FDA statement on Generally Recognized as Safe determinations

FDA statement on Generally Recognized as Safe determinations

Published: Wednesday, March 12, 2014

Editor's Note: When a company announces or communicates a GRAS self-determination, FDA reminds companies in this statement that companies should not state or imply that FDA has reviewed the GRAS self-determination on their food ingredient. FDA acknowledges that companies can make an independent GRAS determination without notifying FDA, and that the agency has a voluntary GRAS notification program that allows companies to notify FDA of their self-determination. The issuance of this statement indicates that FDA is concerned about misrepresentations of the FDA's role in GRAS self-determinations.

Food and Drug Administration

FDA statement on Generally Recognized as Safe determinations

On March 11, 2014, Senomyx, Inc. issued a public statement suggesting that its food ingredient Sweetmyx (also known as S617) was generally recognized as safe (GRAS). The statement appeared to suggest that the U.S. Food and Drug Administration (FDA) had made the GRAS determination. In fact, the agency had not made this determination nor had it been notified by Senomyx regarding a GRAS determination for this food ingredient. The  company's statement has been corrected and now notes that a third party organization made the determination.

A company can make an independent GRAS determination without notifying the FDA. However, the agency does have a voluntary GRAS notification program whereby a company can inform the FDA of the company's determination. The FDA maintains an inventory of such GRAS Notices on its website, allowing the public to confirm whether FDA has filed and responded to a GRAS notice.

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

For more information on the GRAS notification process, please see:  Generally Recognized as Safe (GRAS).

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