Eliminating Self-Affirmed GRAS? Interpretation of Enterprises’ Concerns

On March 10, 2025, U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. directed the Food and Drug Administration (FDA) to explore rulemaking to eliminate the self-affirmed Generally Recognized as Safe (GRAS) pathway, which could mark a significant shift in the U.S. food regulatory landscape.

With years of compliance experience, CIRS Group provides an in-depth interpretation as follows:

1. Eliminating self-affirmed GRAS is not a whim

FDA has been calling for the elimination of self-affirmed GRAS for a long time, and there has been no lack of experts in the industry who do not recognize its attitude. As far as we know, one of the main problems is that part of the self-affirmed GRAS dossiers are not prepared rigorously enough, and the arbitrariness is large, which leads to the credibility of self-affirmed GRAS to decline, which in turn triggers a lot of questions, prompting the relevant departments to consider reforming the self-affirmed GRAS.

2. The current self-affirmed GRAS status is still effective

At present, FDA has not issued a formal eliminating announcement. Therefore, at this stage, self-affirmed GRAS is still valid, the revision and change of regulations usually need to go through certain procedures and time, and will not be canceled immediately. On the other hand, after the elimination of self-affirmed GRAS, companies can only choose to submit GRAS Notices to the FDA, which will also make the FDA face greater pressure on reviewers, and these issues have yet to be resolved. Therefore, it is expected that eliminating self-affirmed GRAS in the short term will not be easy to land, so enterprises do not need to be too anxious, instead, pay attention to the subsequent regulatory developments.

3. Ways for enterprises to cope with: focus on the quality of the self-affirmed GRAS dossiers

In fact, the requirements for preparing a self-affirmed GRAS dossier should be consistent with those for FDA GRAS, as both essentially follow the same dossier system, and there should be no difference in quality. self-affirmed GRAS merely means that the dossier is not submitted to the FDA in terms of procedure, but it does not imply that its quality can be lower than the FDA GRAS standard. 

As long as we strictly control the quality when preparing the self-affirmed GRAS dossier, enterprises will be able to quickly submit it to the FDA for review if self-affirmed GRAS is eliminated in the future. Of course, companies may also choose to follow the FDA GRAS pathway from the outset to enhance the authority and market recognition of their ingredients. 

Fortunately, as a professional GRAS notification service provider, CIRS applies the same rigorous standards when preparing both self-affirmed GRAS and FDA GRAS dossiers. 

Regarding the potential cancellation of self-affirmed GRAS, CIRS will continue to monitor the situation and provide timely updates and professional interpretations to help enterprises navigate regulatory changes with confidence.

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.