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January 24, 1964

UNITED STATES of America, Libelant,
An Undetermined Number of Shipping Packages * * * Labeled in Part:* * * 'VITASAFE FORMULA M' 'Vitasafe Formula W' 'Vitasafe CF' 'Vitasafe Queen Formula with Royal Jelly Supplement for Women', etc., Claimant

The opinion of the court was delivered by: LANE

This action, which arises under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., was initiated by the government's filing of a libel of information in this court wherein the United States, having seized a quantity of vitamin and mineral capsules and labeling for the articles located at Middlesex, New Jersey, under powers granted the United States by 21 U.S.C. § 334, sought to have these articles condemned. The items were in the possession of the Vitasafe Corporation, Division of Consolidated Sun Ray, Inc., and also in the possession of the United States Post Office after delivery for shipment in interstate commerce. The asserted ground for seizure was that the designated articles were misbranded within the meaning of 21 U.S.C. §§ 343(a), 352(a), and 352(f)(1). The items were concededly introduced into and traveling in interstate commerce within the meaning of the act.

 The libel was amended to specifically include the products 'Vitasafe CF' and 'Vitasafe Queen Formula with Royal Jelly Supplement for Women,' by name, which were found at the premises of Claimant when the monition was executed. A further amendment was allowed pursuant to Rule 15(a) of the Federal Rules of Civil Procedure, so as to include the allegation that the seized articles were misbranded while held for sale after shipment in interstate commerce, as well as when introduced into and while in interstate commerce.

 The United States alleges that the Vitasafe capsule, as an article of food within the meaning of 21 U.S.C. § 321(f), is misbranded under 21 U.S.C. 343(a) in that:

 I. Its labeling, when viewed as a whole, represents, suggests and implies that the nutritional needs for men and women differ, and that the 'Formula M' capsules are designed to satisfy the special needs of men as contrasted to the 'Formula W' capsules which are designed to satisfy the special needs of women, which representations, suggestions, and implications are contrary to fact;

 II. The listing on the label of, and references in the labeling to, certain ingredients implies and suggests that the nutritional value of Vitasafe capsules is enhanced by the presence of such ingredients, when in fact such implications and suggestions are false and misleading in that the presence of these ingredients is of no nutritional significance for dietary supplementation. The ingredients so listed are: vitamin K (menadione), rutin, lemon bioflavonoid complex, monopotassium glutamate, l-lysine monohydrochloride, dessicated liver, sodium caseinate, leucine, lysine, caline, histidine, isoleucine, phenylalanine, threonine, tryptophane, manganese, potassium, zinc, magnesium, sulfur, calcium, and phosphorous.

 III. The statements in the labeling to the effect that the quoted 'Minimum Adult Daily Requirements' (MDR) are a recommendation of the Food and Nutrition Board, National Academy of Science -- National Research Council, are false and misleading because the Food and Nutrition Board has not recommended any 'Minimum Daily Requirements' but has established 'Recommended Dietary Allowances' (RDA) which differ from the MDR and are not the allowances designated in the labeling as the 'Minimum Daily Requirements.'

 IV. The overall impression suggested and implied by the statements in the labeling concerning the large amounts of common foods that must be consumed in order to furnish quantities of nutrients equal to the quantities of such nutrients present in one Vitasafe capsule is false and misleading since such large quantities of food would not be needed to supply the necessary dietary requirements for these nutrients and since the labeling does not list all the various nutrients furnished by the stated quantities of food designated in the labeling.

 It is further alleged that the Vitasafe capsule, as a drug within the meaning of 21 U.S.C. § 321(g) is misbranded under 21 U.S.C. § 352(a) in that:

 V. Its labeling contains false and misleading representations, suggestions, and implications that the article is an adequate and effective treatment for depression, tension, weakness, nervous disorders, lethargy, lack of energy, lassitude, impotence, aches and pains, aging, impaired digestion, loss of appetite, skin infections, lesions and scaliness, night blindness, photophobia, fatigue, headache, insomnia, diarrhea, edema of the legs, hypersensitivity to noise, swelling, redness, soreness and burning of the tongue, impairment of memory, inability to concentrate, dermatitis, cracking of the lips, lesions at the corners of the mouth, growth filure in children, sore, swollen and bleeding gums, defective calcification of the bones, lowered resistance to disease and lowered vitality, which representations, suggestions, and implications are false and misleading since the article is not an adequate and effective treatment for the disease conditions and symptoms as stated and implied.

 VI. Its labeling contains false and misleading representations, suggestions, and implications that practically everyone in this country is suffering from or is in danger of suffering from a dietary deficiency of vitamins, minerals and proteins which is likely to result in specific deficiency diseases, such as scurvy, as well as a great number of non-specific symptoms and conditions, which threatened deficiency is represented as being due to loss of nutritive value of food by reason of the soil on which the food is grown, and the storage, processing, and cooking of the foods, which representations, suggestions, and implications are false and misleading since they are contrary to fact.

 It is further alleged that the article was misbranded within the meaning of 21 U.S.C. § 352(f)(1) in that its labeling fails to bear adequate directions for use of the article as a 'lipotropic factor' which it is represented to be.

 Claimant denies the essential allegations of misbranding and has moved for the dismissal of this action on the grounds that the large amounts of promotional material seized pursuant to monition were illegally seized since they do not constitute 'labeling' within the meaning of the act.

 This court has held that the approximately 3,730,000 pieces of written, printed and graphic matter are labeling within the meaning of 21 U.S.C. 321(m) and were properly seized. The memorandum opinion dated April 16, 1962, setting forth this decision *fn1" is incorporated by and made a part of this opinion.

 The issues before the court as defined in the pretrial order and as argued at the trial are:

 (1) Does the labeling of the seized res make the representations, suggestions, and implications as alleged in the amended libel of information?

 (2) Are any of these representations, suggestions, and implications false or misleading in any particular within the meaning of 21 U.S.C. §§ 343(a) and 352(a)?

 (3) Does the labeling of the seized article bear adequate directions for use of the article as a 'lipotropic factor' as required by 21 U.S.C. § 352(f)(1)?

 The evidence adduced at trial consisted wholly of real proof and expert testimony. The real proof offered by the government was extensive. It consisted of some forty-seven samples of literature seized which, together with the vitamin capsules, constituted parts of claimant's integrated sales and distribution program. The exhibits were, for the most part, elaborate advertising circulars directed to the general public and correspondence to prospective or present customers. They proclaim the various asserted virtues of the Vitasafe product, and are often accompanied by pictures representing the plight of vitamin-deficient sufferers before Vitasafe, the happy results of the Vitasafe treatment, doctors presumably in wholehearted agreement with the claims made, the capsules themselves, and like subjects.

 Also offered as proof were four plastic canisters containing vitamins, on the exterior of which appear a list of 'ingredients' and minimum daily requirements of same, along with the name of the product, the corporation distributing it, number of capsules contained, et cetera.

 The prime evidence offered by both parties was the testimony of experts whose function was to assist the court in establishing the character of the labeling's impression on those who read it, the truth of the labeling thus understood, and the adequacy of the directions for use of the product as a 'lipotropic factor.' A careful evaluation of this expertise is necessary for the proper determination of this case.

 The first witness called by the government was Gottfried M. Hochbaum, Chief of the Behavioral Science Section of the United States Public Health Service, a psychologist by profession. *fn2" Dr. Hochbaum's area of expertise may be generally described as the relationship between public relations and public health. He explained his work thus:

 'Some of our research was designed to identify factors which determine under what conditions people will or will not do certain things about their health as recommended by physicians, for example, why patients may not follow a doctor's prescription as to diets, toward exercises and other things; why people would or would not, and under what conditions people turn to a physician to help or other sources, pharmacists, neighbors, or anyone else. So, much of our research has dealt with identifying such factors.

 'Other research focused on communication, particularly communication in the health area. That is, how do people acquire information or misinformation in the health area, how do they develop certain habits from brushing their teeth to certain nutritional habits and others.

 'And thirdly, we have carried out research on how this knowledge can be translated in improving the education of the public in the health area, which involves communication, change of attitudes and habits, and so forth.'

 Dr. Hochbaum was eminently well qualified to testify to the type of consumer at which Vitasafe's advertising was directed and to give an expert opinion on the content of the labeling, as it is understood by these people.

 Dr. Hochbaum characterized the various forms of advertising engaged in by claimant company as material which would probably be discarded by people with a reasonable amount of intelligence and education. But, on the other hand, it would be read by people who are in the low socio-economic level; people in the habit of reading pulp magazines of the 'True Love Stories' variety. He noted that these magazines use the same type of pictures and headlines in the same style as used in subject advertising material. It was the doctor's opinion that the type of woman who reads these pulp magazines would, upon examining the advertising material here in evidence '* * * identify with the women in these pictures, * * * immediately connect (the problems illustrated in the advertising) with their own problems, because that is the way they have been used to reading these stories. They would immediately see in those headlines some of the problems they, themselves, experience, frustrations, marital problems, and so forth. A lot of these features would attract their attention and arouse their interest in reading on.'

 Dr. Hochbaum, in answer to a question of the court, agreed that he was referring to material like C-1 of Exhibit G-1 wherein is displayed five headlines with pictures of a girl or a girl and a man. One reads, 'I couldn't stop torturing him,' and another, 'Our fights have turned to kisses.' There is also a picture of a couple, presumably husband and wife, he being stretched out on a couch. The headline is, 'I'm worried. * * * My husband's idea of a good time -- sleeping all day Sunday.'

 The doctor testified:

 '* * * I believe that this kind of material would arouse the interest of many people who suffer from real or imaginary complaints, these vague variety of complaints such as tiredness, nervousness, real or imaginary, sexual impotence, marital problems, and so forth, because many of these people with little education who are very naive cannot identify the causes of their difficulties, and because they cannot * * *, they look for some magic formula, something that will change their lives and satisfy all their needs and remove their frustrations, so they turn to something like this with the real hope that this would provide a solution to their problems. And everything in here is in the form that would appeal to exactly this kind of people, attract these kinds of readers.'

 In evaluating the very many ailments that claimant's advertising lists under 'Some Examples of What Lack of Vitamins and Minerals Can Mean,' Dr. Hochbaum stated that people who can be expected to read such material would begin to identify themselves with the various ailments listed. As they read down the list and come to symptoms which do not particularly fit them, they are likely to acquire an attitude of susceptibility to suggestion and say, for example, 'Come to think of it, last week my tongue did feel a little swollen.' Thus, they are caught in this net that is thrown out in the form of a listed multitude of symptoms. He stated that the advertising techniques by claimant company are those employed in many similar fields and that in devising and using such techniques, psychologists and various market consulting firms may well have been employed.

 Further, Dr. Hochbaum testified that Vitasafe's offer of different 'plans' for men and women implied to the average reader, unequipped to know the truth of the implication, that the nutritional needs of men and women are significantly different and that different kinds of nutritional treatment are therefore required. In this context, moreover, the term 'high-potency capsule' implies that the consumption of the products will effect marital adjustment in some positive way.

 The second expert witness for the government was Milton Wight Taylor, Professor of Biochemistry and Chairman of the Department of Agricultural Biochemistry at Rutgers University since 1954. *fn3" He is a member of many professional societies and has authored some 50 technical papers in the field of nutrition.

 Dr. Taylor's testimony was that the literal language of Vitasafe advertisement Exhibit G-1(H) asserts that the consumption of any one of four or five foods in the groups shown would provide the user with the amount of the listed vitamin contained in the Vitasafe capsules. But the average reader might well assume that all the food pictured must be eaten to provide the vitamin equivalents in his diet. And the witness stated that an individual who ate one selection of each of the groups of foods connected to a vitamin would receive a good deal more than listed in the capsule because many of the foods listed are sources of many other vitamins and minerals; that a consumer who is receiving by means of his regular diet the average value in any particular vitamin would be receiving no benefit from additional vitamins contained in Vitasafe capsules; and that various vitamins listed in the advertising of claimant company, while essential in diets, show amounts so infinitesimal compared with the amounts contained in regular diets that the capsule ingredients could not possibly be of any benefit to consumers.

 Dr. Taylor asserted that excessive vitamins over the minimum daily requirement are, at best, of no benefit and that adding additional amounts of watersoluble vitamins, vitamin B-2 for example, to a diet already containing adequate quantities of the vitamin, merely results in excretion of the excess. With reference to claimant company's advertising he states that Exhibit G-1 (H-1) depicts a quantity of carrots which would probably supply in the neighborhood of twenty to thirty times the requirement of vitamin A. But, carrots are not depicted in claimant company's advertising as a source of vitamin A, but rather as a source of vitamin E, -- and yet carrots are not an outstanding source of vitamin E. In this connection, he said:

 'Almost without exception the foods contain other nutrients besides the ones which are shown in the exhibit. It is almost impossible to get foods which do not contain several nutrients. It is very difficult, when we are working with experimental rations, to produce such things. We can use things like starch or sugar and synthetic vitamins, minerals. We do not use natural foods, because they contain so many things.'

 The witness further stated that a vitamin capsule would provide nothing that is needed by the consumer if he is an average American eating average meals. Only if his diet were unusual and restricted, like an elderly person surviving on little more than tea and ...

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