FDA WARNING_LETTER - California Veterinary Supply - December 14, 2023

On November 30, 2023, the FDA issued a Warning Letter to CalVetSupply.com (Elizabeth Field) concerning the distribution of unapproved and misbranded veterinary products for aquarium fish. An FDA website review in November 2023 identified products like Aquarium Amoxicillin, Aquarium Azithromycin, and others, marketed with claims indicating their use for disease treatment in animals, thus classifying them as drugs under section 201(g)(1)(B) of the FD&C Act.

These products are deemed "new animal drugs" under section 201(v) of the FD&C Act, intended for minor species (nonfood-producing fish), but lack required FDA approval, conditional approval, or index listing (sections 512, 571, or 572). This renders them unsafe and adulterated under sections 512(a) and 501(a)(5), violating section 301(a). The FDA expressed particular concern due to these over-the-counter products containing medically important antimicrobials, raising public health concerns regarding antimicrobial resistance.

Furthermore, the products are misbranded under section 502(o) because CalVetSupply.com has not registered its manufacturing establishment with the FDA nor drug-listed its products, as required by sections 510(b) and (j). This also constitutes a violation of section