Notice of intent to publish a targeted Ministerial Order to exempt Natural Health Products from certain labelling provisions in the Natural Health Products Regulations

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Introduction
Background
Proposed approach
Next steps

Introduction

Health Canada is proposing to publish a Ministerial Order with an exemption for certain natural health products (NHPs) from new labelling provisions in the Natural Health Products Regulations that will come into force in June 2025. The Ministerial Order would:

• Allow time for the Department to consider flexibilities to support industry compliance, while protecting the intended consumer benefits of the labelling requirements;
• Continue market access for products to allow for consumer choice and market competition;
• Permit time for the Department to finalize guidance and tools necessary to support implementation.

The proposed Ministerial Order is a result of implementation challenges faced by regulated parties and would be a temporary measure that complements ongoing departmental activities to support industry in the implementation of the Regulations. This includes finalizing updates to the NHP product monographs and changes to the guidance to improve clarity. The Department continues to prioritize meeting consumer objectives as it completes this work.

Background

The Regulations Amending the Natural Health Products Regulations (the Regulations) were registered on June 21, 2022. They amended the Natural Health Products Regulations with the objective of improving product labelling so that information is clear, consistent, and legible, providing consumers with access to information to make safe and informed choices.  The Regulations will come into force on June 21, 2025, after which newly licensed NHPs must meet the new labelling requirements, whereas currently licensed products have a transition period until June 21, 2028, to comply.

Extensive consultations took place throughout the regulatory development process, and adjustments were made to the regulatory proposal before final publication. However, since publication of the Regulations and supporting Guidance document in 2022, Health Canada has heard from industry stakeholders that companies are facing challenges with implementing the new requirements.  In response, the Department initiated a series of stakeholder engagement sessions to:

• gain a clear understanding of industry’s key challenges with regards to implementing the new labelling requirements;
• identify potential solutions; and
• validate solutions with industry and non-industry stakeholders to support transparency and ensure that consumer objectives are not compromised.

Through the sessions Health Canada has determined that certain products are facing challenges fitting all the required information on their label without compromising the readability. For example, products with many ingredients or many risk statements, or when multiple formatting flexibilities are used concurrently.  The Department is exploring alternative flexibilities, simplified requirements, and the enhanced use of digital labelling that could support better consumer outcomes.

Health Canada is engaging with impacted stakeholders to assess the issues and propose solutions, which is expected to continue to spring 2025.

Proposed approach

Health Canada intends to publish a ministerial regulation in the form of a Ministerial Order made under the authority of s. 30.05 of the Food and Drugs Act exempting NHPs from specific labelling provisions in the Natural Health Products Regulations, under certain conditions. The exemption would apply to NHPs newly licensed between June 21, 2025, and June 21, 2028. During this time newly licensed NHPs could either comply with the new labelling provisions or the previous labelling requirements, consistent with the transition period for NHPs licensed before June 21, 2025.

Products would be exempt from the following regulatory provisions based on the conditions set out hereafter: sections 17 to 22 of the Regulations Amending the Natural Health Products Regulations: SOR/2022-146 on the condition that the product is labelled in accordance with the Natural Health Products Regulations as they read immediately before June 21, 2025.

The exemption would apply between June 21, 2025, and June 21, 2028, after which the Ministerial Order would be repealed.

Next steps

The Department will continue to hold targeted consultation sessions with industry and health stakeholders before publishing the Ministerial Order in the Canada Gazette, Part II.