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FDA to Issue Final GRAS Rule by August 2016 under Consent Decree

The U.S. Food and Drug Administration (FDA) has until August 31, 2016, to submit a final rule on generally recognized as safe (GRAS) substances under a Consent Decree issued by the United States District Court for the District of Columbia. However, the August 2016 deadline may be extended with agreement of all parties.

The Consent Decree, issued on October 20, 2014, stems from a lawsuit (Case No. 1:14-cv-267-RC) filed by the Center for Food Safety alleging that FDA's proposed rule on GRAS substances (see 62 Fed. Reg. 18938 (April 17, 1997)) was not promulgated in accordance with the rulemaking requirement of the Administrative Procedure Act. The Agency re-opened the comment period on the 1997 proposed rule on GRAS substances in December 2010.

The proposed rule outlines a voluntary GRAS Notification procedure, whereby companies can notify FDA that a particular use of a substance is determined to be GRAS and provide information detailing the basis upon which that conclusion was reached. After evaluating a GRAS notice, FDA responds to the notifier by written correspondence. The actions taken by FDA in response to a GRAS Notification generally include one the following: the Agency 1) does not question the basis for the notifier's GRAS determination; 2) determines that the notice does not provide a sufficient basis for a GRAS determination; or 3) ceases to evaluate the GRAS notice at the notifier's request. While the rule was never finalized, the Agency started accepting GRAS Notifications in 1998. More than 500 GRAS notices have been submitted to FDA for consideration.

For more information, see the article, CFS Files Suit to Vacate FDA's GRAS Notification Program.