House Bill Would Require Notification of GRAS Substances and Institute New User Fee System for FDA GRAS Reviews and Food Substance Reassessments
On August 12, 2025, Rep. Frank Pallone, Jr. (D-NJ) introduced H.R.4958, the Grocery Reform and Safety Act (GRAS Act), which would remove the Generally Recognized as Safe (GRAS) exemption from the Food Additive Definition found in Section 201(s) of the Federal Food, Drug, and Cosmetic Act. Under the terms of the proposed GRAS Act, companies would be required to submit a notification to the Secretary of Health and Human Services prior to marketing a substance that they have deemed generally recognized as safe (GRAS), which details the scientific evidence forming the basis for the GRAS determination. The Secretary shall make the notice and supporting information publicly available on FDA’s website and provide for a 60-day comment period.
According to the bill, the GRAS notification “shall include publicly available supporting data and information sufficient to demonstrate the identity and composition, the manufacturing process, the intended effect, and the safety of the food substance” underlying the determination. The bill does not address how confidential business information (CBI) would be addressed in the context of the mandated GRAS notifications.
Specific information required to be submitted in the GRAS notice includes the following:
a) information on the cumulative effects of such substance;
b) information on hazard, dose response, and exposure;
c) information on the application of adequately protective safety factors to ensure an appropriate margin of safety to take into account uncertainties in hazard identification, dose response, exposure, and sensitivities;
d) information demonstrating the analysis that the weight of the evidence shows that such substance has not been found to be carcinogenic;
e) information demonstrating the analysis that the weight of the evidence shows that such substance has not been found to induce reproductive toxicity or developmental toxicity in humans or animals, including through an endocrine mode of action; and
f) such other information that forms the recognition of safety as the Secretary of Health and Human Services may publicly specify.
Prior to marketing the substance, a manufacturer must receive a written statement from the Secretary not objecting to the determination that the substance is GRAS under the conditions prescribed in the notice.
The bill also directs FDA to reassess the safety of at least 10 substances—to include prior-sanctioned substances, food contact substances, and color additives—within three years of enactment and every three years after.
Notably, the proposed legislation authorizes FDA to collect user fees from food manufacturers to cover 100% of the Agency’s costs in reviewing GRAS notifications and conducting food substance reassessments.
The bill was referred to the House Committee on Energy and Commerce on August 12, 2025.
A bill before the U.S. Senate would also require notification of GRAS substances. See the Packaginglaw.com article, U.S. Senate Bill Would Eliminate Self-GRAS Pathway to Market Food Substances, for information on that bill.