Counselor for Robert F. Kennedy Jr. are considering a significant rewrite to the rules of the Food and Drug Administration regulating food additives, to fulfill Kennedy and President-elect Donald Trump’s “Make America Healthy Again” promise to remove toxic chemicals from food sources.
The proposed crackdown, which is still in its early stages and must get a signature from Trump and the transition team, targets provisions in the FDA’s regulations on food additives that the agency considers “generally recognized as safe,” or GRAS.
Adviser Kennedy, Trump’s choice for secretary of the Department of Health and Human Services, has also floated other approaches to curb the use of food additives, including working with agricultural producers to replace subsidies and incentives offered by the government for certain types of food. Kennedy argued that he was not well.
“I think the overall posture of the FDA should really be a lot of deregulation. I think we should have a golden age of innovation and drug development. No one can stand in the way,” Calley Means, top adviser to the Kennedy transition team. , said this month on “The Liz Wheeler Show.”
That is to say that the “interpretation of destructive regulations” has broken the law of additives in the GRAS process, saying that it has become a “totally rigged system.”
“But when it comes to food, when it comes to ‘generally recognized as safe,’ the complete self-policing of this industry, allowing us to put chemicals in our food that are prohibited in every other country and have hundreds of studies saying they are dangerous. , there must be a review,” said Means.
“It’s a banana system”
Advocacy groups and experts have long blamed the FDA “loose” in the regulation of this food additive, which allows companies to quietly decide which chemicals they consider safe enough to add to their products without going through the agency’s supervision.
“This is a bananas system. This is not the way that new food chemicals should be approved and come to 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 gain a spot on the list of substances that are “generally recognized as safe,” making it easier to market food with the additive, officials admit that companies often skip it. .
“It undermines the credibility of the system when it can get chemicals on the market without prior review by the FDA,” said the agency’s top food official, Jim Jones, at an event hosted by the Alliance for a Stronger FDA. earlier this year.
Bill Freese, director of science for the Center for Food Safety, said the company has decided to go ahead and “declare itself” that the food additive is safe, despite failing to get a sign-off from FDA reviewers during the voluntary process. .
That has strayed away from the original intent of the provision, Freese said, which should be narrowly “grandfathered in” foods with a long history of safe use like salt and vinegar.
“This GRAS Exemption should be limited. The FDA is just widening the loophole until it just swallows 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 a new food ingredient would be problematic.
Eliminating food additives would dramatically increase the FDA’s workload. The agency should present new notices as well as review chemicals that have already been given the green light.
FDA officials have long urged Congress to increase funding for monitoring food additives, warning that resources are running low even for the current task.
One idea to expand FDA funding — attaching a fee to applications submitted by food manufacturers, similar to a “user fee” program for medical products — also failed to gain traction on Capitol Hill. Kennedy was also critical of the “user fee” approach to medicine, and called for its repeal.
Other obstacles could come through the courts, especially because of previous Supreme Court decisions this year which reduces agency power.
The advocacy group lost a previous federal lawsuit against the FDA that tried to get notification back in 2021. In that case, the judge found that “it remains unclear under the statute whether FDA has the authority to make GRAS notification mandatory.”
“I’m sure there are things that are within the FDA’s power to close the loophole, to make it more difficult for companies to take advantage of the GRAS process. We need to see,” said Benesh.
While Kennedy’s team acknowledges the issue may need to be resolved through legislation on Capitol Hill, changing the procedure to simply go through the executive branch is on the table, advisers said.
Kennedy previously said he asked Trump to “declare a national emergency, but not for infectious diseases, but for chronic diseases” as another way to supercharge the authorities amid expected blowback from the food industry.
“It’s not monolithic, it’s not an all-powerful industry. They can be disrupted. So that’s what gives us hope. The voters and President Trump’s microphone are on our side,” Means said.
