In the Matter of the Complaint Against COSVETIC LABORATORIES, HEAD START RETAIL, THE MAN'S VITAMIN at Atlanta, GA P.S. Docket No. 7/68 October 10, 1979 Quentin E. Grant Administrative Law Judge APPEARANCE FOR COMPLAINANT: Thomas A. Ziebarth, Esq. Consumer Protection Office United States Postal Service Law Department Washington, DC 20260 APPEARANCE FOR RESPONDENT: Christopher S. Barnard, Esq. Katz, Paller & Land 470 East Paces Ferry Road, NE Suite 2000 Atlanta, GA 30305
In a complaint filed July 12, 1979, complainant alleged that respondent attempts to obtain remittances through the mails for its product, THE MAN'S VITAMIN, by means of false advertising representation in violation of 39 U.S.C. 3005.
Paragraph 3 of the complaint alleges that respondent's advertising makes the following materially false representations:
(a) Sexual debilities and impotence in the American male are most commonly caused by deficiencies in the vitamins and minerals contained in THE MAN'S VITAMIN, especially zinc and vitamin B6;
(b) It is difficult to obtain zinc and vitamin B6 through normal food sources;
(c) The use of THE MAN'S VITAMIN will improve the average male's sexual potency and capacity for sexual enjoyment;
(d) The zinc contained in THE MAN'S VITAMIN will increase the user's capacity for sexual performance; and
(e) The use of THE MAN'S VITAMIN is effective in preventing the problem of an enlarged prostate during old age.
Respondent filed an Answer denying generally the allegations of the Complaint.
An administrative hearing was held before the undersigned on August 16, 1979, in Atlanta, Georgia. At this hearing, Complainant presented the testimony of an expert witness on its behalf. Respondent called no witnesses, but, by stipulation of the parties, was permitted to file the affidavit of its expert.
Both parties have filed proposed findings of fact and conclusions of law which have been considered and adopted to the extent indicated and otherwise rejected as not supported by, or contrary to, the evidence or because they are irrelevant or immaterial to the decision.
1. Respondent's advertising materials explicitly solicit the remittance of money through the mails (CX-1 through 9). These advertisements contain an order coupon the language of which clearly states or implies that it is to be mailed with some remittance to respondent for the product, THE MAN'S VITAMIN.
2. Respondent's advertising materials make, directly or indirectly, in substance and effect, whether by affirmative statements, omissions or implication, the representations alleged in paragraph 3, subparagraphs (b), (c), and (d) of the Complaint. These representations (quoted and underscored below) are made by the text of Respondent's advertisements in the following manner:
(b) It is difficult to obtain zinc and vitamin B6 through normal food sources.
"Needless to say, it is difficult to obtain these nutrients through food sources." (CX-1)
(c) The use of THE MAN'S VITAMIN will improve the average male's sexual potency and capacity for sexual enjoyment .
"A MAN NEEDS A MAN'S VITAMIN."
"No matter how much of a man you are. The Man's Vitamin is a pure and natural combination designed to aid in the joining of physical and emotional patterns, so that you may enjoy life to the fullest." (CX-2)
"To increase your sexual potentials, use the convenient post-paid envelope in the center of the magazine." (CX-1)
"And who knows what extra minerals can do for your sex drive."
"No matter how much a man you are, the right vitamins and minerals will make you feel more of a man." (CX-3)
(d) The zinc contained in THE MAN'S VITAMIN will increase the user's capacity for sexual performance .
"Nutrition Solves Sexual Problems."
"Peak Laboratories has developed a vitamin supplement for sexual problems."
"No matter how much of a man you are, ... you're a man, and a man needs a Man's Vitamin." (CX-1, 3)
"CAN A VITAMIN IMPROVE A MAN'S SEXUAL POTENCY?
Yes, it can . . . One of these nutrients is zinc. . ."
"To increase your sexual potentials, use the convenient postpaid envelope in the center of the magazine." (CX-1)
3. With respect to the representation alleged in paragraph 3(a) of the Complaint I find that respondent's advertisements represent that the most common cause of impotence in the American male is deficiency in zinc and vitamin B6. The representation is found in the following portions of CX-1:
"But its especially vital to the male since a deficiency of zinc and B6 are the most common causes of impotence."
I do not find that respondent's advertisements go so far as to represent that all sexual debilities are most commonly caused by deficiencies in the vitamins and minerals contained in THE MAN'S VITAMIN.
4. I do not find that respondent's advertisements make the representation alleged in paragraph 3(e) of the Complaint that use of THE MAN'S VITAMIN is effective in preventing the problem of an enlarged prostate during old age. Respondent is careful to say only that the product "may even be the solution" to enlarged prostate during old age. This wording in the context in which it appears (CX-2) falls short of the representation alleged.
5. The label of the product contains the following directions and listing of ingredients:
DIRECTIONS: Take one each day with breakfast or lunch.
One tablet supplies the following ingredients and percentage of the U.S. RDA:
% of
U.S. RDA
Thiamine 10 mg. 666
Riboflavin 10 mg. 588
Niacin 25 mg. 125
Pyridoxine HCL 25 mg. 1028
Cyanocobalamin 500 mcg. 8333
Folic Acid 400 mcg. 100
Calcium (from bone
meal) 150 mg. 15
Phosphorus (from
bone meal) 75 mg. 7
Zinc Gluconate 20 mg. 16 (Zn)
Vitamin E 200 I.U. 666
Manganese 10 mg. *
* No U.S. RDA established for this nutrient.
6. Complainant's case relies primarily on the testimony of Johnnie W. Prothro, Ph.D., a nutritionist. Dr. Prothro received her Ph.D. from the University of Chicago in 1952. Her Curriculum Vitae is a part of the record. (CX-12) Dr. Prothro is a professor at Tuskeegee Institute.
Dr. Prothro was asked (Tr. 18) with respect to each of the vitamins and minerals contained in THE MAN'S VITAMIN, "whether there is any indication in the makeup of that nutrient that it has any effect on sexual performance or impotency or debility." Her answers may be summarized as follows:
Thiamine (B1) - ". . . I am not familiar with any studies that would indicate a relationship." (Tr. 18) She indicated that the absence of studies tends to indicate that claims for the substance in connection with sexual performance would be unwarranted. (Tr. 19)
Riboflavin (B2) and Niacin (G) - "There is, to my knowledge, no study directly relating these to sexual performance, debility or impotence." (Tr. 19)
Pyridoxine (B6) - "I know of no studies that relate Pyridoxine directly to sexual performance." (Tr. 20)
Cyanocobalamin (B12) - "I know of no studies that relate Vitamin B12 directly to sexual performance, debility or impotence." (Tr. 20)
Folic Acid - ". . . I would give the same answer in terms of folic acid." (Tr. 20)
Calcium and Phosphorus - "I know of no direct relationship of these." (Tr. 21)
Zinc Gluconate - "I do not know of any cases of males who have already entered sexual maturity in this country who, as a result of being given a zinc supplement, would show improvement [in sexual performance or potency]." (Tr. 21)
Vitamin E - "I do not know, in the human, of any studies that would document the role of Vitamin E in reproduction although, there again, there are studies in laboratory animals. . . . studies conducted on female animals in which case ... a very low intake of Vitamin E can bring about abortion." (Tr. 22)
Manganese - "I know of no relationships." (Tr. 22)
Dr. Prothro was then asked the incidence of deficiency in these nutrients in the average American diet. She replied that it was adequate with respect to thiamine, riboflavin and niacin, with a slight inadequacy with respect to pyridoxine (B6). B12 levels are, in general, adequate. The same is true of calcium and phosphorus. (Tr. 24) It is estimated that the average diet contains between 12 and 15 mg. of zinc per day with the recommended intake (RDA) being 15 mg. With respect to Vitamin E, she said, "We don't have cases of Vitamin E deficiency in the population." (Tr. 25) There is no RDA for manganese.
7. Dr. Prothro believes that lower levels of zinc are more likely to be found among the lower income groups because zinc is found especially in meat protein (Tr. 26). The pyridoxine level is not as closely related to income because it is present in a larger variety of foods than zinc, including a variety of plants. Dr. Prothro testified that if there is variety in the diet the individual is likely to consume adequate amounts of zinc and B6 (pyridoxine) (Tr. 27). Among the ordinary foods that are good sources of zinc and B6 are wheat germ, whole bran, fish, beef, lamb, pork, peanuts, walnuts, chicken, and turkey (Tr. 43, 44).
8. Respondent's advertising claims that THE MAN'S VITAMIN contains 20 mg. of zinc (CX-1). The fact is that the 20 mg. of the ingredient containing the zinc is zinc gluconate, the actual zinc content being less than 3 mg (Tr. 28). Three milligrams of zinc, according to Dr. Prothro, is about 1/5 the RDA of zinc, "a relatively small amount if you're really trying to bring about a big effect" (Tr. 29).
9. The nutritional availability of the small amount of zinc in THE MAN'S VITAMIN is reduced by the presence of calcium and phosphorus (Tr. 27-31).
10. Dr. Prothro testified that she had no reason to think that the amounts of zinc and B6 in THE MAN'S VITAMIN would have any effect on the sexual performance of an adequately nourished person (Tr. 31). However she testified that there are deficiencies of zinc and B6 in the average American diet.
11. The only study in the United States known to Dr. Prothro clearly relating a nutrient in the product to human sexual performance involved a single male whose delayed sexual maturation was advanced by the use of zinc in a dosage of around 200 mg. of zinc sulfate (Tr. 14-16). Dr. Prothro was not aware that there is any effect of zinc on sex performance in the fully adult male (Tr. 32).
12. According to Dr. Prothro, the level of zinc in THE MAN'S VITAMIN is so low that even in the case of a person with a zinc deficiency it would have little or no effect on the level of serum zinc. The level of zinc used in medicine to treat certain disorders is much higher than the level in respondent's formulation (Tr. 32).
13. Dr. Prothro testified that the highest concentration of zinc in the male is in the eye, the next highest in the sex organs and that the reproductive organs have a higher concentration of zinc than the serum level of blood (Tr. 53, 54).
14. The affidavit of Dr. James T. Cooper, a practitioner of family medicine, with special interest in nutrition and bariatrics (weight control) stresses the high concentrations of zinc in the male sex organs and cites a report made in 1961 of a study of Iranian males who exhibited hypogonadism and delayed sexual maturity as a result of zinc deficiency, correction of which alleviated these conditions. The affidavit also mentions studies (unidentified) of pyroluric (the word is not defined) males, impotent due to zinc deficiency, who returned to normal sexual activity through zinc supplement therapy.
15. Dr. Cooper's affidavit states that a deficiency of vitamin B6 will result in a broad range of symptoms including dermatitis, dizziness, nausea, irritability, confusion, and nervous disturbances which would have a negative effect on one's capacity for sexual enjoyment. The affidavit further states that stressed individuals and individuals on high protein diets need additional levels of B6.
16. Dr. Cooper states in paragraph 12 of his affidavit that past and current medical literature does not include reference to any specific test and studies of the relationship between THE MAN'S VITAMIN ingredients and sexual functioning. This statement is in complete accord with Dr. Prothro's testimony concerning lack of studies in the area involved. But then Dr. Cooper goes on to state that because of the deficient or only marginally adequate intake of zinc and vitamin B6 in the average American diet, the ingestion of the nutrients in THE MAN'S VITAMIN can reasonably be expected to have a "positive effect on those functions dependent upon these nutrients, including overall energy levels and capacity for sexual performance and enjoyment." Dr. Cooper's affidavit concludes with a ringing endorsement of the noncontroversial statement of a colorful former Commissioner of the Federal Communications Commission, whose profession happens to be the law, not medicine or nutrition, that "diet affects your physical appearance, your energy levels, your intellectual and creative abilities, your mental health and general feeling of well being, even your ability to enjoy love and sexuality."
17. Dr. Prothro testified that her opinions as to the matters in issue conform with the consensus of informed scientific and medical opinion. Dr. Prothro's preparation for testifying in this matter consisted of reviewing studies in the nutrition literature and "limited studies in the medical literature." She did not review material involving sexual reproduction medicine (Tr. 34).
1. It is not controverted that respondent's advertising seeks remittances of money or property through the mails for its product, THE MAN'S VITAMIN.
2. To the extent found in Findings of Fact 2 and 3, above, and to that extent only I conclude that respondent's advertising makes material representations as alleged in paragraph 3 of the complaint.
3. Complainant has failed to sustain its burden of proof as to the falsity of the representations characterized in paragraphs 3 (a), (c) and (d) of the complaint. It relied solely on the testimony of Dr. Prothro, a nutritionist without any clinical or consulting experience in sexual problems or any other special expertise in the field of nutrition as related to sexual problems. Her answers to the critical questions posed by complainant's counsel were unsubstantial and guarded, for instance:
"I can't say that I am familiar with any studies that would clearly show * * *" (Tr. 14); "* * * there is, to my knowledge, no study directly relating these [ingredients] to sexual performance, debility or impotence" (Tr. 19); "I know of now studies * * *" (Tr. 20); "I know of no direct relationship * * *" (Tr. 21); "I do not know of any cases * * *" (Tr. 21); "I know of no relationships." (Tr. 22); "* * * I have no reason to think that * * *" (Tr. 31).
Dr. Prothro's strongest testimony was her agreement with a leading question of counsel that "absence of studies in the area tends to indicate that claims * * * for the substance * * * would be unwarranted" (Tr. 19). I conclude that Dr. Prothro's experience and preparation for testimony do not furnish adequate support for her conclusions that her opinions as to the matters in issue conform with the consensus of informed scientific and medical opinion. In fact, Dr. Prothro did not express any clear cut, unequivocal opinions on any important matter in issue.
4. Dr. Prothro and complainant's expert, Dr. Cooper, were in essential agreement that past and current medical literature do not include reference to specific tests or studies of the relationship between THE MAN'S VITAMIN ingredients and sexual functioning. However, they both agreed that there are deficiencies of zinc and pyridoxine (vitamin B6) in the average American diet. Dr. Cooper's unequivocal opinion, said to be in conformity with the consensus of informed medical opinion, that ingestion of THE MAN'S VITAMIN, containing zinc and pyridoxine, would have a positive effect on overall energy levels and capacity for sexual performance and enjoyment more than offset the testimony of Dr. Prothro insofar as her testimony, taken in the light most favorable to respondent, might be viewed as expressing a contrary opinion.
5. Based on the uncontroverted evidence that there are deficiencies of zinc and vitamin B6 in the average American diet, one might conclude that it is difficult to obtain zinc and vitamin B6 through normal food sources, in spite of Dr. Prothro's listing of a number of meats, nuts, and grains relatively rich in both ingredients. In view of the admitted dietary deficiency, it would be inappropriate to find material falsity in the representation concerning difficulty in obtaining zinc and vitamin B6.
6. None of the foregoing conclusions is intended, or should be taken, as belittling or disparaging in any way the qualifications of Dr. Prothro in the field of nutrition. Her curriculum vitae reveals that she is highly qualified in that field, generally,
7. The complaint is dismissed.