How are NHPs regulated?
In Canada, Natural Health Products (NHPs) are regulated by the Natural and Non-prescription Health Products Directorate (NNHPD) under the Natural Health Products Regulations (NHPR), which came into effect in 2004.
All NHPs must be approved by Health Canada before they are allowed to be legally sold in Canada. Always look for a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) on the product’s label, which indicates that it has been approved by Health Canada.
In order to be authorized for a NPN, information supporting the safety and efficacy of a product must first be assessed by Health Canada. Health claims must be supported by valid, high-quality scientific and/or traditional evidence. Safety and efficacy must also be supported with sufficient evidence. This evidence can include: clinical trial data, journal articles, pharmacopoeias and traditional resources.
The level of evidence required by Health Canada to support a proposed health claim on an NHP is dependent upon the nature of the claim being made, the risk associated with the claim, and the condition correlated to the claim. For example, a multivitamin that “helps with the maintenance of good health” is a lower-risk product than an omega-3 product that “helps to reduce serum triglycerides and support brain function.” As a result, these products will provide Health Canada with different levels of evidence to approve their claim.
In order to sell a NHP in Canada, all manufacturers, packagers, labellers and importers of NHPs must have a site licence. To obtain a site licence, sites must maintain proper distribution records and procedures for product recalls. They also require proper procedures for safe handling, storage and delivery of their products. Each site must also meet good manufacturing practice (GMP) requirements.
For a list of resources to help you navigate the Natural Health Product Regulations, visit our NHP Resources page.