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