A green tea probiotic strain (Lactobacillus plantarum APsulloc 331261) originally found by Amorepacific qualifies as an NDI as affirmed by the U.S. FDA.
The NDI (New Dietary Ingredient) is a notification for which U.S. FDA (Food and Drug Administration) requires manufacturers of dietary supplements containing new dietary ingredients to submit a safety notification to the FDA before their products are introduced into the U.S. market. The notification must include details of the manufacturing process, a description of the new dietary ingredients, the history of use or other evidence of safety establishing that they are reasonably expected to be safe, and any other information in support of the notification, thus complying with FDA requirements. Amorepacific submitted the notification for its Lactobacillus plantarum APsulloc 331261, which was then acknowledged as an NDI by the U.S. FDA.
Amorepacific discovered new probiotic strains, namely Lactobacillus plantarum APsulloc 331261, in its Jeju Dolsongi organic green tea field in 2010 and since then has further continued with its study of the plant. Through the study, Amorepacific demonstrated that its world-first patented green tea probiotic strains are superior to commonly known strains in terms of survival and persistence in the intestinal tract and their anti-inflammatory properties. In particular, Amorepacific has successfully brought its antibiotic resistance and virulence factor assessment criteria up to the level of the EFSA (European Food Safety Authority) guideline to further ensure the safety of its green tea probiotic strains.
In February 2020, Amorepacific established its Green Tea Probiotics Research Center under its R&D Center to deepen its study of green tea probiotic strains and microbiome, and in March last year, the company’s brand VITALBEAUTIE introduced ‘Green Tea Probiotics’ containing green tea probiotic strains for intestinal health. To date, over 15 million packs have been sold and the product is set to enter Amazon Global in the second half of this year, following its introduction to Vietnam and China.
"The safety of our green tea probiotic strains has been recognized once again and this time, by the internationally trusted U.S. FDA as a qualified New Dietary Ingredient. We will continue to deepen our study of green tea probiotic strains and microbiome and make our best effort to introduce more safe and innovative products for our customers all around the world," said Park Youngho, Head of Amorepacific R&D Center.