## Facts

- The United States sued distributors/relabelers of hormone drug products in California under the Federal Food, Drug, and Cosmetic Act (FDCA).
- The drugs were manufactured in the eastern United States and shipped to defendants in California bearing a prescription caution: “To be dispensed only by or on the prescription of a physician.”
- After receipt, defendants relabeled the products and removed the prescription-only caution before distribution and sale.
- The government alleged the relabeled products were misbranded because they lacked adequate directions for use and adequate warnings and were dangerous to health when used as labeled.
- The government relied on FDA determinations and medical testimony that the hormones were not safe for use except under supervision of a licensed practitioner.
- The district court denied permanent injunctions and dismissed the complaints, finding the government’s proof insufficient.

## Issues

1. Whether distributing the relabeled hormone drugs without the prescription caution constituted introduction of misbranded drugs into interstate commerce in violation of 21 U.S.C. § 331(a).
2. Whether defendants’ relabeling and distribution of the drugs while held for sale after interstate shipment, resulting in misbranding, violated 21 U.S.C. § 331(k).
3. Whether the evidence (including FDA classification and expert testimony) established misbranding such that permanent injunctive relief under 21 U.S.C. § 332 was required.

## Decision

- The Ninth Circuit reversed the district court.
- The court held the hormone drugs, as relabeled and distributed without the prescription caution, were misbranded under 21 U.S.C. § 352.
- The court concluded defendants’ post-shipment relabeling that caused misbranding violated 21 U.S.C. § 331(k), even if subsequent sales were intrastate.
- The court directed entry of permanent injunctions restraining further introduction or post-shipment handling that would result in misbranding.

## Legal Principles

- A drug is misbranded under 21 U.S.C. § 352(f)(1) unless its labeling bears “adequate directions for use”; for drugs not safe except under professional supervision, adequate lay directions cannot be provided.
- Removing prescription-only cautions from drugs requiring medical supervision and marketing them for general public use results in misbranding, including for inadequate directions and inadequate warnings and where use as labeled may be dangerous to health. (21 U.S.C. § 352(a), (f)(2), (j)).
- Under 21 U.S.C. § 331(k), relabeling or other acts affecting a drug held for sale after interstate shipment that cause the drug to become misbranded are prohibited, capturing post-shipment intrastate distribution.
- In FDCA enforcement actions, once statutory misbranding is shown, injunctive relief under 21 U.S.C. § 332 may issue without proof of specific consumer injury; denial may be an abuse of discretion where ongoing violations are shown.

## Conclusion

The Ninth Circuit held that defendants’ removal of prescription-only labeling from potent hormone drugs and sale to the public rendered the products misbranded under the FDCA, and that post-shipment relabeling causing misbranding violated federal law; the court reversed and ordered permanent injunctions.


United States v. El-O-Pathic Pharmacy, 192 F.2d 62 (9th Cir. 1951)