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3.3.5 Canada
The Canadian Food and Drug Act and findings of an Expert Advisory Committee on
Herbs and Botanical Preparations were consulted by Kozyrskyj (1997) to provide an
overview of the issues regarding regulation of herbal products in Canada. Case reports of
herbal toxicity were identified to illustrate some of the hazards of herbal products, and
references were provided to guide health professionals in searching the literature for
clinical trials that have evaluated the efficacy of these drugs.
Herbal products not registered as drugs in Canada are sold as foods and are thus
exempt from the drug review process that evaluates product efficacy and safety. An
Expert Advisory Committee on Herbs and Botanical Preparations was formed in 1984 to
advise the Health Protection Branch (HPB). HPB published lists of hazardous herbal
products in 1987, 1989, 1992 and 1993. The last publication elicited a large response
from consumers and the herbal industry. As of 1995, the list was still under review
(Kozyrskyj, 1997).
The recently formed Office of Natural Health Products (currently the Natural Health
Products Directorate) (Sibbald, 1999) is responsible for all regulatory functions including,
but not limited to pre-market assessment for product labelling, licensing of manufacturers,
post-approval monitoring and compliance and implementation of the recommendations
of the standing House Health Committee.
In December 2000, the provincial government of British Columbia approved regulations
that established traditional Chinese medicine as an alternative form of primary
health care. The cost is not covered under Canadian medicare and practitioners face
several practice restrictions. For example, ‘no acupuncturist or herbalist may treat an
active serious medical condition unless the client has consulted with a medical practitioner,
naturopath or dentist or doctor of traditional Chinese medicine, as appropriate’
(Johnson, 2001).
3.3.6 Chile
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In 1992 the Unidad de Medicina Tradicional was established with the aims of incorporating
traditional medicine with proven efficacy into health programmes and of contributing
to the establishment of their practice. Herbal medicines are legally differentiated
into: (a) drugs intended to cure, alleviate or prevent diseases; (b) food products for medicinal
use and with therapeutic properties; and (c) food products for nutritional purposes
(Calixto, 2000).
Herbal products with therapeutic indications and/or dosage recommendations are
considered to be drugs. Distribution of these products is restricted to pharmacies. A registration
for marketing authorization is needed for herbal products, homeopathic products,
and other natural products. An application for such registration consists of the complete
formula, the labelling, samples of the product, and a monograph which permits identification
of the formula and characteristics of the product (Zhang, 1998).