FDA Issues Warning on GRAS Determinations

WASHINGTON—Companies that make a determination that an ingredient is generally recognized as safe (GRAS) should not imply FDA has made such a finding, FDA said Wednesday.

In a constituent update, FDA's Center for Food Safety and Applied Nutrition (CFSAN) specifically referenced a public statement from Senomyx, Inc. According to FDA, the statement implied the agency made the determination that a food ingredient (Sweetmyx) was GRAS.

"When making a GRAS self-determination, companies should not state or imply that the FDA has made a GRAS determination of their food ingredients," CFSAN stated.

Companies can notify FDA that they have made a GRAS determination but they are not required to do so, according to CFSAN. FDA maintains an inventory of GRAS notices on its website, allowing the public see whether the agency has responded to such notices.

San Diego-based Senomyx clarified in a statement that the GRAS determination was made by the Expert Panel of the Flavor and Extract Manufacturers Association of the United States (FEMA). The company maintained its original press release was correct but some media misinterpreted one of the statements. According to Senomyx, FEMA has made GRAS determinations covering more than 2,800 ingredients over the past half century. 

Senomyx said the GRAS determination paves the way for PepsiCo and Firmenich to pursue commercialization of the new flavor ingredient in the United States and other countries.