FDA Warns Nine Manufacturers, Distributors of Unapproved Antimicrobials for Animals

SILVER SPRING, Md., Dec. 14, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is announcing the issuance of nine warning letters to manufacturers and distributors of unapproved and misbranded antimicrobial animal drugs for violations of federal law. The agency is concerned because these products contain antimicrobials that are important in human medicine and using them without medical oversight contributes to the development of antimicrobial resistance. Antimicrobial resistance happens when microorganisms like bacteria become resistant to the antimicrobials that are designed to kill them.

The marketed products are not the subject of a New Animal Drug Application, nor are they Conditionally Approved or on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species – the main legal pathways for animal drugs to reach the marketplace. Therefore, the FDA has not verified their safety or effectiveness as part of the animal drug review process or facility inspections. 

The animal products referenced in the warning letters are marketed and labeled for minor species such as aquarium fish and pet birds. They contain antimicrobials that are important in human medicine, such as amoxicillin, penicillin, tetracycline, and erythromycin, and are being illegally marketed over the counter.

"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." 

All approved animal drugs containing these antimicrobials are only legally available by prescription from a licensed veterinarian. Veterinarians use their specialized training and experience to properly diagnose and treat animal health issues. Providing animals with the appropriate drug is more likely to effectively resolve infections and reduce the need for extended treatment with antimicrobials. Judicious use of antimicrobials reduces the risk of developing antimicrobial resistance and helps ensure better health outcomes.

Additionally, it's important to note that using unapproved animal drugs in humans can be especially dangerous because these products have not been evaluated by the FDA, and because many animal drugs are not identical to similar products approved for use in people. Self-diagnosis and treatment with unapproved animal antimicrobials could delay effective treatment, allowing infections to become more severe and/or more resistant to antimicrobials.

Anyone currently using or administering the products included in these warning letters should safely dispose of them. Animal owners or caretakers should consult a licensed veterinarian, and people should consult a licensed health care provider, to obtain an accurate diagnosis and appropriate treatment. Consumers, veterinarians, and health care providers are encouraged to report human and animal adverse events associated with these products to the FDA's Center for Veterinary Medicine: How to Report Animal Drug and Device Side Effects and Product Problems.

The following companies received warning letters:

• American Aquarium Products
• Aquanest Biotic
• Aquarium Pharmacy LLC
• California Veterinary Supply
• Chewy Inc.
• Kraft Drug
• Midland Veterinary Services LLC
• Silver Lease LLC
• Valley Veterinary Clinic LTD

The FDA has asked the companies to respond to the warning letters within 15 days of receipt to state how they will address the violations cited in the warning letters. Failure to address the violations promptly may result in the FDA's legal action, including product seizure and/or a court order requiring a company to stop manufacturing and distributing unapproved products.

The FDA will continue to monitor the marketplace and take necessary steps to protect human and animal health against companies selling unapproved animal drugs that can put people and animals at risk. 

Additional Information

• How to Report Animal Drug and Device Side Effects and Product Problems
• FDA's Concerns About Unapproved Animal Drugs
• Ornamental Fish Drugs and You
• CVM: Antimicrobial Resistance

Media Contact: Veronika Pfaeffle, 301-310-2576 and Janell Goodwin, 240-393-3067
Consumer Inquiries: [email protected] or 888-INFO-FDA

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products. 

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SOURCE U.S. Food and Drug Administration