Aquanest Biotic – FDA Warning Letter, Dec 14, 2023

On November 30, 2023, the FDA issued a Warning Letter to James Curtiss regarding the distribution of unapproved and misbranded veterinary products for aquarium fish and birds through the website https://aquanestbiotic.com. An August 2023 review of the website identified products like Fish Amoxi, Fish Kef, and Bird Azith, marketed with claims establishing them as drugs intended for disease treatment in animals.

These products are deemed unapproved new animal drugs under section 201(v) of the FD&C Act because they are for minor species (nonfood-producing fish and birds) and lack FDA approval, conditional approval, or index listing as required by 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 due to these over-the-counter products containing medically important antimicrobials, raising public health concerns about antimicrobial resistance.

Furthermore, the products are misbranded under section 502(o) because they are not drug listed with FDA, nor were they manufactured in a facility registered with FDA, as required by sections 510(b) and (j). Introducing or delivering these misbranded drugs into interstate commerce also violates section 30