In the Matter of the Complaint Against

ATHENA PRODUCTS, LTD.
3176 Marjan Drive at
Atlanta, GA 30340

ATHENA PRODUCTS, LTD.
P. O. Box 81371 at
Atlanta, GA 30366

and

ATHENA PRODUCTS, LTD.
P. O. Box 29274 at
Atlanta, GA 30359

P.S. Docket No. 7/99

Duvall, William A.

APPEARANCE FOR COMPLAINANT:
Kristin L. Malmberg, Esq.;
Thomas A. Ziebarth, Esq.;
Law Department,
United States Postal Service,
Washington, D.C. 20260

APPEARANCE FOR RESPONDENT:
Tom B. Benham, Esq.;
6600 Powers Ferry Road, N.W.,
Atlanta, GA 30339

INITIAL DECISION; Statement of The Case

In a Complaint filed October 22, 1979, the Consumer Protection Division, Law Department, United States Postal Service, (Complainant) charged that Athena Products, Ltd., 3176 Marjan Drive, Atlanta, Georgia, (Respondent) is engaged in conducting a scheme to obtain money through the mail by means of false representations in violation of 39 U. S. Code § 3005.

It is alleged that attention is attracted to the scheme by means of advertising matter distributed to the public which is calculated and intended to induce readers thereof to remit money through the mail to Respondent. A copy of the advertising matter referred to was attached to the Complaint and a copy thereof is attached hereto as Appendix A.

It is alleged in paragraph III (hereinafter, 3) of the Complaint that by means of the advertising matter, of which Appendix A is a copy, Respondent expressly or impliedly represents to the public in substance and effect that:

"(a) NEW START NATURAL HAIR VITAMINS will nourish hair.

"(b) NEW START NATURAL HAIR VITAMINS will make the user's hair healthier.

"(c) An individual who maintains a well-balanced diet may have poorly nourished hair that can be remedied with NEW START NATURAL HAIR VITAMINS.

"(d) Individuals experiencing poor hair growth are likely to be suffering from a zinc deficiency.

"(e) NEW START NATURAL HAIR VITAMINS will be effective in aiding hair growth of individuals without a severe deficiency of zinc.

"(f) Biotin in NEW START NATURAL HAIR VITAMINS will prevent hair loss and reverse baldness.

"(g) Scientifically valid studies have credited biotin with preventing hair loss and reversing baldness.

"(h) The folic acid in NEW START NATURAL HAIR VITAMINS will maintain color and delay greying of an individual's hair.

"(i) The iodine and calcium pantothenate in NEW START NATURAL HAIR VITAMINS will cause the hair of an individual to become thicker and more lustrous.

"(j) The iron and copper in NEW START NATURAL HAIR VITAMINS will cause an individual to have improved blood circulation to the scalp.

"(k) Niacin, inositol, vitamin B-12 and other nutrients in NEW START NATURAL HAIR VITAMINS help the body to provide proper nutrition to the hair."

Finally, Complainant charges that the foregoing representations are materially false as a matter of fact.

In the Answer to the Complaint Respondent asserted a number of defenses.

As its First Defense, Respondent alleged that the Complaint failed to state a claim upon which relief may be granted.

The Second Defense was directed to the specific allegations of the Complaint, as follows:

a. Respondent denied the allegations concerning the existence of a scheme on its part; but Respondent admitted that it does direct advertising material to the public which is calculated and intended to induce readers to remit money to buy the product offered for sale through the mail by Respondent;

b. Respondent admits that Appendix A is its advertisement or a copy thereof;

c. Respondent admits the allegations of paragraphs 3(a), 3(b), and 3(k) of the Complaint;

d. Respondent denies the allegations of paragraphs 3(c) through 3(j) of the Complaint; and

e. Respondent denies that the representations set forth above are materially false as a matter of fact.

Respondent's Third, Fourth and Fifth Defenses were withdrawn at the hearing. (Tr. 385)

On motion by Respondent, the hearing was held in Atlanta, Georgia.

FINDINGS OF FACT

The Use of The Mail

1. Based upon Respondent's advertisements (Comp. Exs. 1, 2 and 3), the admissions in paragraphs 1 and 2 of the Second Defense of its Answer, and based upon the test correspondence (Comp. Exs. 4-11; Tr. 13-25), I find that Respondent is engaged in conducting an enterprise for obtaining money through the mails. This Finding of Fact forms part of the basis for Finding of Fact Nos. 5 through 12. All quotations in Findings of Fact Nos. 5 through 12 are from Appendix A.

The Product

2. The product being sold through the mails which is involved in this proceeding (Ex. C-7 and C-11) is called NEW START NATURAL HAIR VITAMINS (hereinafter called the "product"). As indicated in Appendix A (and by the label) the product contains the following ingredients (Ex. C-7): ^1/

Directions: One or two tablets daily as a dietary supplement. Take after eating or with dinner.

Contents: Each film coated tablet contains $M03,32,09,06$G$J$JRDA *$D$QCalcium Pantothenate$Y100 mg. $Y1000$QNiacin (Nicotinic Acid)$Y30 mg. $Y150$QBiotin$Y200 mcg.$Y100$QFolic Acid$Y0.4 mg. $Y100$QCyanocobalamin (Vitamin B-12)$Y6 mcg.$Y100$QCholine$Y50 mg. $Y **$QInositol$Y50 mg. $Y **$QPABA$Y30 mg. $Y **$QIron +$Y18 mg. $Y100$QCopper +$Y2 mg. $Y100$QIodine (from Kelp)$Y0.15 mg.$Y100$QManganese +$Y5 mg.$Y **$QZinc +$Y25 mg.$Y100$Q*3*(in a base containing dried yeast powder)$X

+ as Organic Gluconate

* Percent of U.S. Recommended Daily Allowances for adults and children 4 or more years of age.

** U.S. RDA has not been determined.

Caution: Protect from excessive light, heat and moisture. Keep out of reach of children

Distributed by: Athena Products Ltd., Atlanta, GA 30340

Are The Representations Made by The Respondent

3. Based on the admission in paragraph 3(a) of the Second Defense of its Answer, I find that Respondent makes the representation which is set forth in paragraph 3(a) of the Complaint.

4. Based on the admission in paragraph 3(b) of the Second Defense of its Answer I find that Respondent makes the representation set forth in paragraph 3(b) of the Complaint.

5. I find that Respondent represents, as charged in paragraph 3(c) ^2/ that an individual who maintains a well-balanced diet may have poorly nourished hair that can be remedied with the product. A portion of Respondent's advertising matter providing support for this finding is found in Appendix A in the following language:

"Great looking hair begins with healthy hair. This means starting out with the basics -- sound nutrition that feeds your hair as well as the rest of you. *** even if you're very diet conscious you may not be doing enough to keep your hair in top shape. ***

"That's why you should be taking New Start Natural Hair Vitamins as part of your daily hair care routine. ***"

6. I find that Respondent makes the representation set forth in paragraph 3(d). Support for this finding is found in Appendix A in the following language:

"The New Start formula features zinc and biotin. *** Zinc provides hair building protein to hair follicles. Without sufficient zinc, hair cannot grow. ***"

7. Respondent makes the representation alleged in paragraph 3(e). Support for this finding appears in the following language in Appendix A:

"So regardless of your hair type or style, feed your hair the food it needs to grow its very best." (This statement obviously refers to Respondent's product.)

8. Respondent makes the representation alleged in paragraph 3(f). Support for this finding is contained in the following language from Appendix A:

"*** The New Start formula features zinc and biotin, *** Biotin is the vitamin that has been credited in recent studies with preventing hair loss and reversing baldness in some case."

9. Respondent makes the representation set forth in paragraph 3(g) and this finding is supported in the language quoted above with respect to Finding of Fact No. 8.

10. Respondent makes the representation set forth in paragraph 3(h). Support for this finding is the following quotation from Appendix A:

"New Start Natural Hair Vitamins also contain folic acid, which can maintain hair color and delay greying; ***"

11. Respondent makes the representation alleged in paragraph 3(i). Support for this finding is found in the following language from Appendix A:

"New Start Natural Hair Vitamins also contain *** iodine and calcium pantothenate, which are responsible for (the growth of) thicker more lustrous (strands of) hair; ***"

12. Respondent makes the representation set forth in paragraph 3(j) as shown by the following language found in Appendix A:

"New Start Natural Hair Vitamins also contain *** iron and copper to provide ideal blood circulation to the scalp;***"

13. Based upon the admission in paragraph 3(k) of the Second Defense of its Answer, I find that Respondent makes the representation which is set forth in paragraph 3(k) of the Complaint.

14. The representations found to be made by Respondent are material representations because they are of such character and content as would normally be expected to cause readers thereof at whom they are directed to respond by ordering and making remittances of money for Respondent's product.

The Witnesses

The following persons were called to testify as expert witnesses by the indicated parties: For the Complainant - Karl Jules Kramer, M.D. (curriculum vitae, Ex. C-12), Board certified in Dermatology and, also, in Internal Medicine, and Robert David Reynolds, Ph.D., (curriculum vitae, Ex. C-13), Biochemist, Experimental Oncologist and now a Research Chemist in the Nutrition Institute, United States Department of Agriculture; for the Respondent - Irwin I. Lubowe, M.D. (curriculum vitae, Ex. R-4), Life Member in American Academy of Dermatology and Syphilology, Fellow in American College of Allergies, the American Medical Association, and, also, of the New York Academy of Sciences, and Member of the International College of Applied Nutrition, Richard Stephen Lord, Ph.D., (curriculum vitae, Tr. 304-306), Biochemist, formerly National Institutes of Health (NIH) Postdoctoral Fellow at the University of Arizona, and, also NIH Special Fellow in Bethesda, Maryland, and Frances Paul Hagan, B.S. in Journalism, Washington University, Master's degree in International Public Administration, University of Southern California, and, currently, studying for a Ph.D. in Economics at Georgia State University (curriculum vitae as it pertains to this proceeding, Tr. 350-352, 355-356). Richard Lee Blumberg, Respondent's Vice-President for Marketing also testified during the hearing. (Tr. 262-268)

Hair

15. There was general agreement with Dr. Kramer's testimony as to the nature of hair and its growth cycle. Basically, what is generally known as hair is a chemically stable, dead substance. (Tr. 38, 104, 286-287) Hair is really a product of the hair follicle, and hair follicles are present on all areas of the human body except the palms and soles and certain other specialized areas. In essence, hair is a product of this living hair follicle.

16. Hair grows in different stages. Considering one particular hair follicle for present purposes, it will produce hair for approximately four years. That is the growing stage, known medically as the anagen stage. After that, a particular hair will rest for approximately four months, which is called the resting stage, or the telogen phase or stage. After that period of rest, the hair follicle will produce a new hair which will then force out the old hair, and the individual will experience that as hair loss.

17. Through the process just described, the average person will lose approximately 75 hairs a day, although there is a variation around that average number. At any one time on the scalp, approximately 85 percent of the hairs are growing and 15 percent of the hairs are resting. In humans, this is all done asynchronously, that is, there is no one particular time when all the hairs rest or when all the hairs grow. Thus, humans experience a continual, steady hair loss without any obvious changes in the scalp such as when animals shed fur in the spring or grow it in the winter.

18. There are other events that cause apparent hair loss, one type of such event being the occurrence of certain diseases. For example, severe infections of the scalp will produce scarring; they can produce loss of hair follicles and then apparent loss of hair.

19. There are certain scalp diseases that dermatologists see in their practice that will make their appearance as loss of hair or baldness. There, also, is what is commonly termed normal male pattern baldness, which most people call baldness, that will cause apparent increased amount of hair loss. Whether male pattern baldness is a disease is a question to which no definitive answer has been provided.

20. There are other factors that can produce an apparent increase or excessive loss of hair over a period of time. For example, referring to a previous statement, if there were an event that would place all the hairs of the scalp in the resting, or telogen, stage at the same time, then after all those hairs rested, about four months later, and all the follicles began to produce new hair, those old hairs would fall out. The person would experience what would be for the individual an excessive loss of hair over a period of time.

21. The most common occurrence that will shock the hairs into the resting stage is childbirth. It is fairly common to see excessive loss of hair approximately four months after childbirth and severe illnesses. There are numbers of other illnesses that would produce the same process, which is referred to as telogen effluvium.

22. When men or women discuss the condition of their hair they often complain about the loss of luster or texture, or dryness, or brittleness. The majority of those complaints really refer to the physical characteristics of hair. It frequently is explained to such a patient that the hair is dead, that it is much like a fur coat. If hair is physically abused, it will have a dull, brittle appearance. Most of those complaints are believed to be based upon physical damage to the hair, such as over-drying, use of harsh shampoos, hair fashion, waving, perm waves, that sort of thing. Such damage bears no relationship to the living part of the hair, the hair follicel. (Tr. 38-41)

23. The causes of excessive hair loss are varied, and some of them were mentioned before in connection with apparent hair loss. First, when a man is losing his hair in so-called male pattern baldness, that would be a cause of excessive hair loss which will be discussed later in more detail. Secondly, there are specific scalp diseases that physicians would see in their practice that would cause excessive hair loss. Thirdly, there are temporary conditions such as the telogen effluvium, previously mentioned, that would cause excessive hair loss.

At this point a topic is introduced concerning phases of which there is some disagreement between Dr. Kramer and Dr. Lubowe, whose views hereinafter will be presented. The remainder of this section summarizes Dr. Kramer's testimony.

24. Approximately 90 to 95 percent of all baldness, that is, visible absence of hair, in our society is so-called male pattern baldness. This is what people generally refer to when they refer to bald men. The medical profession is of the view that male pattern hair loss is a genetically predetermined condition that requires the present of male-like hormones, or androgens, to produce the appearance of baldness or to produce excessive hair loss leading to baldness. Testosterone is probably the most commonly discussed androgen or male-type hormone, and it is necessary to have testosterone in order to have male-type baldness. However, the problem in male-type baldness is not the amount of testosterone circulating in the blood stream. This was the thought for many years, but it has been conclusively proved that that is not the problem with male pattern baldness. The problem is that the hair follicles themselves are able to change testosterone into another androgen, called dyhydrotestosterone, which is referred to in the medical literature as DHT. This DHT is produced directly in the hair follicle and, over a number of years, causes destruction of that hair follicle. In essence, the hair follicle self-destructs, as a result of which the patient then loses that producer of hair.

25. Therefore, the problem in male pattern baldness is that hair follicles in certain areas of the scalp contain a substance, or an enzyme, which converts the testosterone to DHT. The hair follicle self-destructs, and over a period of years the man becomes bald. Other areas of the scalp either do not produce this enzyme or they do not produce large quantities of it, and, therefore, those hairs are not lost. This is basically an overview of the modern interpretation of male pattern hair loss which accounts for 90 to 95 percent of what people commonly refer to be bald.

26. There are substances, sometimes referred to as anti-androgens or anti-male hormones, which may, in a genetically predisposed male, prevent the appearance of male pattern hair loss. Unfortunately, these anti-androgens, at least up to the present time, are hormones themselves and have serious side effects when administered to humans. If a male who is losing his hair is given estrogen, which is a female hormone, and anti-androgens, the progression of male pattern hair loss can be prevented. But this course is pursued at great expense because men under these circumstances are feminized, they will have breast enlargement, decreased libido, and a potential for other serious problems. Therefore, while arrest of male pattern baldness is possible, it is neither practical nor safe at this time.

27. If a safe, effective, internal treatment for male pattern hair loss, one that produced no adverse side effects, were to be discovered, it would be one of the significant medical breakthroughs of the decades. It would come to the attention of respected medical authorities, it would be properly tested, and it would be used if such were the case. (Tr. 51-54)

The Testimony Related To Respondent's Product

28. Dr. Kramer's views in regard to the product in general and in regard to the specific ingredients will now be stated. So far as medical literature is concerned, there is no evidence that biotin, however administered, will have any effect on male pattern baldness. If the contrary were true, it would be known in the medical profession. (Tr. 54)

Similarly, there is no evidence that graying or alterations in hair color are related to folate or folic acid. There are situations commonly seen in general medical practice in which there may be a relatively minor deficiency of folic acid in the diet, for instance during pregnancy or in certain blood diseases, but hair problems are not associated clinically with those minor deficiencies. (Tr. 54)

Iodine is a necessary nutrient for the health and well-being of the body. With the total absence of iodine or iodides there may be a thyroid abnormality or goiter. Persons with thyroid problems are, or should be, under the care of a physician by whom proper medication would be prescribed. There is no reason to believe that iodine, taken internally, will cause a person to have thicker or more lustrous hair. (Tr. 55-56)

Calcium pantothenate, in general, is used for the pantothenate part of the substance. Pantothenic acid is essential to health, but, except for extreme experimental conditions or bizarre freaks of nature, a deficiency of pantothenic acid does not occur in humans. It is found in most of the foods consumed by humans with the result that, except for the rarest exceptions, it is almost impossible to produce a pantothentic or pantothenate acid deficiency. In an individual who does not have such a deficiency, and such an individual represents by far the largest part of the population, pantothenic acid, alone, will not cause the hair to become thicker or more lustrous. (Tr. 56-57)

Iron and copper are essential trace elements to the human, and they have many functions in the human economy. Absence or decreased amounts of iron storers in the body can produce disease, and it may be that diseased storers of iron may produce clinical disease.

Iron and copper taken internally, however, have no effect in terms of improving blood circulation to the scalp. If these minerals did have that effect, it would not have any impact on hair loss or growth except in the most extreme cases. If one had a blockage of the artery of the scalp, the skin in that area would die, the patient would loss a portion of skin and, also, the hair that area. Blood circulation, per se, has nothing to do with hair loss, and the medical conception of hair loss is unrelated to circulation. For many years so-called rubifacients, chemicals that are supposed to increase circulation, were used in the treatment of male pattern baldness. These substances were found to be useless in male pattern baldness and in baldness in general. (Tr. 57-58)

Niacin is necessary for the health and well-being of humans. A severe deficiency of niacin causes pellagra, a disease in which one has extensive dermatitis, diarrhea, severe mental changes, and in some cases death. Niacin, however, has no specific effect on hair, per se. Even patients who die with pellagra generally have a pretty good head of hair, leading to the conclusion that even in extreme niacin deficiency there is no specific effect on the hair, beyond what one would see in a severely ill, terminal patient. (Tr. 58-59)

No human requirement has been established for inositol, hence, there is no specific, relevant deficiency state. Inositol has nothing to do with the characteristics or appearance of human hair. (Tr. 59)

Choline is another substance for which neither a human requirement nor a deficiency state, has been established. (Tr. 59)

Para aminoobenzoic acid (PABA) is freely available in the average diet, but it has no specific role in hair generation, growth, loss, or appearance. (Tr. 59)

In preparing to testify in this proceeding Dr. Kramer relied on his background of education, knowledge and experience. More specifically, he reviewed most of the general, standard textbooks in the field of dermatology, the Index Medicus which is an index of accepted medical writings, and, so far as possible, findings on particular substances pertinent to this proceeding. (Tr. 62) In that vein, hair is part of the human body, and if there is an essential nutrient which is absent from the human body, then there would, perhaps, be an effect on hair, but no more so than on any other organ of the body. In fact, based on available evidence, such an absence probably would have less effect on hair than it would on any other more important organ system of the human body. Therefore, a person having a hair problem related to deficiency of one of the pertinent substances is a very sick individual who is not going to worry about his hair. (Tr. 60-61)

Against this background of education, experience and research, Dr. Kramer stated: (1) that he knows of no human hair abnormality that would be correctable by ingestion of cyanocobalamin (Vitamin B-12), in the form of a capsule or pill such as Respondent's product; (2) while manganese deficiency has been described in severe circumstances, it does not have a commonly accepted role in either the production or the appearance of hair; and (3) there is no specific evidence that either chromium or selenium affects hair. (Tr. 60) The hair of persons who are not grossly deficient in the ingredients of Respondent's product would not in any way be affected by the taking of such product. (Tr. 62)

The opinions expressed by Dr. Kramer are in accord with the consensus of informed medical and scientific opinion in respect to the matters concerning which he testified. (Tr. 62-64)

On cross-examination it was brought out that the subject of nutrition, per se, is not usually dealt with as a separate course in medical schools in this country. Nutrition is taught as a concomitant or adjunct to the general medical curriculum. (Tr. 66)

In his internship and residency at Johns Hopkins University Hospital Dr. Kramer encountered probably more nutrition-related diseases than a physician would see in a residential suburban community. In his two-years at the National Institutes of Health, Dr. Kramer's area of research was in the field of glucose insulin metabolism, which is related to nutrition. At Johns Hopkins, he encountered patients with pellagra, a niacin deficiency-related disease which is seen now in this country primarily in alcoholics. For two months during his residency he was the resident on the metabolic ward in which starvation studies are done. Thus, while he did not have any course in medical school that dealt solely with the field of nutrition, he has studied the subject in his internship, his residency, and in connection with his private practice. (Tr. 67-69, 72-74)

Tests can be made of hair samples to determine the presence of minerals in the hair. One of the purposes of these tests is to determine, possibly for certain selected minerals, whether there may be a mineral deficiency in the body itself. The theory behind such testing is that the hair is a result of a tissue in the body and, as such, it reflects the various contents that other tissues of the body may have. There is much interest in hair analysis although it is in a fairly early stage of investigation. There are difficulties encountered in performing these analysis and it is sometimes difficult to interpret the results. Hair analysis is not regularly used by physicians in diagnosing the problems of patients. Its primary use now is to make an estimation of the nutritional status of populations rather than of specific individuals. Thus, while there is much current interest in hair analysis, it presently is not regularly used by respected physicians for the analyses of problems of an individual. (Tr. 75, 75)

when confronted with a statement from Moschella, a source previously quoted by Dr. Kramer, about low levels of zinc in the hair of certain children, in which statement the researchers speculated that even relatively affluent children might have dietary zinc deficiencies, Dr. Kramer correctly pointed out that the researchers labelled their though as a "speculation" - scarcely a definitive finding. In addition, the studies were of children, who differ from adults in a number of ways. (Tr. 79, 80)

There followed a discussion of certain conditions and whether they are sub-clinical, i.e. without objective symptoms, or clinical, i.e. in the later identifiable stage of the condition. Deficiency diseases may take years to develop. It was brought out that Dr. Kramer has never conducted, nor has he ever known anyone who has conducted, tests to determine whether or not: hair will grow without zinc (Tr. 81); biotin will prevent or alleviate baldness (Tr. 85; folic acid will have any effect in maintaining hair color and delaying graying (Tr. 90); iodine and calcium pantothenate will affect the thickness and luster of hair (Tr. 93); iron and copper will affect hair growth (Tr. 94; and niacin, inositol and vitamin B-12 have any effect on hair growth. (Tr. 94, 96) Dr. Kramer knows of such tests, and particularly of those conducted on animals. In the texts he has researched, it is indicated that it is "difficult if not impossible" to extrapolate the results in animal experimentation to humans. (Tr. 91) In addition, as a generalization in all of these dermatologic texts, it is stated with clarity and certainty that vitamin supplementation has no value in the treatment of hair disease. The foregoing two statements are derived from studies, reports and comments that appear in treatises in the context of situations in which it is presumed that there is no deficiency. (Tr. 95)

On further cross-examination Dr. Kramer repeated that he does not know of a nutritional deficiency that will affect hair as a sole manifestation of that deficiency; nutritional deficiencies severe enough to produce changes in the hair are exceedingly rare in the United States population and are seen only in severely malnourished individuals. (Tr. 96)

Except for a very few cases, he does not concern himself with nutritional problems of his patients. Therefore, he has made no effort to see whether his patients have subclinical nutritional deficiencies. His previous testimony indicates that while there may be particular marginal nutritional deficiencies, people with those problems are not going into a dermatologist's office complaining of hair problems. (Tr. 97)

With respect to protein deficiency, studies, most of which, again, have been done with children, have shown that in order for it to produce clinical hair abnormalities there will be other physiologic derangements before the hair is affected. The studies of protein malnutrition just referred to, however, dealt with other, more serious effects of protein malnutrition, but they do include statements that a physician does not see hair abnormalities except in cases of severe protein malnutrition. There are people who are moderately protein malnourished. There may be numbers of them in the population, but hair abnormalities are not seen in these people. (Tr. 98-99) It is true that between different individuals, they may become protein malnourished at different levels of protein intake. But in an individual who is malnourished in protein, one is not going to see hair abnormalities before one sees other manifestations of the protein deficiency. (Tr. 100)

Hair analysis is a useful research tool in certain circumstances to determine protein malnutrition. For example, the witness explained:

It "is being used as a tool for studies of populations, underdeveloped countries primarily, to develop information on protein malnutrition to direct the supplementation of diets in these countries. I think there's a basic problem here. It's as if one has diabetes and has an elevated blood sugar and you take a blood test and measure the elevated blood sugar, and you diagnose diabetes. The conclusion is not that diabetes is a blood disease. What you are measuring is blood sugar in the blood as indicative of diabetes.

"In the same way that -- if you measure -- if you use hair analysis *** to diagnose protein malnutrition, that's perfectly reasonable, but that says nothing whatsoever about the characteristics of the hair itself. It is a measure of protein deficiency, but it doesn't refer to the characteristics, or the growth, or the appearance of the hair itself." (Tr. 101)

Since hair is a stable, dead substance, there is no nutrient that the average person in this country would either apply or ingest that would have an effect solely on the hair or on the follicle. Of course, any substance that one eats affects all parts of the body, including the follicle. But there is no special substance that would have a specific action on the follicle. (Tr. 104) There is no vitamin supplementation that may be taken, internally or externally, by the members of the population of this country that will have a favorable effect on hair growth. Ingestion of excessive amounts of vitamin A can cause damage to the hair follicle, but there is no vitamin supplement one can take to promote or improve the growth or the appearance of the hair.

Baldness in women is unusual except for certain dermatologic conditions and the postpartum hair loss described by the witness. The testimony concerning baldness, therefore, related primarily to males, whereas the testimony relating to the condition and appearance of hair, its shine, luster and that type of characteristic, applies to both men and women. (Tr. 104-105)

In explanation of earlier remarks relating to vitamin B-12, Dr. Kramer said that there is a disease known as Addisonian pernicious anemia. He continued by saying "*** In that disease, one may see both abnormal hair growth and abnormal hair color. The problem, the basic difficulty or defect in that condition is the inability of the stomach cells to produce a chemical called 'intrinsic factor,' which we all have in our stomachs. We need intrinsic factor in order to absorb Vitamin B-12 into the body when it is ingested. A person with Addisonian pernicious anemia lacks that intrinsic factor. Therefore, no matter how much Vitamin B-12 he ingests, it's not going to alter the blood problems and the hair problems. And the only why that you can treat that condition is by injectable or intravenous Vitamin B-12. At the present time, we can't make intrinsic factor and treat it now." (Tr. 106)

With respect to the availability to the United States population of the ingredients found in Respondent's product, the medical literature indicates that is is possible that there are areas in this country where there may be mild deficiencies of one or another of those substances. However, even if that were true, a large body of informed medical opinion is that such deficiencies would not affect hair, its growth, texture, its other characteristics, or baldness. (Tr. 109)

29. Complainant's next witness was Dr. Reynolds (supra, p. 8; Comp. Ex. 12), whose testimony is now summarized. Biochemistry, literally, is the chemistry of life; the study of chemicals; the compounds, both large and small; how they interact to form and bring about the phenomenon known as life; and how these life processes are regulated with respect to concentrations and interactions. Among the compounds concerned with life and which in most organisms are required for life are the vitamins and minerals. Some, but not all, of the minerals are required for life, and some are considered to be toxic. The items referred to in this proceeding as vitamins and minerals can be generally agreed to be essential and required for life. They are required for may, but not all, of the life processes. Each type of organism, plant or animal, has its own different requirements. (Tr. 113-114)

The generally accepted classes of nutrients, predominantly, are the carbohydrates, proteins, fats, vitamins and minerals, all of which, to varying degrees, are required for life as we know it on this planet. The requirements vary from organism to organism. Many of the requirements which are seen in man, for example, do not occur in other mammals and in lower orders of animals. Other requirements which we see in the animals may not be observable in man.

Inasmuch as hair is comprised of dead cells, and cells are made up of various nutrients, the role of the various nutrients with respect to hair is that the hair contains some of these nutrients in an alterable form, especially the trace minerals. Other nutrients that go into the making of the hair cells, which are then on the hair follicle prior to their dying, such as minerals, various proteins, some of the carbohydrates are altered biochemically in the process of hair growth, and may no longer be recognizable within the hair strand itself. Inasmuch as they are nutrients, some are required for hair production. (Tr. 115)

The Recommended Dietary Allowances (RDA), as defined at page 2, 1974 Recommended Dietary Allowances, Eighth Edition, are defined as follows:

"The Recommended Dietary Allowances are the levels of intake of essential nutrients considered, in the judgment 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."

In order for an RDA to be set, there first must be several years of intense discussion by a group of extremely eminent scientists within the United States. Many other countries have their own RDA, which in many cases, are similar or identical to those of the United States. With respect to these RDA's, the scientists get together at various times throughout the years, bringing together the published reports and respected medical and scientific journals concerning requirements, with respect to conditions, health, and deficiencies of particular nutrients, from water all the way through the various vitamins and minerals. From these studies and discussions a number is distilled which is a recommended intake of the various nutrients which would promote health in virtually all of the healthy persons within the United States. The Recommended Dietary Allowances are not requirement levels. This is a very important distinction.

To distinguish between a requirement and a Recommended Dietary Allowance it is useful to select Vitamin C as an example. Vitamin C deficiency brings about a condition widely known as scurvy. To prevent scurvy in individuals, an extremely small amount of Vitamin C is required. Depending on the individual, this may be in the order of a few to five to seven milligrams per day. In order to insure safety for the great majority of the population, a very wide safety factor is included in the RDA's in order to help insure that the vast majority of the population does not approach the requirement level but is, in fact, well above the requirement so that health is maintained. This takes into account the broad availability of each nutrient to each individual. The Recommended Dietary Allowances are sufficiently high to take into account this availability. (Tr. 116-118)

A requirement for a particular nutrient is the availability of a sufficient quantity of that substance to prevent a clinically observable symptom of that deficiency. As so defined, with respect wo the vitamins and minerals for which RDA's have been set, deficiencies in this country are rare, and the fact that a person may ingest less than the RDA of a particular nutrient does not mean that the person is deficient in that nutrient. (Tr. 123)

Inasmuch as hair is dead tissue, the ingredients of Respondent's product will not nourish it. Hair cells, bone marrow cells and cells of the lining of the intestine are considered to be the fastest growing cells in the body. Rapid growth, however, does not necessarily imply a higher requirement for any of the specific nutrients. It implies a requirement for the compounds that go into making up the follicles, or hair cells, themselves. But other nutrients may be in less demand by the hair cells because they may not be required is so great a quantity in order to produce the hair cells and then the hair strand. Once a hair is formed, the ingestion of more nutrients will not affect it in terms of nourishment. Similarly, the growth of hair within the hair follicle is one of the cell structures most resistant to deficiency symptoms.

If a deficiency is produced within a test organism, such as a laboratory rat or a human being, the hair in many cases continues to grow even though the organism may be put at risk with respect to that particular nutrient elsewhere in the body. (Tr. 124-126)

If a person were grossly deficient in the nutrients in Respondent's product, sufficiently deficient to bring about a manifestation of what is popularly known as "sick hair" or "sicklooking hair," the symptoms of sick hair would be so minimal compared to the other deficiency symptoms that the hair would not be a reason for taking this particular preparation. In the normal, walking adult, it is extremely difficult to produce a specific deficiency of these nutrients, and the only way in which a general deficiency of these nutrients can be produced is to have massive food restriction. (Tr. 127-128)

Dr. Reynolds next discussed the individual ingredients in Respondent's product.

Zinc is a Trace Mineral which is found in virtually every living cell in the body. It occurs in a wide range of concentrations in the different cells within the body, depending upon the requirements. Zinc is used as a metal cofactor in a variety of enzymes, many of which are in the general area of nucleic acid metabolism, some in the area of protein metabolism. There is a variety of types of metabolism which it can influence. Zinc can be said to have an influence on hair production in that nucleic acid metabolism takes place in every replicating cell; there are replicating cells in the hair follicles which do produce the hair strand. However, zinc deficiency in the adult population of the United States is virtually unknown. (Tr. 128-129) Zinc has no effect on the rate of hair growth in the human. (Tr. 131)

Biotin is one of the earliest vitamins to be discovered. It is considered to be required for all living organisms. However, the human being has no RDA for this vitamin inasmuch as the bacteria within the intestine synthesize approximately two-and-a-half times as much biotin as required. In fact, more Biotin is excreted than is taken in per day. It has no known effect on hair growth. (Tr. 131-132) There are no studies known to the witness in which it is concluded that internally taken Biotin will prevent hair loss or reverse baldness. (Tr. 135

A deficiency of Biotin is extremely difficult to produce. The person must eat a tremendous quantity of raw egg white which contains a substance called avidin, and this, in turn, causes a reduction in available Biotin. (Tr. 130-134)

Folic acid is a vitamin and since the cells within the hair follicles are dividing rapidly, a total deficiency of folic acid to the cells and hair follicles would stop the growth of hair. Deficiencies of folic acid, solely of folic acid, in the adult American population are extremely rare. Despite extensive research of the literature on folic acid, the witness was unable to discover any valid scientific report of finding that it would maintain hair color or delay graying or prevent graying. (Tr. 135-136)

Iodine is a required nutrient, but there are no reports known to the witness of hair loss associated with the surgical removal of the thyroid gland. This fact leads to the conclusion that iodine or thyroxine, one of the substances into which iodine is synthesized, plays no role in the growth of hair in humans. Neither will it cause the hair to become thicker and more lustrous. (Tr. 136-138; 206-208)

Pantothenic acid is a precursor to a compound known as coenzyme A, which is required in a large number of biochemical reactions. There are reports that pantothenic acid deficiency may produce hair loss, but this occurs in experimental animals, not in humans. There is extreme danger in extrapolating from animal studies to human studies. It is, also, extremely difficult to produce an observable deficiency of pantothenic acid in humans without a highly purified, highly synthetic, or semi-synthetic diet, accompanied by a pantothenic acid antagonist in the diet. (Tr. 138-139) Pantothenic acid has nothing to do with the luster or thickness of one's hair. (Tr. 141)

Both iron and copper are required for the synthesis of hemoglobin, but they will not and do not improve the circulation of blood to the scalp. (Tr. 141)

With reference to cyanocobalamin, or vitamin B-12, if a person with Addisonian pernicious anemia has altered hair coloring and an overall diminution of the amount of hair, in the absence of "intrinsic factor" (supra, pp. 22-23), the ingestion of any concentration of Vitamin B-12 taken orally, regardless of how massive, will have no effect in reversing any of the symptoms of that disease. (Tr. 142)

A deficiency of niacin causes the individual to have pellagra. The clinical symptoms of this disease are sometimes referred to as the three D's - diarrhea, dermatitis and dementia. It is extremely rare for a person to have the single deficiency of niacin in the United States at the present time. About the only way in which pellagra occurs now is as a result of the ingestion of large quantities of alcohol, which causes a complete or massive restriction of virtually all other nutrients. (Tr. 143-144).

There are no requirements in humans for choline, inositol and PABA. Thus, there are no known deficiency symptoms, and no effect therefrom on the hair. (Tr. 144)

Manganese is a trace element which is required for life. The symptoms of manganese deficiency in the adult human are essentially non-existent. If such a deficiency exists, and none has been documented in the adult population, it has nothing to do with hair growth. (Tr. 145)

Chromium is a required trace element for humans. One group in the laboratory at the National Institutes of Health has been studying chromium nutrition in both experimental animals and in humans for about 20 years. Chromium deficiencies have been created in white rats, but there has been no indication of any problem in hair growth, thickness, graying or nutrition. Present efforts indicate that it is extremely difficult to detect chromium in humans in sufficient amount to permit the assessment of a deficiency. (Tr. 145-146)

Selenium is another trace element which is required for human life. It has no effect, however, in helping the body to provide proper nutrition to the hair. There is speculation that New Zealanders may be selenium-deficient. As a population, however, they have very nice heads of hair. (Tr. 146-147; 208-209)

Dr. Reynolds described the detailed procedures through which one must go in order to have a paper published in an authoritative, recognized professional journal. He indicated his wide-ranging research of authoritative writings which he conducted in preparation for his testimony in this proceeding. Against this background, his testimony was in conformity with the consensus of informed scientific opinion. (tr. 149-152)

On cross-examination the witness pointed out that while the results of studies with animals are not to be applied directly to humans, animal studies are a prerequisite to good human studies. Researchers must have an idea of what to expect, but this does not mean that they will see in humans the same things that they see in experimental animals. The results of animal studies are used as guidelines in conducting studies with humans. (Tr. 153-154)

Dr. Reynolds expressed the view that scientific knowledge relative to vitamins will change in the next 10 to 20 years, but the change will be in the area of the fine-tuning of knowledge of vitamin biochemistry, vitamin metabolism and vitamin requirements. He cited as an illustration supporting his view the gradual changes in the concentrations of particular nutrients and the addition of certain nutrients to the succeeding issues of the RDA, the ninth edition of which was published under date of 1980. (Tr. 156-157) Between the 1974 and the 1980 issues a number of additions was made to the RDA, particularly in the trace mineral field. (Tr. 159)

There are many reasonable well-educated people who have a good background in nutrition and biochemistry who maintain that the RDA's are too low. Furthermore, the general population of "middle America" is well educated as to the dietary requirements for good nutrition. The basis for this view is not stated, but the witness is of the opinion that the great majority of the intakes reflect a fairly consistent, good practice of their knowledge, although there are many exceptions when good nutrition is not practiced for reasons of personal preference. Adult "middle Americans" do not need vitamin supplementation of their diets, but because of the growing process and because of the eating habits of children, it is good practice to provide a child with a supplement which furnishes essentially the RDA of most of the vitamins. The supplementation of a child's diet is in the nature of a prophylactic dietary measure. (Tr. 159-163)

Respondent's Exhibit 1 is composed of two parts: first, a voluminous report entitled "Preliminary Findings of the First Health and Nutrition Survey, United States, 1971-1972: Dietary Intake and Biochemical Findings"; and the other part consists of a copy of the cover page of DHEW Publication No. (HRA) 74-1219-1 which bears the same title as the first part of the exhibit, and copies of pages 8, 19, 24, and 181 of the full Report, described above. The second part of Respondet's Exhibit 1 will be referred to herein as Resp. Ex. 1-A. Page 181 of Resp. Ex. 1-A sets forth, among other things, the 1974 RDA for iron. (Tr. 168)

Figure 2 on page 8 of Resp. Ex. 1-A shows that for all income levels the intake of iron by all children 1 to 5 years old surveyed, all persons in the ages of 12 through 17, all females of the ages of 18 through 44, and, in the income above poverty level, all ages and both sexes except those males 18 to 44 years of age are below the RDA in their mean iron intake. (Tr. 170-171) Despite the foregoing facts, there is no showing that these persons are ill, and there is no statement that relates to hair condition or loss.

The situation just related with respect to iron deficiency was expressed graphically in the tables described above. The same information is given a numerical percentage value in a presentation appearing on the third page of Resp. Ex. 1-A. Other deficiencies are represented but the other substances in which the shortages occurred are not in Respondent's product. It was pointed out by the witness (Reynolds) that there is a large distinction between the requirement for various nutrients, on the one hand, and the RDA for them, on the other hand, and that the RDA is designed to provide a wide margin of safety over that which is required. (Tr. 172)

Attention was then directed to a monograph published in the Federal Register of Friday, March 16, 1976, by the Food and Drug Administration, Department of Health, Education and Welfare, entitled "Vitamin and Mineral Drug Products for Over-the-Counter Human Use." Respondent made use of this document, which was received as Respondent's Ex. 2, in the manner indicated below.

A. The witness (Tr. 173) indicated his agreement with the following statement from page 16132 of the Federal Register document, which in its entirety extends from page 16126 through 16201: ^3/

"Although a balanced diet provides adequate amounts of essential nutrients, some individuals may not be receiving a balanced diet for various reasons and many wish to supplement their diets."

Added text:

"Dietary supplements of vitamins and minerals are marketed for this purpose are regulated as 'foods for special dietary use' as distinguished from OTC drug use. Dietary supplements are regulated by a separate set of regulations which were originally promulgated in 1941 and are clearly outside the purview of this Panel."

Comment:

As will be seen, Respondent's product is said to be sold for the purpose of preventing or overcoming subclinical symptoms produced by deficiencies in certain vitamins or mineral trace elements. If Respondent's Ex. 2 is adopted by the Commissioner of the Food and Drug Administration, a question may well be raised as to whether Respondent's product properly should be sold by a mail order business. In the words of the panel at page 16131-2:

"The panel therefore concludes that representation of a vitamin or mineral preparation for use in the 'prevention' or for the 'treatment' of a vitamin or mineral deficiency is clearly a representation for therapeutic usage, and that such a preparation should be subject to this document and regulated as a drug, not as a dietary supplement."

B. The following statement was read to the witness (Tr. 173):

"The Panel recognizes that the greatest need for prevention and treatment of vitamin and mineral deficiency will be found largely within certain groups in the population with special nutritional and metabolic needs. A listing of such target groups includes, for example, persons on a restricted diet; persons with intestinal disease which impairs normal dietary intake or absorption; those individuals with known increased requirements for vitamins and minerals, such as pregnant and lactating women; those individuals at increased risk because of increased blood loss, e.g., iron deficiency in women of child-bearing age; and individuals who tend to neglect the adequate intake of vitamins and minerals and in addition have impaired metabolic function, e.g., alcoholics, and individuals who are taking certain drugs which either impair the absorption of vitamins and minerals from the diet or interfere with their normal utilization by the body." (R-2, p. 16133)

Comment:

All of the conditions mentioned in the above statement are such that the persons who have these conditions should be under the care of a physician who would prescribe to meet the needs of the individual patients. (Tr. 174) Those needs and their symptoms would be far more serious than any relating to the condition of the hair. (supra 17, Tr. 60-61)

C. Dr. Reynolds agreed (Tr. 174) with a statement on page 16138 of Ex. R-2, that --

"Although requirements for vitamins and minerals are not increased by age, socioeconomic conditions and reduced physical activity among the aged may lead to sharp curtailment in the intake of vitamin-or mineral-containing food."

Added text:

"Neither the Food and Nutrition Board of the NAS/NRC nor the World Health Organization (WHO) recognizes any need for increasing the vitamin and mineral allowances for healthy elderly individuals above those recommended for young and healthy adults. In fact, the Food and Nutrition Board decreases slightly the recommended dietary allowances for adult males over the age of 51 years for niacin, riboflavin, thiamine, and iodine, and for females over the age of 51 years, it decreases the allowances of niacin, riboflavin, iodine and iron."

* * *

"under such conditions of dietary restriction, the use of a vitamin and mineral preparation in the prevention or for the treatment of deficiency may be indicated. When such is the case, the doses of vitamins and minerals recommended elsewhere in this document as effective in the prevention and treatment of specific deficiency states or multiple-deficiency states in adults are adequate for use in the elderly population. Therefore, the Panel finds no indication or need for any special OTC vitamin or mineral preparation for geriatric use and any claims referring to such need are false and misleading." (Ex. R-2, p. 16138)

D. The following statement from page 16153 of Ex. R-2 was read to the witness who replied in the negative when he was asked whether he agreed with it (Tr. 175):

"There is evidence to indicate that various groups in the American population consume low to marginal amounts of pantothenic acid in their diets."

Added text (immediately following the foregoing sentence):

"In most of these studies, adequacy of dietary intake was determine by a comparison between dietary intake of groups with suspected pantothenic acid deficiency and the U.S. RDA's of 3 to 10 mg. Comparison was also made between urinary excretion levels and standard excretion values for normal individuals. It has been found that pregnant and nonpregnant teenage girls (Refs. 2 and 6) and a group of low-income women (Ref. 9) consumed a level of pantothenic acid below recommended amounts in self-selected diets. In addition, the amount of pantothenic acid in the diet has been shown to vary with protein content of the diet (Ref. 7) and the cost of the diet in general (Refs. 8 and 10). In no case, however, was any clinical indication of pantothenic acid deficiency found." (Ex. R-2, p. 16153)

* * *

"Based upon the available data, the Panel concludes that pantothenic acid deficiency is virtually unknown in the U.S. population and that pantothenic acid, as a single ingredient, is not warranted for OTC drug use. However, the Panel concludes that pantothenic acid may be safely used in daily dosage of 5 to 20 mg in combination products containing other essential nutrients for use in the prevention of multiple vitamin deficiencies such as may occur in conjunction with chronic alcoholism, malabsorption syndromes, or severely restricted nutrient intake caused by lack of a nutritionally balanced diet. ***" (Ex. R-2, p. 16153)

Comment:

The conditions last listed above are those for which Dr. Reynolds stated patients should be under a physician's care. (Tr. 174; supra, p. 36)

E. The following statement was read to Dr. Reynolds who was asked whether he agreed or disagreed with it (Tr. 180):

"A diet deficient in iodine is the most common cause of simple goiter, an enlargement of the thyroid gland involving an increase in the size and number of epithelial cells. Endemic goiter occurs in populations living in mountainous and inland areas where soils have been leached of iodine and the dietary intake of seafoods is minimal. Those states in the Great Lakes region and in the Pacific northwest are the major endemic areas in the United States.

"Although the incidence of goiter in the United States has decreased markedly since the introduction of iodized salt (Ref. 6), several recent surveys indicate that approximately 5 percent of the population in Michigan and Texas have goiters (Refs. 11, 12, and 13), with a higher frequency among females of the childbearing age." (Ex. R-2, p. 16181-16182)

Comment:

The implication was that the goiters found in Michigan and Texas were caused by iodine deficiency. Dr. Reynolds disagreed with the statement (Tr. 180). That such disagreement was the appropriate response is demonstrated by the statement which immediately follows the quoted excerpt, but which was not incorporated in the question put to the witness. The sentence is:

Added text:

"It is important to emphasize that these cases of goiter are not necessarily related to iodine deficiency, since their occurrence is not correlated with indices of iodine under-nutrition as indicated, for example, by the daily urinary excretion of iodine (Ref. 14)." (Ex. R-2, p. 16182)

Thus, while counsel did read to the witness portions of Resp. Ex. 2, (Tr. 183) the parts read were taken out of context, the wrong implications were suggested and the portions containing the true import of the discussions of particular subject matters were not incorporated into the questions.

The term "clinical symptom" was defined by the witness as "something which can be detected by a physician upon observation" such as pellagra, or niacin deficiency. An example of a "subclinical symptom" was said to be "lower concentrations of some of the metabolites of niacin." (Tr. 184) A subclinical deficiency, if permitted to persist for a sufficiently long time, may result in a clinical deficiency. On the other hand, a subclinical deficiency may produce increased aging which may not be observable to a physician. (Tr. 186)

It was estimated that approximately one-third to one-half of the ingredients listed on the label of Respondent's product are thought to be responsible for healthy growth of hair. All of the ingredients must be present in some quantity for human life to exist, so to this extent they are necessary for the production of hair. Those which bear directly on the ability of the follicle to produce hair include calcium pantothenate, niacin, folic acid, vitamin B-12, iron and zinc. (Tr. 188-189) Some of those ingredients concerning which the witness knew of no evidence of their being needed in the production of hair are selenium, chromium and manganese.

All of the minerals listed as ingredients of Respondent's product can be analyzed in hair samples if the sample is sufficiently large. This fact does not mean, however, that the cell in which the hair grows uses these minerals in the growth of hair. For example, the greatest concentration of some minerals is higher at the end farthest from the follicle. Part of what is seen at the end of the hair is what has been picked up from the environment. These are the current views of Dr. Reynolds, but if later research so warrants it is possible that he could change his mind. (Tr. 190-192)

Dr. Reynolds was asked for the basis of his statement that the hair follicle is one of the most resistant of all cells to nutritional deficiencies. The basis for that opinion is the published data which he has read and the information which he has received orally from persons working in this field. The deficiency of specific vitamins or minerals, in most cases, fails to elicit a loss of hair, or a reduction in the growth of hair, or the thickness of the hair when other clinical symptoms are observable and measurable. For example, a severe iodine deficiency produces an observable goiter and the normal bulging of the eyes. Yet, there is no evidence known to the witness in which iodine deficiency results in slow growth of hair, affects the thickness of the hair, or produces the falling out or premature graying of hair. (Tr. 206) On the other hand, he knows of no evidence that iodine deficiency does not cause a loss of hair. While he has seen no comment that iodine deficiency does or does not cause hair loss, or improper hair growth, if such conditions had been a major side effect of iodine deficiency, the researchers involved would have mentioned it. (Tr. 207)

Dr. Reynolds has not personally conducted or observed any experiments which prove that hair can grow without zinc, nor is he aware of any such tests or experiments by others. (Tr. 212) He stated the same with respect to: the effect of biotin on hair loss; whether folic acid has any beneficial effect in maintaining hair color and delaying grayness in humans; whether iodine and calcium pantothenate will help the growth of thicker or better (more lustrous) hair; whether iron and copper provide any beneficial effect in hair growth; whether niacin, inositol and vitamin B-12 help to provide proper nutrition to the hair; and whether choline, PABA, chromium and selenium are beneficial to hair growth. (Tr. 212-216)

A publication entitled "Dietary Levels of Households in the United States" was issued in 1965-1966 by the United States Department of Agriculture. In this publication there was a statement which indicated that a significantly larger proportion of diets in the Spring (21 per cent) supplied less than two-thirds of the recommended allowances for one or more nutrients than in each of the other three seasons (18 per cent). For the period covered by the publication it was indicated that the dietary levels of half of the population studies were rated less than good. (Tr. 216-217) There was no indication of the health or the condition of the hair or scalp of the individuals covered by the study.

On re-direct examination, it was stated that the study which formed the basis of Respondent's Ex. 1 was conducted by interviewing members of households, and asking what foods and how much of each had been eaten by household members during the previous 24 hours. With respect to the children's diets, the interviews generally were conducted with the mother but sometimes with the father. The "24-hour recall" as this method is known leads to a certain amount of inaccuracies with respect both to what was eaten and how much was eaten. There are errors of overstatement and of understatemen. (Tr. 217-218)

The daily intake by average Americans (excluding pregnant and lactating women) between the ages of 15 and 51 of the ingredients of Respondent's product as compared with the RDA (1974 and 1980) n4 is shown below: $M04,16,19,13,17$QIngredient n5$B Avge. Da. Intake$B1974 RDA$B1980 RDA$D$QCalcium$B5-20$B5-10 mg.$B4-7 mg.$Q Pantothenate$QNiacin$B16-33 mg.$B12-20 mg.$B13-18 mg.$QBiotin$B100-300 microgms.$Bnone set$B100-300 microgm.$QFolic Acid$B37-2300 microgm.$B400 microgm.$B400 microgm.$QVitamin B-12$B5-15 microgm.$B3 microgm.$B3 microgm.$QCholine$B400-900 mg.$Bnone stated$Bnone state$QInositol$Bno data$Bnot listed$Bnot mentioned$QPABA$Bno data$Bnot listed$Bnone known$QIron +$B10.6 mg.$B10-18 mg.$B10-18 mg.$QCopper +$B1 mg.$B2-3 mg.$B2-3 mg.$QIodine (from$Babout 400 microgm.$B80-150$B150 microgm.$Q Kelp)$B$B microgm.$QManganese +$B2.5 mg.$Bnot estab-$B2.5-5 mg.$Q$B$B lished$QZinc +$B8.5 mg.$B15 mg.$B15 mg.$Q*4*+ = as Organic Gluconate$QChromium$B50-100 microgm.$Bnot estab-$B.05-0.2 mg.$Q$B$B lished$B (estimate)$QSelenium$B.1 microgm/g$Bnot estab-$B.05-0.2 mg.$Q$B in diet$B lished$B (estimate)$X

n4 Statements of the amounts of the various ingredients which are ingested daily and which are set forth in the 1974 and 1980 RDA were made by Dr. Reynolds. The 1980 data were based on preliminary data. (Tr. 219-222) Reference has been made to the 1974 and 1980 publications, themselves, only to assure that correct figures are shown without the possible intervention of transcription errors.

n5 The first 13 of the listed ingredients are shown on the label of Comp. Ex. 7. The label of Comp. Ex. 11 includes, also, the 2 additional ingredients. In Comp. Ex. 11, the last 7 ingredients are chelated.

Of the foregoing nutrients, Dr. Reynolds stated that the intake of iron by women and the intake of copper and zinc by both men and women are at the level of about 50 percent or slightly greater of the RDA. Because of the way in which the RDA's are derived, i.e., with the increases in amounts of nutrients over the requirements levels, this disparity would not, in the opinion of the witness, adversely affect hair growth. (Tr. 222)

If a qualified, scientific investigator, in looking for symptoms of a nutritional deficiency, sees any effect on human hair attributable to or accompanying such deficiency, he would make a note of the observation. If a report by a qualified, scientific investigator makes no mention in his report of an adverse effect on human hair in connection with his study, it is proper to infer that such an effect was not observed and was not present. (Tr. 228)

Although biochemical levels of the subjects of the study reported in Respondent's Exhibit 1 were studied, it is nevertheless true that the basic input into that study was predicated on the information gathered by the 24-hour recall method. Because of the basic input lacks scientific reliability, the results of later studies based on that input are open to question. Average intake can be surveyed with more precision in 1980 than was possible in 1971-1972 when the study reported in Respondent's Exhibit 1 was conducted. (Tr. 229-234)

The witness was asked by Respondent's Counsel if certain references appeared on the indicated pages of the book "Trace Elements in Human and Animal Nutrition" 4th Edition, by E. J. Underwood, as follows and the reply was in the affirmative: $M03,08,45,11$Q*2*Trace Elements$JTranscript$D$Rp. 75 $BPigmentation in sheep is affected by copper deficiency.$B235-6$R$R91$BMalnourished infants with anemia and other adverse conditions due to copper deficiency.$B236$R$R92$BRefining of certain cereals results in losses of copper.$B236$R$R187$BManganese intakes vary with whether the individual eats white flour or extraction flour$B237$R$R212$BAlopecia in zinc-deficient rats.$B237$R$R227$BMinimum zinc requirements of humans com- patible with growth, health, well-being vary with type of diet consumed, climatic conditions, and the existence of stress imposed by trauma, parasitic infestations and infections.$B237-8$R$R229$BVariation in zinc content is high within types of foods as well as among the dif- ferent classes of food due to the effects of soil type and fertilizer treatment.$B238$R$R287$BIodine concentrations vary due to the effects of soil content and fertilizer$B238$R$R327$BThe level of selenium in foods varies with soil condition under which grown.$B238$X

These statements are irrelevant because (1) they relate to animals; (2) the, and their contexts, do not mention or refer to hair; (3) they mention conditions other than hair loss, graying, etc.; (4) they relate to artificial or unrealistic dietary intakes; (5) they relate to conditions for which persons are, or should be, under the care of a physician; or (6) they relate to substances in which no deficiency has been shown to exist or no need in man has been established. (Tr. 238-249)

30. Respondent's first witness was Richard Lee Blumberg (supra. p. 9). Mr. Blumberg's testimony related primarily to the advertisements of Respondent's product; his refund policy; and his lack of the use of false pretense in the sale of the product involved in this proceeding. (Tr. 262-268)

31. Following Mr. Blumberg, Dr. Irwin I. Lubowe, M.D. (supra, p. 8, Resp. Ex. 4) was called as a witness by Respondent. (Tr. 268) Eighty per cent of Dr. Lubowe's patients have thesaurosis (storing of unusual amounts of normal or foreign substance) of the scalp and hair and 20 per cent come to him with skin disorders. When a patient comes to his office, a complete history is taken and he is given a physical examination. Dr. Lubowe does not see major dietary deficiencies, but he thinks he sees subclinical deficiencies as a result of deficient vitamin intakes. These deficiencies are not manifested by particular disorders of the skin, but frequently there are such symptoms as brittleness, thickening, scaling, itching of the scalp and loss of hair. (Tr. 271-272)

The majority of hair fall in the male is male pattern baldness. Dr. Lubowe stated that male pattern baldness is due to an excessive secretion of male hormone in the scalp. (Tr. 272) His treatment for this condition consists of a topical lotion and also what he calls antiandrogen, a chemical that neutralizes the male hormone in the scalp. He stated that the hair loss returns to normal. Besides giving his patients a topical lotion, he also includes, and has done so for 25 years, a combination of vitamins and minerals. (Tr. 272-273)

The formula that he uses is a sustained-release capsule which means that when the capsule is taken in the morning, the particles are in the body for about 10 to 12 hours. The capsule contains "thaimine, 6 milligrams; riboflavin, 6 milligrams; pyridoxine, 6 milligrams; vitamin B-12, 6 micrograms, nicotinic acid, niacinamide, 250 milligrams; pantothenic acid, 6 milligrams; ascorbic acid, 50 milligrams; alpha tocopherol, which is vitamin E, and 16 hydrochloride." In the last few years or so, he has been "using a B-complex which is known as B-complex 50 which means all the ingredients of the B-complex are now 50 milligrams. But we combine this with a Trace Mineral capsule which contains potassium, magnesium, copper, zinc, inositol, and folic acid." (Tr. 273)

In response to a question by Complainant's Counsel, Dr. Lubowe stated that many patients who come to him have had hair loss for one or two years. After being given the treatment described above, he was "able to reduce the hair fall in about 40 to 60 percent of the patients." In support of the foregoing statement, Dr. Lubowe quoted the following sentence from a book entitled "The Biology of Hair Growth" by William Montagna, President of the Oregon Primate Research Institute, and Richard Ellis:

"The following deficiencies are said to cause impaired hair growth: Vitamin A, riboflavin, biotin, inositol, pantothenic acid, pyridoxine and vitamin E." (Tr. 274)

Dr. Lubowe also cited and quoted from Resp. Ex. 6, an excerpt from "Human Hair Growth in Health and Disease" by Dr. David Ferriman, D.M., F.R.C.P., of London, England, to the effect that (1) "protein deficiency, as in kwashiorkor, is a well-recognized cause of alopecia" and (2) "recent evidence shows that iron deficiency is a factor in producing alopecia." (Tr. 275) The statement from the Montagna book, by its own terms, is speculative and inconclusive since it simply states that certain deficiencies (some of which are non-existent) "are said to cause impaired hair growth." Clearly, a person with Kwashiorkor or an iron deficiency of sufficient proportion to produce symptoms of hair loss is, or should be, under the care of a physician who would detect, diagnose and treat the more serious conditions, not the "impaired hair growth." (supra, pp. 17, 37; Tr. 60-61, 174)

Dr. Lubowe also quoted the following excerpts from Respondent's Exhibit 9, which he said are pages from a book entitled "Mental and Elementhal Nutrients" by Carl C. Pfeiffer, identified by Dr. Lubowe as a Ph.M.D., a researcher, a psychiatrist and the head of the Brain Biochemical Center:

"In times past, severe fevers frequently resulted in the loss of head hair. For instance, typhoid fever was frequently followed by hair loss. We find that excess copper will result in hair loss in women, and this may be caused by the birth control pill or by the last trimester of pregnancy. It can also be caused by excessive copper in the drinking water or lack of zinc in the diet. ***

"Dietary factors which may be deficient in hair loss in patients are vitamin B-6, zinc, and sulfur. The first two may be lost because of pyroluria, while sulfur may be low in the diet because of failure to eat sulfur-containing nutrients such as yolk of the egg. Some of the best results in hair strength and restoration have occurred when patients got adequate zinc, vitamin B-6, and egg yolks. ***"

"*** Hair and nails do not grow well and the brittle nails may have white spots or be generally, opaquely white in zinc deficiency. The hair will be brittle and lack pigment, and may change to a deeper color with zinc therapy. ***" (Tr. 281-282)

n6 Despite a search of numerous texts, and a telephone call to the National Medical Library at the National Institutes of Health, Bethesda, Maryland, no reference to an academic or professional degree of Ph.M.D. could be found, nor could such a degree be identified.

Dr. Lubowe's own opinion is that zinc is an essential trace mineral without which the hair bulb or follicle can not produce hair. (Tr. 287)

Dr. Lubowe reviewed a paper he wrote on the effect nutrition on skin and hair, which he said was scheduled for publication in the next issue of "Applied Nutrition," the publication of the International Academy of Nutrition. He indicated that for some of his patients he orders chemical analysis of the hair. If there is a deficiency in trace minerals, he prescribes a supplement containing calcium, magnesium, zinc, manganese and potassium. To activate the minerals, there is added a slight amount of vitamin D, B-6 and glutamic acid chloride. (Tr. 285)

Also in the article, Dr. Lubowe points out that persons on crash diet sometimes ingest insufficient amounts of proteins, calories and vitamins with the result that there is rapid loss of weight, and, also, of hair. When the diet is stopped and the person resumes a normal intake of vitamins, hair growth returns.

Dr. Lubowe also states in his article the descriptions of various minerals that are used in the diet, their deficiencies, and also the therapeutic effects. The minerals discussed are copper, iodine, zinc, fluoride, chromium, cobalt, manganese, molybdenum, and selenium. There is in the article an outline of the various trace elements, what their recommended daily allowance is, and the sources in food for the Trace Minerals. (Tr. 285)

With respect to the part played by biotin in preventing hair loss and preventing baldness, Dr. Lubowe said:

"Biotin has recently been introduced as a topical preparation. It's incorporated in a gel or a solution, and it's known to reduce hair fall; and in some cases in which the hair fall was only present for a year or two, hair growth was observed. And this is due to the fact that it is an antiandrogen. It neutralizes and metabolizes the excessive male hormone in the scalp. And that's the reason for its use. Now, it may do the same thing when it's taken internally; It may do the same thing." (Tr. 288)

This testimony, to the extent that it is responsive to the question asked, and without reference to the accuracy or inaccuracy of the stated premise of the answer, simply means that the witness does not know, or will not state, what part, if any, biotin, in the form in which it is presented in Respondent's product, plays in preventing hair loss and baldness.

Asked whether he had an opinion whether folic acid is helpful in maintaining hair color and delaying graying, Dr. Lubowe replied:

"Yes. If there is a deficiency in folic acid, then anemia occurs; and frequently with anemic, there is loss of pigment. By taking folic acid, sometimes the pigment will reoccur.

"And I'd like to mention the fact here that folic acid may also be a factor in the rejuvenation of hair. In dermatology, recently psoriasis was treated by a chemical called methroxate which is an antifollicle compound. In other words, when it's taken internally to improve the psoriasis, it destroys the folic acid. However, when that occurs, large amounts of hair is lost. With that, if the folic acid is given internally, then the methroxate is neutralized. It's no longer effective in psoriasis, and it will cause the regrowth of hair. This appeared in many scientific papers in the archives of Dermatological and many of Dermatologic magazines." (Tr. 289)

Commenting as to whether iodine and pantothenate are possibly responsible for growing thicker or better hair, or causing the growth, Dr. Lubowe said:

"If there is a lack of iodine, usually there is a disturbance of the thyroid gland, and the patient has what is hypothyroidism. *** In hypothyroidism, there is a great deal of hair loss. That's one of the symptoms that's observed in hypothyroidism. And they are given iodine internally which will therapeutically and this will cause the regrowth of hair and also helps in the improvement of the thyroid condition.

"The pantothenic acid -- my experience with this is that pantothenic acid, when combined with PABA, or para-aminobenzoate acid will cause repigmentation of graying hair and also improve the thickness of the hair shaft. And we mentioned the fact in one of the books that it's now being used in Switzerland as a therapeutic agent." (Tr. 289-290)

Dr. Lubowe's view on the effect, in terms of hair growth, of iron, copper, niacin, inositol, vitamin B-12, selenium, chromium and manganese are recorded in the order just stated.

Iron and copper

"Well, as I mentioned in the book -- a book entitled Human Hair Growth in Health and Disease, Dr. Ferriman indicates that very frequently in the female, there is hair loss due to deficiencies of iron -- calcium, particularly, I don't have any experience in growth of hair.

Q You mean copper?

A Copper, yes." (Tr. 290-291)

Niacin, inositol and vitamin B-12

"Well, we read a few excerpts from the book of Adelle Davis, and Linda Clark on the value of inositol and hair loss. And since B-12 is a member of the B-complex, we can give it in conjunction with the B-complex. I think it helps the hair when there is a subclinical deficiency of it." (Tr. 291)

Selenium chromium and manganese

"Well, I don't have any particular explanation about selenium and chromium because it's just been introduced to the vitamin field. I know that in conjunction with vitamin E that the combination will have an effect on strengthening the heart. What was the other one, selenium, chromium, and --

Q Manganese.

A Manganese. Well, manganese is one of the essential Trace Minerals for hair growth which I mentioned previously." (Tr. 291-292)

Dr. Lubowe is of the opinion that the vitamins and minerals in Respondent's product are necessary in order that the body will be able to maintain - but not to grow - normal and healthy hair. The average diet in the United States, due to the processing and refining of foods, provides very much less than the "required RDA" (a contradiction in terms). Therefore, he favors vitamin and mineral supplementation of the diet. Respondent's product would be beneficial to people who are losing their hair if the hair loss is not due to hormonal causes. (Tr. 292, 293)

The incidence of male pattern baldness in women has risen quite a bit in the last 10-20 years. Dr. Lubowe attributes this fact to a neuro-hormonal disturbance. Of the women who come to his office, 20 percent have female pattern baldness. But the majority of them have baldness due to seborrheic alopecia, very often due to excessive use of cosmetics; namely, hot hair dryer, straightening the hair, waving, rolling, teasing, and bleaching and dyeing. When these cosmetic procedures are diminished and the patients are aided by giving them mineral and vitamins, there is a stoppage of hair loss and regrowth. (Tr. 293, 294)

In Dr. Lubowe's opinion, very few physicians are very well educated in the field of nutrition. He regards Dr. Carlton Fredericks as one of the foremost nutritional experts in the world and the views of Dr. Frederick's are entirely in accord with those of Dr. Lubowe. He stated that he thought that the views he expressed in his testimony relative to the value of a vitamin supplement represent "a consensus of thinking among nutritionists." (Tr. 286)

On cross-examination Dr. Lubowe defined a subclinical deficiency as a "subnormal deficiency; the amount of vitamins and minerals in the body when one takes a laboratory test and has demonstrated as below the normal. And with this appears a dryness of the skin, a dryness and scaling of the scalp, and also hair loss." (Tr. 295) He agreed that dryness and hair loss would be clinical symptoms, but he said they would not be a "major deficiency." If someone comes to his office with what he defines as a subclinical deficiency the "patient is examined and a history is taken; we examine the hair and scalp. If there is itching or scaling of the scalp, a patient is given topical medication, usually consisting of cortisone and progesterone." And the patient is put on a very high protein diet supplemented with the combination of the B-complex and the Trace Minerals. The patient also is given a shampoo which contains hydrolyzed protein. (Tr. 296)

In one of his books Dr. Lobowe reported that a Boston nutritionist was successful in restoring original hair color by having his patients ingest various vitamins and minerals, especially calcium pantothenate and PABA, but other researchers were unable to duplicate the clinical findings. In the Lubowe book it is stated, also, that "All research findings must be confirmed by many scientists in order to be accepted as successful to be used for therapy." Dr. Lubowe still agrees with that statement. (Tr. 297)

32. Respondent next called Dr. Richard Stephen Lord (supra, p. 9; curriculum vitae, Tr. 304-306). Dr. Lord owns and operates a State-and Federally-licensed laboratory in Atlanta doing elemental analysis of hair and consultation with physicians on diet and nutrition. (Tr. 306) The bulk of the hair analysis in Dr. Lord's laboratory is done at the request of physicians in family practice. The specialists for whom he performs such tests include ophthalmologist, dentists, dermatologists, pediatricians, obstetricians and gynecologists. In fact, he does tests for almost any medical specialists except surgeons. (Tr. 306)

The tests give information in three general categories. One is the bulk elements like calcium and magnesium; another is the essential trace elements; and the third category is toxic heavy metals. The kind of information is basically whether or not someone is exposed to too much of a toxic metal or is not getting sufficient amount or an imbalanced amount of essential trace elements.

Approximately five percent of the patient population that he tests would be considered in a nutritionally deficient state -- or at least there is an indication of that from the laboratory data -- for any one given element for which the test is run. If the criterion is whether any one of the 15 or so elements that are tested for is out of range, the percentage is much higher, perhaps 30 or 40 percent, of the people in whom one or another element is significantly below the reference range. (Tr. 307)

In Dr. Lord's opinion, probably conservatively, over half the population suffers from conditions that would best be described as having degenerative diseases, advancing at rates much higher than they should, which would not be considered clinically as in a frank nutrition deficient status but in which nutrition plays a very important role.

The RDA was established as a guideline and essentially all scientists recognize that fact and they agree that it is a guideline. The interpretation of the guideline then can be done in many ways. If one wants to consider whether a population is free of frank nutritional deficiency states, then the RDA is a good guideline; however, if you are measuring the occurrence of optimal health and the freedom of a population from conditions that can arise from any of the kinds of nutritional factors that we know about, then it is not a very good measure because the RDA is set up primarily to do the former thin, that is, to insure that as a population, we did not have frank nutritional states.

The difference between optimal and deficiency states, so far as the RDA is concerned, is related to the fact that there are many health conditions in which nutrition is a vital factor, but in which there cannot be a diagnosis of a frank deficiency state such as beriberi or pellagra or scurvy, which are very rare in this population.

However, optimal nutrition is a completely different subject. We never reach the true optimum, but the distance that one is from the optimum determines how fast the systems degenerate, and that includes all the systems, from the systems of the skin, internal organs, nervous system, and the rest. If the RDA's are followed to try to determine for an individual what his intake should be in order to avoid degenerative diseases, then there is not a good guideline. (Tr. 308, 309)

The use of coffee, alcohol and cigarettes are the kinds of factors that make the RDA's not very useful for trying to determine an individual's nutritional needs because they are based on the total population average, without taking into account all these kinds of factors that lower the nutritional status or raise nutritional requirements. It is well established at this time that each of the items mentioned has one or more defects of increasing requirements for given nutrients.

The physicians who use the laboratory are the ones who are, generally, fairly advanced in their nutritional education and understanding and are aware that using "a shotgun approach," giving all the nutrients that we know are required, is good but it is only a very beginning step in making full clinical application of nutritional therapies because there are such vast differences in individual needs. These physicians have hair testing done to find out in a given patient what his needs are in terms of an essential trace element or toxic element. If, for example, a low zinc level is discovered, then the doctor will use zinc in his therapy far above the amounts that would be in a normal multi-vitamin/mineral, if, indeed, there were any in the normal or multi-vitamin/mineral.

The same applies for other vitamins. Of course, there are few tests that will tell the doctors much about vitamines per se, so they have to use just the clinical signs there. But the hair test will tell the doctor if a patient needs an essential element. The physicians with whom Dr. Lord has consulted have told him that their results are not a now-and-then kind of thing, but a matter of a very high consistency in the results they get when using nutritional therapies. In Dr. Lord's opinion, the most frequent situation in which nutritional therapy is used now, for a variety of reasons, is in psychiatric disorders. (Tr. 310, 311)

Dr. Lord is of the opinion that there may be only one or two medical schools in the country which have a nutritional course at all, and even in those schools it's usually a very brief course. He stated that in terms of the advanced knowledge of nutrition that is available today, physicians have little access to it in their training, and thus, really don't make much application of it in practice.

The witness also expressed the view that, based upon his knowledge, the variation in the soil content of specific areas of the country is such that the crops and other things that are grown from these areas will sometimes not have the essential nutrients and essential minerals that one would necessarily expect to have from certain products. (Tr. 313)

Cooking is well-known to destroy most of the vitamins because they are both heat and chemically labile, or subject to destruction by chemical and temperature factors. There are losses of essentially all vitamins on cooking and, in fact, on standing even in a freezer because of the chemical lability.

In terms of minerals, that does not apply, but in the case of the minerals, when foods are cooked in water and the cooking water is poured off, then there is a great loss of mineral content.

So far as transportation is concerned, once again the longer a food is stored at any temperature, then the greater the loss of vitamin content. On top of that, the fact is that foods these days are grown specifically for transportation purposes rather than for nutrient content. The major factors that affect vitamin and mineral content are the origin and preparation of foods. (Tr. 314)

The whole field of nutrition is much more complicated than most people will ever be able to understand in terms of the impact of toxicants and nutrients in the body. Most people go from one diet regime to another looking for some help. Because of these facts one is led to believe that the level of information of understanding is not too great. Even people who are reasonably educated about nutrition perhaps might not consume proper food just because of the limitations of time and convenience and the fact that at some time, it may be difficult to purchase proper foods in restaurants and fast-food establishments. (Tr. 315)

Dr. Lord has examined the list of ingredients of Respondent's product and he stated that the vitamins and minerals contained in New Start Natural Hair Vitamins are generally recognized as the vitamins and minerals necessary for the body to be able to grow normal and healthy hair. He is of the opinion that there is a significant percentage of the population which has a sufficient deficiency in these vitamins and minerals to have an adverse effect on hair growth and any of its ramifications. He said that replacement of these vitamins and minerals will improve the growth of hair. (Tr. 316)

If a person develops subclinical symptoms as the result of a nutritional deficiency the hair is one of the first parts of the body to show the effects according to Dr. Lord.

Continuing, Dr. Lord said:

"The hair follicle itself is one of the most active metabolic tissues in the body in terms of its energy requirements and its requirement for nutrients. Some specific nutrients have very high demand in hair follicle. Any my own experience in the kind of laboratory work that I do gives other evidence of the fact that hair reflects changes quicker than other tissues. For example, changes in lead exposure are reflected much more rapidly in hair than they are in blood or liver or muscle tissue and so forth.

"In the case of minerals, it turns out that hair acts as sort of a molecular sponge because it has a tremendous number of binding sites for metal ions like zinc, iron, and calcium. So when changes occur, the changes in the availability of those nutrients to the hair follicle are seen very rapidly in the level in the hair. And, of course, well-documented cases such as iodine deficiency is a resultant of hypothyroidism and hair loss that accompanies that disease, and it is true for other nutrients as well." (Tr. 317, 318)

Among other views expressed by Dr. Lord are the following:

1. Hair cannot grow without zinc.

2. Antibiotics frequently destroy a large part of the intestinal flora, and biotin supplies are reduced when one takes those medications.

3. Biotin is necessary to the growth of hair.

4. He is not aware of any experiments or tests that show that folic acid is not helpful in maintaining hair color and delaying graying.

5. There are still reports of places in the United States where iodine deficient people are found.

6. Any time an iodine deficiency results in hypothyroidism hair loss generally occurs.

7. The pantotheate moiety in calcium pantothenate is a precursor for coenzyme A, which sits at the center of the most crucial biochemical cycle in all cells; and thus, is obviously required for the hair follicle to grow as well.

8. An adequate supply of copper and iron are required for the formation of the heme group in hemoglobin. Since the hair follicle requires oxygen and since hemoglobin takes oxygen to all tissues, in that sense these minerals have an effect on hair growth.

9. Niacin is an essential nutrient that is required for any living cell to function. Thus, the follicle must have niacin in order to produce hair.

10. The follicle must have vitamin B-12 in order to produce hair. Inositol is not specifically one of the nutrients that is heavily demanded in the production of hair, but in the sense that the hair follicle is an integral part of the total body system, it would be affected by inositol, and, presumably, by its absence. (Tr. 318-320)

11. There is no clinical syndrome that can be assigned to a selenium-deficient state, although it is recognized as an essential nutrient. (Tr. 324-25)

12. The state of knowledge in 1980 in the field of nutrition is not very mature, and the RDA levels are grossly inadequate. (Tr. 325-327)

In his laboratory, Dr. Lord can test for 21 elements, which are calcium, magnesium, phosphorus, sodium, potassium, zinc, copper, iron, manganese, chromium, cobalt, molybdenum, lead, cadmium, aluminum, nickel, boron, barium, strontium, mercury, selenium.

Dr. Lord defined a subclinical deficiency of vitamins or minerals as a deficiency that would not be detected by a physician in the course of a routine physical examination. However, he said that without question harm can be occurring to a person as a result of such a subclinical deficiency. (Tr. 329)

The effect of a subclinical deficiency of vitamins and minerals on hair growth and in the area of hair loss is very difficult to pinpoint. Some indications are observable in animals, for example, by modification of the amounts of copper and pantothenic acid in the diet of sheep. (Tr. 331)

Dr. Lord said that his testimony in regard to the need for additional vitamin supplementation and mineral supplements in our society, and the effect that they have upon the growth of hair, represents the thinking of people who are doing the type of work that he is doing in the field of nutrition. (Tr. 328)

On cross-examination it was brought out that people in Dr. Lord's profession test hair for chemicals and minerals, but not for vitamins. The witness stated that the hair is an accurate barometer for the nutritional status of an individual in terms of the elements for which Dr. Lord tests. Dr. Lord was handed an article by a Dr. Joan McKenzie, of New Zealand, which appeared in the March, 1979, issue of the American Journal of Clinical Nutrition, a recognized and respected journal. In this article Dr. McKenzie stated:

"It was concluded that the measurement of zinc serum, urine, hair, and toenails did not provide indications of zinc status."

Although the article appeared in a recognized medical journal, with all the attendant peer review that is required for publication, Dr. Lord disagreed with the above-quoted conclusion. (Tr. 333-335; but see Resp. Ex. 2, p. 16194, center column, 1st complt. para. where it is stated "No technique has been demonstrated to provide direct evidence of zinc deficiency.")

The presence of chemicals or minerals in the hair can vary with ambient contents of the atmosphere or environment, or with persons who use certain brand name products in shampooing their hair. Of the hair samples sent to him for testing for any one element, five per cent reveal a deficient state, and 30-40 per cent are deficient in one or more other elements. In some cases he receives hair samples for testing only when the subject's physician has some reason to believe that the person may have a deficiency. In some instances doctors have hair sample tests performed routinely as a part of their first physical examination procedure. (Tr. 336-337)

In Dr. Lord's view, there are some nutrients that hair requires more than others, and those nutrients are in Respondent's product, but there is no nutrient that the hair, exclusively, requires. Some nutrients in Respondent's product are essential to the health of the hair in the sense that they are necessary for the life of the individual, but there is no nutrient that is required only for the hair. (Tr. 338)

Dr. Lord differed with the levels of recommended dietary allowances stated in the 1974 edition of their publication, because they represent the recommendations for various allowances of nutrients as known at the time of their publication. Information is changing so rapidly that the scientists who participated in the preparation of the allowances would, if polled, have different views today. However, when it was suggested to Dr. Lord that it had been proposed in the preliminary 1980 Recommended Dietary Allowances that the RDA for vitamin E, for example be lowered and the RDA for C be increased, both by 33 percent; that B-6 be increased by 10 percent; manganese by 15 percent; iodine 20 to 50 percent; and some 12 trace elements be added which were not given in any amounts in the 1974 edition, he did not regard these changes as being particularly big or sweeping. Dr. Lord agreed that the National Academy of Sciences, under whose auspices the RDA's are adopted, constitute the very best brain power on the question of nutrition in the country, and that the RDA determination is the recognized standard of dietary needs and desirable levels of nutrition. (Tr. 339, 340)

In performing laboratory tests Dr. Lord uses a single sample of hair. The precise method is to weight 250 milligrams of hair, wash it carefully, dissolve it in nitric acid, and oxidize it further with hydrogen peroxide. The sample is then diluted up into diluent nitric acid solvent. At that point, no matter what color the hair is, the hair sample is a uniform pale-yellow solution. A very small volume of solution, which is all that's needed, is aspirated into an instrument called atomic emissions spectrometer, which gives a readout of 19 of the elements in about 60 seconds.

The other two, mercury and selenium, are measured on the same sample by taking an aliquot nd measuring them by a technique known, for the mercury, as a cold vapor technique, and for selenium, as a hydride technique. (Tr. 340-341)

The taking of an antibiotic by a person would tend to destroy that person's internal ability to manufacture biotin. Persons taking antibiotics, however, are under the care of a physician who would know this fact. Furthermore, after one has completed the course of antibiotics, usually in five to ten days, the bacteria which manufacture biotin return to the intestinal canal. (Tr. 341-342)

The factors considered by the scientists who set the RDA's are such that they take into account the fact that a significant percentage of the United States population drinks coffee, smokes, and uses alcohol. Allowances are made for these persons in the levels at which the RDA's are set. (Tr. 343-344)

33. The last witness to testify was Francis Paul Hagan (supra, p. 9, Tr. 350-352, 355-356). Mr. Hagan is of the opinion that there are large numbers of people in this country who are nutritionally deficient. He bases this opinion on the 1965 Household Food Consumption Survey conducted by the Department of Agriculture; the 1972 Ten-State Nutrition Survey; and on the 1974 Health and Nutrition Examination Survey (HANES study).

In the HANES study, a probability sample was employed in which a representative group of a population is selected ethnically, geographically, and income-wise. A 24-hour dietary recall was taken on a sample of that population. In addition hematocrits, hemoglobin serum A, serum C were performed and detailed anthorpomorphic measurements were taken. All of these were run through and cross-checked a half dozen different ways before they were published.

The written document that was published and the testimony of the man who headed it before the Senate Committee on Nutrition and Human Needs lead Mr. Hagan to believe that there was considerably more done than a simple dietary recall. He knows of no studies that are more detailed on such a widespread basis. (Tr. 357-358)

With respect to the RDA's, Mr. Hagan thinks that the RDA's are derived after an immense amount of careful research based on accepted scientific findings. The quarrel that he would have with it is that the RDA is based on the amount necessary to prevent disease, plus an upward adjustment, which is largely guesswork, based on some studies to take care of variations in the population. The RDA is not set up to maintain optimum health. (Tr. 359)

One of Mr. Hagan's interests while studying has been in the area of hair. The list of ingredients shown as being contained in Respondent's product is a new statement in terms of vitamins and minerals necessary for the body to be able to grow normal and healthy hair. However, the statement could be improved by adding still other ingredients, although those shown are the major ones. (Tr. 359)

Mr. Hagan expressed the following views:

1. Hair will not grow in the absence of zinc.

2. In the sense that folic acid is necessary for normal metabolism, it has an effect upon hair or hair color.

3. Hair will not grow in the absence of iodine.

4. Hair will not grow in the absence of calcium pantothenate. It may be influential in controlling hair color.

5. Because of their involvement in the heme protein and hemoglobin, iron and copper are beneficial for hair growth.

6. Niacin is beneficial for the growth of hair since it is involved in the metabolism of substances which are essential for hair growth.

7. Inositol is beneficial for hair growth since it is involved in the metabolism of substances which are essential for hair growth.

8. Vitamin B-12 is a substance without which hair will not grown.

9. Mr. Hagan is co-author of a book which relates selenium to cancer prevention and the lessening of heart attack risk. If selenium is claimed to relate to the growth, fall or color of hair, no mention was made of that claim.

10. Chromium is said to be important in its involvement with glucose tolerance factor and metabolism in general.

11. Manganese is an essential mineral and is involved in a number of chemical and biological systems. There was no mention of hair.

12. Choline and PABA have been mentioned in published reports as being involved in hair growth, and they are among the necessary biological components. (Tr. 360-362)

The following are additional opinions of Mr. Hagan.

The cooking, processing and storage of food cause losses of the vitamin-mineral content of such food. It is very difficult to tell whether the vitamin content of certain crops will vary with the different conditions of the soil in which they are grown, but the vitamin content varies considerably with the seasons in which they are grown. (Tr. 365)

People vary enormously in their nutritional status with differences in their lifestyles, depending particularly on their dietary choices. The HANES study (Resp. Ex. 1), which was conducted by the National Center for Health Statistics in response to a directive from the Secretary, Department of Health, Education, and Welfare, is prefaced by the statement that Americans apparently do not make good choices in their dietary intakes.

If the average person eats the standard American diet as shown by the HANES study and by the Ten State Nutrition Survey (the site of which the record does not reveal), he probably will have less than optimum nutrition and, consequently, less than optimally growing hair. Thus, the addition of a supplement such as Respondent's product to the dietary intake would be expected to have a beneficial effect. (Tr. 366-367)

On cross-examination, Mr. Hagan stated that animal experiments are generally a starting point for investigations, particularly into nutrition, but also, into cancer, environmental exposure, and so forth. Generally, if the animal model is appropriately chosen, the results will be indicative of the kind of results that can be expected from human experimentation. Human hair and animal fur are similar in that both are keratin protein, but they are different in the way keratinization occurs. Each animal has its specific hair or fur growth cycle. (Tr. 368)

Commenting with respect to the adequacy of nutrition that would be achieved by ingesting the RDA and all essential nutrients, the witness said:

"I think that your problem is with adequate nutrition. If you define adequate nutrition as the RDA, the RDA starts off by saying that it's necessary for adequate nutrition of almost all normally healthy persons. So by definition, the RDA starts off not being ready -- not being exactly for 100 percent of the people, but it's almost all the people. They further qualify that and say normally healthy people.

"Now, it's difficult to define what a normally healthy person is. We lost 800,000 people a year through heart attacks and cancer. And obviously, these diseases must be in progress all the time."

If a person is receiving what Mr. Hagan believes to be adequate nutrition, Respondent's product would not help the hair of such person. (Tr. 379)

Evaluation of The Evidence

Documentary Evidence

34. In terms of documentary evidence, Respondent relied primarily on two exhibits - Respondent's Exhibits 1 and 2.

Respondent's Exhibit 1 is a copy of the report of Preliminary Findings of the First Health and Nutrition Examination Survey, United States, 1971-1972: Dietary Intake and Biochemical Findings (The HANES Report). This is an impressive looking exhibit with, perhaps, 150 pages, of which, approximately 125 are devoted to tabular presentations of data, and with the remaining 25 pages being devoted to narrative matter.

Respondent remonstrated at the criticism leveled by one of Complainant's witnesses at the HANES Report because it was based upon a 24-hour food intake recall survey. The fact is that the Report, itself, raised even more serious doubts about the reliability of the material therein presented. Some examples are:

"These preliminary findings are based on the examination of 10,126 persons aged 1-74 years in a representative subset of 35 of the 65 (PSU's)* making up the total sample. A sample of 14,147 persons was selected to be examined at these 35 locations which were visited between April 1971 and October 1972.

* primary sampling unit.

These 14,147 sample persons are a probability sample ofe total U.S. population; if a high proportion of them had been examined, the examined group could also have been regarded as a probability sample of the total population. However, despite intensive efforts, the program succeeded in examining only 10,126 of these sample persons. This represents 72.8 percent of the sample persons when adjustments are made for the differential sampling rates for the age, sex, and income defined population subgroups. (The unadjusted overall response rate was 71.6 percent.)

"Surveys of the National Center for Health Statistics, including all earlier programs of the Health Examination Surveys, have achieved higher levels of response than have been reached for the 35-stand subsample in this first HANES. The 72.8 percent response rate fails to meet fully the requirements of the original probability design." (p. 2. The pages, except the cover page, of the Exhibit are unnumbered in print. Based on the number of the cover page, the remaining pages of text were numbered through page 18.)

* * *

"Twenty-four hour recall data were analyzed by comparing mean intakes of population groups of known demographic characteristics to standards. This is the main purpose of the data, even though it is known that recall intakes have limited value in light of great variability of nutrient distributions." (p. 18)

Respondent's Exhibit 2 also was relied on heavily by Respondent. More information is obtainable from Resp. Ex. 2 then was brought out at the hearing. One point that was discussed was the possibility that Respondent may be offering for sale to the public a product containing ingredients of many of which the average American has a sufficiency from the normal diet without need of dietary supplementation. (Tr. 118-123) The following is a tabulation of the ingredients of Respondent's product and a reference to Respondent's Exhibit 2 for statements that are pertinent to this proceeding. (The statements are "thumbnail" excerpts which are quoted to reflect the essence of the text.)

A prefatory comment in this Exhibit is as follows:

In accordance with the OTC drug review regulations (21 CFR 330.10), the Panel's findings with respect to OTC vitamin and mineral drug products are set out in three categories:

Category I. Conditions under which OTC vitamin and mineral drug products are generally recognized as safe and effective and are not misbranded.

Category II. Conditions under which OTC vitamin and mineral drug products are not generally recognized as safe and effective or are misbranded.

Category III. Conditions for which the available data are insufficient to permit final classification at this time.

Most of the comments quoted from the body of Resp. Ex. 2 relate to Category I as above defined. $M03,16,11,39$QIngredient$B$BComment in Respondent's Exhibit 2$D$QCalcium$Bp. 16153$B A number of studies have been$Q Pantothenate$B$Bconducted in efforts to establish a$Q$B$Bpantothenic acid deficiency in man$Q$B$B(Refs. 23 through 27). In most of$Q$B$Bthese studies no clinical symptoms of$Q$B$Bpantothenic acid deficiency were$Q$B$Bobtained with only the removal of the$Q$B$Bvitamin from the diet. Inclusion of$Q$B$Bthe pantothenic acid antagonist,$Q$B$Bomega-methyl pantothenic acid,$Q$B$Bresulted in symptoms including$Q$B$Bfatigue, insomnia, neurological$Q$B$Bdisorders, decreased eosinopenic$Q$B$Bresponse to ACTH, and increased$Q$B$Bsensitivity to insulin (Refs. 23 and$Q$B$B25).$Q$Q$B$B * * *$Q$Q$Bpp. 16153-$Be. Conclusion. The Panel has$Q$B16154$Breviewed the scientific literature,$Q$B$Bthe submitted data, and the marketing$Q$B$Bhistory of vitamin and mineral$Q$B$Bingredients. Based upon the$Q$B$Bavailable data, the Panel concludes$Q$B$Bthat pantothenic acid deficiency is$Q$B$Bvirtually unknown in the U.S.$Q$B$Bpopulation and that pantothenic acid,$Q$B$Bas a single ingredient, is not$Q$B$Bwarranted for OTC drug use.$X

The panel did conclude that calcium pantothenate could be sold (1) in certain combinations and (2) for prevention and therapy for certain special groups when the need therefor has been identified and recommended by a physician. (See p. 16136) $M03,18,11,45$QIngredient$B$BComment in Respondent's Exhibit 2$D$QNiacin$Bp. 16151$B Niacin deficiency, which has been$Q$B$Bgreatly reduced by the enrichment of$Q$B$Bflour, continues to be a problem$Q$B$Bamong food faddists, alcoholics, and$Q$B$Bpatients with debilitating illness.$Q$B$BA survey revealed low circulating$Q$B$Blevels of niacin in 34 percent of$Q$B$BChinese, 46 percent of Black, 56$Q$B$Bpercent of Caucasian, and 60 percent$Q$B$Bof Puerto Rican school children$Q$B$Btested in New York City (Ref. 26).$Q$B$BTwenty-nine percent of randomly$Q$B$Bselected hospitalized patients in a$Q$B$Bmunicipal hospital in New Jersey had$Q$B$Ba deficiency of this vitamin (Ref.$Q$B$B27). Dietary histories revealed that$Q$B$Bthis was attributable to a deficient$Q$B$Bintake of the vitamin in one-third of$Q$B$Bthe patients (Ref. 27).$Q$B$B * * *$Q$Q$B$B (1) Dosage -- (i) For prevention of$Q$B$Bdeficiency. For adults and children$Q$B$B1 year of age and older, the oral$Q$B$Bdosage is 10 to 20 mg daily. For$Q$B$Bchildren under 1 year of age, the$Q$B$BPanel recommends the advice and$Q$B$Bsupervision of a physician.$Q$Q$B$B (ii) For treatment of deficiency.$Q$B$BFor adults and children 1 year of age$Q$B$Band older, the oral dosage is 25 to$Q$B$B50 mg daily. For children under 1$Q$B$Byear of age, the Panel recommends the$Q$B$Badvice and supervision of a physician.$Q$Q$B$B (2) Labeling. The Panel recommends$Q$B$Bthe following Category I labeling: $Q$Q$B$B Indications -- (a) For prevention of$Q$B$Bdeficiency. "For use in the$Q$B$Bprevention of niacin deficiency when$Q$B$Bthe need for such therapy has been$Q$B$Bdetermined by a physician."$Q$Q$B$B (b) For treatment of deficiency.$Q$B$B"For use in the treatment of niacin$Q$B$Bdeficiency when the need for such$Q$B$Btherapy has been determined by a$Q$B$Bphysician."$Q$QBiotin$Bp. 16144$B d. Conclusion. The Panel has$Q$B$Breviewed the scientific literature,$Q$B$Bthe submitted data, and the marketing$Q$B$Bhistory of vitamin and mineral$Q$B$Bingredients. Based upon the$Q$B$Bavailable data, the Panel concludes$Q$B$Bthat biotin deficiency is virtually$Q$B$Bnonexistent in the U.S. population$Q$B$Band that an OTC preparation of$Q$B$Bbiotin, singly or in combination, is$Q$B$Bnot warranted.$Q$QFolic Acid$Bp. 16149$B (2) Labeling. The Panel recommends$Q$B$Bthe following Category I labeling: $Q$Q$B$B (i) Indication -- For prevention of$Q$B$Bdeficiency. "For use in the$Q$B$Bprevention of folic acid deficiency$Q$B$Bwhen the need for such therapy has$Q$B$Bbeen determined by a physician."$Q$Q$B$B (ii) Warnings -- (a) For products$Q$B$Bcontaining 1 mg folic acid per unit$Q$B$Bof dose. (1) "Caution: The use of$Q$B$Bfolic acid for treatment of anemia$Q$B$Bwithout the direction of a physician$Q$B$Bmay be dangerous."$Q$Q$B$B (2) "Do not exceed the recommended$Q$B$Bdaily dosage."$Q$Q$B$B (b) For combination products for$Q$B$Bthe treatment of multiple$Q$B$Bdeficiencies which contain a$Q$B$Bprevention dose of 1 mg folic acid.$Q$B$B"This product cannot be safely used$Q$B$Bfor the treatment of folic acid$Q$B$Bdeficiency."$Q$Q$B$B (g) Category II conditions under$Q$B$Bwhich folacin is not generally$Q$B$Brecognized as safe and effective or$Q$B$Bis misbranded. The Panel recommends$Q$B$Bthat the Category II conditions be$Q$B$Beliminated from OTC folacin drug$Q$B$Bproducts effective 6 months after the$Q$B$Bdate of publication of the final$Q$B$Bmonograph in the FEDERAL REGISTER.$Q$Q$B$B The OTC drug use of folacin under$Q$B$Bthe following condition is$Q$B$Bunsupported by scientific data and by$Q$B$Bsound theoretical reasoning.$Q$Q$B$B The Panel concludes that the use of$Q$B$Bfolacin for the treatment of folic$Q$B$Bacid deficiency is not supported and$Q$B$Bcan be safely undertaken only under$Q$B$Bthe direct supervision of a physician$Q$B$Band therefore requires a prescription$Q$B$Bmode of therapy.$Q$QCyanocobalamin$Bp. 16147$B Dietary deficiency of Vitamin B-12$Q (Vitamin B-12)$B$Bis rare. For practical purposes,$Q$B$Bdietary deficiency occurs in indiv-$Q$B$Biduals with normal gastrointestinal$Q$B$Bfunction only after several years on$Q$B$Ba very strict vegetarian diet.$Q$B$BDietary deficiency does not occur in$Q$B$Bovolacto vegetarians (those who add$Q$B$Beggs and milk to a vegetarin diet).$Q$B$B * * *$Q$Q$B$B The documented indications for$Q$B$Breliable oral vitamin B-12 therapy$Q$B$Bare limited to dietary vitamin B-12$Q$B$Bdeficiency in the rare vegan (an$Q$B$Bindividual adhering to a strict vege-$Q$B$Btarian diet including no animal$Q$B$Bproducts) or in individuals adhering$Q$B$Bto certain other types of vegetarian$Q$B$Bdiets. Deficiency due to malabsorp-$Q$B$Btion associated with diseases of the$Q$B$Bstomach (e.g., pernicious anemia)$Q$B$Band/or the small intestine (e.g.,$Q$B$Bileal resection, bacterial over-$Q$B$Bgrowth, tropical sprue) or due to$Q$B$Brare genetic defects resulting in$Q$B$Bmalabsorption or block in the meta-$Q$B$Bbolic utilization requires patenteral$Q$B$Btherapy and the careful surveillance$Q$B$Bof a physician.$Q$QCholine$Bp. 16146$B d. Conclusion. The Panel has$Q$B$Breviewed the scientific literature,$Q$B$Bthe submitted data, and the marketing$Q$B$Bhistory of vitamin and mineral$Q$B$Bingredients. Based upon the$Q$B$Bavailable data, the Panel concludes$Q$B$Bthat choline deficiency is virtually$Q$B$Bnonexistent in the U.S. population$Q$B$Band that an OTC drug preparation of$Q$B$Bcholine, singly or in combination, is$Q$B$Bnot warranted.$Q$QInositol$Bpp. 16130-$B Finally, the submissions to the$Qand PABA$B 16131$BPanel include ingredients of no$Q$B$Bestablished nutritional or thera-$Q$B$Bpeutic value which are not sources of$Q$B$Bthe vitamins or minerals approved for$Q$B$Bthese combinations. The Panel$Q$B$Brecognizes no additional nutritional$Q$B$Bor other benefits from the addition$Q$B$Bof these compounds to vitamin and$Q$B$Bmineral preparations and therefore$Q$B$Brecommends that their addition not be$Q$B$Ballowed. Included in this group are$Q$B$Bsuch compounds as buckwheat,$Q$B$Bhesperidin, inositol, lecithin,$Q$B$Bbioflavonoids, p-aminobenzoic acid,$Q$B$Brutin, and sulfur.$Q$QIron$Bp. 16185$B (1) Dosage -- For prevention of defi-$Q$B$Bciency. For menstruating and$Q$B$Blactating women, the oral dosage is$Q$B$B10 to 30 mg daily. For pregnant$Q$B$Bwomen, the oral dosage is 30 to 60 mg$Q$B$Bdaily. For children 6 months to$Q$B$Bunder 5 years of age, the oral dosage$Q$B$Bis 10 to 15 mg daily.$Q$Q$B$BFor infants under 6 months of age,$Q$B$Bthe Panel recommends the advice and$Q$B$Bsupervision of a physician. For$Q$B$Bcombination products other than for$Q$B$Buse in pregnancy, the oral dosage for$Q$B$Badults and children 5 years of age$Q$B$Band older is 10 to 20 mg daily.$Q$Q$B$B (2) Labeling. The Panel recommends$Q$B$Bthe following Category I labeling: $Q$Q$B$B (2) Labeling. The Panel recommends$Q$B$Bthe following Category I labeling: $Q$Q$B$B (i) Indication -- For prevention of$Q$B$Bdeficiency. "For use in the$Q$B$Bprevention of iron deficiency when$Q$B$Bthe need for such therapy has been$Q$B$Bdetermined by a physician."$Q$QCopper$Bp. 16179$B d. Conclusion. The Panel has$Q$B$Breviewed the scientific literature,$Q$B$Bthe submitted data, and the marketing$Q$B$Bhistory of vitamin and mineral$Q$B$Bingredients. Based on the available$Q$B$Bdata, the Panel concludes that copper$Q$B$Bis not appropriate for the OTC drug$Q$B$Bmarket for the prevention or$Q$B$Btreatment of copper deficiency since$Q$B$Bcopper deficiency in man is rare and$Q$B$Bbecause of the potential for copper$Q$B$Btoxicity at relatively low levels of$Q$B$Bintake.$Q$QIodine$Bp. 16182$B d. Conclusion. The Panel has$Q$B$Breviewed the scientific liternature,$Q$B$Bthe submitted data, and the marketing$Q$B$Bhistory of vitamin and mineral$Q$B$Bingredients. Based upon the$Q$B$Bavailable data, the Panel concludes$Q$B$Bthat there is no rationale for the$Q$B$Binclusion of iodine in OTC drug$Q$B$Bproducts for the prevention or$Q$B$Btreatment of iodine deficiency.$X

(See, also, quotes from pp. 16181-16182 at p. 38, supra) $M03,12,09,45$QIngredient$B$BComment in Respondent's Exhibit 2$D$QManganese$Bp. 16189$B d. Conclusion. The Panel has$Q$B$Breviewed the scientific literature,$Q$B$Bthe submitted data, and the marketing$Q$B$Bhistory of vitamin and mineral$Q$B$Bingredients. Based upon the$Q$B$Bavailable data, the Panel concludes$Q$B$Bthat because of the potential for$Q$B$Bmanganese toxicity, and in the$Q$B$Babsence of any demonstrated need for$Q$B$BOTC drug preparations of manganese to$Q$B$Bprevent a deficiency, manganese is$Q$B$Bnot generally recognized as safe or$Q$B$Beffective therapy for any disease$Q$B$Bcondition.$Q$QZinc$Bp. 16195$B Zinc sulfate is the only zinc$Q$B$Bsource which may be used as a$Q$B$BCategory I source of zinc. Dosage$Q$B$Bmust be based on elemental zinc (Zn,$Q$B$Bmolecular weight 65.4).$Q$Q$B$B (1) Dosage -- For prevention of defi-$Q$B$Bciency. For adults and children 1$Q$B$Byear of age and older, the oral$Q$B$Bdosage is 10 to 25 mg daily. For$Q$B$Bpregnant and lactating women, the$Q$B$Boral dosage is 25 mg daily. For$Q$B$Bchildren under 1 year of age, the$Q$B$BPanel recommends the advice and$Q$B$Bsupervision of a physician.$Q$Q$B$B (2) Labeling. The Panel recommends$Q$B$Bthe following Category I labeling: $Q$Q$B$B Indication -- For prevention of defi-$Q$B$Bciency. "For use in the prevention$Q$B$Bof zinc deficiency when the need for$Q$B$Bsuch therapy has been determined by a$Q$B$Bphysician."$X

Thus, Respondent's Exhibit 2, on which Respondent placed significant reliance, indicates that Respondent's product contains ingredients which, in the opinion of the panel of professionals appointed by the Commissioner of Food and Drugs, are available in the diet without supplementation (e.g., biotin, choline), or they are of no established nutritional or therapeutic value (e.g., inositol, PABA), or of which deficiency states are rare (e.g., vitamin B-12, copper), or the OTC sale of which may present danger to the consumer (e.g., folic acid, manganese), or which should be taken only after the need therefor has been determined by a physician (e.g., niacin, iron, zinc), or for the OTC sale of which there simply is no rationale (e.g., iodine). For some reason, perhaps because no product containing them was submitted, the panel did not consider chromium and selenium.

Respondent's Exhibits 1 and 2 are voluminous documents which obviously are the product of much thought, effort and time on the part of the groups by whom they were sponsored and by whom they were prepared and reviewed. A striking fact is that nowhere in the entirety of both exhibits is there a word about baldness, loss of color, texture or curl, or any other matter related to hair.

Dr. Lubowe and Mr. Hagan cited "The Biology of Hair Growth", Montagna and Ellis, copyright 1958 by Academic Press, New York, from which they quoted excerpts from Chapter 14, "Nutritional Factors Influencing Hair and Wool Growth" by M. L. Ryder, Wool Industries Research Association, Leeds, England. In that chapter human hair is mentioned four times, as follows (page citations are to the pages of the book):

"In human beings a very poor diet is needed to cause loss of hair, probably because a smaller fraction of the total available protein is diverted to hair formation." (306)

* * *

"The vitamins of B complex are, however, important in other animals, and Vitamin B, taken over long periods, was found to restore human hair pigmentation (Lanczox, 1941)." (311)

* * *

"Deficiency of riboflavin and pantothenic acid in Negro children not only caused depigmentation, but made their hair grow straight (Hughes, 1946)".

* * *

"Human hair follicles abound in glycogen (Montagna, et al. 1951, 1952)". (326)

While the author of the chapter uses the word "hair" frequently, from the context it is obvious that he is speaking of the "hair" of rats and mice. Otherwise, as one might expect because of Ryder's business affiliation, his article is devoted primarily to sheep's wool. With respect to the statement quoted above from page 311 of Montagna and Ellis, note is taken of the fact that the restored pigmentation took place, if at all, only after taking vitamin B "over long periods." Nor does the author say which member or members of the vitamin B group were taken. Respondent's product is packaged to last 25 days taking the pills at the rate of two a day, and the cost, including "handling and postage" is $8.95. Even if one did not weary with waiting for restored hair pigmentation, the cost of the remedy could become overly burdensome to the point of discouragement and abandonment. Additionally, the protocols for the procedures by which the results were said to be achieved are unknown. There is no mention of testing.

Oral Evidence

35. The thrust of Dr. Kramer's testimony is found in the following three summaries of statements made by him: (1) a person having a hair problem related to a deficiency of one or more of the ingredients of Respondent's products is a very sick individual whose hair is the least of his worries (Tr. 60-61); (2) if there is an essential nutrient which is absent from the human body, such an absence probably would have less effect on the hair than on any other organ of the body (Tr. 60-61); and (3) the hair of persons not grossly deficient in the ingredients of Respondent's product would not in any way be affected by the taking of such product (Tr. 62).

Dr. Kramer's testimony was lucid, forthright, based on medical and scientific information, uncontradicted by any persuasive, credible, scientific or medical evidence, and it was in accord with the consensus of informed medical and scientific opinion.

Dr. Lubowe still adheres to the view, now discarded by the informed medical profession, that whether a man develops male pattern baldness depends on the amount of testosterone circulating in the bloodstream. Actually, he said that male pattern baldness is "due to an excessive secretion of male hormone in the scalp." (emphasis supplied) (supra, p. 46; Tr. 272) A significant portion of Dr. Lubowe's testimony, not considered herein, is based on admittedly unscientific writings of such authors as Adelle Davis and Fay Lavan. Finally, Dr. Lubowe's answers to many, if not most, of the questions put to him were evasive, vague, uninformative, or unresponsive. (See, e.g., supra, pp. 50-52). Dr. Lubowe said that his testimony represents "a consensus of thinking among nutritionists."

Dr. Reynold's testimony, reduced to its essentials, was in accord with the conclusions in the Monograph which appeared in the Federal Register of March 16, 1979, and is Respondent's Exhibit 2. This document, in turn, is in agreement with the 1974 RDA as reflected in the testimony. The opinions of Dr. Reynolds, from the standpoint of the biochemist, were in accord with the expert medical opinions of Dr. Kramer in such matters as the need for, and deficiency states of, certain nutrients. The opinions of Dr. Reynolds are in accord with the consensus of informed scientific thought.

Dr. Lord, although acknowledging the vast expertise of the members of the National Academy of Science and the members of the Food and Nutrition Board, stated that the RDA established by the latter Board are "grossly inadequate." He said that there is a general dietary deficiency in such areas as selenium and vitamin B-12. To the contrary, Respondent's Exhibit 2 contains the statement that "Dietary deficiency of vitamin B-12 is rare." Respondent scarcely can have it both ways. As for selenium, no RDA had been established at the time Dr. Lord testified and at present the estimated RDA is 0.05-0.2 micrograms. Dr. Lord's testimony represented the "consensus of thinking people" who do the same type of work he does.

Mr. Hagan stated that folic acid, niacin, inositol, chromium and manganese contribute to hair growth in that they are involved in metabolism. He did not claim that they have special significance to hair or to the follicle. Insofar as experimentation with animals is concerned, they are a starting point, particularly for nutrition, and in certain other areas. If the animal model is appropriately chosen, the results will be indicative of the kind of results that can be expected from human experimentation. In general, Mr. Hagan's views with respect to the under-nutrition of the population were in agreement with those of Dr. Lord. he said that if a person eats the standard American diet he will have less than optimum nutrition and that the addition of Respondent's product to his diet would be expected to have a beneficial effect. On the other hand, if a person ingests what Mr. Hagan believes is adequate nutrition, Respondent's product would not help the hair.

The Truth or Falsity of The Representation

36. Based upon the evaluation of the evidence indicated above it is found that the representations found to have been made by Respondent are false as to matters of material fact, as follows:

Representation 3(a):

NEW START NATURAL HAIR VITAMINS will nourish hair.

Refutation: n7

Respondent's product will not affect the hair of anyone not grossly deficient in the product's ingredients. (Dr. Kramer, Tr. 62, supra, p. 17)

Representation 3(b):

NEW START NATURAL HAIR VITAMINS will make the user's hair healthier.

Refutation:

Same as for representation 3(a).

Representation 3(c):

An individual who maintains a well-balanced diet may have poorly nourished hair that can be remedied with NEW START NATURAL HAIR VITAMINS.

Refutation:

Same as for representation 3(a); a person receiving nutrition believed by Mr. Hagan to be adequate would not benefit the condition of his hair by taking Respondent's product. (Mr. Hagan, Tr. 371; supra, p. 69)

Representation 3(d):

Individuals experiencing poor hair growth are likely to be suffering from a zinc deficiency.

Refutation:

Zinc deficiency in the adult population of the United States is virtually unknown. Zinc has no effect on the rate of hair growth. (Dr. Reynolds, Tr. 129, 131; supra, p. 28)

Representation 3(e):

NEW START NATURAL HAIR VITAMINS will be effective in aiding hair growth of individuals without a severe deficiency of zinc.

Refutation:

Once a hair is formed it will not be helped by more nutrients. Since hair is dead tissue, the ingredients of Respondent's product will not nourish it. (Dr. Reynolds, Tr. 124-125; supra, p. 26, 27)

Representations 3(f) and 3(g):

Biotin in NEW START NATURAL HAIR VITAMINS will prevent hair loss and reverse baldness.

Scientifically valid studies have credited biotin with preventing hair loss and reversing baldness.

Refutation:

So far as the medical literature reveals, there is no evidence that biotin, however administered, will have any effect whatsoever on male pattern baldness. (Dr. Kramer, Tr. 54, supra, p. 14; Resp. Ex. 2, p. 16144, supra, p. 73)

Representation 3(h):

The folic acid in NEW START NATURAL HAIR VITAMINS will maintain color and delay greying of an individual's hair.

Refutation:

Searches of the medical and scientific literature failed to produce evidence that there is any relationship between graying or alterations in hair color and folic acid. (Dr. Kramer, Tr. 54, supra, p. 14; Dr. Reynolds, Tr. 136, supra, p. 29)

Representation 3(i):

The iodine and calcium pantothenate in NEW START NATURAL HAIR VITAMINS will cause the hair of an individual to become thicker and more lustrous.

Refutation:

Iodine and calcium pantothenate will not cause one's hair to be thicker and more lustrous. (dr. Kramer, Tr. 56, 57, supra, p. 14, 15; Dr. Reynolds, Tr. 141, 206, supra, p. 29, 30)

Representation 3(j):

The iron and copper in NEW START NATURAL HAIR VITAMINS will cause an individual to have improved blood circulation to the scalp.

Refutation:

The stated substances in Respondent's product will not produce the promised results. (Dr. Kramer, Tr. 57, supra, p. 15; Dr. Reynolds, Tr. 141, supra, 30)

Representation 3(k):

Niacin, inositol, vitamin B-12 and other nutrients in NEW START NATURAL HAIR VITAMINS help the body to provide proper nutrition to the hair.

Refutation:

The ingestion of the listed ingredients of Respondent's product will not affect the hair. (Dr. Reynolds, Tr. 142-147, 208-209; supra, 28-31)

n7 The "Refutations" stated are illustrative only. Other statements could be selected which would serve fully and equally as well to demonstrate the falsity of Respondent's advertising claims.

CONCLUSIONS OF LAW

1. The Complainant has the burden of proof in this proceeding.

2. By means of the exhibits and the testimony of competent, credible expert witnesses the Complainant sustained its burden of proof.

3. The views and opinions of Complainant's witnesses were in conformity with the consensus of informed medical and scientific opinion, whereas no claim for such standing was even made for the testimony of Respondent's witnesses.

4. The Respondent did not go forward with competent, credible proof that overcame that of Complainant.

5. Advertising matter is to be considered as a whole and the meaning is to be determined in light of the probable impact of the entire advertisement on the person of ordinary mind. Donaldson v. Read Magazine, 333 U.S. 178, 189 (1948); Peak Laboratories, Inc. v. United States Postal Service, 556 F.2d 1387, 1389 (5th Cir. 1977); Unique Ideas, Inc. v. United States Postal Service, 416 F. Supp. 1141, 1145 (S.D.N.Y. 1976).

6. Persons of ordinary mind reading Respondent's classified advertisements and circulars would interpret them substantially as characterized in paragraphs 3(a) through 3(k) of the Complaint.

7. The representations found to have been made by Respondent are material representations because they are of the kind and character which would persuade readers to order and pay for Respondent's product.

8. Complainant has established the falsity of Respondent's representations by the preponderance of the competent, credible evidence.

9. "When it appears that an advertiser deliberately induces its patrons to purchase its product in the believe that its value far exceeds its true worth it is sufficient to support a finding that a fraudulent scheme was being conducted. Leach v. Carlile, 1922, 258 U. S. 138, ***. This is so, even where there is a promise to refund the purchase price should the article sold prove unsatisfactory. Farley v. Heininger, 70 App. D.C. 200, 105 F.2d. 79, 84, cert. den. 1939, 308 U.S. 587, 60 S. Ct. 110, 84 L. Ed. 491." Borg-Johnson Electronics v. Christenberry, U.S.D.C., S.D.N.Y., 169 F. Supp. 746, 751 (1959)

10. While it no longer is necessary to prove intent to defraud under 39 U. S. Code 3005 since the enactment of Public Law 90-590, approved October 17, 1968, if material misrepresentations are made by means of which a seller obtains money through the mail, there has been an act for which the issuance of a mail-stop order is authorized and warranted.

11. The Respondent in this proceeding is conducting a scheme for obtaining money or property through the mails by means of materially false representations within he meaning of 39 U. S. Code 3005.

Proposed findings of fact and conclusions of law submitted by the parties have been fully considered, and to the extent indicated herein, they have been adopted. Otherwise such proposed findings of fact and conclusions of law are rejected for the reason that they are unsupported by or contrary to the evidence or because of their immateriality.

Accordingly, an order of the type authorized by section 3005 of Title 39, United States Code, substantially in the form attached should be issued against this Respondent.

William A. Duvall, Chief Administrative Law Judge

Applicable to both the Chromium and Manganese is footnote b to the table of Trace Elements on page 168 of RDA (1980). This footnote cautions:

"Since the toxic levels of many trace elements may be only several times usual intakes, the upper levels for the trace elements given in this table should not be habitually exceeded."

Natural Calm

The product contains, among other substances, 20 mg. of pantothenic acid.

"Pantothenic acid is widely distributed in foods and is particularly abundant in animal tissues, whole grain cereals, and legumes; it also occurs in lesser amounts in milk, vegetables, and fruits, which helps to assure its presence in diets that are adequate with respect to the other B-complex vitamins. Isolated dietary deficiencies are unlikely; marginal deficiencies may exist, however, in generally malnourished individuals, along with deficiencies of other B-complex vitamins (Leevy et al., 1965; Tao and Fox, 1976). Human milk contains approximately 2 mg/liter and cows' milk about 3.5 mg/liter. Synthesis by intestinal microflora has been suspected but the amounts produced and the availability of the vitamin from this source are unknown.

"Available evidence suggests that pantothenic acid is a relatively nontoxic substance. As much as 10 g of calcium pantothenate per day was given to young men for six weeks with no toxic symptoms reported (Ralli and Dumm, 1953). Other studies indicate that daily doses of 10-20 g may result in occasional diarrhea and water retention (Harris and Lepkovsky, 1954)."

* * *

"The evidence summarized here suggests that an intake of 4-7 mg/day would be adequate for adults; a higher intake may be needed during pregnancy and lactation. * * *" (RDA, p. 123; see Table 10, p. 178)

Nutrition for Women

Vitamin B-2: "For practical reasons, the riboflavin allowances in this report have been computed as 0.6 mg/1000 kcal for people of all ages. However, for elderly people and others whose calorie intake may be less than 2000 kcal, a minimum intake of 1.2 mg/day is recommended. In contrast to thiamin, there is no evidence that riboflavin requirements are raised when energy utilization is increased." (RDA, p. 89)

For pregnant and lactating women it is recommended that the allowance be increased, respectively, by 0.3 mg/day and 0.5 mg/day. (id.)

Nutrition for Women contains 200 mg., which it says is 11,765 percent of the RDA.

Folic Acid: "Folacin is the generic descriptor for compounds having nutritional properties and chemical structure similar to those of folic acid (pteroylglutamic acid, PGA)." (RDA, p. 106)

* * *

"Adults The bulk of evidence suggests that 25-50 percent of dietary folacin is nutritionally available. On the assumption that 100-200 mcg of PGA are needed daily to maintain tissue reserves, the RDA is set at 400 mcg of total folacin activity in the diet for normal nonpregnant, nonlactating adults and adolescents. This is the same value recommended by a WHO Expert Group in 1972. (The figure 400 mcg is an expression of total PGA equivalents assayable with L. case in extracts of diets treated with conjugase.)

"The total folacin content of mixed diets, according to L. case assay, varies over a rather wide range. Table 6 shows the folacin content of diets from a number of countries.

"An intake of 400 mcg of total folacin activity in the diet does not seem unusual in many parts of the world, and under certain conditions the diet might be expected to contain up to 1 or 2 mg of folacin." (RDA, p. 109)

Each tablet of Nutrition for Women contains 800 mcg or, per the label, 400% of the RDA. Two tablets daily are allowed by the directions.

Vitamin B6: "Although a number of methods have been devised for determination of the various forms of the vitamin, data on the vitamin B-6 content of foods are insufficient, and adequate information on the availability of vitamin B-6 is lacking (Nelson et al., 1976, 1977; Gregory and Kirk, 1978a; Haskell, 1978)."

* * *

"Although vitamin B-6 is relatively nontoxic (Bauernfeind and Miller, 1978; Brin, 1978), a vitamin B-6 dependency has been induced in normal human adults given a supplement of 200 mg of pyridoxine daily for 33 days while they were ingesting a normal diet (Canham et al., 1964). (RDA, p. 97)

* * *

"In view of the influence of protein intake on vitamin B-6 needs, the range of requirements observed in the several studies reported, and the uncertainty of the availability of the vitamin in the diet, a daily dietary allowance of 2.2 mg of vitamin B-6 is recommended for adult males and 2.0 mg for adult females." (RDA, p. 99)

Allowances for pregnant and lactating women are increased, respectively, by 0.6 mg/day and by 0.5 mg/day. (id.) pp 100.

The information in the second quotation above raises the question as to whether this product should be taken without professional medical supervision since each tablet, of which two are allowed, contains 200 mg. of vitamin B6.

Vitamin B12: "The average diet in the United States probably supplies between 5 and 15 mcg/day of the vitamin, but the range can be from as low as 1 to as high as 100 mcg/day (Chung et al., 1961; Lichtenstein et al., 1961; Smith, 1965; Santini and Corcino, 1974)." (BCA, p. 114)

* * *

"The capacity of the body to reutilize the vitamin and replenish its stores after an interval of days makes it unnecessary to consume vitamin B-12 every day either as food or as a dietary supplement." (BCA, p. 115)

* * *

"Thus nutritional equilibrium can be maintained by normal individuals over a rather wide range of intakes and guantities present in most mixed diets in the United States. The RDA for adults is therefore set at 3.0 mcg. of vitamin B-12. This value has been selected as one that will maintain adequate vitamin B-12 nutrition and a substantial reserve body pool in most normal persons. It is recognized that dietary intake will frequently exceed the RDA, but this is not considered a justification for either raising the allowance or modifying the diet." (RDA, p. 117)

The RDA for pregnant and lactating women is an additional 1 mg/day.

Nutrition for Women contains, per tablet, 1,000 mcg. of vitamin B12, or 16,667 per cent of the RDA, according to the label.

Iron: "In order to provide for the necessary retention of 1 mg/day in adult males and postmenopausal females, and assuming an average availability of 10 percent of the food iron, an allowance of 10 mg/day is recommended. The allowance for women of childbearing age is set at 18 mg/day in order to meet the additional needs imposed by menstrual iron losses. The increased requirement during pregnancy cannot be met by the iron contained in habitual diets in the United States, nor by the existing iron stores of many women; therefore, daily supplements of iron are recommended. These usually range from 30 to 60 mg/day; the amount should be determined by the physician administering prenatal care. Iron needs during lactation are not substantially different from those of nonpregnant women, yet continued supplementation of the mother for 2-3 months after parturition is advisable in order to replenish stores depleted by pregnancy (NRC, 1970)." (RDA, p. 138)

Nutrition for Women contains 30 mg. per tablet. The directions are to take one or two tablets daily.

Vitamin E: "In human adults, evidence of deficiency has only been observed in patients with long-standing failure to absorb fat (Binder et al., 1965)." (RDA, p. 63)

* * *

"Inasmuch as there is no clinical or biochemical evidence that vitamin E status is inadequate in normal individuals ingesting balanced diets in the United States, the vitamin E activity in average diets is considered satisfactory. Recent analyses of adult human tissues have indicated sufficient amounts of the vitamin (Bieri and Evarts, 1975; Underwood et al., 1970)." (RDA, p. 66)

* * *

"In the absence of reports that a significant percentage of the adult United States population has low plasma tocopherol levels (<0.5 mg/100 ml), or that any symptomatology attributable to insufficient vitamin E exists as a significant health problem, it is assumed that most adult diets in the United States are adequate in this respect. A range of 7-13 mg d-a-tocopherol equivalent (10-20 IU) can be expected in balanced diets supplying 1800-3000 kcal, whereas some high-fat diets may contain over 17 mg (25 IU). During pregnancy and lactation, the increased caloric intake should normally be accompanied by sufficient additional vitamin E (2-3 mg a-tocopherol equivalent per day) to compensate for the amount deposited in the fetus and secreted in milk." (RDA, p. 67)

In the table at the back of the publication the actual recommended allowances are 10 mg/day for adult males and 8 mg/day for adult females, except that additional amounts of 2/ and 3/ day are recommended, respectively for pregnant and lactating women.

META-E contains 400 I.U. of vitamin E per tablet. The directions allow one or two capsules daily, or as directed by a physician.

Food for Thought

L-Glutamine: "It is well known that foods contain literally many thousands of organic substances, most of which have some biological function in the plant or animal from which the food is derived or which are a by-product of plant metabolism. However, only very few of these organic substances -- about 25 -- are essential dietary nutrients for higher animals or humans (the vitamins, essential amino acids, and essential fatty acids). Many other organic compounds in foods, often present in quite large amounts, provide much of the energy needs of the animal body. Examples of such energy-yielding compounds * * *; nonessential amino acids, such as * * * glutamic acid; * * *. Although these contribute energy and flavor, they are not essential nutrients." (RDA, p 179)

Lecithin and RNA: In a category designated "SUBSTANCES KNOWN TO BE GROWTH FACTORS FOR LOWER FORMS OF LIFE BUT FOR WHICH NO DIETARY REQUIREMENT FOR HIGHER ANIMALS OR HUMANS IS KNOWN" are listed lecithin and nucleic acids. (RDA, p. 183)

Choline: "Because of lack of clinical and experimental evidence of choline deficiency and lack of knowledge concerning choline biosynthesis and utilization in human beings, choline cannot be considered a vitamin for man. Even if choline is considered an ancillary nutrient for human beings, no quantitative requirements can be stated because the magnitude of the contribution of endogenous choline is unknown." (RDA, p. 181)

Food for Thought contains 50 mg of choline bitartrate. One or two tablets daily are allowed.

Inositol: "Myoinositol, which is what is usually menat when "inositol" occurs alone (Stedman's Medical Dictionary Illustrated, 23rd ed., 1976) in one of another group of substances of which it is said that "no evidence of a dietary requirement for these substances exists in humans." (RDA, p. 183)

Food for Thought contains 50 mg. of inositol.

EX SEL

Selenium: "In view of the well defined selenium requirement of many animal species and the role of selenium in an important enzyme system, it can be stated that selenium must be essential for man as well. However, disease states attributable to selenium deficiency or excess have not yet been described in human subjects, even though large population groups are living in areas where selenium deficiency and excess have resulted in severe disease in livestock." (RDA, p. 162)

* * *

"Although balanced diets in some areas furnish in excess of 200 mcg/day (Sakurai and Tsuchiya, 1975) the demonstrated chronic toxicity of relatively low dietary levels in experimental animals suggests a maximal intake of 200 mcg/day for adults, which should not be exceeded habitually if the risk of long-term chronic overexposure is to be avoided.

* * *

"Selenium intakes within the range of 50-200 mg/day can be obtained easily from a varied diet. The considerable regional differences in the selenium content in foods of vegetable origin are largely compensated for by the wide national distribution of foods within the United States." (RDA, p. 163)

Ex Sel contains 75 meg. of selenium per capsule. The directions recommend one or two capsules per day. If a person takes two capsules, that amount of selenium plus his normal daily intake may well put him over the 200 microgram total which the RDA authors say should not be habitually exceeded."

Vitamin E: Se META-E, supra.

Zinc: "Pronounced zinc deficiency in man (Prasad, 1966), resulting in hypogonadism and dwarfism, has been found in the Middle East and is suspected to occur in other countries where the intake of available zinc is low. Severe zinc deficiency has also been described in the United States in cases of acrodermatitis enteropathica (Moynahan, 1974) and of malabsorption syndrome (Sandstead et al., 1976), but these are not diet related. On the other hand, recent evidence suggest that marginal states of zinc nutrition do exist in segments of the United States Population. Accelerated rates of wound healing (Pories et al., 1976) and improved taste acuity (Henkin et al., 1971) in human subjects with low zinc stores, observed as a result of increased zinc intake, suggest that the zinc requirement of these subjects was not fully met by their diets. Marginal zinc deficiency was described in a survey of apparently healthy children in Denver." (RDA, p. 144)

* * *

"The turnover of body zinc has been calculated from radioisotope studies ar 6 mg/day (Richmond et al., 1962); Engel Et al., 1966). In view of these data, and allowing for absorption of about 40 percent of dietary zinc, an intake of 15 mg/day is recommended for adults, with an additional 5 mg during pregnancy and 10 mg during lactation." (RDA, p. 145)

* * *

"However, there is increasing evidence that excessive intakes of zinc may aggravate marginal copper deficiency (Klevay, 1975); therefore, chronic ingestion of zinc supplements of more than 15 mg/day, in addition to the dietary intake, is not recommended without medical supervision." (RDA, p. 146)

The purchaser is advised by the label of the product to take one tablet per day of Euzinc-D, which provides 60 mg. per day, or 4 times the amount recommended in the RDA.

RNA and RX for Aging

RNA: "This is the principal item featured in connection with the sale of both of these products. It was pointed out earlier (Food for Thought, above) that RDA (1980) witnesses claimed to have heard of or read about or seen at higher amounts and with respect to which "no evidence exists for their need by humans, nor is it likely that such a need could be established (since it is known that these substances can be synthesized in the tissues of higher animals, except possibly in various rare genetic abnormalities)." (RDA, p. 183)

DISCUSSION

All of these comments from RNA are quoted for the purpose of showing the similarity between the testimony of Complainant's witness and the results of an investigation conducted by investigators who were "chosen for their special competencies" and which culminated in the publication of the report which is the 1980 ediction of the RDA. Certain salient points are immediately apparent and these will be mentioned.

1. Complainant's witnesses stated that their testimony is in accord with (1) the testimony that would be given by the majority of scientists in the country who are informed about the areas concerning which they were examined (Dr. Schwartz, Tr. 298); or (2) the consensus of informed scientific and medical opinion (Dr. Ayers, Tr. 385). Although Dr. Hunt was not asked the specific question, the fact that her testimony was to the same effect as that of Schwartz and Ayers and the RDA establishes that her opinions also reflect this medical and scientific consensus.

2. In RDA the text is studded with references to studies and reports, and each chapter or category of subjects is followed by a voluminous group of "references" showing the journals or other sources in which the studies or reports previously mentioned are printed and may be found. The Report of the Committee on Dietary Allowances of the Food and Nutrition Board has no "axe to grind", no purpose to serve other than to bring to light and set down in one place the most current and correct information obtainable about the matters they were charged to investigate.

3. When these two completely independent and learned groups of scientists and medical doctors arrive at such closely parallel views, their expressions on the pertinent matters represent the current consensus of informed scientific and medical opinion.

The expert witnesses called by Respondent did not have the objectivity of approach manifested by the Complainant's witnesses. They were interested, to a significant degree, in promoting their theory of the practice of medicine. Some of them called it "holistic" medicine, some "orthomolecular," some said their practice is based more on nutrition than is usually the case. All of that was very interesting since each undertook to enhance his own medical theories, but these matters were not at issue. The central issue of course was whether the Respondent in selling its products through the mails was doing so on the basis of certain specific representations which are alleged to be false.

There are certain basic propositions which are now stated. Complainant's witness had not conducted, seen, read or heard of double blind, controlled tests of Respondent's products which resulted in a showing that Respondent's claims are false. On the other hand, Respondent's witnesses had not conducted any such tests of Respondent's products which resulted in a valid finding that Respondent's claims are true. Each of Respondent's some time or another of tests tending to support Respondent's claims, but not one of Respondent's witnesses gave a citation to a reference that could be identified by subject, author, journal, page and date, although one name or another was mentioned from time to time. Examples are Drs. Frank, Shute and Pauling. Dr. Frank's claimed success with experiments to retard aging and Dr. Shute's claimed success in treating cardiac and other conditions have never been capable of replication and, thus, have been discarded by the main body of medical thought. Dr. Pauling's work was referred to without citation. The same was true with respect to other names that were used from time to time.

Respondent's witnesses did not in their testimony even claim to reflect the consensus of informed medical and scientific opinion. (e.g., Susser, Tr. 763; Lord, Tr. 493-4)

All of the witnesses agreed that if a person has a feeling that the taking of some vitamin or mineral supplement might help him there is no objection to this taking reasonable doses as a prophylatic measure for a short period of time. Prolonged usage or large doses are better taken with the advice of a physician. The witnesses differed as to how the person should decide to use supplement. Generally, the Complainant's witnesses said it is wasteful to take supplementation unless there is a specific need such as a known or suspected deficiency. Respondent's witnesses all said that all persons should take a wide variety of vitamins and minerals as insurance against the possibility that they might have a latent or incipient deficiency which should be stopped before it produces a frank deficiency state.

Complainant's witnesses testified that with a few minor exceptions to average diet of the United States population supplies most of the nutrients the body needs. Respondent's witnesses claimed that this average diet is woefully deficient in nutrients for various reasons, such as growing in nutrient-deficient soil, or having the nutrients removed by transportation, storage, washing and cooling.

Complainant's witnesses stated that unless there is a deficiency in some of the nutrients sold by Respondent, the taking of Respondent's products would do little in most cases except produce expensive urine. Respondent's witnesses agreed with the above language, but they wanted to define the word "deficiency" in a way that is not generally accepted. Respondent's witnesses also said that many if not most people are walking around unaware that they have latent, sub-clinical deficiencies which stand a good chance of becoming overt and striking them down.

Complainant's witnesses spoke openly, answered questions frankly regardless of which party the answer might favor and gave informational background, when needed, in support of their answers. Respondent's witnesses hedged, wanted to indulge in word games, and verbally squirmed in their responses to questions. Instead of answering questions about the effect of ingesting a certain nutrient, such questions were used as spring boards for adorning the record with anecdotes of spectacular cures of such problems as underdeveloped children, people with bad memories, and excess weight effected through the use of vitamins and minerals.

Complainant's witnesses testified clearly and unequivocally that Respondent's products would not, and could not, perform as claimed for them in the statements in the advertising literature. Respondent's witnesses came behind them with oblique, indirect language suggesting various possible situations never shown really to exist, and sought to suggest, without saying, that the products would perform as represented.

The evidence presented by Complainant is representative of the consensus of the best scientific and medical information and opinion currently available on the issues in this proceeding. The evidence presented by Respondent does not reflect, incorporate, or express the consensus of current, informal medical and scientific opinion. The Complainant's witnesses are entitled to full credibility, whereas Respondents witnesses are simply not so entitled. I say this with respect to Respondent's witnesses because of their appearance and demeanor on the stand in some cases (Gushleff and Susser) because of their extreme partisanship as reflected in the tenor of their answers to certain questions (all of Respondent's witnesses) and because of the evasive responses to many questions which could, and should, have been answered simply and directly (all of Respondent's witnesses).

ULTIMATE FINDINGS OF FACT

1. Athena Products, Ltd. (hereinafter sometimes Respondent or Athena) at various addresses shown in the caption hereof, in its advertising solicits the remittance of money through the mail in the sale of RNA, RX for Aging, Euzinc-D, Cellulite PM, Cellulite RR3, Ex-Sel, Food for Thought, META-E, Natural Calm, Athena Nutrition for Women, Chromill-GTF, Power Tabs, Athena Stay Young Program, Youth Factor, and In-Trim (formerly Control).

2. Respondent has directed that orders for the fifteen products which are the subjects of this proceeding be sent to some or all of the addresses shown in the caption hereof.

3. Respondent has not previously solicited, and as of the time of the hearing did not then solicit, the remittance of money for any of the aforementioned fifteen products to the following address:

P. O. Box 277, 977 Montreal Road, Clarkston, Georgia 30021. The Complaint was dismissed as to this address.

4. There were received in evidence exhibits which are true and correct copies of letters ordering the fifteen products from Respondent in test purchases by the Complainant, as follows: Exhibit numbers 3, 22, 42, 62, 82, 102, 122, 142, 162, 182, 202, 222, 242, 262, and 282.

5. There were received in evidence the following exhibits which are true and correct copies of money orders, with dates of issue as shown, mailed to Respondent by Complainant's representatives for the purchase of the fifteen products named in Finding of Fact (F.F.) 1: $M03,12,28,17$QExhibit No.$BProduct and Docket No.$BDate of Issue$D$G 4$BRNA (10/137)$BJune 4, 1980$G 23$BRX for Aging (10/136)$BJune 4, 1980$G 43$BFuzinc D (10/141)$BJune 5, 1980$G 63$BCellulite PM (10/135)$BOctober 17, 1980$G 83$BCellulite PM (10/134)$BJune 10, 1980$G103$BEx Sel (10/133)$BJune 5, 1980$G123$BFood for Thought (10/132)$BJune 4, 1980$G143$BMETA E (10/131)$BJune 3, 1980$G163$BNatural Calm (10/129)$BJune 4, 1980$G183$BAthena Nutrition for$BAugust 18, 1980$G$B Women (10/130)$G203$BChromill-GTF (10/128)$BJune 9, 1980$G223$BPower Tabs (10/139)$BJune 4, 1980$G243$BAthena Stay Young Program$BJune 4, 1980$G$B (10/140)$G263$BYouth Factor (10/138)$BJune 5, 1980$G283$BIn-Trim or Control (10/127$BApril 7, 1980$G$B (Stip., Tr. 432)$X

6. There were received in evidence the following exhibits which are true and correct copies of the envelopes in which the fifteen test purchase products were contained and which were received by Complainant's representatives: $M02,12,37$QExhibit No.$BProduct and Docket No.$D$G 5$BRNA (10/137)$G 24$BRX for Aging (10/136)$G 44$BEuzinc D (10/141)$G 64$BCellulite PM (10/135)$G 84$BCellulite TR3 (10/134)$G104$BEx Sel (10/133)$G124$BFood for Thought (10/132)$G144$BMETA-E (10/131)$G164$BNatural Calm (10/129)$G184$BAthena Nutrition for Women (10/130)$G204$BChromill-GTF (10/128)$G224$BPower Tabs (10/139)$G244$BAthena Stay Young Program (10/140)$G264$BYouth Factor (10/138)$G284$BIn-Trim or Control (10/127)$G$B (Stip., Tr 432)$X

7. In its advertisements Respondent makes the representations alleged in each Complaint.

8. The representations made by Respondent are material in that they are of the kind and character that would be calculated to, and do, cause the reader thereof to remit sums to Respondent to purchase the products so advertised and represented.

9. The representations found to have been made by Respondent are false as to material matters of fact.

10. Respondent solicits remittances of money through the mail by means of false, material representations.

CONCLUSIONS OF LAW

1. Respondent solicits remittances of money through the mail to the names and addresses shown in the caption hereof for products called RNA, RX for Aging, Euzinc D, Cellulite PM, Cellulite TR3, Ex Sel, Food for Thought, META-E, Natural Calm, Athena Nutrition for Women, Chromill-GTF, Power Tabs, Athena Stay Young Program, Youth Factor, and In-Trim or Control consisting of ingredients as heretofore stated.

2. Respondent guarantees that purchasers will be satisfied with the product or they can obtain a full cash refund.

3. An advertisement is to be considered as a whole and the meaning is to be determined in light of the probable impact of the entire advertisement on the person of ordinary mind. Donaldson v. Read Magazine, 333 U.S. 178, 189 (1948); Peak laboratories, Inc. v. United States Postal Service, 556 F.2d 1387, 1389 (5th Cir., 1977); Unique Ideas, Incl, v. United States Postal Service, 416 F. Supp. 1141, 1145 (S.D.N.Y., 1976). Based upon the foregoing criterion, Respondent makes the representations set forth in paragraphs 3 of the Complaints.

4. Person of ordinary mind reading Respondent's advertisements would interpret them substantially as characterized in the Complaints in the proceeding.

5. The representations found to have been made by Respondent are material representations because they are of the kind and character which would persuade readers to order and pay for Respondent's product.

6. The material representations heretofore found to have been made by Respondent in its advertising material are false as a matter of medical fact.

7. The fact that the placebo effect may occur in the case of some users does not support the efficacy of the product or the truthfulness of Respondent's representations. Stauffer Laboratories v. F.T.C., 323 F.2d 75 (9th Cir., 1965); Original Cosmetics Products, Inc. v. Strachan, et al., 459 F. Supp. 456 (S.D.N.Y., 1978) aff'd. w/o Op. 603 F.2d 214, 2d Cir. 1979, cert den. 444 U.S. 915 (1979).

8. Expert opinion testimony need not be based upon tests of the particular product in issue to constitute sufficient evidence of false advertising representations. Reilly v. Pinkus, 338 U.S. 269, 274 (149); Original Cosmetic Products, Inc. v. Strachan, supra.

9. A finding of falsity can be based on the testimony of expert witnesses whose testimony is in accord with the consensus of informed medical or scientific opinion when there is no contradictory evidence which is said to be in accord with such a consensus of opinion. Athena Products, Ltd., P.S. Docket No. 7/99 (I.D., Aug 8, 1980, decision now on appeal); Standard Research, P.S. Docket No. 7/78 (I.D., Dec. 18, 1979); Standard Research, P.S. Docket No. 7/48 (I.D., Aug. 31, 1979); Modern Age Products, Inc., P.S. Docket No. 5/102 (P.S. Dec., June 29, 1977; I.D., April 6, 1977); Nutrient Laboratories, P.S. Docket No. 5/48 (I.D., Nov. 17, 1976).

10. The views and opinions expressed by Complainant's witnesses are in accord with the consensus of informed scientific and medical opinion.

11. There was no claim that the views and opinion of Respondent's witnesses were in conformity with the consensus of informed scientific and medical opinion.

12. The falsity of Respondent's representations has been established by the preponderance of the competent, credible evidence.

13. Respondent's offer of a refund to dissatisfied purchasers does not overcome the effects of the making of false sales representations. Borg-Johnson Electronics v. Christenberry, U.S.D.C., S.D.N.Y., 169 F. Supp. 746, 751 (1959).

14. Respondent is engaged in conducting a scheme or device for obtaining money or property through the mails by means of materially false representations within the meaning of 39 U.S. Code 3005.

15. The constitutionality of the statute under which this proceeding was brought has been upheld for years, as well as recently. 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.

16. Respondent's stipulations at the hearing were that it had solicited remittances of money through the mails to some or all of the addresses in the caption hereof for all of the 15 products which are the subjects of this proceeding by means of the advertising materials which have been identified and received in this record as evidence. Those advertisements have been found to contain all the representations alleged in the 15 complaints, and all of those representations have been found to be materially false as a matter of fact. The proof as to the post office boxes to which the remittances were to be sent is contained in Respondent's stipulations.

An order of the type authorized by Section 3005 of Title 39 United States code, substantially in the form attached, should be issued against the Respondent at the various addresses listed in the caption hereof.

Proposed findings of fact and conclusions of law submitted by the parties have been fully considered, and to the extent indicated herein, they have been adopted. Otherwise, such proposed findings of fact and conclusions of law are rejected for the reasons that they are unsupported by or contrary to the evidence or because of their immateriality or irrelevance.

The seventeenth century French philosopher, mathematician and statesman, Blaise Pascal, once ended a letter by saying: "I have made this letter longer than usual, only because I have not had the time to make it shorter." M. Pascal was a wise and admirable man.

1/ Ex. C-11 indicates the presence of chromium (amino acid chelate) and chelated selenium not present in Ex. C-7. Also, whereas in Ex. C-7 certain substances are labeled as iron, copper, iodine, manganese and zinc+, in Ex. C-11, these substances are preceded by the word "Chelated" is a chemical term that refers to "a metal atom that is surrounded by a larger molecule, grabbing it like a crab." (Tr. 44-45)

2/ Unless otherwise indicated, all references in F.F. 5-12, incl., to paragraphs refer to paragraphs in the Complaint.

3/ The witness stated that he had never before seen the document. The statements with which the witness was asked to agree or disagree were read out of their contexts and did not always reflect the tenor of the particular sections in which they appeared. To give better balance, other statements will be included herein and in each instance the other statements will be identified as "Added text". When considered appropriate, a "comment," labeled as such, is added.