Midland Vet Services – FDA Warning Letter, Nov 30, 2023

On November 30, 2023, the FDA issued a Warning Letter to Jeffrey Kenkel regarding the manufacture and distribution of unapproved and misbranded veterinary products for aquarium fish and birds. The FDA reviewed product labels on websites like Chewy.com and Fishick.com for products including Aqua-Mox, Aqua-Ceph, and Aqua-Cipro.

The FDA determined these products are drugs under section 201(g)(1)(B) of the FD&C Act due to claims of intended use for disease cure, mitigation, treatment, or prevention in animals. They are considered "new animal drugs" under section 201(v) because they are for minor species (nonfood-producing fish and birds) and lack FDA approval, conditional approval, or index listing, making them unsafe and adulterated under sections 512(a) and 501(a)(5). Introducing these into interstate commerce violates section 301(a).

Furthermore, the products are misbranded under section 502(o) because they are not drug listed with the FDA, and the manufacturing facility is not registered, violating sections 510(b) and (j). The FDA expressed particular concern as these over-the-counter products contain medically important antimicrobials, raising public health concerns regarding antimicrobial resistance.

The letter requires a written response within fifteen working days detailing corrective actions, an explanation of