On August 12, 2016, FDA finalized a long-awaited proposed rule, "Substances Generally Recognized as Safe." The final rule sets forth the mandatory criteria and scientific evidence that can be used to demonstrate the use of a substance in human or animal food is "generally recognized as safe" ("GRAS"). FDA's Center for Food Safety and Applied Nutrition and FDA's Center for Veterinary Medicine ("CVM") have been using the voluntary GRAS notification procedure as opposed to the former voluntary GRAS affirmation petition since 1997 and 2010, respectively. The final rule officially confirms the use of the GRAS notification procedure. The voluntary notification procedure helps the agency monitor food safety efforts. Under the final rule, this procedure will be accompanied by a response by the agency within 180 days of a GRAS notice, with a potential to extend its response by another 90 days. FDA will issue additional guidance on the GRAS regulation, which will become effective on October 17, 2016. Additionally, FDA will accept public comments until September 16, 2016.
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