Amino Up Chemical Co. Ltd. and Maypro Industries announced that the U.S. Food and Drug Administration 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 12, 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.”