Court Enjoins Arizona Animal Drug Manufacturer from Distributing Unapproved Drugs

A federal court ordered an Arizona company to stop distributing unapproved animal drugs that violate the Federal Food, Drug, and Cosmetic Act (FDCA), the Department of Justice announced.

In a civil complaint filed on August 29, 2023, in the U.S. District Court for the District of Arizona, the United States alleged that AniCell Biotech LLC and its founder and chief executive officer, Brandon T. Ames, violated the FDCA at the company’s facility in Gilbert, Arizona, by manufacturing and distributing unapproved animal drugs. According to the complaint, AniCell Biotech makes and distributes animal cell- and tissue-based products (ACTPs) derived from the amniotic tissue of horses for use in animals.

According to the complaint, AniCell and Ames claimed on their website and in promotional pamphlets that their products were intended for use in animals to treat various diseases and to promote tissue regeneration and healing. The complaint further alleged that AniCell and Ames made and sold new animal drugs that were considered adulterated and unsafe because they had not been approved by the U.S. Food and Drug Administration (FDA). According to the complaint, FDA provided defendants with multiple warnings, including a written warning letter regarding its need to submit its new animal drugs to the FDA for approval.

“Animal drug manufacturers have a duty to ensure that their products are safe and manufactured and sold in accordance with the law,” said Acting Assistant Attorney General Yaakov Roth of the Justice Department’s Civil Division. “The Department will continue to work closely with FDA to pursue appropriate actions against drug manufacturers that violate the law.”

“Marketing unapproved new animal drugs that claim to cure, mitigate, treat or prevent diseases in animals can pose serious safety risks to consumers’ pets,” said Acting Director Dr. Timothy Schell of the FDA’s Center for Veterinary Medicine. “The FDA will continue to pursue actions against those who may put animal patients in harm’s way by manufacturing and distributing unapproved new animal drugs.”

The defendants agreed to settle the suit and be bound by a consent decree permanently enjoining them from violating the FDCA. Under the court’s order, entered on April 17, the defendants must comply with specific requirements set forth in the injunction and the FDCA prior to manufacturing or distributing any new animal drugs.

Trial Attorney Coleen Schoch of the Civil Division’s Consumer Protection Branch handled the case, with assistance from Associate Chief Counsel of Enforcement Jaclyn E. Martinez Resly of the FDA’s Office of the Chief Counsel.

Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch.