WASHINGTON, D.C. — The Department of Health and Human Services announced a policy proposal on Monday requiring food manufacturers to notify the Food and Drug Administration when they determine an ingredient is “generally recognized as safe,” or GRAS. Manufacturers with GRAS substances already on the market must notify the FDA how the additive is used, and this information will be made public in a database.

Acting FDA Commissioner Kyle Diamantas said the shift addresses a long-standing lack of regulatory visibility into self-determined ingredients. “Shifting to a mandatory notification system closes a decades-old information gap, giving the FDA the comprehensive visibility needed to enhance postmarket safety,” Diamantas said during a press call.

The proposal establishes a two-stage review process for new ingredient notifications. The FDA will review new ingredient notifications within 45 days to ensure they meet legal requirements. Following that initial check, the agency will complete a substantive review of GRAS notifications within 180 days and may request additional information from manufacturers.

Diamantas emphasized that the rule operates within existing statutory boundaries. “The proposed rule advances and improves transparency and the agency’s oversight of the U.S. food supply while respecting the limitation to our authority,” he said. “We believe that these initiatives will actually improve the FDA's ability to effectively execute on its mission by having greater transparency into the number of ingredients in the food supply.”

The regulatory framework traces back to legislative changes in the mid-20th century. In 1958, Congress enacted the Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act, which established that substances generally recognized as safe (GRAS) by qualified experts are excluded from the definition of 'food additive' and do not require premarket approval by the FDA. 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.

The current proposal does not establish pre-market approval of chemicals, which would require Congress to amend the Food, Drug and Cosmetics Act of 1938. An estimated 10,000 additives are allowed in food in the U.S. Jennifer Pomeranz, associate professor of public health policy and management at NYU School of Global Public Health, noted the opacity of the previous system. “Without this requirement there is no method for the FDA to identify their existence, as food companies do not disclose these self-GRAS ingredients to FDA, on food labels, or otherwise,” Pomeranz said.

HHS Secretary Robert F. Kennedy Jr. framed the announcement as part of a broader effort to address public health trends. “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,” Kennedy said in a press release. “Food is the most powerful weapon that we have in our arsenal to change the trajectory of the chronic disease epidemic.”

He linked the GRAS proposal to other recent administrative actions. “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 a policy celebration. The Department of Health and Human Services and the U.S. Department of Agriculture submitted the federal government’s first definition of ultra-processed food for final review alongside the GRAS proposal. HHS and the USDA filed a joint request for information in July 2025 seeking input on defining ultra-processed foods.

“Parents should not need a chemistry degree to understand what their children are eating,” he said. “We cannot reverse America's chronic disease epidemic without transforming our food system.” A senior HHS spokesperson described the move as a long-awaited priority, stating that “GRAS reform is the preeminent regulatory reform that food advocates on both sides of the aisle have been saying is the most important food reform that the United States needs to do for the past 20 years.”

Food policy adviser Vani Hari supported the announcement. “This is a major step forward,” Hari said in an interview. “The biggest benefit of the new policy would be transparency, so we can know what we are eating.”

Critics argued the proposal falls short of necessary structural changes. Former FDA Commissioner David Kessler said the proposed GRAS actions do not tackle the root causes of chronic diseases. “They’re not even tackling what’s in the food supply today,” Kessler said.

Kessler filed a citizen petition a year ago asking the FDA to classify refined starches as unsafe and remove them from GRAS status. Robert F. Kennedy Jr. said in February he would act on David Kessler’s legal petition and sent its position to the White House, but no action has been taken yet.

Nutritionist Marion Nestle expressed skepticism about the depth of the reform. “That’s ALL??? What took them so long for something so simple and obvious?” Nestle wrote in an email.

“This is an improvement, but the company is still responsible for the science and will still be hiring its own experts to say the additive is safe. Oh well, this is at least a step to getting a hold on what’s out there.” The GRAS proposal will be posted to the Federal Register and open for public comment for 120 days until early December.

The proposal marks the first time the federal government has mandated notification for ingredients determined to be generally recognized as safe by industry experts. By creating a public database of these substances, the FDA gains visibility into additives that previously required no disclosure. This shift occurs as an estimated 10,000 additives remain allowed in the U.S. food supply, with nearly 60% of the American diet consisting of ultra-processed foods.

The rule does not alter the fundamental legal standard established in 1958, which excludes GRAS substances from the definition of food additives. Instead, it layers a notification requirement onto the existing self-determination process. The agency will now have a formal mechanism to track these ingredients, though critics note that the scientific determination of safety remains with the manufacturers. The public comment period extending into early December provides a window for stakeholders to influence the final implementation of the database and review protocols.

Why It Matters

This proposal closes a decades-old information gap by requiring manufacturers to disclose self-determined safe ingredients, which previously remained invisible to regulators and the public. While the rule does not establish pre-market approval or alter the 1938 Food, Drug and Cosmetics Act, it creates a mandatory notification system for an estimated 10,000 additives. The resulting public database and structured review timelines provide the FDA with comprehensive visibility needed to enhance postmarket safety oversight.