Summary of US FDA GRAS Status from July to October of 2026

The Generally Recognized as Safe (GRAS) notification pathway remains a critical route for food ingredient regulatory compliance and commercialization in the United States. Following our previous reviews for Q1 and H1 2026, CIRS Group compiled the latest GRAS notification updates published on the official U.S. Food and Drug Administration (FDA) website from July through October 15, 2026.

It should be noted that the FDA’s official database may not reflect the latest developments immediately due to publication delays. Some substances may have completed the GRAS notification process, while their publicly available status has yet to be updated. CIRS Group continues to monitor FDA updates, and this article reviews the developments based on information published between July and October 2026.

Overview of FDA GRAS Updates (July–October 2026)

During this period, the FDA updated the status of 59 substances:

• 18 substances received a "No Questions" letter (successfully completing the evaluation process).
• 40 substances remain pending review.
• 1 substance had its evaluation ceased.

Figure 1. FDA GRAS updates from July to October of 2026

Of the 59 substances that underwent status updates from July to October of 2026, 13 were microbiome-related substances, 19 were sugar substitute ingredients, 1 were HMOs, 8 were enzyme preparations, and 18 were other types of substances.

Figure 2. Categories of substances updated from July to October of 2026

FDA GRAS substances notified from July to October of 2026

From July to October of 2026, 18 substances received the “FDA has no questions” letter. Among them, 2 were microbial substances, 8 were sugar substitute ingredients, 1 were HMOs, 1 were enzyme preparation, and 6 were other types of substances.

The applicant companies hailed from multiple countries, including China, the United States, Canada, India, Germany, the United Kingdom, Ireland, Bulgaria, the Netherlands, South Korea, Australia, Finland, and several other countries. Chinese and U.S. companies were the two main sources of substances that passed notification, with 10 and 6 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

From July to October 2026, a total of 10 substances submitted by Chinese companies received “FDA has no questions” letters. These included five sugar substitute/sweetener ingredients, one probiotic, and one HMO. The remaining three substances were β-glucan, L-theanine, and β-carotene.

Table 2. Substances from Chinese companies receiving “FDA has no questions” letters

4. Substances from Chinese companies in pending status

According to updates on the FDA’s official website, from July to October 2026, a total of 16 new substances submitted by Chinese companies were added to the GRAS review pipeline. These included six sugar substitute ingredients, four microorganism-related substances, and six other substances (comprising five L-ergothioneine and one L-theanine).

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

From July to October 2026, FDA GRAS notification status showed a concentrated distribution across several product categories. Sugar reduction and alternative sweeteners remained the most active segment, with 19 notifications updated. Steviol glycosides and D-allulose continued to attract interest, while recombinant sweet proteins, represented by brazzein and thaumatin, saw a notable increase in activity, with seven notifications updated. Microorganism-related substances (13 notifications) and enzyme preparations (8 notifications) continued to expand steadily. In other areas of synthetic biology, interest increasingly shifted toward functional small-molecule ingredients. L-ergothioneine stood out, with five new notifications entering the review pipeline, while L-theanine and β-carotene also emerged as areas of interest for companies advancing their GRAS strategies.

Of the 59 substances covered in this update, 26 were submitted by Chinese companies, accounting for approximately 44% of the total. Chinese companies demonstrated strong R&D capabilities in areas including steviol glycosides, D-allulose, and L-ergothioneine. CIRS Group has a U.S. subsidiary and a full-time team of experts in the United States, backed by an experienced international regulatory consulting team. We help companies navigate the GRAS notification process efficiently. Please contact us for further information.

*Notes:

1. Data source: FDA official GRAS inventory and recently published accepted GRAS notifications (updated October 15, 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.

What Can CIRS 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, and 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 of 24 Chinese Certified Toxicologists (DCST), 2 American Board Certified Toxicologists (DABT), and 1 European Registered Toxicologist (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.