CIRS Supports Kingdomway in Obtaining a “FDA Has No Questions” Letter for Brazzein

On October 7, with comprehensive support from CIRS Group, Inner Mongolia Kingdomway Pharmaceutical Limited (hereinafter referred to as “Kingdomway”) officially received a “FDA Has No Questions Letter” from the U.S. Food and Drug Administration (FDA) for its fermentation-derived brazzein (GRAS Notice No. 001305). This milestone marks the successful completion of the FDA’s review of the company’s GRAS notice for the product.

It not only demonstrates international recognition of Kingdomway’s capabilities in synthetic biology research and development and product quality, but also sets a new benchmark for Chinese biomanufacturing companies seeking to enter the global high-intensity sweetener market. It further highlights CIRS Group’s professional expertise in international food regulatory submissions.

Overview of the Product

Product name: Brazzein

Production method: Microbial fermentation

Product description:

Brazzein is a naturally occurring sweet-tasting protein found in the wild West African plant Pentadiplandra brazzeana. It is approximately 500–2000 times sweeter than sucrose and is widely recognized as one of the most promising next-generation natural high-intensity sweeteners.

The intended use covered by this GRAS notice is as a general-purpose sweetener in foods, excluding infant formula and products under the jurisdiction of the U.S. Department of Agriculture. Potential applications include beverages, dairy products, baked goods, confectionery, tabletop sweeteners, and other food and beverage categories.

Significance of the FDA GRAS’ No-Questions Letter

Kingdomway’s fermentation-derived brazzein receiving FDA has no questions letter indicates that the FDA has completed its review of the submitted GRAS notice without raising questions regarding the notifier’s GRAS conclusion. This milestone supports the product’s potential entry into the U.S. food and beverage market, subject to applicable regulatory requirements.

Traditional production of brazzein relies on extraction from natural plants, which yields very limited quantities and entails high costs, making large-scale industrial applications challenging. By combining synthetic biology with precision fermentation, Kingdomway has achieved scalable, cost-effective, high-quality production of brazzein, overcoming limitations associated with natural sourcing.

This technological advancement offers the global market a high-performance sweetening solution that combines a naturally occurring protein with commercial production feasibility. It also aligns with global sugar-reduction trends and the food and beverage industry’s growing demand for clean-label products and natural sweeteners.

The Letter is expected to support Kingdomway’s further promotion and commercialization of brazzein in global markets, expand its synthetic biology product portfolio, and enable food and beverage brands worldwide to develop and upgrade reduced-sugar products.

About Kingdomway

Inner Mongolia Kingdomway Pharmaceutical Limited was established in March 2004 and is a wholly owned subsidiary of Xiamen Kingdomway Group, a leading A-share-listed company with an integrated nutrition and health industry value chain.

Located in the Tuoketuo Industrial Park in Hohhot, Inner Mongolia, the company has received several recognitions, including National High-Tech Enterprise, National Intellectual Property Demonstration Enterprise, National Green Factory, Autonomous Region Technology Innovation Demonstration Enterprise, and “Specialized, Sophisticated, Distinctive, and Innovative” SME.

Kingdomway is committed to innovation and development in the biopharmaceutical sector. Its nutritional fortification ingredients and biopharmaceutical products are sold in dozens of countries and regions worldwide.

Its key products include coenzyme Q10, DHA algal oil, arachidonic acid (ARA) oil, vitamin K2, NMN, PQQ, nattokinase, astaxanthin, and other high-tech products.

About CIRS Group

CIRS Group’s Food Business Division has more than 15 years of experience in food regulatory compliance and has supported numerous successful regulatory submissions. Its experience covers a wide range of products, including human milk oligosaccharides (HMOs), such as 2’-FL, LNnT, and LNT; steviol glycosides; inositol; brazzein; lycopene; enzymatically modified steviol glycoside Reb M2; NMN; inactivated Akkermansia muciniphila; Fusarium-derived protein; D-allulose; glucosamine hydrochloride; N-acetylglucosamine (NAG); beta-carotene; zeaxanthin; astaxanthin; and PQQ.

CIRS Group’s U.S. subsidiary has full-time experts with more than 20 years of hands-on experience in GRAS and NDI submissions. Leveraging close collaboration between its Chinese and U.S. teams, CIRS Group provides end-to-end support, from dossier quality assessment and supplementary scientific evidence to official submission, regulatory review communications, and ongoing compliance support.

Depending on the product’s intended use and target market, CIRS Group helps companies assess the appropriate regulatory pathway among GRAS, NDI, FAP, CAP, SRIS, AFIC, and other applicable U.S. food and feed regulatory pathways. This helps minimize potential delays caused by selecting an inappropriate regulatory route.

Through collaboration between Chinese and U.S. regulatory experts and ongoing follow-up at key stages of regulatory engagement, CIRS Group combines dedicated project management in China with technical execution in the United States, enabling responsive service, reduced time-zone barriers, and effective communication. These integrated services help companies address overseas market access requirements for novel food ingredients, food additives, dietary supplement ingredients, and animal food ingredients more efficiently.

What Can CIRS Do for You

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.

Get In Touch

CIRS Group can help you identify the correct regulatory route and build a practical approval strategy. Click to contact our food regulatory experts or get in touch with us via service@cirs-group.com.