outward signs of aging. With respect to Dr. Benjamin Frank, the witness said that she does not regard as famous anyone, including Dr. Frank, the claimed results of whose studies and test can be reproduced. (Tr. 110-114)
6. On cross-examination Dr. Hunt said she is not aware of any experiments conducted by others, and she has conducted none, that demonstrate that Respondent' claims for the product are false. However, she said that the claims made by Respondent for this product can not be produced because SOD is a protein and when it is ingested it is going to be attacked by enzymes and broken down so that it can not be absorbed as an enzyme. (Tr. 129-130)
7. Dr. Ayers stated that SOD is an enzyme that is active in neutralizing or removing cellular breakdown products, known as free radicals. There is no need in human nutrition for supplementation of SOD, since the body synthesizes its own. In an orally taken product of this type, becaue it is protein, once it gets through the stomach into the intestinal tract it encounters a variety of proteolytic enzymes and the different levels of acidity and alkilinity of the various portions of the digestive tract have their net effect to breakdown proteins into their constituent parts of the proteins and which can be more or less complex. Once they get absorbed as amino acids they enter the general body pool, the body does with them what they want to, and there is no telling where the body will put them. Exogenously administered SOD will be absorbed as amino acids but not as SOD.
8. This product can not slow the aging process. When ingested this product can not inhibit and neutralize free radicals or replace the cells' ribonucleic acid. It is not an effective remedy for arthritis, senility or deterioration of the senses. Dr. Ayers did not know the source of the placenta cells that are in this product, but he is certain that they would have to be dead. Dr. Ayers has seen Dr. Benjamin Frank's name on an article, but he did not know Dr. Frank and he does not personally know of his work. (Tr. 355-357)
9. On cross-examination Dr. Ayers stated he is not aware of any experiments or clinically controlled studies conducted by other persons which demonstrate that the claims made by Respondent for the product Youth Factor or for its ingredients are false. He says he is sure they exist, but he can not give the citation as to where they may be found. (Tr. 360)
10. Commenting on the value of oral supplementation of the product Youth Factor Dr. Lord said that the first component that is listed on exhibit CX 274 is superoxide dismutase which is an enzyme that occurs in foodstuffs, an it occurs in virtually every tissue in the human body. Its purpose is to free the tissues of a very destructive agent, superoxide, which is generated from molecular oxygen in the cells. The superoxide dismutase insofar as it is a proteinaceous product is going to be digested to some degree, probably largely digested, in the digestive process when taken orally. There is some evidence that small portions of these large molecules can enter the blood stream; however, outside of that marginal evidence, the metal component of that enzyme is clearly something that would be of benefit to people who are lacking in molybdenum, it is a molybdo-enzyme. First of all the essentiality of molybdenum is clearly established and studies have been done showing the benefit of adding molybdenum in uric acid metabolism and in this matter of scavenging for superoxides.
11. The superoxides occur from molecular oxygen, they are generated in the cell, they are just one form of free radical-generating agents that can be very destructive in the cell. All tissues must have the ability to get rid of these agents, and one of the ways they do that is by producing this enzyme, superoxide dismutase, which converts the superoxide radical into another form which is harmless to the cell.
12. Youth Factor would be helpful in doing many of the things previously discussed in regard to the product RNA. One of the reasons that the cells lose their ability to produce their RNA and DNA is because of the presence of components such as the superoxide in the cell. This product, then, would be getting back at an even earlier cause of aging that causes the initial destruction of the cell's ability to reproduce itself. Youth Factor would help slow the aging process in anyone who has a need for molybdenum. There is good evidence that there are people who have a need for molybdenum. The ingestion of this product inhibits and neutralizes free radicals. According to Dr. Lord, who said that it helps also in regard to the replication of the cell's own ribonucleic acid. Dr. Lord said that one other potential for the product is with the loss of the ability to maintain intestinal function which is probably one of the earliest losses in the aging process, which, in turn affects the other degenerations.
13. This product would have, also, a beneficial effect so far as conditions such as arthritis, senility, deterioration of the senses, things of that nature are concerned. Dr. Lord said this is true because of the pervading effects of superoxide and such radicals in all tissues, those degenerative conditions would be effected also. He pointed out that one of the aspects of nutrition that indicates this kind of a product can be beneficial is the occurrence of superoxide dismutase (SOD). Because it is an enzyme, the occurrence in the intact form is only n raw foods which is one of the reasons that we have great benefit from consuming raw vegetables, fruits, nuts, and so forth on a regular basis. When foods are thoroughly cooked, this enzyme is destroyed.
14. Dr. Lord stated that SOD is very difficult to get, the effect of uncooked versus cooked foods. The evidence that has been obtained has been obtained by looking at several generations of an animal such as a cat in which one group is fed an uncooked food and the other a cooked food. The effects are very dramatic in those cases, in which case the cats on cooked food diets eventually become unable to reproduce, to have a full term birth and have multiple degenerative effects first in the nervous system, in the reproductive system, and then in other body functions. That is just another of the the kinds of evidence that he alludes to when he says that there is a large body of evidence indicating that we should not just look for frank nutritional deficiencies, but, rather, one should try to look at total nutritional impact.
15. Dr. Lord is of the view that there is abundant evidence that the American diet is shifting towards less raw or slightly steamed foods to the consumption of prepared highly cooked foods. (Tr. 465-470)
16. The need for nutritional supplementation of superoxide dismutases in human nutrition, for example, as that substance is contained in Youth Factor, is on the basis of two known factors. One is the need for molybdenum in the diet. Molybdenum is one of the trace elements that is tripped from many foods that are consumed, and so there is evidence that a fair number of people do not get the molybdenum that they would if they had what would be called a good diet. The second effect is the simple fact that the intestinal mucosa cells have the greatest demand for continual replenishment of superoxide dismutase. When that demand is increased because of the superoxides and other free radicals in the intestinal lumen, the health effect is generated and superoxide dismutase in a product like this or in raw foods would diminish that effect on the intestinal mucosa cells.
17. Again referring to RECOMMENDED DIETARY ALLOWANCES, page 164, Dr. Lord was asked if he agrees or disagrees with the statement, under the category of molybdenum:
"Deficiency states in human subjects are not known. As molybdenum is essential for the function of important oxidation of aldehydes and sulfites, and no disturbances of these functions have ever been related to molybdenum deficiency in man, it must be concluded that man's requirement is so low that it is easily furnished by the diet."
18. Dr. Lord agreed that molybdenum deficiency symptoms have not been systematically documented. He said that there are no known human populations of whom it can be said that they have symptoms because of molybdenum deficiency. He disagreed, however, with the conclusion on page 164, 1980 RDA, that all diets therefore are adequate in nutrition and molybdenum.
19. The first way to determine molybdenum deficiency would be to look at dietary intake in the case of molybdenum and measure molybdenum in foodstuffs and compare that information with the amount that should be, but is not being supplied in the diet. There are cases in which you can just simply look at the diet and have evidence of low molybdenum. The second method is that you can do a laboratory test for molybenum levels.
20. Superoxide dismutase is an enzyme, and when taken in supplemental form such as in this product, Youth Factor, that would be, then, a protein. The body acts on protein taken orally by first beginning digestion in the stomach and thn carrying it further by splitting the peptide bonds of various enzymes from pancreatic secretions in the small intestines. Pepsin is a digestive enzyme in the stomach. Whether any of the superoxide dismutase would survive the activity of the digestive enzyme peptic on superoxide dismutase taken by mouth depends on the level of acid secretion of pepsin enzymes.
21. Dr. Lord said that his statements about the effects of supplemental superoxide dismutase are based on both biochemical supposition and clinical studies. He said that the clinical studies include those published in journals like GERIATRICS indicating beneficial effects from using such compounds, but he could cite no reference to any such study.
22. Dr. Lord hedged considerably when asked whether the opinions he had expressed with regard to supplemental RNA and superoxide dismutase are a minority view with respect to the scientific community or the accepted view. While he never gave a direct answer to the question, he said such things as "There are very few people that are aware of work certainly on a nutritional basis in these areas, but those people that I talk to, that is all I can tell you about." "Physicians treating patients normally know nothing of RNA, what RNA even stands for" and "They probably wouldn't even trust a view [of his]. I know a number that wouldn't." (Tr. 493-494) He later amended his statement concerning the ignorance he attributed to practicing physicians on the subject of RNA and DNA by saying such physicians are not aware of nutritional studies in which RNA and DNA in foodstuffs are limited. He cited no authority in support of this latter assessment either. (Tr. 496)
23. Dr. Grumbles said that he routinely prescribes superoxide dismutase orally. He often suggests that it is chewed and held in the mouth a little while because it is more readily absorbed into the system that way thqn it is just swallowed. But when swallowed, it also seems to have a definite effect.
24 Superoxide dismutase is best described as a free radical chaser he said. He explained this by saying that one of the products of living is that there are oxidation processes going on in the body which produce segments of molecules called free radicals which tend to create sticky substances and are thought to be involved in a great many processes of illnesses, including even cancer, but aging is suspected of being one of these factors. Smog, environmental pollutants and things of this sort, such as exposure to ozone, increase very greatly the free radicals in the system. In experimental animals a study done with exposure of young rats to hyperbaric oxygen caused such great increase in free radicals that if they are exposed for three weeks at two atmosphere's pressure of oxygen, by six weeks their lungs would be almost entirely fibrous. The administration of RNA, in this case parenterically, completely protected these animals from that type of damage from free radical aggravation.
25. These free radicals have an overall detrimental effect on the body insofar as aging is concerned. Since this product helps in eliminating these free radicals it is his opinion that it is beneficial regarding the aging process. (Tr. 626-628)
26. In his opinion, a significant percentage of the capsule containing 50 micrograms of superoxide dismutase will be absorbed. Superoxide dismutase, when taken by mouth, is protein. The digestive system attempts to digest protein taken by mouth and at the same time we are all aware that the administration of enzymes can have very definite effects systemically, not just locally in the intestinal tract. To some degree the digestive enzymes would act on the protein and bredk it up into small parts.
27. In his opinion some of the superoxide dismutase would be absorbed into the cell, and he said if it is not, he is deceiving himself because he prescribes superoxide dismutase very often in aging patients with cardiac problems, and his impression is that it does have some effectiveness. He does not have laboratory data substantiating the oral administration of it in a hard scientific fashion. It is his clinical experience that leads him to believe that it does. He uses 50 microgram size tablets of superoxide dismutase usually, and prescribes them three times a day, which is three times the dosage that is contained in the transcript of the product label of Youth Factor. He would expect to see less benefit with the 50 micrograms than he does with the 150.
28. He is not aware of any studies that have been published that he considers very hard reliable investigations that have indicated that the exogenous administration by mouth of superoxide dismutase is absorbed.
29. When he uses superoxide dismutase in his clinical practice, he does not mix superoxide dismutase with any other ingredient, but he also administers digestive enzymes, especially bromaline, simultaneously, which is another by mouth and at the same time we are all aware that the administration of enzymes can have very definite effects systemically, not just locally in the intestinal tract. To some degree the digestive enzymes would act on the protein and break it up into small parts.
27. In his opinion some of the superoxide dismutase would be absorbed into the cell, and he said if it is not, he is deceiving himself because he prescirbes superoxide dismutase very often in aging patients with cardiac problems, and his impression is that it does have some effectiveness. He does not have laboratory data substantiating the oral administration of it in a hard scientific fashion. It is his clinical experience that leads him to believe that it does. He uses 50 microgram size tablets of superoxide dismutase usually, and prescribes them three times a day, which is three times the dosage that is contained in the transcript of the product label of Youth Factor. He would expect to see less benefit with the 50 micrograms than he does with the 150.
28. He is not aware of any studies that have been published that he considers very hard reliable investigations that have indicated that the exogenous administration by mouth of superoxide dismutase is absorbed.
29. When he uses superoxide dismutase in his clinical practice, he does not mix superoxide dismutase with any other ingredient, but he also administers digestive enzymes, especially bromaline, simultaneously, which is another subject. The superoide dismutase that he uses in his clinical work, is not human superoxide dismutase.
30. Listed in the transcript of the product label there is placenta in the amount of 300 milligrams contained in this product. It is Dr. Grumbles' understanding that this placenta is dead placenta cells. He is not convinced that there is any beneficial effect resulting from the use of a product containing 300 milligrams of dead placenta cells in capsule form.
31. Some of the patients that he gives superoxide dismutase to are the same patients that receive RNA in capsule form. Some of them are not. He does not have any specific protocol. He uses the superoxide dismutase much more widely than the RNA.
32. He said that the action of Youth Factor would be to help eliminate the free radicals which are, by generally accepted theories of aging at the present time, considered to be an important factor. All that he can say, would be that it would have some possible theoretical effect in slowing the aging process and he would give a larger dosage, but certainly that dosage could very well be of some value.
33. He has a study in progress with respect to the beneficial effect of exogenously administered superoxide dismutase which leads him to believe that superoxide dismutase is absorbed in the cell, but that study is incomplete, it is being prepared for publication, but it has not been published. He has been recommending the use of exogenously administered by mouth superoxide dismutase for about two years and he has been aware of this product for about one month. (Tr. 639-644)
34. As to which is the better way of determining the needs of nutritional substances, through trial and error and results from trial and error, or through blood tests, he said that the blood tests are just about worthless. A nutritional trial has to be, in most cases, the only way.
35. First of all the measurements are made in nanogram quantities, and a nanogram is, he said, a billionth of a gram, and a gram is a thirtieth of an ounce, so the quantities are in billionths of an ounce; you are measuring it in the blood only, not in the tissues, so you can have a normal blood level and be deficient in nutrient in your tissues. This has been well substantiated. In things like calcium and you are missing fifty percent of your body calcium. The same thing is true with potassium, you can have a normal blood potassium and be missing fifty percent of your body potassium. These are things that are well substantiated, well accepted in orthodox medicine, so if you try to use so-called scientific blood determinations to determine vitamin deficiency it is a primitive way to do it.
36. It is also primitive t do it by trial and error, but if you have a patient who has a problem such as low energy or such as impotency or such as depression and you put him on a program of nutrients which seems appropriate for him according to what you find from the overall history and physical and other studies, and they get better very quickly it could be placebo effect for sure, but most of the time it is not. It is not because he is very aware of the placebo effect and in his experience he does everything to avoid placebo effect.
37. Dr. Susser does not know of anything in Youth Factor that has any toxicity when it is given in any rational dose. Selenium in massive doses might have some toxicity, but he does not know that the other substances can cause any serious problem in any reasonable dose. He has used a lot of superoxide dismutase and a lot of linoleic acid, and both those have been very beneficial to many of his patients, but he has not had much experience with placenta.
38. With the superoxide dismutase he has seen some difficult conditions respond, conditions such as herpes simplex infection or recurring cold sores. Inflammatory conditions like arthritis improve. One rheumatoid arthritis patient on whom he tried many things, some of which had worked and some had not, had a superb response when he was given superoxide dismutase. He has used linoleic acid on a lot of people as a retardant for arteriosclerosis. Linoleic acid is an unsaturated fatty acid, and it is important in the prostaglandin mechanism. It has worked very well for people with arteriosclerotic manifestations, and it has worked for some people with prostate conditions. It is also his opinion that superoxide dismutae inhibits and neutralizes free radicals. Some of the theories of aging include the likelihood that the aging process is sped up by free radical acitivity, and superoxide dismutase is a free radical inhibitor in that respect. It is ani-inflammatory. Dr. Susser also said that there is some information that superoxide dismutase seems to be associated with free radical formation. Free radicals come from various sources. They come from radiation and they can come from toxicity in the bowel.
39. Dr. Susser has not used the ingredients of this product alone for senility, but he has used them with other substances, and his feeling would be that it would be very beneficial for senility. There are, he said, probably two major categories of senility; one is based on vascular degeneration; and the other is based on some sort of cellular degeneration. The linoleic acid has been valuable in vascular problems, and the superoxide dismutase in anti-inflammatory, and if there is a degenerative process in the brain, superoxide dismutase might very well work on that. (Tr. 741-744)
40. He does not know whether topically applied RNA can be absorbed into the cell. Referring to the ingredients of Youth Factor as shown on CX 274, he said that superoxide dismutase when taken by mouth is a protein, an enzyme. In his opinion superoxide dismutase can be absorbed intact when taken by mouth. It must be still active on absorption because he sees really powerful results from it. He has no knowledge of any studies or articles in peer review scientific journals that stand for the proposition that superoxide dismutase when taken by mouth is absorbed intact.
41. When he responded earlier on direct-examination that this product, Youth Factor, would be effective in nutrition, he answered affirmatively because of his understanding that superoxide dismutase would be absorbed intact. If it were not absorbed intact, this product might have some benefit with respect to the claims being made for it, but he does not think enough is known about what it breaks down into. He said: "My observation is it works and there is evidence that suggests that it could be absorbed, that it's probably absorbed intact, or could very well be absorbed intact, and if it isn't and still works --I don't want to get trapped by science. You see, I believe that we should use science, I believe we should use science to its ultimate, but we have not nearly reached the scientific knowledge that we need to make all these determinations. ***"
42. The opinions that Dr. Susser expressed with respect to the product RNA and the product Youth Factor are not consistent with the consensus of informed opinion of his fellow members of the American Medical Association, but they would be consistent with the consensus of the members of the nutritional organiztions that he belongs to such as the International Academy of Preventive Medicine, the American Holistic Medical Association, and the American Academy of Medical Preventics.
43. Considering the scientific community to be composed of pharmacologists, biochemists, MD's and nutritionists, the views that he expressed above with respect to RNA and superoxide dismutase would be considered a minority opinion. (Tr. 758-763)
More than a month prior to the hearing the parties were advised by the Administrative Law Judge that official notice would be taken of the 1980 edition of the "Recommended Dietary Allowances." There was no objection. It is appropriate to give certain background information about this publication. The preface of the work is a good place to start.
"The Recommended Dietary Allowances (RDA) were first published in 1943 to "provide standards serving as a goal for good nutrition." Those allowances were not considered permanent but rather were recommendations on the best scientific knowlege at the time. Since 1943, the report has been revised at approximately 5-year intervals, as additional data have become available.
"Initially, the RDA were intended as a guide for planning and procuring food supplies for national defense." Over the years, this purpose has been extended to such other areas as interpreting food consumption records of groups and evaluating the adequacy of food supplies in meeting nutritional needs, planning and procuring food suplies for groups and establishing guides for public assistance programs, development of new food products by industry, establishing guidelines for nutritional labeling of foods, and developing nutrition education programs. As the applications of RDA continue to expand, it is increasingly important that their significance and limitations be clearly understood."
In a "Notice" appearing on page ii of the Report, there is the following comment regarding the make-up of the Committee on Dietary Allowances of the Food and Nutrition Board, and about the review of the study and report before publication.
"NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the Councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competencies and with regard for appropriate balance.
"This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the Academy of Engineering, and the Institute of Medicine.
"The study was supported by The National Institute of Health, United States Public Health Service, Contract No. NO1-AM-4-2209."
In the introductory portion of the report there is the following information:
"Recommended Dietary Allowances (RDA) are the levels of intake of essential nutrients considered, in the judgment of the Committee on Dietary Allowances of the Food and Nutrition Board on the basis of available scientific knowledge, to be adequate to meet the known nutritional needs of practically all healthy persons.
"RDA are recommendations for the average daily amounts of nutrients that population groups should consume over a period of time. RDA should not be confused with requirements for a specific individual. Differences in the nutrient requirements of individuals are ordinarily unknown. Therefore, RDA (except for energy) are estimated to exceed the requirements of most individuals and thereby to ensure that the needs of nearly all in the population are met. Intakes below the recommended allowance for a nutrient are not necessarily inadequate, but the risk of having an inadequate intake increases to the extent that intake is less than the level recommended as safe.
"RDA are recommendations established for healthy populations. Special needs for nutrients arising from such problems as premature birth, inherited metabolic disorders, infections, chronic diseases, and the use of medications require special dietary and therapeutic measures. These conditions are not covered by the RDA.
"RDA ae intended to be met by a diet of a wide variety of foods rather than by supplementation or by extensive fortification of single foods. RDA have not been set for all recognized nutrients. (Estimated safe and adequate intakes have been set for some nutrients in this edition). Therefore diets should be composed of a variety of foods that are acceptable, palatable, and economically attainable by the consumer using the RDA as a guide to assessment of their nutritional adequacy.
* * * *
"Estimation of the recommended allowances follows essentially four steps:
(1) Estimating the average requirement of a population for a given nutrient and the variability of requirement within that population,
(2) Increasing the average requirement by an amount sufficient to meet the need of nearly all members of the population,
(3) Increasing the allowance to account for inefficient utilization by the body of the nutrients as consumed (poor absorption, poor conversion of precursor to achieve forms, etc.),
(4) Using judgment in interpreting and extrapolating allowances when information on requirements is limited.
* * *
Nutrition Education
For nutrition education programs, it is customary to group foods according to the nutrients for which the foods are major sources. Guidelines are usually provided to illustrate how nutrient needs can be met by selecting from among a relatively few groups of foods. Such food groupings and food guides are useful for illustrating the essential elements of a basic diet, but it is important that such guides be adapted and modified imaginatively to meet the needs of individuals and families with different levels of income, cultural patterns, and lifestyles. The RDA for nutrients can be obtained from a wide variety of food combinations and dietary patterns --any of which can be adequate, provided that care is exercised in food selection."
In view of the history, purpose, authorship and review of the current RDA, that report must be recognized as expressing the consensus of modern, informed, scientific and medical thought in the field of nutrition. If later developments (Illegible Text)