The U.S. Department of Health and Human Services (HHS) recently announced on a significant proposed change to the Food and Drug Administration's (FDA) regulation of substances that are "generally recognized as safe," or GRAS. The proposal would require manufacturers to notify the FDA when they conclude that a substance added to human or animal food is GRAS, replacing the voluntary notification framework that has existed for decades.
For companies that manufacture, market, or use ingredients based on GRAS determinations, the proposal could significantly change regulatory strategy and compliance practices. Importantly, however, the proposal is not yet in effect. Companies may continue to rely on the existing GRAS framework while the rulemaking proceeds.
What Is Changing?
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), a substance that is GRAS under the conditions of its intended use is excluded from the statutory definition of a "food additive" and therefore is not subject to the FDA's food-additive premarket approval requirements.
Under the FDA's existing regulations, a company may independently conclude that a substance is GRAS without submitting that conclusion to the FDA. Companies may voluntarily submit a GRAS notice to the FDA and obtain a response, commonly a "no questions" letter, but notification is not currently required.
The FDA's proposal would fundamentally change the notification component of that system. A manufacturer concluding that a substance is GRAS would be required to submit a GRAS notice to the FDA containing the information supporting that conclusion.
The proposal therefore does not eliminate the GRAS exemption. The statutory GRAS pathway would remain, and the FDA is not proposing to convert GRAS substances into food additives requiring affirmative premarket approval. Rather, the principal change is that companies would be required to notify the FDA when they determine that a substance is GRAS, instead of relying on that determination without notifying the agency.
What Is Not Changing, At Least Yet?
The proposal does not appear to change the fundamental scientific standard for determining whether a substance is GRAS. GRAS status would continue to depend on general recognition among qualified experts, based on the applicable statutory and regulatory criteria, that the substance is safe under the conditions of its intended use.
In addition, mandatory notification is not equivalent to FDA premarket approval. HHS has characterized the proposal as increasing transparency and FDA oversight rather than establishing a new food-additive approval regime for substances that qualify as GRAS. This distinction may become particularly important as stakeholders evaluate the FDA's asserted statutory authority for the rule.
What Should Companies Do Now?
Although no immediate change in compliance is required, companies that rely on the GRAS pathway should consider using the rulemaking period to assess their potential exposure.
In particular, companies may wish to:
- Inventory existing GRAS determinations. Identify ingredients and uses that rely on internal or third-party GRAS determinations for which no GRAS notice has been submitted to the FDA. Companies that purchase ingredients from suppliers should consider determining which party possesses and controls the underlying GRAS documentation.
- Review the strength and currency of existing GRAS files. Older determinations may warrant particular attention. Companies should consider whether the scientific literature, estimated levels of consumer exposure, manufacturing information, and intended conditions of use remain consistent with the original determination, and whether new information or changes in how the substance is used could affect the GRAS conclusion.
- Identify products dependent on self-GRAS conclusions. Understanding which products, customers, and supplier relationships depend on a particular GRAS determination can help companies assess the business consequences if the FDA ultimately questions that determination.
- Evaluate confidentiality issues. Because mandatory submissions would increase FDA and public visibility into previously private GRAS determinations, companies should assess potentially confidential commercial information in their supporting files and consider how the FDA's disclosure rules would apply.
- Review supplier and customer agreements. Ingredient suppliers and downstream manufacturers may wish to consider which party is responsible for establishing GRAS status, maintaining supporting documentation, and making any future FDA submission.
- Consider participating in the rulemaking. Companies and trade associations should evaluate whether to submit comments addressing the scope of mandatory notification, treatment of existing GRAS determinations, implementation periods, confidential information, the streamlined submission process and the practical burdens associated with the proposed requirements.
Where Does the Rulemaking Stand?
As of August 10, 2026, the FDA has proposed (not finalized) the new GRAS notification requirements. HHS announced the proposal as part of the administration's broader food-chemical and nutrition policy agenda.
The proposal will proceed through the federal notice-and-comment rulemaking process. Interested parties will have an opportunity to submit comments before the FDA determines whether to issue a final rule and, if so, whether to modify the proposal. Any final rule would establish its own effective date and applicable compliance or transition periods.
For companies relying significantly on GRAS determinations, however, the proposal warrants attention now. Even if the details change during rulemaking, the FDA has made clear that increased visibility into, and oversight of, GRAS determinations is a significant regulatory priority. Companies that understand their existing GRAS portfolios and the supporting scientific record will be better positioned both to participate in the rulemaking and to respond if mandatory notification ultimately becomes a regulatory requirement.
How We Can Help
Baker Donelson's Food Safety and Regulation, FDA Regulatory and Compliance, and Food and Beverage Teams are closely monitoring the FDA's proposed changes to the GRAS framework and can assist food manufacturers, ingredient suppliers, and other stakeholders in evaluating the potential impact on their businesses. Our attorneys can help companies assess existing GRAS determinations and supporting documentation, identify products and ingredients that may be affected by a mandatory notification requirement, evaluate regulatory and confidentiality considerations, and develop strategies for compliance if the proposal is finalized. We can also assist clients and industry groups in preparing comments on the proposed rule and engaging with FDA throughout the rulemaking process. As the FDA's proposal progresses, Baker Donelson will continue to monitor significant developments and help clients navigate the evolving regulatory landscape. For any questions, please contact Theodora T. McCormick.