Health and Human Services Secretary Robert F. Kennedy Jr. has taken steps to eliminate provisions that have allowed the food industry to determine on its own whether new ingredients are safe for consumption. This move would completely change the way companies obtain regulatory approval for additives.
On Monday, Kennedy directed the Food and Drug Administration to explore the possibility of revising the Substances Generally Recognized as Safe (GRAS) rule. This rule currently permits food manufacturers to skip premarket review for certain chemicals or additives if they are deemed safe by qualified experts.
Companies have two options to obtain GRAS status. They can either petition the FDA to review an ingredient or they can self-affirm that their products are safe based on the findings of a scientific expert panel.
Kennedy criticized the self-affirmation pathway to regulatory approval, stating that manufacturers have taken advantage of a loophole to introduce new chemicals into the food supply without sufficient safety data.
“Closing this loophole will enhance transparency for consumers, ensure that ingredients added to foods are safe, and ultimately contribute to Making America Healthy Again,” Kennedy stated.
In addition to exploring potential rulemaking, the Department of Health and Human Services is collaborating with Congress to consider potential legislation regarding GRAS. Meanwhile, the FDA may begin to scrutinize self-affirmed GRAS determinations more closely, as noted by law firm Akin.
However, ending the self-affirmation pathway would increase the workload for the FDA at a time when the federal workforce is being reduced under the Trump administration. Several food safety positions have already been eliminated, leading Deputy Commissioner of Human Foods Jim Jones to resign.
The decision to review GRAS follows Kennedy’s directive to major food companies such as Kraft Heinz and WK Kellogg to eliminate artificial dyes from their products by the end of his term.
The Consumer Brands Association, representing large packaged food companies, acknowledged the discussions.
“It was a productive meeting, and we anticipate ongoing collaboration with the secretary and experts within HHS to prioritize public health, enhance consumer trust, and support consumer choice,” the trade group stated.
While food and health organizations welcomed Kennedy’s GRAS review, some raised concerns about the FDA’s need to regulate ingredients that have entered the market without proper review.
“The real threat to consumers is not the new food chemicals that bypass FDA review,” said Scott Faber, senior vice president for government affairs at the Environmental Working Group. “The true danger lies in the thousands of chemicals already present in our food without FDA scrutiny, some of which have never been reviewed by the FDA for many years.”