FDA Final Rule Issued

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September 7, 2016

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Gradient News Alert

FDA Final Rule Confirms Voluntary Notification for GRAS Substances

The US Food and Drug Administration (FDA) has issued its Final Rule regarding the regulation of food ingredient uses as Generally Recognized As Safe (GRAS). The Rule becomes effective on September 16, 2016 and finalizes the long standing 1997 Proposed Rule from FDA for voluntary notification to the agency of GRAS determinations. FDA addressed a number of issues in the Rule that were raised in a 2010 investigation of its 1997 GRAS Proposed Rule by the US Government Accountability Office and a myriad of public commenters. In addition to finalizing the rule, FDA also clarified the technical information needed to demonstrate that the intended use of a food ingredient is GRAS using scientific procedures. The agency reiterated the importance of publication to establish “general recognition of safety,” and will provide draft guidance in the near future on using GRAS panels, including potential conflict-of-interest concerns.

Gradient scientists have the experience and expertise to address food safety issues. We can prepare GRAS and Food Contact Notifications for submission to FDA, convene and manage a GRAS panel of experts to evaluate a proposed food ingredient use, and oversee the analytical testing required by FDA for substances in food and food contact materials.

Click to see information on a selection of Gradient’s GRAS Panel Experts.

For more information on Gradient’s services, please contact:

Eric M. Dubé, M.P.H.
Senior Environmental Health Scientist




Gradient is an environmental and risk sciences consulting firm renowned for our specialties in Toxicology, Epidemiology, Risk Assessment, Product Safety, Contaminant Fate and Transport, Industrial Hygiene, Geographic Information Systems, and Environmental/Forensic Chemistry. We employ sound science to assist national and global clients in resolving their complex problems relating to chemicals in the environment, in the workplace, and in consumer products.


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