Proposed Regulatory Changes for Natural Health Products

Seventy-nine per cent of Canadians use natural health products (NHPs), such as vitamins, minerals, amino acids and probiotics. Currently, all NHPs available for sale in Canada are reviewed by Health Canada, and approved if they meet certain standards for safety, efficacy and quality. This pre-market approval system has made Canada a leader in the regulation of NHPs.

Health Canada is considering changes to the way NHPs are regulated. Their original proposal could have caused several unintended negative implications on the Canadian NHP marketplace, including limiting consumer freedom of choice, reducing information available to consumers and economic burdens on small businesses.

Following consultations in 2017, Health Canada’s refined proposal takes into consideration some of the concerns raised, but lacks clarity on important details. It is important that Health Canada creates the right framework for NHPs — one that builds on the strengths of the existing regulations, respects cultural diversity and allows the millions of Canadians who rely on NHPs to make informed choices. 

Next Steps

Health Canada is in the process of planning additional consultation sessions for the month of June. We will keep you updated when the details of these meetings are released. Check this page regularly for any news.

For more information on what was heard during the previous rounds of consultation, click here

Learn more

NHPs Are Already Responsibly Regulated

NHPs have been regulated under the Natural Health Products Regulations since 2004. The regulations require products to be assessed for safety, efficacy and quality, and pre-approved for sale in Canada. Site licences are also required for companies manufacturing, importing or distributing NHPs.

By virtue of the pre-market approval system, Canada is a global leader in regulating NHPs, ensuring that safe, effective and high-quality products enter the marketplace without the undue restriction of consumers’ freedom of choice. Our goal is to ensure that the strong elements of the existing regulations remain in place as Health Canada explores ways to change how all self-care products are regulated.

How the Proposal Could Potentially Impact Small- to Medium-sized Businesses

  • Over 100,000 products are licensed under the current regulations. The original proposal could have required businesses to reformulate, relabel or invest substantially in additional research on products already deemed effective and readily available in stores.
  • A variety of evidence sources can currently be referenced to support claims. The level of evidence deemed acceptable ranges from traditional sources to gold standard clinical evidence. The amount of evidence required is dependent on the product type and claim being made. It is imperative that an appropriate level evidence for NHPs be maintained and that traditional sources of evidence remain acceptable. Changes to evidence requirements could unintentionally impact the market and could lead to limiting consumer choice, which may result in the online purchasing of unregulated products from abroad.
  • The proposal could cause consumer confusion and place the burden on retailers to educate them, as some NHPs may have NPNs while some may have less information on the label.

CHFA Supports Modernization

CHFA supports the review process in an effort to improve the regulatory environment, but cannot support the abandonment of the existing regulatory system that has been in place for the past 13 years. CHFA is working on behalf of our members to ensure any changes made are an improvement to this system and doesn’t lead to the dismantling of the entire NHP regulatory framework. We continue to engage with the Natural and Non-prescription Health Products Directorate (NNHPD), as appropriate to ensure our collective concerns and perspectives are heard, addressed and incorporated into the next versions of the proposed policy. The Canadian NHP sector currently produces safe, effective and high-quality products, which are relied upon by 79 per cent of Canadians.

Want to find out more?

Click here to sign up for our newsletter and receive updates about this proposal as they develop, as well as information about vitamins, supplements and natural living tips. 

Click here to find out more about these proposed changes and how they will impact you.

Click here for a list of frequently asked questions (F.A.Q.s) about Health Canada's original proposal.

Click here to read our blog detailing these recent developments. 

Click here to learn more about the existing NHP Regulations.