Health and Human Services Secretary Robert F. Kennedy Jr. has directed the Food and Drug Administration (FDA) to review and potentially revise the “Generally Recognized as Safe” (GRAS) rule. The goal is to close a regulatory loophole that allows food companies to self-affirm the safety of certain additives without premarket review.
Kennedy criticized the self-affirmation process, arguing that it has enabled manufacturers to introduce chemicals into the food supply with limited safety data. “Eliminating this loophole will provide transparency to consumers, help get our nation’s food supply back on track, and ultimately Make America Healthy Again,” Kennedy stated.
In addition to potential rule changes, the Department of Health and Human Services is exploring legislative solutions with Congress. In the interim, the FDA may also increase its scrutiny of self-affirmed GRAS determinations.
The move follows Kennedy’s recent push for major food companies like Kraft Heinz and WK Kellogg to remove artificial dyes from their products. While nutrition advocates welcomed the initiative, some experts stress that additional FDA oversight is needed to assess thousands of chemicals in the food supply that have not undergone a recent FDA review.
The Consumer Brands Association emphasized the GRAS system’s role in food innovation but was willing to collaborate with the FDA to ensure consumer safety.