FDA Proposes to Make GRAS Notifications Mandatory

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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.