SILVER SRPING, MD. — On Dec. 14, the US Food and Drug Administration (FDA) issued nine warning letters to manufacturers and distributors of unapproved and misbranded animal drugs containing antimicrobials for violation of federal law. According to the agency, it is concerned that the antimicrobials contained in the drugs could lead to the development of antimicrobial resistance.

The products were not conditionally approved or on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, the main legal pathways for animal drugs, according to the FDA. Because of this, the agency cannot verify their safety or effectiveness.

The products are marketed and labeled for minor species including pet birds and aquarium fish. They contain antimicrobials that are used in human medicine, such as amoxicillin, penicillin, tetracycline, and erythromycin, and are illegally marketed over the counter, according to the FDA. Approved animal drugs that contain antimicrobials are only legally available via a prescription from veterinarians.  

The companies that received the warning letters include Chewy, American Aquarium Products, Aquanest Biotic, Aquarium Pharmacy LLC, California Veterinary Supply, Kraft Drug, Midland Veterinary Services LLC, Silver Lease LLC, and Valley Veterinary Clinic LTD.

“These unapproved animal drugs pose a two-fold risk to public health,” said Tracey Forfa, J.D., director of the FDA’s Center for Veterinary Medicine. “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. Second, inappropriate use of medically important antimicrobials contributes to the development of antimicrobial resistance, which affects both human and animal health.”

The FDA encourages anyone using the products to safely dispose of them.

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