The Justice Department announced this week that the United States filed a complaint to enjoin a Gilbert, Arizona, company from manufacturing and distributing products the government alleges to be adulterated and unapproved new animal drugs.
In a civil complaint for permanent injunction filed Aug. 29, in the U.S. District Court for the District of Arizona, the United States alleges that AniCell Biotech LLC and its owner, Brandon T. Ames, violated the Federal Food, Drug and Cosmetic Act (FDCA). According to the complaint, the defendants manufacture products under the brand names EquusCell and CanisCell consisting of injectable and intravenous liquids, eye drops and grafts derived from the amniotic tissue of horses. The complaint alleges that the defendants claim on their website and in promotional pamphlets that their products are intended for use in horses, dogs and cats to treat various diseases, such as osteoarthritis and renal failure, and to promote tissue regeneration and healing.
According to the complaint, the defendants’ products are not generally recognized by qualified experts as safe and effective for the purposes claimed by the defendants and lack approval by the U.S. Food and Drug Administration (FDA). The complaint further alleges that new animal drugs sold in interstate commerce without FDA approval are considered adulterated. The complaint states that FDA repeatedly told the defendants, including through a 2018 warning letter, that their products constituted new animal drugs under the law and could not be sold without FDA approval.
“The FDCA is critical to ensuring the safety of animal drugs,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The department will continue to work with FDA to take action against animal drug manufacturers that do not comply with the law.”
“New animal drugs must undergo FDA review to ensure that, among other things, they are safe and effective for their intended uses,” said Director Tracey Forfa J.D. of the FDA’s Center for Veterinary Medicine. “When companies distribute unapproved new animal drugs like these by ignoring or attempting to bypass the public health safeguards of FDA pre-market review and post-market monitoring, they not only violate the law, but they also violate the trust of their people who rely on their products to be safe and effective to treat animals in need.”
Trial Attorney Coleen Schoch of the Justice Department’s Consumer Protection Branch is handling the case with the assistance of Associate Chief Counsel for Enforcement Jaclyn E. Martínez Resly of the FDA’s Office of the Chief Counsel.
The claims made in the complaint are allegations that, if the case were to proceed to trial, the government must prove by a preponderance of the evidence.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at www.justice.gov/civil/consumer-protection-branch.
