American Aquarium Products – FDA Warning Letter, Dec 14, 2023

On November 30, 2023, the FDA issued a Warning Letter to Devon Trigg concerning the distribution of veterinary products for aquarium fish via the website https://www.americanaquariumproducts.com/. An August 2023 review of the website identified AAP Aquatronics Discomed, AAP Aquatronics Myacin, and AAP Aquatronics Spectrogram as products marketed with claims indicating their use for the cure, mitigation, treatment, or prevention of diseases in animals, classifying them as drugs under section 201(g)(1)(B) of the FD&C Act.

These products are deemed unapproved new animal drugs under section 201(v) of the FD&C Act because they are for use in nonfood-producing minor species and lack FDA approval, conditional approval, or index listing as required by sections 512, 571, or 572. Consequently, they are considered unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act. The FDA expressed particular concern as these over-the-counter drugs contain antimicrobials medically important for human disease treatment, raising public health concerns regarding antimicrobial resistance.

Furthermore, the products are misbranded under section 502(o) of the FD&C Act because they are not drug listed with the FDA, and the manufacturing facility is not registered