US Secretary of Health and Human Services Robert F. Kennedy Jr. and the US Food and Drug Administration are currently in talks to revise the Substances Generally Recognised as Safe (GRAS) protocol for food ingredients, potentially eliminating the self-affirmed status.
This potential rule change, if implemented, would bolster the FDA's involvement in ingredient validation significantly — though the Trump Administration recently fired a significant number of probationary FDA staff working in this niche.
Currently, the FDA encourages manufacturers to submit GRAS notices through the regulator, but the industry is also able to self-affirm a substance's safety without notifying the FDA.
To date, the FDA has confirmed the GRAS status of more than 1,000 food ingredients — holding all supporting data on a public inventory.
By eliminating the self-affirmation process, manufacturers would be required to inform the FDA when they intend to use a novel ingredient, as well as providing safety data.
This change could place significant strain on the regulator, which is currently overstretched due to a recent round of layoffs.
“For far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals — often with unknown safety data — to be introduced into the US food supply without notification to the FDA or the public,” said Secretary Kennedy.
“Eliminating this loophole will provide transparency to consumers, help get our nation’s food supply back on track by ensuring that ingredients being introduced into foods are safe, and ultimately Make America Healthy Again.”
“The FDA will continue to follow our authorities and leverage our resources to protect the health of consumers to ensure that food is a vehicle for wellness," added Acting FDA Commissioner Sara Brenner.