The market

Over the last decade there is a reported increase in the sale and use of herbs in Canada. In North America herbal remedies constitute a $2-billion-a-year industry that is growing at a pace of 15% annually.

Legal status

Herbal products were generally regulated as foods or drugs under the Food and Drugs Act coming under the supervision of the Directorates of both Food Safety and Drug Safety. Since some of the products sold as food with medicinal claims were considered harmful the Canadian Government has entrusted Health Canada to control the registration of herbal products through a body called the Natural Health Products Directorate (NHPD). Its objective is to provide safe, effective and high quality natural health products and prevent adverse effects to consumers. NHPD has established the Food and Drugs Act to regulate herbal remedies, homeopathic medicines, vitamins, traditional medicines, probiotics, amino acids and essential fatty acids. The regulations include provisions on product licensing, site licensing, GMP, adverse reaction reporting, clinical trials and labelling.

In order to address the issue of regulation of herbs, Health Canada has constituted Expert Advisory Committees on herbs and botanical preparations and has been issuing information letters, guidelines and policy statements to develop an appropriate framework for regulating herbal remedies. Today herbal remedies are regulated as drugs in Canada and must therefore conform to labelling and other requirements as set out in the Food and Drugs Act and Regulations. Thus in contrast to the United States, large numbers of herbal medicines with indication claims are legally sold on the Canadian market.

Herbs and botanicals are acceptable as drugs on the basis of acknowledged claims and quantitative statements of the active ingredient. Under the Food and Drugs Act herbal products are generally regulated either as foods or as drugs depending on the pharmacological activity of the ingredients, the intended purpose of the product and the representations made regarding its use including medicinal claims.

Amendments to the Food and Drugs Act in the form of Schedule 705 outlines substances not permitted for use in or as food and those substances acceptable as foods under specified conditions. In response to certain concerns raised, an Expert Advisory Committee reconstituted in 1993 recommended removal of seven herbs and botanical preparations from the ‘unacceptable as food’ list. Of these seven, five – namely wormwood, feverfew, Levant wormseed, mugwort, St. John’s wort – are now acceptable as food, with the other two – goldenseal root and Oregon grape root – now acceptable as food under specified conditions. According to legislations in the form of Bills C-85/C-7/C-8 to the Controlled Drugs and Substances Act (CSDA), some products such as cannabis and khat are controlled substances with different regulations and restrictions applicable to their sale and supply. Further an information letter issued by the Canadian Health Protection Branch contains a list of herbs considered hazardous.

The regulations of the Food and Drugs Act require a marketed herbal product claiming to have medicinal properties to carry a drug identification (DIN) or general public (GP) number. These numbers indicate that there has been a review of the product’s formulation, labelling and instructions for use, and are intended to provide assurance that any content and health claims are accurate. All natural health products require a licence and information on the product, including medicinal ingredients, source, potency, non-medicinal ingredients and recommended use. If a product number is preceded by the distinct letters NPN, then the product has been reviewed and approved by Health Canada for safety and efficacy. As a general practice, herbal remedies used for minor self-limiting conditions are allocated DINs based on logical pharmacological rationale and bibliographic references which include verified traditional uses that have not been superceded by more recent research and study.

An information letter issued on 5 January 1990 outlines the regulatory requirements of herbal medicines and provides advice on the mechanisms for applications for DIN for these products. Herbal medicinal products in this letter are classified into two major groups:

1. Herbs listed in pharmacopoeias and major pharmacological reference works: they generally have their properties, dosage, indications and contraindications for a well-established use. Products containing such herbal ingredients are reviewed in the same manner as other drug products and are widely available on the market either on prescription or as non-prescription drugs.
2. Herbs which have received relatively little attention in scientific literature and therefore may not be well known in Canada. Nonetheless, there is literature available on their traditional use on an empirical basis, and these references are considered to be useful in supporting acceptability of herbal drug products. It was expected that herbal drugs from this group would be used for minor self-limiting conditions. These products which are based on traditional or folkloric use should be designated as traditional medicines, and some details for application for DIN have been announced.