FDA WARNING_LETTER - top dog pet store llc - May 31, 2024

On July 31, 2024, the FDA issued a Warning Letter to Anthony Michael Pavon concerning the marketing of unapproved new animal drugs, Green Magic and Bulldog Cartel Parvo Combat, on the website thetopdogpetstore.com. An FDA review in May 2024 determined these products are drugs under section 201(g)(1) of the FD&C Act due to claims indicating their use for treating animal diseases. The FDA found these products to be unapproved new animal drugs under section 201(v) of the FD&C Act, as they are not generally recognized as safe and effective. Consequently, their introduction into interstate commerce is prohibited under section 301(a). Lacking FDA approval or index listing, the products are deemed unsafe under section 512(a) and adulterated under section 501(a)(5). They are also misbranded under section 502(o) for not being drug listed. The firm must respond within fifteen working days, detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to address these violations may lead to legal action, including seizure and/or injunction, emphasizing the firm's responsibility for compliance with all federal laws and FDA regulations.