## Facts

- The United States brought an in rem action under the Federal Food, Drug, and Cosmetic Act (FDCA) seeking seizure and condemnation of 23 phonograph records titled in part “Time To Sleep,” along with related promotional items (album text, leaflet, “Sleep Guaranteed” certificate, display cards, and a poster).
- The promotional materials represented the records as a tested method to induce sleep and relieve insomnia, suggesting reliable therapeutic benefit.
- The records and materials had been shipped in interstate commerce.
- The claimant, Ralph Slater, appeared pro se and sought return of the seized items.
- After a non-jury hearing, the district court dismissed the government’s libel and ordered the property returned.
- The United States appealed.

## Issues

1. Whether the phonograph records and accompanying promotional materials were a “device” under FDCA § 201(h) because they were intended to affect a function of the human body.
2. If the records were a device, whether the labeling was “false or misleading in any particular” and therefore misbranded under FDCA § 502(a), making the items subject to condemnation under FDCA § 304(a).

## Decision

- The Second Circuit reversed the district court.
- The court held the phonograph records were a “device” under FDCA § 201(h)(2) because they were contrivances intended to affect a bodily function—sleep.
- The court held the records were misbranded under FDCA § 502(a) because the labeling conveyed therapeutic efficacy in inducing sleep and addressing insomnia that the evidence did not support.
- The court concluded the articles were subject to seizure and condemnation under FDCA § 304(a).

## Legal Principles

- The FDCA’s definition of “device” includes any “contrivance,” and coverage turns on intended use as shown by labeling and promotional claims, not on whether the item resembles a traditional medical instrument.
- A product intended to affect a bodily function (including sleep) falls within FDCA § 201(h)(2).
- Labeling is misbranding if it is “false or misleading in any particular”; exaggerated efficacy claims can be misleading even if the product might provide minor non-therapeutic effects.
- Evidence that claims of therapeutic effectiveness are unsupported, and that reliance may delay appropriate medical evaluation or treatment, supports a finding that labeling is misleading under FDCA § 502(a).

## Conclusion

The court held that phonograph records marketed as inducing sleep are FDCA “devices,” and that promotional materials overstating sleep-induction and insomnia-relief benefits rendered the devices misbranded, requiring condemnation and rejecting return of the seized articles.


United States v. 23, More or Less, Articles, 192 F.2d 308 (2d Cir. 1951)