U.S. New Dietary Ingredient (NDI) Updated: Which New Substances Can be Used in Dietary Supplements?

The U.S. New Dietary Ingredient (NDI) database was updated on May 8, with a total of 27 substances having their status updated. 

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 December 18, 2025. 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 27 substances updated

Since NDIN 1409, a total of 27 notifications have been submitted, of which 13 have successfully been notified, and 14 have not, with a pass rate of less than 50%. The notifications that did not pass include 12 objection letters (involving 5 cases of insufficient identity information, 2 cases of insufficient safety evidence, and 5 cases of both insufficient) and 2 letters regarding other regulatory issues that do not meet the definition of dietary ingredients.

For specific information on the NDIN numbers, names, companies, and FDA responses of the 27 substances, see the table below. 

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 notices. 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.

To learn more details on how to understand the FDA’s response to NDI, please read our previous article - US NDI Notification: A Step-by-Step Guide to Understanding FDA Letters.

About CIRS

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, feed and pet food, 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 team members in CIRS Food Business Division have over 10 years of professional experience in food compliance, with more than 80% hold 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:

• Health food registration and filing in China;
• Application for “Three New Foods” 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.