FDA Issues No Questions Letter for Natural Preservative, Chiber™ Produced by Chinova Bioworks
Chinova Bioworks Receives FDA Generally Recognized As Safe (GRAS) Status For Natural Preservative, Chiber™
News provided byChinova Bioworks Inc.
Jul 27, 2022, 8:30 AM ET
FREDERICTON, New Brunswick, July 27, 2022 (GLOBE NEWSWIRE) -- Chinova Bioworks (Chinova), a Canadian company addressing consumers’ demand for healthy, natural, clean-label ingredients, received a No Questions Letter from the U.S. Food and Drug Administration (FDA) regarding their Generally Recognized As Safe (GRAS) Notice No. GRN 000997 application for Chiber™ Mushroom Fiber, a natural food and beverage preservative.
The FDA created the GRAS procedure to ensure companies performed the necessary research and testing, demonstrating their food ingredients are safe for the public at the intended levels and use specified within the application. A No Question Letter is the FDA’s communication showing an ingredient is permitted for use. FDA GRAS status is recognized in many countries outside the U.S. and aids in garnering regulatory ingredient acceptance abroad.
Chiber™ is a natural mushroom fiber derived from the upcycled stems of white button mushrooms. This fiber functions as a natural preservative used to improve the quality, freshness, and shelf-life of various food and beverage products such as cottage cheese, plant-based meats, and hummus.
"We’re excited to get this additional level of regulatory acceptance for Chiber™, as it shows our commitment to making it a healthy and transparent ingredient for consumers. Mushrooms have long been overlooked by our food system for their incredible functional properties, but we have found a great use for this mushroom fiber as a natural replacement for artificial preservatives," said David Brown, Co-founder and Chief Operations Officer of Chinova Bioworks. "After years of preparation, analysis, and research needed to show the safety, quality, and natural processing, we are so pleased to have received this No Questions Letter from the FDA."
Prior to receiving the FDA No Questions Letter, Chinova Bioworks convened an independent expert panel of scientists to evaluate Chinova’s GRAS conclusion in accordance with scientific procedures under 21 CFR 170.30(a)(b). The company also enlisted the guidance of Intertek, a leading provider of comprehensive science-based quality, safety and sustainability assurance solutions, to assist them in developing and implementing the necessary tests and to help the company prepare for its GRAS evaluation.
"Regulatory compliance can be intimidating for companies looking to expand into regions outside of their own country, since each one has its own guidelines," said Dr. Shahrzad Tafazoli, Director, Safety & Regulatory Food & Nutrition Group, from Intertek, the lead regulatory scientist for Chinova. "Chinova Bioworks and Intertek worked collaboratively to prepare the safety studies, toxicology reviews and show the effectiveness of Chiber™ in a variety of food and beverage products."
Chinova Bioworks also received FEMA-GRAS status for Chiber™ on June 10, 2019, from the Flavor and Extract Manufacturers Association which has one of the longest and most widely recognized GRAS assessment programs in the world. With the GRAS uses of Chiber™ recognized by FEMA and through the FDA’s GRAS voluntary GRAS notification program, Chinova’s Chiber™ now has a global regulatory reach as a safe and effective natural preservative.
The positive evaluation of Chiber™ by the U.S. FDA comes on the heels of Chinova Bioworks receiving Series A funding, allowing the company to expand its manufacturing capabilities. The company is now working on another innovative functional mushroom ingredient that offers wine, beer, seltzer, and cider producers a vegan alternative to synthetic fining agents. This innovation is planned for a launch in mid-August of 2022.
About Chinova Bioworks:
Chinova Bioworks is a Canadian company that addresses the growing consumer demand for healthy, natural, clean-label ingredients. Chinova has developed a natural preservative extracted from the stems of white button mushrooms for various food and beverage products. Chinova's natural, clean-label technology reduces the reliance on artificial ingredients & improves quality, freshness, and shelf-life, encouraging healthier long-lasting effects, increased customer satisfaction, and reduced food waste. The company has raised $10M in investment with a team representing 90% of women in STEM.
For more information, please visit www.chinovabioworks.com
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Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers' operations and supply chains. Intertek Total Quality Assurance expertise, delivered consistently with precision, pace and passion, enabling our customers to power ahead safely.
For more information, please visit www.intertek.com.
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