Making Decisions About Herbal Therapies: Regulation of Herbal Products

In response to growing concerns about the regulatory environment for herbal remedies, Health Canada developed a new regulatory framework for natural health products, which came into effect January 1, 2004.

This framework is the product of extensive consultation with a range of stakeholders. Previously natural health products were sold as either drugs or foods under the Foods and Drugs Act and Regulations. The new Natural Health Products Regulations call for improved labelling, good manufacturing practices, product and site licensing, and provision for a full range of health claims that will be supported by evidence.

The products that fall within the new Regulations include herbal remedies, homeopathic medicines, vitamins, minerals, traditional medicines, probiotics, amino acids and essential fatty acids. All natural health products in Canada require a product licence before being marketed. For site licensing, there is a two year transition period (2004-2005) and for product licensing, a six year transition period (2004-2009) for products who already have drug identification numbers (DIN). This will allow manufacturers, labellers, packagers, importers and distributors time to meet the new requirements.

Obtaining a product license will require detailed information on the product submitted to Health Canada, including medicinal ingredients, source, potency, non-medicinal ingredients and recommended use. Once a product has been assessed by Health Canada, the product label will bear a product licence number preceded by the distinct letters NPN, or, in the case of a homeopathic medicine, by the letters DIN-HM. The product licence number on the label will inform consumers that the product has been reviewed and approved by Health Canada for safety and efficacy.

With improved, standardized labelling, consumers will be able to make more informed decisions about the natural health products they buy. Labels will be required to specify directions for use, the recommended use or purpose (health claim), medicinal and non-medicinal ingredients, and any cautions, contra-indications or known adverse reactions associated with the product.

For further information on the regulatory framework, contact:

Natural Health Products Directorate, Health Canada
2936 Baseline Road
Qualicum Tower A
Postal Locator: 3302A
Ottawa, Ontario
K1A 0K9
(613) 948-8096 (Ottawa) or 1-888-774-5555
www.hc-sc.gc.ca/hpfb-dgpsa/nhpd-dpsn/