Proposed Regulatory Changes for Natural Health Products

In September 2016, Health Canada proposed changes to the way natural health products could be regulated. From April to June 2017, many concerned consumers and members of the natural health product industry attended several rounds of Health Canada’s in-person, cross-country consultations, to learn about the proposed changes and voice their concerns.

With the latest round of in-person consultation now complete, Health Canada will continue to refine the proposal, review the feedback received and take into consideration some of the concerns raised. As clarity is still required in many areas, CHFA expects to receive further updates in fall 2017 regarding next steps and further consultation.

If you missed a session, read our article to learn more about the refined proposal and click here to see what was discussed in the latest rounds of consultations. Health Canada has also posted a summary of the consultations that took place in April and May 2017 and a summary of the June 2017 consultation is available here.

Next Steps

The next steps for the proposal will be announced on Health Canada’ website in the coming months. Continue to check this page for updates. 

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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 will 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.