## Facts

- Coco Rico, Inc. manufactured a coconut-flavored concentrate in Puerto Rico used by local soft drink bottlers.
- The concentrate used in Puerto Rico contained potassium nitrate, added to develop and fix color and flavor.
- The United States brought in rem seizure and condemnation actions against three lots of bottled soft drinks containing the concentrate at bottlers’ premises in Puerto Rico.
- The government alleged the potassium nitrate was an unsafe food additive, rendering the beverages adulterated under the Federal Food, Drug, and Cosmetic Act (FDCA) and subject to forfeiture.
- Pursuant to district court warrants, the government seized the three lots; Coco Rico appeared as claimant and did not dispute the presence of potassium nitrate.
- Coco Rico argued (1) the seized beverages and concentrate had not moved outside Puerto Rico and thus were not subject to federal forfeiture, and (2) potassium nitrate should be treated as generally recognized as safe (GRAS), excluding it from “food additive” status.
- On summary judgment, the government submitted affidavits from FDA food chemists stating they knew of no scientific studies showing potassium nitrate was safe in beverages, did not recognize it as safe for that use, and considered the detected levels toxicologically concerning.
- Coco Rico submitted an affidavit from a food chemist asserting she knew of no evidence the nitrate levels used were unsafe and analogizing to FDA-approved nitrate use in curing meats.

## Issues

1. Whether the FDCA’s seizure and adulteration provisions may be applied to soft drinks manufactured and sold only within Puerto Rico when the claimant also participated in interstate marketing of similar products.
2. Whether potassium nitrate used in soft drinks falls within the GRAS exception to the FDCA’s “food additive” definition, and whether the claimant’s expert affidavit created a genuine dispute precluding summary judgment.

## Decision

- The First Circuit affirmed the district court’s summary judgment for the United States.
- The court held federal authority under the FDCA was not defeated by the claimant’s Puerto Rico-only distribution of the seized lots.
- The court held potassium nitrate, as used in the beverages, was a food additive not generally recognized as safe and therefore “unsafe” under the FDCA, making the beverages adulterated and subject to condemnation.
- The court concluded the claimant’s expert affidavit did not establish scientific support or expert consensus sufficient to raise a genuine issue of material fact under the GRAS standard.

## Legal Principles

- A substance that becomes a component of food is a “food additive” unless it is generally recognized by qualified experts, based on scientific procedures, to be safe under the conditions of its intended use.
- GRAS status requires affirmative, scientifically grounded general recognition among qualified experts; lack of proof of harm or a single expert’s assertion is insufficient.
- FDA acceptance or regulation of a substance for one use (e.g., curing meats) does not establish GRAS status for materially different uses (e.g., beverages); the intended use conditions control.
- Summary judgment is appropriate in FDCA food-additive litigation where the claimant fails to produce evidence of scientific studies and expert consensus capable of showing GRAS status.

## Conclusion

The court upheld condemnation of the seized soft drinks, ruling that potassium nitrate in beverages was a non-GRAS, unsafe food additive under the FDCA and that the claimant’s evidence did not create a triable factual dispute; intraterritorial distribution within Puerto Rico did not bar federal enforcement.


United States v. An Article of Food . . . Coco Rico, Inc., 752 F.2d 11 (1st Cir. 1985)