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Canadian Regulatory Update.
In the late fall of 1997 Health Canada issued a public announcement completely repudiating Codex Alimentarius (see HerbalGram #39, page 28), and stating that Canada does not and will not support Codex at any level. Even if Codex does pass the review procedure in the World Trade Organization (WTO), it will not affect the availability of herbal medicines or nutritional supplements in Canada because, if these are taken for therapeutic purposes and are not clearly recognizable as food items, then they are considered to be "therapeutic products" and are not regulated under the food guidelines which Codex affects.

The legal status of herbs in Canada is currently undergoing serious scrutiny. The Advisory Panel on Natural Health Products has been created by the Health Minister and given a wide mandate to review and revise the entire regulatory framework of natural health products and to create new regulatory guidelines that ensure consumer access to safe and effective products. The panel has 17 members with broad representation, including five consumer groups, two Western clinical herbalists, a naturopath, two complementary M.D.s, a pharmacist, a wholesaler, a manufacturer, two Traditional Chinese Medicine practitioners, a representative from the Assembly of First Nations, and an importer. Panel members have been working since June 1996. A preliminary report should be available early in 1998. So far the panel is leaning towards creating a separate regulatory category, within the Therapeutic Products Directorate but distinct from the drugs category, with classification of herbs and drugs bei ng based on four criteria: dose volume, dosage form, claims made, and relative risk.

So far, under the influence of the Panel, a number of concessions have been made by Health Canada and the general tone of the discussions has been conciliatory and cooperative. The Drug Status Manual which restricted over 60 herbs from sale has been scrapped and replaced with the Therapeutic Products Compliance Guide which lists and restricts only six herbs -- Gotu kola (Centella asiatica), Nux vomica (Strychnos nuxvomica), Comfrey (Symphytum officinal), Chaparral (Larrea tridentata), Germander (Teucrium chamaedrys), and Calamus (Acorus calamus). These may not be sold in any form. There are 16 herbs listed by the Foods Directorate as posing a possible health hazard if consumed regularly as foods -- in other words these herbs would be required to have a Drug Identification Number (DIN) from the Therapeutic Products Directorate before being permitted for sale in Canada. They are Chaparral, Ephedra (Ephedra sinica), Germander, Gotu kola, Horsetail (Equisteum arvense), Kava kava (Pi per methysticum), Khat (Catha edulis), Senna (Senna alexandrina), Cascara (Rhamnus purshiana), Calamus, Comfrey, Yellow jessamine (Gelsemium sempervirens), Magnolia (Magnolia liliflora), Pleurisy root (Asclepias tuberosa), Stephania (Stephania tetrandra) and Arnica (Arnica spp.).

Any herb or natural health product for which a medical claim is made is still subject to Drug Identification Number (DIN) regulations. The panel is suggesting that structure/function claims and risk reduction claims be permitted on traditional herbal products by using a much simpler notification scheme and not the DIN procedure and placing the burden of proof on Health Canada to prove harm instead of on the manufacturer to prove safety.

The director general of the Therapeutic Products Directorate of the Health Protection Branch has determined that Schedule A (the list of diseases that a patient cannot self diagnose or treat such as impotence, alcoholism, obesity, and menopause) should be scrapped; he will make this recommendation to the Health Minister.

The Standing Committee on Health (a parliamentary group) commenced public hearings in December and is considering the whole issue of natural medicine and how best it fits into the current health care model. The committee looks likely to endorse the recommendations of the advisory panel, made after careful consideration by all interested parties. The committee report should be made by late spring 1998 and then the Health Minister will decide how to proceed.

A recent nationwide poll showing that 70 percent of the population think the health care plan should include herbs and natural medicine is bound to influence his decisions.

It is not beyond the realms of possibility that Canada could adopt and implement a model of regulation that sets a precedent for other countries to have safe, sensible, and cost effective regulations that ensure freedom of choice and consumer safety.

Article copyright American Botanical Council.


By Chanchal Cabrera