Advisers to Robert F. Kennedy Jr. are weighing a significant rewrite to the Food and Drug Administration’s rules governing food additives, to fulfill Kennedy and President-elect Donald Trump’s “Make America Healthy Again” pledge to get toxic chemicals out of the food supply.
The proposed crackdown, which is still in its early stages and will need to get a sign-off from Trump and his transition team, targets a provision in the FDA’s regulations on which food additives are considered by the agency to be “generally recognized as safe,” or GRAS.
Advisers to Kennedy, Trump’s pick for secretary of the Department of Health and Human Services, have also floated other approaches to curbing the use of food additives, including working with agricultural producers to change the subsidies and incentives offered by the government for certain kinds of foods Kennedy argues are unhealthy.
“I think the overall posture of the FDA should be actually a lot of deregulation. I think we should have a golden age of innovation and drug development. Nobody’s standing in the way of that,” Calley Means, a top adviser to Kennedy’s transition team, said this month on “The Liz Wheeler Show.”
Means said “corrupt regulatory interpretations” had broken the regulation of additives under the GRAS process, saying it had become a “totally rigged system.”
“But when it comes to food, when it comes to ‘generally recognized as safe,’ complete self-policing from this industry, allowing them to put chemicals in our food that are banned in every other country and have hundreds of studies saying are harmful, there needs to be a review,” Means said.
“This is a bananas system”
Advocacy groups and experts have long denounced the FDA’s “loophole” in its regulation of these food additives, which allows companies to quietly decide which chemicals they deem safe enough to add to their products without going through the agency’s oversight.
“This is a bananas system. This is not the way that new food chemicals should be approved and come into our food supply,” said Melanie Benesh, vice president of government affairs at the Environmental Working Group.
While companies with new chemicals can choose to go through a “voluntary” process to earn a spot on the agency’s list of substances that are “generally recognized as safe,” making it easier to market foods with the additives, officials acknowledge companies often bypass it.
“It does undermine the overall credibility of the system when it is possible to get a chemical on the market without prior review by the FDA,” the agency’s top food official, Jim Jones, said at an event hosted by the Alliance for a Stronger FDA earlier this year.
Bill Freese, science director for the Center for Food Safety, cited times companies have decided to go ahead and “self-certify” that their food additives were safe, even after failing to earn the sign-off of the FDA’s reviewers during the voluntary process.
That has strayed far from the original intent of the provision, Freese said, which was supposed to narrowly “grandfather in” foods with a long history of safe use like salt and vinegar.
“These GRAS exemptions should be limited. The FDA just expanded the loophole until it just literally swallowed the entire statute,” he said.
Obstacles in Congress and the courts
Making it mandatory for companies to go through the GRAS notification process before using any new food ingredients will likely face hurdles.
Cracking down on food additives would dramatically broaden the FDA’s workload. The agency would have to both screen new notifications as well as look back at previously greenlighted chemicals.
FDA officials have long called for Congress to step up funding for oversight of food additives, warning that resources were stretched thin even with the current duties.
One idea to broaden FDA’s funding — attaching fees to applications submitted by food manufacturers, similar to the “user fees” programs for medical products — has also failed to gain traction on Capitol Hill. Kennedy has also been critical of the “user fees” approach for drugs, and has called to undo it.
Another obstacle could come through the courts, especially in light of a Supreme Court ruling earlier this year that curtailed agency power.
Advocacy groups lost a previous federal lawsuit against the FDA trying to require the notifications back in 2021. In that case, the judge found that “it remains unclear under the statute whether FDA even has the authority to make GRAS notifications mandatory.”
“I think there are certainly things within FDA’s power to narrow the loophole, to make it harder for companies to take advantage of the GRAS process. But there is some legal precedence saying that this is Congress’ problem to fix, so we’ll just have to see,” said Benesh.
While Kennedy’s team acknowledges the issue may end up needing to be hashed out through legislation on Capitol Hill, changing the procedure solely through the executive branch is on the table, an adviser said.
Kennedy has previously said he is asking Trump to “declare a national emergency, but not for infectious disease, but for chronic disease” as another way to supercharge his authorities amid blowback they expect from the food industry.
“This is not a monolithic, this is not an all-powerful industry. They can be disrupted. So that’s what gives me hope. The voters and President Trump’s microphone are on our side,” Means said.