## Facts

- Nutri-cology, Inc. and related defendants marketed products labeled as nutritional or dietary supplements.
- The United States alleged the products were unapproved “drugs” and “new drugs” under the Federal Food, Drug, and Cosmetic Act (FDCA) because they were promoted to prevent or treat diseases and conditions.
- The FDA monitored Nutri-cology beginning in 1982 and repeatedly notified it in writing (including multiple letters in 1982, 1985, and 1988) that the products were unapproved drugs/new drugs; the agency also met with counsel in 1982 and 1988.
- Nutri-cology maintained the products were foods (e.g., herbs, oils, vitamins) rather than drugs/new drugs.
- The FDA’s last communication was in June 1988; the government filed suit on May 2, 1991.
- The district court issued an ex parte temporary restraining order on May 8, 1991, barring marketing of nine products representing about 80% of Nutri-cology’s business.
- The district court denied a preliminary injunction and later denied reconsideration, despite finding a colorable showing of FDCA violations, because the government did not establish irreparable harm.

## Issues

1. Whether the district court abused its discretion by denying a preliminary injunction for failure to show irreparable harm despite a colorable showing of FDCA violations.
2. Whether the district court could consider the government’s delay in filing suit when assessing irreparable harm and balancing hardships in an FDCA enforcement action.
3. Whether the district court abused its discretion in denying the government’s motion for reconsideration.

## Decision

- The Ninth Circuit affirmed the denial of the preliminary injunction and the denial of reconsideration.
- The court held the district court applied the correct preliminary-injunction framework and did not abuse its discretion in finding irreparable harm was not shown.
- The court held the government’s delay was a permissible factor in evaluating irreparable injury and the balance of equities.
- The court rejected the government’s position that FDCA enforcement effectively presumes irreparable harm or eliminates ordinary equitable discretion.
- The court upheld denial of reconsideration because no basis such as new evidence, changed law, or clear error required altering the ruling.

## Legal Principles

- Preliminary injunctive relief remains governed by traditional equitable standards, reviewed on appeal for abuse of discretion.
- A colorable (or likely) showing of a statutory violation does not automatically establish irreparable harm or entitle the movant to a preliminary injunction.
- Courts may weigh the movant’s delay in seeking preliminary relief as evidence that immediate irreparable injury is not occurring.
- In FDCA enforcement actions, courts retain discretion to balance hardships and consider the public interest; the FDCA does not categorically displace these equitable inquiries.
- Motions for reconsideration are disfavored and generally require new evidence, an intervening change in law, or a clear error to justify relief.

## Conclusion

The Ninth Circuit held that even in FDCA enforcement litigation, the government must satisfy ordinary equitable requirements for a preliminary injunction, and the district court acted within its discretion in denying relief based on lack of irreparable harm, the government’s delay, and equitable balancing, as well as in denying reconsideration.


United States v. Nutri-cology, Inc., 982 F.2d 394 (9th Cir. 1992)