## Facts

- The United States, acting through the FDA, filed an in rem seizure action under the FDCA seeking condemnation and destruction of two drums of black currant oil (BCO).
- BCO is extracted from black currant seeds and was imported in drums by Traco Labs, Inc.
- Traco encapsulated the oil in soft gelatin capsules made of gelatin and glycerin and sold the capsules as a dietary supplement.
- The FDA conceded BCO is “food” in the broad sense, but argued that selling it in gelatin–glycerin capsules made the oil a “food additive” not generally recognized as safe, rendering it adulterated under 21 U.S.C. § 342(a)(2)(C).
- The claimants contended the capsule functioned as a container or delivery vehicle and did not transform the oil into a food additive.
- The district court granted summary judgment for the claimants, rejecting the FDA’s food-additive theory.

## Issues

1. Whether black currant oil, when placed in gelatin–glycerin capsules and sold as a dietary supplement, is a “food additive” under 21 U.S.C. § 321(s).
2. If not a food additive, whether the FDA may nevertheless condemn the seized drums as adulterated under the FDCA’s food-additive adulteration provision, 21 U.S.C. § 342(a)(2)(C).

## Decision

- The Seventh Circuit affirmed summary judgment for the claimants.
- The court held that BCO in gelatin capsules is not a “food additive” within the meaning of 21 U.S.C. § 321(s).
- Because the oil was the principal substance consumed and the capsule was functionally a container, the FDA could not treat the product as presumptively unsafe under the food-additive regime.

## Legal Principles

- Under the FDCA, classification matters: if a substance is a “food additive,” it is presumptively unsafe unless shown to be generally recognized as safe (GRAS); if it is “food” in the generic sense, it is presumed safe and the FDA must prove it is injurious to health.
- A natural substance that is itself the primary article of consumption does not become a “food additive” merely because it is encapsulated or delivered in a dosage form.
- A gelatin capsule that principally serves as a delivery vehicle may be treated like packaging or a container for purposes of determining whether the consumed substance is an additive to another food.
- The FDA may not shift statutory burdens by redefining a primary food as a food additive solely based on marketing or presentation.

## Conclusion

The court concluded that encapsulating black currant oil in gelatin–glycerin capsules did not convert the oil into a “food additive,” so the FDA could not condemn the seized drums as adulterated under the FDCA’s food-additive provision absent proof under the standards applicable to foods in the generic sense.


United States v. Two Plastic Drums, More or Less, of an Article of Food, Labeled in Part “Viponte Ltd. Black Currant Oil Batch No. BOOSF 039,” 984 F.2d 814 (7th Cir. 1993)