Natural Health Product Regulation

Canadians can be proud that our country is a global leader in the regulations of natural health products (NHPs). Our rigorous and advanced regulatory system protects our health and safety while ensuring we have access to innovative, safe, effective and high quality NHPs that 79 per cent of Canadians rely on.

The Canadian approach to regulation is often referred to as a “pre-approval” system, which means that all NHPs must be licensed by Health Canada before they are allowed to be legally sold to Canadians. Other countries have alternative methods for regulating products similar to NHPs. For example, the United States calls these products Dietary Supplements and they are regulated as food products, where oversight is done through “post-market reporting.” This means that Dietary Supplements can be marketed and sold in the U.S. without pre-approval and manufacturers are expected to report any adverse effects.

In Canada, natural health products are regulated under the Natural Health Products Regulations (NHP Regulations), and these regulations have been in place since 2004. They are based on 53 recommendations made by the Standing Committee on Health (SCOH) in 1998. The SCOH met with hundreds of witnesses, including consumer groups, Health Canada, the Canadian Food Inspection Agency, International regulators, and received numerous submissions over a half a year of consultation.

Based on the robust consultation process, an appropriate framework was created for the regulations of NHPs. This work resulted in the passage of the NHP Regulations, which came into effect in 2004. Along with the regulation came the establishment of the then Natural Health Products Directorate (NHPD), now the Natural and Non-prescription Health Products Directorate (NNHPD), a branch of Health Canada dedicated to the review and oversight of NHPs.

All NHPs that are currently available for sale in Canada must be licensed with a Natural Product Number (NPN), which is printed on the front of the package. To obtain an NPN, Health Canada reviews research that supports the safety, quality and claims associated with the products. You can look up this NPN in Health Canada’s online database, which provides details including what is in the product, and what claims have been approved based on the evidence submitted and reviewed by Health Canada.

 


Natural health products are safe.

All NHPs must be approved by Health Canada before they are allowed to be legally sold in Canada. 

Many NHPs have a long history of safe use for various conditions, with a large and growing body of scientific research. All products authorized for sale must provide valid, high-quality scientific and/or traditional evidence supporting their safety.

Evidence may include clinical trial data or references to published studies, journals, pharmacopoeias and traditional resources. The type and amount of supporting evidence required depends on the proposed health claim of the product and its overall risks.

In order to sell a natural health product in Canada, a company must have a product and site licence. In addition to providing safety evidence to support the product, these licenses require manufacturers to maintain proper distribution records and have proper procedures for product recalls and for the handling, storage and delivery of their products.

Natural health products are effective.

In order to receive a product licence, companies who manufacture NHPs must complete a Product Licence Application. This detailed document about the product must include:

  • medicinal ingredients,
  • source material,
  • dosage,
  • potency,
  • non-medicinal ingredients, and
  • recommended use(s).

To be granted a NPN, information supporting the efficacy of a product must be provided and assessed by Health Canada. The level of evidence that is required to be submitted for NHPs seeking approval in Canada depends on the claim being made and the overall risk of the product, and the condition it is being used for. A product such as a multivitamin that makes a claim, “helps with the maintenance of good health,” will have to provide different evidence than an omega-3 that makes the claim, “helps to reduce serum triglycerides and support brain function.” This evidence could include clinical trial data or references to published studies, journals, pharmacopoeias and traditional resources.

Natural health products are high-quality.

To get product and site licenses, specific labelling and packaging requirements must be met, Good Manufacturing Practices (GMP) must be followed, and suitable safety and efficacy evidence must be provided.

Always look for the NPN or DIN-HM on a product label. This number is your assurance that the product has been authorized for sale in Canada, and is safe and effective when used according the instructions on the label.

Today, there are over 100,000 licensed NHPs available for consumers to choose from. As a consumer, you may not know exactly what goes into the review process for an NHP. However, when you buy one at your local CHFA Member health food store, you should feel confident knowing that the company selling that product has provided evidence to support its safety and quality.  Additionally, evidence supporting any health claims associated with that product is submitted and reviewed by Health Canada before the product is authorized for sale. The Licensed Natural Health Product Database provides information on the product licence and highlights which claims have been approved.  

All of this information, and more, is available on Health Canada’s website here.

Recently, Health Canada launched a proposal called the Consulting Canadians on the Regulation of Self-Care Products in Canada. It proposes changes that could significantly alter the way natural health products are regulated, and impact many of products you use on a daily basis. Learn more about this proposal and help us stop it by clicking the button below. 

Are you interested in learning more about the benefits of NHPs and how to use them to support a naturally healthy lifestyle? Explore our blog and Lifestyle Tips pages, and consider signing up for our newsletter. To find a CHFA Member natural health store near you, click here.

Do you own a business in the natural health industry? Learn about the many benefits of becoming a CHFA Member here