In the Matter of the Complaint Against COSVETIC LABORATORIES, P.O. Box 10101, Atlanta, GA 30319, P.O. Box 14048, Atlanta, GA 30324, P.O. Box 95503, Atlanta, GA 30347, P.O. Box 10225, Atlanta, GA 30319 and HEAD START, P.O. Box 10064, Atlanta, GA 30319 P.S. Docket No. 7/38 August 15, 1979 Quentin E. Grant Administrative Law Judge APPEARANCE FOR COMPLAINANT: Daniel S. Greenberg, Esq. Consumer Protection Office Law Department U. S. Postal Service Washington, DC 20260 APPEARANCE FOR RESPONDENT: Jack Paller, Esq. Katz, Paller & Land 470 East Paces Ferry Road, N.E. Atlanta, GA 30305
The complaint in this matter was filed on March 16, 1979. It alleges that respondent, employing the captioned names and addresses, is engaged in conducting a scheme or device for obtaining money or property through the mails by means of false representations within the meaning of 39 U.S.C. 3005.
Specifically, the complaint alleges that by means of certain advertisements seeking to induce readers thereof to remit money or property through the mails for its product "The Nail Vitamin" (also referred to as "The Nail System Vitamins" and "Vitamins for Your Nails") respondent represents:
"(1) That ingestion of the vitamins will cause most women to grow beautiful nails;
"(2) That the vitamins provide a substantial benefit, over and above the user's normal daily diet, in effecting the result described in subparagraph A(1), supra ;"
and that by means of other advertisements, also seeking remittance of money or property through the mails for such product respondent represents:
"(1) That ingestion of the vitamins will improve the structure and strength of most women's nails;
(2) That ingestion of the vitamins will eliminate or significantly reduce white spots in mails for most women who have said spots;
"(3) That the vitamins provide a substantial benefit, over and above the user's normal daily diet, in effecting the results described in subparagraphs B(1) and (2), supra .
Respondent filed an answer denying all material allegations of the complaint except for an admission that through its advertisements it seeks remittances of money or property through the mails.
At respondent's request a hearing was held in Atlanta, Georgia on May 3, 1979. Both parties introduced evidence thereat and both have filed proposed findings of fact and conclusions of law.
1. Respondent is engaged in a scheme or device to obtain money or property through the mails for its product, THE NAIL VITAMIN, also called THE NAIL SYSTEM VITAMINS and VITAMINS FOR YOUR NAILS, hereinafter referred to as the product (Cplt. Ex. A, B; CX-1 through CX-9; Answer IV).
2. The product contains the following ingredients (CX-10):
Vitamin A (Palmitate) 5,000 IU 100%
Vitamin D
(Ergocalciferol) 300 IU 75%
Calcium
(Calcium Carbonate) 100 mg 10%
dCalcium Pantothenate 50 mg 45%
PABA 30 mg **
Thiamine (Mononitrate) 10 mg 866%
Niacin (Nicotinic Acid) 25 mg 125%
Zinc (Zinc Sulfate) 15 mg 100%
Manganese
(Manganese Sulfate) 5 mg *
Dried Yeast 300 mg -
Egg Albumin 200 mg -
Respondent's advertisements concerning the product make the representations alleged in the complaint.
a. The representation that ingestion of the product will cause most women to grow beautiful nails is found in the following portions of the advertisement attached to the Complaint as EX. A.:
"Growing beautiful nails has become a lost art ... Nutrition's Role in Beautiful Nail Growth ... the diet of women with beautiful nails ... A total of 11 essential ingredients in a single tablet that's shown that the modern way to grow beautiful nails is from the inside."
b. The representation that the product provides a substantial benefit, over and above the user's normal daily diet, in causing most women to grow beautiful nails is implicit and explicit in Exhibit A to the Complaint. Explicit wording is as follows:
"... the better the diet, the better the nails ... all special vitamins. And special minerals ... the modern way to grow long beautiful nails ... ."
c. The representation that ingestion of the product will improve the structure and strength of most women's nails is found in Exhibit B to the Complaint and CX-2, 3, and 4:
"Only by supplementing the metabolic processes of nail formation can one affect the structure and strength of nails."
d. The representation that ingestion of the vitamins will eliminate or significantly reduce white spots in nails for most women who have such spots is found in CX-2 as follows:
"The condition of your nails reflects your overall nutritional state ... The Nail System: Contains zinc ... low zinc levels cause white spots in nails."
CX-3, 4 and 5 contain nearly identical wording, thus making the same representation.
e. The representation that the product provides a substantial benefit, over and above the user's normal daily diet, in improving the structure and strength of, and eliminating or significantly reducing white spots in, the nails of most women is made in the following portions of respondent's advertisements:
"Only by supplementing the metabolic processes of nail formation can one affect the structure and strength of nails."
"[The product] contains ... zinc ... Low zinc levels cause white spots in nails."
3. Two expert witnesses testified for Complainant. One was Sarah Hunt, Ph.D., Professor of Nutrition and Chairwoman of the Department of Community Health Nutrition at Georgia State University. Dr. Hunt has taught nutrition to medical students and serves as a consultant on nutrition to the nutrition committee of the Medical Association of Georgia and to the Atlanta Medical Association. Her expertise encompasses all the "whys and the wherefores" of nutrients including the source of nutrients, their metabolic pathways, use and functions of nutrients in the body, required amounts of nutrients, and the effects of deficiencies in nutrients (Tr. 10, 11). Dr. Hunt's curriculum vitae (CX-11) and her testimony as to her qualifications show that she was well qualified to testify as to the truth or falsity of the representations made by respondent concerning the product.
Complainant's other expert witness, Henry Jordon Whyte, M.D., is a dermatologist in private practice and Associate Professor of Dermatology at Emory University in Atlanta, Georgia. He has also taught dermatology at the medical school of Dartmouth College and at the University of Pittsburgh (Tr. 176, 177). In Dr. Whyte's practice he sees and treats a number of patients who come to him primarily for nail problems. Dr. Whyte was well qualified to testify as to the issues involving the truth or falsity of respondent's representations concerning the product.
4. Dr. Hunt testified as to the sources and functions of each ingredient listed on the label of the product. She testified that there are some known deficiencies in Vitamin A in very low socio-economic groups in the United States today. They are manifested primarily in poor growth in children, because of the relationship between Vitamin A and protein in growth, and night blindness. She testified that there is no reason to believe that the Vitamin A in respondent's product improves the length or strength of nails. She testified that Vitamin D, calcium, PABA, thiamine, niacin, and manganese play no part in the formation of nails. Further, she testified that there are no known deficiencies, producing clinical manifestations, in the United States of Vitamin D, dcalcium pantothenate, thiamin, niacin, manganese, or zinc.
5. Dr. Hunt testified that zinc, an enzyme activator necessary for protein synthesis, could play a part in the formation of keratin, a protein in the nails. However, the only known symptoms of deficiencies in zinc are slow growth in children who do not eat meat and decrease of taste acuity in adults. Clinical manifestations of zinc deficiency have nothing to do with the nails (Tr. 26). An article in the Journal of the American Medical Association reporting studies in progress suggests the possibility of zinc deficiency as a cause of white spots in nails. But the article reports nothing conclusive in this regard (RX-3). According to Dr. Hunt, white spots in nails are usually caused by trauma (Tr. 56).
6. Dr. Hunt testified that dried yeast and egg albumin are excellent sources of protein which plays a part in nail formation (Tr. 27, 28). The protein of which the nail is composed is keratin. It is synthesized from amino acids which come from other proteins consumed. The only amino acids in respondent's product which can contribute to formation of keratin are in the egg albumin and dried yeast (Tr. 40, 41). However, she also testified that there are very few instances of protein deficiency in the United States today; that the average protein intake is over 100 grams per day; that the protein in each tablet of the product is approximately 2/3 of one gram (Tr. 28, 29).
7. Dr. Hunt did not testify specifically as to whether riboflavin plays a part in nail formation but did state that the amount of that ingredient in the product is only 1/100th of the recommended daily allowance (RDA) of riboflavin (Tr. 30).
8. Dr. Hunt testified that ingestion of the product would result in some distribution of nutrients to the nails but that the only ingredients in the product that would be of any value to the nails would be the amino acids in the dried yeast and egg albumin (Tr. 52). She testified that most people get enough protein and that if one has enough protein you have the building blocks for keratin, the nail protein (Tr. 42).
9. She testified that she does not believe there are deficiencies in the quality of the American diet today, defining deficiency as being less than 66 percent of the recommended dietary allowance (RDA) recommended for the general population group to provide all that is necessary for that population under ordinary circumstances (Tr. 45). The recommended dietary allowance is designed more for optimal health than for just sustaining health (Tr. 46).
10. Dr. Hunt testified that respondent's product will not cause most women to achieve the results represented in respondent's advertising as found above (F. of F. No. 2).
11. Dr. Hunt testified that her testimony is in conformity with the consensus of professional opinion in the field of nutrition (Tr. 32).
12. James T. Cooper, M.D. testified for respondent. Dr. Cooper is board certified in family practice, certified by the American Board of Bariatric Medicine, and teaches a course in nutrition at Emory University School of Medicine. Bariatric medicine deals with weight control and involves among other things the art and science of nutrition, one of the cornerstones of weight control (Tr. 113, 114).
13. Dr. Cooper testified that the ingredients in respondent's product are related to nail growth "in one way or another". He has used the ingredients in his practice "in one way or another" and testified that he has from a medical standpoint evaluated the benefits to the nails of his patients from the use of such ingredients.
14. Since 1963, Dr. Cooper has examined approximately 10,000 patients (Tr. 132). Dr. Cooper's patients do not come to him primarily for treatment of nail problems (Tr. 150). But he examines their nails as part of the initial physical examination, the nails being "a mirror of what is going on in the body" and an important part of diagnostic information (Tr. 119). Dr. Cooper described his patients as a cross-section, representative of the adult population from age 13 on. He testified they come to him with the usual cross-section of problems experienced by the American public; obesity, hypertension, diabetes, digestive problems, all of them having the complaint that they don't feel good (Tr. 137, 158).
15. Dr. Cooper gives an RDA tablet called Dialite to nearly all of his patients, often adding minerals and other nutritional supplements. The Dialite tablets are different from respondent's product, according to Dr. Cooper. He did not specify the exact differences (Tr. 124). But he testified that the Dialite tablets include the ingredients in respondent's product in different amounts (Tr. 128, 157). Believing that their diets are usually not adequate in protein, Dr. Cooper prescribes a diet for most patients designed to give them more protein (Tr. 126, 168, 169). This is consistent with his testimony that if a woman came to him with a nail problem, he would not simply give her respondent's product, or a similar product, because a nail problem is usually a sign of protein deficiency (Tr. 140-150).
16. On subsequent visits, occurring usually monthly, or more often, he watches the changes in the nails. Based on his observations he concludes that respondent's product will produce for most women the results represented by respondent as found above (F. of F. No. 2). It takes about 4 months for improvements to be noticed by patients (Tr. 171).
17. Dr. Cooper testified that most nail cracking, splitting, and breaking problems are due to protein deficiency (Tr. 140, 150) and that zinc or B-complex deficiency can also produce such problems (Tr 150). His testimony indicates that zinc deficiency is found only in areas of zinc deficient soil (Tr. 123). He testified that most of the patients who have adequate amounts of protein intake every day when they first come to him do not show any nail changes (Tr. 147).
18. Dr. Cooper acknowledged on cross-examination that respondent's product contains only a miniscule amount of protein (Tr. 151). He also testified that there is no absolute deficiency in the United States today of any of the ingredients in respondent's product. (Tr. 154). But he stated that the condition of the nails is one of the chief indicators of "subclinical malnutrition syndrome" (Tr. 155) which in line with his other testimony would be, in connection with nails, usually malnutrition in the protein area (F. of F. No. 17, supra ).
19. Toward the end of his cross-examination, Dr. Cooper was asked how he could isolate the effect of a product like respondent's on a patient's nails if the patient had also been given other treatments and supplements. Dr. Cooper then mentioned for the first time a "perfect control group" he has, consisting of a certain unspecified number of patients who do not tolerate or will not take vitamins in any form. According to Dr. Cooper, the members of this group do not do as well "as far as the appearance of the nail and the way they feel in general" (Tr. 170, 171).
20. Dr. Cooper testified that another of respondent's products, a protein protective coating, can contribute to the strength and structure of nails (Tr. 132, 133).
21. Dr. Cooper stated that his opinions concerning respondent's product are consistent with the consensus of enlightened medical opinion (Tr. 132).
22. Respondent also produced as witnesses three young women who testified that they had been subjects in a study made, as they were advised at the outset thereof, to see if the use of respondent's product together with the protein protective coating would produce any improvement in their nails (Tr. 73-112). According to an employee of Braswell, Incorporated who conducted the study, all three women were at the time employees of Braswell Incorporated, one of the corporations associated with respondent. They were directed to use both products every day over a period of 60 days (Tr. 74, 75). They did so and each one testified, in substance, that she had experienced marked improvements in her nails. They believed, variously, their nails had become stronger, harder, more flexible, and not as brittle over the 60-day period. Before and after pictures of their nails were taken but not produced at the hearing.
23. Dr. Whyte, complainant's rebuttal witness, has, unlike Dr. Cooper, treated a number of patients primarily for nail problems in his practice as a dermatologist. According to Dr. Whyte the primary cause of nail breakage is physical, resulting from porosity of the nail plate which permits water to penetrate the nail. Repeated wetting and drying of the nail causes nail damage. He successfully treats breaking and cracking nails with soaking of the nails in a simple solution followed by painting with bath oil. He stated that nails do not contain any connective tissue whatsoever (Tr. 181). This contradicted Dr. Cooper's testimony. In his opinion nutritional deficiency is not a common cause of breaking or flaking of nails (Tr. 178). In his opinion none of the common causes of nail problems can be effectively treated with respondent's product (Tr. 179). He testified that his opinions represent the consensus of dermatological opinion.
24. Dr. Whyte testified that white spots on the nails are manifestations of diskeratosis, or faulty keratinization of the matrix of the nail that emerges from under the nail plate. This condition is caused by minimal trauma, so minimal that it is often not remembered. He was familiar with the report in the AMA Journal concerning the possibility that zinc deficiency may cause white spots. He said he did not know whether ingestion of zinc might prevent the kind of white marks mentioned in that report (Tr. 191, 192).
25. With respect to the testimony of the young women who participated in the study conducted by respondent, Dr. Whyte testified that it takes four to six months for nails to grow out, and increased thickness and strength of the nails (if it can be produced) has to come from the base and would require at least three to four months to manifest itself. Consequently, he stated, the 60 day period of respondent's study (F. of F. No. 22, supra ) is too short a period for achievement of any valid conclusions. Dr. Cooper's testimony coincided with Dr. Whyte's as to the period of time required for changes in nails to be noticeable (Tr. 119). Dr. Whyte testified also that the subjects of that study probably had a bias toward observing the results they reported because of their knowledge of the purpose of the study and their desire to have better nails. He also testified that their use of the protein protective coating, or conditioner, probably accounted for any improvement in nail conditions experienced by the participants in the study (Tr. 190).
26. Dr. Whyte doubted the validity of Dr. Cooper's opinion as to the part vitamins played in nail improvement observed in his patients because it was not based on a scientifically reliable double blind test. In Dr. Whyte's opinion anecdotal studies such as Dr. Cooper's are worthless. He testified that lack of support by a scientific double-blind study discredited both Dr. Cooper's study and the experience reported by Dr. Cooper (Tr. 194).
1. 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 (1948); 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 Consumer Council , 425 U.S. 748 (1976).
2. Applying the above standards to respondent's advertising of the product in question, I find that respondent makes representations substantially as characterized in the complaint.
3. I find that such representations are made as to the efficacy of the vitamin tablets (treated as the product in the foregoing findings of fact) used alone, without the concurrent use of the protein protective coating sometimes offered by respondent as part of a "Nail System" including the vitamin tablets.
4. Based on the testimony of complainant's witnesses Sarah Hunt, the nutritionist, and Dr. Henry Jordon Whyte, a well-qualified dermatologist, I conclude that complainant has made a prima facie case that respondent's representations are false in fact.
5. I attach no weight to the testimony of the Braswell employees who participated in respondent's study because (1) of the likelihood that their observations were infected with bias toward seeing the results they wanted to achieve; (2) because 60-days was too short a period for changes in nail strength and structure to be observable; and (3) because the subjects used in addition to the product a protein protective coating which could account for the results they reported. The study was too lacking in scientific approach to be of any value in this proceeding.
6. I conclude from the opinion of Dr. Whyte within whose particular field of practice and expertise nail problems reside, that nutritional deficiencies are not a common cause of nail problems.
7. Dr. Cooper, although not possessing the credentials of Dr. Whyte, a dermatologist, to testify concerning the structure of the nails and the causes of nail problems, was qualified to testify about the nutritional aspects of the case. His testimony concerning his experience in the use of an RDA tablet in his practice was interesting but not persuasive on the issues of the truth or falsity of respondent's product. His testimony and opinions when carefully analyzed are not sufficient to overcome complainant's prima facie case.
8. Although Dr. Whyte disagreed with Dr. Cooper's opinion that nutritional deficiency is the commonest cause of nail problems, he did not entirely discount such deficiencies as a possible cause of such problems. Therefore, the parties are in basic agreement that nutritional deficiencies can be a cause of nail problems. The experts acknowledged the possibility that zinc deficiency can cause nail problems, but such deficiency has not been established as anything but a cause of slow growth in children who do not eat meat or a deficiency which may exist in areas of zinc-poor soil.
9. Analysis of all the evidence leads to the conclusion that nutritionally related nail problems usually involve protein deficiency. The protein of which the nail is composed is keratin. It is synthesized from the amino acids which come from other proteins consumed. The only amino acids in respondent's product which can contribute to formation of keratin are in the egg albumin and the dried years. Both Dr. Cooper and Dr. Hunt agreed that the amount of such protein in the product is insignificant, miniscule. Both doctors agreed that there is no clinical deficiency of protein in the United States. Based on the miniscule amount of protein in the product and the absence of such clinical deficiency, Dr. Hunt concluded that ingestion of the product will not do for nails what respondent represents.
10. Dr. Cooper introduced the concept of "subclinical malnutrition syndrome" and expressed the opinion that nail problems are a subclinical indicator of malnutrition and went on to describe his experience in use of an RDA tablet with respect to its effect on nail problems. Based on his experience he concluded that respondent's product will affect nails in the ways represented by respondent. I find Dr. Cooper's opinion unpersuasive for the following reasons:
a. The product contains too little protein to account for the results reported by Dr. Cooper.
b. There is no evidence that the soil in the geographical area in which Dr. Cooper practices is zinc deficient. Therefore, improvements in nails observed by Dr. Cooper have not been persuasively related to the zinc in the product.
c. The pill given by Dr. Cooper to his patients is different from respondent's product. How much different is impossible to determine from the record here. Dr. Cooper testified that his pill includes the ingredients of respondent's product but in different amounts. He did not exclude the possibility that his RDA pill also contains additional ingredients. In the absence of evidence that Dr. Cooper's pill is nearly identical in all respects to respondent's product Dr. Cooper's experience lacks an important element of a valid scientific test.
d. Dr. Cooper's testimony that the 10,000 to 12,000 patients he has treated represent a cross-section of the population is obviously too broad. Clearly, they represent, at most, a cross-section of the population in the geographical area of his practice who have a large variety of medical problems for which they are given treatment. Dr. Cooper's testimony does not persuade me that it was his RDA tablet alone, and not the result of other treatment given for such conditions as diabetes, hypertension, digestive problems, and others, which accounts for improvement he observed in nail conditions.
e. Dr. Cooper's so-called "perfect control group" was not identified as to numbers, basic medical problems and treatment therefor, etc. to the extent necessary to eliminate causes other than the absence of an RDA tablet from their treatment as accounting for their not doing as well as to nail appearance as patients taking the pill.
f. To the extent that Dr. Cooper's opinions were based on the concept that there is connective tissue in nails, they appear to be illfounded. According to Dr. Whyte whose qualifications as to knowledge of nail structure were superior, there is no connective tissue in nails.
11. I conclude that the representations made by respondent as to the product as alleged in the complaint and found above are materially false in fact.
12. Respondent is engaged in the conduct of a scheme for obtaining money or property through the mail by means of representations materially false in fact in violation of 39 U.S.C. 3005.
13. An order pursuant to 39 U.S.C. 3005 in the form attached should be issued.