## Facts

- Natick Paperboard Corp. and Crown Paperboard Co., Inc. manufactured paperboard made from recycled waste paper and sold it in interstate commerce, including material used for food packaging.
- Recycled paperboard could contain polychlorinated biphenyls (PCBs), toxic compounds that can enter products through industrial waste.
- The FDA adopted a regulation setting a tolerance of no more than 10 parts per million (ppm) PCBs in paper food-packaging materials intended for use with human food, animal feed, or feed components, unless a functional barrier prevents PCB migration to food.
- The FDA took the position that paper food-packaging material exceeding the tolerance could be treated as “adulterated food” under the Federal Food, Drug, and Cosmetic Act (FDCA) and subject to seizure.
- The manufacturers sought declaratory and injunctive relief, asserting that food packaging is not “food” under the FDCA and that the FDA’s seizure policy and notice were overbroad.
- The district court granted summary judgment for the government, holding the FDA had authority to recommend seizure of PCB-contaminated paper packaging as adulterated food.

## Issues

1. Whether paper materials intended for direct contact with food fall within the FDCA definition of “food,” permitting treatment as “adulterated food.”
2. Whether the FDA may seize PCB-contaminated paperboard before it is actually used as food packaging, and what showing is required for such a pre-use seizure.
3. Whether the manufacturers’ pre-enforcement challenge to the FDA’s seizure authority and regulation was ripe and justiciable.

## Decision

- The First Circuit affirmed the summary judgment for the government.
- The court held the FDA could treat food-contact paperboard containing PCBs above the tolerance level as “adulterated food” when the material is intended for direct food-contact use.
- The court upheld the possibility of pre-use seizure but construed the regulation to require a limiting condition: the FDA must be able to show the paperboard is intended or destined for use as food packaging (e.g., held by a food packager, in transit to one, ordered by one, or manufactured for that purpose).
- The court rejected the request for broad declaratory and injunctive relief and declined to restrict FDA seizure authority beyond the limiting construction it adopted.

## Legal Principles

- Under the FDCA, “food” includes not only edible articles but also “components” introduced into food; contaminants migrating from packaging into food may be treated as components for regulatory purposes.
- The FDA may regulate and proceed against food-contact packaging materials as “adulterated food” when contamination above an established tolerance is likely to migrate into food absent a functional barrier.
- Pre-use seizure of contaminated packaging material is permissible if the FDA can prove the seized goods are intended for, likely to be used for, or otherwise destined for direct-contact food packaging, rather than being generic paper products with no food-contact destination.
- Courts generally avoid preemptive interference with FDA seizure powers where the statutory scheme provides condemnation proceedings and judicial process to test the legality of seizures in конкрет enforcement actions.

## Conclusion

The First Circuit upheld the FDA’s authority to treat PCB-contaminated food-contact paperboard as adulterated food and to seize it even before use, while limiting pre-use seizures to situations where the government can demonstrate the paperboard is intended or destined for direct food-contact packaging.


Natick Paperboard Corp. v. Weinberger, 525 F.2d 1103 (1st Cir. 1975)