Synergia Life Sciences has received an FDA “No Question” letter in response to a GRAS Notification for the intended use of the MenaquinGold brand of vitamin K2 MK-7, according to a press release. “Intended use,” in this case, is as a food ingredient and as a nutrient in supplements or foods for special dietary uses intended for children 1 to 13 years old.
The FDA opinion comes after several months of critical evaluation and correspondence clarifying the scope of use, the standardized manufacturing process, specifications, and safety narrative. The press release notes that this is the first time that FDA has issued such a letter for use of MK-7.
Dr. Vladimir Badmaev, M.D., Ph.D., author of several publications on vitamin K and Medical Advisor to Synergia Life Sciences, said in the press release: “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.”
Dr. Dilip Mehta, Chief Executive Officer of Synergia Life Sciences Pvt. Ltd., added: “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, concluded: “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.”