FDA moves to withdraw swine drug carbadox

The US Food and Drug Administration (FDA) intends to withdraw the veterinary antibiotic carbadox because it leaves carcinogenic residues in meat products.

Carbadox was first approved in the early 1970s for use in swine to control bacterial infections. The product has been banned in the EU since 1999, in Canada since 2004, and is not permitted for use on food-producing animals in Australia.

Prompted by mounting evidence questioning the drug’s safety, the FDA’s Center for Veterinary Medicine (CVM) conducted a preliminary risk characterisation from 2012 to 2014, which determined that the lifetime cancer risk from consumption of pork liver containing carcinogenic carbadox residues is higher than that allowed under the FDA’s framework for regulating new animal drugs.

Also in 2014, the Codex Alimentarius Commission – the main global body that advises the World Health Organization and United Nations – concluded that ‘there is no safe level of residues of carbadox or its metabolites in food that represents an acceptable risk to consumers,’ and recommended that it should not be used in food producing animals.

The FDA says it held discussions with US supplier Phibro last year about the company’s plans to generate safety data, but the resultant plans ‘did not sufficiently address’ the agency’s questions, hence the move to withdraw approval.