Any other construction of Section 352(f)(1) would provide the manufacturer and shipper with a convenient loophole through which he could evade the Act with resulting danger to public health. He need only include in the labeling either dosage directions alone, or with the addition of one or more bodily diseases or ailments for which he claims the drug is efficacious, and by a contemporaneous advertising campaign lead the public to believe that the drug is a remedy for a multitude of ailments. In such cases, if claimant's first and third defenses be good, there is no section of the Act which protects the public against the resulting harm.
I am not impressed by the argument of counsel for claimant that the administrative interpretation hereinbefore set out sustains his construction of Section 352(f)(1). Keeping in mind the Congressional intent, I am of opinion that the clear meaning of the Administrator in this interpretive regulation is that not only the dosage, but the disease or diseases for which such dosage is recommended or advertised, must appear in the labeling if the labeling is to be held to bear adequate directions for use. This conclusion finds support in the case of United States v. Colgrove, D.C.S.D. Cal., 83 F.Supp. 880, cited in the government's brief as No. 5992, in which case the District Court granted an injunction restraining defendants from introducing into interstate commerce any product without a label bearing adequate directions for use of such product in the treatment of all ills for which it was advertised, which directions were to include the dosage to be taken in each of such conditions.
Paragraphs (A) and (B) of claimant's first defense in the answer to the libel, and the third defense therein, will therefore be stricken as insufficient defenses.
It will next be considered whether the alleged fact that the booklet, 'Dynamic Digest,' was not disseminated prior to August 15, 1947, if true, is a defense to the allegation that certain articles of drug which were shipped prior to that date were misbranded for lack of inclusion in the labeling of the names of the diseases and ailments for which they were recommended for use in 'Dynamic Digest,' together with directions for their use in such ailments. All but five of the articles of drug mentioned in the libel were advertised in both 'Health Mysteries' and 'Dynamic Digest,' with substantially the same recommendations and representations with respect to their remedial and curative qualities. One of the five shipments as to which the allegations are based solely on claims made in 'Dynamic Digest' was made after August 15, 1947. As to another of the five, the allegation of misbranding is based not only on claims made in 'Dynamic Digest,' but also on omission from the labeling of any directions for use other than mere prescription of the quantity and frequency of dosage. Therefore, the words 'but avers that 'Dynamic Digest' was not disseminated by it prior to August 15, 1947,' appearing in Paragraphs 21, 22, 23, 27, 29, 33, 34, 35, 36, 38, 39, 41 and 42 of the fourth defense will be stricken as immaterial.
This leaves for consideration three articles of drug advertised only in 'Dynamic Digest,' of which some shipments were made prior to August 15, 1947, with respect to which the sole basis of the libel is that claims of therapeutic qualities as to certain diseases were made in 'Dynamic Digest.'
It is my opinion that the drugs in these particular shipments could not be said to be misbranded under the terms of Section 352(f)(1) by reason of omission from the labeling of those diseases and ailments for which the drugs had not been held out in any way to the public as cures or palliatives prior to the respective dates of shipment. Therefore, I will overrule the motion to strike the words 'but avers that 'Dynamic Digest' was not disseminated by it prior to August 15, 1947,' appearing in Paragraphs 25, 31 and 43, of the fourth defense, insofar as they relate to those shipments of the three articles of drug last referred to made prior to August 15, 1947. Of course, the government may still prevail in its charge that these drugs were misbranded, if it can prove that it was the intention of the shipper at the time of shipment to make the claims for them which were afterwards made in 'Dynamic Digest;' but this proof cannot rest alone on the fact that 'Dynamic Digest' was subsequently disseminated.
Finally, with reference to the second defense, namely, that dissemination of the booklets 'Health Mysteries' and 'Dynamic Digest' has been abandoned by the claimant: It does not appear from any of the pleadings that the booklets are alleged to have been abandoned prior to the shipping date of any of the shipments which were seized. Their abandonment after shipments were made could constitute no defense to the allegation of misbranding, since under the Act misbranded drugs may be seized at any time after they are shipped in interstate commerce. 21 U.S.C.A. § 334. Therefore, the motion to strike the second defense will be sustained as the pleadings now stand. However, I believe that if the answer were amended to show that the abandonment of dissemination of the booklets took place before the date of some or all the shipments, this would be a good defense, at least conditionally, as to those shipments which were subsequent to the abandonment. I say conditionally, because it is only to the extent that the abandonment of such dissemination creates an inference that the shipper did not intend, when it shipped the drugs in interstate commerce, that they be used for the treatment of the diseases named in the booklets, that the abandonment can be said to be effective as a defense. The government might introduce evidence to show that, notwithstanding such abandonment, it was still the intention of the shipper that the drugs be used for the treatment of the diseases mentioned in the booklets; but in the absence of such proof, it is my opinion that the abandonment would warrant the inference that there was no intent to misbrand as to drugs shipped thereafter.
One of the arguments advanced by claimant is that since the Federal Trade Commission has been given authority by Congress to prevent false advertising, whereas such authority has been denied to the Food and Drug Administration, it should be held that the Federal Trade Commission is the only agency of government which can operate in this field. But it is well settled that the action of either of these agencies -- that of the Food and Drug Administration relative to misbranding, and that of the Federal Trade Commission relative to false advertising -- is not the exclusive remedy afforded to the government in a case where both misbranding and false advertising are present. In other words, the fact that the government may seize an article because it is misbranded does not prevent the Federal Trade Commission from issuing a cease and desist order with reference to false advertising concerning that article; and conversely, the issuance of a cease and desist order does not prevent the government from proceeding against the article because of the misbranding. United States v. 5 Cases of Capon Springs Water, 2 Cir., 1946, 156 F.2d 493; United States v. Research Laboratories, 9 Cir., 1942, 126 F.2d 42, certiorari denied 317 U.S. 656, 63 S. Ct. 54, 87 L. Ed. 528.
An order may be entered in accordance with this opinion.