DocketNumber: 30
Citation Numbers: 93 L. Ed. 2d 52, 69 S. Ct. 106, 335 U.S. 345, 1948 U.S. LEXIS 2742
Judges: Douglas, Black, Frankfurter, Murphy, Jackson
Filed Date: 12/6/1948
Status: Precedential
Modified Date: 10/19/2024
Opinion of the Court by
announced by Mr. Justice Reed.
This case and United States v. Urbuteit, post, p. 355, decided this day, are here on certiorari to resolve a conflict among the circuits in the construction of the Federal Food, Drug, and Cosmetic Act of June 25, 1938. 52 Stat. 1040, 21 U. S. C. § 301 et seq.
Kordel was charged by informations containing twenty counts of introducing or delivering for introduction into interstate commerce misbranded drugs. He was tried without a jury, found guilty, and fined two hundred dollars on each count. 66 F. Supp. 538. This judgment was affirmed on appeal. 164 F. 2d 913.
Kordel writes and lectures on health foods from information derived from studies in public and private libraries. Since 1941 he has been marketing his own health food products, which appear to be compounds of various vitamins, minerals and herbs. The alleged misbranding consists of statements in circulars or pamphlets distributed to consumers by the vendors of the products, relating to their efficacy. The petitioner supplies these pamphlets as well as the products to the vendors. Some of the literature was displayed in stores in which the petitioner’s products were on sale. Some of it was given
It is undisputed that petitioner shipped or caused to be shipped in interstate commerce both the drugs and the literature. Seven of the counts charged that the drugs and literature were shipped in the same cartons. The literature involved in the other counts was shipped separately from the drugs and at different times — both before and after the shipments of the drugs with which they were associated. The question whether the separate shipment of the literature saved the drugs from being misbranded within the meaning of the Act presents the main issue in the case.
Section 301 (a) of the Act prohibits the introduction into interstate commerce of any drug that is adulterated or misbranded.
In this case the drugs and the literature had a common origin and a common destination. The literature was used in the sale of the drugs. It explained their uses. Nowhere else was the purchaser advised how to use them. It constituted an essential supplement to the label attached to the package. Thus the products and the literature were interdependent, as the Court of Appeals observed.
It would take an extremely narrow reading of the Act to hold that these drugs were not misbranded. A crimi
It would, indeed, create an obviously wide loophole to hold that these drugs would be misbranded if the literature had been shipped in the same container but not misbranded if the literature left in the next or in the preceding mail. The high purpose of the Act to protect consumers who under present conditions are largely unable to protect themselves in this field
The first clause of § 201 (m) — all labels “upon any article or any of its containers or wrappers” — clearly
One article or thing is accompanied by another when it supplements or explains it, in the manner that a committee report of the Congress accompanies a bill. No physical attachment one to the other is necessary. It is the textual relationship that is significant. The analogy to the present case is obvious. We need not labor the point.
The false and misleading literature in the present case was designed for use in the distribution and sale of the drug, and it was so used. The fact that it went in a different mail was wholly irrelevant whether we judge the transaction by purpose or result. And to say that the prior or subsequent shipment of the literature disproves that it “is” misbranded when introduced into commerce within the meaning of § 301 (a), is to overlook the integrated nature of the transactions established in this case.
Moreover, the fact that some of the booklets carried a selling price is immaterial on the facts shown here. As stated by the Court of Appeals, the booklets and drugs were nonetheless interdependent; they were parts of an integrated distribution program. The Act cannot be circumvented by the easy device of a “sale” of the advertising matter where the advertising performs the function of labeling.
There is a suggestion that the offense in this case falls under § 301 (k) of the Act which includes misbranding of a drug while it is held for sale after shipment in interstate commerce.
We have considered the other objections tendered by petitioner and find them without merit.
Affirmed.
Section 301 in relevant part reads as follows:
“The following acts and the causing thereof are hereby prohibited:
“(a) The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded.
“ (b) The adulteration or misbranding of any food, drug, device, or cosmetic in interstate commerce.
"(c) The receipt in interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.
“(k) The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, or cosmetic, if such act is done while such article is held for sale after shipment in interstate commerce and results in such article being misbranded.”
The term label is defined as “a display of written, printed, or graphic matter upon the immediate container of any article.” §201 (k).
“Sec. 303. (a) Any person who violates any of the provisions of section 301 shall be guilty of a misdemeanor and shall on conviction thereof be subject to imprisonment for not more than one year, or a fine of not more than $1,000, or both such imprisonment and fine; but if the violation is committed after a conviction of such person under this section has become final such person shall be subject to imprisonment for not more than three years, or a fine of not more than $10,000, or both such imprisonment and fine.
“(b) Notwithstanding the provisions of subsection (a) of this section, in case of a violation of any of the provisions of section 301, with intent to defraud or mislead, the penalty shall be imprisonment for not more than three years, or a fine of not more than $10,000, or both such imprisonment and fine.”
The informations, in charging violations of § 301 (a), did not allege that the acts committed were done “with intent to defraud.” Hence the maximum penalty was imprisonment for not more than a year, or a fine of not more than $1,000, or both. Prosecution by information was therefore authorized by the statute (see Duke v. United States, 301 U. S. 492) and by Rule 7 (a) of the Federal Rules of Criminal Procedure.
See United States v. Dotterweich, 320 U. S. 277, 280; United States v. Sullivan, supra, p. 696.
See § 701 and § 201 (c); 1940 Reorg. Plan No. IV, § 12, 54 Stat. 231, 5 U. S. C. § 133 (u).
The Federal Security Agency by regulation (21 C. F. R. Cum. Supp. § 2.2) has ruled:
“Labeling includes all written, printed, or graphic matter accompanying an article at any time while such article is in interstate commerce or held for sale after shipment or delivery in interstate commerce.”
See note 1, supra.
The purpose of § 301 (k) was described in H. R. Rep. No. 2139, 75th Cong., 3d Sess. 3 (1938), as follows:
“In order to extend the protection of consumers contemplated by the law to the full extent constitutionally possible, paragraph (k) has been inserted prohibiting the changing of labels so as to misbrand articles held for sale after interstate shipment.”