## Facts

- The United States brought an in rem condemnation action under the Federal Food, Drug, and Cosmetic Act (FDCA) seeking forfeiture of bottles of “Sterling Vinegar and Honey” and copies of two books by Dr. D. C. Jarvis, *Folk Medicine* and *Arthritis and Folk Medicine*.
- Balanced Foods, Inc., a wholesaler of health-food products, sold both the vinegar-and-honey product and Jarvis’s books.
- Jarvis’s books, widely distributed in general commerce, advocated a cider vinegar and honey mixture as a remedy for various ailments; the seized product was a premixed commercial version of that mixture.
- The government alleged the books were “labeling” for the product because they were sold and displayed in proximity to the product and allegedly made false or misleading therapeutic claims, rendering the product a misbranded drug.
- The seizure occurred at Balanced Foods’ New York warehouse where both the bottles and the books were stored.
- The district court treated the books as FDCA “labeling,” found misbranding, and condemned both the bottles and books; Balanced Foods appealed.

## Issues

1. Whether the sale and display of independently published books in the same commercial setting as a product the books recommend constitutes “labeling” that “accompanies” the product under 21 U.S.C. § 321(m).
2. If the books are not “labeling,” whether the government can sustain misbranding and condemnation under 21 U.S.C. §§ 352(a) and 334 based on the books’ alleged misleading claims.

## Decision

- The Second Circuit reversed the condemnation judgment.
- The court held that, on this record, Jarvis’s books were not “labeling” that “accompanied” the vinegar-and-honey product within the meaning of the FDCA.
- Because the misbranding theory depended on treating the books as labeling, the basis for condemnation failed.
- The court did not decide whether the books’ therapeutic claims were true or false, because that question was not material once the books were deemed outside the product’s labeling.

## Legal Principles

- “Labeling” under 21 U.S.C. § 321(m) includes written matter not physically attached to a product only if there is a sufficient connection showing the material “accompanies” the product in a labeling sense.
- Mere co-location or contemporaneous sale of an independently marketed, generally circulated publication with a product does not, without more, convert the publication into FDCA “labeling.”
- When the asserted misbranding depends entirely on third-party written materials being classified as labeling, failure to establish that classification defeats misbranding under 21 U.S.C. § 352(a) and condemnation under 21 U.S.C. § 334.

## Conclusion

The Second Circuit rejected an expansive reading of “accompanying” that would treat widely distributed, independently published books as drug labeling merely because a seller offers both the books and a related product, and it reversed the FDCA condemnation for lack of a sufficient nexus between the books and the product.


United States v. 24 Bottles “Sterling Vinegar & Honey”, 338 F.2d 157 (2d Cir. 1964)