Justice Department charges Arizona company, says its animal drugs not approved
Aug. 30 (UPI) -- The Justice Department filed a complaint Wednesday against Arizona-based AniCell Biotech LLC for allegedly selling unapproved animal drugs.
"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 Justice Department said in a press release Wednesday.
According to the Justice Department complaint, the products sold by AniCell Biotech LLC have not been approved by the Food and Drug Administration and "are not generally recognized by qualified experts as safe and effective for purposes claimed by the defendants."
The Justice Department says the FDA warned AniCell Biotech LLC multiple times, including in a letter sent to the company in 2018, that their products were unapproved and could not be legally sold.
"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," said the Direct of FDA's Center for Veterinary Medicine Tracey Forfa J.D.
