WASHINGTON – In a significant move, U.S. health officials unveiled a proposed rule change on Monday, which would mandate that food manufacturers inform regulators prior to adding new ingredients or additives to processed or packaged foods.
This initiative aims to revise a long-standing policy criticized by advocates as a regulatory loophole that has allowed thousands of untested ingredients to enter the U.S. food market unchecked.
Under the new rule proposed by the Food and Drug Administration, companies would be required to document and submit their safety data for any new ingredients. This would enable regulators to conduct investigations if there are any safety concerns. At present, companies can independently determine if an ingredient is “generally recognized as safe” without needing to notify or submit evidence to the FDA, although some do so voluntarily.
“Transitioning to a mandatory notification system addresses an information gap that has persisted for decades, providing the FDA with crucial oversight necessary to bolster post-market safety,” declared acting FDA Commissioner Kyle Diamantas during a briefing on Monday.
The proposal will be open for public comments over the next 120 days, inviting stakeholders to share their viewpoints.
Government scrutiny of ultraprocessed food continues, but with few details
In a separate move, the FDA said it 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 has 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 packaged foods 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 labeling or other restrictions on processed foods.
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 considered top priorities for Health Secretary Robert F. Kennedy Jr., who entered government vowing to crack down on artificial colors, additives and other ingredients.
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 often 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 new 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 that type of mandatory review would need to be enacted by Congress in order to rewrite FDA’s authority over the food supply.
“What we’re doing is requiring companies that utilize the pathway to notify us of their conclusions so that we have greater visibility into those conclusions and consumers have awareness,” Diamantas said.
Under the proposal, the FDA would be expected to review new ingredient submission within 180 days. If FDA regulators have safety concerns they could request additional information from manufacturers or request that they delay introducing the ingredient.
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 consumer advocacy group Center for Science in the Public Interest, that “undermines the integrity of our food safety system.”
Food industry officials contend their internal reviews of additives are as rigorous as the FDA’s own processes.
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