In mid-June Canada adopted the Natural Health Products Regulations, which were published in Canada Gazette Part II. Previously, natural health products (NHPs), had been sold as either drugs or foods under the Food & Drugs Act and Regulations, since there was no other category in which they could be classified. The Natural Health Products Regulations are the result of a comprehensive and inclusive consultation process with Canadian consumers, academics, healthcare practitioners and industry stakeholders, and are a key element in fulfilling the House of Commons Standing Committee on Health’s 53 recommendations. The new regulations call for improved labeling, good manufacturing practices, product and site licensing and provisions 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 and minerals, traditional medicines, probiotics, amino acids and essential fatty acids. All natural health products in Canada will now require a product license before being marketed. Obtaining a 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 license number preceded by the distinct letters NPN (Natural Product Number), or, in the case of a homeopathic medicine, by the letters DIN-HM (Drug Identification Number-Homeopathic Medicine). The product license number on the label will inform consumers that the product has been reviewed and approved by Health Canada for safety and efficacy.

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

In making health claims, industry relies on a variety of standards of evidence, such as history of use or traditional references, observational studies, expert committee reports and clinical or trial data. However, Health Canada says that ongoing research will continue to be necessary. To address this need for more research, Health Canada has committed $5 million over five years to create the Natural Health Products Research Program. Funding for this program will be drawn from the existing fiscal framework. The Natural Health Products Research Program has been developed over the past two years through active dialogue with all relevant stakeholder groups. Working closely in partnership with the community at large and the Canadian Institutes of Health Research, the Natural Health Products Research Program will support the creation of a sustainable national natural health product research presence in order to meet the needs of Canadians.

There will be a transition period for the regulations that will span from two to six years—two years for site licensing and six years for products with drug identification numbers (DINs)—to allow manufacturers, labelers, packagers, importers and distributors time to meet the new requirements.