The opinion of the court was delivered by: MOORE
On October 19, 1948, the government filed a libel against various quantities of articles alleged to be articles of drug and to have been shipped in interstate commerce by Alberty Food Products, a co-partnership. Various dates of shipment are alleged, beginning March 26, 1947, and ending November 10, 1947. The libel charges misbranding, within the meaning of Section 352(f)(1) of the Federal Food, Drug, and Cosmetic Act. 21 U.S.C.A. § 301 et seq. Different bases for the allegations of misbranding are alleged with reference to different shipments. They fall into three groups. As to one group of shipments, it is alleged that they were misbranded because they did not contain in the labeling a statement listing various diseases and ailments of the human body as to which they were claimed to possess therapeutic value, in two booklets disseminated by the manufacturer, packer and distributor, denominated respectively 'Health Mysteries' and 'Dynamic Digest.' Another group is alleged to be misbranded for lack of the same information in the labeling, but with reference to 'Dynamic Digest' alone. The third group is alleged to be misbranded, not only because its labeling contains no reference to the diseases for which claims are made in 'Health Mysteries' and 'Dynamic Digest,' but also because the labeling contains no directions for use other than a designated quantity and frequency of dosage.
Alberty Food Products on December 2, 1948, filed its answer to the libel, setting up, among other defenses, (A) that Section 352(f)(1) of the Act does not sustain the allegations of the libel for the reason, as claimant avers, that the provision that the labeling contain 'adequate directions for use' does not require that the labeling of a drug state the diseases or conditions of the body for which the drug when used as directed will be effective, nor does it require that the labeling of a drug state each of the diseases and conditions of the body for which the drug is advertised as a therapeutic treatment; (B) that the dissemination of the booklets 'Health Mysteries' and 'Dynamic Digest' has been abandoned by the claimant following cease and desist orders of the Federal Trade Commission heretofore issued against the claimant on the ground that the booklets contain false advertising; (C) that the labeling upon each of the articles prescribes maximum quantity and dosage, and therefore satisfies the requirements of Section 352(f)(1) of the Act, and (D) that the booklet entitled 'Dynamic Digest' was not disseminated prior to August 15, 1947, whereas some of the articles alleged to be misbranded for lack of information in the labeling about diseases and ailments concerning which claims are made in 'Dynamic Digest' were alleged to have been shipped in interstate commerce prior to that date.
The government has moved to strike the above defenses from the answer on the ground that they are insufficient in law, and on the further ground as to some of them that they are immaterial.
The relevant portions of the Act, together with the interpretive regulation with reference thereto issued by the Commissioner of Food and Drugs on December 22, 1939, as amended April 10, 1941, are as follows:
Section 352: 'A drug or device shall be deemed to be misbranded --
'(f) Unless its labeling bears (1) adequate directions for use; * * * .'
Section 334: '(a) Any article of food, drug, device, or cosmetic that is adulterated or misbranded when introduced into or while in interstate commerce * * * shall be liable to be proceeded against while in interstate commerce, or at any time thereafter, on libel of information and condemned in any district court of the United States within the jurisdiction of which the article is found * * * .'
21 C.F.R.Cum.Supp.Section 2.106: '(a) Directions for use may be inadequate by reason (among other reasons) of omission, in whole or in part, or incorrect specification of:
'(1) Directions for use in all conditions for which such drug or device is prescribed, recommended, or suggested in its labeling, or in its advertising disseminated or sponsored by or on behalf of its manufacturer or packer, or in such other conditions, if any there be, for which such drug or device is commonly and effectively used; * * * .'
It is obvious that in the use of drugs for self-medication the health of the consumer may be endangered in any of three ways: First, if the drug is misbranded either by omission from the labeling of a statement of its ingredients, or by false statements in the labeling with reference to the contents of the package, or with reference to the efficacy of the drug in the treatment of certain diseases; secondly, if the drug is placed on the market with no mention in the labeling of any disease or ailment for which the manufacturer intends it to be used as a cure or palliative, while at the same time the manufacturer falsely advertises it to the public through other means as having therapeutic value in certain diseases; and, thirdly, if the labeling mentions some diseases or ailments for which the drug is claimed to be a remedy, while the manufacturer falsely advertises to the public by other means that it is a remedy for other and different diseases and ailments. The peril to public health from the first of these means is apparent from its mere statement, and Congress has provided protection against the danger in Section 352(a) of the Act. It is perhaps not so clearly apparent from the other two means. Nevertheless the danger therein is real and substantial. Where no diseases or ailments whatever are mentioned in the label, if the consumer who purchases the product is one who is not aware of the advertised claims he is left to speculate without guide as to the diseases or conditions for which it is intended to be used, and therefore may use it for some condition in which it is neither effective nor intended to be so, but may be harmful. If the consumer is aware of the advertising, he is led to purchase the drug for self-medication in some disease or condition for which it is not effective, and may be harmful. In the third situation, a consumer who has knowledge of the advertiser's claims may purchase the drug for use, not for an ailment specified in the labeling, but in some disease or condition for which the advertiser falsely claims it is efficacious, though not mentioned in the labeling; and in such case, if the advertiser's advice be followed, the result is the same as in the second situation. A purchaser is led into a form of self-medication which is of no benefit to him, which may be directly harmful, and which is further deleterious to his health because of the fact that it deters or prevents him from seeking other means of relief.
The section of the statute under consideration must be construed in the light of the underlying Congressional purpose, and so as to give effect to the Act as a whole, if a reasonable construction can be arrived at which may accomplish that end.
The words, 'adequate directions for use,' necessarily relate to some purpose which is to be served by the use, and that purpose must be consistent with the intent of the Act as a whole to protect the public health. For what purpose are drugs used? Obviously, as a remedy for some ailment of the body. It seems equally obvious that no drug can be said to contain in its labeling adequate directions for its use, unless every ailment of the body for which it is, through any means, held out to the public as an efficacious remedy be listed in the labeling, together with instructions to the user concerning the quantity and frequency of dosage recommended for each particular ailment. See the following unreported cases, cited in the government's brief: United States v. 150 Pkgs. Bush Mulso Tablets, D.C.E.D. Mo., 83 F.Supp. 875; United States v. 516 Cases, Nue-Ovo, D.C.S.D. Col.
It may be that compliance with this requirement, thus freeing the shipper from any liability under Section 352(f)(1), would result in the drug being misbranded under Section 352(a) of the Act; and doubtless this is the precise result which was intended in those cases where false and ...