## Facts

- The United States sought to stop Anderson Seafoods, Inc. and its president from distributing swordfish with mercury levels exceeding 0.5 parts per million (ppm), alleging the fish was “adulterated” under the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 342(a)(1).
- Anderson filed a class action against federal health and FDA officials seeking (1) a declaration that fish with 2.0 ppm or less of mercury were not adulterated and (2) an injunction limiting FDA enforcement consistent with that declaration.
- The cases were consolidated; the district court denied both sides’ requested injunctions but entered declaratory relief.
- The district court declared that swordfish containing more than 1.0 ppm of mercury are adulterated under § 342(a)(1) and determined mercury in swordfish is an “added substance” within the statute.
- Evidence showed mercury in swordfish tissues is attributable at least in part to human activity (environmental pollution), though some mercury may occur naturally.

## Issues

1. Under FDCA § 342(a)(1), is mercury in swordfish an “added substance” when only part of the mercury results from human activity, and if so, does the “added substance” standard apply to the entire amount present?
2. Was the evidence sufficient to support the district court’s declaratory determination that swordfish containing more than 1.0 ppm mercury are adulterated under § 342(a)(1)?

## Decision

- The Fifth Circuit affirmed the district court.
- The court held that mercury in swordfish qualifies as an “added substance” under § 342(a)(1) when human activity contributes to its presence, and the statutory “added substance” standard applies.
- The court rejected the argument that only the human-attributable fraction should be treated as “added” for purposes of applying § 342(a)(1).
- The court upheld the 1.0 ppm adulteration line, concluding the district court’s findings were supported by the record and not clearly erroneous.

## Legal Principles

- FDCA § 342(a)(1) applies a stricter adulteration test to “added substances”: a food is adulterated if it contains a poisonous or deleterious substance that “may render it injurious to health.”
- For substances that are not “added,” § 342(a)(1) provides a more forgiving exception: the food is not adulterated if the substance’s quantity does not ordinarily render the food injurious to health.
- When a poisonous or deleterious substance in food is present in part due to human activity, the substance is treated as “added” for purposes of § 342(a)(1), and the “may render injurious” standard governs.
- A district court’s factual findings supporting an adulteration threshold are reviewed on appeal under the clearly erroneous standard.

## Conclusion

The Fifth Circuit affirmed a declaratory judgment that mercury in swordfish is an “added substance” under FDCA § 342(a)(1) when partially attributable to human activity and upheld the finding that swordfish with more than 1.0 ppm mercury is adulterated under the statute’s “may render injurious to health” standard.


United States v. Anderson Seafoods, Inc., 622 F.2d 157 (5th Cir. 1980)