"Unapproved Herbal Medicines and Risks to Your Health"
Many people are looking to complementary or herbal medicines in the belief that they can cure or prevent illness
and to improve their overall health. Health Canada has authorized the marketing of several hundred of these
medicines for use in the treatment of minor conditions which can be safely self-diagnosed and treated by consumers.
The mandate of the Drugs Directorate of Health Canada is to ensure that Canadians have access to safe, effective
and high quality drugs.
Prior to authorizing the sale of a herbal medicine, Health Canada verifies that it has been traditionally used for the
specific conditions listed on the label and that there is no evidence of serious risk associated with its use.
Unfortunately, a number of these products are being sold without the approval of Health Canada and could be
hazardous to your health. Before medicating yourself, check to ensure that the product has been approved under
Canada's Food and Drugs Act and Regulations.
How do I know if a herbal medicine has been approved by Health Canada?
Look for a Drug Identification Number (DIN) or a General Public Number (G.P.) that has an eight (8) digit number on
the label. These unique numbers are only assigned when a drug has been found to meet the requirements of
Canada's Food and Drugs Act. If a product does not have one of these numbers, it has not been approved.
Some other indications that a product has not been approved are the lack of labelling in both French and English or
the lack of an ingredient declaration or of dosage instructions. A non-prescription drug that claims it can treat or
prevent serious diseases is also not likely to have been approved by Health Canada.
Why are some herbal medicines dangerous?
Most herbal medicines, if used properly, are safe. There are, however, dangerous herbs which have been
known to cause serious liver or kidney disease, while others are suspected of causing certain types of cancer.
Deaths have occurred with the incorrect use of certain products. Some medications that have been illegally imported
from Asian countries have been found to contain dangerous amounts of heavy metals such as arsenic and mercury.
Others have been found to be adulterated with drugs usually available only by prescription and which could be harmful.
These drugs include benzodiazepines, steroids, hormones, diuretics and anti-inflamatories. If the label makes a
drug claim and there is no DIN or G.P. number, then the product has not been authorized for sale in Canada and could
cause serious harm.
What is Health Canada doing about this?
Health Canada helps safeguard your health by carrying out pre-market reviews of all drugs before they are
authorized for sale. Other Health Canada activities include customs surveillance to prevent the importation of illegal drugs that may be
unsafe and inspection of manufacturers' premises to ensure that products are manufactured to acceptable standards
of quality. Products are also examined to ensure that they contain the ingredients indicated on the label and there is
regular analysis of products on the market to ensure that they do not contain unsafe ingredients. Health Canada
removes from sale any drugs that do not meet the requirements of Canada's drug laws. Hundreds of these products
are removed from shelves each year.
What can you do to protect yourself from unsafe drugs?
Although Health Canada conducts customs and post market surveillance, illegal or hazardous products can
still find their way onto retail shelves. You can protect yourself by using only drugs that have been approved for sale
by Health Canada and by reading, understanding and following the label directions. If you experience an adverse
effect with any drug, report it to your doctor or pharmacist who can then inform Health Canada. Health Canada
maintains a database of all adverse drug events reported and investigates serious events to help ensure that drugs
available for sale are safe and effective when used appropriately.
Also, in order to help you safeguard your health, your doctor needs to know your complete medical picture.
Herbal medicines are part of this picture. Be sure to discuss the use of any non-prescription medicine with your
doctor or pharmacist, especially if you have a serious disease. The treatment of complicated serious conditions
requires the special skills and knowledge of a trained health care practitioner.
While the same standards are applied to domestic and foreign products, Health Canada is sensitive to the
cultural differences regarding the use of herbal medicines. The measures imposed are not intended to restrict the
choices available to citizens in the type of health care they wish to employ, but rather to ensure that the products
available for sale do what they claim and to encourage a level playing field for all manufacturers/distributors in the
Canadian marketplace.
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