FDA WARNING_LETTER - Kraft Drug - December 14, 2023

The FDA issued a Warning Letter to Daniel Kraft on November 30, 2023, concerning the manufacture and distribution of veterinary products for aquarium fish and birds, sold via kraftsdrug.com. An August 2023 website review identified products like Aquarium Amoxicillin, Aqua-mox, Aquarium Azithromycin, and others, marketed with claims for disease treatment/prevention in animals, classifying them as drugs under the FD&C Act.

These products are deemed unapproved new animal drugs because they lack FDA approval, conditional approval, or index listing, which are required for legal marketing. 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 products contain medically important antimicrobials, raising public health concerns regarding antimicrobial resistance.

Furthermore, the products are misbranded under section 502(o) of the FD&C Act because they have not been drug listed with the FDA, and the manufacturing facility is not registered with the FDA, as required by sections 510(b) and (j). Introducing or delivering these unapproved and misbranded drugs into interstate commerce violates section 301(a) of the FD&C Act.

The letter requires a written response within fifteen working days detailing corrective actions, steps to prevent recurrence, and supporting documentation.