Warning Letters Sent by FDA to Manufacturers of Antimicrobial Animal Drugs

The Food and Drug Administration (FDA) has issued warning letters to Chewy and eight other manufacturers and distributors of antimicrobial animal drugs. The FDA claims that these medications are unapproved and misbranded, raising concerns about their potential impact on the development of antimicrobial resistance.

According to the FDA, the use of these products, which contain antimicrobials that are critical in human medicine, without proper medical oversight can contribute to the rise of antimicrobial resistance. The agency has not conducted a thorough evaluation of the safety or effectiveness of these products through its animal drug review process or facility inspections. Furthermore, the products are being illegally marketed over the counter.

The antimicrobial animal drugs in question are marketed and labeled for minor species such as aquarium fish and pet birds and include substances like amoxicillin and penicillin. However, their legality and adherence to regulatory standards are now being called into question.

Chewy and representatives from other companies, including Kraft Drug and California Veterinary Supply, have yet to respond to requests for comment on the matter.

As the FDA takes action to address potential risks associated with unapproved and misbranded antimicrobial animal drugs, it serves as a reminder of the importance of adhering to proper regulations and oversight to protect both animals and humans.