Proposed rule would require companies to notify FDA of new food additives

As a result, thousands of chemical additives are present in the American food supply that have not undergone rigorous safety testing or received FDA approval.

The FDA’s proposed rule, which is open to public comment for the next 120 days, stops short of closing the GRAS loophole entirely but marks a “significant step towards” increased food transparency, Acting FDA Commissioner Kyle Diamantas said.

“Americans deserve confidence that the ingredients in their food are subject to transparent, science-based oversight, and today’s actions strengthen both sides of that equation,” Diamantas told reporters Monday. “By proposing mandatory GRAS notifications, we are closing critical information gaps and giving the FDA greater visibility into substances entering the food supply.”

U.S. Health and Human Services also announced Monday that the FDA, alongside the U.S. Department of Agriculture, is submitting the federal government’s first proposed definition of ultra-processed foods for final review.

“Nearly 60% of the American diet is made up of ultra-processed foods, and childhood obesity now affects more than one in five American children,” HHS Secretary Robert F. Kennedy, Jr. said. “We cannot reverse America’s chronic disease epidemic without transforming our food system. These historic actions bring greater transparency to what’s in our food and stronger science to federal nutrition policy.”

Some industry groups condemned the action as “politically motivated,” with the Consumer Brands Association claiming that “some rogue unelected bureaucrats are trying to push this misguided definition.”

“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,” Rhonda Bentz, CBA executive vice president of public affairs, stated.

“Further, substituting rhetoric for real policy is not a serious attempt at addressing public health concerns and will, instead, create widespread consumer confusion and increase grocery costs.”

While the FDA has not yet released the text of the proposal, the most commonly used definition of “ultra-processed foods” by researchers and stakeholders comes from a classification system known as NOVA.

Under NOVA, ultra-processed foods are “industrial formulations made entirely or mostly from substances extracted from foods (oils, fats, sugar, starch, and proteins), derived from food constituents (hydrogenated fats and modified starch), or synthesized in laboratories from food substrates or other organic sources (flavor enhancers, colors, and several food additives used to make the product hyperpalatable).”