MONTREAL, Aug. 26 -- According to the Federal Food, Drug, and Cosmetic Act (Section 413b of the act (21 U.S.C. 350b) it is required that manufacturers and distributors who wish to market dietary supplements that contain "new dietary ingredients" obtain the Food and Drug Administration's approval to be allowed to sell their products in the US market.
The Food and Drug Administration (FDA) approved Neptune Krill Oil(TM) (NKO(TM)), Neptune Krill Aquatein(TM) (NKA(TM)) and Neptune LyO-Krill(TM) (NLK(TM)) as new dietary supplements for human consumption in the US market.
Neptune Technologies & Bioressources Inc. submitted to the Division of Standards and Labelling, a pre-market notification for Neptune Krill Oil(TM) (NKO(TM)), Neptune Krill Aquatein(TM) (NKA(TM)) and Neptune LyO-Krill(TM) (NLK(TM)) as dietary supplements that contain "new dietary ingredients". After reviewing the information submitted, FDA classified Neptune's products as safe for human consumption. "FDA acceptance of NKO(TM), NKA(TM) and NLK(TM) provides Neptune with an undisputable seal of credibility which opens the door to further clinical testing as well as to the US market", indicated Dr. Tina Sampalis, Vice-president Research of Neptune. "Our clientele's safety is of primary importance to Neptune and we are very pleased to have surpassed one of the most difficult and time consuming obstacles to be encountered in the US market by nutraceutical manufacturers", she added.
"This approval enables Neptune to freely market and sell its products in the US market, the largest nutraceutical market in the world. We are confident that our products will raise the bar of quality and efficacy in their respective niches" says Louis A. Lapointe, Sales Director of Neptune.
Neptune Technologies & Bioressources Inc. exploits extraction processes for marine biomasses such as krill and other underexploited marine resources such as red crab and calanus, in order to offer its products to the nutraceutical, cosmetic, cosmeceutical and biopharmaceutical markets. Due to its technologies, Neptune Technologies & Bioressources Inc. is strategically well positioned in the huge and emerging health and wellness markets in which natural biomass extraction will play an important role in developing nutrigenomics, the next wave in nutritional research.
Neptune Technologies s& Bioressources Inc. is listed on the TSX Venture Exchange where its shares trade under the ticker symbol NTB, therefore this transaction is subject to its approval.
The TSX Venture Exchange has not reviewed and does not accept responsibility for the adequacy and accuracy of this news release.