Phaseout Set for Antibiotics in Animal Feed in the United States

The FDA has issued three nonbinding guidance plans outlining the agency's intentions, including one each for food producers, drug companies, and veterinarians that work with the agriculture industry. The guidance plans predate a US federal court order issued in March 2012 that directed the agency to start formal proceedings to revoke approvals for production use of antibiotics, pursuant to notices issued in 1977 but was never enforced. Over the coming three years, the FDA will work with industry to eliminate such "production" uses of antibiotics, while increasing the role of veterinarians in directing the use of antibiotics to treat illness in livestock.

A major goal of the cooperative program was to preserve food producers' ability to have antibiotics available for treating infections, and one of the three draft guidance documents outlines procedures by which veterinarians can authorize the use of specific anti-infective drugs in animal feed. Another draft guidance is aimed at antibiotic drug producers, advising on how to voluntarily seek to have approvals removed for production uses of their drugs while keeping authorization for disease treatment; the guidance also spells out how drug firms can amend the products' labels to include veterinarian oversight. The final guidance provides a strategic framework for the phasing out of the production of antimicrobial drugs for use in food-producing animals.

“I know there will be those who will ask why we have not taken mandatory action to ban production uses of antimicrobials,” said Michael Taylor, the FDA deputy commissioner for foods. “The answer is that, with the willingness of drug companies and others in the animal production industry to collaborate in implementing our strategy, we can make changes more quickly than if we had to rely solely on a cumbersome regulatory process that would require us to seek change, regulatory change, drug by drug, labeled use by labeled use.”

“This is an ineffective response to the real and sobering threat of rising antibiotic resistance, which threatens human health,” responded Avinash Kar, staff attorney of the environmental action group Natural Resources Defense Council (NRDC; New York, NY, USA), noting that the guidance plans are nonbinding, and therefore unenforceable. “We may hear the right kind of noises from industry, but there is no assurance that improvements will actually follow. Once again, FDA is making much ado about nothing; pretending to act while barely acting at all.”

Related Links:
US Food and Drug Administration
Natural Resources Defense Council