Toltrazuril Shop – FDA Warning Letter, May 16, 2024

The FDA issued a Warning Letter to Yvette Pittman, operating as Toltrazuril Shop, for illegally marketing unapproved new animal drugs. The firm sells "Toltrazuril Shop Liquid Solution" (2.5%, 5%, 10%) and "Toltrazuril Shop Powder" (5%) via its websites and social media, promoting them for treating coccidiosis and Equine Protozoal Myeloencephalitis (EPM) in various animals. The FDA determined these products are "drugs" under section 201(g)(1) of the FD&C Act due to their intended use. They are further classified as "new animal drugs" under section 201(v) because they lack general recognition of safety and effectiveness. As these products are not FDA-approved or index-listed, they are considered unsafe under section 512(a) and adulterated under section 501(a)(5) of the FD&C Act. Introducing or delivering these unapproved and adulterated drugs into interstate commerce is prohibited by section 301(a). The FDA highlighted concerns about competition with legally marketed drugs and the lack of data on residues in food-producing animals, posing risks to both animal and human food safety. The firm must respond within fifteen working days, detailing corrective actions and preventative measures, or provide justification if they believe no violation exists, to avoid potential legal action like seizure or injunction.