FDA WARNING_LETTER - Equine Podiatry Solutions, LLC - June 14, 2022

The FDA issued a Warning Letter to Derrick Cooke regarding the marketing of "Desmosphyrine" as an unapproved veterinary product for treating animal diseases. FDA reviewed the firm's website (www.beatlaminitis.com) and social media in October and November 2021, and March 2022, finding claims that establish Desmosphyrine as a drug under section 201(g)(1)(B) of the FD&C Act due to its intended use for diagnosis, cure, mitigation, treatment, or prevention of disease in animals. The product is deemed an unapproved new animal drug under section 201(v) because it is not generally recognized as safe and effective. Since it lacks FDA approval or index listing (sections 512, 571, and 572), it is considered unsafe (section 512(a)) and adulterated (section 501(a)(5)). Introducing such an adulterated drug into interstate commerce is prohibited by section 301(a) of the FD&C Act. The firm must respond within fifteen working days, detailing corrective actions, recurrence prevention, and supporting documentation. Failure to adequately address these violations may lead to legal action, including seizure or injunction.