United States v. 23, More or Less, Articles, etc.

The United States government (plaintiff) sought to seize and condemn phonograph records and accompanying literature that purported to promote sleep in people with insomnia. The records’ titles included the phrase “Time To Sleep,” and the literature touted the records as presenting an amazing and tested sleep-induction method. The literature also included a certificate purporting to guarantee sleep and other promotional materials. The government contended that the records were devices within the meaning of § 201(h) of the federal Food, Drug, and Cosmetic Act (the act). That section defined device to include any instrument, apparatus, or contrivance, or any component, part, or accessory of an instrument, apparatus, or contrivance that was intended (1) to diagnose, cure, mitigate, treat, or prevent diseases in humans or animals; or (2) to affect any structure or bodily function in humans or animals. At a bench trial in federal district court, medical experts testified that insomnia was not a disease but rather a symptom of other illnesses or emotional disturbance. The experts also testified that sleep was a bodily function in humans and animals. The district court entered a judgment dismissing the government’s request for seizure and ordering that the records and literature be returned to the owner. The government appealed.