George Misko Quoted in Chemical Watch News Article on FDA’s GRAS Rule Likely ‘Inevitable’

Keller and Heckman Partner George Misko was quoted in the Chemical Watch News article, “Work to update US FDA’s GRAS rule moves forward behind the scenes.” The article explains that the U.S. Food and Drug Administration (FDA) intends to move forward with its proposal to reform the GRAS process. However, the government shutdown could further delay the draft rule, and the final rule may take more than a year to implement, followed by potential legal challenges, according to George. Even so, he noted, “it’s probably inevitable that this regulation is going to go into effect.”

In anticipation of the GRAS rule update, George advises companies using the self-affirmed GRAS pathway to ensure they are “on solid ground” in their conclusions. Alternatively, manufacturers of food-contact substances (FCSs) for use in packaging may want “to consider taking the next step beyond a self-determined GRAS position, which is submitting a food contact notification (FCN) to obtain clearance from the agency.”

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