FDA WARNING_LETTER - Valley Vet Supply - December 14, 2023

On November 30, 2023, the FDA issued a Warning Letter to Arnold Nagely concerning Valley Vet's distribution of veterinary products for aquarium fish and birds, specifically citing products like Fishbiotic Amoxicillin and Aqua-Mox. The FDA's review of the firm's website (https://www.valleyvet.com/) revealed claims establishing these products as drugs intended for the cure, mitigation, treatment, or prevention of diseases in animals, making them subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The products are deemed "unapproved new animal drugs" under section 201(v) of the FD&C Act because they are for use in minor species (nonfood-producing fish and birds) and 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) of the FD&C Act. The FDA expressed particular concern as these over-the-counter products contain medically important antimicrobials, raising public health concerns regarding antimicrobial resistance.

Furthermore, the products are "misbranded new animal drugs" under section 502(o) of the FD&C Act because they have not been drug listed with the FDA, and their