With reference to our posts of April 17, 2012, March 23, 2012 and May 27, 2011, United States Magistrate Judge Theodore H. Katz has once again issued an Order in favor of the National Resources Defense Council (NRDC).

The National Resources Defense Council (NRDC) and a coalition of other environmental groups including the Center for Science in the Public Interest (CPSI), and the Union of Concerned Scientists have challenged USFDA's approval of the prophylactic use of Penicillin and Tetracyclines in animal feeds. These approvals date back to the 1950's.

In 1977, the Food and Drug Administration proposed banning the use of Penicillin and Tetracylines for growth promotion in food animal production. However, in the past 35 years, FDA has neither held hearings nor taken any further action on this issue. Now that a federal district court has ruled in favor of the plaintiffs, FDA (absent a successful appeal) will be compelled to carry forward with its initial plan to start proceedings that could lead to the restriction or withdrawal of the drugs in food animal production.

The Complaint, which may be found on our May, 27, 2011 post, was filed in Federal District Court (SDNY) and requested:

1. That FDA withdraw approvals for Penicillin as an animal feed additive (21 CFR 588.460) and Tetracyclines as animal feed additives (21 CFR 588.128, 588.450).

2. That FDA respond to Citizens Petitions (posted on our 5/27/11 entry) filed in 1999 and 2005 as required by the APA (5 USC 706(1)) and by 21 CFR 10.30(e)(1).

3. That the Court declare that FDA's failure to withdraw the above approvals violates the APA (5 USC 706(1)) and the FDCA (21 USC 360b(e)(1)).

The Memorandum, Opinion, and Order of June 1, 2012 is posted below. Specifically, the Court has rejected FDA’s “voluntary” program as detailed in Guidance Document #209 (available on our post of April 17, 2012) and has again instructed FDA to re-examine the two above referenced Petitions.

The case reference is 11 Civ. 3562 (THK) Southern District of New York. National Resources Defense Council, et al., v. United States Food and Drug Administration, et al.