Overview of FDA GRAS Notices in the First Half of 2026

With the first half of 2026 concluded, Chinese ingredient companies are demonstrating strong momentum in U.S. GRAS notices; the number of approvals secured in this period alone (16) is close to the total for the entire year in 2025 (19). Drawing on publicly available FDA GRAS notice data, CIRS Group has compiled updates from January to June. By systematically reviewing metrics such as total volume, ingredient categories, outcomes, and the origins of applicants, CIRS provides valuable insights for food ingredient companies looking to enter the U.S. market.

It should be noted that updates on the FDA website may be delayed, and many substances may have actually completed GRAS notice, but their status has not yet been updated. This article is based on the final information available on the FDA website for the first half of 2026.

Summary of FDA GRAS notices in the first half of 2026

The statistical results show that a total of 63 substances had their information updated; among them, 33 substances received “FDA has no questions” letter, 5 ceased to be evaluated, and 1 notice did not provide a basis for a GRAS determination. Additionally, 24 substances are still pending.

Figure 1. Overview of GRAS notices in the first half of 2026

A total of 63 substances were notified in the first half of 2026, including 16 microorganism-related substances, 14 sugar substitutes/sweeteners, 9 HMOs, 5 enzymes, and 19 substances in other categories.

Figure 2. Overview of GRAS notice categories in the first half of 2026

Substances notified in the first half of 2026: a total of 33 substances

A total of 33 substances were notified in the first half of 2026, including 8 microorganism-related substances, 6 sugar substitutes/sweeteners, 8 HMOs, 2 enzymes, and 9 substances in other categories.

The applicants originated from multiple countries, including China, the United States, Denmark, Australia, Korea, Canada, Japan, and India. Among them, Chinese and American companies were the two main contributors of substances that obtained GRAS notices, with 16 substances and 8 substances, respectively.

Table 1. FDA GRAS substances notified in the first half of 2026

Substances notified by Chinese companies in the first half of 2026: a total of 16 substances

In the first half of 2026, a total of 16 substances from Chinese companies received “FDA has no questions” letters, including 6 microorganism-related substances, 1 sugar substitutes/sweeteners, 6 HMOs, and 3 substances in other categories.

Of these, 7 were processed by CIRS USA, accounting for over 43% of the total.

Table 2. Substances from Chinese companies receiving “FDA has no questions” letters in the first half of 2026

Substances notified by Chinese companies in pending status in the first half of 2026: a total of 10 substances

According to the latest information available on the FDA website, in the first half of 2026, Chinese companies had a total of 10 newly pending substances. Sugar substitutes/sweeteners were the primary category of submissions, with 5 substances pending, including rebaudioside, D-allulose, stevioside, and erythritol. Among HMOs, one substance—2'-fucosyllactose—is under review, and among microbiome-derived substances, one algal oil-derived substance is also under review. The remaining 3 newly added substances under review are β-glucan, L-theanine, and short-chain chondroitin sulfate oligosaccharides.

Note: Due to potential delays in updates on the FDA website, it cannot be ruled out 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 in the first half of 2026

Summary

A review of GRAS notices in the first half of 2026 shows that microbial-derived substances, sugar substitutes/sweeteners, and HMOs have consistently been the most popular categories of ingredients for GRAS submissions. Among the applicants, Chinese companies ranked first in the number of submissions, with a total of 16 substances receiving “FDA has no questions letter” (based on FDA updates) and another 10 substances currently pending.

Notably, the number of GRAS submissions by Chinese ingredient companies is accelerating. According to earlier statistics from CIRS, Chinese companies received “FDA has no questions letter” for a total of 19 substances throughout 2025, whereas in the first half of 2026 alone, the notified number has already matched the total for the entire year of 2025. This strong momentum fully demonstrates the technical capabilities and international competitiveness of Chinese ingredient companies.

As global demand for new food ingredients continues to expand, the value of GRAS notice is becoming increasingly evident. Proactively planning for regulatory compliance may become a key consideration for companies looking to expand their international footprint. 

*Data Source: The inventory of GRAS notices and the latest released accepted GRAS dossiers (updated as of 2025/12/30).

*Note:

1. As FDA doesn’t disclose dossier acceptance dates, the statistics for substances in pending status are primarily based on the submission dates recorded in the released dossiers.
2. The statistics are based on the published dossiers with GRN No., and are for reference only.
3. The data in this article is based on statistics from officially accepted and publicly available GRAS notices with verifiable GRAS numbers. The data is provided for reference only.

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, 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.