The US Food and Drug Administration (FDA) today issued warning letters to nine manufacturers and distributors of products for animals containing unapproved and misbranded antimicrobial drugs.
The products, which are marketed and labeled for minor species such as aquarium fish and birds, contain medically important antibiotics such as amoxicillin, penicillin, tetracycline, and erythromycin. The FDA says the companies are violating federal law, because the products have not gone through the main legal pathways for animal drugs to reach the marketplace and are being sold over the counter illegally. FDA-approved animal drugs containing medically important antibiotics—those that are also used in human medicine—require a prescription from a licensed veterinarian.
The FDA says the products pose a "two-fold" risk to public health.
"First, these products haven't been through the FDA drug review process, and we don't know whether they're safe or effective, or even contain what the label states," Tracey Forfa, JD, director of the FDA's Center for Veterinary Medicine, said in a press release. "Second, inappropriate use of medically important antimicrobials contributes to the development of antimicrobial resistance, which affects both human and animal health."
The warning letters were sent to American Aquarium Products, Aquanest Biotic, Aquarium Pharmacy LLC, California Veterinary Supply, Chewy Inc., Kraft Drug, Midland Veterinary Services LLC, Silver Lease LLC, and Valley Veterinary Clinic LTD.
The FDA says anyone currently using the products included in the warning letters should safely dispose of them. The agency has given the companies 15 days to respond.