FDA Has No Questions to GRAS Notification Regarding Oligonol for Food and Beverage Applications
SAPPORO, JAPAN & PURCHASE, NY, USA --- Amino Up Chemical Co., Ltd. and Maypro Industries today announced that the U.S. Food and Drug Administration ("FDA") has issued a - Generally Recognized as Safe (GRAS) Letter of No Questions for Oligonol® - the world’s first commercially produced low-molecular-weight polyphenol, for use in foods and beverages.
The GRAS process is an FDA-recognized pathway that permits companies to have GRAS reviews carried out by independent panels of scientists, followed by GRAS determinations if an ingredient meets the FDA's criteria for safety. After completing the GRAS self-determination in 2009, Amino Up Chemical has now validated the panel’s findings via the safety notification dossier to the FDA which was acknowledged with the agency’s letter issued on June 12th, 2014. In 2007, Amino Up received a Letter of No Objection from the FDA for the use of Oligonol as a “New Dietary Ingredient” (NDI) in nutritional supplement products. This makes Oligonol one of the few products in the marketplace to have achieved both, FDA-notified GRAS and NDI status.
“Receiving a Letter of No Questions is an achievement that we are proud of because it confirms our commitment to safety and quality of our products.” said Hajime Fujii, President of Amino Up. “Having reached this important regulatory milestone, we will continue to work closely with Maypro to further increase our sales of Oligonol in the United States.”
“This validation of safety will help us develop new opportunities for Oligonol, particularly in the functional food and beverage segment,” said Dan Lifton, President of Maypro’s Proprietary and Branded Ingredients business. “We are very grateful to Amino Up Chemical for their commitment to clinical research on the efficacy and safety of the ingredients they manufacture which we are proud to represent.”
Oligonol is a patented low-molecular-weight lychee fruit based polyphenol with proven superior bioavailability, manufactured by Amino Up Chemical Co., Ltd., in Sapporo, Japan and distributed in the United States by Maypro Industries. Supported by more than 20 human studies, Oligonol has been clinically shown to improve blood circulation and support cardiovascular health, increase endurance and reduce fatigue, improve skin health and reduce visceral fat.*
About Amino Up Chemical Co., Ltd.
Amino Up Chemical is a biotechnology company that develops and commercializes novel natural bioactive compounds and supports clinical and basic research on its products, both in-house and at prestigious universities and clinics around the world. Amino Up's products include Oligonol, AHCC® (the top immune-supporting nutraceutical produced from mushroom mycelium extract) and ETAS™ (innovative asparagus extract for stress relief, better sleep and clear mind). Both AHCC and Oligonol have won multiple industry awards, including the prestigious Nutracon Award.
About Maypro Industries
Since 1977, Maypro Group has been a global supplier of the highest quality nutraceutical ingredients to the supplement, sports nutrition, pet & veterinary, cosmetic, functional food and fine chemical industries. Maypro is a minority-owned affiliate of Marubeni Corporation, a Tokyo-based “Global Fortune 200” company with over US$40 billion in annual revenues and offices in 125 countries worldwide. Headquartered in Purchase, New York, Maypro operates 6 subsidiary companies based respectively in New York, Tokyo and Shanghai.
For more information, please visit www.maypro.com. IF YOU WOULD LIKE MORE INFORMATION ABOUT OLIGONOL®, PLEASE CALL DANIELLE BERNARDO AT 914-251-0701 x. 144 or via email at Danielle.Bernardo@maypro.com.
*These statements have not been evaluated by the Food & Drug Administration. This ingredient is not intended to diagnose, treat, cure or prevent any disease.