The U.S. Food and Drug Administration (FDA) recently alerted the public to its issuance of nine warning letters to various manufacturers and distributors. These companies have allegedly been involved in the marketing and distribution of unapproved and misbranded antimicrobial drugs for animals, in direct violation of federal law.
The FDA’s primary concern is that these products contain antimicrobials crucial to human medicine. The use of such substances without medical oversight can contribute significantly to the development of antimicrobial resistance, a phenomenon where microorganisms like bacteria develop resistance to the antimicrobials designed to eliminate them.
The FDA has clarified that none of the products in question are part of a New Animal Drug Application or are Conditionally Approved or on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species. This means that these products have not undergone the FDA’s review process for safety or effectiveness, nor have the facilities manufacturing them been inspected.
These animal products, including those intended for minor species like aquarium fish and pet birds, contain human-important antimicrobials such as amoxicillin, penicillin, tetracycline, and erythromycin. They are currently being illegally marketed over the counter.
The FDA emphasizes that all approved animal drugs containing these antimicrobials should only be available via prescription from a licensed veterinarian. Veterinarians’ specialized training and experience are critical in diagnosing and treating animal health issues properly. Proper drug administration increases the likelihood of effective infection resolution and reduces the need for extended antimicrobial treatment.
Moreover, the FDA warns the public about the potential dangers of using unapproved animal drugs in humans. These products have not been evaluated by the FDA, and many 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.
The companies that received the warning letters include 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. These companies have been given 15 days from the receipt of the warning letters to respond with a plan to address the violations cited by the FDA.
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