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UNITED STATES v. ARTICLES OF DRUG

March 4, 1965

UNITED STATES of America, Libellant,
v.
ARTICLES OF DRUG Consisting of Undetermined Quantities of Vitamin, Mineral, and Other Dietary Preparations * * *, FOODS PLUS, INC., (Claimant), Defendant



The opinion of the court was delivered by: WORTENDYKE

In its libel of information praying seizure and condemnation of certain articles of drug therein particularized, in the possession of Foods Plus, Inc., (hereinafter Foods Plus or claimant) in this District, the United States of America charges that the articles described were misbranded when introduced into, while in, and while held for sale after such shipment in interstate commerce, within the meaning of 21 U.S.C. § 352(a) *fn1" and § 352(f)(1). *fn2" Seizure was effected on January 30, 1962, under appropriate process, and notice of claim to the articles seized was filed by Foods Plus, Inc. Claimant denies the misbranding charged. This Court has jurisdiction of the subject matter of the cause and of the parties in interest therein. 21 U.S.C. § 334(a).

Libelant charges that the articles seized were misbranded under § 352(a) in that their labeling, i.e., the labels upon their containers and the booklet entitled 'Foods Plus 1962 Vitamin Catalog' (hereinafter catalog) which accompanied the articles, contain statements which represent and suggest that the articles are superior to similar products available on the market because they were formulated by one Carlton Fredericks, Ph. D., who is alleged in the catalog to be an internationally prominent nutritionist; that vitamins are more effective in combination with each other and with minerals; and that the nutritional requirements of old people differ from those of adults generally.

 The Government further charges that eight of the seized articles of drug were misbranded under § 352(a) in that their labeling (the catalog) represented them to be effective to promote a healthy, vigorous feeling; to promote growth in children; to convert fatty tissues into energy; to prevent tiredness and poor appetite, and the like.

 Finally, the libel alleges that all of the seized articles were misbranded under § 352(f)(1) because Foods Plus, through its intimate relationship with Carlton Fredericks, a radio commentator in the field of nutrition, represented the various articles to be effective in the prevention and mitigation of disease conditions, but that neither he nor any labeling (the catalog included) prescribed 'adequate directions for use' of the articles as required by § 352(f) (1).

 Claimant stipulated that the products seized were received after shipment in interstate commerce, and that its catalog constitutes labeling of the seized articles as defined in § 321(m) of the Act, *fn3" within the meaning of §§ 352(a) and 352(f)(1). Claimant also concedes that some of the seized articles are drugs as defined in § 321(g) of the Act. Claimant denies, however, that the statements made in its catalog amount to the representations charged by the Government, or lack the directions for use of its products required by § 352(f)(1). More specifically, claimant insists that its catalog does not state that its products are superior to similar products available on the market, but that it merely discloses that Carlton Fredericks is claimant's consultant; that he has prescribed the formulas for certain of claimant's products offered in the catalog; and that he endorsed those products. Claimant does admit that its catalog states that there are no finer quality vitamins at any price, and that claimant's vitamins are the finest quality vitamins at lowest possible prices. The catalog admittedly characterizes Fredericks as an internationally prominent nutritionist, but it does not state that he is internationally and prominently recognized as an authority on nutrition. Claimant also denies that its catalog states that the nutritional requirements of people of old age are different from those of adults generally, but insists that the statement therein that vitamin and mineral deficiencies may become more common as we grow older because of restricted diets, digestive disturbances, difficulties in chewing and limited taste preferences is a true statement of fact. In sum, claimant contends that every statement set forth in its catalog is true and correct.

 With regard to the Government's charge that the claimant's products are misbranded under § 352(f)(1) of the Act, claimant denies (1) that the radio broadcasts of Federicks were advertising for or representations in behalf of claimant's products; (2) that said broadcasts recommended the use of claimant's products in the treatment of various diseases; and (3) that claimant's labeling fails to list those diseases or conditions. Although the Government's contentions based upon § 352(a) may be valid, V. E. Irons, Inc. v. United States, 1 Cir. 1957, 244 F.2d 34, cert. den. 1957, 354 U.S. 923, 77 S. Ct. 1383, 1 L. Ed. 2d 1437; United States v. ' Vitasafe Formula M', D.C.N.J.1964, 226 F.Supp. 266, since the articles in question are clearly misbranded under § 352(f)(1), the question as to their misbranding under § 352(a) has not been further considered.

 Shortly after issue was joined, claimant moved for summary judgment in favor of the libellant, upon the ground that claimant recognized that an honest difference of opinion could exist as to whether the articles were misbranded under § 352(a). For this reason claimant sought a decree holding that the articles seized were misbranded under § 352(a) but authorizing their release from seizure for the purpose of relabeling by claimant in conformity with the requirements of the section. In support of this motion, claimant represented that its previous contractual relationship with Carlton Fredericks had by then terminated. Claimant persisted, however, in contending that the articles were not misbranded under § 352(f)(1), and refused to consent that the suggested decree so adjudicate. Claimant's motion was denied, and libellant's cross-motion for leave to amend the libel by including a prayer for injunctive relief prevailed.

 (1) the Food and Drug Act (specifically 21 U.S.C. § 352(f)(1)) requires that 'adequate directions for use' of a drug be borne by its 'labeling';

 (2) the articles seized, which comprise various quantities of some 43 different formulas of vitamin, mineral and other dietary preparations, are drugs; and

 (3) the labeling associated with the formulations does not contain adequate directions for the use of the articles seized. Therefore, argues the Government, these articles are misbranded, and were subject to seizure under 21 U.S.C. § 334.

 The initial question here presented is whether the seized articles are drugs under the Act and so within the proscription of § 352(f)(1). In § 321(g)(2) the term drug is defined as 'articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.' The Government conceded that it was required to show by the evidence that '(a) during the course of his radio programs, Carlton Fredericks made certain claims for the preventive, curative, and therapeutic properties of vitamins, minerals and proteins for use in certain disease conditions (and) (b) these claims were in reality representations or * * * advertisements for all the Foods Plus products, including those under seizure * * *.' The crux of the Government's case is that Carlton Fredericks' radio broadcasts, his reputation, and his listening audience were exploited by Foods Plus in such a way as to implant in the mind of a person listening to these broadcasts (especially that of a regular listener), the idea that many of the ills of man, from simple malaise to a great number of diseases, could be prevented, mitigated, or cured by the ingestion of Foods Plus vitamins and dietary supplements.

 Concededly accurate transcripts of radio broadcasts by Carlton Fredericks over Stations KGMC, Englewood, Colorado, WOR, New York City, and KLZ, Denver, Colorado, clearly disclose that, despite occasional admission, that only medical people could advise a person on the therapeutic use of vitamins, Carlton Fredericks extolled the value of vitamin and mineral supplementation for use by the layman in the prevention, treatment and cure of disease.

 On November 23, 1961, during a broadcast over Station KLZ in Denver, Fredericks said:

 'Greetings, my friends, this is Carlton Fredericks, the program is Living Should be Fun. * * * This radio nutrition class (a weekly item on his daily programs) is on the air every Thursday on this station at this time. And the course is continuous so that the lessons you missed will be repeated * * * we are now discussing the subject of Vitamin E. You've missed the discussion of Vitamin B Complex and Vitamin C and Vitamin A and D and the bioflavonoids. But those will be repeated as I said in the next session * * *. In the interim you can catch up with some of what you missed by reading my Vitamin Guide which is a publication I wrote really to answer a specific question * * * what kind of a vitamin supplement did you put together to take case of your children when * * * you were dissatisfied with the vitamin drop preparations which were on the market at the time?

 'Well, I'm still dissatisfied * * * and the formula I put together for my children has been placed on the market by several companies. And the vitamin supplements which Mrs. Fredericks and I use are on the market from dozens of companies. I'm ...


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