On August 12, 2016, the US FDA issued a final rule which outlines the criteria for GRAS substances in human or animal food, strengthening the FDA’s oversight.
The rule addresses:
• the evidence that can be used to demonstrate safety.
• role of publications in evaluating whether the scientific evidence of safety is “generally available and accepted”;
• formalizes the voluntary GRAS notification procedure;
• amends the pre-market approval requirements.
Per the FDA, companies should inform the agency of GRAS conclusions through the notification procedure. Additional guidances related to the GRAS regulations will be issued in the future.
This rule goes into effect on October 17, 2016.