PURCHASE, N.Y.FDA issued a generally recognized as safe (GRAS) letter of no questions to Amino Up Chemical and Maypro Industries for the use of Oligonol® 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 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 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, a commercially produced low-molecular-weight polyphenol, 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.
“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."
Previous research shows Oligonol may help protect the kidneys of diabetic consumers.