Ruling Affects Feed-Grade Antimicrobials

A federal judge has ordered the U.S. Food and Drug Administration (FDA) to initiate proceedings to withdraw approval for the use of tetracycline and penicillin in animal feed. This action is in response to a lawsuit filed by The Natural Resources Defense Council, Center for Science in the Public Interest and the Union of Concerned Scientists in the Manhattan federal court in May and stems from action taken in December by FDA to withdraw two 1977 notices proposing to withdraw certain uses of the antimicrobials in feed intended for food-producing animals.

U.S. Magistrate Judge Theodore Katz ordered the U.S. Food and Drug Administration to begin proceedings unless makers of the drugs can produce evidence that their use is safe. If they can't, then the FDA must withdraw approval for non-therapeutic use of those drugs, the judge ruled.

The FDA had started such proceedings in 1977, prompted by its concerns the widespread use in livestock feed of certain antibiotics - particularly tetracyclines and penicillin, the most common. But the proceedings were never completed and the approval remained in place.

The agency chose to withdraw the 1977 proceedings because: “FDA is engaging in other ongoing regulatory strategies developed since the publication of the 1977 NOOHs with respect to addressing microbial food safety issues; FDA would update the NOOHs to reflect current data, information, and policies if, in the future, it decides to move forward with withdrawal of the approved uses of the new animal drugs described in the NOOHs; and FDA would need to prioritize any withdrawal proceedings (for example, take into account which withdrawal(s) would likely have the most significant impact on the public health) if, in the future, it decides to seek withdrawal of the approved uses of any new animal drug or class of drugs.”

The FDA had called the proceedings “outdated” and had been focusing its efforts on promoting voluntary reform and the judicious use of antimicrobials in the interest of best using the agency’s overall resources to protect the public health.

The FDA has not publically commented on the ruling.

The case is Natural Resources Defense Council et al. v. FDA, in the U.S. District Court for the Southern District of New York, no. 11-3562.