Food Safety Regulations 'Unlawfully Withheld' By FDA, Court Rules

The Food and Drug Administration has officially broken the law by failing to release regulations needed to implement the Food Safety Modernization Act (FSMA), the 2011 legislation meant to overhaul the nation's food safety system.

That was the key finding in the case of Center for Food Safety v. Hamburg, released Monday by U.S. District Judge Phyllis Hamilton of the Northern District of California. The Center for Food Safety had sued Margaret Hamburg, the FDA commissioner, after the agency failed to release seven key regulations by July 2012, which the FSMA had set as the deadline for their release.

The Center for Food Safety asked the court to order the FDA to release the regulations in a timely manner. The FDA responded that the rules were complicated and technical, and that releasing them prematurely would compromise their efficacy. (The agency didn't directly address widespread accusations that the regulations were held up by the White House for political reasons.)

It looked like the lawsuit took a hit this January when the FDA released the two most important draft rules for public comment. But those two proposals weren't enough for the judge.