FDA NDI Database Update: 25 New Substances Reviewed with Under 40% Approval

The U.S. New Dietary Ingredient (NDI) database was updated on July 13, 2026, with a total of 25 substances having their status updated. CIRS has organized the updated data for you.

It should be noted that there is a lag in the NDI database updates. The latest FDA response times in this update report are all earlier than April 1, 2026. Currently, the actual number of completed NDI notifications is actually greater than the data currently published on the official website. CIRS Group will continue to pay close attention to subsequent updates on the FDA official website.

Status of the 25 substances updated

Since NDIN 1436, a total of 25 notifications have been submitted, of which 10 have successfully been notified, and 15 have not, with a pass rate of less than 40%. The notifications that did not pass include 9 objection letters (involving 3 cases of insufficient identity information, 1 cases of insufficient safety evidence, and 5 cases of both insufficient) and 6 letters regarding other regulatory issues that do not meet the definition of dietary ingredients or insufficient content.

For specific information on the NDIN numbers, names, companies, and FDA responses of the 25 substances, see the table below. Among them, those highlighted in yellow are notifications submitted by Chinese companies.

CIRS Group reminds that the U.S. NDI notification allows the use of private data, but also requires more detailed and comprehensive data than GRAS notifications. During the preparation of the application, companies should carefully understand the data requirements of the NDI notification, systematically organize the substance identity information, production processes, and safety data, ensuring that the information is complete and traceable to meet the FDA’s review requirements.

For more details on how to understand the FDA’s response to NDI, you can click on “US NDI Notification: A Step-by-Step Guide to Understanding FDA Letters”.

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.