The Food and Drug Administration will consider potential rulemaking to eliminate the self-affirmed Generally Recognized as Safe pathway for food ingredients and chemicals.
Department of Health and Human Services Secretary Robert F. Kennedy Jr. officially directed FDA to take steps toward potential rulemaking that would limit food manufacturers’ ability to add ingredients or chemicals without notifying the agency.
Food manufacturers are encouraged to submit GRAS notices to the FDA, but companies can self-affirm that a substance is GRAS without notifying the agency. If the self-affirmation process is eliminated, it would require companies to publicly notify the FDA of their intended use of new ingredients along with safety data before it can be introduced into the food supply.
Kennedy and others in the Make America Healthy Again movement have criticized this system, and argue that addressing this “loophole” would increase food safety, health and transparency.
“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 U.S. food supply without notification to the FDA or the public,” Kennedy said in a release.
Ultimately, FDA would need Congress to change the law to fully set up a pre-market review for GRAS ingredients or change the notification requirement. HHS said it was committed to working with lawmakers on legislation that would completely close the “GRAS loophole.” This, coupled with potential future rulemaking, are “crucial steps” to Make America Healthy Again, HHS wrote in the release.
During his confirmation hearing last week, Trump’s nominee for FDA commissioner, Martin Makary, echoed some of Kennedy’s criticisms of food chemicals and GRAS. He told senators that if confirmed, he is committed to examining the safety of some food chemicals.
A committee vote on Makary’s confirmation is scheduled for later this week.
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Separately, Kennedy announced on X Monday that he met with executives of food giants KraftHeinz, General Mills, Tyson Foods, Kellogg, Smuckers and PepsiCo. Kennedy said they discussed “advancing food safety and radical transparency to protect the health of all Americans, especially our children. We will strengthen consumer trust by getting toxins out of our food.”
Consumer groups have long pushed for action addressing GRAS. Specifically, they want to see reforms establishing a pre-approval system to review safety data.
However, these groups have also noted that even if Kennedy is passionate about setting up a new system, it would be difficult to accomplish with substantial staffing cuts to the agency.
Peter Lurie, president and executive director at the Center for Science in the Public Interest, said GRAS is an inadequate system to protect consumers that the group has pushed back against for years. Therefore he’s glad Kennedy has identified it as a priority.
However, Lurie said Kennedy will likely run into opposition from the food industry and the general anti-regulation leanings of the Trump administration.
“Industry is not likely to take this lying down,” Lurie said. “This is a process that has worked very well for them.”
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