Health Secretary Robert F. Kennedy Jr. on Monday unveiled a plan aimed at tightening a decades-old loophole that has allowed food companies to put certain chemicals in their products without first notifying the nation’s food regulators, according to federal health officials.
The practice known as “generally recognized as safe” (GRAS) allows companies to self-certify the safety of certain food chemicals or substances. The Trump administration’s new proposed rule would require food companies to notify the Food and Drug Administration when they make such determinations and include the basis for those conclusions.
“Shifting to a mandatory notification system closes a decades-old information gap,” Kyle Diamantas, the acting FDA commissioner, told reporters Monday. He said the plan “improves transparency” while “respecting the limitations of our authority,” adding that officials would work with Congress to further address the loophole.
Companies have not been mandated to tell the FDA when they include some chemicals or substances in their products for uses viewed generally as safe, though they can opt to do so. That means there are probably hundreds of such ingredients added to the food supply without strict government oversight. Chemicals that have been generally considered safe include those acting as preservatives in some breakfast cereals, emulsifiers in certain ice creams and salad dressings, and select low calorie sweeteners that are found in sugar-free desserts and candies. They can often be found in ultra-processed foods that make up more than half of Americans’ diets and which studies have increasingly linked to health problems.
Overhauling the loophole has been part of Kennedy’s food agenda as the nation’s top health official as well as a priority for the Make America Healthy Again (MAHA) movement he champions.
Some food safety and nutrition experts said they welcomed the proposal, referring to it as a long-overdue change. Others said they feared the FDA does not have the resources to review the submissions from companies, potentially leading to substances continuing to flood the market without regulators having time to adequately review them.
Melanie Benesh, vice president for government affairs for the advocacy nonprofit Environmental Working Group, called the move the “first step toward meaningful reform.”
“True GRAS reform requires more than mandatory notification,” she said in a statement. “It must also include strong, science-based safety standards and thorough, independent FDA review before chemicals are allowed in our food. And it must address the thousands of substances already on the market that have not been meaningfully reviewed in decades.”
In one of Kennedy’s first food-related moves as secretary, he declared an intent for the FDA to “explore potential rulemaking” to tighten the GRAS loophole.
Since 1958, the FDA has been charged with evaluating the safety of new food additives. However, exceptions were made for substances generally deemed safe, such as vinegar, flour and standard spices.
While the specific rules have changed over time, companies are allowed to make their own determinations on whether certain substances are considered safe, which food safety advocates say has been expanded to a variety of ingredients over time, without informing the FDA. That has become the primary way the majority of substances are entering the nation’s food supply, Diamantas said.
“Industry hijacked the loophole and drove a convoy of chemical trucks through it straight into the American food supply,” Kennedy said at a Monday news conference.
There have been instances when additives included in food through the GRAS loophole had later raised safety concerns, such as tara flour used in a leek-and-lentil crumble that was associated with at least 130 people being sent to the hospital and sickening hundreds of others.
The FDA will review what each company submits within 45 days to ensure all that the relevant information is included. Within 180 days, the agency will review the submission more substantively, Diamantas said.
Under the proposal, companies won’t be prohibited from adding the substances to their food while that process is ongoing, and there is no requirement that the FDA must formally approve or review the chemical, which Diamantas suggested would have required an act of Congress. Kennedy called on Congress to give the FDA more resources “to keep pace with the changing food supply.”
For substances already in the food supply, the FDA is aiming to create a process for companies to submit information about how the chemical is used in food.
Some in the food industry prefer changes to be done through Congress, rather than through regulation. One person involved in the food industry, who spoke on the condition of anonymity to be candid, said the industry has been concerned that it would take time for the FDA to comb through companies’ information on potential new substances, adding they believe changes should be done through legislation and come with more funding for the agency.
Americans for Ingredient Transparency, a coalition launched last year backed by the food industry and other lobbying groups, said in a statement that Congress should establish “a transparent, nationally uniform framework for food ingredient oversight.”
David Kessler, a former FDA commissioner under both Republican and Democratic presidents, petitioned the FDA last year to revoke the GRAS status of some commonly used ingredients in ultra-processed foods.
Of the announcement Monday, Kessler said that “the proposed GRAS actions do not tackle the root causes of chronic disease in this country.”
The White House’s budget office finished reviewing the GRAS proposed regulation on July 31, an indication that a rule would be released for public comment soon. On CNN earlier this month, Kennedy said the proposal would come out “within probably a month,” saying it had undergone an “extensive interagency process.”
Federal officials have also been crafting a definition of “ultra-processed” foods, and as of last week, the White House budget office received for review a white paper on a proposed definition.
This comes as Kennedy, the founder of a prominent anti-vaccine group, has for months been publicly leaning into his work on food and nutrition ahead of the midterm elections and downplaying the push to overhaul vaccine policy. GOP pollsters have referred to vaccine skepticism as politically risky. However, White House officials are working to draft an executive order focused on the childhood vaccine schedule and autism amid President Donald Trump’s push.
The MAHA movement was formed after an unlikely political alliance between Kennedy and Trump during the 2024 campaign. It has various factions that defy traditional partisan lines, such as those pushing for changes to the food supply, tighter regulations over pesticides and eliminating vaccine mandates.
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