Health Canada & Natural Health Products – Office of the Auditor General Release of NHP Program Report

Health Canada & Natural Health Products – Office of the Auditor General Release of NHP Program Report

Health Canada has a robust regulatory framework for natural health products (NHPs) to ensure products are safe and effective for Canadian consumers, but how closely are these regulations being enforced?

A recent performance audit was conducted by the Office of the Auditor General of Canada. The purpose of the audit was to determine whether pre-market licensing and post-market activities done by Health Canada ensured products offered to Canadians are safe and accurately represented on the marketplace.

The audit report found that Health Canada fell short of making sure products are safe and effective.
From poor manufacturing practices to false or poor product label information, many potentially unsafe products made it to the retail level. Of 75 licensed NHPs that were examined, 88% were advertised with misleading information and 56% were advertised with misleading label information, such as unauthorized health claims, incomplete lists of medicinal ingredients or label information too small to be legible.

As many unsafe licensed and unlicensed products became available to consumers, Health Canada’s response to serious issues with NHPs was not always successful.

It was found that Health Canada did not have a program to actively monitor high-risk unlicensed products on the market.

Rather than using a risk-based approach, Health Canada instead monitored only in response to complaints.

With the increased demand for hand sanitizer since the start of the COVID-19 pandemic, Health Canada successfully modified its approach to licensing this products category to help address market shortages and curb the spread of the virus. The Directorate took a proactive approach to monitoring COVID-19 related product promotion and successfully removed many instances of advertisements claiming NHPs could mitigate, treat, diagnose or even cure COVID-19. Although many false claims surrounding NHPs and COVID-19 were addressed, there are still a number of licensed and unlicensed products found to be making such claims.

While there were many oversights, promising changes are coming from these findings.

The department has agreed with the recommendations made and responded with plans such as:
  • Establishing a risk-based approach to NHP fabrication compliance
  • Continuing to pursue regulatory and policy changes to improve labelling of NHPs
  • Implementing a proactive risk-based approach to monitoring advertising on social media
  • Taking steps to propose new tools to strengthen the ability to deter and address non-compliance

Need help ensuring your natural health product is safe for the Canadian market?

Contact our experienced team here at SNI and our regulatory experts can assist you!

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