The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) proposed a rule requiring manufacturers to notify FDA whenever they conclude the use of a substance added to human or animal food is generally recognized as safe (GRAS).

Since Congress established the GRAS exemption in 1958, manufacturers have been allowed to reach their own conclusions that certain substances are GRAS “under the conditions of their intended use.” Although FDA has long provided voluntary notification programs, companies have not been required to notify the agency when making these determinations.

The proposed rule would modernize the framework by making GRAS notifications mandatory, expanding the public-facing inventory of submitted notices, significantly improving transparency, and strengthen FDA’s ability to oversee ingredients in the food supply.

For substances already on the market based on self-GRAS conclusions, the proposal would establish a “time-limited streamlined submission pathway” that would allow manufacturers to provide FDA information about existing uses. The agency would be able to prioritize post-market safety evaluations and minimize regulatory burden.

“Americans deserve confidence that the ingredients in their food are subject to transparent, science-based oversight, and today’s actions strengthen both sides of that equation,” said Acting FDA Commissioner Kyle Diamantas, JD. “By proposing mandatory GRAS notifications, we are closing critical information gaps and giving the FDA greater visibility into substances entering the food supply. By advancing a proposed definition of ultra-processed foods, we seek to create a stronger foundation for future nutrition research. Together, these reforms represent a significant step toward a more transparent and modern food safety system.”

The Natural Products Association (NPA), Council for Responsible Nutrition (CRN), American Herbal Products Association (AHPA), and Consumer Healthcare Products Association (CHPA) responded to the proposal and said they will monitor the situation.

“Under a proposed rule scheduled for publication in the Federal Register on August 11, 2026, FDA would move from the current voluntary GRAS notification process to a mandatory notification program for certain substances used in human and animal food,” NPA wrote. “If finalized, the rule would significantly change how companies document and notify FDA of GRAS conclusions, with important implications for ingredient manufacturers, suppliers and finished product companies. NPA is reviewing the proposal and its potential impact on the natural products industry and will continue engaging with FDA throughout the rulemaking process.”

CRN welcomed the efforts to enhance transparency and ensure FDA has appropriate visibility into food ingredients. CRN argued the solution is not to eliminate or overly burden the self-GRAS pathway, but to make companies more responsible for how they conduct self-GRAS reviews.

CRN also urged FDA to reinforce “national uniformity” when regulating GRAS ingredients. A growing patchwork of state-specific requirements would create conflicting obligations, increase costs and complexity, and undermine the predictability of federal food safety frameworks.

“CRN shares FDA’s commitment to consumer safety and transparency but requiring every new GRAS determination to be evaluated by FDA would add regulatory burden, complexity, and unpredictable timelines without necessarily improving consumer safety,” said Andrea Wong, PhD, senior vice president and chief science officer at CRN. “A workable approach is to ensure the existing GRAS framework is used responsibly and to give FDA the resources and enforcement tools it needs to strengthen oversight while preserving responsible innovation.”

“AHPA welcomes FDA’s embrace of GRAS as a pathway to market for food, including dietary supplement, ingredients with their publication of the proposed rule,” said AHPA President & CEO Graham Rigby. “Through continued engagement with FDA during this rulemaking process—including comment submission—AHPA will maintain its focus on ensuring the agency possesses the resources and specialized expertise necessary to ensure public access to herbal and botanical ingredients.”

CHPA supports efforts to increase transparency and strengthen consumer confidence in the food supply but warned about potential consequences to dietary supplements and over-the-counter (OTC) medicines.

Under existing laws, substances that are GRAS are treated differently from food additives based on expert scientific evaluation. CHPA maintains any significant changes to GRAS must remain consistent with the authority Congress provided to FDA while preserving the “rigorous safety standards” of the current system.

“Improving transparency does not require upending a system that has long relied on scientific expertise and risk-based oversight,” said Scott Melville, president and CEO of CHPA. “FDA should pursue practical reforms that strengthen public confidence while making the best use of agency resources to protect public health.”

For more information, visit www.hhs.gov or www.fda.gov.