In the Matter of the Complaint Against: NUTRIENT LABORATORIES, INC., P.O. Box 80308 at Chamblee, GA 30341 and P.O. Box 4283 at New Windsor, NY 12550 and P.O. Box 81105 at Atlanta, GA 30366 and P.O. Box 95543 at Atlanta, GA 30347 and P.O. Box 2511 at Newburgh, NY 12550 P.S. Docket No. 5/48 11/17/76 Grant, Quentin E.; Administrative Law Judge Daniel S. Greenberg, Esq. Law Department United States Postal Service Washington, D.C., for Complainant Jack Paller, Esq. Atlanta, Georgia, for Respondent Before: Quentin E. Grant, Administrative Law Judge
This proceeding was initiated on July 29, 1976 when the Consumer Protection Office of the Law Department of the United States Postal Service filed a complaint in which it alleged that respondent is engaged in conducting a scheme or device for obtaining money or property through the mails by means of false representations in violation of 39 U.S.C. 3005.
The complaint specifically alleges that respondent attracts attention to such scheme by means of advertising matter referring to a product called "The Skin Vitamin" (sometimes referred to hereinafter as the "product") and further alleges as follows:
"(2) That, by means of said advertisement, and in similar matter, Respondent represents, directly or indirectly, by means of affirmative statement, implication, or omission, in substance and effect:
(a) That ingestion of 'The Skin Vitamin' (hereinafter referred to as the 'tablets') plays a significant part, over and above the contribution of the user's daily diet, in:
(i) preventing cellulite and wrinkles;
(ii) eliminating or significantly reducing cellulite and wrinkles;
(b) That the tablets, taken in conjunction with the program outlined by Respondent, play a significant part in:
(i) preventing cellulite and wrinkles;
(ii) eliminating or significantly reducing cellulite and wrinkles;
(c) That ingestion of the tablets will improve the appearance of the skin of most users;
(d) That most users will notice significant improvement in the appearance of their skin within 2 weeks after beginning Respondent's program;"
Finally, the complaint alleges that the representations alleged are materially false in fact.
Respondent's answer to the complaint denies the allegations set forth in subparagraphs (a)(i) and (ii) and (b)(i) and (ii) of paragraph 2 of the complaint, set forth above. The answer admits the allegations set forth in subparagraphs (c) and (d) of paragraph 2 of the complaint but denies that the representations alleged therein are materially false.
Respondent's answer admits that by means of the advertising alleged in the complaint it seeks to induce readers thereof to remit money or property through the mails for the product.
A hearing in the matter was held on September 9, 1976 at which both parties presented evidence. Thereafter both parties submitted proposed findings of fact and conclusions of law.
1. Respondent is engaged in a scheme or device for obtaining money or property through the mails (Ans. 6; CX-1 - CX-8).
2. Attention is attracted to such scheme or device by means of advertising calculated to induce readers thereof to remit money or property through the mails (Ans. 6; CX-1). A typical copy of such advertising is attached hereto as Exhibit A.
3. The product involved is called "The Skin Vitamin." It consists of capsules which, according to the label on the jar in which they are supplied, contain the following ingredients:
%MDR*
Vitamin E (as DL-Alpha Tocopheryl Acetate) 100 IU **
Vitamin B2 (Riboflavin) 15 mg 1250
Vitamin B6 (Pyridoxine HCL) 5 mg **
Biotin 5 mg ***
Niacinamide 25 mg 250
Pantothenic Acid (as Calcium Pantothenate) 100 mg **
Folic Acid 0.4 mg **
Linoleic Acid 10 mg ***
Lecithin 100 mg ***
Para-aminobenzoic Acid 30 mg ***
Calcium (as DiCalc, Phosphate) 50 mg 6.7
Magnesium (as Mag. Hydroxide) 50 mg **
* Minimum Daily Requirement
** MDR has not been determined
*** Need in Human Nutrition Not Established
4. That portion of respondent's advertising under the heading "The Skin Vitamin Fights Cellulite and Wrinkles" makes the representations alleged in subparagraphs 2(a) and 2(b) of the complaint, supra, i.e., that ingestion of the product plays a significant part, over and above the contribution of the user's daily diet, and that the product taken in conjunction with a program furnished by respondent plays a significant part, in preventing, eliminating or significantly reducing cellulite and wrinkles.
The clear implication of that portion of the advertisement is that the average reader's diet is deficient in one or many of the ingredients contained in the product, and that such a diet will cause, or continue, wrinkling of the skin and the formation of cellulite.
The program referred to in that portion of the advertisement consists of a diet for overweight persons, taking of sauna baths and an exercise program. The nature of the program is not disclosed until the purchaser receives it in a booklet which accompanies the product.
5. Throughout the advertisement is found the representation that ingestion of the product will improve the appearance of the skin of most users as alleged in paragraph 2(c) of the complaint.
6. In the last paragraph of the advertisement is found the representation, alleged in paragraph 2(d) of the complaint, that most users will notice significant improvement in the appearance of their skin within two weeks.
7. Robert David Reynolds, Ph.D, Acting Laboratory Chief, Vitamin and Mineral Nutrition Laboratory, USDA, Agriculture Research Center, Beltsville, Md., testified for complainant. Dr. Reynolds was well qualified to testify as to most of the ingredients contained in the product and, particularly, as to their presence in the average daily diet, their uses, recommended daily allowances (RDA) thereof, and dietary deficiencies in such ingredients (CX-10, Tr. 22-23).
Dr. Reynolds prepared a chart, received in evidence as CX-11 (Tr. 59), which listed the ingredients of The Skin Vitamin, together with the average daily intake of these ingredients, the ratio of the amount contained in The Skin Vitamin to the normal daily intake, the Recommended Dietary Allowance, the normal sources of these ingredients, their functions, and the symptoms of deficiency of these ingredients in the human body.
Dr. Reynolds' figures were taken from "Recommended Dietary Allowances" (8th Edition, 1974), which is recognized as the best available evidence of dietary allowances for the United States (Tr. 25-26), and from a publication of the U.S. Department of Agriculture entitled "Household Food Consumption Survey, 1965-1966, Report No. 11," also considered to be reliable (Tr. 27-28).
He stated that the RDA is the level of intake of an essential nutrient considered to be adequate not just to meet the known nutritional needs of practically all healthy persons, but to allow a wide margin over the eliciting of deficiency symptoms (Tr. 26, 49-50).
Dr. Reynolds explained that those persons who would not be included in his definition of "healthy" people were those suffering from specific maladies or pathologies for which they are being, or should be, treated by a physician, including everything from the common cold to cancer, heart disease, broken bones, accidents of any type, in addition to those suffering from vitamin deficiency. While the percentage of people so suffering is in the neighborhood of 50%, he explained that his testimony was based on the intake values taken from the population at large, and not restricted only to the 50% of healthy adults (Tr. 45-47, 60).
8. Following is a summary of the testimony of Dr. Reynolds with respect to the individual ingredients of The Skin Vitamin.
(a) Vitamin E
Dr. Reynolds testified that the RDA of Vitamin E is 12 to 15 IU per day, and the daily intake is 11 to 13 IU per day (CX-11; Tr. 28). Although The Skin Vitamin contains 7 to 9 times the RDA of Vitamin E, Dr. Reynolds testified that considerably less than 1% of the population of the United States suffers from a deficiency of Vitamin E and, further, that it plays no part in preventing cellulite or wrinkles (CX-11; Tr. 60-61).
(b) Vitamin B2 (riboflavin)
The RDA of riboflavin is 1.2 to 1.6 mg., and the daily intake is 1.34 to 2.25 mg. Although The Skin Vitamin contains 6 to 11 times the RDA, Dr. Reynolds testified that less than 1% of the American population was suffering from such a deficiency of B2 as to elicit clinical symptoms. While he testified an extreme deficiency of Vitamin B2 might result in skin wrinkling, he testified that it would be uncommon to find a deficiency of Vitamin B2 alone; such a person would probably be deficient in most of the other nutrients in the diet, and would be suffering from many other conditions, such as lack of growth, weakness, scaliness of the skin, loss of appetite, general malaise. He further stated that such a person either would be or should be under a doctor's care (CX-11; Tr. 31, 62-63).
(c) Vitamin B6 (pyridoxine)
The RDA of Vitamin B6 (pyridoxine) is 2 mg., and the daily intake is 1.2 to 2.1 mg. Although The Skin Vitamin provides approximately 2 to 2-1/2 times the daily intake, Dr. Reynolds testified that pyridoxine plays no part in preventing or eliminating cellulite or wrinkles (CX-11; Tr. 31, 63-65).
Although Dr. Reynolds testified that women in their third trimester of pregnancy may be deficient in Vitamin B6, these women are generally under a doctor's care. He further stated that it is standard medical practice to recommend a multiple vitamin supplement for women throughout the course of pregnancy. Judicial notice is taken of the fact that birth control pills are a prescription drug so it may be assumed that women on such pills are similarly under medical supervision.
(d) Biotin
There is no established RDA for biotin. Although biotin is used in the maintenance of the sebaceous glands within the skin, The Skin Vitamin contains only 1.7% to 5% of the amount of biotin received in the daily diet. Additionally, biotin is synthesized by microorganisms in the intestines (CX-11; Tr. 31, 34-35, 65).
(e) Niacinamide
The RDA of niacinamide is 13 to 18 mg., and the daily intake is 16 to 33 mg. Although The Skin Vitamin provides 25 mg., Dr. Reynolds testified that any deficiency of this ingredient would probably be considerably less than 1% of the population (CX-11; Tr. 66).
(f) Pantothenic Acid
There is no established RDA for pantothenic acid, although 5 to 10 mg. are recommended, and the daily intake is 5 to 20 mg. Although The Skin Vitamin contains 5 to 20 times the amount obtained in the diet, Dr. Reynolds testified that considerably less than 1% of the population of the United States is deficient in pantothenic acid (CX-11; Tr. 67).
(g) Folic Acid
The RDA of folic acid is 400 mg., and the daily intake is 148-2300 mg. Although The Skin Vitamin supplies an amount equal to that provided by the daily diet, Dr. Reynolds testified that any deficiencies in folic acid are generally associated with problems in metabolism of the vitamin itself, rather than with a deficiency of the particular vitamin, and that a person with such a metabolic deficiency would not be helped by administration of the particular ingredient in the form of a pill. Such a person must receive medical care (CX-11; Tr. 67-69).
(h) Remaining Ingredients of The Skin Vitamin
Dr. Reynolds testified that, although he was unable to determine the daily intake of para-aminobenzoic acid, its deficit would not cause symptoms unless the person were also folic acid deficient (Tr. 69) which would be serious and, additionally, could not be corrected by The Skin Vitamin.
Dr. Reynolds did not testify in detail concerning the remaining ingredients of the product, i.e., linoleic acid, lecithin, para-aminobenzoic acid, calcium (as DiCalc phosphate) and magnesium (as magnesium hydroxide) but expressed the opinion that the conditions caused by deficiency of any of the ingredients of the product (with the exception of Vitamin B6) would result in severe medical problems, and that these problems would probably be due to a metabolic malfunction for which a person should be under medical care. Addition of ingredients which are deficient because of metabolic problems will be of no value to the user (Tr. 67-69).
9. In sum, Dr. Reynolds stated that there was nothing in the product which would play a significant part, over and above the contribution of the user's daily diet, in preventing, eliminating, or significantly reducing cellulite or wrinkles and in the normal healthy person that The Skin Vitamin would not contribute anything over and above the program outlined in the booklet accompanying the product toward preventing, eliminating or significantly reducing wrinkles and cellulite in the normal healthy person (Tr. 37-39).
10. Joseph Thomas Judd, Ph.D., Laboratory Chief, Lipid Nutrition Section, Agricultural Research Service, USDA, also testified for complainant. Dr. Judd was well qualified to testify concerning fat metabolism (CX-9).
Dr. Judd stated that while lecithin plays a role in fat metabolism it neither causes removal of fat per se, nor physically moves fat deposits from one part of the body to another. He explained that there is a certain rate at which fat is metabolized within the body, depending upon the need for energy and upon hormonal factors. Although lecithin plays a part in metabolizing fat, it is not a controlling agent; if the body does not need additional energy or heat, the addition of lecithin would not cause the body to somehow break down or metabolize more fat than it would have had the user not ingested The Skin Vitamin.
Additionally, he testified that the main source of lecithin is its synthesis by the body, rather than external sources. Lastly, Dr. Judd testified that neither the lecithin nor any other ingredient contained in The Skin Vitamin would contribute anything over and above either the user's daily diet or the program outlined in Respondent's booklet (CX-7) toward preventing, eliminating, or reducing cellulite or wrinkles (Tr. 73-76, 79-82, 85-87).
11. Another witness for complainant was Carnot Evans, M.D., a dermatologist in private practice who also works part-time for the Food and Drug Administration. Dr. Evans was well qualified to testify concerning the skin and the effects of The Skin Vitamin thereon (Tr. 92, 93; CX-12).
Dr. Evans explained that the appearance of the skin is influenced by color, pigmentation, general texture of the skin, extent of vascularity (blood vessels in or around the skin), and by increases or decreases in thickness of the skin at particular areas. Abnormalities, or pathologies, of the skin could be caused by inflammatory conditions, neoplasms (tumors), infections, etc. (Tr. 94-96). He also testified that the appearance of the skin is affected by exposure to the sun in that a great degree of exposure presents the appearance of aged skin, which includes wrinkling, discoloration, and in general an appearance totally different from skin which has not been so exposed (Tr. 96-97).
Dr. Evans testified that ingestion of The Skin Vitamin would not correct the appearance of the skin which had been marred or in some way affected by these various conditions (Tr. 99-101).
According to Dr. Evans The Skin Vitamin would not prevent, eliminate or reduce wrinkles. Dr. Evans explained that hereditary influence, sunlight, and hormones play a part in wrinkling (Tr. 106), and that the treatment of wrinkles requires surgical procedures. He further explained that this procedure does not remove wrinkles per se but, rather, makes them less apparent. He stated that there is a consensus of dermatological opinion that wrinkles cannot be prevented, eliminated, or reduced by ingestion of nutrients; that dietary intake above and beyond the ordinary diet plays no role in preventing, eliminating, or reducing wrinkling; and that skin problems in general based upon lack of nutrition are a rarity, perhaps a fraction of 1%. Addressing himself specifically to The Skin Vitamin, he stated that this product will not play a significant part, over and above the user's diet or the program outlined in CX-7, in preventing, eliminating, or reducing wrinkles (Tr. 101-103, 111-113).
12. The fourth witness for complainant was Vincent F. Cordaro, M.D., a physician employed by the Food and Drug Administration, well qualified to testify concerning the effect of The Skin Vitamin on cellulite (Tr. 115-117).
Dr. Cordaro testified that approximately 95% of obesity is due to excess intake of calories, with the remaining 5% due to various diseases. He explained that obesity would be treated by reducing caloric intake, i.e., cutting down on the amount of food eaten.
He stated that cellulite is not a medical term but, rather, is a term used in advertising to denote deposits of fat in certain areas of the body (particularly in women), and includes fat pads around the hips, thighs, and shoulder girdle. Dr. Cordaro stated that cellulite is exactly the same thing as fat, and that treatment would be the same as treatment for any other type of fat, i.e., reducing caloric intake and increasing exercise (Tr. 117-118).
Dr. Cordaro further stated that there was nothing in The Skin Vitamin which would play a significant part over and above the contribution of the user's daily diet, or the contribution of the program outlined in CX-7, in preventing, eliminating, or reducing cellulite (Tr. 118, 119).
13. The testimony of complainant's expert witnesses conformed to the consensus of informed opinion in their particular fields of expertise (Tr. 41, 76, 102, 120).
14. Respondent presented one witness, William H. Saunders, M.D., a general practitioner, who practices what he terms preventive medicine. He believes that nutrition is a principal tool for bringing about better health (Tr. 131).
Dr. Saunders prefaced the bulk of his testimony with the statement that he had no assurance as to any specifics concerning whether the biochemicals contained in The Skin Vitamin can act on the body or not. He testified that "it is such an extremely complicated field that I do not have that much intelligence" and that "I don't feel other people do either" (Tr. 134).
Dr. Saunders testified that he would consider that anyone who has gray hair, wrinkles, dental cavities, lack of energy, varicose veins, stomach upsets, etc. as not having good health (Tr. 138, 139). He stated that he does not treat patients primarily for cellulite, wrinkles, or improvement of skin appearance, the conditions involved in this proceeding (Tr. 166).
Dr. Saunders stated that The Skin Vitamin contains vitamins which are necessary and have been reported as beneficial for certain skin conditions and that he would try it for a skin condition to see if it would work (Tr. 140). However, he was unable to express an opinion as to whether vitamins alone have caused improvement in skin appearance (Tr. 169).
Dr. Saunders testified that all wrinkles are premature, an abnormality, resulting from a biochemical imbalance which may be corrected before they occur and possibly alleviated after they occur (Tr. 142).
Dr. Saunders admitted that he has never specifically treated anyone for wrinkles; that the average person would go to a dermatologist if interested in wrinkles. He stated that he didn't know if a proper diet would eliminate wrinkles once developed, but considered it a possibility (Tr. 153).
With regard to obesity, generally, Dr. Saunders was of the opinion that it is due primarily to diets not properly balanced with respect to vitamins and minerals, not to excessive caloric intake, and that correction of the imbalance will eliminate the condition (Tr. 147, 148). He acknowledged that his opinion is not in conformity with the consensus of informed medical opinion (Tr. 176).
15. Although the burden was on complainant to prove the falsity of respondent's representations, it is noted that respondent did not produce any evidence concerning the controlled tests, referred to in its advertisement, having to do with absence from diets of certain vitamins. Also respondent did not offer evidence concerning the views of major nutritionists, also referred to in its advertisement, that the vitamins and minerals contained in The Skin Vitamin are essential for healthy, young skin.
1. Respondent is engaged in a scheme for obtaining money through the mails by means of representations substantially as characterized in the complaint.
2. Based on the testimony of complainant's expert witnesses, as outlined above, I find that such representations are materially false in fact. I reject the opinions of respondent's expert, insofar as they conflict with those of complainant's experts on the matters in issue, as being contrary to the consensus of informed opinions in the particular specialized fields of science involved.
3. Although scientific, including medical, opinion is subject to change with the development of additional knowledge, the opinion evidence offered by complainant is in conformity with the consensus of current opinion in the particular fields involved. Further the information as to nutritional requirements relied on by Drs. Reynolds and Judd in support of some of their opinions appears to be the best available at the present time and is accepted as reliable, probative and sufficiently certain to support their opinions.
4. Respondent attacks the evidence given by complainant's experts as unworthy of belief on the ground that they are antagonists to the use or need of vitamins as a supplement to the American diet. But the issue to which their testimony was directed is not that broad. That issue, summarized, is whether respondent's product will improve skin appearance, prevent or eliminate wrinkles, and prevent, eliminate or reduce cellulite as respondent represents in its advertising. Any general opinion these experts may have entertained as to the absence or need of vitamin supplementation in the average American diet is not perceived as infecting their opinions on the issues with any invalidating bias.
5. The meaning of representations contained in advertising 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 (1948); Vibra-Brush Corp. v. Schaffer, 152 F. Supp. 451 (S.D. N.Y. 1957); Borg-Johnson Electronics v. Christenberry, 169 F. Supp. 746 (S.D. N.Y. 1959).
6. The average person reading respondent's advertisements would interpret them substantially as characterized in the complaint.
7. An order pursuant to 39 U.S.C. 3005 in the form attached should issue.