Synergia Life Sciences Pvt. Ltd. (India) has announced that it received a “no question” letter to a GRAS (generally recognized as safe) Notification (GRN000887), submitted to the FDA (U.S. Food and Drug Administration) 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.
“Synergia is excited to receive this hard worked on GRAS Notification response from FDA,” said Dr. Dilip Mehta, chief executive officer of Synergia Life Sciences Pvt. Ltd. “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.”
“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,” added Dale Kriz, managing director of Nu Science Trading LLC (Phoenix AZ), distributor of MenaquinGold for the North American nutritional market.“Currently, we are working on several innovative products incorporating Natural MenaquinGold to cater to this growing market segment.”
Dr. Vladimir Badmaev, MD PhD, author of several publications on vitamin K and medical advisor to Synergia Life Sciences said, “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 pre-clinical, epidemiological and clinical studies published over the last decade.”