In Canada, NHPs are regulated by the Natural and Non-Prescription Health Products Directorate (NNHPD) under the Natural Health Products Regulations (NHPR). These regulations came into effect in 2004. The regulations were developed following extensive consultations, they reflected the desire of Canadians for a regulatory framework appropriate to the level of risk associated with NHPs. Almost 20 years later, Canada is still the only country that has a dedicated set of regulations governing NHPs.
All NHPs must be approved by Health Canada before they are legally allowed to be sold in Canada. Always look for a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) on the product label. Canadians should feel confident that the products they use are safe, effective, and high-quality.
For a product to receive an 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 which may 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.
Overall, NHPs are safe, lower-risk products that 82% of Canadians use as a part of their proactive healthcare.
The changes that Health Canada is forcing on NHPs will require this class of products to bear an unnecessary amount of regulation. For almost 20 years, Canada has been a global leader in the regulation of NHPs, leveraging a dedicated regulatory framework that supports safety and efficacy of these products.
Health Canada’s proposed changes will decimate NHPs hurting many Canadian businesses, increase prices, and limit the amount product choice you see on store shelves – a cost our industry and Canadians cannot bear in these inflationary times.