By Mark L. Itzkoff
On March 12, 2014, FDA issued an unusual statement regarding the GRAS status of a new flavor ingredient. FDA issued the statement in response to a March 11 press release from Senomyx regarding the GRAS status of a new flavor ingredient, Sweetmyx. FDA stated that the press release “appeared to suggest that the U.S. Food and Drug Administration (FDA) had made the GRAS determination” while the agency had not made the determination and the company had not notified FDA of its determination. At least one news story also reported that the GRAS determination had been issued by FDA. Senomyx has now issued a second statement clarifying the original press release and acknowledging that the GRAS determination was made by the Expert Panel of the Flavor and Extract Manufacturers Association of the United States (FEMA).
In the agency’s statement, FDA notes that companies may make independent GRAS determinations without notifying FDA. The agency also notes that FDA has a voluntary program (the GRAS Notification Program) whereby a company can inform FDA of its GRAS determination. The statement also warns that when announcing GRAS determinations, “companies should not state or imply that the FDA has made a GRAS determination on their food ingredients.”
The FDA statement comes at a time when GRAS status and the GRAS Notification Program has come under strong criticism from the Pew Charitable Trusts (see our story here) and the Natural Resources Defense Council (see story here), and is the subject of a lawsuit filed by another consumer group (see story here).
