In the Matter of the Complaint Against G.H.P. LABORATORIES, INC. at 1551 Dunwood Village Parkway, P. O. Box 888651, Atlanta, GA 30338, 5999 New Peachtree Rd., P. O. Box 47154, Doraville, GA 30362, 6094 Boylston Dr., N.E., P. O. Box 28453, Atlanta, GA 30328, 3545 Broad Street, P. O. Box 80501, Atlanta, GA 30366, 3104 Briarcliff Rd., N.E., P. O. Box 29452, Atlanta, GA 30359 and P. O. Box 1324, Norcross, GA 30091 P.S. Docket No. 10/149 June 24, 1981 Quentin E. Grant Administrative Law Judge APPEARANCE FOR COMPLAINANT: Daniel E. Lewis, Esq. Consumer Protection Division Law Department United States Postal Service Washington, DC 20260-6100 APPEARANCE FOR RESPONDENT: Tom Benham, Esq. Benham & Cohen 6600 Powers Ferry Road, NW Suite 210 Atlanta, GA 30339
In a Complaint filed March 3, 1981, Complainant alleges that Respondent is violating 39 U.S.C. 3005 by engaging in a scheme to obtain money or property through the mails by means of materially false representations made in its direct mail solicitations concerning its products GEROVITAL HP and GEROVITAL HP CREAM.
The specific allegations of the Complaint concerning the alleged misrepresentations are as follows:
"3. By means of such advertising circulars, and others similar thereto, Respondent represents, expressly or by implication, in substance and effect, that:
a. Gerovital HP will retard aging.
b. Gerovital HP is an effective remedy for such maladies as:
1. depression
2. hypertension
3. arthritis
4. heart problems
5. impotency
6. stress
c. PABA (para amino benzoic acid) is a necessary human vitamin.
d. Gerovital HP has the same metabolic effects as procaine ingestion.
e. Gerovital HP Cream will retard the aging process of skin.
f. Gerovital HP Cream contains absorbably protein that passes directly through the skin and into cells.
g. Gerovital HP Cream is an effective remedy for skin that is dull, wrinkled and blemished with age spots.
h. RNA Supplement is capable of altering the cell's genetic make-up."
Respondent filed an Answer denying all the allegations of the Complaint and setting forth defenses under the First and Fourteenth Amendments to the Constitution of the United States.
On Respondent's motion the hearing was continued from April 6 to April 22, 1981, and the location thereof was changed to Atlanta, Georgia.
Both parties have filed proposed findings of fact and conclusions of law all of which have been considered. They are adopted to the extent indicated and are otherwise rejected as unsupported by, or contrary to, the evidence or because of their irrelevancy or immateriality.
1. Based on the testimony of Postal Inspector Michael P. Flynn concerning test purchases made from Respondent of its products GEROVITAL HP and GEROVITAL HP CREAM (Tr. 101-117), Complainant's Exhibits CX-5 through CX-13, and a stipulation agreed to at the hearing (Tr. 208), I find that Respondent is engaged in selling those products and receiving money or property therefore through the mails at the addresses set forth in the caption of this decision.
2. GEROVITAL HP is sold by Respondent in the form of a capsule. The ingredients thereof and directions for use are shown on the label of the product as follows (CX-12):
GEROVITAL
HP with PABA and G-9P
50 SOFT GELATIN CAPSULES Directions: One or two capsules daily as a dietary supplement. Take after morning meal if possible. Contents: Each capsule contains PABA 100 mg ** G-9P (a specially processed com- pound containing L-lysine (10 mg). Hesperidin Complex (5 mg) Deactivated Frewer's Yeast (50 mg) and Wheat Germ Oil (10 mg) Vitamin E 15 I.U. Vitamin C 60 mg Folic Acid 0.4 mg Vitamin B-1 10 mg Vitamin B-2 10 mg Niacinamide 25 mg Vitamin B-6 10 mg Vitamin B-12 50 mcg Biotin 150 mg Pantothenic Acid 20 mg Choline 25 mg Inositol 20 mg Iodine 150 mcg Magnesium 25 mg Zinc 15 mg In a base of double-bleached lecithin and soybean oil.
. . .
Distributed by: GHP Labs Atlanta, GA. 30340
3. The label of GEROVITAL HP CREAM discloses the ingredients and prescribes directions for use thereof as follows (CX-12):
GEROVITAL HP SPECIAL SKIN CREAM WITH SOLUBLE COLLAGEN AND SOLUBLE RNA ONE OUNCE The highly absorbent natural cream that provides moisture and helps soften "age lines" and other signs of aging. DIRECTIONS: Rub a small amount into face and other problem areas of the skin in morning and at night before retiring. Distributed BY: GHP Labs Atlanta, GA. 30340 CONTAINS: Purified Water, Mineral Oil, Lanolin, Alcohol, Soluble Ribo Nucleic Acid (RNA), Vitamin E, Specially Solubilized Infant Collagen, Cetyl Alcohol, Laneth 16, Glyceryl Stearate, p.e.g. 100 Stearate, Isopropyl Lanolate, Propylene Glycol, Dimethicone, Carbomer 934, Triethanolamine, Imidazolidinyl Urea, Methyl and Propyl Parabens.
4. Attached hereto as Exhibit A is a typical example of advertising matter used by Respondent in promoting the sale of subject products (CX-5). Applicable Rules of Interpretation of Advertising
The meaning of advertising representations is to be judged from a consideration of an advertisement in its totality and the impression it would most probably create in ordinary minds. Donaldson v. Read Magazine , 333 U.S. 178; Vibra-Brush Corp. v. Schaffer , 152 F. Supp. 461 (S.D.N.Y. 1957); Borg-Johnson Electronics v. Christenberry , 169 F. Supp. 746 (S.D.N.Y. 1959). Express representations are not required. It is the net impression which the advertisement is likely to make upon purchasers to whom it is directed which is important, and even if an advertisement is so worded as not to make an express representation, if it is artfully designed to mislead those responding to it the mail fraud statutes are applicable. G. J. Howard v. Cassidy , 162 F. Supp. 568. See also Virginia State Board of Pharmacy v. Virginia Citizens Council , 425 U.S. 748 (1976).
5. Applying the above standards of interpretation I find that the representations alleged in the Complaint, with the exception of subparagraph 3(h), (underscored below) are made expressly or impliedly in the language from Respondent's advertising quoted following the various allegations:
(a) Gerovital HP will retard aging .
"Over 25 years of research prove that GEROVITAL HP can help keep you young."
"But, injections are not the only way to get the anti-aging benefits of procaine." "Don't fail to take advantage of the essence of this world famous anti-aging treatment, today." Throughout its advertising Respondent ties the GEROVITAL HP to the European Gerovital formula, pioneered by Dr. Ana Aslan, and claims for GEROVITAL HP all the anti-aging benefits said to have been achieved in Europe with Gerovital as described in the part of Respondent's advertising entitled "The Gerovital Story: Unlocking the Secrets of the Fountain of Youth" (CX-5).
(b) Gerovital HP is an effective remedy for such maladies as :
1. depression
2. hypertension
3. arthritis
4. heart problems
5. impotency
6. stress
"...Gerovital [HP] causes the body to function exactly as it would with procaine injections." Respondent's advertising ties its product to all the claims made for the European Gerovital formula among which are the following (as set forth in "The Gerovital Story"):
"It has a well-documented history of success in diminishing just about all the symptoms of old age --senility, impaired vision and hearing, depression, impotency, hair loss, hypertension, etc."
"In 1956, Dr. Aslan presented studies which showed that Gerovital had countered the degenerative effects of old age --depression, hypertension, arthritis and heart problems, as well as increasing muscular vigor and producing an overall 'regenerative effect at the cellular level.'"
"DEAE produces mental stimulation and has an anti- depressant effect. Both of these vitamins are a part of the body's stress reaction system."
"In Germany, where the product has been legalized for 15 years, the federal police take it to guard against impotency and stress."
(c) PABA (paraaminobenzoic acid) is a necessary human vitamin .
"Procaine is a vitamin substance synthesized from the B-vitamin, PABA, a basic part of the body's stress reaction system."
"PABA works in the glands, hair and intestines and aids the body in blood cell formation, protein metabolism and skin functions, and stimulates the production of other essential B-vitamins."
(d) Gerovital HP has the same metabolic effects as procaine ingestion .
"But, injections are not the only way to get the anti-aging benefits of procaine."
"Supplemented in oral form, Gerovital causes the body to function exactly as it would with procaine injections." "...Gerovital has been formulated to provide most of the benefits of the complete procaine treatment at a fraction of the cost of the European Treatment." "Gerovital Benefits now available to you." "Don't fail to take advantage of the essence of this world famous anti-aging treatment, today."
(e) Gerovital HP Cream will retard the aging process of skin.
"Fortunately, a way to retard the aging process of the skin is currently being tested. Under this method, parts of the body that suffer the effects of aging receive injections of fresh embryonic cells.
"And, we have now developed a way to provide the rejuvenating benefits of cellular therapy in a hand and body cream which contains RNA and infant soluble collagen to give you skin that denies your age."
(f) Gerovital HP Cream contains absorbable protein that passes directly through the skin and into cells .
"Fortunately, a way to retard the aging process of the skin is currently being tested. Under this method, parts of the body that suffer the effects of aging receive injections of fresh embryonic cells. The treatment is called 'cellular therapy.' And, we have now developed a way to provide the rejuvenating benefits of cellular therapy in a hand and body cream which contains RNA and infant soluble collagen to give you skin that denies your age.
"The special Gerovital formulation contains absorbable protein that passes directly into the skin to nurture the rebirth of healthy, new skin. But, only soluble collagen [contained in Gerovital HP] can permeate the cell directly."
(g) Gerovital HP Cream is an effective remedy for skin that is dull, wrinkled and blemished with age spots .
"As the years go by, skin that was once taut loses its suppleness and elasticity. And, instead of being clear and smooth it becomes dull, wrinkled, and blemished with age spots. Fortunately, a way to retard the aging process of the skin is currently being tested. Under this method, parts of the body that suffer the effects of aging receive injections of fresh embryonic cells. The treatment is called 'cellular therapy.' And, we have now developed a way to provide the rejuvenating benefits of cellular therapy in a hand and body cream which contains RNA and infant soluble collagen to give you skin that denies your age."
6. The statement in Respondent's advertising that Respondent has developed a way to provide the rejuvenating benefits of cellular therapy in a hand and body cream which contains RNA and infant soluble collagen is not a representation that the RNA supplement is capable of altering the cell's genetic makeup. This statement is the only one in Respondent's advertising that mentions RNA. Therefore, Complainant has not established the making by Respondent of the representation alleged in subparagraph 3(h) of the Complaint.
7. Complainant called as expert witnesses Sorell Schwartz, Ph.D., and Karl Kramer, M.D.
Dr. Schwartz received his bachelor's degree in pharmacy from the University of Maryland in 1959, his Ph.D. in pharmacology from the Medical College of Virginia (now Virginia Commonwealth University) in 1963. He is a professor of pharmacology at Georgetown University Schools of Medicine and Dentistry.
Dr. Kramer practices dermatology in Miami, Florida. In 1965 he received a BA degree in chemistry from Cornell University. he graduated from Johns Hopkins School of Medicine in 1969. From 1971 to 1973 he was a clinical associate at the Gerontology Research Center (now the National Institute of Aging) in the National Institutes of Health where he was involved in an on-going study of human aging. He is board certified in dermatology and internal medicine. He has been in private practice in dermatology since 1976. The curricula vitae of Dr. Schwartz and Dr. Kramer show that they were well-qualified to testify in this matter (CX-1, 2).
8. Respondent's advertising concentrates on PABA (para- aminobenzoic acid) as the most important ingredient in the Gerovital HP capsule. It states that PABA is the active ingredient of the procaine treatment developed by Dr. Ana Aslan in Rumania and said to be used successfully in Europe in diminishing "just about all the symptoms of old age-senility, impaired vision and hearing, depression, impotence, hair loss, hypertension, etc."
9. According to Dr. Schwartz, PABA is an inactive chemical substance, part of the waste products of human metabolism. It is also a breakdown product (or metabolite) of many local anesthetics, such as procaine (novocaine). PABA is not an essential vitamin to man - not essential to man's nutrition. There is no known deficiency of PABA in man. PABA does not have the same pharmacological effect as procaine which is that of a local anesthetic. PABA has no pharmacological effect taken internally.
In topical application it acts as a sun screen (Tr. 16-18, 22).
10. Dr. Schwartz testified that Respondent's product, Gerovital HP, has no relationship to Dr. Aslan's product, Gerovital H3 (Tr. 19). According to Dr. Schwartz, who talked with Dr. Aslan rather extensively in 1978 when they were on a panel together, her product, Gerovital H3, is a putative stabilized form of procaine. Such stabilization prevents the breakdown of the procaine which accounts, according to Dr. Aslan, for the particular benefits claimed for Gerovital H3. In his opinion, therefore, Dr. Aslan would not support the view that PABA, a breakdown product of procaine, would be an effective substitute for procaine (Tr. 68, 69).
11. Dr. Schwartz stated that some of the ingredients of the capsule are not useful vitamin supplements, but that the capsule could be most accurately described as a vitamin supplement. In his opinion, except for cases of possible accelerated aging due to vitamin deficiency, none of the ingredients of the capsule taken individually, or in combination, would contribute to the retardation of aging and would in no case reverse the aging process (Tr. 20, 21).
12. Dr. Schwartz stated that the Gerovital HP capsules are not an effective remedy for depression, hypertension, arthritis, heart problems, or impotency. He stated that they could contribute to the relief of stress for persons whose stress has caused an increased utilization of vitamins (Tr. 22, 23).
13. Dr. Schwartz stated that the Gerovital HP Cream contains no ingredient which will, from a pharmacological standpoint, retard the aging process of the skin; that it contains no absorbable protein that can pass directly through the skin and into the cells; that the ingredient RNA (ribonucleic acid) applied topically (externally) has no effect on the cells; that the product provides temporary benefits to the skin as a moisturizer but is not a remedy for skin that is dull, wrinkled, or blemished with age spots (Tr. 23-25).
14. Dr. Schwartz's opinions are consistent with the informed pharmacological and scientific consensus (Tr. 25-27). He stated that those involved in determining therapeutic efficacy of materials do not consider a claim valid unless accompanied by valid controlled clinical trials and that his testimony was given from that stand- point.
15. On cross-examination when questioned as to the effect on his thinking of the RDA (Recommended Dietary Allowances, a study by the National Research Council and published by the National Academy of Sciences) Dr. Schwartz indicated that it would have an impact as far as the need for PABA in human nutrition is concerned (Tr. 30, 31). The RDA (Ninth edition 1980) states that no evidence exists for the need of PABA by humans and that it is not likely that such a need could be established because it can be synthesized in the tissues of the higher animals (p. 183).
16. Dr. Schwartz acknowledged that nutrition is not his primary field and that the science of nutrition is constantly evolving and that his own opinions change as science progresses (Tr. 31-33). He stated that he would not accept any product as being effective in retarding aging without a valid clinically controlled study (Tr. 62).
17. Complainant's medical expert, Dr. Kramer, testified that PABA is not a vitamin, thus not necessary for humans (Tr. 82), and that there is no known deficiency of PABA in man (Tr. 75). He stated that there are no known therapeutic benefits of internally administered PABA. With respect to PABA he reviewed the literature, including textbooks in internal medicine, nutrition, and dermatology, and the Index Medicus for the past six or seven years, and found no reports of valid clinical trials indicating that PABA is effective as a rejuvenator.
He testified that PABA is a breakdown product of procaine but does not have the same pharmacological effect as procaine. He stated that there is no relationship between Respondent's Gerovital HP capsules and the product Gerovital H3 developed by Dr. Ana Aslan except a similarity in name and the presence in Respondent's product of PABA, a breakdown product of the procaine in Dr. Aslan's product.
18. Dr. Kramer went through the list of ingredients in the Gerovital HP capsule and stated that he found nothing that taken individually or in combination with the other ingredients would retard the aging process or cause rejuvenation. He testified that the capsules would not be an effective remedy for depression, hypertension, arthritis, heart problems, or impotency, but that they might conceivably help a severely stressed person by means of vitamin supplementation (Tr. 81, 82).
19. Dr. Kramer stated that there is nothing in the Gerovital HP Cream which will retard the aging process of skin. He went through each ingredient and concluded that the cream is simply a moisturizing preparation and has no efficacy beyond that. He said that the protein ingredient, solubilized infant collagen, will not penetrate the skin beyond the epidermis and into the collagen, the structural component of the skin, and that the RNA will not penetrate the skin and in any manner replace the human RNA (Tr. 78, 79). He said that the cream would temporarily cause the skin to look less dull, would help dry, chapped skin with little cracks and peeling to appear less dry, but would not have any effect on age spots or age related wrinkles (Tr. 79, 80).
20. Dr. Kramer's opinions are consistent with the informed medical and scientific consensus (Tr. 82).
21. Dr. Kramer testified on cross-examination that the claims made by Respondent for PABA and its need in human nutrition will have to be proven by clinically controlled studies before he will accept them.
22. Although the evidence establishes that PABA is not the equivalent of procaine, since Respondent ties its claims for PABA closely to procaine used in Europe in Gerovital H3, referred to in Respondent's advertising as the "Fountain of Youth," Complainant's Exhibit 3 has relevance. This is an article published in The Journal of the American Geriatrics Society (Vol. XXV, No. 1, Jan. 1977) entitled "The Systematic Use of Procaine in the Treatment of the Elderly: A Review." It was commissioned by the National Institute on Aging of the National Institutes of Health. It is the work of three doctors of medicine. According to the abstract of the article, it is a review and evaluation of the world literature on the systemic use of procaine in the treatment of the aging process and the common chronic diseases of later life. The study concludes that except for a possible antidepressant effect, there is no convincing evidence that procaine (or Gerovital) has any value in the treatment of disease in older patients.
At page 2 of this article the statement is made that no direct effects of PABA have been identified in man.
23. The expert witnesses called by Respondent were William C. Douglas, M.D. and Morton Walker, a former doctor of podiatric medicine, now a free-lance medical journalist.
24. Dr. Douglas received a bachelor's degree in chemistry from the University of Rochester in 1949 and his medical degree from Miami University School of Medicine in 1957. From 1962 until 1978 he was engaged in the practice of emergency medicine as Director of the Emergency Department at the Sarasota Memorial Hospital, Sarasota, Florida. This practice involved the first hour of initial treatment of severely ill and severely wounded patients. Since 1978 Dr. Douglas has engaged in the practice of nutrition and preventive medicine. Aside from education in nutrition in connection with a course in pediatrics in medical school, Dr. Walker took no training in nutrition until after he left emergency medicine in 1978 when he began to attend semi-annual meetings of the American Academy of Preventics, an organization or medical doctors interested in nutrition and related fields of preventive medicine. At that time he also began to educate himself by joining a number of other nutritional organizations, reading their bulletins and reading every book he could find on nutrition. When asked by Respondent's counsel whether he felt he had developed an expertise in the field of nutrition, he replied that nutrition is an extended, vast field, that you can never approach learning it all, that it is a very fast moving field, but he believes he can be classified as an expert if there is any such thing today (Tr. 119-124).
25. In his practice in nutrition, Dr. Douglas has introduced hundreds of patients to PABA. He said that it is difficult to attribute certain results to the ingestion of one particular vitamin or nutrient but pointed out one effect PABA has had on himself and some of his patients, i.e., halting and in some cases reversing the graying of hair (Tr. 124, 125). He cited a study performed 50 years ago on laboratory animals in which a PABA deficient diet caused their hair to turn gray, and introduction of PABA to the diet restored the hair to its normal color. His experience with PABA and the animal study indicate to Dr. Walker that PABA is an essential nutrient; for that reason he prescribes it for his patients (Tr. 124-127; 130). But he said that it has not been established in human nutrition as an essential nutrient (Tr. 130). He stated that the consensus today is that it is not (Tr. 138, 151).
26. Dr. Douglas when asked whether he believed that PABA would have any benefits in regard to aspects of aging other than hair replied that it is impossible to judge whether any agent is going to stop the aging process because everyone ages at a different rate (Tr. 128). He could not state with any degree of certainty that PABA in Gerovital HP or other products would benefit some people in respect to retarding aging but said that there were strong indications that it could be an anti-aging factor right along with other nutrients. He could see no reason why it could not be but could not say that it is. He did not believe that procaine, per se , is an anti-aging factor (Tr. 130).
27. Dr. Douglas stated that he had never seen hair color change in people who have had the small dosage thereof contained in the multi-vitamin (Tr. 158).
28. Dr. Douglas was not aware of any studies which show that a PABA deficiency is common in man but believes that there may very well be such a deficiency in a large number of people, especially the elderly (Tr. 151, 152).
29. Dr. Douglas stated that he did not know whether Gerovital HP will retard aging in persons who are not vitamin deficient and said he had no opinion as to whether it would be an effective remedy for depression, hypertension, arthritis, heart problems, or impotency. But he believes that it would be effective against stress because all of the B-complex vitamins are anti-stress factors (Tr. 153).
30. Respondent's other expert, Morton Walker, practiced podiatric medicine for 17 years, leaving practice in 1969 because he found he had a talent to communicate with the written word; consequently, for the past 12 years he has been a full-time freelance journalist. He has written over 1000 magazine and medical journal articles and 15 books, the latter for the popular lay press for dissemination of information on health, diet, nutrition, exercise, and all aspects of wholistic health, orthomolecular medicine, and alternative health care. He has received many awards for his writing (Tr. 164-166).
He has developed an education in the field of nutrition primarily from interviewing physicians and nutritionists and from reading in medical libraries (Tr. 166, 167). He is also on the lecture circuit lecturing to physicians in the American Academy of Medical Preventics, to the National Health Federation, and to the American people (Tr. 167, 168).
Dr. Walker considers himself as an expert in the field of nutrition (Tr. 170).
31. Dr. Walker claimed to have educated himself with respect to PABA. He believes it is a necessary human vitamin or nutrient, a "nutrient vitamin" or a "vitamin nutrient," a co-enzyme which assists the body in carrying out all its enzymatic processes. It is one of the B-complex of vitamins known by biochemists as Vitamin H-1 (Tr. 177, 178).
Dr. Walker uses Gerovital HP capsules daily (Tr. 192). He stated that it has lessened the grayness of his hair and that he is trying to get it to grow hair on his head .. without success so far (Tr. 193).
According to Dr. Walker, deficiencies of PABA exist and are manifested by a syndrome (symptom complex) including fatigue, irritability, nervousness, headache, constipation, and digestive disorders such as rumbling in the abdomen and flatulence (Tr. 178).
32. Dr. Walker stated that Gerovital HP definitely works to retard the aging process because of the ingredient PABA, a nutrient which, together with folic acid, creates pantothenic acid which has been established as an essential nutrient. Without PABA you will not have pantothenic acid. PABA "does a variety of good" in the body so that body cells are made to maintain themselves in a state of "optimal wellness" or homeostasis.
33. Dr. Walker testified that Gerovital HP will provide "positive benefits" to people suffering from depression, hypertension, arthritis, heart problems, impotency, and stress because PABA does all those things (Tr. 179).
34. Dr. Walker stated that Gerovital HP Cream will definitely provide positive benefits to improve the appearance of skin that is dull, wrinkled, and blemished with age spots because of its nutrient ingredient, PABA, which does those things (Tr. 180).
35. Dr. Walker testified that PABA acts as a sun screen in both topical application and taken internally, the latter because PABA "is quite advantageous to bring pigmentation back to depigmented skin." [A sunscreen is defined as "a screen to protect against the sun; esp : a substance used in suntan preparations to protect the skin from excessive ultraviolet radiation." Webster's New Collegiate Dictionary , 1980.] He found salts and alcohols of PABA listed among the ingredients of Gerovital HP Cream. [PABA is not listed on the label as an ingredient] Dr. Walker could not furnish any written authority for his opinion because the journals, in which he skims hundreds of articles each week, are all mixed up in his mind (Tr. 182, 183).
36. Dr. Walker testified that there is procaine in Gerovital HP because the ingredient PABA is the important ingredient in procaine (Tr. 185, 186). The other three expert witnesses all said that PABA is not the equivalent of procaine, but, rather, one of its breakdown products.
37. On cross-examination Dr. Walker rationalized his view that PABA is an essential vitamin, i.e., one that the body cannot produce in sufficient amounts, on the basis that PABA is synthesized not by the body but by friendly bacteria in the intestines when we have ingested a sufficient quantity of such bacteria (Tr. 187, 188).
38. Dr. Walker disagreed with the abstract contained in Complainant's Exhibit 3, the article entitle "The Systemic Use of Procaine in the Treatment of the Elderly: A Review" (see F. of F. No. 22, supra ) including the statement that there is no convincing evidence that procaine has any value in the treatment of disease in older patients.
Dr. Walker flatly stated that his views regarding the efficacy of PABA are supported by every one of the 285 articles reviewed by the authors of the review (CX-3) as to which those authors drew the conclusion above stated. When asked if he had read every one of them, Dr. Walker stated that it is "likely" that he has "skimmed most of them" in connection with co-authoring a book entitled "Nutrients to Age Without Senility" which includes a chapter on the use of Gerovital as a nutrient to bring benefit to the elderly and overcome all of the conditions listed in the Complaint.
39. When asked for a recognized medical or nutritional authority which says that PABA is an essential vitamin, Dr. Walker referred to an unidentified article in the Journal of Applied Nutrition published by the International College of Applied Nutrition (Tr. 201).
40. Dr. Walker stated that his opinions that PABA is an essential vitamin and as to its efficacy represent the consensus of some 8000 physicians who use nutrition as a therapeutic modality instead of drugs, as well as the full gamut of medical journals commonly read in traditional medicine (Tr. 202).
41. Dr. Walker acknowledged that the publication Recommended Dietary Allowance (see F. of F. No. 15, supra ) is an authoritative publication and does not list PABA as an essential vitamin. He further stated that the RDA states that it is designed to keep people from having deficiency symptoms of disease, a state of suboptimal health in Dr. Walker's opinion (Tr. 293, 294).
42. The RDA (p. 1) in fact states that the allowances recom- mended are the levels of intake of essential nutrients considered, in the judgment of the Committee on Dietary Allowances of the Food and Nutrition Board, on the basis of available scientific knowledge, to be adequate to meet the known nutritional needs of practically all healthy persons. It further states that the RDA (except for energy) are established for healthy population and are estimated to exceed the requirements of most individuals and thereby to ensure that the needs of nearly all in the population are met (p. 1).
Complainant's expert witnesses were well qualified by education, experience and familiarity with literature and opinion in their respective fields and in the field of nutrition to express the medical, pharmacological, and scientific consensus as to the lack of efficacy of Respondent's products to perform as represented by Respondent.
The consensus they stated, that no need for PABA in human nutrition has been established, was acknowledged by Respondent's medical and nutritional expert, Dr. Douglas, although he personally entertained a contrary view. The view of Complainant's experts is supported by the RDA which Respondent's counsel brought into the picture in his cross-examination of Dr. Schwartz.
The review article in the Journal of the American Geriatric Society (CX-3) supports the view of Complainant's experts that PABA, as a breakdown product of procaine, is not of value in the treatment of the conditions listed in the Complaint.
Respondent's Dr. Douglas, a practitioner of nutrition, indicated a belief that ingestion of PABA in Gerovital HP might retard the aging process but he was not prepared to express the opinion that it definitely would have that kind of efficacy. He had no opinion as to the efficacy of that product to produce the other results represented except for relief of stress as to which all the experts agreed it could accomplish. Thus, Dr. Douglas' opinions did not essentially controvert those of Complainant's experts.
Dr. Morton Walker, the free-lance writer, purported to state the consensus of 8000 physicians who treat disease with nutrition instead of drugs. Unlike Respondent's other witness, Dr. Douglas, Dr. Walker was not a member of that group of physicians. He came across more as a popularizer of new and different approaches to nutrition and treatment of disease than a careful, thoughtful expert. He was prone to uncritical rejection of all authorities in conflict with his views, i.e., the RDA and the article in the Journal of the American Geriatric Society reviewing and evaluating the world literature on systemic use of procaine in the treatment of the aging process and common diseases of later life (CX-3). Yet he was unable to - or, at least, did not - produce even one of the numerous articles and studies which he said lent support to his views. They were, to use his words, "all mixed up" in his mind. Dr. Walker gave certain testimony so at variance with uncontroverted facts and common sense, or so careless, as to cast doubt on the validity of most of his opinions. For instance, he testified that PABA taken internally acts as a sunscreen and that there is procaine in Gerovital HP because it contains PABA. The uncontroverted evidence is that PABA is only a metabolite or breakdown product of procaine and that Dr. Aslan attributes her success in use of procaine to her stabilization of procaine so as to forestall or delay its breakdown. Another example of testimony damaging his credibility is his statement that PABA is an essential nutrient or vitamin (one that the body does not produce) because it is synthesized not by (although within) the body but by ingested favorable bacteria in the intestines. Yet another example is his flat statement that everyone of the 285 articles examined by the authors of the review article on systemic use of procaine (CX-3) support Walker's views which are contrary to the conclusion reached by the authors of the article. Thinking that this statement should be tested I asked Dr. Walker if he had read every one of those 285 articles. His response was that it was "likely" that he had "skimmed most" of them. This leads me to conclude that he probably has not read all of such articles so as to know whether or not they support his views.
Some of Dr. Walker's unrestrained enthusiasm for PABA can be explained by the fact of his co-authorship of a book, presumably yielding him income, containing a chapter attributing to Gerovital all the efficacies represented by Respondent.
1. Respondent is engaged in a scheme or device to obtain money or property through the mails for its products Gerovital HP and Gerovital HP Cream by means of representations substantially as characterized in the Complaint with one exception: Respondent does not represent that the RNA Supplement [in the cream] is capable of altering the cell's genetic make-up.
2. Based on the testimony of Complainant's expert witnesses, Exhibit CX-3, and the RDA, I find that such representations are false in fact, except the representation that the capsule is an effective remedy for stress. They are material in that their natural tendency is to induce readers to purchase the products. The testimony of Respondent's witness Dr. Douglas was not substantially in conflict with that of Complainant's experts. I give little weight to the opinions expressed by Dr. Walker for the reasons given above.
3. 39 U.S.C. 3005 has been repeatedly held by the Courts to be constitutional under First and Fourteenth Amendment attack. Original Cosmetics Products, Inc. v. John Strachan and United States Postal Service , 459 F. Supp. 496 (S.D.N.Y., 1978) aff'd w/o Op. 2d Cir., 78-6165, 4/30/79; Hollywood House International, Inc. v. Klassen , 508 F.2d 1276 (1974). The Court in Original Cosmetics, supra , held that the recent U. S. Supreme Court decision in Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council, 425 U.S. 748 (1976) does not require a contrary result.
4. Complainant has established its case by a preponderance of the reliable and probative evidence.
5. Respondent's scheme or device is in violation of 39 U.S.C. 3005. Consequently an order pursuant to that statute in the form attached should be issued.