FDA proposes mandatory GRAS notifications as US moves to define ultra-processed foods

The US FDA has unveiled its proposal requiring companies to notify the agency every time they conclude an ingredient is generally recognized as safe (GRAS). The move will close a route that the FDA says has allowed manufacturers to put substances into the food supply without informing regulators since 1958.

The proposed rule was published in the Federal Register on August 11, 2026, under docket number FDA-2025-N-3262. Comments are set to close December 9. If passed, the rule will amend 21 Code of Federal Regulations (CFR) parts 170 and 570. These sections cover substances added to human and animal food, and it reaches food contact substances that migrate from packaging.

In practice, companies will still reach their own GRAS conclusions, as the proposal does not create premarket approval. The US Department of Health & Human Services (HHS) announced the rule on August 10, 2026.

The announcement came alongside a second action. The FDA and the US Department of Agriculture (USDA) submitted the federal government’s first proposed definition of ultra-processed foods (UPFs) for final review. The text of the proposed definition has not yet been released.

“Nearly 60% of the American diet is made up of UPFs, and childhood obesity now affects more than one in five American children,” says HHS Secretary Robert F. Kennedy Jr. “We cannot reverse America’s chronic disease epidemic without transforming our food system.”

Kennedy at the HHS ties the GRAS overhaul and UPF definition to the administration’s chronic disease agenda.“President Trump and I promised to Make America Healthy Again, and today we are turning that promise into policy.”

Counting the uncounted 

Currently, a company can decide a substance is GRAS and bring it to market in silence. Notification has been voluntary since the program launched as a pilot in 1997, and the 2016 final rule kept it that way.

The FDA has filed more than 1,200 GRAS notices since the program began as a pilot in 1998, according to the proposed rule, including over 670 since January 2016. Foreign firms submitted 617 of the total, and 503 of those came from countries where English is not the primary language. The Center for Veterinary Medicine had filed 75 animal food notices as of March 2025.

What the FDA does not know is the bigger number. Citing outside estimates it says it cannot verify, the agency puts roughly 10,000 additives in use as of January 2011, including about 1,000 human food substances that companies had self-affirmed without ever filing a notice.

Enforcement without penalties 

The proposal will open a time-limited streamlined pathway for substances already on the market under self-GRAS conclusions. Manufacturers could file basic information about existing uses instead of a full notice. The FDA states this will let it prioritize post-market safety evaluations while holding down the compliance burden.

Enforcement, however, is not as robust. If a company fails to notify, the rule states the FDA would treat that noncompliance as a factor when it prioritizes substances for post-market review. As of yet, no penalty has been specified.

“Americans deserve confidence that the ingredients in their food are subject to transparent, science-based oversight, and today’s actions strengthen both sides of that equation,” says Acting FDA Commissioner Kyle Diamantas.

“By proposing mandatory GRAS notifications, we are closing critical information gaps and giving the FDA greater visibility into substances entering the food supply.”The acting FDA Commissioner says mandatory notification closes information gaps without extending the FDA’s premarket authority.

Compliance timeline

The rule would take effect 60 days after a final rule is published, with compliance required 18 months after that.

The FDA would have 45 days to decide whether to file an incoming submission as a GRAS notice. Once filed, the agency would generally respond within 180 days, with the proposal allowing up to two additional 90-day extensions.

A notifier asking the FDA to stop evaluating a notice would leave the notification requirement unmet. A response finding an insufficient basis for the GRAS conclusion would not, though the FDA says such a finding could inform post-market action.

Counting compliance costs 

The FDA puts the present value of compliance costs at about US$89.6 million over 10 years at a 3% discount rate, with a lower bound of US$34.9 million and an upper bound of US$210 million. That comes to roughly US$10.5 million annually.

The proposal also revises the threshold of regulation procedures and would let companies file a food contact notification in place of a GRAS notice for packaging substances.

The ultra-processed food definition took a different route. FDA and HHS sent a document titled “Proposed Definition of Ultra-Processed Food” to the Office of Information and Regulatory Affairs on August 3 as a white paper rather than a proposed rule. A white paper carries no binding labeling or formulation requirement.

HHS says the definition incorporates feedback from thousands of stakeholders through a joint request for information issued with USDA in July 2025. Additionally, it states that the absence of a standard federal definition has limited research consistency across the government.

Critics call for more

Consumer groups are calling the GRAS proposal a first step, but maintain that there is still more to be done.

“FDA’s proposal is an important step, but it underscores the limits of what the agency can accomplish under its existing statutory authority,” says Stephanie Harris, FMI – The Food Industry Association’s chief public policy officer and general counsel. “Durable reform requires Congress to give the FDA the clear mandate, tools, and resources necessary to modernize the GRAS program effectively and establish a national uniform standard.”FMI – The Food Industry Association calls the proposal an important step but presses Congress to act.

“Congress should act this year to establish a nationally uniform, science-based framework for ingredient transparency that strengthens the FDA’s role, avoids a fragmented state-by-state patchwork, and provides consumers and the food industry with clarity and confidence. We look forward to working with lawmakers on both sides of the aisle, as well as the White House, to make this a reality.”

At the same time, Brian Ronholm, director of food policy at Consumer Reports, goes further, pointing out that the missing enforcement provision and the substances already in circulation.

“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,” he asserts.

“If the process for this proposed rule gets drawn out, it may be years before anything is implemented, if at all, so this should not preclude states from passing laws that protect consumers more quickly.”