A federal court has issued a permanent injunction against an Arizona-based animal drug manufacturer, ordering the company to stop producing and selling unapproved animal drugs that violated federal law, the Department of Justice announced this week.
AniCell Biotech LLC, located in Gilbert, Arizona, and its founder and CEO, Brandon T. Ames, were found to have manufactured and distributed unapproved animal cell- and tissue-based products (ACTPs) derived from horse amniotic tissue. According to the civil complaint filed in the U.S. District Court for the District of Arizona, the company falsely promoted these products as treatments for various animal diseases and as tools for promoting healing and tissue regeneration—despite never obtaining required approvals from the U.S. Food and Drug Administration (FDA).
The court’s April 17 order permanently enjoins AniCell and Ames from continuing these activities unless and until they meet strict conditions outlined in the Federal Food, Drug, and Cosmetic Act (FDCA) and the consent decree agreed upon with the Justice Department.
“Animal drug manufacturers have a duty to ensure that their products are safe and in compliance with federal law,” said Acting Assistant Attorney General Yaakov Roth of the Justice Department’s Civil Division. “This case underscores our commitment to working with FDA to hold violators accountable and protect animal health.”
Despite multiple warnings from the FDA—including an official warning letter—AniCell allegedly continued to sell its products without submitting them for FDA review or approval, actions that the agency said could pose serious health risks to pets and other animal patients.
“Marketing unapproved animal drugs that claim to treat diseases can jeopardize the health of animals and mislead pet owners and veterinarians,” said Dr. Timothy Schell, Acting Director of the FDA’s Center for Veterinary Medicine. “We will not hesitate to take enforcement action when the safety of animal patients is at risk.”
Under the terms of the court order, AniCell and its leadership must meet a number of strict legal and procedural requirements before resuming any manufacturing or sales of new animal drugs.
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