Health and Human Services Secretary Robert F. Kennedy Jr. is looking to end provisions that have allowed the food industry to “self affirm” whether new ingredients are safe for consumption in a move that would overhaul the way companies receive regulatory approval for additives.
Kennedy last Monday directed the Food and Drug Administration to explore potential rulemaking that would revise the Substances Generally Recognized as Safe rule, which allows food manufacturers to bypass premarket review on certain chemicals or additives if they are considered safe among qualified experts.
Companies have two pathways to achieve GRAS status. While companies can petition the FDA to review an ingredient and grant it GRAS status, they also can “self-affirm” that their products are safe based on the conclusion of a scientific expert panel.
The health secretary called out the self-affirmed pathway to regulatory approval, saying manufacturers have “exploited a loophole” to allow new chemicals into the food supply “often with unknown safety data.”
“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,” Kennedy said in a statement.
In addition to potential rulemaking, the federal health department is working with Congress to explore potential legislation on GRAS. In the meantime, the FDA could begin exercising greater scrutiny on self-affirming GRAS determinations, according to law firm Akin.
Ending the self-affirmation pathway, however, would create significantly more work for the FDA at a time when the Trump administration is slashing the federal workforce. A number of food safety jobs have already been eliminated, prompting Deputy Commissioner of Human Foods Jim Jones to step down.
The directive to review GRAS comes after Kennedy reportedly directed some of the nation’s largest food companies, including Kraft Heinz and WK Kellogg, to remove artificial dyes from their products before the end of his term.
The Consumer Brands Association, which represents packaged food giants, said in a statement to Food Dive that the GRAS system plays “an important role in enabling companies to innovate to meet consumer demand.”
“The consumer packaged goods industry is committed to maintaining the integrity of America’s food supply and consumer transparency,” said Sarah Gallo, Consumer Brands Association’s senior vice president of product policy. “As the administration looks to revise GRAS, we stand ready to work with agency experts on continued analysis of safe ingredients and increase consumer transparency.”
While nutrition and health groups welcomed Kennedy’s GRAS review, some questioned whether the FDA needs to do more to regulate ingredients that were able to make their way to the market without review.
“The most significant danger facing consumers is not the new food chemicals that escape any meaningful FDA review,” Scott Faber, senior vice president for government affairs at the Environmental Working Group, said in a statement. “[T]he most significant danger is that thousands of chemicals are already being used in our food without ever having been reviewed by the FDA, or without having been reviewed by the FDA for many decades.”
