Senators Introduce Bill that would Fundamentally Reshape FDA’s GRAS Framework

On July 17, 2025, Senators Ed Markey (D-MA) and Cory Booker (D-NJ) introduced the “Ensuring Safe and Toxic-Free Foods Act of 2025.” If enacted, this bill would fundamentally reshape FDA’s generally recognized as safe (GRAS) framework by, among other things, requiring that companies submit GRAS notifications for all ingredients currently marketed under “self-GRAS” determinations, amending the Federal Food, Drug, and Cosmetic Act’s (FDCA’s) “GRAS” definition to exclude certain new/novel ingredients, and, within 2 years of enactment, potentially sunsetting the GRAS pathway altogether. This alert summarizes these and other key provisions of the rule.

Key Changes to the GRAS Pathway

The bill would replace the FDCA’s current GRAS provision with an entirely new provision under which substances used in foods would be deemed “unsafe,” and therefore not permissible for use in foods, unless they are:

1. Approved food additives;
2. Subject to a GRAS notification that was submitted to FDA before enactment of the bill and has either received a “no questions letter” from FDA or remains pending before the agency; or
3. Subject to a GRAS notification that was submitted to FDA after enactment of the bill but before the effective date of the bill (i.e., 2 years from the date of enactment), that meets criteria specified in the bill, and to which FDA has not objected.

This provision poses a few key implications. First, because the bill does not otherwise contain a “grandfathering” provision for ingredients currently marketed under “self-GRAS” determinations, the bill would, in effect, require that manufacturers submit GRAS notifications for all substances currently marketed under self-GRAS determinations. Manufacturers would have 2 years to submit these notifications and would need to ensure that their notifications include certain specific information outlined in the bill. Once a notification has been submitted, the bill would allow self-GRAS substances to remain on the market pending FDA’s review of the notification.

Second, because the bill provides only for the lawful marketing of substances subject to GRAS notifications submitted before the bill’s effective date, the bill as currently drafted would seemingly foreclose the possibility of submitting GRAS notifications after the bill’s effective date. In other words, it appears that within two years of enactment the bill would effectively sunset the GRAS pathway altogether.

Key Changes to the FDCA’s “GRAS” Definition

The bill would also amend the FDCA’s “GRAS” definition to exclude the following from the definition of GRAS:

1. Substances that are “carcinogenic” as defined in the bill (i.e., substances “found to induce cancer when ingested by humans or animals”), which sets forth a definition similar to that provided in the “Delaney Clause”;
2. Substances that “show evidence of reproductive toxicity or developmental toxicity” as defined in the bill; [1]
3. Substances that are “otherwise identified as toxic by the National Toxicology Program, the [EPA], the Agency for Toxic Substances and Disease Registry, or the California Office of Environmental Health Hazard Assessment;”
4. Substances that were “not marketed for use in foods in the [US] prior to enactment of the [bill];” and
5. Substances that were “not synthesized, characterized, or isolated prior to the date of enactment of the [bill].”

These exclusions could have far-reaching implications for industry, e.g., by preventing new/novel ingredients developed after the bill’s enactment from leveraging the GRAS pathway.

Other Key Provisions

The bill would also impose the following key requirements:

• A requirement that FDA publish all future GRAS notifications and supporting information (submitted after the bill’s enactment but before its effective date) on its website and allow for a 60-day public comment period. By contrast, FDA currently does not publish pending GRAS submissions or allow for a public comment period.
• A requirement that FDA reject GRAS notifications if, among other factors, it determines that any data used to support a notification was provided by an expert with a “conflict of interest.” The bill defines “conflict of interest” somewhat ambiguously as “a financial interest that could potentially compromise the professional judgment or objectivity of an individual.”
• A requirement that FDA publish on its website the basis of its determination to object or not object to GRAS notifications, including any scientific memoranda “produced or relied on by [FDA] in making such determination.” This would seemingly require FDA to publish more information than the no questions letters and withdrawal letters it currently publishes in response to GRAS notifications.
• A requirement that FDA issue guidance to “strengthen” the recommendations in its 2022 Guidance on Best Practices for Convening a GRAS Panel.
• A requirement that FDA review at least 50 GRAS notifications per year until all pending GRAS notifications have been reviewed.
• A requirement that FDA reassess every 3 years the safety of at least 10 substances currently used in foods, prioritizing substances subject to a food additive petition, color additive petition, or citizen petition requesting a reassessment, restrictions, or revocation of an existing authorization of the substance. This is similar to what would be required under another recently introduced bill, the Food Chemical Reassessment Act of 2025, which we summarized in this client alert.

Notably, the bill does not include a preemption provision, which means it would not prohibit states from enacting additional GRAS restrictions.

This bill is similar to the Ensuring Safe and Toxic-Free Foods Act of 2023 and the Toxic Free Food Act of 2024, which Senator Markey and Representative DeLauro introduced, respectively, in the last congress (similar versions of which have been introduced in prior congresses), which also sought to require that all GRAS substances be notified to FDA.

While it is unclear whether this bill—which currently has only Democratic sponsors—will progress, we anticipate that the bill, or at least certain components of it, could gain newfound support in the current political environment, particularly given the bipartisan interest in GRAS reform stemming from the rise of the “Make America Healthy Again” movement. We therefore recommend that stakeholders continue to track this and other key legislative efforts underway at the federal and state levels and assess potential implications for their operations.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.