On November 6, U.S. Senator Roger Marshall (R-KS), a member of the Senate Health, Education, Labor, and Pensions (HELP) Committee and MAHA Caucus, introduced the highly anticipated “Better Food Disclosure Act” (the “Better FDA Act”). The bill aims to close the so-called “GRAS loophole.” Although the bill, which was developed with input from industry stakeholders and the MAHA community, was expected to establish a uniform national standard for food substances to address the patchwork of state laws, it does not contain a preemption provision. Further, while anticipated to be bipartisan, the bill is currently cosponsored only by Republicans, Sens. Rick Scott (R-FL) and Katie Britt (R-AL).
The bill would amend the Federal Food, Drug, and Cosmetic Act (FDCA) to deem any “food substance generally recognized as safe” (GRAS substance) to be adulterated unless it is either included in a newly established GRAS listing system or under review by the Agency. Importantly, the definition of a food substance generally recognized as safe mirrors the current language in the FDCA and does not differentiate between how a GRAS substance attained its GRAS status. Accordingly, the bill’s requirements could be read to cover not only substances for which FDA has issued a “no questions” letter in response to a GRAS Notice and substances that manufacturers have self-GRAS’ed, but also the substances that FDA has affirmed as GRAS and codified in 21 C.F.R. parts 182, 184, 186, 582 and 584. For existing GRAS substances, a manufacturer must submit a notice to FDA within two years of the bill’s enactment. For new GRAS substances, the manufacturer must submit a notice at least 120 days prior to first use. The bill does not specify what must go into such notice, instead directing FDA to promulgate implementing regulations within two years.
Upon receiving a notice, FDA would have 180 days either to accept the notice and add the substance to the GRAS list or to issue a preliminary determination to exclude it. If FDA fails to make a preliminary determination to exclude the substance within that timeframe, the substance would be automatically added to the list.
If FDA excludes a substance or later removes it following reevaluation, the manufacturer must, within 180 days, either: (1) request reconsideration and provide any additional information FDA requests (where a final determination will be made in 180 days), (2) submit a food additive petition, or (3) submit a plan to phase out the substance’s use.
The bill also authorizes FDA to reevaluate any food additive, color additive, or GRAS substance in response to a citizen petition or notice from a state official, or on the Agency’s own initiative (which FDA already has the authority to do). FDA must publish a Federal Register notice requesting data for any substance under reevaluation. Based on the reevaluation, FDA may amend or revoke the relevant regulation. For GRAS substances, FDA may require a food additive petition or remove the substance from the GRAS listing system via rulemaking. Petitions and notices from state governmental officials with clear and convincing scientific evidence will be prioritized. FDA career staff who have relevant scientific and regulatory expertise will conduct the reevaluation. The bill explicitly prohibits delegation of such reviews to political appointees or non-career personnel.
Importantly, the bill does not include a national uniformity clause that would preempt state laws restricting or banning certain food substances. Reports suggest that such a provision was initially included but later removed in response to pressure from the MAHA community and state lawmakers. In the press release, Sen. Marshall stated, “While we remain committed to working with everyone to establish a strong national standard of ingredient safety, we cannot ignore the reality that our current federal oversight is inadequate – and states have stepped up to hold both food companies and Washington accountable.” The release also mentions that over a hundred food-related bills have been introduced in state legislatures, of which seven have been enacted in five states (Arkansas, Louisiana, Texas, Utah, and West Virginia).
This bill is one of several bills introduced or expected to be introduced in Congress to reform the GRAS framework, including the “Ensuring Safe and Toxic-Free Foods Act of 2025.” FDA is also expected to propose a rule to “require the mandatory submission of GRAS notices for the use of human and animal food substances that are purported to be GRAS,” which would likely mirror many of the provisions of Senator Marshall’s bill.
It is unclear whether this bill will gain traction. There has been speculation that the bill may get attached to another legislative vehicle, such as the Farm Bill.
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.
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