## Facts

- The United States brought an in rem forfeiture action seeking condemnation of 1,232 cases of “American Beauty Brand” canned oysters under the Federal Food, Drug, and Cosmetic Act.
- The government alleged the oysters contained sharp shell fragments, some small enough to be swallowed and potentially lodge in the esophagus or injure the mouth.
- The claimant asserted the product was manufactured using modern, industry-standard or better equipment and methods intended to remove shell as much as feasible.
- Evidence from both sides indicated that, with available technology, complete elimination of shell fragments in processed oysters was not possible.
- The claimant presented evidence that millions of cans had been sold without consumer complaints.
- The government argued condemnation was warranted based on the injurious character of the shell fragments rather than the amount present.

## Issues

1. Whether oyster shell fragments in canned oysters are an “added” poisonous or deleterious substance under 21 U.S.C. § 342(a)(1).
2. If the fragments are not “added,” whether the quantity present “ordinarily render[s]” the oysters injurious to health under 21 U.S.C. § 342(a)(1).

## Decision

- The court dismissed the libel for condemnation and ordered the product restored to the claimant.
- The court held the shell fragments were not an “added” substance but naturally associated with oysters and their processing.
- Because the substance was not “added,” the government was required to prove the quantity of fragments ordinarily rendered the food injurious to health.
- The government failed to prove ordinary injuriousness based on quantity on this record.

## Legal Principles

- Under 21 U.S.C. § 342(a)(1), a food containing a non-added (naturally occurring) deleterious substance is not adulterated unless the quantity ordinarily renders it injurious to health.
- When the alleged deleterious substance is not “added,” proof of ordinary injuriousness depends on the amount present, not merely the substance’s potential to cause harm.
- Condemnation requires evidence that the challenged condition exceeds what is unavoidable with current processing methods and that the resulting quantity ordinarily creates a health hazard.

## Conclusion

The court refused to condemn the canned oysters because shell fragments were treated as naturally associated with the product, and the government did not prove that the quantity present would ordinarily make the oysters injurious to health as required by § 342(a)(1).


United States v. 1,232 Cases American Beauty Brand Oysters, 43 F. Supp. 749 (W.D. Mo. 1942)