Notice: Health Canada Review of Vitamin D Levels for Non-Prescription Use

June 4, 2018
Our file number: 18-104907-757

The current non-prescription limit of 1,000 International Units (IU) for vitamin D was added to Schedule F (now the Prescription Drug List (PDL)) in 1997. Since that time, additional scientific evidence regarding safe levels of vitamin D supplementation has been published.

Health Canada has received queries from consumers, physicians and industry regarding the non-prescription level on the PDL. Some international regulatory counterparts have non-prescription limits for vitamin D which exceed that of Health Canada’s. Given the evolving scientific evidence and interest from stakeholders, the Therapeutic Products Directorate will be undertaking a review to determine whether the vitamin D level on the PDL should be increased for non-prescription use.

The results of this review will be published on Health Canada’s website, targeted for early 2019 and any proposed amendments to the PDL will be posted for a public consultation. Should an amendment proceed, a six-month delayed implementation would ensue to comply with Canada’s international trade obligations under the World Trade Organization’s Agreement on Technical Barriers to Trade, and to enable sponsors to amend their licences and labels as needed.

Should you have questions or comments regarding the content of the Notice, please contact:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Products and Food Branch
Health Canada
Holland Cross, Tower B
1600 Scott Street
Address Locator 3102C1
Ottawa, Ontario
K1A 0K9

Telephone: 613-948-4623
Facsimile: 613-941-1812
E-mail: hc.policy.bureau.enquiries.sc@canada.ca