Overview of the Natural Health Product Regulations

Public concerns regarding the regulation of herbal remedies together with the increasing popularity of natural health products (NHPs), prompted the establishment of a new regulatory authority, the Natural Health Products Directorate (NHPD), a division of Health Canada.

The NHPD regulations came into effect on January 1, 2004. Under this system, all natural health products must be licensed for sale in Canada. In addition a site license is required by manufacturers, packagers, labelers and importers of natural health products. The regulations are being phased in over a six year period as the NHPD reviews the product formulation, instructions for use, manufacture, and labeling of all the NHPs currently on the market. Natural health products (not including homeopathic products) that are approved under these regulations are given an NPN. An NPN informs the user that the product has been reviewed and meets the NHPD requirements for sale in Canada.

Definition of a Natural Health Product
Natural health products are defined by the Natural Health Products Directorate as vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines such as traditional Chinese medicines, probiotics, and other products like amino acids and essential fatty acids.1

NHPD Requirements for Safety and Efficacy of NHPs
The NHPD evaluation of a natural health product involves assessment of the “totality of evidence related to the natural health product".2 The strength, quality and credibility of the evidence submitted determines the health claim that will be authorized.3

There are three levels of permitted claims: structure-function, risk-reduction and therapeutic. The therapeutic category, which may claim disease prevention or treatment, requires a much higher level of evidence, including randomized controlled clinical trial results. Risk-reduction claims are usually based on observational studies such as prospective cohort studies that support the alteration of a major risk factor for a disease or condition. Structure-function claims may be based on different levels of evidence and describe the effect of a NHP on a physiological function or structure in the human body.4

The NHPD regulations require standardized labeling and adherence to Good Manufacturing Practices. Product license holders are required to maintain a post-market surveillance program and report to Health Canada the occurrence of adverse reactions associated with the licensed product. The regulations require that NHPs are subjected to tests for important quality parameters such as pesticide, microbial, and heavy metal content.

With the establishment of the NHPD, Canada has taken an international lead in the regulation of a unique and complex industry. Through the authorized health claim and conditions of use, the NHPD regulations inform consumers and professionals of the safety and efficacy of each particular natural health product.

This regulated information empowers users with the ability to discriminate between NHPs on the market, using their own personal standards of evidence. It also allows for the recognition of distinct products with a strong foundation of scientific evidence and a commitment to ongoing research. The establishment of these requirements is a major step forward in advancing natural health product standards, safety and efficacy, as well as accountability in this unique industry.

For further information about the Natural Health Products Directorate see

For further information about the Natural Health Product Regulations see Health Canada’s document "At-a-glance: A Regulatory Framework for Natural Health Products"

1 Health Canada Website, Natural Health Products, URL: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/index_e.html
2 Health Canada, Natural Health Products Directorate. Evidence for Safety and Efficacy of Finished Natural Health Products, December 2006, p.2.
3 IBID. p.i
4 IBID, p.3