October 19, 2026

Chinese ingredient manufacturers are showing increasingly strong activity in the U.S. Generally Recognized as Safe (GRAS) notification process, with new filings covering L-ergothioneine, probiotics, HMOs, sweeteners, beta-glucan, L-theanine and other functional ingredients.

According to an analysis from HPA-Global regulatory strategic partner CIRS Group, 59 substances experienced status updates in the FDA GRAS database between July and October 15, 2026. Of those, 18 received FDA “has no questions” responses, 40 were newly listed as under review and one notification was withdrawn by the notifier.

Chinese companies accounted for 26 of the 59 substances, or approximately 44% of the total activity identified by CIRS. Ten substances notified by Chinese companies received FDA “has no questions” responses, while another 16 were newly listed as under review.

Among the 10 Chinese-company substances receiving “has no questions” responses were five sweetener or sugar-reduction ingredients, one probiotic, one human milk oligosaccharide (HMO), beta-glucan, L-theanine and beta-carotene.

Examples include 2′-fucosyllactose (2′-FL), D-allulose, enzymatically modified steviol glycosides, L-theanine and Bifidobacterium animalis subsp. lactis CGMCC 18610.

Ergothioneine Activity Accelerates

One of the most notable trends is the growing number of Chinese companies pursuing U.S. GRAS status for L-ergothioneine, an ingredient attracting increasing interest in healthy aging, cellular health and longevity-focused formulations.

CIRS identified five new L-ergothioneine GRAS notices from Chinese companies among the substances newly under review during the period.

The filings involve companies including Abiochem Biotechnology, Shanghai Recom Biotechnology, Bloomage Biotechnology, SiyoMicro Bio-Tech and EGTBio (Shanghai), with the ingredients generally produced through microbial fermentation or other biotechnology processes.

The concentration of filings suggests increasing competition among Chinese manufacturers seeking to establish regulatory pathways for supplying ergothioneine to the U.S. food and nutrition markets.

Probiotics and Biotechnology Ingredients Also Expand

Chinese companies are also continuing to pursue U.S. market access for probiotic strains.

New notices under review include strains of Bifidobacterium breve, Lactiplantibacillus plantarum, Lacticaseibacillus paracasei and Bifidobacterium animalis* subsp. *lactis.

More broadly, the GRAS activity reflects continued growth in ingredients manufactured through fermentation, enzymatic conversion and synthetic biology, including next-generation sweeteners and functional compounds.

CIRS reported that sugar-reduction and sweetener ingredients represented the most active category during the period, with 19 substances receiving status updates, followed by 13 microorganism-related ingredients and eight enzyme preparations.

What This Means for the Industry

The latest GRAS activity highlights the growing international ambitions of China’s functional ingredient sector.

Rather than focusing exclusively on supplying the domestic Chinese market, an increasing number of Chinese ingredient manufacturers are pursuing regulatory pathways that enable them to compete directly in the United States and other international markets.

The activity around ergothioneine, probiotics, HMOs, sweeteners and fermentation-derived ingredients is particularly significant because these categories are closely aligned with several major global nutrition trends, including healthy aging, microbiome health, sugar reduction and biotechnology-based ingredient production.

For international supplement and functional-food companies, this could mean a growing number of Chinese-origin ingredients entering the global supply chain with U.S. regulatory documentation behind them, potentially increasing both ingredient availability and competition.

It is important to distinguish an FDA “has no questions” response from a formal FDA approval. Under the GRAS notification process, FDA evaluates the notifier’s conclusion that an ingredient is GRAS under its intended conditions of use and may respond that it has no questions regarding that conclusion.

Source: CIRS Group analysis of FDA GRAS Notices, updated through October 15, 2026; U.S. Food and Drug Administration GRAS Notice database. FoodDB
Read the original CIRS Group analysis (Chinese)

For more details, visit: www.hpaglobal.org/connect