What is the status of vitamin K and submissions containing vitamin K?
Currently, vitamin K is an ingredient listed on Part II of Schedule F without qualifiers and is therefore not a natural health product (NHP). This means that, at this time vitamin K is only available by prescription. A Notice of Intent was posted in Canada Gazette, Part I, (CGI) on April 9, 2005, to add qualifiers to this ingredient on Schedule F. The Notice of Intent proposed to amend Part II of Schedule F to the Food and Drug Regulations of the Food and Drugs Act to provide exemptions to allow nonprescription status for: • vitamin K1 and K2 in products intended for external use in humans; and • vitamin K1 and K2 in oral dosage forms for use in humans when the maximum recommended daily dose is equal to or less than 120 micrograms (0.120 milligrams). In a coincident amendment, it is also proposed to add vitamin K1 and K2 to Item 3 of Schedule 1, Included Natural Health Product Substances, to the Natural Health Products Regulations. However, the dosage forms and strengths of vitamin K r
