Kordel v. United States

In Kordel v. United States (1948) 335 U.S. 345, the United States Supreme Court interpreted the term "labeling" in the FDCA in the course of considering an appeal challenging a criminal conviction for introducing misbranded drugs into commerce. The precise issue was whether "circulars or pamphlets distributed to consumers" for vitamin products, which were "displayed in stores in which the ... products were on sale" or "given away with the sale of products" (Kordel, at pp. 346-347), constituted "labeling" within the meaning of the FDCA. Due to the phrase "accompanying such article" in the definition of "labeling" (21 U.S.C. 321(m)), Kordel broadly interpreted "labeling" as not requiring "physical attachment or contiguity." (Kordel, at p. 351.) Of central importance to our own analysis, Kordel defined the term "accompanying." It stated that "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." (Kordel, supra, 335 U.S. at p. 350.) Applying this definition, the dispositive issue was whether "the false and misleading literature was designed for use in the distribution and sale ..." of the product. (Ibid.)