Tag Archive for: GRAS

FDA Proposes to Make GRAS Notifications Mandatory

/in ,

For decades, companies have been able to “self-affirm” that a substance is generally recognized as safe (GRAS) without notifying FDA, allowing certain substances to enter the food supply without direct agency review.  That framework could soon change.

In a proposed rule published August 11, 2026, FDA would require any person who introduces a substance into interstate commerce under the Federal Food, Drug, and Cosmetic Act’s (FFDCA’s) GRAS provision to notify FDA of the basis for that conclusion, with a handful of exceptions and a streamlined option for substances already in commerce.

Existing Regulatory Framework

Since 1958, the FFDCA has required premarket review and approval for food additives.  Section 201(s) defines “food additive” to include substances that are intended or expected to directly or indirectly become a component of or otherwise affect the characteristics of food.  Importantly, however, it excludes substances that are GRAS from this definition, thereby exempting them from premarket review.

Overy the years, FDA regulated GRAS substances through several mechanisms, including promulgating regulatory lists of GRAS substances and allowing interested parties to petition the agency to affirm a substance’s GRAS status.  In 1997, FDA pivoted to a voluntary “GRAS notification” system, under which a firm can notify FDA of its determination that a substance is GRAS under the conditions of its intended use.  Firms that submit a GRAS notice can immediately begin introducing the substance into interstate commerce without waiting for a response from FDA.

FDA typically responds to GRAS notices in one of three ways:

  1. Issuing a “no questions” letter, indicating that FDA does not question the basis for the GRAS conclusion;
  2. Indicating that the notice does not provide a sufficient basis for a GRAS conclusion; or
  3. Stating that FDA has ceased its evaluation of the notice at the submitter’s request.

But GRAS notices are optional.  Under the current framework, a firm can simply determine that a substance is GRAS introduce it into commerce without direct FDA oversight.  According to the proposed rule, in 2011, it was estimated that of the more than 10,000 additives used in food, 1,000 were substances for which firms had claimed independent conclusions of GRAS status.

Last year, Health and Human Services Secretary Robert F. Kennedy, Jr., directed FDA to explore revising its regulations to eliminate the self-affirmed GRAS pathway.  In the meantime, several lawmakers have introduced federal legislation to eliminate self-affirmed GRAS, and state legislators have proposed bills that would require manufacturers of self-affirmed GRAS to report information supporting the determination to their states.

What is FDA Proposing?

The proposed rule would amend 21 CFR parts 170 and 570 to make the current GRAS notification program mandatory.  Under proposed § 170.205(a), any person introducing a substance into interstate commerce under the FFDCA’s GRAS provision must notify FDA of the basis for their GRAS conclusion.

Notably, this requirement would extend to substances already in the food supply.  However, FDA is proposing a time-limited, streamlined reporting option for these substances.  Firms exercising this option would only be required to describe the substance’s conditions of intended use, including the foods in which the substance is used or is in contact with, its levels of use, and its purpose.  Submission of the statutory basis for the GRAS conclusion would be voluntary but recommended.

The proposed rule lists seven exceptions to the mandatory GRAS notification requirement:

  • No questions letter: a no questions letter covers the substance under the conditions of its intended use.
  • Substances listed or affirmed as GRAS under the conditions of its intended use under parts 182, 184, or 186.
  • Substances considered GRAS under the conditions of its intended use: this includes (1) certain food ingredients widely consumed before 1958 and (2) substances affirmed as GRAS under parts 184 and 186 if their conditions of use are not significantly different from those reported in the regulation.
  • Established FDA process: substances evaluated by FDA through Voluntary Premarket Consultations, Voluntary Premarket Meetings, and Animal Cell Culture Consultations, if documentation made publicly available by FDA does not recommend or otherwise identify the need for a GRAS notice.
  • TOR exemption: substances whose intended use is the subject of an exemption under the threshold of regulation process in § 170.39.
  • Effective premarket notification for an FCS: substances whose conditions of intended use are covered by a premarket notification for a food-contact substance, provided that the substance in interstate commerce originates from the manufacturer or supplier listed in the FCN.
  • Time-limited option to submit certain information to FDA: the streamlined reporting option for substances already in the food supply described above.

The proposed rule does not create a premarket approval framework.  Firms could continue marketing a substance before submitting a GRAS notification or while a notification is pending before FDA.  Noncompliance would not be subject to direct enforcement; instead, it would serve as a factor in the agency’s prioritization of a substance for post-market review.

FDA would continue to publicly post GRAS notices and related correspondence on its GRAS Notices Inventory.

Who Is Affected?
  • Ingredient makers and suppliers, facing notice obligations for both new and legacy substances;
  • Food-contact and packaging producers, since the rule reaches indirect additives and packaging migrants;
  • Flavor houses and other firms relying on expert-panel GRAS conclusions, which would need to bring legacy substances into the notification or streamlined-submission system;
  • The animal food sector, through a parallel part 570 program with its own AFIC and AAFCO exceptions; and
  • Foreign firms, which filed a large share of GRAS notices to date and would face a new English-translation requirement.
What to Watch Next

FDA proposes a 60-day effective date, an 18-month compliance date for the notification requirement, and a one-year window for streamlined legacy submissions.  The comment period on the proposed rule closes December 9, 2026.

GRAS Reform Update: Where Do Things Stand?

/in ,

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.

Are You Ready for Mandatory GRAS Notifications?

/in ,

The second Trump administration’s first Unified Regulatory Agenda of Federal Regulatory and Deregulatory Actions, published September 4, 2025, indicates that FDA is close to initiating a rulemaking to overhaul the generally recognized as safe (GRAS) regulations—a change that could significantly raise regulatory expectations for food manufacturers and ingredient suppliers.

What Does the Unified Agenda Say?

According to the unified agenda listing, “the proposed rule, if finalized, would amend the [GRAS] regulations…to require the mandatory submission of GRAS notices for the use of human and animal food substances that are purported to be GRAS.”  Substances that are listed as GRAS for the intended use by regulation, or have been granted a “no questions” letter by FDA, would be exempted.

The listing further notes that the rulemaking would clarify that FDA maintain and regularly update a public-facing GRAS notice inventory for all substances subject to the mandatory GRAS notice requirement for their intended uses.  It would also clarify the process by which FDA would determine that a substance is not GRAS.

The agenda indicates that a proposed rule is expected to be published in October 2025.

Putting It in Context

Under current regulations, companies can self-affirm that a substance—which includes ingredients as well as substances added indirectly (such as from food packaging)—is GRAS based on scientific evidence.  FDA’s GRAS notification program is voluntary; companies may notify FDA but are not required to.

The proposed rule would shift the system so that formal submission (notice) to the FDA becomes mandatory for most substances purported to be GRAS, except those already regulated or with prior FDA “no questions” letters.

The agenda listing follows Health and Human Services Secretary Robert F. Kennedy, Jr.’s March 2025 directive to FDA to explore revising the GRAS final rule and related guidance to eliminate the self-affirmation pathway.  “Eliminating this loophole will provide transparency to consumers, help get our nation’s food supply back on track by ensuring that ingredients being introduced into foods are safe, and ultimately Make America Healthy Again,” Secretary Kennedy said.