Health Canada has announced its intention to publish a Ministerial Order that will temporarily exempt certain Natural Health Products (NHPs) from specific labelling requirements set to come into effect in June 2025. This move aims to provide industry stakeholders with additional time to comply with the updated regulations while maintaining consumer transparency and market accessibility.

Scope & Purpose

The upcoming Ministerial Order will allow newly licensed NHPs to comply with either the current or previous labelling regulations during a transitional period. This exemption is a response to industry concerns regarding the challenges of implementing the new labelling requirements, particularly for products with extensive ingredient lists or multiple risk statements.

Health Canada is committed to ensuring that labelling improvements benefit consumers without creating undue burdens on manufacturers. The exemption will help:

• Provide additional time for industry compliance efforts.
• Maintain consumer access to NHPs without market disruptions.
• Allow Health Canada to finalize guidance and tools to support implementation.

What Are the Changes?

The Ministerial Order will introduce a temporary exemption for NHPs newly licensed between June 21, 2025, and June 21, 2028. During this time:

• Newly licensed NHPs may choose to comply with either the updated labelling requirements or the previous regulations.
• Exemptions will specifically apply to sections 17 to 22 of the amended Natural Health Products Regulations (SOR/2022-146).
• The exemption will remain in place until June 21, 2028, after which all products must comply with the new labelling requirements.

Health Canada continues to explore long-term solutions such as alternative flexibilities, simplified labelling requirements, and the use of digital labelling to enhance compliance and consumer transparency.

How Can I Be Prepared?

To ensure compliance and a smooth transition, NHP manufacturers should:

1. Review Existing Product Labels: Assess whether current labels meet the updated requirements and identify any potential compliance gaps.
2. Monitor Health Canada Guidance: Stay informed on new implementation tools and regulatory updates that may impact compliance.
3. Consider Digital Labelling Solutions: Explore whether digital enhancements can support better information accessibility for consumers.
4. Engage in Industry Consultations: Participate in Health Canada’s ongoing engagement sessions to provide feedback and gain clarity on expectations.
5. Plan for Long-Term Compliance: Develop a timeline to transition to the new labelling requirements before the June 2028 deadline.

Get Expert Advice

Navigating evolving NHP regulations can be complex. At dicentra, we specialize in helping businesses stay compliant with Health Canada’s Natural Health Products Regulations. Our team can assist with:

• Labelling reviews to ensure compliance with both current and upcoming requirements.
• Regulatory strategy development to minimize business disruptions.
• Guidance on integrating digital labelling solutions for enhanced consumer access.

If you need assistance in preparing for these regulatory changes, contact us below for expert support.