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United States v. Article of Drug Consisting of Undetermined Quantities of Vitamin

decided: July 11, 1966.


Hastie and Smith, Circuit Judges, and Kirkpatrick, District Judge.

Author: Kirkpatrick

KIRKPATRICK, District Judge.

This appeal is from a judgment of the District Court condemning as misbranded, within the meaning of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. ยง 334, a quantity of vitamin products. The misbranding charged by the Government was that the labeling of the products was not in compliance with Section 352(f) (1) of the Act in that it failed to bear "adequate directions for use." The appellant, Foods Plus, Inc., the manufacturer and owner of the seized articles, filed a claim for them in the District Court.

Having earlier in the proceeding allowed the Government to amend its libel by adding a prayer for an injunction, the Court, in addition to condemning the products, enjoined the claimant from any act which would result in the products under seizure, or any similar products, being introduced into interstate commerce if misbranded in the manner which the Court had found violative of the Act.

The trial judge found as a fact that the articles seized (which comprised various quantities of some 43 different formulas of vitamin, mineral and other dietary preparations) were drugs -- a finding not now disputed.

The labeling in this case consisted of a catalog of the vitamin and mineral products offered for sale by the claimant, it having been stipulated that its catalogs were labels within the meaning of the Act.

Whether labeling contains "adequate directions for use" of an article necessarily depends upon what it is intended to be used for. In this case, although the catalogs were in a general way suggestive of therapeutic values for the products, they contained nothing whatever to indicate for what diseases or conditions the various preparations were supposed to be beneficial and, in consequence, nothing to show how they were to be used or administered. Since failure to include this information constituted the inadequacy of labeling charged, proof of the intended use of the preparations was a vital part of the Government's case. The Government undertook to show that the claimant intended its vitamin products to be used as medicaments for the prevention, mitigation or cure of various diseases in man, and the Court made a finding to that effect. Whether the evidence was sufficient to support that finding is the point upon which this case turns.

The evidence consisted mainly of transcripts of a series of radio broadcasts by one Carlton Fredericks whom the claimant described in its catalog as an "internationally prominent nutritionist." The broadcasts were commentaries covering the general subject of public health, principally in the field of nutrition, with heavy emphasis being placed upon the therapeutic value of vitamins and of food products fortified by vitamins, the central idea being that many of the ills of man, from simple malaise to serious diseases, can be beneficially treated by the use of vitamins and minerals as dietary supplements.

Neither Foods Plus, Inc., nor the trade name of any of its products was mentioned in any of the Fredericks broadcasts. However, advertisements of Foods Plus vitamins were presented in commercials, some of which immediately succeeded the Fredericks programs. Whenever a listener responded to Fredericks' broadcast invitations to write to him for nutritional information, advice or literature, the claimant, which had Fredericks under contract to turn over to it all such letters, would send the listener its catalog.

Fredericks' picture, together with a statement of his academic degree and his fame as a nutritionist, appeared on the first page of the catalog as well as the fact that he was the claimant's "Chief Consultant" and that he had "scientifically formulated the exclusive formulas in this catalog" and that he personally endorsed the product. In addition to the above, it was in evidence that he was employed by the claimant by written agreement as its consultant to (among other things) "aid in the sale and promotion of the products of Foods Plus." He was to receive a weekly salary and agreed not to perform any of the services specified in the contract for any person or corporation other than the claimant.

Upon evidence of the foregoing facts, the Court found that there existed a close relationship between Fredericks and the claimant, that the claimant adopted as its own representation Fredericks' broadcast claims that vitamins were efficacious for the prevention and treatment of human disease, and that the claimant intended its products to be used for the purposes recommended by Fredericks.

The facts are practically undisputed and we find no reason to disturb the inference drawn from them by the trial judge or the conclusion that the articles seized in this action were misbranded as alleged in the libel.

The appellant relies strongly upon United States v. 24 Bottles "Sterling Vinegar & Honey, etc.", Balanced Foods, Inc., Claimant, 2 Cir., 338 F.2d 157, but that case cannot be taken as a precedent governing the present one. In both cases the issue was simply the sufficiency of evidence to prove a contested issue of fact, namely, an intention or purpose on the part of the claimant of seized goods. In the Balanced Foods case the question was whether certain condemned books which extolled the virtues of a vinegar and honey concoction sold by the claimant were "labels", and the Court held that the evidence was insufficient to establish that degree of relationship which would have made the books labels within the meaning of the Act and subject to condemnation. The Court said, "There was no evidence of any joint promotion of either book with Vinegar and Honey, however. It perhaps could be inferred that the officers of Balanced Foods realized that sale of the books would tend to promote sale of Vinegar and Honey. But there can be no inference that it sold the books for that purpose." In the present case the question was as to the intention that the articles should be used for a purpose not disclosed by the catalog. The Court held that the evidence offered to show what that intention was was sufficient. In fact there was the strongest kind of evidence that the broadcasts were used to disclose the uses intended.

The appellant contends that the District Court had no personal jurisdiction over it and, therefore, no power to enter the injunction. The libel was amended to ask for injunctive relief nearly a year before the case came to trial. An extensive trial was had and the appellant raised this question for the first time in its post-trial brief. It is unnecessary to cite cases for the proposition that, if a defendant goes to trial on ...

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