The Trump administration said Monday it will require companies to notify federal regulators whenever they determine a food additive is “generally safe” for consumption.
The proposed rule is a major update to an exemption that’s existed since 1958 and allows food makers to self-determine whether a food additive is safe based on existing scientific evidence or its long history of use.
Companies can voluntarily report their findings to the Food and Drug Administration under the Generally Recognized as Safe, or GRAS, exemption.
Now, reporting will be mandatory so regulators and the public know what is going into their food, and how companies arrived at the conclusion it is safe.
HHS also said Monday it is taking efforts to finalize the first-ever federal definition of “ultra-processed foods” through rulemaking.
The steps are key parts of Health and Human Services Secretary Robert F. Kennedy Jr.’s attempts to “Make America Healthy Again” by scrutinizing chemical additives and processed foods and whether they are driving high rates of obesity and disease in the U.S.
“These two actions will change how the federal government oversees what’s in our food and how we understand the foods Americans eat,” Mr. Kennedy said. “Parents should not need a chemistry degree to understand what their children are eating. Americans deserve real transparency. They deserve real food.”
Most Americans are probably unfamiliar with the GRAS exemption. However, administration officials described it as one of the biggest updates to food regulation in modern history and a “bold, sweeping move.”
HHS officials said an Eisenhower-era law, known as the Food Additive Amendments, required that entities submit a formal petition for FDA approval of an ingredient before it can be added to the food supply.
At the same time, it created an exemption for foods generally recognized as safe.
Mr. Kennedy said at the time, Congress was thinking of substances like vinegar, salt and flour, which have a long history of safe use.
“Over time, that narrow exemption became a massive loophole,” Mr. Kennedy said. “Companies can make their own GRAS determinations and put substances into the food supply without even notifying the FDA.”
Mr. Kennedy said the exemption explains why Europe has fewer artificial additives in its food than the U.S., and that the food industry continues to develop new compounds and chemical additives.
“Our bodies did not evolve consuming many of these substances,” he said. “That makes rigorous science and transparent safety review even more important.”
Paperwork filed by the administration on Monday pointed to GRAS-fueled confusion in the past, as regulators grappled with whether it was permissible to use stevia leaf in sweeteners, protein-rich tara flour in foods or caffeine in alcoholic beverages.
HHS said under the new GRAS framework, companies with products on the market can use a streamlined submission pathway to provide the FDA with information about existing uses.
Members of the food industry have pushed back against the idea that GRAS is a gross and dangerous loophole, arguing that it is a regulatory pathway established by Congress and overseen by the FDA.
But rather than fight GRAS reforms outright, the Consumer Brands Association — a major lobby for makers of consumer packaged goods — has argued in favor of establishing uniform standards that apply to all companies.
The association is part of a coalition, Americans For Ingredient Transparency, that is leading the lobbying effort.
“AFIT supports meaningful, science-based modernization of the GRAS program and efforts to strengthen consumer confidence in the safety and transparency of our food supply,” AFIT senior adviser Patrice Onwuka said Monday. “The most durable way to achieve those goals is through bipartisan congressional action that establishes a transparent, nationally uniform framework for food ingredient oversight.”
Industry leaders also fear that any FDA crackdown will result in a regulatory bottleneck. It is urging the agency to be adequately staffed to handle paperwork related to the change.
“Congress must also ensure the FDA has the resources to fully implement GRAS reform,” Mr. Onwuka said.
The American Feed Industry Association, which represents the business interests of livestock feed and pet food manufacturers, aired similar concerns about FDA staffing and said it will provide input to regulators.
“The AFIA is reviewing the proposal and will provide comments to the agency to ensure that any codified changes to the GRAS framework include the necessary resources and process improvements to make the system work effectively for animal food,” AFIA President and CEO Constance Cullman said.
The Trump administration did not release many details about the other aspect of its announcement — an attempt to define ultra-processed foods — but the Consumer Brands Association said it is concerned.
“America’s packaged food supply is safe and has been a staple in American households for decades. That’s something that a guidance document, crafted without credible experts, cannot change,” said Rhonda Bentz, the association’s executive vice president of public affairs. “Any so-called definition that captures 80% of the nation’s food supply while picking winners and losers is fundamentally flawed, not based on sound science and politically motivated.”
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