By Mark L. Itzkoff
On October 20, 2014, FDA and the consumer group called the Center for Food Safety (CFS) filed a consent decree in the U.S. District Court for the District of Columbia that requires FDA to promulgate a final rule regarding the GRAS Notification (GRASN) Program by August 31, 2016. The decree resolves a lawsuit by CFS filed last February seeking to invalidate FDA’s GRAS Notification Program. (See our report on the lawsuit here.)
In the lawsuit, CFS noted that FDA has operated the GRASN Program for over 15 years under the provisions of a proposed rule published in 1997. CFS asked the court to vacate the proposed rule and reinstate the GRAS Affirmation Petition process that had been used prior to the proposed rule. FDA and CFS have now agreed to settle the lawsuit. Under the provisions of the consent decree, FDA is required to submit for publication a final rule on “Substances Generally Recognized to be Safe” by August 31, 2016. In addition, FDA agrees to commit the necessary resources to meet the deadline. The decree also provides a process for extending the deadline if the agency is unable to issue the final rule “despite [its] best efforts.”
The consent decree appears to be a significant victory for the current GRASN Program. The agency had previously announced its intent to finalize the proposed rule in 2015, so the deadline imposed by the decree will only reinforce FDA’s current schedule. Further, the decree does not require any changes to the current GRASN Program and would not invalidate the current program even if FDA fails to meet the new deadline. In other words, FDA will continue to operate the program as it has since 1998 and will issue a final rule on the program as it already intended to do. We will be following FDA’s progress on the final rule and will report new developments in this blog.
