Bestzyme announced today that its flagship product Mellia™ Brazzein has received a "No Questions" letter from the U.S. Food and Drug Administration (FDA) regarding its Generally Recognized as Safe (GRAS) status. This regulatory milestone enables the company to market the natural protein sweetener for a wide range of applications in the food and beverage industry.
The FDA's acknowledgment follows Bestzyme's successful Self-GRAS certification completed in July 2024, providing official confirmation of the product's safety profile and regulatory compliance. This approval represents a significant advancement in the natural sweetener industry and opens doors for international market expansion.
Novel Sweetener with Natural Origins
Brazzein is a sweet protein naturally found in the fruit of the West African plant Oubli (Pentadiplandra brazzeana Baillon). What distinguishes Bestzyme's approach is the company's development of sustainable, industrial-scale production methods using precision fermentation technology, eliminating the need for plant extraction.
"This FDA milestone validates years of research and development focused on creating a truly innovative sugar reduction solution," said Iris Jiang, Senior BD Manager at Bestzyme. "Mellia™ Brazzein represents a significant breakthrough in addressing the growing consumer demand for healthier food options without sacrificing taste."
Clinical and Metabolic Advantages
The molecular structure of Mellia™ Brazzein offers distinct advantages over conventional sweeteners. As a protein, it is rapidly digested into amino acids in the human body without raising blood glucose levels or disrupting the gut microbiome. This makes it particularly valuable for individuals managing diabetes or those seeking to reduce sugar consumption for health reasons.
The product delivers a clean sweet taste profile with high sweetness intensity and flavor-modifying properties. These characteristics make it suitable for multiple food categories including beverages, dairy products, confectionery, chocolate, health supplements, and prepared foods.
Market Implications and Industry Trends
The global market for sugar reduction ingredients is expanding rapidly, driven by increasing health consciousness and regulatory pressures to reduce sugar content in processed foods. According to industry analysts, the alternative sweetener market is projected to grow significantly over the next decade as consumers increasingly seek healthier dietary options.
Bestzyme's entry into this market with an FDA-approved product positions the company to capitalize on these trends. The zero-calorie profile of Mellia™ Brazzein addresses specific consumer concerns about artificial sweeteners while providing food manufacturers with a versatile ingredient for reformulation efforts.
Sustainable Production Approach
The company's precision fermentation process represents a sustainable manufacturing approach compared to traditional extraction methods. This production technology allows for consistent quality and scalable output without the environmental impact associated with agricultural expansion or intensive harvesting.
"Our fermentation-based production platform enables us to produce this naturally-occurring protein at commercial scale with consistent quality and without seasonal variability," explained a company representative. "This manufacturing approach aligns with our commitment to sustainable practices while meeting market demands."
Corporate Strategy and Future Directions
Bestzyme, a subsidiary of GenScript Biotech Corporation, views Mellia™ Brazzein as a cornerstone in its functional protein product pipeline. The company specializes in biology manufacturing with a focus on enzymes, functional proteins, and biopharmaceutical raw materials.
Through its proprietary synthetic biology technology platform, Bestzyme has developed capabilities spanning molecular design, strain engineering, and process scaling. This integrated approach has yielded dozens of high-performance products with applications across multiple industries including food and nutrition, animal health, household care, pharmaceuticals, and green manufacturing.
The company indicates that this product launch represents just one element of a broader strategy to develop biologically-derived ingredients that support health-conscious consumer choices while advancing sustainable manufacturing practices.
Regulatory Context and Significance
The FDA's "No Questions" letter regarding GRAS status is a critical regulatory milestone for novel food ingredients in the United States. This designation indicates that the agency has reviewed the safety data provided by the manufacturer and has not identified any concerns that would prevent the ingredient from being considered safe for its intended use.
For food manufacturers looking to reformulate products with reduced sugar content, this regulatory clearance removes a significant barrier to adoption and provides confidence in the ingredient's safety profile. The GRAS status specifically allows for Mellia™ Brazzein to be used as a general-purpose sweetener across diverse food categories.
Competitive Landscape
Mellia™ Brazzein enters a competitive landscape of alternative sweeteners that includes both artificial options like aspartame and sucralose as well as natural alternatives such as stevia and monk fruit. What distinguishes brazzein in this market is its protein-based structure, which offers different functional properties and potential advantages in certain applications.
The product's entry into the market comes at a time when food manufacturers are actively seeking new ingredients to address sugar reduction goals while maintaining consumer acceptance. The clean taste profile of Mellia™ Brazzein may provide advantages in applications where other high-intensity sweeteners have faced challenges with aftertaste or flavor interactions.
With this regulatory approval secured, Bestzyme is positioned to collaborate with food and beverage manufacturers on product reformulations that address both consumer preferences for natural ingredients and public health objectives related to reduced sugar consumption.
