October 20, 2026

Chinese nutritional ingredient manufacturer Inner Mongolia Kingdomway Pharmaceutical Limited has reportedly achieved an important U.S. regulatory milestone for its fermentation-derived brazzein, a high-intensity sweetening protein with potential applications in reduced-sugar foods and beverages.

According to an October 10 announcement from HPA-Global partner CIRS Group, Kingdomway received a U.S. Food and Drug Administration (FDA) “no questions” response on October 7 concerning its Generally Recognized as Safe (GRAS) notification, identified as GRN 1305.

CIRS provided regulatory support throughout the submission process, helping Kingdomway navigate U.S. safety documentation and regulatory requirements.

Regulatory verification note: Although CIRS reports that the letter was received, the FDA’s public GRAS inventory, last updated October 15, continued to list GRN 1305 as pending. The reported outcome therefore awaits independent confirmation through publication of the FDA’s response.

What Is Brazzein?

Brazzein is a naturally occurring sweet-tasting protein originally identified in the West African plant Pentadiplandra brazzeana.

The protein is approximately 500–2,000 times sweeter than sucrose, making it a promising ingredient for manufacturers developing reduced-sugar products.

Unlike conventional sugar, brazzein can provide intense sweetness at very low usage levels.

Potential applications include:

• Functional beverages and nutritional drinks.
• Dairy products and dairy alternatives.
• Protein powders and nutritional formulations.
• Baked goods and confectionery.
• Tabletop sweeteners and other reduced-sugar foods.

Kingdomway manufactures its brazzein through microbial fermentation rather than direct extraction from the plant.

The approach uses a genetically engineered strain of Komagataella phaffii to produce the sweetening protein under controlled manufacturing conditions.

Precision fermentation offers opportunities to manufacture specialized ingredients at commercial scale while reducing dependence on limited botanical sources.

U.S. GRAS Notification Supports International Expansion

Kingdomway submitted its brazzein preparation to the FDA through the agency’s GRAS notification program.

The FDA’s public record identifies the company’s intended use as a general-purpose sweetener in foods at levels consistent with current good manufacturing practices.

The notification excludes infant formula, alcoholic beverages, and products under the jurisdiction of the U.S. Department of Agriculture.

A GRAS “no questions” letter means the FDA has completed its review without questioning the notifier’s conclusion that the ingredient is generally recognized as safe under its specified conditions of use.

Importantly, such a letter is not equivalent to FDA approval of an ingredient.

For manufacturers, however, a completed GRAS notification with a favorable FDA response can provide additional regulatory confidence and support commercial discussions with U.S. food and beverage companies.

CIRS Provides Regulatory Support

CIRS Group supported Kingdomway throughout the GRAS notification process, drawing on its experience with U.S. food ingredient regulations and international regulatory submissions.

The company’s food regulatory services include GRAS notifications, New Dietary Ingredient (NDI) notifications, ingredient safety assessments, scientific documentation, and regulatory compliance strategies.

According to CIRS, cooperation between its Chinese and U.S. regulatory teams helps manufacturers address scientific documentation requirements, communicate with regulatory authorities, and select appropriate market-entry pathways.

The Kingdomway project illustrates the increasing importance of specialized regulatory expertise as Chinese ingredient manufacturers expand beyond their domestic market.

Kingdomway Expands Its Ingredient Portfolio

Inner Mongolia Kingdomway Pharmaceutical Limited is a subsidiary of Xiamen Kingdomway Group, a Chinese company active in nutritional ingredients and health-related products.

Its existing ingredient portfolio includes coenzyme Q10, DHA algal oil, arachidonic acid (ARA), vitamin K2, NMN, PQQ, astaxanthin, and other specialized nutritional ingredients.

The development of fermentation-derived brazzein represents another step in the group’s expansion into biotechnology-based ingredients.

It also reflects growing investment among Chinese ingredient manufacturers in synthetic biology and precision fermentation technologies.

What This Means for the Industry

Opportunities for Reduced-Sugar Nutrition Products

Brazzein could provide food, beverage, and nutritional supplement manufacturers with another high-intensity sweetening option as demand for reduced-sugar formulations continues.

Its potential applications in protein beverages, functional nutrition products, and powdered supplements may be particularly relevant to manufacturers seeking alternative sweetening systems.

Growing Chinese Competition in Advanced Ingredients

Kingdomway’s investment in fermentation-derived brazzein illustrates how Chinese ingredient suppliers are moving beyond traditional vitamin and nutritional ingredient manufacturing into more technologically specialized products.

This development could create additional competition and supply opportunities in the international sweetener industry.

Importance of U.S. Regulatory Compliance

For Chinese manufacturers entering the American market, a well-supported GRAS notification can be an important component of commercialization.

However, suppliers must ensure that their ingredients, production methods, specifications, and intended applications are covered by appropriate safety conclusions and regulatory documentation.

Implications for International Ingredient Suppliers

Precision fermentation is increasingly being used to manufacture proteins, sweeteners, and other specialty ingredients that may be difficult or expensive to obtain from traditional sources.

International companies should monitor these developments as new manufacturing technologies reshape ingredient availability, competitive positioning, and regulatory expectations.

For the broader nutrition industry, Kingdomway’s brazzein project represents another example of Chinese biotechnology companies pursuing opportunities in global food ingredient markets.

HPA-Global will continue monitoring these developments and working with its regulatory partners to keep members informed about emerging technologies, regulatory requirements, and international market opportunities.

Sources:

• CIRS Group – CIRS Supports Kingdomway in Obtaining a “FDA Has No Questions” Letter for Brazzein (October 10, 2026)
• U.S. FDA – GRAS Notice No. 1305, Inner Mongolia Kingdomway Pharmaceutical Co., Ltd.
• U.S. FDA – How the GRAS Notification Program Works

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