10.16.20
Synergia Life Sciences Pvt. Ltd., the makers of vitamin K2 as MK-7 ingredient MenaquinGold, announced that it has received an FDA “no question” letter in response to a GRAS notification the company submitted in October of last year. The ingredient is intended for use as a food ingredient and nutrient in a supplement, or a special dietary use product intended for children between the ages of one and 13 years old.
“Synergia is excited to receive this hard worked-on GRAS notification response from FDA,” Dr. Dilip Mehta, CEO of Synergia, said. “The MK-7 has increasingly been accepted as an important nutrient for human health, as a ‘multitasking’ vitamin contributing especially to bone, cardiovascular, and metabolic health. The current GRAS notification response from FDA is a significant step forward in the growing recognition of vitamin K2 as MK-7 as a safe nutritional supplement in children and adolescents.”
Synergia reports that the FDA’s opinion on MenaquinGold is the first of its kind for the use of vitamin K2 as MK-7. MK-7 has been shown in clinical trials to be the most effective and bioavailable form of vitamin K2, following several months of evaluation and correspondence between the company and the agency to clarify the scope of sue, the standardized manufacturing process, specifications, safety narrative, and scientific references.
The GRAS notification relates specifically to the Synergia-manufactured ingredient, which is manufactured through a fermentation technology production process utilizing the Bacillus lichenformis strain of fermentation bacteria.
“This GRAS notification will have a positive impact in the expansion of the vitamin K2 as MK-7 market and provide confidence to various food and nutritional supplement manufacturers on the safety evaluation of vitamin K2 as MK-7, especially MenaquinGold,” Dale Kriz, managing director of Nu Science Trading LLC, the distributor of MenaquinGold, said. “Currently, we are working on several innovative products incorporating natural MenaquinGold to cater to this growing market segment.”
“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 which is well supported scientifically with several preclinical, epidemiological, and clinical studies published over the last decade,” Dr. Vladimir Badmaev, MD, PhD, who has authored several publications on vitamin K and serves as the medical advisor to Synergia, said.
“Synergia is excited to receive this hard worked-on GRAS notification response from FDA,” Dr. Dilip Mehta, CEO of Synergia, said. “The MK-7 has increasingly been accepted as an important nutrient for human health, as a ‘multitasking’ vitamin contributing especially to bone, cardiovascular, and metabolic health. The current GRAS notification response from FDA is a significant step forward in the growing recognition of vitamin K2 as MK-7 as a safe nutritional supplement in children and adolescents.”
Synergia reports that the FDA’s opinion on MenaquinGold is the first of its kind for the use of vitamin K2 as MK-7. MK-7 has been shown in clinical trials to be the most effective and bioavailable form of vitamin K2, following several months of evaluation and correspondence between the company and the agency to clarify the scope of sue, the standardized manufacturing process, specifications, safety narrative, and scientific references.
The GRAS notification relates specifically to the Synergia-manufactured ingredient, which is manufactured through a fermentation technology production process utilizing the Bacillus lichenformis strain of fermentation bacteria.
“This GRAS notification will have a positive impact in the expansion of the vitamin K2 as MK-7 market and provide confidence to various food and nutritional supplement manufacturers on the safety evaluation of vitamin K2 as MK-7, especially MenaquinGold,” Dale Kriz, managing director of Nu Science Trading LLC, the distributor of MenaquinGold, said. “Currently, we are working on several innovative products incorporating natural MenaquinGold to cater to this growing market segment.”
“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 which is well supported scientifically with several preclinical, epidemiological, and clinical studies published over the last decade,” Dr. Vladimir Badmaev, MD, PhD, who has authored several publications on vitamin K and serves as the medical advisor to Synergia, said.
