## Facts

- The United States (through FDA enforcement) filed an in rem action in federal district court seeking condemnation of 32 audio tape recordings sold by Potentials Unlimited.
- Potentials Unlimited marketed the recordings as hypnosis-based products that could produce therapeutic or physical effects.
- The claimed uses included treating back pain, removing warts, and enlarging bust size, along with other similar health- and body-related claims.
- Potentials’ catalogue stated that the recordings worked “like magic” by “saturating the subconscious mind with positive suggestions.”
- Potentials Unlimited appeared as the claimant and argued that the recordings were not “medical devices” under the Federal Food, Drug, and Cosmetic Act (FDCA).
- Potentials also contended that the messages on the recordings were protected speech and that condemnation would violate the First Amendment.

## Issues

1. Whether audio recordings marketed with claims that they cure, mitigate, treat, or prevent disease, or affect the structure or function of the body, qualify as “devices” under the FDCA based on their intended use.
2. Whether applying the FDCA condemnation remedy to such recordings impermissibly restricts speech in violation of the First Amendment.

## Decision

- The court ruled for the United States and ordered condemnation of the seized recordings.
- The court treated the recordings as FDCA “devices” because their intended use, as shown by advertising and catalogue claims, was to treat conditions or affect the body.
- The court rejected the First Amendment defense, treating the action as regulation of the marketing and sale of an item offered as a therapeutic product, rather than a ban on ideas.

## Legal Principles

- FDCA “device” status turns on intended use, and intended use may be established by labeling, advertising, catalogues, and related marketing materials.
- An “article” can fall within the FDCA’s device definition even when its claimed therapeutic effect is said to occur through conveyed messages (such as hypnosis suggestions) rather than through chemical action.
- The First Amendment does not bar FDCA enforcement aimed at preventing the distribution of items marketed with medical or body-altering claims when the government is regulating a commercial product offered for therapeutic use.

## Conclusion

In *United States v. Undetermined Quantities of Article of Device*, the district court allowed FDCA condemnation of hypnosis recordings sold with claims of treating ailments and changing bodily characteristics, concluding that the recordings were “devices” based on their intended uses as reflected in marketing materials and rejecting the claimant’s First Amendment objection.


United States v. Undetermined Quantities of Article of Device, Med. Devices Rep. (CCH) ¶ 15055 (1982)