Source: Powder & Bulk Solids 

The US FDA issued Warning Letters to Toltrazuril Shop and Linessa Farms LLC on May 16, 2024, for selling Toltrazuril, an unapproved antiprotozoal drug used to treat coccidiosis and equine protozoal myeloencephalitis (EPM) in various animals. The FDA’s letters cited violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), stating that these products are unapproved new animal drugs and their interstate sale is illegal. Toltrazuril Shop sells a 5% liquid solution for multiple animals, while Linessa Farms had Toltrazuril listed on its website.

The FDA highlighted that Toltrazuril is not approved for use in cats, dogs, and other farm animals in the U.S., though it is used in other regions for specific conditions. The FDA-approved alternative, Ponazuril, is used for treating coccidia and EPM. The FDA stressed that unapproved drugs undermine legal markets and pose safety concerns for human food products derived from treated animals.

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