FDA Warns Nine Manufacturers, Distributors of Unapproved Antimicrobials for Animals

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.

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