U.S. consumer groups sue FDA over FSMA accredited labs program

According to The National Law Review, on August 19, two consumer groups—Center for Food Safety (CFS) and Center for Environmental Health (CEH)—filed suit against the U.S. Food Drug Administration (FDA) in California federal court for its failure to promulgate final regulations and complete actions by mandatory deadlines set by Congress in the Food Safety Modernization Act of 2011 (FSMA).

At issue in the lawsuit is Section 422 of the Federal Food, Drug, and Cosmetic Act (FDCA) as amended by FSMA, which required that by Jan. 4, 2013, the FDA establish a program to detect and address foodborne illness outbreaks with more accredited laboratories and provide a database of accredited labs. Among other requirements, the agency was to establish a program for the testing of food by accredited laboratories; establish a publicly available registry of accreditation; and develop model standards that a laboratory must meet in order to be accredited by a recognized accreditation body.

In the complaint, CFS and CEH conclude that, “FDA’s failure to implement FSMA’s laboratory accreditation provisions by their statutory deadlines is an abdication of the agency’s fundamental responsibilities. Moreover, the agency’s unlawful withholding and unreasonable delay is putting millions of lives at continued risk from contracting foodborne illnesses, contrary to Congress’ commands. This lawsuit therefore seeks to require FDA to complete the laboratory accreditation actions FSMA requires by court-established deadlines.”

The National Law Review article

CFS, CEH filed complaint (pdf)