Washington, D.C. — August 10, 2026 — The U.S. Department of Health and Human Services (HHS) today announced a major proposed reform to strengthen oversight, transparency, and public confidence in the safety evaluation of substances added to the nation’s food supply.

The proposed rule would require manufacturers to submit notifications to the U.S. Food and Drug Administration (FDA) when concluding that a substance is Generally Recognized as Safe (GRAS) for its intended use in human or animal food. This proposed change aims to modernize the GRAS framework by improving regulatory visibility, expanding public access to information, and strengthening post-market oversight of food ingredients.

Strengthening Transparency Under the GRAS Framework

Since the establishment of the GRAS provision in 1958, manufacturers have been able to independently conclude that certain substances are generally recognized as safe under their intended conditions of use. While the FDA has maintained a voluntary GRAS notification program, manufacturers have not previously been required to notify the agency when making GRAS conclusions.

Under the proposed rule, manufacturers would be required to notify FDA regarding GRAS conclusions. The proposal would also expand the existing public inventory of GRAS notifications, improve FDA’s ability to monitor ingredients entering the food supply, and increase transparency for both consumers and industry stakeholders.

For substances already marketed based on previous self-determined GRAS conclusions, the proposal would establish a time-limited pathway allowing manufacturers to notify FDA of existing GRAS uses. This approach would enable FDA to prioritize post-market safety evaluations where appropriate while improving overall regulatory oversight.

Supporting Science-Based Food Safety Decisions

HHS stated that the proposed action is intended to strengthen the scientific foundation of nutrition policy, enhance transparency across the food system, and support evidence-based decision-making regarding food ingredients.

The proposal forms part of broader U.S. government efforts to improve food safety oversight and transparency. Recent initiatives include efforts to strengthen nutrition science, update dietary guidance, establish nutrition regulatory science programs, and enhance systematic post-market assessment of substances already present in the food supply.

Public Comment Period

FDA is requesting public input on the proposed rule and additional approaches that may improve regulatory efficiency while ensuring the agency has sufficient information to fulfill its responsibility to protect consumers. Public comments will be accepted through December 9, 2026.

HHS encourages food manufacturers, ingredient suppliers, researchers, consumer organizations, state regulators, and other interested stakeholders to review the proposal and provide comments during the public consultation period.

About the GRAS Framework

The GRAS pathway allows certain substances added to food to be considered safe based on qualified scientific evidence and broad recognition of safety among experts. The proposed rule represents a potential significant change in how GRAS conclusions are communicated and monitored in the United States, with increased emphasis on transparency and regulatory oversight.

Reference

https://www.hhs.gov/press-room/fact-sheet-hhs-announces-proposed-gras-rule.html