United States v. " VITASAFE FORMULA M"

• Decision Date: 05 February 1964
• Docket Number: Civ. No. 875-60.
• Citation: 226 F. Supp. 266
• Parties: UNITED STATES of America, Libelant, v. 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.
• Court: U.S. District Court — District of New Jersey

226 F. Supp. 266

UNITED STATES of America, Libelant, v. 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.

Civ. No. 875-60.

United States District Court D. New Jersey.

January 24, 1964.

As Amended February 5, 1964.

David M. Satz, Jr., U. S. Atty. for District of New Jersey, by William E. Brennan, Attorney, Department of Health, Education and Welfare, for libelant.

Bass & Friend, New York City, by Milton Bass, New York City, for claimant.

LANE, District Judge.

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.

Pursuant to monition, there were seized at the Vitasafe Corporation's premises 906 packages containing Vitasafe capsules, and approximately 3,730,000 pieces of written, printed, and graphic material designed to promote the sale of the Vitasafe capsules.

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 failure 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 decision¹ 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.² 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

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