Aquarium Pharmacy LLC – FDA Warning Letter, Dec 14, 2023

On November 30, 2023, the FDA issued a Warning Letter to Cynthia Marie Bounds regarding the distribution of unapproved and misbranded veterinary products for aquarium fish via aquariumpharmacy.com. An August 2023 website review revealed products like Aquarium Amoxicillin and Aquarium Ciprofloxacin, marketed with claims for disease treatment in animals, thus 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, making them unsafe and adulterated. The FDA is particularly concerned as these over-the-counter antimicrobials are medically important in human medicine, raising public health concerns regarding antimicrobial resistance.

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

The letter requires a written response within fifteen working days detailing corrective actions, including steps to prevent recurrence. Failure to comply may result in legal or regulatory action, including seizure and injunction, potentially against all non-compliant products. The FDA suggests exploring index listing or approval processes for legal marketing.