Natural Vitamin K2 Self-Affirmed GRAS

An independent panel, using scientific procedures and safety-assessment criteria established by FDA, has determined that natural vitamin K2 (menaquinone-7), is self-affirmed GRAS for use in dairy products. The panels analysis included a critical review of extensive safety, toxicology and clinical-research data.

Menaquinone-7 is extracted from natto, a traditional, fermented Japanese health food, often eaten for breakfast with steamed rice. Natto is created by fermenting soaked, steamed soybeans with Bacillus subtilis Natto.

Vitamin K2 intake is linked to improved bone and cardiovascular health. It also plays a role in helping the body utilize calcium. A Dutch study in 2004, as reported in The Journal of Nutrition (134:3,100-3,105), concluded menaquinone (vitamin K2) intake can help prevent coronary heart disease (CHD). However, phylloquinone (vitamin K1) intake had no effect on CHD.

This GRAS process for natural vitamin K2 was cooperatively facilitated by NattoPharma and P.L. Thomas & Co., Inc. Above and beyond this self-affirmed GRAS designation, the companies are submitting the GRAS assessment document to FDA for comment. They plan to submit an extension of GRAS status for uses beyond dairy applications.