Information Kit - Regulation of Natural Health Products

What are natural health products?

Natural health product (or NHP) is a term used in Canada to refer to a range of health products including: vitamin and mineral supplements, herbal and plant-based remedies, traditional medicines (such as Traditional Chinese Medicines), homeopathic medicines, omega and essential fatty acids and probiotics.

In addition, many everyday consumer products, such as certain toothpastes, antiperspirants, shampoos, facial products and mouthwashes are also classified as NHPs in Canada because of their medicinal ingredients and intended uses.

NHPs are products which are used and marketed for a variety of health purposes, such as for the prevention or treatment of an ailment or condition, the reduction of health risks, or the maintenance of good health.

The Natural Health Products Regulations

In Canada, the commercial sale of natural health products is subject to the licensing provisions of the Natural Health Products Regulations, which came into force on January 1, 2004.

The purpose of the Regulations is to help assure that Canadians have access to NHPs that are safe, effective and of high quality.

To be legally sold in Canada, all NHPs must have a Product Licence, and the Canadian sites which manufacture, package, label and import these products must have Site Licences.

There are specific labelling and packaging requirements as well as good manufacturing practice standards and evidence norms that must be met in order to obtain product and site licences.

Further information on product and site licensing requirements is available under Key Components of the Regulations of this information kit.

Who do the Regulations apply to?

The licensing requirements of the Natural Health Products Regulations apply to any person or company which manufactures, packages, labels and/or imports NHPs for commercial sale in Canada.

The licensing requirements do not apply to health care practitioners who compound products on an individual basis for their patients or to retailers of NHPs.

Who Administers the Regulations?

The Natural Health Products Regulations are administered by Health Canada's Natural Health Products Program, which is comprised of three directorates, each with their own specific roles and responsibilities. They are: the Natural and Non-prescription Health Products Directorate, Marketed Health Products Directorate and Health Products and Food Branch Inspectorate.

The Natural and Non-prescription Health Products Directorate (NNHPD)

The NNHPD is lead directorate of the Natural Health Products Program and is the regulating authority for the commercial sale of NHPs in Canada. The NNHPD is responsible for the assessment and issuance of product and site licences.

The Marketed Health Products Directorate (MHPD)

The MHPD provides a consistent approach to post-approval safety surveillance, assessment of signals and safety trends and risk communications concerning all regulated marketed health products, including NHPs. The management of adverse reactions involving NHPs is also the responsibility of the MHPD. Individuals having experienced an adverse event are encouraged to report it to the MHPD immediately.

The Health Products and Food Branch Inspectorate (HPFBI)

The HPFBI is responsible for the enforcement of the Regulations and carries out any required compliance action, including product recalls and investigations. Consumer and industry complaints or concerns regarding licensed or un-licensed NHPs or sites are handled by the HPFBI and should be addressed to them directly at 1-800-267-9675.

External Advisory Committees

Health Canada also consults regularly with two external advisory committees: the Management Advisory Committee (MAC) and Expert Advisory Committee (EAC). Comprised of industry and consumer representatives, the MAC advises Health Canada on the administration of the Natural Health Products Regulations. Members of professional and scientific communities make up the EAC, which provides expert advice to Health Canada on issues relating to the safety, efficacy and quality of NHPs.

Identifying natural health products that have been licensed for sale

NHPs that have been licensed for sale in Canada will bear a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) on the label, followed by an eight-digit number (e.g. NPN 12345678).

The presence of a NPN or DIN-HM means that the product has been authorized for sale in Canada and is safe and effective when used in accordance with the instructions on the label.

Stakeholders can learn more about licensed NHPs by accessing the Licensed Natural Health Products Database (LNHPD).

Key Components of the Natural Health Product Regulations

Product Licensing

All NHPs sold in Canada require a product licence before being marketed. Obtaining this licence requires the submission of a Product Licence Application (PLA), which must include detailed information on the product (e.g. its medicinal and non-medicinal ingredients, dose, potency and recommended uses) along with evidence supporting its recommended conditions of use. Once a product has been assessed and deemed safe, effective and of high quality, a product licence will be issued along with an 8-digit Natural Product Number (NPN) or Homeopathic Medicines Number (DIN-HM) which must appear on the label.

Evidence requirements for safety and efficacy

The safety and efficacy of health claims associated with NHPs must be supported by appropriate evidence so that consumers and Health Canada can have assurance that products are indeed safe and effective. Health Canada accepts varying types of evidence to support the safety and efficacy of NHPs, ranging from clinical trial data to references to published studies, journals, pharmacopoeias and traditional resources. The type and amount of supporting evidence required is dependant on the proposed health claim of the product and its overall risks.

Labelling

All NHPs must adhere to specific labelling requirements which are in place to ensure that consumers can make safe and informed choices about the NHPs they choose to use. Examples of the type information required on the label of NHPs include: product name, dose, route of administration, product licence number, recommended use (i.e. its health claim), complete list of ingredients, and any risks associated with the product's use, such as cautions, warnings, contra-indications and known adverse reactions.

Site Licensing and Good Manufacturing Practices

Canadian manufacturers, importers, labellers and packagers of natural health products must have site licences. Obtaining this licence requires the submission of a Site Licence Application (SLA) complete with supporting documentation demonstrating that the manufacture, packaging, labelling and importation of NHPs follows appropriate good manufacturing practice standards.

Good Manufacturing Practices, or GMPs, are ongoing measures designed to ensure an effective overall approach to product quality control and risk management. They do so by setting appropriate standards and practices for product testing, manufacturing, storage, handling and distribution.

Additional Resources

Additional information is available online or by contacting the Natural and Non-prescription Health Products Directorate.