United States v. 24 Bottles
338 F.2d 157 (1964)
Premium Feature
Subscribe to Lexplug to listen to the Case Podcast.
Rule of Law:
For written material to constitute 'labeling' under the Federal Food, Drug, and Cosmetic Act, it must be presented to the customer in an immediate, functional connection with the product at the point of sale, serving the same purpose as if it were physically attached.
Facts:
- Dr. D. C. Jarvis authored a book titled “Folk Medicine,” which suggested that a mixture of cider vinegar and honey was a remedy for various ailments.
- “Folk Medicine” became a popular book, leading many people to try the recommended vinegar and honey mixture.
- Several companies, including Sterling, began manufacturing and selling pre-mixed vinegar and honey products in response to the book's popularity.
- Sterling’s Vinegar and Honey bottles included a label that only stated they contained "aged in wood cider vinegar blended with finest honey."
- Dr. Jarvis’s books, “Folk Medicine” and its sequel “Arthritis and Folk Medicine,” mentioned Sterling cider vinegar by name as suitable for medicinal use.
- Balanced Foods, Inc., a wholesaler of health foods and related products, stocked and sold both Sterling Vinegar and Honey and Dr. Jarvis’s books.
- Balanced Foods, Inc. initially started selling "Folk Medicine" almost two years before it began stocking Sterling Vinegar and Honey, and sold significantly more copies of the book than bottles of the product.
- At the retail level, Dr. Jarvis’s books were typically shelved with other books, often several feet away from the Sterling Vinegar and Honey bottles, and there was no evidence of combined displays.
Procedural Posture:
- The United States initiated an in rem action (a lawsuit against property) in the District Court for the Southern District of New York, seeking to condemn bottles of Sterling Vinegar and Honey and copies of two books, “Folk Medicine” and “Arthritis and Folk Medicine.”
- The District Court for the Southern District of New York issued an order condemning the products, determining that they were misbranded drugs because the books constituted 'labeling' for the Vinegar and Honey and contained misleading claims.
- Balanced Foods, Inc., appealed the District Court's condemnation order to the United States Court of Appeals for the Second Circuit.
Premium Content
Subscribe to Lexplug to view the complete brief
You're viewing a preview with Rule of Law, Facts, and Procedural Posture
Issue:
Does the display and sale of books recommending a health product, alongside the product itself but without immediate, integrated promotion, constitute 'labeling' under 21 U.S.C. § 321(m), thereby subjecting the product to misbranding prohibitions if the books contain misleading claims?
Opinions:
Majority - Lumbard, Chief Judge
No, the display and sale of the books “Folk Medicine” and “Arthritis and Folk Medicine” alongside Sterling Vinegar and Honey did not constitute "labeling" for the product under the Federal Food, Drug, and Cosmetic Act. While the Act's definition of "labeling" extends beyond physically attached materials to include written matter "accompanying such article," this "accompanying" material must perform the "same function" as a physical label by being presented to the customer in "immediate connection" with the product's view and purchase. This standard, derived from Kordel v. United States, distinguishes true labeling from mere advertising, which is not covered by the Act. The court found no evidence of "integrated use" or "joint promotion" by Balanced Foods or its retailers. Balanced Foods sold the books and product separately, having stocked the book nearly two years before the product and selling far more books. Retailers shelved the books with other publications, often at a distance from the product, rather than in an immediate connection. The Federal Food, Drug, and Cosmetic Act is intended to address misleading claims directly linked to a product's sale, with general misleading claims falling under the Federal Trade Commission Act.
Analysis:
This case significantly refines the interpretation of 'labeling' under the Federal Food, Drug, and Cosmetic Act, establishing a high bar for linking external written materials to a product for misbranding purposes. It clarifies that mere promotion or a general relationship between a book and a product is insufficient; rather, a direct, functional connection at the point of sale is required. This precedent helps define the boundaries of FDA's regulatory authority over product claims, particularly concerning independent publications or third-party endorsements, necessitating evidence of integrated marketing or display to prove 'labeling.' Future cases would need to demonstrate a tangible connection between the product and the written material during the sales transaction itself.
