## Facts

- The FDA seized **29 cartons** containing soft‑gel capsules labeled in part as a **nutritional supplement**: “Black Currant Oil 1000 mg per capsule.”
- Each capsule contained **undiluted black currant oil (BCO)** inside a soft‑gel shell made primarily of **gelatin and glycerin**.
- The United States filed an **in rem** libel of information under the Federal Food, Drug, and Cosmetic Act (FDCA), alleging the capsules were **adulterated** because they “bore or contained” an **unsafe food additive**. See 21 U.S.C. §§ 321(s), 342(a)(2)(C), 348.
- The government proceeded on a single theory: once BCO is placed into a gelatin capsule, the **capsule shell is the “food,”** and the BCO becomes a **“food additive”** (a component added to that food) that was not shown to be generally recognized as safe (GRAS).
- The claimant, **Oakmont Investment Co.**, argued BCO is **“food”** under 21 U.S.C. § 321(f) and that the gelatin capsule is merely a **delivery vehicle**, so BCO is not an additive to some separate “food.”
- The FDA conceded that **pure BCO sold as an oil** (for example, in a bottle) qualifies as **food**, but argued that the dosage form (soft‑gel capsule) changes the analysis.
- The district court rejected the government’s food‑additive theory, **dismissed the libel**, and ordered the cartons **released**.
- The United States appealed to the First Circuit.

## Issues

1. Whether **undiluted black currant oil**, packaged in soft‑gel capsules and sold as a nutritional supplement, is **“food”** under 21 U.S.C. § 321(f) or a **“food additive”** under 21 U.S.C. § 321(s).
2. Whether the United States could sustain condemnation where it chose to proceed **only** on an unsafe‑food‑additive theory and failed to establish the predicate classification that BCO was a “food additive.”

## Decision

- The First Circuit **affirmed** the dismissal of the government’s seizure action and the order releasing the cartons.
- The court held that **pure, undiluted BCO in soft‑gel capsules** is properly treated as **food**, not a **food additive**, on the record and theory presented.
- The court rejected the government’s attempt to define the relevant “food” as the **gelatin/glycerin capsule shell** and then treat the BCO as an “additive” to that shell; the capsule functioned as a **container or delivery system** for the oil.
- Because the United States relied solely on the statutory route that requires showing the article “bears or contains” an **unsafe food additive**, and because it did not prove BCO was a **food additive** in this setting, the condemnation claim failed.
- The court did **not** decide whether BCO is safe or unsafe as consumed; it resolved only the classification question needed to evaluate the government’s chosen theory.

## Legal Principles

- Under the FDCA, “**food**” includes articles used for food or drink and components of such articles. 21 U.S.C. § 321(f).
- A “**food additive**” is a substance expected to become a component of food or affect its characteristics, unless it is generally recognized as safe (GRAS) by qualified experts for its intended use. 21 U.S.C. § 321(s).
- The “food additive” category operates as a **narrower class** within the Act: it targets substances **added to food**, not the main edible substance itself simply because of its packaging or dosage form.
- The statutory scheme assigns different burdens depending on classification: treating a substance as a **food additive** carries a presumption of unsafety unless GRAS is established, while treating it as **food** places the burden on the government to prove adulteration through other available routes.
- A court will not accept a theory that effectively redefines the “food” as the **capsule vehicle** in order to re-label the consumable oil as an “additive,” when the capsule is best viewed as a means of delivery.
- When the government selects a single FDCA theory for condemnation, it must satisfy that theory’s elements; failure to prove a required classification (here, “food additive”) is dispositive.

## Conclusion

The First Circuit held that undiluted black currant oil sold in soft‑gel capsules is “food” rather than a “food additive,” so the government could not condemn the seized cartons based solely on the allegation that the product contained an unsafe food additive.


United States v. 29 Cartons of an Article of Food, 987 F.2d 33 (1st Cir. 1993)