## Facts

- Blue Ribbon Smoked Fish, Inc. processed and distributed ready-to-eat smoked and other seafood products in interstate commerce from a Brooklyn facility.
- Over several years, federal and state inspections repeatedly documented unsanitary conditions and detected *Listeria monocytogenes* in the facility and in products, including cold-smoked fish lacking a terminal heat treatment.
- In January 2000, New York authorities revoked Blue Ribbon’s state license based on sanitation and contamination concerns; it was later reissued, but inspections continued to find deficiencies.
- An FDA inspection in August 2000 found missing or inadequate HACCP-related documentation and controls for certain cold-smoked products; Blue Ribbon recalled product and promised corrective measures.
- A January 2001 inspection again found continuing deficiencies and unsanitary conditions; Blue Ribbon implemented multiple corrective actions and later testing did not detect *L. monocytogenes*, but the government asserted an ongoing risk of recurrence.
- The United States brought a civil FDCA enforcement action seeking a permanent injunction to stop operations unless Blue Ribbon met detailed sanitation, HACCP, expert-consultant, testing, and FDA-oversight conditions, with shutdown/recall obligations triggered by failed inspections.
- Corporate officers/co-owners with operational responsibility were named as defendants; they challenged individual liability and argued the injunction was overbroad and effectively business-ending.

## Issues

1. Whether summary judgment was proper that defendants violated the FDCA by introducing or holding for sale “adulterated” food under 21 U.S.C. §§ 331(a), 331(k), and 342(a)(4).
2. Whether the detailed permanent injunction exceeded the district court’s equitable authority or constituted an abuse of discretion under 21 U.S.C. § 332(a), including requirements imposing substantial compliance costs.
3. Whether corporate officers with operational responsibility could be bound by injunctive relief under the FDCA based on their authority to prevent or correct violations.

## Decision

- The Second Circuit affirmed the grant of summary judgment for the United States.
- The court affirmed the permanent injunction in full, including affirmative requirements (sanitation measures, HACCP development and implementation, expert involvement, product testing, FDA approval/oversight) and cost-shifting provisions tied to compliance and potential recalls.
- The court upheld the inclusion of responsible corporate officers as proper subjects of injunctive relief.

## Legal Principles

- Food is “adulterated” under 21 U.S.C. § 342(a)(4) when it is prepared, packed, or held under insanitary conditions whereby it may become contaminated or injurious to health; proof of an actual illness outbreak is not required.
- FDCA civil enforcement under 21 U.S.C. §§ 331 and 332(a) does not require intent or culpable causation; regulated entities have a duty to implement measures to prevent violations.
- Courts may issue broad, forward-looking injunctions under 21 U.S.C. § 332(a) when there is a reasonable likelihood of recurring violations, and may require specific affirmative compliance steps to prevent recurrence.
- Economic hardship to the regulated entity does not bar injunctive relief aimed at protecting public health.
- Corporate officers with authority and responsibility to prevent or correct FDCA violations may be bound by injunctive orders, even without proof of personal involvement in each violation.

## Conclusion

The Second Circuit upheld a comprehensive FDCA injunction against a smoked-seafood processor and its responsible officers, concluding that repeated insanitary conditions and *Listeria* findings supported adulteration and that detailed preventive conditions and compliance costs were within the court’s equitable power to prevent recurring violations.


United States v. Blue Ribbon Smoked Fish, Inc., 56 F. App’x 542 (2d Cir. 2003)