FDA agrees to new deadlines for FSMA rules

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FDA agrees to new deadlines for FSMA rules

Published: Friday, February 21, 2014

FDA agrees to new deadlines for FSMA rules

The Food and Drug Administration (FDA) agreed to incrementally issue final rules for the Food Safety and Modernization Act (FSMA) between Aug. 30, 2015 and May 31, 2016 to settle a lawsuit brought by the Center for Food Safety (CFS) and the Center for Environmental Health.

The two advocacy groups sued FDA for failing to deliver seven rules required by FSMA by the 2012 deadline set in the law. FDA missed the deadline as it worked with the affected industries to design final regulations for the most significant update of the American food system in 70 years. The federal district court in Oakland had ruled that all seven proposed rules must be issued by Nov. 30, 2012 and final rules by June 2015. FDA appealed that ruling, but has dropped its appeal after agreeing to a new set of deadlines. Under the new agreement, FDA must issue the following regulations under the following court-overseen schedule: 

  • Aug. 30, 2015 - preventative controls for human and animal food; 
  • Oct. 31, 2015 - imported food and foreign suppliers; 
  • Oct. 31, 2015 - produce safety; 
  • March 31, 2016 - food transportation; and 
  • May 31, 2016 - intentional adulteration of food

The American Herbal Products Association (AHPA) has been actively engaged in the FSMA rulemaking process to help ensure that final rules are consistent with the Congressional intent for FSMA while maximizing flexibility for compliance and eliminating confusion for affected domestic and international businesses. In comments recently submitted on proposed FSMA rules, AHPA urged FDA to publish a second set of proposed rules and invite additional comments before issuing a final rule.

"AHPA views the proposed FSMA Rules as a complex new set of regulations with large and broad economic and cultural consequences," said AHPA President Michael McGuffin. "Given the significant potential impact of these rules, it is critical for FDA to draft effective rules and these new deadlines give the administration more time to address the numerous and significant concerns voiced by impacted industries."