The “Make America Healthy Again” (MAHA) movement has rapidly turned food additive regulation from a niche issue into a mainstream political and business priority. Longstanding debates over ingredient safety, chemical transparency, and FDA oversight are receiving renewed attention from policymakers, states, consumer advocates, and industry. One of the clearest targets is the so-called self-affirmed GRAS loophole—the pathway that allows companies to conclude a food additive is generally recognized as safe without formal Food and Drug Administration (FDA) premarket review. The growing challenge to self-affirmed GRAS signals a broader shift toward stricter scrutiny of food additives, greater public disclosure, and a more aggressive regulatory environment for companies in the food space.
Key Takeaways
- FDA Reform Is Coming: FDA has advanced rulemaking that could significantly change the self-affirmed GRAS framework.
- Pressure Is Growing: Congress and states are pursuing new ingredient transparency, warning labels, and review requirements.
- Preparation Matters: Companies relying on legacy GRAS positions should assess documentation, data supporting GRAS positions, and supply-chain exposure now.
U.S. Food Additive Regulation: The Basic Framework
The 1958 Food Additives Amendment
Food additives are regulated by the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. §§ 301–399i, as amended by the Food Additives Amendment of 1958, Pub. L. No. 85-929, 72 Stat. 1784. The amendment established a premarket approval system for food additives. After its enactment, any company seeking to use a new substance in food generally had to petition FDA for authorization.
Petitioners seeking approval must demonstrate that the substance is safe for the proposed use (e.g., that a new preservative is safe for use as an ingredient in flour). For its part, the FDA engages in a formal rulemaking process and may not approve a petition unless the data demonstrates that the intended use of the additive will be safe under the specified use conditions.
In evaluating safety, the FDA considers the likely intake of the additive, the cumulative effects of the substance in the diet, and appropriate safety factors. The governing standard, set forth in regulation, is whether there is “reasonable certainty in the minds of competent scientists that the substance is not harmful under the conditions of its intended use.” 21 C.F.R. § 170.3(i). The statute also includes the Delaney Clause, which functions as a categorical, hazard-based override of that risk-based standard: no additive may be deemed safe if it is found to induce cancer in humans or animals. 21 U.S.C. § 348(c)(3)(A).
If FDA approves a food additive petition, it may impose use limitations, specifications, or tolerances. Any limitations are specified in the final rule. This framework applies not only to direct food additives, but also to certain indirect additives such as components of food packaging. The FDA is generally not required to re-review previously approved additives.
Before turning to GRAS and the limits of the FDA’s premarket review system, the threshold question is this: what counts as a “food additive” in the first place? That matters because if a substance falls within the statutory definition of a food additive—and no exception applies—it cannot be lawfully used in food without an applicable authorization or meeting an exemption.
A food additive is any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food. The statutory definition reaches substances used in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food.
A substance may be a direct additive (such as a sweetener) or an indirect additive that reaches food through contact materials, such as packaging, coatings, adhesives, or equipment.
The concept is intentionally broad. A substance may affect the characteristics of food by changing texture, shelf life, color, flavor, stability, moisture retention, or processing behavior, among other things. The statute also contains several important exclusions, including pesticide chemical residues, pesticides used on crops, color additives, substances approved for use in food before September 6, 1958, and new animal drugs.
The GRAS Exception: When Substances Bypass the Food Additive Process
Among the exceptions to the food additive approval process, the most significant is the GRAS exception. The 1958 Food Additives Amendment expressly excludes substances that are generally recognized as safe under the intended use (i.e., GRAS) from the definition of “food additive.”
In other words, a substance is not a food additive if it is:
“[G]enerally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use[.]”
21 U.S.C. § 321(s).
In 2016, FDA issued a final rule on GRAS substances, formally modernizing the agency’s approach to GRAS determinations by creating a voluntary notification system.[1] Under the rule, companies may submit a GRAS notice to FDA, but are not required to do so. Unlike the food additive petition process, FDA does not formally approve the substance through rulemaking. Instead, FDA typically responds with a “no questions” letter, indicating it has no current questions regarding the notifier’s GRAS conclusion based on the submitted information. Because the 2016 rule preserved the ability of manufacturers to make GRAS determinations without mandatory FDA notification, it is central to the current debate.
When a manufacturer conducts its own safety determination of a new substance to be used in a food product (or for a new use of an existing substance) without a formal FDA review, that is often referred to as a self-affirmed GRAS determination. The GRAS legal standard is the same that the FDA would apply in making a GRAS determination—the only difference is who makes the determination and whether the FDA is notified. Thus, a self-affirmed GRAS conclusion is not a lower safety standard, but a different procedural pathway.
In practice, companies typically support a self-affirmed GRAS pathway with a technical dossier that addresses the ingredient’s identity, manufacturing process, intended use levels, dietary exposure, and relevant safety data, often supplemented by a review from an independent panel of qualified experts. The key concept is “general recognition”: the evidence must be sufficient not only to support safety, but to support expert consensus based on information generally available to the scientific community.
That said, self-affirmed GRAS conclusions are not immune from enforcement. If the FDA later determines the available evidence does not support GRAS status for the intended use, the ingredient may be treated as an unsafe food additive, and products containing it may be considered adulterated under the FDCA.
Why Critics Call Self-Affirmed GRAS a “Loophole”
Critics call the self-affirmed GRAS pathway a “loophole” because substances that qualify as GRAS are excluded from the statutory definition of “food additive,” meaning they do not need to go through FDA’s formal food additive petition process. In practice, this can allow new additives to enter the food supply without prior FDA review when a manufacturer independently concludes the intended use is generally recognized as safe.
A few things have changed since 1958. Yet the statutory framework does not require FDA to proactively revisit earlier assumptions in light of new scientific thinking, emerging data, or new and changed chemical uses. As a practical matter, many substances used in food may never undergo formal premarket review by FDA. Some critics therefore argue that the self-affirmed GRAS exception has, in effect, swallowed the rule.
A central concern is transparency. Because companies are not required to notify FDA of private GRAS determinations, neither FDA nor consumers have full visibility into the number or type of substances entering the market through this pathway. In practical terms, that lack of visibility can make oversight more difficult. FDA may face challenges in prioritizing reviews, assessing cumulative exposure, responding to new science, or maintaining public confidence in the safety of ingredients. For industry, the same transparency gap can fuel calls for reform, increased litigation risk, and regulatory scrutiny following changes in FDA leadership.
Supporters of the current framework offer a different view. They argue that the self-affirmed GRAS pathway allows efficient innovation for lower-risk ingredients, conserves limited FDA resources, and still requires a rigorous scientific safety standard grounded in expert consensus. In that view, the debate is less about whether safety review exists and more about who performs it and whether additional transparency is warranted.
Risks to Industry in Relying on Self-Affirmed GRAS
A self-affirmed GRAS conclusion can also create significant business risk, particularly for controversial or novel ingredients. Although companies may market substances without premarket approval if they independently conclude the ingredient is GRAS for its intended use, FDA retains enforcement authority when it determines that conclusion is unsupported or the product otherwise violates the FDCA.
One prominent example is CBD in conventional foods. FDA has repeatedly stated that CBD cannot lawfully be added to conventional foods, has issued warning letters asserting that CBD-containing foods are adulterated, and has said it is not aware of any basis to conclude that CBD is GRAS for use in conventional foods.
Public statements like these create significant risks for companies manufacturing CBD or selling food products containing CBD, including, among other things, exposure to consumer false advertising lawsuits, lost business opportunities or funding, decreased valuation or stalled growth, and regulatory enforcement.
These concerns extend beyond CBD to other novel or controversial ingredients. The CBD example illustrates a central risk: even where a company believes it has a defensible GRAS position, FDA may later disagree, creating substantial regulatory, litigation, and commercial exposure after the product is already in the market.
The Current Administration’s MAHA-Driven Approach to Self-Affirmed GRAS
Against a backdrop of risk and continued debate—and with the MAHA movement placing this issue squarely in the policy spotlight—FDA has signaled that reform of the self-affirmed GRAS pathway is a regulatory priority.
FDA has now moved beyond general discussion of GRAS reform and has taken initial steps toward rulemaking to address the current framework.[2] Public agenda materials indicate the agency is considering amendments that would require the mandatory submission of GRAS notices for substances marketed for human and animal food uses, a significant change from the existing system, under which companies may reach private GRAS conclusions without notifying FDA.
The full text of the proposed rule has not yet been published in the Federal Register, but the direction is clear: FDA is actively evaluating whether to narrow or replace the voluntary model. Any final rule is likely to face scrutiny because the GRAS exemption is grounded in the statute itself. FDA may therefore have more authority to reform the system’s mechanics—increasing transparency, strengthening recordkeeping, clarifying evidentiary expectations, or expanding post-market oversight—than to eliminate self-affirmed GRAS entirely without congressional action.
In a recent appearance on The Ultimate Human Podcast, FDA Deputy Commissioner for Food Kyle Diamantas[3] described the GRAS exception as originally intended for familiar substances like salt, vinegar, pepper, and flour, but one that “became the tail that wags the dog” over time.[4] He noted that in 1958, “we did not have the complex supply of ingredients that we now have,” and said the pathway “became a pathway that some would say has been exploited” for “close to seven decades.” He emphasized that reform requires a formal rulemaking process with notice and comment so that changes are durable.
Diamantas further explained that FDA is engaged in an interagency process to revise GRAS regulation, describing it as “an absolute priority for this administration.” He also highlighted FDA’s new post-market review program, through which the agency is developing a framework to reassess certain chemicals in the food supply, many introduced decades ago. The practical takeaway: even if a self-affirmed GRAS pathway survives in some form, companies should expect greater documentation demands, increased FDA visibility into GRAS determinations, and more active post-market scrutiny of legacy ingredients.[5]
FDA is not the only actor focused on reform. Congress has also entered the debate.
Congress Takes Aim at the Self-Affirmed GRAS “Loophole”
The most recent activity in Congress shows that self-affirmed GRAS reform has become a bipartisan legislative issue, with multiple bills seeking to increase transparency and FDA oversight. On January 30, 2026, Representative Mike Lawler introduced the GRAS Oversight and Transparency Act,[6] which would create an interagency review board to evaluate certain GRAS determinations. The proposal focuses especially on older self-affirmed GRAS substances and demonstrates mounting concern that many ingredients entered the market decades ago with little public visibility.
Separately, broader reform bills introduced in 2025 would go further. Senator Roger Marshall’s Better Food Disclosure Act of 2025[7] would require the FDA to maintain a public list of all GRAS substances and end the fully private pathway for new ingredients. Meanwhile, Senators Ed Markey and Cory Booker’s Ensuring Safe and Toxic-Free Foods Act of 2025[8] would require companies to submit GRAS determinations to the FDA, require the FDA to publicly post GRAS notices for 60 days, allow FDA to object to GRAS notices, allow the FDA to reassess GRAS statuses, require public notice of all determinations, restrict GRAS eligibility for certain chemicals, and provide for oversight of selection of GRAS panel experts to eliminate bias.[9]
The practical takeaway is that Congress is no longer treating private GRAS determinations as a niche regulatory issue. While the proposals differ in scope, the common themes are greater disclosure, stronger FDA review, reassessment of legacy determinations, and less reliance on private safety conclusions alone.
States Step In: The Growing Patchwork of Ingredient Regulation
Even without federal reform, states are increasingly shaping ingredient policy through their own bans, warning-label requirements, and disclosure proposals. Examples include the California Food Safety Act, Texas’s recent warning-label law for foods containing certain listed ingredients, and West Virginia’s law restricting specified food dyes and preservatives in foods sold in the state.
Most recently, on April 21, 2026, the New York Assembly passed the Food Safety and Chemical Disclosure Act (AB 1556/SB 1239) in a 106-32 vote, mostly along party lines, after the bill passed the Senate unanimously on March 23, 2026. If signed by Governor Hochul, the law would take effect one year after enactment. The bill bans the manufacture, distribution, and sale of food containing Red Dye 3, potassium bromate, or propylparaben. It also creates a mandatory reporting framework for self-affirmed GRAS substances, requiring manufacturers to submit detailed reports—including safety data, dietary exposure estimates, and the basis for any GRAS determination—to the Commissioner of Agriculture and Markets. Those reports would be made publicly available in a searchable online database. The GRAS reporting requirements exempt substances that have already received FDA “no questions” letters, substances covered by FDA prior-sanction or GRAS regulations, and small businesses with 100 or fewer employees; however, the ingredient bans apply regardless of business size.
Other states have also introduced proposals that would require disclosure of ingredients relying on self-affirmed GRAS determinations. For industry, the practical result is that companies must now consider not only FDA risk, but also a growing patchwork of state compliance, enforcement, and litigation exposure.
That growing patchwork is one reason segments of the food industry are increasingly calling for stronger federal preemption or a uniform national standard, arguing that state-by-state requirements can create costly compliance burdens, reformulation pressures, and inconsistent rules for products sold nationwide.
If the Rules Change: Practical Steps for Industry on Self-Affirmed GRAS
If the self-affirmed GRAS pathway is narrowed or replaced, the impact will extend well beyond regulatory theory. For many companies, the immediate challenge will be locating supporting files, validating legacy GRAS conclusions, and maintaining continuity of supply. Advance preparation may be the difference between a manageable compliance project and a costly disruption.
So how can industry prepare for potential changes in the self-affirmed GRAS pathway? Companies should consider conducting an internal inventory of ingredients that rely on GRAS positions, gathering underlying dossiers and historical correspondence, and identifying any gaps in data, documentation, or substantiation.
Businesses should also reassess whether older determinations remain supportable in light of current science, changed uses, and cumulative exposure. Contract reviews with suppliers, contingency planning for reformulation, and close monitoring of federal and state developments can help reduce risk. Even if no immediate rule change occurs, stronger documentation and a clearer understanding of ingredient reliance positions will place companies in a stronger position for future scrutiny.
Companies monitoring potential GRAS reform do not need to wait for a final rule to take prudent action. Practical steps now may reduce disruption later.
- Inventory GRAS-Reliant Ingredients: Identify products and ingredients supported by self-affirmed GRAS positions.
- Locate Supporting Files: Confirm access to dossiers, expert opinions, historical correspondence, and safety data.
- Review Legacy Determinations: Prioritize older conclusions or expanded uses for reassessment.
- Check Supplier Contracts: Evaluate representations, warranties, indemnities, and data-access rights.
- Monitor Regulatory Developments: Track FDA rulemaking, congressional proposals, and state ingredient laws.
- Plan for Contingencies: Assess reformulation, relabeling, or alternative sourcing options for higher-risk ingredients.
Final Takeaway
The self-affirmed GRAS pathway is no longer a quiet technical corner of food law. It is now the focus of regulators, legislators, states, and consumer advocates alike. Whether reform comes through FDA rulemaking, congressional action, or state initiatives, companies that understand their ingredient portfolios, strengthen their documentation, and plan ahead now will be best positioned for what comes next.
This article provides a high-level overview and does not constitute legal advice.
[1] Substances Generally Recognized as Safe, 81 Fed. Reg. 54,960 (Aug. 17, 2016) (codified at 21 C.F.R. pts. 20, 25, 170, 184, 186, 570, 584).
[2] https://www.reginfo.gov/public/do/eAgendaViewRule?RIN=0910-AJ02&pubId=202504
[3] https://www.fda.gov/about-fda/fda-organization/kyle-diamantas
[4] Calley Means & Kyle Diamantas, On MAHA, Food Dye Reform, GRAS Loopholes & US Food Crisis, The Ultimate Human with Gary Brecka (podcast), Episode 260, April 9, 2026
[5] https://www.fda.gov/food/hfp-constituent-updates/fda-update-post-market-assessment-chemicals-food-supply-0
[6] GRAS Oversight and Transparency Act, H.R. 7291, 119th Cong. (2026); see Press Release, Cong. Mike Lawler, Lawler Introduces Food Safety Bill to Strengthen Oversight of GRAS Designations (Jan. 30, 2026).
[7] Better Food Disclosure Act of 2025, S. 3122, 119th Cong. (2025); see Press Release, Sen. Roger Marshall, Senator Marshall Introduces Legislation to Ensure Safer Food for American Families (Nov. 6, 2025).
[8] Ensuring Safe and Toxic-Free Foods Act of 2025, S. 2341, 119th Cong. (2025); see Press Release, Sen. Edward J. Markey, Amid Trump Cuts to the FDA, Senators Markey and Booker Introduce Legislation to Get Dangerous Chemicals Out of Food (July 17, 2025).
[9] Office of Sen. Edward J. Markey, Ensuring Safe and Toxic-Free Foods Act of 2025: One-Pager (2025).
