GRAS Reform: FDA's Generally Recognized as Safe Review & Proposed Changes

What Is GRAS?

"Generally Recognized as Safe" (GRAS) is a designation under the Federal Food, Drug, and Cosmetic Act (FD&C Act) that exempts certain food substances from the standard food additive approval process. Under Section 201(s) of the FD&C Act, a substance added to food is exempt from premarket approval if it is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use.

When Congress created the GRAS exemption in 1958, it was intended for basic, familiar ingredients — salt, vinegar, baking powder, vegetable oil. These were substances with long histories of safe use that no reasonable scientist would question. The FDA was supposed to review and formally approve most other chemicals before they entered the food supply.

That is not what happened. Over the following decades, the GRAS exemption evolved from a narrow carve-out into one of the most consequential regulatory gaps in U.S. food safety. Today, companies can determine — on their own, without notifying the FDA — that a substance qualifies as GRAS and begin using it in food products immediately. This practice, known as "self-affirmed GRAS" or "self-determined GRAS," has allowed hundreds of chemicals to enter the American food supply without any government review whatsoever.

Current Regulatory Status

The GRAS regulatory framework involves three distinct pathways, each with different levels of FDA oversight:

1. GRAS substances listed by FDA regulation (21 CFR 182, 184, 186): These substances have been formally evaluated by the FDA and are listed in the Code of Federal Regulations as GRAS for specific uses. Examples include salt (sodium chloride), caffeine, and acetic acid. No notification is required for these substances when used in accordance with the listed conditions.

2. FDA GRAS Notification Program (21 CFR 170 Subpart E): Established in 1997 and finalized in 2016, this voluntary program allows companies to submit a GRAS notice to the FDA. The notice must include a seven-part submission covering the substance's identity, intended use, safety data, and the basis for the GRAS determination. Within 30 days of receipt, the FDA acknowledges the notice, then evaluates whether the submission provides a sufficient basis for the GRAS determination.

The FDA responds with one of three types of letters:

• "No questions" letter: The FDA does not question the basis for the notifier's GRAS determination. This is the most common favorable outcome.
• Insufficient basis letter: The notice does not provide a sufficient basis for a GRAS determination, either because the data is incomplete or because available information raises safety questions.
• Ceased evaluation letter: At the notifier's request, the FDA stopped reviewing the notice — often because the company decided to withdraw rather than receive a negative determination.

As of late 2025, approximately 1,240 GRAS notices have been submitted since the program's inception in 1998. In 2024, 13 substances received "no questions" letters, while 55 submissions remained pending as of early 2025.

3. Self-affirmed GRAS (the loophole): Under the current system, companies can convene their own expert panels, reach a GRAS determination internally, and begin using a substance in food — all without ever notifying the FDA. The agency has no record of these determinations, no ability to review the underlying safety data, and no mechanism to challenge or revoke the determination unless it discovers a safety problem independently.

A 2022 analysis by the Environmental Working Group found that nearly 99% of new chemicals used in food or food packaging since 2000 were approved not by the FDA, but by the food and chemical industry itself. A separate review identified 56 companies relying on undisclosed GRAS safety determinations for 275 chemicals. These are sometimes called "secret GRAS" substances because neither the FDA nor the public knows they exist.

Criticism of the self-determination pathway: The conflicts of interest embedded in the current system are well documented. The company that stands to profit from a substance's approval selects and compensates the experts who evaluate its safety. The FDA does not limit who can serve as an "expert," does not exclude experts with financial ties to the manufacturer, and does not require that supporting data be published or peer-reviewed.

In December 2022, the FDA issued final guidance on best practices for convening a GRAS panel, recommending that panel members be unrelated third parties with no financial interest in the outcome. The guidance advises excluding employees of the manufacturer, attorneys or agents of the proponent, and scientists whose own work is used as evidence of safety. However, this guidance is non-binding. Companies are not required to follow it, and evidence suggests many do not.

Key Deadlines

Date	Milestone	Status
1958	GRAS exemption created in the Food Additives Amendment	Historical
1997	FDA proposes GRAS Notification Program (voluntary)	Historical
August 2016	FDA finalizes GRAS Notification Rule (21 CFR 170 Subpart E)	Complete
September 2021	Court grants FDA summary judgment in CSPI/CFS lawsuit challenging GRAS rule	Complete
December 2022	FDA issues final guidance on best practices for convening a GRAS panel	Complete
March 2025	HHS Secretary Kennedy directs FDA to explore rulemaking to eliminate self-affirmed GRAS	Complete
November 6, 2025	Senator Marshall introduces Better Food Disclosure Act (S. 3122)	Introduced
December 1, 2025	FDA submits proposed mandatory GRAS notification rule to OMB/OIRA for review	Under OMB review
February 10, 2026	FDA launches comprehensive BHA reassessment; issues RFI	Active
April 13, 2026	BHA RFI comment period closes	Upcoming
Spring/Summer 2026 (est.)	FDA publishes proposed rule requiring mandatory GRAS notifications	Pending OMB clearance
TBD	FDA expected to issue RFIs for BHT and azodicarbonamide	Announced, no date
TBD	Congressional action on Better Food Disclosure Act (S. 3122)	Pending committee review

Detailed Analysis

The Road to Mandatory Notification

The push to close the GRAS self-determination loophole has accelerated dramatically since 2025. Three parallel forces are converging:

FDA Rulemaking. On December 1, 2025, the FDA submitted a proposed rule to the Office of Management and Budget (OMB) that would require mandatory submission of GRAS notices for all substances claimed to be GRAS. The rule would amend 21 CFR Parts 170 and 570 to cover both human and animal food substances, including indirect additives such as substances migrating from food packaging.

Under the proposed rule, substances already listed as GRAS by FDA regulation or that have received a "no questions" letter would be exempt from the new notification requirement. All other self-affirmed GRAS substances would need to be formally notified to the FDA. The proposed rule has been under OMB review since December 2025. As of March 2026, the FDA's food chemical safety chief has indicated the proposal is expected this spring, though the exact publication date depends on OMB clearance.

This would be the most significant change to the GRAS system since the voluntary notification program was established in 1997. For the first time, the FDA would have visibility into every substance entering the food supply under a GRAS claim.

Congressional legislation. On November 6, 2025, Senator Roger Marshall (R-KS) introduced the Better Food Disclosure Act of 2025 (S. 3122), co-sponsored by Senators Rick Scott (R-FL) and Katie Britt (R-AL). The bill goes further than the FDA's proposed rule in several ways:

• It would require notification for all GRAS substances, including those already on the market — not just new ones. Manufacturers of existing GRAS substances would have two years after enactment to file notifications.
• It would require the FDA to maintain a public listing database of all GRAS substances.
• It would establish a post-market review process to assess the continued safety of food additives, color additives, and GRAS substances.
• Any substance not listed by the FDA or under active review would be legally "adulterated" under Section 402(a)(2)(C) of the FD&C Act.
• New GRAS substances would need to be notified at least 120 days before first use.

Upon receiving a notice, the FDA would have 180 days to determine whether to add the substance to the GRAS list or issue a preliminary determination to exclude it. If the FDA fails to respond within that timeframe, the substance would be automatically added. Notably, the bill does not include a preemption provision that would override state-level food additive bans — a provision that was reportedly removed after pushback from the Make America Healthy Again (MAHA) movement.

MAHA executive direction. HHS Secretary Robert F. Kennedy Jr. has made GRAS reform a centerpiece of the MAHA agenda. In March 2025, Kennedy directed the FDA to explore rulemaking to eliminate the self-affirmed GRAS pathway entirely. He has described GRAS as a statutory "loophole" originating in 1958 that has enabled widespread use of industrial ingredients without premarket FDA review.

The MAHA initiative has provided political cover for FDA action on food chemicals that historically faced industry resistance. Kennedy's public statements framing GRAS reform as a consumer protection issue — rather than a regulatory burden — have created an unusual bipartisan alignment on food safety.

Controversial GRAS Substances Under Scrutiny

The GRAS reform effort is unfolding alongside targeted FDA reviews of specific substances. These reviews serve as test cases for how a reformed GRAS system might function:

Butylated hydroxyanisole (BHA). On February 10, 2026, the FDA announced a comprehensive reassessment of BHA, a synthetic antioxidant preservative used across hundreds of food products, packaging materials, and cosmetics. The FDA simultaneously issued a Request for Information (RFI) seeking data on BHA's use in human food and food-contact applications across 12 specific areas, including product categories, use levels, dietary exposure data, and safety studies.

BHA is listed as GRAS under 21 CFR 182.3169 and is authorized as a food additive under 21 CFR 172.110. However, the National Toxicology Program classifies BHA as "reasonably anticipated to be a human carcinogen" based on animal studies. HHS Secretary Kennedy stated: "If BHA cannot meet today's gold-standard science for its current uses, we will remove it from the food supply." The RFI comment period closes April 13, 2026, after which the FDA will evaluate whether BHA's GRAS status and food additive authorizations remain scientifically justified.

Carrageenan. This seaweed-derived thickener and stabilizer is widely used in dairy products, plant-based milks, and processed foods. The FDA considers food-grade carrageenan GRAS, and the agency reaffirmed its safety as recently as 2018. However, carrageenan has been the subject of sustained scientific debate. Cell-based and animal studies have documented inflammatory effects, and consumer advocacy groups have petitioned for its removal from organic food standards. The critical distinction — between food-grade carrageenan and its degraded form, poligeenan (a known carcinogen not used in food) — is often conflated in public discourse, complicating the regulatory picture.

Potassium bromate. Used as a flour treatment agent to strengthen dough and improve rise, potassium bromate is classified by the International Agency for Research on Cancer (IARC) as a Group 2B possible human carcinogen. It has been banned in the European Union, United Kingdom, Canada, Brazil, and China. In the United States, it is regulated as a prior-sanctioned substance — not a food additive — which places it outside the standard GRAS framework. California has banned potassium bromate in food products effective January 1, 2027. Louisiana has prohibited its use in school food starting in the 2028-2029 school year. The FDA has not initiated federal action.

Azodicarbonamide (ADA). Primarily used as a dough conditioner in commercial bread production, ADA is also used as a foaming agent in the manufacture of plastic and rubber products. The FDA permits its use in bread at up to 45 parts per million. When ADA breaks down during baking, it produces semicarbazide, which has raised safety concerns. ADA is banned in the European Union and Australia. While many large U.S. food companies voluntarily stopped using ADA after public pressure campaigns, it remains federally permitted. The FDA has indicated it will seek information on ADA and BHT following the BHA reassessment.

The Litigation Backdrop

Legal challenges have shaped the current GRAS landscape. In 2017, a coalition of public interest groups — including the Center for Science in the Public Interest (CSPI), Center for Food Safety, Environmental Defense Fund, Breast Cancer Prevention Partners, and the Environmental Working Group — filed suit challenging the FDA's 2016 GRAS Final Rule. The lawsuit alleged that the rule unlawfully delegated the FDA's safety oversight responsibility to food manufacturers with obvious financial conflicts of interest, violating the Administrative Procedure Act.

In 2018, the court dismissed CSPI, Breast Cancer Prevention Partners, and the Environmental Working Group on standing grounds. In September 2021, the District Court granted the FDA's motion for summary judgment on the remaining claims. The court acknowledged concerns about the GRAS process but determined that the FDA's rule was not "arbitrary and capricious" because the agency had provided a reasoned justification, including the need to allocate limited resources to higher public health priorities.

The court's ruling effectively validated the voluntary notification system — but the political landscape has shifted so dramatically since 2021 that the voluntary system may not survive regardless. The FDA's own proposed rule would accomplish through regulation what the plaintiffs sought through litigation.

State-Level Action

The federal GRAS reform effort exists against a backdrop of aggressive state-level action on food chemicals. California's Food Safety Act (AB 418, 2023) banned Red No. 3, potassium bromate, brominated vegetable oil, and propylparaben from food products. California subsequently added titanium dioxide to its banned list. Multiple states have followed with their own food chemical restrictions, creating a patchwork of requirements that the Better Food Disclosure Act notably does not preempt.

As of early 2026, at least 10 states have enacted or introduced legislation restricting specific food additives, with Louisiana, Illinois, and New York among those imposing school-food prohibitions on substances that remain federally permitted. This state-level momentum has increased industry pressure for a unified federal approach — which GRAS reform could partially provide.

Affected Product Categories

GRAS reform touches virtually every segment of the food industry. The substances at issue are used across the broadest possible range of food products:

• Processed and packaged foods — BHA, BHT, and other GRAS preservatives appear in cereals, snack foods, baked goods, frozen meals, and shelf-stable products.
• Dairy products — Carrageenan is widely used as a stabilizer in ice cream, yogurt, chocolate milk, and cream cheese.
• Plant-based and alternative proteins — Plant-based milks, meat alternatives, and protein products rely heavily on GRAS-designated emulsifiers, stabilizers, and flavoring agents.
• Infant formula — Some GRAS substances appear in infant formula, where the safety threshold is especially strict. Mandatory notification would provide additional scrutiny for these uses.
• Baked goods — Potassium bromate and azodicarbonamide are used in commercial bread production. ADA is also used in flour tortillas and other baked products.
• Animal feed — The proposed GRAS rule covers animal food substances under 21 CFR Part 570, affecting livestock feed, pet food, and aquaculture feed manufacturers.
• Food contact materials — Indirect food additives migrating from packaging, processing equipment, and storage containers are included in the proposed mandatory notification requirement.
• Dietary supplements — Many supplement ingredients rely on GRAS determinations for their food-use authorizations. Mandatory notification would require supplement manufacturers to document these determinations.

What Companies Should Do

The convergence of FDA rulemaking, congressional legislation, and MAHA-driven enforcement creates a clear action agenda for food industry companies:

1. Audit your GRAS inventory. Identify every ingredient in your product portfolio that relies on a GRAS determination — whether self-affirmed, FDA-notified, or listed by regulation. For self-affirmed GRAS substances, locate the underlying safety data, expert panel reports, and GRAS determination documentation. If that documentation is incomplete or unavailable, begin assembling it now.

2. Prepare for mandatory notification. The FDA's proposed rule is expected to publish in spring or summer 2026. Once finalized, companies will need to submit GRAS notices for all self-affirmed GRAS substances. Begin preparing these notices now, particularly for substances with complex safety profiles or limited published data. Each notice requires a seven-part submission covering identity, intended use conditions, safety data, and the basis for the GRAS determination.

3. Monitor the BHA reassessment as a model. The FDA's BHA review — including its 12-area RFI — previews how the agency will evaluate challenged GRAS substances under a reformed system. Companies using BHA should submit comments by April 13, 2026. Companies using other substances under potential review (BHT, azodicarbonamide) should begin proactively assembling safety data.

4. Evaluate expert panel compliance. If your GRAS determinations relied on expert panels, assess whether those panels would meet the FDA's 2022 guidance on best practices. Panels that included employees of the manufacturer, experts with financial conflicts, or scientists whose own research was the primary safety evidence may face heightened scrutiny under a mandatory notification regime.

5. Track state-level restrictions. With no federal preemption provision in the Better Food Disclosure Act, state-level bans and restrictions will continue to proliferate. Companies need a systematic approach to tracking which substances are restricted in which states, particularly for products distributed nationally.

6. Plan for the retroactivity scenario. If the Better Food Disclosure Act passes, manufacturers would have two years to file notifications for existing GRAS substances. Begin cataloging substances that would require notification under this scenario, and assess whether your current safety documentation meets the standard for FDA review.

7. Watch the timeline. The OMB review of the proposed GRAS rule has been underway since December 1, 2025. OMB reviews typically take 90 days but can extend longer. Publication could come as early as spring 2026. Once published, a 60- to 90-day comment period is standard, followed by a final rule — likely in late 2026 or 2027. Plan for compliance within 12 to 18 months of the proposed rule's publication.