Kordel v. United States
335 U.S. 345, 1948 U.S. LEXIS 2742, 93 L. Ed. 2d 52 (1948)
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Rule of Law:
The term "labeling" under the Federal Food, Drug, and Cosmetic Act includes written materials that supplement or explain drugs, even if shipped separately from the drugs, provided they have a common origin and destination, are used together in the sale, and are part of an integrated distribution program.
Facts:
- Kordel wrote and lectured on health foods, deriving information from studies in public and private libraries.
- Since 1941, Kordel marketed his own health food products, which were compounds of various vitamins, minerals, and herbs.
- The alleged misbranding consisted of statements in circulars or pamphlets relating to the efficacy of Kordel’s products.
- Kordel supplied both his products and these pamphlets to vendors.
- Some of the literature was displayed in stores where Kordel’s products were on sale, some was given away with product sales, some sold independently, and some mailed to customers by vendors.
- Kordel shipped or caused to be shipped both the drugs and the literature in interstate commerce.
- Seven of the counts involved drugs and literature shipped in the same cartons; the literature for other counts was shipped separately from the drugs and at different times (both before and after drug shipments).
Procedural Posture:
- Kordel was charged by informations containing twenty counts of introducing or delivering for introduction into interstate commerce misbranded drugs.
- Kordel was tried without a jury in federal district court, found guilty on all counts, and fined two hundred dollars on each count (66 F. Supp. 538).
- The judgment of the district court was affirmed on appeal by the Circuit Court of Appeals (164 F. 2d 913).
- The Supreme Court of the United States granted certiorari to resolve a conflict among the circuits regarding the construction of the Federal Food, Drug, and Cosmetic Act.
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Issue:
Does the term "accompanying such article" in Section 201(m) of the Federal Food, Drug, and Cosmetic Act include literature shipped separately from the drugs it describes, thereby making the drugs misbranded if the literature contains false or misleading statements?
Opinions:
Majority - Mr. Justice Douglas
Yes, the term "accompanying such article" in Section 201(m) includes literature shipped separately from the drugs, thereby making the drugs misbranded if the literature contains false or misleading statements. The Court found that the drugs and literature had a common origin and destination, were used together in the sale, and the literature explained the drugs' uses, serving as an essential supplement to the package label. A narrow reading requiring physical attachment or same-container shipment would create an obvious loophole and defeat the high purpose of the Act to protect consumers. The Court reasoned that one article is "accompanied" by another when it supplements or explains it, much like a committee report accompanies a bill, making physical attachment unnecessary; the textual relationship and integrated nature of the transaction are significant. The false literature was designed for, and used in, the distribution and sale of the drug, making the timing or method of shipment irrelevant. The Court also rejected the argument that control over such advertising was exclusively transferred to the Federal Trade Commission, asserting that advertising performing the function of labeling remains within the FDCA's purview. It further clarified that Section 301(a) (introduction of misbranded drugs) fairly includes this conduct and is distinct from Section 301(k) (misbranding while held for sale), which has a different and sometimes more restricted scope.
Dissenting - Mr. Justice Black
No, for certain counts, the drugs were not misbranded at the time of their introduction into interstate commerce under Section 301(a). While Justice Black agreed with the majority's interpretation that "labeling" and "accompanying" do not require physical attachment, he emphasized that the Federal Food, Drug, and Cosmetic Act defines several distinct offenses based on a drug's relationship to interstate commerce. The twenty counts of the information specifically charged violations of Section 301(a), which prohibits the "introduction or delivery for introduction into interstate commerce" of misbranded drugs. For thirteen of these counts, the undisputed evidence showed that the literature relied upon as "labeling" was shipped much later than the drugs (e.g., 1.5 years later). Therefore, the drugs were not "accompanied" by the literature when they were introduced into interstate commerce. Justice Black argued that this conduct would properly fall under Section 301(k), which prohibits misbranding while drugs are "held for sale after shipment in interstate commerce," and that the Court should not broaden the coverage of Section 301(a) to cover situations Congress specifically addressed in Section 301(k), even if it believed Congress left a 'hiatus'.
Analysis:
This case significantly expanded the interpretation of "labeling" under the Federal Food, Drug, and Cosmetic Act, making it clear that promotional materials do not need to be physically attached or shipped simultaneously with a drug to fall under the statute's misbranding provisions. The Court adopted a functional approach, focusing on the integrated nature of the distribution program and the supplementary role of the literature. This decision reinforced the Act's broad consumer protection purpose by preventing manufacturers from circumventing misbranding regulations through the strategic separation of drugs and their explanatory materials. It established a precedent that future courts would use to assess the interconnectedness of products and their associated informational materials in consumer protection laws.
