Summary of U.S. FDA GRAS Acceptance and Approval Status in the First Quarter of 2026

In recent years, there has been a steady increase in the number of GRAS notices submitted to the U.S. FDA. Since 2026, the U.S. FDA has been continuously updating its inventory of GRAS notices. CIRS Group has conducted a detailed statistical analysis and summary of FDA GRAS notices from January 2026 to March 2026, which is provided here for companies’ reference.

It should be noted that there is a delay in updates on the FDA website. Many substances may have already received a GRAS notice, but their public status may not be reflected in a timely manner. CIRS Group closely monitors FDA updates, and this article is based on information from the first quarter.

FDA GRAS Updates in the First Quarter of 2026

According to statistics, the status of 22 substances was updated during the first quarter. Specifically, 14 substances have received “FDA has no questions” letter, seven substances are still pending, and one has ceased to be evaluated.

Figure 1. FDA GRAS updates in the first quarter of 2026

Of the 22 substances that underwent status updates in the first quarter of 2026, six were microbiome-related substances, five were sugar substitute ingredients, three were HMOs, two were enzyme preparations, and six were other types of substances.

Figure 2. Categories of substances updated by the FDA as GRAS in the first quarter of 2026

FDA GRAS Substances Notified in the First Quarter of 2026

In the first quarter of 2026, 14 substances received the “FDA has no questions” letter. Among them, three were microbial substances, four were sugar substitute ingredients, two were HMOs, and five were other types of substances.

The applicant companies hailed from multiple countries, including China, the United States, Australia, Germany, South Korea, Canada, Japan, Israel, and India. Chinese and American companies were the two main sources of substances that passed notification, with six and four substances, respectively, receiving the “FDA has no questions” letters.

Table 1. Substances receiving “FDA has no questions” letters

Substances from Chinese companies receiving “FDA has no questions” letters

Substances from Chinese Companies in Pending Status

According to updates on the FDA website, Chinese companies had a total of two new substances under review in the first quarter of 2026, one HMO and one microbiome-related substance.

Note: Due to delays in updates on the FDA website, it is possible that some of these substances have already completed the review process but have not yet been publicly disclosed.

Table 3. Substances in pending status submitted by Chinese enterprises

Summary

The inventory of FDA GRAS notices for the first quarter of 2026 continues to be updated, with sugar substitutes (four newly notified) and microbiome-related substances (three newly notified) remaining the mainstay of submissions. Meanwhile, HMOs continue to innovate, directly addressing consumers’ personalized nutritional needs. Chinese biotechnology companies led the way this quarter, with a total of six substances receiving “FDA has no questions” letters (based on FDA updates), demonstrating the competitiveness of Chinese enterprises in the global ingredients market.

CIRS Group has a branch office and a team of full-time experts in the United States, along with an internationally certified technical team with extensive experience, helping companies quickly complete GRAS submissions. We welcome your inquiries or visits.

*Notes:

1. Data source: FDA official GRAS inventory and recently published accepted GRAS notices (updated March 25, 2026).

2. Since the FDA does not disclose submission dates, statistics on substances in pending are primarily based on the submission dates listed in the published submissions.

3. The data in this article is based on publicly available GRAS numbers; the data is for reference only.

About CIRS Food Division

Established in 2012, the Food Business Division of CIRS Group has helped over 1,000 food companies globally in achieving one-stop compliance solutions. CIRS offers a full range of regulatory services, including but not limited to China novel food applications, synthetic biology-derived foods, U.S. GRAS notices, EU novel food applications, health food registration, and food for special medical purposes (FSMP).

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