Vol. 145, No. 25 — December 7, 2011
Registration
SOR/2011-273 November 24, 2011
FOOD AND DRUGS ACT
Regulations Amending the Food and Drug Regulations (1577 — Schedule F)
P.C. 2011-1351 November 24, 2011
His 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 (see footnote b), hereby makes the annexed Regulations Amending the Food and Drug Regulations (1577 — Schedule F).
REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1577 — SCHEDULE F)
AMENDMENTS
1. Part Ⅰ of Schedule F to the Food and Drug Regulations (see footnote 1) is amended by repealing the following:
Apiol, oil of
Apiol (huile d’)
Deanol, and its salts and derivatives
Déanol, ses sels et dérivés
Theobromine and its salts
Théobromine et ses sels
2. Part Ⅱ of Schedule F to the Regulations is amended by repealing the following:
Centella asiatica extract and active principles thereof
Centella asiatica (extrait de) et ses principes actifs
COMING INTO FORCE
3. 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.)
Issue and objectives
This amendment to Parts Ⅰ and II of Schedule F to the Food and Drug Regulations removes the listings for four naturally sourced medicinal ingredients, thus allowing them to have nonprescription status.
The four medicinal ingredients (1. apiol, oil of; 2. centella asiatica extract and active principles thereof; 3. deanol and its salts and derivatives; and 4. theobromine and its salts) are currently in Schedule F to the Food and Drug Regulations without any qualifying phrases or exceptions, and are therefore currently available by prescription only.
Sections C.01.041 to C.01.049 of the Food and Drug Regulations control the sale of medicinal ingredients that are listed in Schedule F. 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.
Since the coming into force of the Natural Health Products Regulations in 2004, all naturally sourced ingredients meeting the definition of a natural health product are governed by these regulations. However, products containing ingredients listed in Schedule F to the Food and Drug Regulations are explicitly excluded from the Natural Health Products Regulations.
Description and rationale
Health Canada undertook a review of the naturally sourced medicinal ingredients listed in Schedule F. As part of this undertaking, the Department’s Drug Schedule Status Committee (“the Committee”) reviewed science assessments for 11 naturally sourced medicinal ingredients and recommended these medicinal ingredients could be regulated (in whole or in part) as nonprescription natural health products under the Natural Health Products Regulations. Four of these eleven medicinal ingredients are presented in this project.
These four naturally sourced medicinal ingredients were added to Schedule F prior to the Natural Health Products Regulations coming into force in 2004. Following the review of the naturally sourced medicinal ingredients on Schedule F, the Committee recommended the following four naturally sourced medicinal ingredients be removed from Schedule F to the Food and Drug Regulations as none of the factors for listing in Schedule F were found to apply.
Manufacturers will be able to apply for market authorization for products containing these medicinal ingredients as natural health products pursuant to the Natural Health Products Regulations once the regulatory amendment comes into force. There are no known marketed-authorized products containing these medicinal ingredients therefore, no marketed products are affected by this regulatory amendment.
Description of the medicinal ingredients:
Apiol, oil of — Apiol oil is found in the essential oils of parsley seed, dill seed, and to a lesser extent in fennel seed, sassafras root bark and other plant species. A review of the available scientific literature indicates that there is a wide margin of safety between the therapeutic and toxic doses of apiol oil. It has toxic effects in humans exposed to doses of approximately 1 g/day; however, the common presence of apiol oil in foods indicates a lack of toxicity at doses likely to be found in herbal medicines. No health hazards or side effects are known in conjunction with appropriate therapeutic dosages of parsley seed, whose medicinal properties are largely attributed to the seed volatile oil apiol content and there are no reports of serious health risks associated with normal dietary ingestion or recommended medicinal use of parsley seed.
Centella asiatica extract and active principles thereof — Centella asiatica is derived from a small plant commonly known as gotukola (gotu kola). Centella asiatica extract is a concentrated preparation. An active principle is the part of the drug upon which the therapeutic action of the drug depends. Centella asiatica is available as a vegetable in South Asian markets. A review of the available scientific literature indicates that there is a wide margin of safety between the therapeutic and toxic doses of centella asiatica. Centella asiatica extract and active principles thereof pose a low risk of undesirable or severe side effects. There is a very low percentage of adverse reactions compared to its length and frequency of use both in food and medicine.
Deanol and its salts and derivatives — Deanol, also known as dimethylaminoethanol or DMAE, is a naturally sourced chemical found in salmon roe, shellfish and fish oils. Deanol is a precursor to choline, a chemical in the body used to make acetylcholine, a chemical that is found in the brain and other areas of the body. A review of the available scientific literature indicates that deanol does not have a narrow margin of safety between the therapeutic and toxic doses.
Theobromine and its salts — Theobromine is a naturally occurring chemical substance that is found in cocoa and chocolate and is also prepared synthetically for commercial purposes. Theobromine affects humans similarly to caffeine, but to a lesser degree. Toxicity from the use of theobromine is very rare and only seen at very high doses in humans and therefore it does not pose a high level of risk relative to expected benefits. As well, theobromine has no known severe side effects at normal therapeutic dosage levels. Due to theobromine’s low potency as a drug and the availability of more effective treatments, it is rarely used therapeutically anymore.
The availability of these four naturally sourced medicinal ingredients as nonprescription products may provide consumers with potential access to licensed natural health products. Potential safety concerns for products containing these nonprescription medicinal ingredients would be considered during the premarket review process under the Natural Health Products Regulations.
Manufacturers may benefit by being provided an opportunity to apply for product licences for natural health products containing these ingredients. There is no immediate impact on manufacturers as there are currently no known products containing these medicinal ingredients on the market in Canada.
There is no change in costs to provincial or privately funded drug benefit plans as there are no known drugs containing these medicinal ingredients on the market in Canada. Should natural health products containing these medicinal ingredients receive market authorization from Health Canada, there would be no anticipated additional costs to provincial or privately funded drugs benefit plans since at this time most do not cover the cost of natural health products.
Health Canada’s nonprescription status for centella asiatica and active principles thereof and theobromine and its salts brings Canada in line with the regulatory approaches of the United States (US), the United Kingdom (UK) and Australia. The nonprescription status for apiol oil and deanol and its salts and derivatives also brings Canada in line with the regulatory approaches of the US, UK and Australia with the following exceptions:
- in the UK, apiol oil is a prescription medicinal ingredient;
- in Australia, deanol and its salts and derivatives is a prescription medicinal ingredient.
The divergence in Health Canada’s nonprescription status for apiol oil and deanol and its salts and derivatives and prescription status in some other international jurisdictions is related to Canada’s specific regulatory framework for natural health products that involves a mandatory pre-market review prior to authorization and a compliance policy that targets unauthorized natural health products that pose an unacceptable risk to the health of consumers.
Consultation
Direct notice of this regulatory proposal was provided to external stakeholders, including provincial and territorial Ministries of Health, medical and pharmacy licensing bodies, and industry, consumer and professional associations in a Notice of Intent sent out on December 29, 2009, and published in the Canada Gazette, Part Ⅰ, on December 26, 2009, with a 75-day comment period. It was also posted on the Health Canada and Consulting with Canadians Web sites. The process for this consultation with stakeholders is described in the Memorandum of Understanding (MOU) to streamline regulatory amendments to Schedule F. The MOU, signed by Health Canada, the Privy Council Office and the Department of International Trade on February 23, 2005, is posted on the Health Canada Web site.
Comments were received from nine respondents. All comments received supported the proposed amendment. No negative comments were received. Seven of the nine comments received supported the removal of the following three ingredients from Schedule F: apiol, oil of; deanol and its salts and derivatives; and theobromine and its salts. Nine comments supported the removal of centella asiatica extract, and active principles thereof, from Schedule F. The comments received included the following:
- — access to these ingredients under the Natural Health Products Regulations will allow Canadians a broader choice of products;
- — we fully agree with Health Canada’s proposal to remove the ingredients from Schedule F as these ingredients do not appear to pose unnecessary risk with use according to available scientific literature; and
- — we do not have any concerns going forward with this deregulatory initiative that will permit safe and effective consumer health products containing these ingredients to be made available without a prescription.
Implementation, enforcement and service standards
This amendment will come into force on the day on which it is registered.
This amendment does not alter existing compliance mechanisms under the provisions of the Food and Drugs Act, the Food and Drug Regulations and the Natural Health Products Regulations enforced by the Health Products and Food Branch Inspectorate.
Contact
Refer to Project No. 1577
Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
1600 Scott Street, Holland Cross, Tower B, 2nd Floor
Address Locator: 3102C5
Ottawa, Ontario
K1A 0K9
Telephone: 613-948-4623
Fax: 613-941-6458
Email: regaff-affreg@hc-sc.gc.ca
Footnote a
S.C. 2005, c. 42, s. 2
Footnote b
R.S., c. F-27
Footnote 1
C.R.C., c. 870