A new dietary ingredient (NDI) notification was originally submitted by Dong-A Pharmaceutical back in December 2015, with the help of a regulatory management consulting firm Ingredient Identity.
"Achieving an NDI status from the FDA validates the safety of the ingredient and will help to greatly expand our business in the United States, specifically in the Dietary Supplement market,” said Yong Sam Kwon, Research Fellow in the Consumer Product Research division of Dong-A Pharmaceutical.
Studies on the extract
The flowering plant, which grows in cool temperate regions of the Northern Hemisphere, has been studied for it antioxidant capabilities, specifically eye and skin health. A search on PubMed revealed that there have been 14 studies in the past 10 years on bog bilberry, seven of which were human studies.
One 2016 study by researchers at Dongguk University found that oral intake of bog bilberry extract for 1000 mg/day for four weeks alleviated eye strain symptoms caused by tablet computer watching. Another study from 2009 found that, in vitro, anthocyanins of bog bilberry extract supported UV-induced skin aging signs.
Currently, up to 500mg/day is the suggested daily usage of bog bilberry deemed safe. “The bog bilberry custom extract is far superior to other conventional bilberry ingredients in the marketplace due to its very unique anthocyanin profile and total polyphenol content, which have been studied extensively in Korea and abroad,” according to the company.
“This success serves as a blue print for many other new ingredients currently in development,” Kwon added. “This NDI status is a great accomplishment given high number of notifications that receive objection letters following the rigorous review process by the FDA."