FDA warns manufacturers, distributors of unapproved antimicrobials for animals

The U.S. Food and Drug Administration (FDA) on December 14 announced it has issued nine warning letters to manufacturers and distributors of unapproved and misbranded medically important antimicrobial animal drugs for violating federal law.

An open bottle of prescription pills

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

The following companies received warning letters:

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

The FDA has asked these 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 or injunction—a court order requiring a company to stop manufacturing and distributing unapproved products.

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

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 FDA says it 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.

A version of this story appears in the February 2024 print issue of JAVMA