## Facts

- The FDA issued an import alert for canned mushrooms processed in China after a food-borne illness outbreak linked to certain Chinese factories.
- First Phoenix Group Limited, Inc. imported two shipments of canned mushrooms labeled as Taiwanese products; Customs and the FDA suspected Chinese origin covered by the alert.
- U.S. Customs detained the shipments at the port of entry; the mushrooms were not released into domestic distribution.
- FDA testing indicated the mushrooms were adulterated and misbranded.
- The United States brought an in rem seizure and condemnation action under the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 334(a).
- First Phoenix argued the government was limited to the FDCA’s import refusal procedure under 21 U.S.C. § 381, which generally provides an opportunity to export refused goods.

## Issues

1. Whether imported food detained by Customs at the port of entry has been “introduced into interstate commerce” for purposes of 21 U.S.C. § 334, permitting a judicial in rem condemnation action.
2. Whether the FDCA confines the FDA to 21 U.S.C. § 381 refusal-of-admission procedures (including an opportunity to export) for goods still in Customs custody, thereby precluding § 334 condemnation.

## Decision

- The Fifth Circuit reversed the district court’s dismissal of the condemnation complaint.
- The court held that the shipments were “in interstate commerce” within the FDCA’s broad definition, even while detained at the port of entry under Customs control.
- The court held that the FDCA does not bar the FDA from proceeding under § 334 against imported goods still held by Customs and does not make § 381 the exclusive route.
- The case was remanded for further proceedings consistent with allowing the government to pursue condemnation under § 334.

## Legal Principles

- For FDCA purposes, “interstate commerce” is defined broadly enough to include imported goods moving from a foreign country into the United States and held at a port of entry.
- Under 21 U.S.C. § 334, the government may seek judicial seizure and condemnation of food that is adulterated or misbranded when introduced into or while in interstate commerce, including while under Customs detention.
- The FDCA’s import refusal mechanism in 21 U.S.C. § 381 (including an opportunity to export refused goods) is not an exclusive remedy that displaces § 334 condemnation authority at the border.
- Statutory text, structure, and legislative history support parallel administrative and judicial enforcement options to protect public health from adulterated and misbranded imports.

## Conclusion

The Fifth Circuit held that imported mushrooms detained at the port of entry were “in interstate commerce” under the FDCA and that the FDA could pursue judicial condemnation under 21 U.S.C. § 334 without being limited to § 381 refusal-of-admission and export procedures.


United States v. Food, 2,998 Cases, 64 F.3d 984 (5th Cir. 1995)