FDA issues warnings of unapproved antimicrobial animal drugs

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The FDA issued 9 warning letters to manufacturers and distributors, citing unapproved and misbranded antimicrobial animal drugs in violation of federal law. According to the FDA,¹ warning letters were issued to the following companies:

• 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 requested these companies provide a response to the warning letters within 15 days of receiving them, outlining their plans to rectify the violations mentioned. Failure to promptly address these violations may lead to legal action by the FDA, which could involve product seizure and/or a court order mandating the cessation of manufacturing and distribution of unapproved products by the company.¹

The agency's apprehension stems from the risk of antimicrobial resistance, since the usage of these drugs without medical supervision could potentially increase this resistance.¹ Antimicrobials are pharmaceuticals that kill or curb the growth of microorganisms. This makes them critical tools for preventing and fighting diseases in both people and animals. However, antimicrobial resistance occurs, it threatens public or animal health by making it difficult or impossible to treat the diseases caused by these microorganisms.²

The marketed products are not the subject of a “New Animal Drug Application” from the FDA, nor are they conditionally approved or on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, which are the main legal pathways for animal drugs to reach the marketplace. As a result, their safety and effectiveness have not been authenticated by the FDA through the animal drug review process or facility inspections.¹

The animal products mentioned 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.¹

“These unapproved animal drugs pose a two-fold risk to public health,” said Tracey Forfa, JD, director of the FDA’s Center for Veterinary Medicine, in the release. “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.”¹

For consumers worried about products mentioned in the warning letters, the FDA recommended that they be safely disposed of and report any adverse events associated with these products to the FDA’s Center for Veterinary Medicine.

Additionally, the FDA would like to remind the public that all approved animal drugs containing these antimicrobials are only legally available by prescription from a licensed veterinarian. The administration stressed that providing animals with the appropriate drug is more likely to effectively resolve infections and reduce the need for extended treatment with antimicrobials.¹

References

1. FDA Warns Nine Manufacturers, Distributors of Unapproved Antimicrobials for Animals. News release. US Food and Drug Administration. December 14, 2023. Accessed December 14, 2023. https://www.fda.gov/news-events/press-announcements/fda-warns-nine-manufacturers-distributors-unapproved-antimicrobials-animals
2. Antimicrobial use and antimicrobial resistance. American Veterinary Medical Association. Accessed August 2, 2023. https://www.avma.org/resources-tools/one-health/antimicrobial-use-and-antimicrobial-resistance#:~:text=Antimicrobials%20are%20used%20to%20prevent,including%20via%20feed%20or%20water