## Facts

- The FDA prepared and distributed a circular/poster, including in post offices nationwide, warning that the “Hoxsey cancer treatment” was worthless for internal cancer and cautioning patients not to be misled by claims of cure or relief.
- The government relied on 21 U.S.C. § 375(b), which authorizes the Secretary to disseminate information about drugs and related products when, in the Secretary’s opinion, there is imminent danger to health or gross consumer deception, and to report investigation results.
- Hoxsey Cancer Clinic sued the Secretary of Health, Education and Welfare and the FDA Commissioner to stop dissemination of the circular.
- The clinic argued § 375(b) was unconstitutional because it permitted dissemination without notice or a hearing, allegedly injuring the clinic’s reputation and business in violation of the Fifth Amendment.
- The clinic sought a preliminary injunction and requested a three-judge district court; defendants moved for summary judgment. The court heard the motions together.

## Issues

1. Whether 21 U.S.C. § 375(b) violates Fifth Amendment due process by authorizing dissemination of public warnings without prior notice or hearing.
2. Whether the circular constituted adjudicatory agency action that determined rights or imposed legal obligations, thereby requiring notice and hearing.
3. Whether the clinic was entitled to injunctive relief and a three-judge court, or whether summary judgment for defendants was proper.

## Decision

- The court held 21 U.S.C. § 375(b) constitutional.
- The court concluded the circular was informational and advisory, not an agency order adjudicating rights or directing conduct.
- Because the circular imposed no binding legal obligations or sanctions, due process did not require notice or a hearing before issuance.
- The court denied the request for a three-judge court and denied injunctive relief.
- The court granted defendants’ motion for summary judgment and dismissed the complaint.

## Legal Principles

- Notice and hearing are generally required when an agency issues an order adjudicating rights or directing a party to do or refrain from doing something; they are not required for nonbinding informational publications.
- Congress may authorize agencies to disseminate public health information to address imminent danger to health or gross consumer deception, including reporting and illustrating investigation results.
- Reputational and economic harm flowing from noncoercive government statements does not, by itself, constitute a deprivation of liberty or property that triggers procedural due process protections.

## Conclusion

The court upheld the statutory scheme permitting federal health officials to warn the public about allegedly dangerous or deceptive medical treatments without prior notice or hearing, reasoning that an informational circular lacking legal force is not an adjudication and does not trigger due process requirements.


Hoxsey Cancer Clinic v. Folsom, 155 F. Supp. 376 (D.D.C. 1957)