The Food and Drug Administration (FDA) is studying the regulatory comment submitted by consumer groups two weeks ago, suggesting that its rule for the process of determining food substances as “generally recognized as safe” (GRAS) be altered before it’s finalized. During last week’s Food Safety Summit in Baltimore, Michael Taylor, FDA’s Deputy Commissioner for Foods and Veterinary Medicine, told Food Safety News that the comment “raises a number of important questions.”
He added that FDA will need to study the “substantial document” to see if it plays into the agency’s efforts to clarify expectations regarding the GRAS determinations that companies make. Many have raised concerns that the GRAS process allows companies to avoid the required statutory food additive petition process and add substances to food without any assurance of their safety. Last year, FDA agreed to finalize by August 2016 its 1997 proposed rule on the process of determining whether substances are GRAS. Both the agency and the food industry have been operating under the proposed procedure which replaces the traditional petitioning process for a manufacturer seeking GRAS status with a “procedure whereby any person may notify FDA of a determination that a particular use of a substance is GRAS,” as an interim since 1997. Taylor wouldn’t comment on what the final rule will contain, but he did note that FDA is also considering releasing guidance documents to help industry meet the agency’s expectations of what it takes to declare an ingredient is GRAS. The agency, consumer advocates and industry share the desire for additives introduced to the food supply to be safe and to foster consumer confidence, he added. “There’s a lot to be done in this realm, and we want to do this in collaboration with the industry, with the consumer community and input from everybody,” Taylor said.
