U.S. health officials on Monday proposed a rule change that would require food manufacturers to notify regulators before introducing new ingredients or additives into processed or packaged foods.
The proposal would change a decades-old policy that advocates have called a regulatory loophole, blaming it for allowing thousands of unvetted ingredients into the U.S. food supply.
Under the proposed rule from the Food and Drug Administration, companies would have to document and submit their safety rationale for new ingredients, giving regulators the opportunity to investigate if they see a potential risk. Currently companies can decide for themselves if an ingredient or additive is “generally recognized as safe,” or GRAS, and there is no requirement to notify or submit evidence to the FDA, although some firms do.
“Shifting to a mandatory notification system closes a decades-old information gap, giving the FDA the comprehensive visibility needed to enhance postmarket safety,” acting FDA Commissioner Kyle Diamantas told reporters on Monday.
The FDA will take comments on the proposal for 120 days.
Susan Mayne, former director of FDA’s food program, said the new requirement would give the FDA a clearer picture of the vast number of ingredients on the U.S. market, though only a small portion would actually undergo review.
“This is a reasonable first step towards a more complete inventory, but most self-affirmed GRAS ingredients will still not be reviewed for safety by the FDA, with food ingredient safety continuing to be risk-based,” said Mayne, who is now a public health expert at Yale University.
The FDA also plans to publish a list of company-submitted ingredients. Mayne said Americans should understand that “inclusion on the list would not mean FDA thinks the ingredient is safe.”
Scrutiny of ultraprocessed food continues, but with few details
In a separate move, the FDA said it has completed work on the federal government’s first-ever definition of ultraprocessed food, but did not release any details or the proposed language. The agency said it submitted the definition to the White House for further review.
Health advocates consider an official definition of ultraprocessed food a key step toward bringing greater scrutiny to meals that are blamed for multiple chronic health problems afflicting Americans. A government-backed definition could pave the way for more federal research and, eventually, possible warning labels or other restrictions.
Neither of Monday’s announcements are likely to immediately impact American diets, which are packed with fats, sodium and sugar and are blamed for a host of chronic diseases such as obesity, diabetes and heart disease. But both initiatives are top priorities for Health Secretary Robert F. Kennedy Jr., who entered government vowing to crack down on artificial colors, additives and other ingredients.
“These two actions will change how the federal government oversees what’s in our food and how we understand the foods that Americans eat,” Kennedy said at an event Monday at HHS headquarters.
Ultraprocessed foods are made using industrial processing and additives, colors, preservatives or other ingredients not found in home kitchens. The foods include sugary cereals, sodas, chips, frozen pizzas and other grocery items.
Scientists have been working to define and classify processed foods for well over a decade. But sweeping definitions come with downsides. They can be applied to foods like whole grain bread, yogurt and granola that are all highly processed but still considered nutritious. Some recent efforts to define ultraprocessed foods include carve-outs for foods that meet nutrition standards, despite having processed ingredients.
FDA proposal would bring new insights on additives used by food companies
In the U.S., an estimated 10,000 additives are allowed in food, including thickeners, preservatives and packaging ingredients.
Consumer advocates have long argued that many of those ingredients have never been properly vetted because of the FDA’s policy allowing manufacturers to certify for themselves that additives are “generally recognized as safe,” or GRAS.
FDA’s Diamantas stressed Monday that the new policy would not require all new ingredients to undergo FDA review. He said mandatory reviews would need to be enacted by Congress.
“What we’re doing is requiring companies that utilize the pathway to notify us of their conclusions so that we have greater visibility,” Diamantas said.
Under the proposal, the FDA would be expected to review new ingredient submissions within 180 days. If regulators had safety concerns they could request additional information or ask the company to delay introducing the ingredient.
Consumer advocates who have long pushed for changes said FDA’s proposal should require more than giving advance notice.
“It must also include strong, science-based safety standards and thorough, independent FDA review before chemicals are allowed in our food,” said Melanie Benesh of the nonprofit Environmental Working Group.
Kennedy said the Trump administration would ask Congress to grant FDA additional powers over ingredients.
“Congress needs to give FDA the additional tools it needs to keep pace with the changing food supply and protect the American people,” Kennedy said.
A rule change in the 1990s created what advocates call a loophole
Any substance intentionally added to food is supposed to undergo formal review — unless the additive is considered safe. Since the late 1950s, the government recognized that many common ingredients in foods, such as spices and vinegar, were widely consumed and understood to be safe for consumption.
The FDA policed the GRAS exemption for years, but it took time and resources. Starting in 1997, the FDA began allowing companies to independently determine that a new additive is safe based on publicly available scientific evidence and the consensus of qualified experts.
However, the list of products deemed GRAS by companies grew to include many synthetic and natural additives, all incorporated into the food supply without independent review.
The process has created a “secret GRAS loophole,” according to the Center for Science in the Public Interest and other health groups.
Food industry officials contend their internal reviews of additives are as rigorous as the FDA’s own process.
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