FDA WARNING_LETTER - Evolution Pets LLC - November 12, 2024

The FDA issued a Warning Letter to William and Susanne Beckett of Evolution Pets concerning the marketing of unapproved new animal drugs, SeizureGuard Plus and Life Span Arthritis & Mobility Advanced Enzyme Therapy. A review of their website and Amazon store from October to November 2024 revealed claims establishing these products as drugs under FD&C Act section 201(g)(1), intended for disease treatment or to affect animal body structure/function. The products are deemed "new animal drugs" under section 201(v) as they are not generally recognized as safe and effective. Lacking an approved new animal drug application, conditional approval, or index listing (sections 512, 571, 572), they are considered unsafe (section 512(a)) and adulterated (section 501(a)(5)). The introduction of such adulterated drugs into interstate commerce is prohibited by section 301(a). The firm must respond within fifteen working days, detailing corrective actions and prevention measures, or face potential legal action, including seizure and injunction. The letter also notes other potential unapproved drugs.