George Misko Quoted in Chemical Watch News Article on Potential GRAS Reform at FDA

Keller and Heckman Partner George Misko was quoted in the Chemical Watch News article, “Uncertain road ahead for GRAS reform at US FDA.” The article notes that while U.S. Food and Drug Administration (FDA) Commissioner Marty Makary has indicated interest in reforming the Generally Recognized as Safe (GRAS) process, the effort to do so may require Congressional action.

Eliminating the self-affirmed GRAS pathway “seems near impossible” without Congressional action, said George. FDA could try “to eliminate the exemption in some other way.”

For example, without rulemaking, FDA could potentially lean on state-level efforts, commented George. Several state-level GRAS bills currently propose reporting for self-affirmed determinations. If any pass, FDA could simply request information based on those reports.

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