On June 4, 2012, Judge Theodore Katz of the US District Court for the Southern District of New York ordered the Food and Drug Administration (FDA) to revisit its April 2012 decision not to ban the use of approximately 200 products, including certain antibiotics, in animal feed. Judge Katz also criticized FDA for its decision to rely on the animal feed industry to voluntarily limit the use of such drugs rather than prohibiting their use. The ruling, which requires FDA to reconsider two Citizen Petitions asking the Agency to withdraw approval of certain antibiotics used in food-producing animals, stated that FDA’s previous denial of both Petitions was “arbitrary and capricious”. Katz said FDA must evaluate the safety risks of the drugs and make a finding that they are unsafe or explain why it will not do so. FDA is expected to appeal the ruling.

The Court’s ruling is the outcome of suit brought against FDA by the Natural Resources Defense Council and several other health and consumer advocacy groups. In a related decision, the same Court ruled in March 2012 that FDA must follow through on a proposal it made decades ago to ban the use of penicillin and two forms of tetracycline in animal feed.

In recent years, FDA has been promoting a plan to establish voluntary limits on antibiotics in animal feed. In its most recent effort, FDA began asking drug makers to stop using 200 products for growth promotion in animals and instead use them only to treat diseases. FDA has stated its voluntary plan would result in a more expeditious decline in the use of these antibiotics than, for example, initiating formal rulemaking to withdraw each subject antibiotic from the market.

The ruling now puts pressure on FDA to either follow the above-noted Court orders or find an alternative regulatory solution amenable to industry, consumer advocates, and Judge Katz. For additional information, please contact Georgia C. Ravitz, Robert G. Edwards, or James H. Hartten at Arent Fox LLP.