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U.S. Department of Health and Human Services

About FDA

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This Week In FDA History - Dec. 9, 1958

Photo of food substances Generally Recognized as Safe
December 9, 1958:
The FDA publishes a list of nearly 200 "Substances Generally Recognized as Safe" (GRAS). The agency has determined that these commonly used food ingredients have an established record of safety and can be used without prior approval.

FDA in 2006

The food additives on the GRAS list published in 1958 were judged to be safe based on a long history of safe use in food before that date. In 1998, the FDA proposed a process for placing new substances on the GRAS list. Under this process, manufacturers give scientific evidence to demonstrate the ingredient's safety, and the FDA may add the ingredient to the
GRAS list if it agrees with this assessment. Sometimes the evidence suggests that this judgment can be made only for particular uses, and the FDA's response to the GRAS request details the acceptable uses for the ingredient. The FDA has received over 200 of these requests for GRAS determinations since this process was proposed.