Robert F. Kennedy Jr. and his advisors are actively considering a major rewrite of the Food and Drug Administration's (FDA) regulations regarding food additives. This move aims to fulfill their "Make America Healthy Again" pledge by removing toxic chemicals from the food supply. The proposed crackdown is in its early stages and requires the approval of President-elect Donald Trump and his transition team. It specifically targets a provision in the FDA's regulations on which food additives are considered "generally recognized as safe" (GRAS).

Unraveling the FDA's Food Additive Dilemma

Proposed Crackdown on Food Additives

Advisers to Kennedy, who is Trump's pick for secretary of the Department of Health and Human Services, have been exploring various approaches to curbing the use of food additives. One such approach is working with agricultural producers to modify the subsidies and incentives offered by the government for certain types of foods that Kennedy deems unhealthy. Calley Means, a top adviser to Kennedy's transition team, emphasized the need for a reevaluation of the current regulatory system. He stated, "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." However, he also pointed out that in the case of food additives, the "corrupt regulatory interpretations" have broken the regulation under the GRAS process, making it a "totally rigged system."Means further explained, "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. This is a bananas system."

Advocacy Groups' Concerns

Advocacy groups and experts have long been critical of the FDA's "loophole" in regulating food additives. Melanie Benesh, vice president of government affairs at the Environmental Working Group, stated, "This is a bananas system. This is not the way that new food chemicals should be approved and come into our food supply." The current system allows companies to quietly decide which chemicals are safe enough to add to their products without the agency's oversight. While companies with new chemicals can choose to go through a "voluntary" process to get their substances on the agency's list of GRAS substances, officials acknowledge that many companies bypass this process.Jim Jones, the FDA's top food official, said at an event hosted by the Alliance for a Stronger FDA earlier this year, "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." Bill Freese, science director for the Center for Food Safety, cited examples where companies have decided to "self-certify" the safety of their food additives even after failing to obtain the approval of the FDA's reviewers during the voluntary process. This has strayed far from the original intent of the provision, which was supposed to narrowly "grandfather in" foods with a long history of safe use like salt and vinegar.

Obstacles in Implementing Changes

Making it mandatory for companies to go through the GRAS notification process before using new food ingredients will likely face significant hurdles. Cracking down on food additives would greatly increase the FDA's workload as it would need to screen new notifications and review previously approved chemicals. FDA officials have long called for Congress to provide more funding for oversight of food additives, as the current resources are stretched thin. One proposed solution, attaching fees to food manufacturer applications similar to the "user fees" programs for medical products, has not gained traction on Capitol Hill. Kennedy has also been critical of the "user fees" approach for drugs and has called for its repeal.Another obstacle could come from the courts, especially in light of a Supreme Court ruling earlier this year that limited agency power. Advocacy groups lost a previous federal lawsuit against the FDA in 2021, with the judge finding that "it remains unclear under the statute whether FDA even has the authority to make GRAS notifications mandatory."While Kennedy's team acknowledges that the issue may need to be addressed through legislation on Capitol Hill, they are also considering making changes through the executive branch. Kennedy has previously suggested declaring a national emergency for chronic disease to enhance his authorities in the face of expected opposition from the food industry.Calley Means remains optimistic, saying, "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."