## Facts

- Federal authorities seized multiple cases of tablets marketed as “Aangamik 15,” also labeled “Calcium Pangamate,” “Pangamic Acid,” and “Vitamin B-15,” manufactured by FoodScience Laboratories, Inc. and shipped in interstate commerce.
- The tablets contained N,N-Dimethylglycine hydrochloride (DMG) and other ingredients.
- The United States brought consolidated in rem actions under the Federal Food, Drug, and Cosmetic Act (FDCA) seeking condemnation of the seized product and an injunction barring further distribution.
- The government alleged the tablets were adulterated because DMG was a “food additive” without an authorizing regulation and not generally recognized as safe (GRAS).
- The government also alleged misbranding because the labeling described the product as “Vitamin B-15” and failed to list each ingredient by its common or usual name.
- After a bench trial, the district court found the product adulterated and misbranded, ordered condemnation, and issued a permanent injunction against further interstate distribution.
- On appeal, FoodScience chiefly argued DMG was a principal ingredient rather than a “food additive,” and did not meaningfully challenge the misbranding findings.

## Issues

1. Whether DMG, as used in the tablets, was a “food additive” under 21 U.S.C. § 321(s), such that the product was adulterated under 21 U.S.C. §§ 342(a)(2)(C) and 348(a) absent an authorizing regulation or GRAS status.
2. Whether the product was properly found misbranded under 21 U.S.C. § 343 based on the “Vitamin B-15” labeling and deficient ingredient listing.
3. Whether the district court properly entered permanent injunctive relief under 21 U.S.C. § 332(a) barring future interstate distribution.

## Decision

- The Seventh Circuit affirmed the judgment.
- The court held DMG was a “food additive” because its intended use resulted in its becoming a component of the tablets and it lacked GRAS recognition by qualified experts.
- Because no regulation authorized DMG’s use and it was not GRAS, DMG was “unsafe” under § 348(a), making the tablets adulterated under § 342(a)(2)(C).
- The court upheld the misbranding determinations, including that labeling the product “Vitamin B-15” was false or misleading and the label failed to list each ingredient by its common or usual name as required by § 343(i).
- The court upheld the permanent injunction as a permissible measure to prevent future FDCA violations.

## Legal Principles

- A substance is a “food additive” under 21 U.S.C. § 321(s) if its intended use results or may reasonably be expected to result in its becoming a component of food, unless it is GRAS for that use or otherwise excluded by statute or regulation.
- The food-additive provisions do not turn on whether the substance is present in small or large quantities; a manufacturer cannot avoid regulation by characterizing an added, non-GRAS substance as a “principal ingredient.”
- Food containing an unsafe food additive is adulterated under 21 U.S.C. § 342(a)(2)(C); a food additive is “unsafe” under 21 U.S.C. § 348(a) absent an authorizing regulation prescribing safe conditions of use (or GRAS status).
- Labeling is misbranding under 21 U.S.C. § 343(a) when it is false or misleading, including representing a non-vitamin substance as a “vitamin” without accepted scientific support.
- For food fabricated from two or more ingredients, 21 U.S.C. § 343(i) requires the label to bear the common or usual name of each ingredient.
- Courts may order condemnation of adulterated or misbranded articles and grant injunctive relief under 21 U.S.C. § 332(a) to prevent future violations of 21 U.S.C. § 331(a).

## Conclusion

The Seventh Circuit affirmed condemnation and a permanent injunction because DMG was a regulated food additive lacking GRAS status and an authorizing regulation, rendering the tablets adulterated, and because the labeling falsely presented the product as “Vitamin B-15” and failed to identify ingredients as required by the FDCA.


United States v. An Article of Food (FoodScience Labs.), 678 F.2d 735 (7th Cir. 1982)