Alberty Food Products v. United States, 13062.
| Decision Date | 15 February 1952 |
| Docket Number | No. 13062.,13062. |
| Parties | ALBERTY FOOD PRODUCTS et al. v. UNITED STATES. |
| Court | U.S. Court of Appeals — Ninth Circuit |
Eugene M. Elson, Los Angeles, Cal., for appellant.
Walter S. Binns, U. S. Atty., Clyde C. Downing, Asst. U. S. Atty., Tobias G. Klinger, Asst. U. S. Atty., all of Los Angeles, Cal. (Arthur A. Dickerman, Attorney, U. S. Food and Drug Administration, Federal Security Agency, Los Angeles, Cal., of counsel), for appellee.
Before DENMAN, Chief Judge, and ORR and POPE, Circuit Judges.
The facts of this case have been stipulated. They appear in detail in the opinion of the District Court. D.C.S.D.Cal. 1951, 98 F.Supp. 23, 25. For our purposes it is sufficient to state that appellants manufacture, pack and distribute certain drugs in interstate commerce. The District Court found the drugs in question to be "misbranded" within the meaning of the Federal Food, Drug and Cosmetic Act in that their labeling failed to bear "adequate directions for use". 21 U.S.C.A. § 352(f)(1). An injunction was issued permanently restraining appellants from introducing into interstate commerce said drugs or any other drug "* * * which is misbranded within the meaning of 21 U.S.C. § 352(f)(1) by reason of the failure of its labeling (1) to enumerate the disease conditions for which said drug is intended and offered to the public, (2) to specify the structures or functions of the body which it is intended to affect and for which it is offered to the public, and (3) to state the dosage and frequency and duration of administration of such drug for the treatment or prevention of such conditions, or for affecting such structures or functions of the body."
The principal contention made on this appeal is that the trial court erred in taking into consideration, in making its finding that the drugs in question were misbranded, certain collateral literature (leaflets and booklets, etc.,)1 sent by appellant to prospective customers. Appellants obtained customer names in various ways: (a) from retail outlets selling the drugs; (b) from demonstrators hired by appellants to work in retail outlets, and (c) from customer inquiries and mail orders. Newspaper and magazine advertising was also used to promote sales of the drugs. These promotional materials contained claims, representations and suggestions relating to use of the drugs not present on the labels.2 It is asserted by appellants that a consideration by the trial court of the literature and advertisements is an invasion of a field exclusively under the jurisdiction of the Federal Trade Commission, which has control of false advertising. This contention fails to grasp the scope and purpose of the inquiry with which the Court was concerned. It is not the truth or falsity of the literature and advertising which is challenged; it is merely consideration, as evidence, of claims promulgated by the manufacturer in measuring whether the information communicated by means of the label adequately describes the diseases or conditions for which the drug was intended as well as relevant facts containing dosage.
In order for the labeling of a drug to bear "adequate directions for use" within the meaning of 21 U.S.C.A. § 352(f)(1) it must, among other things, state the purposes and conditions for which the drug was intended and sufficient information to enable a layman to intelligently and safely attempt self medication. Alberty...
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