On August 10, 2026, the U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. announced a major reform in national food policy:
- An FDA proposed rule requiring mandatory notification for Generally Recognized as Safe (GRAS) conclusions, bringing greater transparency and oversight to substances added to the nation's food supply.
This proposed rule modernizes FDA regulation and oversight of food ingredients by strengthening oversight of substances added to human and animal food under the GRAS framework.
This action strengthens the scientific foundation of nutrition policy, improves transparency and food safety, and advances President Trump’s Make America Healthy Again agenda.
Current Framework
Since 1958, manufacturers have been permitted to conclude that substances are generally recognized as safe under their intended conditions of use. Although the FDA has maintained a voluntary GRAS notification program, manufacturers have not been required to notify the agency when making these conclusions.
What the Proposed Rule Does
The proposal:
- requires manufacturers to notify the FDA when concluding that the use of a substance added to human or animal food is GRAS;
- expands the existing public inventory of submitted GRAS notifications;
- improves the FDA’s visibility into ingredients entering the food supply, allowing for greater post-market oversight; and
- increases transparency for consumers and industry.
For substances already on the market based on prior self-GRAS conclusions, the proposal establishes a time-limited, streamlined submission pathway that would allow manufacturers to notify the FDA of existing GRAS uses while enabling the agency to prioritize post-market safety evaluations, where appropriate.
The FDA is requesting public comment on additional approaches that could improve efficiency while ensuring the agency has the information necessary to fulfill its responsibility to protect consumers from unsafe food additives.
Public comments on the proposed rule will be accepted through December 9, 2026, and may be submitted here.
Part of the Trump Administration’s Broader Nutrition Strategy
Today’s action builds on the Trump Administration’s broader efforts to improve the quality, transparency, and safety of the U.S. food supply.
Recent actions:
- released the Make America Healthy Again Strategy Report;
- updated the Dietary Guidelines for Americans to recommend avoiding highly processed foods and emphasizing diets centered on real food;
- established and funded the Nutrition Regulatory Science Program, led jointly by the FDA and the National Institutes of Health, to strengthen research on ultra-processed foods and other nutrition priorities; and
- established, for the first time in the agency’s history, a systematic post-market assessment process to proactively identify and evaluate substances already on the market and take action, when warranted, to help ensure the food supply remains safe.
Together, these initiatives aim to:
- improve the scientific foundation for future nutrition policy;
- increase transparency throughout the food system;
- strengthen oversight of food ingredients;
- support evidence-based decision-making; and
- help reduce the burden of chronic disease by empowering Americans to make healthier food choices.
Learn More
The proposed rule is available for public comment through Regulations.gov. HHS encourages food manufacturers, ingredient suppliers, researchers, consumer organizations, state regulators, and members of the public to review the proposal and submit comments.