## Facts

- Scenic View Dairy, LLC operated large dairy facilities in western Michigan and, in addition to producing Grade A milk, regularly sold “cull cows” for slaughter for human consumption, including sales routed to out-of-state slaughter channels.
- At slaughter, the USDA Food Safety and Inspection Service detected illegal levels of new animal drug residues in the edible tissues of cows traced back to Scenic View.
- The government contended the residue findings showed Scenic View introduced adulterated food into interstate commerce because the cows contained unsafe drug residues (including residues above tolerance levels or for which no tolerance applied).
- The United States also asserted Scenic View’s on-farm drug practices included extra-label use of approved new animal drugs in a manner not consistent with FDA-approved labeling and not meeting the statutory and regulatory conditions for lawful extra-label use.
- According to the government, Scenic View’s controls and recordkeeping were inadequate to prevent treated animals from being shipped for slaughter before withdrawal times elapsed.
- The United States filed a civil FDCA enforcement action seeking a permanent injunction to stop further violations and moved for summary judgment on liability; it also moved to strike certain affirmative defenses.
- Scenic View responded that its drug use was lawful because it was ordered or directed by a veterinarian.

## Issues

1. Whether the undisputed residue evidence entitled the United States to summary judgment that Scenic View introduced or delivered for introduction into interstate commerce adulterated food (cull cows with unsafe new animal drug residues) in violation of 21 U.S.C. § 331(a).
2. Whether Scenic View’s handling and administration of drugs after interstate shipment caused the drugs (and resulting food) to be adulterated while held for sale, in violation of 21 U.S.C. § 331(k).
3. Whether Scenic View engaged in unlawful extra-label use of new animal drugs, in violation of 21 U.S.C. §§ 331(u) and 360b(a)(4)(A), notwithstanding veterinary involvement.
4. Whether the United States made the showing required for permanent injunctive relief under 21 U.S.C. § 332, and whether defendants’ affirmative defenses could bar that relief.

## Decision

- The court granted the United States’ motion for summary judgment on FDCA liability.
- The court found the residue evidence established, as a matter of law, that Scenic View delivered adulterated food for introduction into interstate commerce in violation of 21 U.S.C. § 331(a).
- The court held Scenic View’s drug practices supported liability under 21 U.S.C. § 331(k) for acts that caused adulteration while drugs were held for sale after interstate shipment.
- The court concluded Scenic View’s extra-label drug use did not meet the conditions for lawful extra-label use under 21 U.S.C. § 360b(a)(4)(A) and related requirements; veterinary direction did not, by itself, defeat liability.
- The court granted the motion to strike in part and denied it in part, removing affirmative defenses that were not legally sufficient in an FDCA injunction action.
- The court determined injunctive relief was warranted based on the record and addressed the terms of injunctive relief through further proceedings and an injunctive order.

## Legal Principles

- Food is adulterated under the FDCA if it contains unsafe new animal drug residues in edible tissues; introducing or delivering adulterated food into interstate commerce violates 21 U.S.C. § 331(a).
- FDCA adulteration provisions applied in this context operate without a requirement that the government prove intent to violate the statute.
- Under 21 U.S.C. § 331(k), conduct involving drugs held for sale after interstate shipment is unlawful when it results in adulteration; deficient drug-use controls and practices that lead to violative residues can support liability.
- Extra-label use of approved new animal drugs is permitted only when the statutory and regulatory conditions are met; veterinary involvement is necessary for lawful extra-label use but is not a blanket defense when the conditions are not satisfied.
- Permanent injunctive relief under 21 U.S.C. § 332 may issue when the government shows a reasonable likelihood that violations will continue without court intervention; repeated residue violations and inadequate corrective measures support that finding.

## Conclusion

In United States v. Scenic View Dairy, LLC, the court entered summary judgment for the United States, holding that repeated illegal drug-residue findings in cows traced to Scenic View established FDCA violations for introducing adulterated food into interstate commerce, causing adulteration through post-shipment drug practices, and engaging in extra-label drug use that failed to meet statutory conditions; the court also struck certain defenses and concluded a permanent injunction was justified to prevent future violations.


United States v. Scenic View Dairy, LLC, 2011 WL 3879490 (2011)