Review Process for GRAS Notifications and Novel Food Applications
For GRAS determinations, the FDA aims to respond to each notification within 180 days.
FDA would like all food manufacturers to follow strictly the agency's views on the criteria for GRAS status.
This may leave some in the food industry guessing about how well-supported a GRAS conclusion should be for a seemingly safe functional ingredient.
The GRAS self-determination process has been used for food ingredients for more than 50 years, yet this process has not been widely used for supplement ingredients because of cost constraints and a full understanding of the process by the supplement manufacturing community.
Since 1958, manufacturers have been allowed to self-determine the GRAS status for specific use(s) of their ingredient(s) used in food products (62 FR 18,937 at 18,940).
Company CEO Robert Brooke also comments, "By introducing
GRAS Associates into the process, we can gain significant access to knowledgeable scientific expertise that is directly familiar with the regulatory approval process.
So, who are the "experts" that make up an independent GRAS panel?
At one time, there was a process in place wherein a GRAS self-determination could be sent to the FDA for a GRAS Affirmation.
FDA's recent FAQ document is helpful in explaining the basic
GRAS concept and dispelling a few misconceptions.
GRAS ingredients and substances typically come from these groups: carbohydrates (sugars and fibers), lipids, proteins, extracts, enzymes, as well as minerals and other substances.
