Canada Reaffirms “Product of Canada” and “Made in Canada” Labelling Standards: CFIA Clarifies Origin Claims Amid Consumer Confusion

Health Canada has announced a critical update for stakeholders in the natural health product (NHP) industry regarding the upcoming changes to the Natural Health Products Regulations. As initially communicated in the Notice of Intent published on February 25, 2025, the Department has now fulfilled its commitment to provide temporary regulatory relief for certain NHPs through a Ministerial Exemption Order.

Key Highlights of the Ministerial Order:

On March 26, 2025, the Exemption Order in Respect of Labelling Requirements for Certain Natural Health Products was officially published in Canada Gazette, Part II, accompanied by the related Regulatory Impact Analysis Statement. The Order will come into effect on June 21, 2025, coinciding with the enforcement date of the new labelling provisions under the amended Natural Health Products Regulations.

The Exemption Order provides that:

NHPs licensed on or after June 21, 2025 are exempt from the new labelling provisions (sections 86 to 94 of the amended Regulations), provided they continue to comply with the previous versions of these sections, as they read immediately prior to June 21, 2025.
This regulatory flexibility allows manufacturers to choose between complying with the previous or the new labelling rules, during the duration of the Exemption Order.
NHPs licensed and labelled prior to June 21, 2025 benefit from a three-year transition period (until June 21, 2028) during which they may continue to be sold using existing labelling.

Repeal and Full Compliance Deadline:

The Exemption Order will be repealed on June 21, 2028, aligning precisely with the conclusion of the transition period for existing NHPs. As such, all NHPs sold in Canada must fully comply with the new labelling requirements by June 22, 2028.

Implications for Industry Stakeholders:

This temporary exemption offers manufacturers and distributors a critical window to better manage inventory, align compliance strategies, and gradually implement the updated labelling provisions under the Natural Health Products Regulations. However, it is imperative that companies use this period to prepare for full regulatory compliance by June 22, 2028, as no further extensions or exemptions are currently anticipated.

The new labelling requirements introduce substantial changes that will require significant investments of time, resources, and capital—including updates to packaging components, label content redesign, technical translations, regulatory reviews, and quality system modifications.

Unless the industry successfully advocates for further exemptions or an extended implementation timeline, all stakeholders will be expected to fully comply by the repeal date of the Ministerial Order. Early planning and proactive engagement with regulatory experts will be essential to mitigate compliance risks and avoid disruptions to product availability in the Canadian market.

Additional Information:

For a detailed understanding of the Order and its implications, stakeholders are encouraged to review the full text of the Exemption Order and the Regulatory Impact Analysis Statement available through the Canada Gazette, Part II.

How MCS Associates Can Support You

MCS Associates is a globally recognized regulatory affairs consulting firm with over four decades of proven expertise in the North American natural health product (NHP) market. Our reputation is built on delivering pragmatic, cost-efficient, and responsive regulatory solutions tailored to the evolving needs of the life sciences industry.

As part of our core competencies, MCS Associates can help interpret Health Canada guidance documents to assess their impact on companies engaged in the manufacturing, packaging, labeling, importation, and distribution of natural health products.

Our NHP regulatory experts can support your team with: