GRAS Reform Update: Where Do Things Stand?
For decades, food manufacturers have relied on a regulatory pathway known as Generally Recognized as Safe—or GRAS—to introduce substances into the food supply without formal FDA approval. Under this framework, a substance may bypass the agency’s premarket review process if qualified experts generally recognize it as safe for its intended use. That practice is now under increasing scrutiny, and the GRAS framework has become the focus of a rapidly developing reform effort at the federal and state levels.
Background
The Federal Food, Drug, and Cosmetic Act (FFDCA) requires premarket review and approval of any substance intentionally added to food as a food additive, unless the substance is GRAS or otherwise excepted from the definition of a food additive. Historically, FDA affirmed substances as GRAS on its own initiative or by petition. Today, that responsibility largely rests with industry.
Companies may voluntarily submit a GRAS notification to FDA, which may respond that there is insufficient basis for a GRAS conclusion or issue a “no questions” letter leaving the determination unchallenged. But this is not required: FDA regulations also allow a company to “self-affirm” a substance as GRAS without notifying the agency, allowing it to enter the food supply without FDA premarket review.
Closing this self-affirmation “loophole” has become a priority for federal officials, lawmakers, and advocacy groups. FDA, Congress, and state legislators are all pursuing reform, as described below.
FDA Actions
FDA is developing a proposed rule to eliminate self-affirmed GRAS by mandating GRAS notification for substances purported to be GRAS. The proposal is expected to exempt substances listed or affirmed as GRAS for the intended use by regulation, or for which FDA has issued a no questions letter. It would also require FDA to maintain a public-facing GRAS inventory and clarify the process under which FDA would determine that a substance is not GRAS.
The Office of Management and Budget has been reviewing the proposed rule since December 1, 2025. FDA leadership reportedly projects publication late this spring or early summer of this year.
In parallel, FDA is working to implement a post-market review program for substances already in the food supply, including those designated as GRAS. Historically conducted on an ad hoc basis, these reviews are expected to follow a structured prioritization framework. FDA released a draft framework for public comment last summer.
As part of that effort, this March, FDA launched a post-market review of butylated hydroxyanisole (BHA) by publishing a request for information in the Federal Register. BHA is a chemical preservative listed as GRAS and authorized as a direct food additive when used as an antioxidant.
Legal uncertainty remains. In 2021, the Southern District of New York denied a challenge to FDA’s self-affirmed GRAS scheme brought by a coalition of NGOs, noting that it is “unclear whether FDA even has the authority to make GRAS notifications mandatory” under FFDCA. “The remedy Plaintiffs seek lies with Congress,” the court said.
Federal Legislation
Perhaps anticipating that litigation may jeopardize FDA’s rulemaking, Congress has introduced at least three bills to eliminate self-affirmed GRAS.
2341 – Ensuring Safe and Toxic-Free Foods Act of 2025 (Sen. Markey, D-MA) would mandate GRAS notifications supported by scientific evidence, including for substances currently self-affirmed on the market, within two years of enactment. Although not highlighted in the bill’s accompanying materials, the legislation also appears to sunset the GRAS pathway altogether after that two-year period. It would require FDA to post notices for public comment, eliminate the GRAS pathway for new substances, exclude from GRAS eligibility substances that are carcinogenic or show evidence of reproductive or developmental toxicity, require FDA to review at least 50 GRAS notices per year until the backlog is cleared, and require FDA to reassess at least 10 food substances or substance classes every three years.
H.R. 4958 – GRAS Act (Rep. Pallone, D-NJ-6) would mandate GRAS notifications for new substances and new uses going forward, with notifications required to demonstrate that the weight of evidence shows the substance is neither carcinogenic nor associated with reproductive or developmental toxicity. The bill would require a written “no objection” response from FDA before a substance may be used as GRAS, mandate a public comment period, require triennial reassessment of at least 10 food substances or substance classes, and authorize FDA to collect user fees.
3122 – Better FDA Act of 2025 (Sen. Marshall, R-KS) would require notifications within two years of enactment for currently self-affirmed substances and at least 120 days before first use for new substances. It would require FDA to maintain a public GRAS list and automatically approve a use as GRAS if FDA fails to respond within 180 days. The bill would also allow FDA to reevaluate a food additive upon petition, state request, or on its own initiative, and would require that reevaluations be conducted by career scientists rather than political appointees.
Two additional bills impose post-market review requirements without revising the broader GRAS framework. H.R.4306 (Rep. Schakowsky, D-IL-9), would require FDA to reassess the safety of at least 10 food substances or substance classes every three years and suggests the first 10 substances for reassessment. H.R.7291 (Rep. Lawler, R-NY-17), would assemble an interagency review board to reassess pre-2000 manufacturer GRAS determinations, including self-affirmations, and recommend revocation where safety has not been demonstrated.
All of these bills are currently pending in committee. None have attracted a cosponsor from the opposing party.
State Legislation
Notably, none of the federal proposals includes preemption provisions, even as states move aggressively in this space. Numerous states have enacted or are considering restrictions on specific additives, including West Virginia, whose ban on synthetic food dyes is currently being litigated.
Other states are targeting self-affirmed GRAS more directly. Bills introduced in Pennsylvania, New Jersey, New York, and California would each require manufacturers of self-affirmed GRAS to report information supporting the determination to the state, which would be made publicly available online. Failure to report would render the additive unlawful for use in that state.
Pennsylvania and California would require the same information and data required as part of a federal GRAS notice. Although New Jersey’s reporting requirement would apply only prospectively to new uses of an additive, the other three bills appear to also cover existing self-affirmed substances.
Additional provisions vary by state. New York would ban three specific substances and prohibit the sale of foods containing certain synthetic color additives in public schools. California would approve existing additives upon report submission, but would subject substances and uses introduced after July 1, 2027, to evaluation by state regulators with an opportunity for public objection. California would also declare additives and dietary ingredients unsafe if they are found to induce cancer when ingested and require systematic post-market reviews.
Of these bills, only New York’s has passed a legislative chamber this session—the state senate, on March 23, 2026. That bill, as well as Pennsylvania’s, has sponsors from both parties.
Verdant Law closely monitors these developments and their implications for the evolving regulation of food additives and the GRAS framework. Please contact us with any questions.
