ORR, Circuit Judge.
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,
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.,)
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 Food Products Co. v. United States, 9 Cir. 1950, 185 F.2d 321, 325; Cf. H.Rep. No. 2139, 75th Cong.3d Session 8.
While appellants agree with this construction they argue that such fact must be determined from the labeling alone. This contention is without merit. It is not sufficient that the labeling contain a minimum of information and the use of the drug be induced by elaborate collateral representations. To permit the operation of such an escape valve would render the aims and purposes of labeling requirements nugatory. Adequate labeling is best suited to obtain the beneficent purposes contemplated by the Act, viz.: broad protection of the consumer from adulterated or misbranded drugs, etc., and as a practical matter places no burden on those motivated by an honest belief that the claims made for their drug will be accomplished by its use.
In the instant case appellants argue that the drugs involved in this case can properly be classified as "dietary supplements and laxatives," and labeling to that effect is sufficient, because such uses and purposes are of common knowledge. Such an argument has no validity because it is admitted that the drugs have been held out to the public as having beneficial and curative qualities other than their commonly known uses.
The finding of the trial Court that the labels in question do not bear adequate directions for use finds ample support in the law and evidence. See United States v. Various Quantities of Articles of Drug,
Judgment affirmed.
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