FDA WARNING_LETTER - FishMoxFishFlex/Simple Pet Health LLC - April 25, 2025

On May 8, 2025, the FDA issued a Warning Letter to Cameron Muir regarding the distribution of unapproved and misbranded animal drug products for aquarium fish and birds, sold via https://fishmoxfishflex.com/.

The FDA's review in April 2025 found products like Fish Mox (Amoxicillin), Fish Flex (Cephalexin), Fish Flox Forte (Ciprofloxacin), Fish Cin (Clindamycin), Fish Doxy (Doxycycline), Fish Zole (Metronidazole), Fish Pen Forte (Penicillin), Fish Sulfa Forte (Sulfamethoxazole/Trimethoprim), and Bird Zithro (Azithromycin). Website claims establish these as drugs intended for disease treatment in animals, making them subject to the FD&C Act.

These products are unapproved new animal drugs under section 201(v) and 512(a) of the FD&C Act, as they lack FDA approval, conditional approval, or index listing. They are considered unsafe and adulterated under sections 512(a) and 501(a)(5). The FDA is particularly concerned due to the presence of medically important antimicrobials, contributing to antimicrobial resistance.

Furthermore, these drugs are misbranded under section 502(o) because the firm's manufacturing establishment is not registered with the FDA, and the drug products are not listed, violating sections