Advocacy groups sue FDA over FSMA delays

By Caroline Scott-Thomas

- Last updated on GMT

Related tags Food safety Law Food and drug administration

Advocacy groups sue FDA over FSMA delays
Two advocacy groups have sued the Food and Drug Administration (FDA) and the Office of Management and Budget (OMB) for delays in implementing the Food Safety Modernization Act (FSMA), which was signed into law on January 4, 2011.

The Center for Food Safety and the Center for Environmental Health filed the lawsuit in a district court in San Francisco this week, citing the FDA’s failure to meet deadlines for seven food safety regulations under the law. Four of those are still awaiting OMB approval, the complaint says.

The lawsuit seeks a court-imposed deadline for the FDA to act on FSMA regulations and to prevent OMB from delaying FDA’s compliance.

“If the Obama Administration has lost the political will to make FSMA a reality, we’re here to help them find it,”​ said executive director of Center for Food Safety Andrew Kimbrell in a statement. “It’s a disgrace that a crucial, lifesaving law sits idle while the bureaucracies of FDA and OMB grind along without a hint of results.”

The complaint claims that the FDA’s failure to meet key FSMA deadlines is “an abdication of the agency’s fundamental responsibilities” and puts lives at risk. Draft regulations on establishing a foreign supplier verification program and produce safety guidance are among those that are more than six months behind schedule.

Food program director at Center for Environmental Health Charles Margulis said: “This unreasonable and dangerous political foot-dragging on FSMA has to stop now. While illness outbreaks continue and Americans question the health and safety of their food supply, FDA issues excuses instead of new regulations. The time is now for modernizing our federal food safety laws.”

A coalition of consumer groups also urged FDA to act on FSMA’s overdue regulations last month​.

According to figures from the Center for Disease Control and Prevention, an estimated 48m people become ill as a result of foodborne illness each year, about 128,000 are hospitalized, and 3,000 die.

The groups’ lawsuit is available online here​.

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