THE FDA “NO QUESTION” GRAS NOTIFICATION FOR VITAMIN K2 (MK-7), MENAQUINGOLD®
Synergia Life Sciences Pvt. Ltd. is pleased to announce that it received FDA “No Question” letter1 to a GRAS Notification (GRN000887), submitted to the FDA on Oct 21, 2019, for the intended use of a form of Natural vitamin K2, menaquinone-7 (MK-7), the MenaquinGold® brand as a food ingredient and as a nutrient in oral nutritional supplement products or foods for special dietary uses intended for children 1 to 13 years old.
After several months of critical evaluation and correspondence clarifying the scope of use, the standardized manufacturing process, specifications, safety narrative, and cited scientific references, the FDA opinioned on Synergia’s GRAS Notification and issued the “No Question” letter. This is the first time that the FDA has issued such a letter for use of MK-7. The GRAS Notification specifically relates to Natural Vitamin K2 (MK-7), MenaquinGold® brand, manufactured by Synergia Life Sciences Pvt. Ltd. through fermentation technology production process utilizing Bacillus licheniformis strain of fermentation bacterium.
Dr. Dilip Mehta, Chief Executive Officer of Synergia Life Sciences Pvt. Ltd., says: “Synergia is excited to receive this hard worked on GRAS Notification response from FDA. The MK-7 has increasingly been accepted as an important nutrient for human health “multitasking” vitamin, contributing especially to the bone, cardiovascular and metabolic health. The current GRAS Notification response from FDA is a significant step forward in the growing recognition of Vitamin K2 (MK-7) as a safe nutritional supplement in children and adolescents”.
Dale Kriz, Managing Director of Nu Science Trading LLC, Phoenix AZ, distributor of MenaquinGold® for the North American nutritional market, says: “ This GRAS Notification will have a positive impact in the expansion of the Vitamin K2 (MK-7) market and provide confidence to various food and nutritional supplement manufacturers on the safety evaluation of Vitamin K2 (MK-7), especially Natural MenaquinGold®. Currently, we are working on several innovative products incorporating Natural MenaquinGold® to cater to this growing market segment.”
Dr. Vladimir Badmaev, MD Ph.D. author of several publications on vitamin K and Medical Advisor to Synergia Life Sciences says “The research on healthy bones in children and young adults, while recognizing the important role of calcium and vitamin D brings up the beneficial and versatile role of vitamin K2 as menaquinone-7 (MK-7) which is well supported scientifically, with several preclinical, epidemiological, and clinical studies published over the last decade.”
1. The text of the FDA response letter corresponding to GRN 000887 is accessible at www.fda.gov/grasnoticeinventory
About Synergia Life Sciences and MenaquinGold®
Synergia Life Sciences is a leading manufacturer and supplier of Natural Vitamin K2 (MK-7) under trade name MenaquinGold®. MenaquinGold® is the most extensively researched Vitamin K2 (MK-7) in the market, and is supported by several clinical trials, extensive safety, and toxicity studies, manufacturing and application patents, well-documented manufacturing processes, validated analytical methods, and stability studies following ICH guidelines. The state-of-art manufacturing facility is NSF cGMP, HACCP, ISO-22000 certified. The MenaquinGold® Natural Vitamin K2 (MK-7) product grades are Non-GMO, Halal, and Kosher certified.
MenaquinGold® is supplied to the global markets for use in functional foods, nutritional and dietary supplements, and pharmaceutical preparations. For more information, visit www.synergialifesciences.com and www.menaquingold.com