FDA WARNING_LETTER - totaltoltrazuril.com - May 16, 2024

The FDA issued a Warning Letter to the firm marketing "Total Toltrazuril - Coccidiosis & Horse EPM Treatment" for violating the Federal Food, Drug, and Cosmetic Act (FD&C Act). From December 2023 to May 2024, the FDA reviewed the firm's website (https://totaltoltrazuril.com/) and social media, determining the product is an unapproved new animal drug.

The product is classified as a drug under section 201(g)(1) of the FD&C Act [21 U.S.C. 321(g)(1)] due to claims of treating or preventing diseases like EPM and Coccidiosis in various animals. Examples of claims include "treat EPM (equine protozoal myeloencephalitis) & Coccidiosis," "preventative and a treatment for disease," and "effectively and safely combats Coccidia and eradicates EPM."

The product is considered a new animal drug under section 201(v) [21 U.S.C. 321(v)] because it is not generally recognized as safe and effective. To be legally marketed, new animal drugs require FDA approval, conditional approval, or index listing under sections 512, 571, and 572 of the FD&C Act. Since this product lacks such approval