California Veterinary Supply – FDA Warning Letter, Sep 10, 2024

In August 2024, the FDA reviewed CalVetSupply.com, identifying the distribution of unapproved and misbranded animal drug products for aquarium fish and birds, including Fish Moxi Amoxicillin and Bird Zithro Azithromycin. These products are considered drugs under section 201(g)(1)(B) of the FD&C Act due to claims establishing their intended use in disease treatment. The drugs are unapproved new animal drugs under section 201(v) because they lack FDA approval, conditional approval, or index listing, rendering them unsafe and adulterated per sections 512(a) and 501(a)(5). Furthermore, they are misbranded under section 502(o) as they are not drug listed with FDA and were not manufactured in an FDA-registered facility, violating sections 510(b) and (j). Introducing these unapproved, adulterated, and misbranded drugs into interstate commerce violates section 301(a) of the FD&C Act. FDA expressed particular concern due to these over-the-counter products containing medically important antimicrobials, contributing to public health risks like antimicrobial resistance. The firm must respond within fifteen working days, detailing corrective actions, recurrence prevention, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction against all non-compliant products. The FDA suggests exploring index listing or approval processes for legal marketing.