Justice Department files complaint on Gilbert company for unapproved animal drugs
Aug 31, 2023, 1:15 PM
(AniCell BioTech website screenshot)
PHOENIX — The Justice Department filed a complaint on Wednesday for a company in Gilbert that distributed adulterated and unapproved new animal drugs, authorities said.
The complaint alleges that AniCell Biotech LLC and its owner, Brandon T. Ames, violated the Federal Food, Drug and Cosmetic Act (FDCA), according to a press release.
AniCell allegedly was manufacturing 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 defendants claimed on their website products are intended for use in horses, dogs and cats to treat various diseases and to promote tissue regeneration and healing but were never approved by the FDA.
“New animal drugs must undergo FDA review to ensure that, among other things, they are safe and effective for their intended uses,” Director Tracey Forfa J.D. of the FDA’s Center for Veterinary Medicine said in the release.
“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.”
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, according to the the release.