In the seven months since Robert F Kennedy Jr took his post as secretary of Health and Human Services, the supplement industry has had time to get used to “policy by press-release” and even by tweet, but an early September announcement concerning possible elimination of self-affirmed GRAS came not as a surprise but still something of a shock.
Publishing its Spring 2025 Unified Agenda of Regulatory and Deregulatory Actions, the FDA provided its first proposed rule building on Kennedy’s March announcement directing staff to explore ending rules that allow companies to declare an ingredient “generally recognized as safe” without notifying the FDA. Insiders read the announcement as an indication that self-GRAS will come to an end, possibly forcing companies with self-GRAS ingredients already on the market to notify the FDA and see their supporting evidence face evaluation.
With the industry facing what could be a major obstacle to product development, we asked trade associations and industry insiders for their take on the new developments.
Duffy MacKay, Senior Vice President, Supplements, Consumer Health Product Association
In its Spring 2025 Unified Agenda, the FDA signaled its intent to revisit the Generally Recognized as Safe (GRAS) framework, potentially eliminating the long-standing self-affirmed GRAS pathway. For decades, this pathway has enabled companies to responsibly bring safe, science-based food and dietary supplement ingredients to consumers without unnecessary delays, relying on rigorous expert evaluation. At the direction of HHS Secretary Robert F. Kennedy Jr., FDA has been tasked with what he describes as ‘closing the self-GRAS loophole’ to enhance transparency. Industry, however, does not view this pathway as a ‘loophole,’ but rather, a well-established, science-driven process that has safely served consumers for decades.
Related:Organic at 40: How the industry is thriving despite regulatory uncertainty
While FDA has not yet released a formal proposal, its inclusion in the Unified Agenda signals the agency has been actively developing the rule to align with broader federal efforts under the Make America Healthy Again initiative. Industry stakeholders also value transparency and are committed to working with regulators to strengthen GRAS in ways that enhance public confidence, while also ensuring consumers have continued access to their dietary supplements and avoiding the dismantling of a process that has delivered innovation and safety for decades.
While we cannot comment on specifics until the proposal is made public, any changes to the GRAS framework must be transparent, science-based, and provide industry with a reasonable timeline to adapt, ensuring that safety, innovation, and regulatory clarity move forward together. Experts in the Administration and industry have expressed approaches that should balance modernization, transparency, and feasibility. The leading ideas on the table include requiring notification only for truly new or novel ingredients, setting clear definitions for what ‘new’ actually means, and recognizing exemptions for ingredients already vetted by third-party systems. And importantly, any new rules should be prospective—not retroactive—to avoid unnecessary and unpopular disruptions to America’s food supply.
Related:Kennedy plans to ban artificial dyes, has ‘understanding’ with food industry
Finally, to make any modernizations to the GRAS system truly effective, FDA will need adequate funding for pre- and post-market review and enforcement, and federal preemption will be essential to avoid a patchwork of state laws.
Loren Israelsen, President, United Natural Products Alliance
There are 3 regulatory pathways for dietary supplements: Old Dietary Ingredient status, New Dietary Ingredient status and GRAS affirmation, with or without notice.
Addressing GRAS without also considering the need for an ODI 2.0 and completion if not revision of the NDI Guidance would be a missed opportunity. The goal here is to have efficient, competent pathways to market for dietary supplements that recognize the desire of consumers for ready access to safe and beneficial supplements.
Related:FDA in 2025: Navigating changes in food and dietary supplement investigations
There will be debates whether FDA has the authority, the capacity and funding to manage a new GRAS system. UNPA will focus it’s efforts on how to make this 3 tiered safety system for DS more efficient and effective.
This is what we believe consumers would want us to do.
There are doubts about whether the FDA has the authority and resources to enforce this policy change. (CANVA)
Ashish Talati, Founding Member, Talati Law Firm
On March 10, 2025, HHS Secretary Robert F. Kennedy Jr. instructed the then acting FDA commissioner to explore rulemaking that would eliminate the self-affirmed GRAS pathway. Just a few months later, FDA is preparing to propose exactly that—requiring companies to submit GRAS notices rather than relying on self-determinations. This is significant because FDA has historically acknowledged that it lacks express statutory authority to mandate such notifications. In both the 1997 proposed rule and the 2016 final rule, the agency noted that Congress deliberately excluded GRAS substances from the definition of “food additive,” thereby allowing manufacturers to independently determine GRAS status without FDA involvement.
How FDA will now justify its authority to mandate GRAS notifications remains to be seen. The agency has indicated that the proposed rule would establish a public GRAS inventory and outline how it determines when a substance does not qualify as GRAS.
If finalized, the rule would mark a fundamental change for the food and dietary supplement industries. Dietary supplement companies have long relied on self-GRAS determinations to support eligibility for the NDI food supply exemption under section 413(a)(1) of the FD&C Act, thereby avoiding the need to submit an NDI notification. Closing that pathway would require firms to engage more directly with FDA, likely lengthening ingredient innovation timelines and subjecting new ingredients to greater regulatory scrutiny.
Andrea Wong, Senior Vice President, Science and Regulatory Affairs, Council for Responsible Nutrition
Rather than dismantling a system that allows scientifically reviewed ingredients to reach the market efficiently, FDA should focus on strengthening enforcement mechanisms to ensure the GRAS process is used responsibly. CRN shares the goal of increasing safety and transparency for consumers and stands ready to work with the FDA to achieve it. The solution is not to eliminate self-GRAS, which would stifle innovation, but to provide FDA with the resources and tools it needs to maintain an effective regulatory system that fosters both safety and progress.
Rend Al-Mondhiry, Partner and Co-chair of the Regulatory Group, Amin Wasserman Gurnani
The fact that this proposed rule showed up on the unified agenda wasn’t a total surprise because we know that reform of the GRAS process is a big priority for this administration, but the timing is truly aspirational. It seems like a significant undertaking to have a proposed rule ready by this fall, and Secretary Kennedy’s prior announcement on GRAS reform acknowledges that federal legislation might be needed. There is also court precedent suggesting this. That could add a layer of complication.
Also, the details are sparse, but we know the intent is to eliminate the self-affirmed GRAS pathway and require companies to submit their GRAS conclusions to FDA. Beyond that, we don’t know what’s in store for self-affirmed GRAS ingredients currently on the market, and what if any changes to FDA’s current GRAS review process might be. It’s hard to imagine a scenario where these are taken off the market with little or no notice, and I suspect there will be a window or grace period where these ingredients can be formally submitted to FDA for review. A notification process could also be utilized, and then FDA could decide which ingredients require a deeper review. It’s unclear if that type of option is on the table, but it could be a less drastic option that also addresses some of the transparency concerns. Either way, it seems there will need to be some sort of prioritization of ingredients to avoid a backlog, as a key question in all of this whether FDA has the resources to take on a potential tidal wave of GRAS reviews without significant market disruption. Also, if companies turn to NDI notifications, that could pose a problem as well because, after almost a decade, we still don’t have a final guidance addressing some of the core issues around what is an NDI that requires notification. And again, we run into questions about FDA resources and whether there are enough qualified FDA staff to review numerous NDINs.
So, in the end, there so many unanswered questions around timing and details. We’ll be tracking any developments closely over the coming months.
Karen Howard, CEO and Executive Director, Organic and Natural Health Association
Per our legal counsel’s perspective, ‘FDA does not have the regulatory authority.’ Ergo, it will be struck down. They can, of course, try just as we stakeholders can use our toolbox to advocate for statutory changes that are long overdue. It appears 2026 will be an interesting year.
Ending GRAS could pose a major obstacle to product development. (CANVA)
Natural Products Association
HHS’s GRAS proposal raises more questions than answers. It is unclear how requiring the submission of GRAS notices for the use of human and animal food substances would impact dietary supplement ingredients. FDA’s premarket review of dietary ingredients is limited to new dietary ingredient notifications—per section 413(a)(2) of the Federal Food, Drug & Cosmetic Act (FD&C Act) and the relevant regulation, 21 CFR 190.6.
The FD&C Act provides an exemption to the premarket notification requirement for NDIs present in the food supply as an article used for food. However, it is a fallacy that self-affirmed GRAS ingredients used in conventional food and beverages—and later marketed in dietary supplements—have not been subject to rigorous safety evaluations. As FDA asserted in its final GRAS rule published in 2016, ‘Fundamental to all conclusions of GRAS status is the criterion that general recognition of safety requires common knowledge throughout the scientific community knowledgeable about the safety of substances directly or indirectly added to food that there is reasonable certainty that the substance is not harmful under the conditions of its intended use.’
NPA has additional questions about the impact of a GRAS rulemaking on FDA’s resources, companies’ intellectual property, the NDI notification process, and dietary ingredients that have already entered U.S. commerce through legitimate, self-affirmed GRAS determinations. NPA cannot comment further on HHS’s proposal until the actual NPRM is published and there is sufficient time to review the details of it.
Meanwhile, NPA is committed to working with the Trump administration to get a better understanding of the impact of the GRAS proposal on dietary ingredients, and the association supports the administration’s focus on ensuring the safety of the nation’s food supply.
Graham Rigby, President and CEO, American Herbal Products Association
AHPA has long recognized that the self-affirmed GRAS process is an important, legal, and rigorous pathway relied upon by companies that operate in both the conventional food and dietary supplement sectors. 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.
FDA’s announcement of its intention to issue a proposed rule that, if finalized, would require mandatory GRAS notifications marks a fundamental shift in how this pathway has traditionally been utilized. While AHPA supports transparency and appropriate safeguards for public health, it is essential that any changes to the GRAS framework be developed in consultation with industry to avoid unintended disruption to the conventional food and dietary supplement marketplace.
AHPA is committed to engaging with FDA and HHS throughout this rulemaking process to ensure that ingredients that have used this legal pathway remain recognized as GRAS, a process for timely review is fully resourced, and the continued access to safe, health-promoting dietary supplements is not compromised.
Charles Mooney, Founder, NutraSeal
I understand the virtuous intent of requiring toxicity studies for new natural ingredients. However, many OTC drugs and food additives had to endure such reviews—which seems like a more logical place to start the revaluation audit of the ingredients Americans consume. The NDI or new dietary ingredient application process seemed to make sense when it started. Many applications were submitted to the FDA over the years, and the process either took too long or was not maintained by the regulators at all.
This has forced many novel ingredient marketers to go the route of self-affirmed GRAS. If this provision is removed, it will limit creativity for markers and options for consumers. If the FDA once again doesn’t keep up with the applications submitted for review, or if they make it too expensive, innovation will be untenable for smaller players.
In the end, the consumer gets hurt: They could lose out on new healthy choices because small innovators of ingredients can’t afford the time or dollars to endure the new process. Worst yet, higher go-to-market costs would have to be passed on to consumers. In both cases, the process will be more expensive and take longer, which could cause ingredient markers to never come to market at all. If that happens, nobody wins.
Here’s a wild idea—which could be said about a lot of government laws and regulations: Why don’t we try to operate the existing NDI system the way it was intended to before we tear it down for something altogether new?
