Legislation introduced in the U.S. Senate in November, informally called the “Better FDA Act of 2025,” is perhaps a bit misleading.
While it involves the Food and Drug Administration (“FDA”), the full title of S. 3122—introduced on November 6—is actually “The Better Food Disclosure Act of 2025,” designed to amend the federal Food, Drug, and Cosmetic Act (“FDCA”) regarding food substances generally recognized as safe (“GRAS”).
S. 3122 is one of two major developments in GRAS reform: the other, FDA’s proposed rule on the subject (“Proposed Rule”), awaits review by the White House Office of Management and Budget (“OMB”) as of December 1.
As EBG wrote in March 2025 and in September 2025, Secretary Robert F. Kennedy, Jr., of the U.S. Department of Health and Human Services (“HHS”) announced on March 10 that FDA would explore potential rulemaking to eliminate the pathway allowing companies to self-affirm that food ingredients are GRAS. To that end, a Unified Regulatory Agenda, published in September, described a proposal to amend 21 CFR parts 170 and 570 to require the mandatory submission of GRAS notices to FDA for the use of human and animal food substances that are purported to be GRAS—effectively ending the self-affirmation pathway.
In this post, we discuss again the implications, whether this potential change happens by rulemaking via the FDA or through legislation via S. 3122.
Eliminating the GRAS Pathway
As we’ve written, pursuant to 21 U.S.C. § 321(s), food ingredients that are GRAS under the FDCA are currently exempt from premarket review and approval as a “food additive” by FDA, having been generally recognized by qualified experts as adequately shown through scientific procedures to be safe under conditions of their intended use.
The FDA, via regulation, has established two available pathways for confirmation of GRAS:
- notification, whereby an entity notifies the FDA of a conclusion that an ingredient is GRAS under the conditions of its intended use. The FDA then reviews the submission and issues a letter stating the FDA either does not question the conclusion or that there is not a sufficient basis for the conclusion (or that the notifier requested the FDA to cease evaluating the notice) (21 C.F.R. § 170.205); and
- self-affirmation, whereby an entity independently determines GRAS status without notifying the FDA (21 C.F.R. § 170.35).
Under the Proposed Rule, which would eliminate the second option and require mandatory submission of GRAS notices for the use of human and animal food substances purported to be GRAS:
- Food substances subject to the Proposed Rule would “include both ingredients and substances added indirectly (i.e., from food packing).”
- Food substances that are listed or affirmed as GRAS for the intended use by regulation, or for which FDA has already issued a ‘no questions letter’ on its GRAS notice inventory,” however, would be exempt.
- FDA would maintain and update the GRAS notice inventory for all substances that are the subject of mandatory GRAS notices for their conditions of intended use.
- A clarified process would govern how FDA determines that a substance is not GRAS.
The elimination of the self-affirmation pathway, however, will likely result in legal challenges: the FDA has previously stated that it “lack[s] express statutory authority to require companies to submit GRAS notices,” 81 Fed. Reg. 54981, and as of late 2025, Congress has yet to amend the FDCA to require the establishment of a premarket GRAS notification procedure.
S. 3122: The Better Food Disclosure Act of 2025
Enter S. 3122, introduced by Sen. Roger Marshall, R-Kansas, on November 6, 2025, and co-sponsored by Senators Rick Scott (R-Florida), and Katie Britt (R-Alabama). The bill would amend the FDCA to require notifications to the FDA regarding food substances generally recognized as safe.
Under the proposed legislation, a GRAS food would in fact be deemed unsafe unless the Secretary of HHS includes it on a GRAS list, or if the substance is under review. Pursuant to the bill, the FDA would maintain a publicly accessible list of all GRAS substances. Notably, the bill does not include a grandfathering provision for ingredients already marketed under a GRAS self-affirmed determination.
Rather, manufacturers of substances self-affirmed as GRAS and sold in interstate commerce as of the date of the enactment of the legislation would have a two-year compliance period in which to submit a notice requesting each such substance’s inclusion on the list. For substances first introduced after enactment, companies would be required to file a notice within 120 days of the ingredient’s proposed use.
S. 3122 would also allow state government officials and concerned citizens to petition the FDA for post-market assessment of the safety of food additives, color additives, and GRAS foods previously on the Secretary’s list, as Senator Marshall’s press release indicates.
Following receipt of 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 agency does not respond within that timeframe, the substance would be automatically added to the list.
Senator Marshall’s press release further notes that on the state level, at least 108 bills have been introduced in 17 states in 2025 regarding ingredients, nutrition education, ultra-processed foods, and physical activity in schools. Seven bills have been enacted in 5 states.
Takeaways
Significantly, S. 3122 does not contain a preemption provision that would address conflict with already passed and existing state laws. Therefore, though such a bill would promulgate a federal standard if passed, without a preemption provision, regulatory enforcement and compliance obligations may render implementation difficult and ripe for confliction.
Regarding the Proposed Rule, it will now very likely drop in December (it was originally slated to be published in October 2025, which turned out to be the month of the 2025 federal government shutdown). Industry stakeholders will then be allowed to comment.
In the meantime, as we’ve noted, entities currently self-affirming GRAS determinations should review their current procedures and consider how the mandatory submission of GRAS notices may impact their businesses. Companies currently using the self-affirmation pathway should familiarize themselves with the current FDA GRAS procedures at 21 C.F.R. §§170.30, 170.35; 81 Fed. Reg. 54960 (Aug. 17, 2016); and 21 C.F.R. Part 170, Subpart E, and determine what changes will need to be implemented should such a change take effect—or what food substances may be exempt. Stakeholders should also be monitoring the growing landscape of state laws relating to food and food ingredients.
