Food manufacturers may have to start disclosing to the U.S. Food and Drug Administration the ingredients they determine to be safe for consumption, according to an announcement made today by the Department of Health and Human Services.
A new rule proposed by federal food regulators could begin to close a loophole that allows food manufacturers to determine, with no FDA oversight or required disclosure, that an ingredient is safe to add to food products.
The Red 40 that gives Flamin’ Hot Cheetos the color that stains fingers is a chemical ingredient that food makers determined safe to eat under federal food safety standards established in 1958.
Those standards put the responsibility on food manufacturers to test and verify the safety of any new chemical ingredients. U.S. companies have been allowed to determine on their own if substances added to their products are Generally Recognized as Safe (GRAS), without notifying the U.S. Food and Drug Administration. GRAS denotes that qualified experts agree that an ingredient is not harmful to consume under its intended uses.
With companies in control, this has resulted in thousands of unknown chemical additives in food that have led to a wide range of health complications.
Ultra-processed foods typically refer to foods made with one or more ingredients not used in home cooking, according to the Johns Hopkins Bloomberg School of Public Health, like chips, boxed macaroni and cheese, frozen meals, hot dogs, and deli meat.
“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 in a statement. “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.”
Although research has linked high consumption of ultra-processed foods to preventable chronic diseases, including type 2 diabetes and heart disease, the agencies say the absence of a standardized federal definition has limited research consistency across the federal government.
The proposed definition incorporates feedback from a public comment period held last summer for three months, as well as industry and consumer organizations and researchers. There are exemptions in the proposal for chemical compounds in the review process before the rule announcement.
According to Consumer Reports, the proposed rule does not go far enough to ensure transparency for companies seeking to add chemical ingredients to the GRAS list. For instance, the group does not like that the proposal still allows food manufacturers to conduct their own testing and research.
“Considering the out-of-control, self-regulatory system we currently have for food ingredients, it’s disappointing that today’s announcement lacks substance and doesn’t propose anything meaningful,” Brian Ronholm, Director of Food Policy at Consumer Reports, said in a statement. “Given the lack of any real enforcement under the proposed rule for failing to submit a GRAS notice, combined with the fact that it would not apply to chemicals already in our foods, it risks maintaining the status quo that allows secret ingredients and chemicals to remain on the market without FDA review.”
Ronholm also criticized the timeliness of the rulemaking process. In June, Consumer Reports and Yuka released a news investigation where they tested the chemical makeup of 40 popular foods like chips and donuts, discovering nearly two-thirds of those products “contained enough of at least one additive to exceed a broader group of reference levels associated with an increased risk of developing cancer, heart disease, or diabetes.”
The investigation found that the outdated GRAS process has led to higher levels of unsafe chemicals in American foods. It’s unlikely that the full impact will ever be known.
“If the process for this proposed rule gets drawn out, it may be years before anything is implemented, if at all,” Ronholm said. “So this should not preclude states from passing laws that protect consumers more quickly.”

