Notice of Consultation on the Prescription Drug List: Vitamin D

May 22, 2019
Our file number: 19-11025-630

This Notice of Consultation provides an opportunity to comment on the proposal to amend the Prescription Drug List (PDL) qualifier for Vitamin D to allow non-prescription status to products containing up to 62.5 µg or 2,500 International Units (IU)/day for oral use. Only the Human part of the PDL is proposed to be revised.

The current listing is:
Drugs containing any of the following: Including (but not limited to): Qualifier: Effective Date:
Vitamin D n/a In oral dosage form containing more than 1,000 International Units of Vitamin D per dosage form or, where the largest recommended daily dosage shown on the label would, if consumed by a person, result in the daily intake by that person of more than 1,000 International Units of Vitamin D 2013-12-19
The proposed listing is:
Drugs containing any of the following: Including (but not limited to): Qualifier: Effective Date:
Vitamin D n/a In oral dosage form containing more than 62.5 µg or 2,500 International Units of Vitamin D per dosage form or, where the largest recommended daily dosage shown on the label would result in the daily intake by that person of more than 62.5 µg or 2,500 International Units of Vitamin D To be determined

Rationale:

Vitamin D (cholecalciferol) facilitates the absorption of calcium and phosphate, which play a significant role in bone mineralization. Vitamin D is synthesized in the skin under influence of the sun, but it can also be obtained from foods and supplements. It was added to Schedule F (now known as the PDL) in 1997, which restricted the amounts of vitamin D levels up to 1,000 IU in non-prescription products.

Health Canada has received requests over the past few years from consumers, physicians and industry regarding potentially increasing the non-prescription vitamin D limit set out on the PDL. In addition, the Natural and Non-prescription Health Products Directorate (NNHPD) has received various product license applications (PLAs) ranging from 2,000 IU to 10,000 IU of vitamin D per daily dose.

With the mounting interest from stakeholders, and given that the scientific evidence regarding supplemental vitamin D has evolved since 1997, Health Canada's Food Directorate undertook a safety assessment to determine whether sufficient safety information existed to justify raising the maximum non-prescription vitamin D level up to 2,500 IU (62.5 µg).

According to the Food Directorate's review Footnote 1, 2,500 IU (62.5 µg) would provide a safe maximum level of vitamin D in non-prescription supplements. The Food Directorate's methodology for obtaining this level involved subtracting the current estimated intake of vitamin D from food (~1000 IU/day) and supplements (~500 IU/day) from the Institute of Medicine's (IOM 2011) Tolerable Upper Intake Level (UL) of 4,000 IU (100 µg)/day for children 9-13, adolescents and adults. It should be noted that the UL is not a recommended intake level. It reflects the highest average daily intake of a nutrient that is likely to pose no risk of adverse effects in the general population. The UL itself was set by adjusting for uncertainty from a "no observed adverse effect level" intake value of 10,000 IU (250 µg)/day. A maximum non-prescription vitamin D level of 2,500 IU (62.5 µg) would continue to allow an acceptable margin of safety. This proposed PDL limit applies to both cholecalciferol (vitamin D3) and ergocalciferol (vitamin D2).

It is important to note that the proposed maximum supplemental vitamin D dosage of 2,500 IU (62.5 µg) is not considered a safe dosage for all subpopulations. The vitamin D Tolerable Upper Intake Level (UL) for infants 0-6 months of age is 1,000 IU (25 µg)/day, for infants of 7-12 months it is rounded to 1,500 IU (38 µg)/day, and for children 1-3 years old it is rounded to 2,500 IU (63 µg)/day. There are other vulnerable subpopulations, documented adverse effects, drug interactions, cautions, warnings, and contraindications that may need to be included on the labels of high-dose vitamin D supplements.

The proposed maximum non-prescription limit of 2,500 IU is not based on a benefit-harms assessment and it is not a recommended level of vitamin D intake. It should be noted that, from a public health perspective, there is no nutritional or health requirement to increase the non-prescription limit of 1,000 IU (25 µg)/day. The Recommended Dietary Allowance (RDA) for vitamin D in healthy people aged 9 to 70 years of age is 600 IU (15 µg)/day and in adults over 70 years of age it is 800 IU (20 µg)/day. The RDA is the daily amount of a nutrient required to meet the needs of about 97.5% of the population. Footnote 2

While Health Canada is undertaking the current consultation on the basis of the above-mentioned safety review, the Food Directorate is conducting a systematic review regarding potential harms of chronic intake of vitamin D between the current prescription level of >1,000 IU and the established UL of 4,000 IU. Stakeholder comments received will be considered in conjunction with the Food Directorate's ongoing systematic review.

Comments on this proposed change to the PDL should be provided to Health Canada in writing, preferably in electronic format, within 60 days from the date of this notice.

Please send your comments to:

Health Canada
Prescription Drug Status Committee
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott Street
Ottawa, Ontario
K1A 0K9
Telephone: 613-957-1058
Facsimile: 613-941-5035
E-mail: drug_prescription_status-statut_d'ordonnance_des_drogues@hc-sc.gc.ca

Next steps:

All comments will be reviewed and summarised. Should Health Canada proceed with the amendment, a Notice of Intent to Amend the PDL will be posted on the Health Canada website.

Additional information on how Health Canada determines prescription status (or non-prescription status) is available in the Guidance Document: Determining Prescription Status for Human and Veterinary Drugs.

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