OTTAWA - The Honourable Anne McLellan, Minister of Health, announced the adoption of the Natural Health Products Regulations, which were published today in Canada Gazette, Part II.
Previously, natural health products (NHPs) have been sold as either drugs or foods under the Food and Drugs Act and Regulations, since there is no other category in which they can be classified. The Natural Health Product Regulations are the result of a comprehensive and inclusive consultation process with Canadian consumers, academics, health care 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 labelling, good manufacturing practices, product and site licensing, and provisions for a full range of health claims that will be supported by evidence.
“Consumers have asked for labelling of all ingredients, for any warnings to be clear and understandable, for assurances of quality and safety, and for a system of product licencing. With the introduction of these Regulations, Canadians will now be in a much better position to make more informed decisions about the natural health products they consume,” stated Minister McLellan.
The products that fall within the new Regulations include herbal remedies, homeopathic medicines, vitamins, minerals, traditional medicines, probiotics, amino acids and essential fatty acids (such as Omega-3).
All natural health products in Canada will now require a product licence 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 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.
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, ongoing research continues to be necessary. To address this need for more research, Health Canada has committed $5 million over 5 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 2 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, which meets the needs of Canadians.
There will be a transition period for the Regulations that will span from 2 to 6 years - 2 years for site licensing and 6 years for products with drug identification numbers (DINs)- to allow manufacturers, labellers, packagers, importers and distributors time to meet the new requirements. During the phase-in period, Health Canada will provide support to industry, and undertake a comprehensive public education and outreach program to ensure that the Regulations are well understood. Health Canada is particularly mindful that much of this industry consists of small and medium sized businesses and that a sustained effort must be undertaken to provide working tools and processes to support these enterprises.
“Canadians have contributed significantly in the development of the Natural Health Products Regulations, and will continue to be consulted as Health Canada moves forward with their implementation,” concluded the Minister.
Office of Anne McLellan
Federal Minister of Health