Is the Repeal of “Self-GRAS” Back on the Agenda? Latest Developments on the U.S. FDA’s Revision of GRAS Rules

On September 4, 2025, as part of the Spring 2025 Unified Agenda, the U.S. FDA proposed a draft rulemaking agenda regarding GRAS, aimed at revising the GRAS provisions in Parts 170 and 570 of Title 21 of the Code of Federal Regulations.

This is a further step taken by the U.S. FDA in response to the directive issued by U.S. Secretary of Health and Human Services Robert F. Kennedy in March of this year, in which he proposed the concept of “eliminating Self-GRAS,” and it has attracted widespread attention within the industry.

Key Points of the Proposed Rule

1. Requires the mandatory submission of a GRAS notification for human and animal food substances claimed to be GRAS.
2. Substances eligible for exemption include those that have been listed or recognized as GRAS by regulation, or those for which a GRAS notification has been submitted and a “no questions letter” has been received from the FDA.
3. The FDA shall establish and continuously update a publicly accessible list of GRAS notifications.
4. The FDA shall clarify the procedure for determining that a substance is not GRAS.
5. Currently, the FDA plans to issue a notice of proposed rulemaking for this proposed rule in October 2025.

The Challenge of the FDA Revoking “Self-GRAS”

A key question is: Does the U.S. FDA have the authority to revoke “Self-GRAS” status and mandate that companies submit GRAS notifications?

For new food additive ingredients, the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires companies to submit food additive petitions to the FDA; this is an authority granted to the FDA by law. However, under the 1958 amendment to the FD&C Act, GRAS substances are excluded from the definition of food additives in the United States. This means that the FD&C Act does not appear to grant the FDA the authority to mandate that companies submit GRAS notifications.

If the FDA were to change GRAS notifications from “voluntary” to “mandatory” before the FD&C Act is amended, it is expected to face challenges from Congress and legal challenges.

A Legal Case:

In 2017, nonprofit organizations such as the Center for Food Safety and the Environmental Defense Fund sued the FDA, arguing that the FDA’s practice of allowing food manufacturers to self-determine GRAS status without disclosing it to the FDA or the public violated the FD&C Act. The FDA countered that the current GRAS rules comply with the FD&C Act. Ultimately, the court ruled that the FD&C Act does not require mandatory disclosure of GRAS determinations, finding that the FDA had reasonably interpreted the Act as permitting a voluntary disclosure program. In 2021, the FDA prevailed in this federal lawsuit.

However, since the FDA now wishes to change course, it appears it must first obtain authorization from the U.S. Congress.

Implications for the Future

In addition to potential legal challenges, once the new regulations are enforced and a large volume of GRAS notifications floods in, will the FDA have sufficient resources to handle the reviews? These issues mean that the initiative to “eliminate self-GRAS and mandate FDA GRAS submissions” faces numerous challenges and uncertainties in the short term.

Nevertheless, this issue has been placed on the FDA’s agenda, and the message it conveys to the public is clear: in the future, self-declared GRAS will no longer suffice. The U.S. government aims to transition toward a more transparent and mandatory regulatory approach, rebalancing the relationship between industry autonomy and regulatory oversight within the U.S. food system.

Strategies for Businesses

The FDA is expected to issue a proposed rule next month; once it is officially published in the Federal Register, the public will be able to submit comments. CIRS (China-US Regulatory Services) will continue to monitor developments in this matter and provide timely professional analysis to relevant companies. Based on potential future trends, we recommend that companies:

• Review existing self-declared GRAS documentation to conduct compliance reviews and data gap analyses (particularly regarding critical safety data).
• Prepare Self-GRAS and FDA-GRAS submissions according to a single set of standards; while the procedures differ in nature, there should be no difference in quality.
• Based on the second point, companies may consider planning for an FDA GRAS notification in advance.

What CIRS Can Do for You

Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services from regulatory compliance, laboratory testing, R&D to data services across multiple industries. This includes chemicals, cosmetics, food and food beverages, medical devices, agrochemical products, disinfectants, and consumer goods. It helps clients gain a competitive advantage by reducing business risks associated with regulatory affairs.

The vast majority of members in CIRS Food Business Division have over 10 years of professional experience in food compliance, with more than 80% holding Master’s or Doctoral degrees in food-related disciplines. The CIRS toxicology expert team consists 24 Chinese Certified Toxicologists (DCST), 2 American Board Certified Toxicologists (DABT), and 2 European Registered Toxicologists (ERT). CIRS has provided one-stop food compliance services to over 1,000 domestic and international food and related enterprises. Leveraging its technical expertise, diverse resources, and global network, the CIRS Food Business Division offers global food compliance services, including but not limited to:

• Health food registration and filing in China;
• Application for “Three New Foods (new food additives, new food raw materials and new food-related products” in China;
• U.S. GRAS, NDI, and CAP notifications;
• EU Novel Food, food additives, and food enzymes applications; and
• Application for new feed ingredients and feed additives in China, the U.S., and the EU.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.