Registration
SOR/2005-307 October 4, 2005

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1385 — Vitamin K)

P.C. 2005-1723 October 4, 2005

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act, hereby makes the annexed Regulations Amending the Food and Drug Regulations (1385 — Vitamin K).

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1385 — VITAMIN K)

AMENDMENT

1. The reference to

Vitamin K
Vitamine K

in Part II of Schedule F to the Food and Drug Regulations (see footnote 1) is replaced by the following:

Vitamin K, except Vitamin K₁ and Vitamin K₂ sold

(a) for external use in humans; or

(b) in an oral dosage form for use in humans if the maximum recommended daily dose is 0.120 mg or less

Vitamine K, sauf la vitamine K₁ et la vitamine K₂ vendues :

COMING INTO FORCE

2. These Regulations come into force on the day on which they are registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Description

This regulatory amendment to Schedule F, Part II, to the Food and Drug Regulations creates nonprescription status for:

(1) 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); and

(2) Vitamin K₁ and K₂ in products intended for external use in humans.

A related amendment adds vitamin K₁ and K₂ to item 3 of Schedule 1 to the Natural Health Products Regulations. However, the dosage forms and strengths of vitamin K remaining on Schedule F to the Food and Drug Regulations would not be considered to be natural health products pursuant to subsection 2(2) of the Natural Health Products Regulations.

Schedule F is a list of medicinal ingredients, the sale of which is controlled under sections C.01.041 to C.01.049 of the Food and Drug Regulations. Part I of Schedule F lists ingredients that require a prescription for human use and for veterinary use. Part II of Schedule F lists ingredients that require a prescription for human use, but do not require a prescription for veterinary use if so labelled or if in a form unsuitable for human use. Vitamin K is presently listed in Part II of Schedule F.

Vitamin K is not a single chemical entity. The term "vitamin K" refers to a group of compounds known as vitamins K₁, K₂, K₃, K₄ and K₅. Vitamin K₁, also known as phylloquinone and phytonadione, is synthesized by plants. Vitamin K₂ is usually derived from microbes and is also known as menaquinone and menatetrenone.

The Drug Schedule Status Committee determines prescription status for medicinal ingredients on the basis of established and publicly available criteria. These criteria include, but are not limited to, concerns related to toxicity, pharmacological properties, and therapeutic applications.

Non-prescription status for Vitamin K₁ and K₂ at 120 micrograms or less for oral use

Vitamin K₁ and K₂ are the major dietary forms of vitamin K. The creation of non-prescription status for vitamin K₁ and K₂ in oral dosage forms when the maximum recommended daily dose is 120 micrograms or less is based on an evaluation of safety data and a review of the approaches used in other regulatory jurisdictions.

Other considerations

No adverse effects associated with vitamin K₁ or K₂ consumption from food or supplements have been reported in humans or animals at the recommended level of 120 micrograms per day or less. A comprehensive search of the literature revealed no evidence of toxicity associated with the intake of vitamin K₁ or K₂ at the level of 120 micrograms per day.

Many regulatory jurisdictions permit vitamin K below certain maximum daily doses to be sold as either a nonprescription drug or, as in the United States, a dietary supplement. The maximum recommended daily dose of 120 micrograms falls within the international range of levels (40 - 130 micrograms) not requiring a prescription.

The factors for placing a substance on Schedule F no longer apply to the oral dosage forms of vitamin K₁ and K₂ when the maximum daily dose recommended on the product label does not exceed 120 micrograms.

Alternative

The alternative option would have been to maintain the status quo; that is, not to allow nonprescription status for vitamin K₁ and K₂ in oral dosage forms when the maximum recommended daily dose is equal to or less than 120 micrograms. Retaining complete prescription status for vitamin K₁ and K₂ is not an appropriate risk management approach. The benefits of having vitamin K₁ and K₂ in oral dosage forms as a nonprescription drug clearly outweigh the risks, when the maximum recommended daily dose is 120 micrograms or less.

Nonprescription status for Vitamin K₁ and K₂ in products for external use in humans

This amendment also removes from Schedule F vitamin K₁ and K₂ when included as a medicinal ingredient in products for external use in humans. Initially, the prescription requirement for vitamin K and several other vitamins was stated only in Division 4 of Part D of the Food and Drug Regulations and pertained only to drugs for internal or parenteral use in humans. When vitamin K was added to Schedule F, an oversight occurred, and no qualifying wording was added to indicate that only vitamin K for internal or parenteral use required a prescription. Without qualification, all dosage forms of vitamin K, including topical products, required prescription status.

Alternative

The alternative option would have been to maintain the status quo; that is, not to allow nonprescription status for vitamin K₁ and K₂ in products intended for external use in humans. This option was not considered to be appropriate, as the safety profile of vitamin K₁ and K₂ in these products is consistent with other non-prescription products.

Addition of Vitamin K₁ and K₂ to the Natural Health Products Regulations

This amendment adds vitamin K₁ and K₂ to item 3 of Schedule 1 to the Natural Health Products Regulations. Schedule 1 of the Regulations sets out the substances that are natural health products providing they meet the definition of natural health product in the Natural Health Products Regulations.

When the Natural Health Product Regulations were first proposed, it was intended that vitamin K be contained in Schedule 1 to those Regulations. However, the listing of vitamin K in Schedule F to the Food and Drug Regulations was an impediment to the inclusion of vitamin K in the Natural Health Product Regulations, because, by virtue of subsection 2(2) of the Natural Health Product Regulations, a substance that is required to be sold pursuant to a prescription is not considered a natural health product. The amendment to Schedule F to the Food and Drug Regulations permits the related amendment to Schedule 1 to the Natural Health Product Regulations.

Alternative

Within the Natural Health Product Regulations, the alternative option would have been to maintain the status quo; that is, not to include vitamin K₁ and K₂ on Schedule 1. This option was not considered to be an appropriate risk management approach, since the Drug Schedule Status Committee has determined that the non-prescription sale of oral dosage forms of vitamin K₁ and K₂ below a certain level and vitamin K₁ and K₂ in products intended for external use is acceptable.

Benefits and Costs

These amendments will impact on the following sectors:

•  Public

The removal of the prescription requirement for vitamin K₁ and K₂ for oral use products when the maximum recommended daily dose is 120 micrograms or less and for vitamin K₁ and K₂ in external use products provides the consumer with easier access.

The public will be required to pay directly for the products as nonprescription products, which are not usually covered by drug insurance plans.

•  Health Care Professionals

A broader group of health care professionals (for example, naturopaths) will have access to this drug product at this dosage as a natural health product and will be able to recommend it to their patients without the need for prescription.

•  Pharmaceutical Industry

These regulatory amendments will permit manufacturers and distributors to sell vitamin K₁ and K₂ in products for oral use when the maximum recommended daily dose is 120 micrograms or less and vitamin K₁ and K₂ in products for external use without the intervention of a health professional, therefore providing the industry with more market flexibility.

•  Natural Health Products Industry

Manufacturers, packagers, labellers, importers and distributors will be able to sell this product as a natural health product.

Consultation

The Regulatory Impact Analysis Statement published with the Natural Health Products Regulations in the Canada Gazette, Part II, on June 18, 2003, clearly indicated that vitamin K could not be listed on Schedule 1 to the Natural Health Products Regulations until its prescription status was reassessed and its listing on Schedule F to the Food and Drug Regulations amended, if necessary.

Direct notice of the portion of this regulatory proposal to amend the Food and Drug Regulations was provided to provincial and territorial ministries of health, medical and pharmacy licensing bodies, and industry, consumer and professional associations on January 5, 2004 with a 30-day comment period. The original proposal recommended allowing nonprescription status for vitamin K₁ in oral dosage forms for use in humans when the maximum recommended daily dose was equal to or less than 80 micrograms. This initiative was also posted on the Therapeutic Products Directorate (TPD) website. Responses were received from 5 stakeholders based on the original proposal. Two additional respondents requested supplemental information regarding the proposal but did not provide specific comments on the proposal.

A Notice of Intent (NOI) was published in the Canada Gazette, Part I, on April 9, 2005 with a 75-day comment period. The NOI was also posted on the TPD website. The NOI included the comments received from stakeholders in the earlier consultation and provided Health Canada's responses to the issues raised. The NOI included two revisions to the proposed amendments. One revision specified that vitamin K₁ and K₂ are the forms of vitamin K that would be subject to the amendments. The other revision increased the nonprescription daily dose for oral use from 80 to 120 micrograms. This latter revision was made on the basis of further review of available information on vitamin K in response to a comment received on the proposed amendment set out in the January 5, 2004 letter to stakeholders.

Comments on the NOI were received from two stakeholders. One stakeholder supported the amendments and one stakeholder objected to the nonprescription limit of 120 micrograms or less for oral use. This stakeholder felt that restricting the nonprescription oral dosage of vitamin K₁ and K₂ to 120 micrograms or less means that naturopathic doctors will not be able to effectively treat patients suffering from serious disorders such as osteoporosis at such a low maximum daily dose. This stakeholder argued that without access to therapeutic dosages, patients are denied their right to receive treatment from the health care professional of their choice. It is Health Canada's decision not to raise the maximum daily dose permitted without a prescription any higher than 120 micrograms to accommodate the use by naturopathic doctors because this level would then inappropriately be made available to the general public as a nonprescription drug.

Compliance and Enforcement

These amendments will not alter existing compliance mechanisms under the provisions of the Food and Drugs Act and the Food and Drug Regulations and the Natural Health Products Regulations enforced by the Health Products and Food Branch Inspectorate.

Contact

Project # 1385
Policy Division
Policy Bureau
Therapeutic Products Directorate
1600 Scott Street
Holland Cross Tower "B", 2nd Floor
Address Locator 3102C5
Ottawa, Ontario
K1A 0K9
Telephone: (613) 948-4623 (Please reference the Project # when you call.)
FAX: (613) 941-6458
E-mail: RegAff Access/HC-SC/GC/CA

Footnote a

S.C. 1999, c. 33, s. 347

Footnote 1

C.R.C., c. 870

NOTICE:
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