The First Bog Bilberry New Dietary Ingredient For The US Market

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Dong-A Pharmaceutical Co. Ltd., an innovator of health, wellness and nutritional finished products and ingredients for the global markets of dietary supplements, foods, and skin care products received New Dietary Ingredient (NDI) status for its patented Bog Bilberry (Vaccinium uligionosum) ingredient from the U.S. Food and Drug Administration, following its submission by Ingredient Identity, a specialized regulatory management consulting firm based in California, USA.

Dong-A Pharmaceutical Co. Ltd., an innovator of health, wellness and nutritional finished products and ingredients for the global markets of dietary supplements, foods, and skin care products received New Dietary Ingredient (NDI) status for its patented Bog Bilberry (Vaccinium uligionosum) ingredient from the U.S. Food and Drug Administration, following its submission by Ingredient Identity, a specialized regulatory management consulting firm based in California, USA.

Dong-A Pharmaceutical has successfully introduced the first commercially available and patented novel Bog Bilberry extract. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) require that manufacturers and distributors of dietary supplements that contain new dietary ingredients to notify the Food and Drug Administration about these ingredients no less than 75 days prior to the intended sales and distribution date. The New Dietary Ingredient notification must include information that is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling. (See Section 413(d) of the FD&C Act, 21 U.S.C. 350b(d)).

Mr. Yong Sam Kwon, Research Fellow in the Consumer Product Research division of Dong-A Pharmaceutical stated “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. This success serves as a blue print for many other new ingredients currently in development. This NDI status is a great accomplishment given high number of notifications that receive objection letters following the rigorous review process by the FDA.”

The current suggested daily usage deemed safe for is up to 500mg/day, which was supported by numerous toxicological studies. 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.

The New Dietary Ingredient Notification (NDIN) was prepared and submitted to the FDA by Ingredient Identity on behalf of Dong-A Pharmaceutical. “We were exceptionally pleased to have been entrusted with this opportunity and with the outcome of this NDI submission. It demonstrates a great success in our clients’ ingredient development strategy and commitment to high quality ingredients intended for the US market.” said Brandon Griffin, CEO of Ingredient Identity.

About Dong-A Pharmaceutical:
Dong-A Pharmaceutical, one of the largest South Korean pharmaceutical companies, manufactures and markets natural products, pharmaceutical products and medical devices worldwide in various therapeutic areas including dietary supplements, cosmetics, gastroenterology, urology, oncology, cardiology and orthopedics. To learn more about Dong-A Pharmaceutical, please visit: http://www.dapharm.com

About Ingredient Identity:
Ingredient Identity is a preeminent regulatory management consulting firm enabling companies in the Food, Animal Feed, Dietary Supplement, Cosmetic and Homeopathic industries to improve profitability while optimizing quality systems under applicable regulations in the US and/or internationally, which collectively help mitigate overall regulatory and legal risks. For more information on the markets served and service offerings, please visit: http://www.ingredientidentity.com

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Brandon Griffin
Ingredient Identity

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