HHS Proposes Mandatory GRAS Notification Rule, Marking First Major FDA Food Ingredient Transparency Reform in Decades

The Department of Health and Human Services on Monday announced a proposed rule that would, for the first time, require food manufacturers to notify the Food and Drug Administration when they determine a new ingredient is "Generally Recognized as Safe," or GRAS. The proposal represents the most significant shift in FDA oversight of the U.S. food supply in decades, though it stops short of the pre-market approval system that consumer advocates and the "Make America Healthy Again" movement have long demanded.

Under the proposed rule, companies seeking to add a new substance to human or animal foods would need to notify the FDA and provide details on how they deemed the additive safe. Manufacturers with GRAS substances already on the market would, for the first time, need to inform the agency how those additives are used — information that would be made publicly available in a database.

"This is a major step forward," said Vani Hari, known as the FoodBabe and an adviser to the administration's food policy efforts, citing "transparency, so we can know what we are eating."

Closing a Decades-Old Information Gap

Under current law, substances intentionally added to food generally require FDA premarket approval unless they qualify for an exemption, including GRAS status. An ingredient can qualify for GRAS when qualified experts recognize it as safe in the context of its intended use. The FDA has operated a voluntary GRAS notification program for years, but manufacturers have not been required to tell the agency when they independently determine an ingredient qualifies for the exemption.

"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," a senior HHS spokesperson said.

Acting FDA Commissioner Kyle Diamantas emphasized that the proposal would not establish "pre-market approval" of chemicals. Congress would need to amend the Food, Drug and Cosmetics Act of 1938 to grant the FDA that power. Still, he said, the mandatory notification system "closes a decades-old information gap."

"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," Diamantas said.

Review Timelines and Implementation

Once the notification of a new ingredient reaches the FDA, the agency will review it within 45 days to ensure it meets legal requirements. Within 180 days, the FDA will complete a more substantive review and may ask manufacturers for more information or determine the application has not met GRAS criteria. An unpublished version of the regulation estimates the proposed rule would cost $10.5 million each year on average, with the bulk of costs falling to companies needing to comply.

Jennifer Pomeranz, an associate professor of public health policy and management at NYU School of Global Public Health, called the proposal a "significant change" that would protect consumers. "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," she said.

Mixed Reactions from Experts

Not all public health experts were satisfied. Former FDA Commissioner David Kessler told STAT, "The proposed GRAS actions do not tackle the root causes of chronic diseases." He noted the move would not address refined carbohydrates and sweeteners found in ultra-processed foods (search)Search disease linked to metabolic disease. "They're not even tackling what's in the food supply today."

Nutritionist Marion Nestle also expressed reservations. "That's ALL??? What took them so long for something so simple and obvious?" she told STAT, adding, "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." Nestle also questioned whether the FDA has adequate staffing to review GRAS notifications following workforce reductions last year.

Ultra-Processed Food Definition Submitted

Alongside the GRAS proposal, HHS and the U.S. Department of Agriculture submitted for final review the federal government's first proposed definition of ultra-processed foods (search)Search disease. HHS Secretary Robert F. Kennedy Jr. stated, "Nearly 60% of the American diet is made up of ultra-processed foods, and childhood obesity (search)Search disease now affects more than one in five American children. We cannot reverse America's chronic disease (search)Search disease epidemic without transforming our food system."

Dariush Mozaffarian, a Tufts University cardiologist and nutrition researcher, told attendees at a policy celebration at HHS headquarters that the two policies — "defining ultra-processed food and closing the GRAS loophole" — rank among the FDA's most consequential nutrition actions in 50 years. "Our food is the top driver of disease, disability, and death in the United States," he said.

The GRAS proposal will be posted to the Federal Register this week and will be open for public comment until early December, after which it must go through the federal rulemaking process before any requirements take effect.