As we previously reported, amendments to the Natural Health Products Regulations will implement new labelling requirements for natural health products (“NHPs”), including a product facts table and revised allergen labelling. The new requirements will come into force on June 21, 2025.
NHPs licensed on or after this date were to comply with the new requirements from the outset, while NHPs licensed prior to this date are provided with a three-year transition period within which to comply (i.e., a compliance date of June 22, 2028). On March 7, 2025, the Minister of Health issued an order extending the scope of the transition period to NHPs licensed on or after June 21, 2025. Accordingly, all NHPs, whether currently marketed in Canada or new products granted marketing authorization on or after June 21, 2025, are exempt from the new labelling requirements until June 21, 2028. All products must comply with either the existing labelling requirements or the new requirements from June 21, 2025 through June 21, 2028, after which all products must comply with the new requirements.
Health Canada's Regulatory Impact Analysis Statement accompanying the order states that the change was motivated by two main concerns expressed by stakeholders: (1) lack of clarity and accuracy of guidance materials that would be used by the industry to support compliance with the new requirements and (2) prescriptive new information and formatting requirements which may impede compliance and compromise the readability of labels. These issues created risks that fewer NHPs would be marketed in Canada and that information on the labels of marketed products would be missing, hard to locate, or hard to understand, resulting in negative health impacts for consumers. Health Canada has stated that it will use the transition period to revise its guidance documents to reflect the new requirements, explore appropriate solutions to stakeholders' concerns, and make further regulatory amendments if needed.
Our Life Sciences team will monitor related developments and is available to consult on labelling requirements for NHPs. Please contact us for more information or to discuss a particular matter.
