A looming FDA rule could overhaul how everyday ingredients are regarded by the agency —putting thousands of supplements and natural products at risk of disappearing behind regulatory red tape. Action Alert!
THE TOPLINE
- A new FDA rule on the GRAS (Generally Recognized as Safe) system is under review, and could significantly change how ingredients are allowed to enter the marketplace—potentially affecting access to thousands of supplements and food ingredients.
- The proposal would likely require mandatory FDA notification for all GRAS determinations, ending “self-GRAS,” which could increase transparency but also overwhelm the agency and create major backlogs.
- Eliminating self-GRAS—the approach Secretary Kennedy has HHS Secretary has consistently reiterated—could restrict access to safe, natural ingredients and stifle innovation. Reform should focus on transparency and risk-based oversight—not a burdensome pre-approval system.
An update to the FDA’s Generally Recognized as Safe (GRAS) framework is around the corner. The Office of Management and Budget (OMB) has reportedly scheduled a meeting for April 20, 2026, to review a proposed rule that could significantly reshape how GRAS determinations are handled in the United States.
It may sound very “in the weeds” to be talking about GRAS. But what’s at stake is your access to thousands of safe, health-promoting ingredients; if we get the wrong kind of GRAS reform, they could disappear in the churn of a bureaucratic approval system. (For background on what GRAS is and how we got here, and how we think reform could be done in ways that work for everyone other than those selling harmful ingredients, you can check out our white paper.)
At this stage, full details of the rule have not been released, but we must stay vigilant and engaged to make sure the rule promotes transparency and supports consumer access to safe, natural ingredients, rather than installing additional bureaucratic red tape that eliminates supplement access.
What the Proposed Rule May Do
The proposed rule would require mandatory submission of GRAS notices to the FDA, effectively ending the practice of “self-affirmed GRAS” determinations that are not disclosed to the agency. (As we’ve explained in previous coverage, self-affirmed GRAS, or “self-GRAS”, is when a company independently concludes an ingredient is GRAS without FDA notification.)
Certain substances will be exempt from this requirement—namely, those already listed as GRAS by regulation or those that have already received an FDA “no questions” letter. The FDA would also maintain and update a public-facing inventory of GRAS notices, providing greater visibility into which substances are being used and on what basis they have been deemed safe.
The rule is also expected to clarify how the FDA determines that a substance is not GRAS, an area that has long lacked clear procedural guidance.
Problems With the Rule
At first glance, some of this sounds like the kind of transparency reform for which ANH has long advocated. But abolishing the self-GRAS pathway would be a huge mistake, as we outlined in our white paper last year.
Depending on how it’s done, abolishing the self-GRAS pathway creates more problems than it solves. Consider the fact that there are currently an estimated 10,000+ ingredients on the market today that are self-GRAS, many of them perfectly safe and natural supplement ingredients. If all of these are going to be forced through a mandatory FDA approval system, the agency would be overwhelmed, creating years, if not decades, of regulatory backlog.
Worse, this kind of blanket approach would likely sweep safe, beneficial ingredients off the market alongside risky ones, reducing consumer access to health-promoting products and potentially harming public health. It would also stifle innovation, particularly for smaller companies that rely on the flexibility of self-GRAS to bring new ingredients to market.
The issue is not the GRAS pathway itself, but the lack of transparency. The public and independent scientists should be able to review the data underlying self-GRAS determinations. But rather than creating a pre-approval regime, reform should focus on shining light on GRAS determinations and prioritizing enforcement against ingredients that pose a demonstrated risk.
>>>Read ANH’s GRAS Reform White Paper
Creating another de facto pre-approval system undermines the original purpose of the GRAS pathway: to streamline the introduction of safe ingredients, including many natural ingredients, into food.
Reform Done Right
There is broad agreement that the GRAS system needs reform. The current lack of transparency allows for potential abuse, and the public deserves greater visibility.
But eliminating self-GRAS entirely would “throw the baby out with the bathwater,” removing a pathway that has enabled the development of many safe and beneficial products.
ANH has outlined a better path forward in its white paper, Reforming GRAS: Food Safety Without Sacrifice, which proposes a tiered, risk-based approach to ingredient review. This model would focus regulatory resources where they are most needed while preserving access and innovation.
Waiting for the Details
The upcoming OMB meeting signals that change is imminent. But until the proposed rule is formally released, key questions remain unanswered.
Will the FDA strike the right balance between transparency and access? Or will it move closer to the burdensome, pre-approval frameworks being pushed in Congress?
For now, the only responsible position is cautious optimism—tempered by vigilance.
We will continue to monitor developments closely and provide updates as more information becomes available.
Action Alert!
