08.02.22
Canadian ingredient supplier Chinova Bioworks recently received a ‘No Questions’ letter from the U.S. Food and Drug Administration (FDA) regarding its Generally Recognized As Safe (GRAS) notice for Chiber Mushroom Fiber, a natural food and beverage preservative.
FDA created the GRAS procedure as a pathway for companies to prove they performed the necessary research and testing, and that their food ingredients are safe for the public at the intended levels for specified use. A "No Question" letter is FDA’s response that an ingredient is permitted for use.
Chiber is a natural mushroom fiber sourced from upcycled stems of white button mushrooms, and functions as a preservative used to improve the quality, freshness, and shelf-life of various food and beverage products including 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."
In order to provide FDA with a GRAS notice, the company 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 provider of quality, safety, and sustainability assurance services, to assist them in developing and implementing the necessary tests for 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 and regulatory, food and nutrition group, from Intertek. "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 (FEMA). With the GRAS uses of Chiber recognized by FEMA and through the FDA’s voluntary GRAS notification program, Chiber now has a global regulatory reach as a preservative.
The positive evaluation of Chiber by the U.S. FDA comes on the heels of the company receiving Series A funding, allowing the company to expand its manufacturing capabilities. The company is also working on another functional mushroom ingredient that offers wine, beer, seltzer, and cider producers an alternative to synthetic fining agents, with a launch planned for mid-August.
FDA created the GRAS procedure as a pathway for companies to prove they performed the necessary research and testing, and that their food ingredients are safe for the public at the intended levels for specified use. A "No Question" letter is FDA’s response that an ingredient is permitted for use.
Chiber is a natural mushroom fiber sourced from upcycled stems of white button mushrooms, and functions as a preservative used to improve the quality, freshness, and shelf-life of various food and beverage products including 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."
In order to provide FDA with a GRAS notice, the company 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 provider of quality, safety, and sustainability assurance services, to assist them in developing and implementing the necessary tests for 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 and regulatory, food and nutrition group, from Intertek. "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 (FEMA). With the GRAS uses of Chiber recognized by FEMA and through the FDA’s voluntary GRAS notification program, Chiber now has a global regulatory reach as a preservative.
The positive evaluation of Chiber by the U.S. FDA comes on the heels of the company receiving Series A funding, allowing the company to expand its manufacturing capabilities. The company is also working on another functional mushroom ingredient that offers wine, beer, seltzer, and cider producers an alternative to synthetic fining agents, with a launch planned for mid-August.
