FDA seeks to close decadeslong loophole for food additives

By Sarah Owermohle, Sandee LaMotte, CNN

(CNN) — The US Food and Drug Administration released a long-awaited plan to close a loophole in food regulation that lets manufacturers put certain chemicals in products without notifying national food regulators.

The FDA is proposing that food manufacturers notify the agency when they use ingredients that are generally recognized as safe, or GRAS, in their products. It’s a step toward healthier food reforms long advocated by the “Make America Healthy Again” movement, but a step behind more aggressive proposals that would require manufacturers to prove that refined sugars and flours are safe through new studies.

Still, MAHA leaders including US Health and Human Services Secretary Robert F. Kennedy Jr. applauded the proposed rule Monday as a major win in the administration’s efforts to crack down on ultraprocessed foods and promote healthier diets.

“Today’s proposed rule lays a blueprint designed to work effectively for FDA oversight, responsible industry, and consumer safety advocates alike,” acting FDA Commissioner Kyle Diamantas told reporters Monday morning.

Another much-anticipated MAHA plan, a definition of ultraprocessed foods, is still working through review with multiple federal agencies including the US Departure of Agriculture. There have been concerns, primarily from the USDA, that the definition could be overly broad and inadvertently classify too many foods as ultraprocessed, according to three people familiar with internal discussions.

But the GRAS rule proposed Monday is seen as a crowning achievement of Kennedy’s food agenda.

“We’ve gone through this with a lot of stakeholders. I think I think there’d be wide agreement if you talk to them that out of the areas that we have authority on, this is a bold sweeping move,” a senior HHS official said.

Legislation underway in Congress would grant FDA more authority to require studies for certain food additives to stay on the market.

Diamantis said the administration is working with Congress “on legislative options to further address the GRAS process and nutrition reform,” and noted those talks have been bipartisan.

At least 111 substances of unknown safety have been added to foods, drinks and supplements sold in the United States without alerting the US Food and Drug Administration, according to a study released this March.

Companies typically need to demonstrate that a new food ingredient is safe by providing widely accepted scientific evidence. However, notifying the FDA of the data is voluntary, meaning food manufacturers can self-determine that their ingredients are safe.

The proposed rule announced Monday would require manufacturers to notify FDA, shifting GRAS standard from a voluntary program to a mandatory system, Diamantis said.

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