During a press conference on Monday, the U.S. Department of Health and Human Services (HHS) announced the proposed changes as part of a broader effort to increase transparency around substances entering the food supply and strengthen the scientific foundation for federal nutrition policy.
The proposed rule, which applies to human and animal food, would require manufacturers to notify FDA when concluding that the use of a substance added to food is Generally Recognized as Safe (GRAS).
Separately, HHS and the U.S. Department of Agriculture (USDA) submitted the federal government’s first proposed definition of ultra-processed foods (UPFs) for final review.
The proposal follows the administration’s earlier call to eliminate the self-affirmed GRAS pathway. In March 2025, HHS Secretary Robert F. Kennedy Jr. directed FDA to explore rulemaking that would eliminate self-affirmed GRAS, arguing that companies could introduce ingredients into the food supply without notifying FDA or the public.
While the earlier announcement focused on eliminating self-affirmed GRAS, the new proposal takes a different approach by making GRAS notifications mandatory. Acting FDA Commissioner Kyle Diamantas said the proposal would require companies introducing a new GRAS substance or new use to notify FDA of the basis for their conclusion.
He said the change would close a longstanding information gap and give FDA greater visibility into substances used in human and animal food.
“By proposing mandatory GRAS notifications, we are closing critical information gaps and giving FDA greater visibility into the substances in our food supply,” Diamantas said.
He added that the GRAS pathway was intended to provide an exemption from the otherwise required premarket approval process.
The proposal also includes a time-limited, streamlined submission pathway for certain substances already in interstate commerce and would establish a public-facing inventory of GRAS notices.
Diamantas emphasized that the proposal is a “blueprint” for public comment, not a final rule.
RFK makes the case for reform
During the press conference, Secretary Kennedy called the current system a “GRAS loophole,” arguing that companies can make GRAS determinations without notifying FDA.
“The companies can make their own GRAS determinations and put substances into the food supply without even notifying the FDA,” he said. “The FDA was left with a major blind spot.”
Kennedy said FDA could not give him a precise figure when he asked how many ingredients were in the food supply, estimating the number could range from 4,000 to 12,000, with around 10,000 likely.
“We don’t even know exactly how many chemicals are in the food that Americans eat every day,” Kennedy said, arguing that the uncertainty makes rigorous science and transparent safety review increasingly important.
Notification vs. approval
Under the proposal, FDA said the system would not constitute a premarket approval program and companies could continue marketing a substance while FDA reviews their notification.
Speaking to NutraIngredients, Daniel Fabricant, Ph.D., CEO and president of the Natural Products Association (NPA), questioned the distinction between notification and approval under the proposed framework.
FDA repeatedly emphasized that the rule is “not a premarket review program” and that companies may continue marketing a substance before FDA completes its review.
However, Fabricant said that if FDA and a company disagree over the agency’s assessment of the GRAS notice, “there is no clear remedy in the proposed rule that doesn’t point to the process not being an approval.”
“You were on the market when you were notified, which is the requirement, but because we didn’t like your notice you’re no longer on the market – that sounds like an approval to most people,” Fabricant said.
Legal authority could be challenged
The proposal could also face scrutiny over FDA’s authority to make GRAS notifications mandatory.
Fabricant described the proposal as an “about face” from FDA’s 2016 position on mandatory GRAS notifications.
The issue could become a significant focus of the rule’s 120-day public comment period. On Monday, Kennedy also acknowledged that congressional action may be needed as the administration pursues broader GRAS reform.
Loren Israelsen, founder and president of the United Natural Products Alliance (UNPA) and a DSHEA architect, told NI that FDA appeared to be taking care to structure the proposal around the possibility of legal challenges.
“For a 140 page notice, it does not seem like a whole lot is changing,” Israelsen said. “Clearly, the FDA is trying to steer clear of legal challenges, which are very likely coming.”
FDA’s potential workload challenge
The proposed rule could also significantly increase the workload for FDA.
Fabricant said the agency currently receives roughly 50 voluntary GRAS notices a year, but mandatory notification could increase that volume from tens to hundreds or potentially thousands of submissions.
That raises questions about whether FDA has the resources and infrastructure to review the additional notices. The Consumer Healthcare Products Association (CHPA) also questioned whether FDA has sufficient resources and review capacity to administer the expanded notification requirements “without creating delays and inefficiencies that could impact product availability.”
“The orders of magnitude for the workflow will be critical—going from 10s to 100s to potentially 1000s,” Fabricant said. “No new resources come with a proposed regulation versus the potential to do so with legislation.”
Potential implications for ingredient innovation
The Council for Responsible Nutrition (CRN) warned that mandatory GRAS notifications could create new regulatory burdens for ingredient companies, potentially increasing costs and extending the timelines for bringing new ingredients to market.
CRN also raised concerns about the additional workload for an already resource-constrained FDA, arguing that the agency could gain greater visibility into GRAS ingredients without eliminating the existing self-GRAS pathway.
“Requiring a full FDA notification for every new GRAS determination could increase costs, extend timelines for bringing safe new ingredients to market, and place additional demands on an already resource-constrained FDA,” CRN said.
The trade group said it has developed a framework for a GRAS registry that it believes could provide FDA with greater visibility while preserving the self-GRAS pathway.
The American Herbal Products Association (AHPA) offered a more supportive response, emphasizing that self-affirmed GRAS is a legal and rigorous pathway.
AHPA welcomed FDA’s recognition of GRAS as a pathway to market for food and dietary supplement ingredients and said it was pleased the proposal preserves industry’s role in the process, including provisions covering self-GRAS ingredients already on the market.
“This process is not a loophole; it requires independent evaluation by qualified experts, often including multiple toxicologists, to evaluate all available safety information to determine whether an ingredient is generally recognized as safe for a particular intended use,” said Graham Rigby, president of AHPA.
However, AHPA said during the rulemaking process it would focus on ensuring FDA has adequate resources and specialized expertise to evaluate the range of herbal and botanical ingredients entering the market through GRAS.
The International Probiotics Association (IPA) said it is carefully assessing the proposal and plans to comment on its potential implications for probiotics.
The group said strains belonging to species with an established safety record and long history of use should be treated differently and exempted from notification requirements.
“This would avoid redundancy—FDA reviewing the same information again and again—and hence would allow FDA to employ resources on reviewing what requires a review,” said Solange Henoud, vice president of regulatory and compliance at Lallemand Health Solutions and IPA secretary and co-chair of its Global Regulatory Committee.
While IPA supports FDA’s efforts to increase transparency, Henoud said the association also supports evidence-based recognition of probiotic safety by regulatory authorities and scientific experts.
Existing ingredients and small businesses
The proposal also includes a time-limited, streamlined submission pathway for certain substances already in interstate commerce and would require information from GRAS notices to be made publicly available through FDA’s existing GRAS Notice Inventory.
However, Fabricant said he did not see a specific phase-in period for small businesses, which he noted is common in significant FDA rules.
He said the proposal instead asks companies to request compliance alternatives.
Potential implications for dietary ingredients
The proposed changes could also raise questions for dietary ingredients used in supplements.
The Global Organization for EPA and DHA Omega-3s (GOED) noted that, in its reading of the proposal, dietary ingredients intended for use in supplements are not eligible for classification under the GRAS provision and therefore may not qualify for the proposed streamlined pathway for certain substances already in interstate commerce.
GOED said this could be relevant for companies operating under the assumption that they can legally market supplements containing self-affirmed GRAS dietary ingredients.
If FDA does not extend the streamlined pathway to those ingredients, some companies could potentially need to submit new dietary ingredient notifications (NDINs), GOED said.
However, GOED does not expect the proposal to significantly affect most of its members, noting that most omega-3 dietary ingredients that were not marketed before October 15, 1994 are already associated with NDINs filed with FDA.
Kessler petition could have broader implications
Israelsen questioned whether the mandatory notification proposal is ultimately the most consequential piece of the administration’s GRAS reform effort, pointing instead to FDA’s expected response to former FDA Commissioner David Kessler’s citizen petition seeking to revoke the GRAS status of certain processed refined carbohydrates.
Kessler’s petition argues that there is no longer a consensus among qualified experts that the current uses of these substances meet the statutory standard for GRAS.
Kennedy said during the press conference that FDA would be taking action on the petition.
Israelsen said the Kessler petition could therefore have greater implications for specific ingredients than the notification proposal itself.
“Maybe that is the real story here,” he said.
The proposed GRAS rule is now open for public comment, with FDA expected to receive feedback on the scope of the notification requirement, its legal authority, implementation, agency resources and the potential impact on ingredient companies.
