By Danielle Masterson
November 7, 2019
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The prebiotic Arabinoxylan Plant Fiber Extract trademarked as Arrabina, is officially considered safe
Comet Bio, a manufacturer of health and sustainable ingredients, just announced it has received GRAS status for its prebiotic dietary fiber Arabinoxylan Plant Fiber Extract, trademarked as Arrabina.
GRAS (Generally Recognized As Safe) signifies that a food ingredient meets the standards accepted by the FDA for proper safety and scientific evidence. For an ingredient to be considered GRAS, scientific data and information about the intended use of the substance must be widely known, and there must be a consensus among qualified experts that the data and information established is safe under the conditions of its intended use.
“Our ingredient is safe”
Achieving our Self-Affirmed GRAS status with the help of Dicentra team was an imperative step to certify that our ingredient is safe,” said Rich Troyer, CEO of Comet Bio.
Troyer told NutraIngredients-USA that they first sought out to achieve a self-affirmed GRAS for their Arrabina™ prebiotic dietary fiber earlier this year. “in order to kick-start this process, we teamed up with our partners over at dicentra, who, from the beginning, proved to be a vital cog in this operation. Certifications such as these can take some time, but due to the hard work of both teams, we surpassed our initial projected timeline.”
Arabinoxylan Plant Fiber Extract is a naturally occurring dietary fiber found in the cell walls of many plants. Comet Bio produces its Arabinoxylan Plant Fiber Extract from upcycled materials such as stalks, leaves, and hulls, making it highly sustainable. Arabinoxylan has been shown to support the growth of beneficial bacteria within the gut and help maintain healthy blood glucose levels.
Comet Bio, with assistance from Dicentra, a leading contract research organization (CRO) and consulting firm for food and supplement safety, compliance and quality, engaged experts to proactively gather and provide the scientific evidence necessary to affirm this important FDA designation. The Independent panel declared Comet Bio’s Arrabina™ dietary fiber as safe for foods, beverages, and dietary supplement applications.
“This status allows us to better serve our customers in the food, beverage, and supplement categories with confidence,” added Troyer.
Teamwork makes the GRAS dream work
Dicentra provided the legwork: research, an initial analysis of GRAS requirements, prepared independent GRAS conclusions, as well as compiled the self-affirmed GRAS dossier for Comet Bio.
“They conducted a thorough review, necessary paperwork submission, and expert research. We couldn’t be happier with the work they have done in order to help us get to this point, and we look forward to continuing our partnership on many other projects,” said Troyer.
Dr. Karol Wojewnik, vice president of business development at Dicentra, said they are excited to provide their services to such an innovative company. “Comet Bio has a bold vision for the future of ingredients and dicentra is proud to have contributed to their success.”
“Obtaining GRAS status is a significant milestone for the commercialization of our ingredient and is an indication of our strong commitment to the efficacy and safety of our ingredients,” said Troyer, who told NutraIngredeints-USA, “As ingredient manufacturers, we operate by a set of rules. The rules not only set boundaries for the development of products in the supplement, food, and beverage space but, most importantly, prioritize the safety of the consumer. Achieving our self-affirmed GRAS is a pivotal moment for both our Arrabina prebiotic dietary fiber and our company as a whole. It signifies that we are doing our jobs and excelling within the regulatory guidelines. In order to better serve the supplement, food, and beverage industries, we must first ensure our product is safe. Today we’ve achieved that benchmark and look forward to the continued development of upcycled healthy ingredients.”