RFK Jr. announces tightening of regulation that lets food makers decide if additives are safe
by Tom Howell Jr. · The Washington TimesThe 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.”
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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.
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“Our bodies did not evolve consuming many of these substances,” he said. “That makes rigorous science and transparent safety review even more important.”
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.
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“Consumer Brands is part of a coalition, Americans for Ingredient Transparency, that is advocating for federal legislation establishing national uniformity for ingredient safety and disclosure and we support GRAS reform being a part of that bill, including establishing a mandatory notification process for all new substances seeking GRAS status from FDA,” Laura Rich, vice president for regulator and technical affairs at the Consumer Brands Association, wrote in a May blog post.
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.
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Tom Howell Jr.
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