Health Canada recently announced that it is exploring a regulatory pathway that would allow products containing cannabidiol (“CBD”) to be purchased without a prescription. Under the current regulatory scheme, all health products containing CBD or other cannabinoids are regulated as prescription drugs, and this consultation aims to explore potential other pathways including regulation as natural health products.
In considering a new pathway, Health Canada’s goal is to protect the health and safety of Canadians while enabling access to safe, effective and high-quality products for human and animal use to treat specific or minor ailments. Interested parties have until June 5, 2025 to submit feedback to Health Canada.
Discussion Paper
In conjunction with the consultation, Health Canada has published a discussion paper entitled “Towards a Pathway for health Products Containing Cannabidiol.” This paper details how the current consultation process builds on the outcome of previous consultations as well as scientific and legislative reviews, highlighting a desire from consumers and industry to have access to health products containing CBD for use in humans and animals without a prescription.
Natural Health Products (“NHPs”) Containing CBD
The discussion paper sets out the current regulatory pathways available for products containing CBD: for non-medical use (sold through provincially-licensed cannabis retailers); for medical purposes (sold through Health Canada-licensed commercial sellers); and in prescription drugs (approved as prescription drugs and sold through pharmacies). Currently, it is not possible to approve a CBD containing product for sale as a NHP under any of these pathways.
Health Canada is considering a proposed pathway that would allow CBD to be the medicinal ingredient in NHPs. THC would not be permitted as a medicinal ingredient in NHPs, and there would be a regulatory limit of 10 ppm (similar to the allowable limit for hemp) in NHPs. This pathway would require pre-approval before products were marketed, including a full safety and efficacy assessment in accordance with the existing framework for approving NHPs. Given that NHPs containing CBD are novel, Health Canada has stated that they would require robust scientific evidence such as that generated through phase 3 clinical trials. They would also have to comply with the same licensing, quality, packaging and labelling, advertising and promotion requirements as other NHPs.
Currently, there are no restrictions on who can sell NHPs, and Health Canada is seeking input as to whether the same should apply to NHPs with CBD, or if sales should be limited to pharmacies.
Health Canada is also considering whether to exempt clinical trials involving NPHs with CBD from the requirement to hold a cannabis research license under the Cannabis Act.
Veterinary Drugs Containing CBD
Currently the only pathways for approval of veterinary products are the prescription drug pathway, and hemp-based veterinary health products. Health Canada is exploring the development of a pathway for veterinary drugs containing CBD that do not require a prescription.
Like NHPs, this would be limited to CBD and the limit of THC would be 10 ppm. At present, based on current evidence, these drugs would also be limited to an oral dose of 0.2 to 2 mg/kg twice daily to treat pain associated with osteoarthritis in dogs. They would consider further amendments if supported by additional evidence. These products would also have to meet all other the requirements for non-prescription drugs and comply with restrictions on advertising and promotion.
Sale will likely be limited to veterinary clinics due to concerns about inappropriate use.
Next Steps: The Consultation
Health Canada has provided summary questions for feedback on both human and animal use, and the responses from stakeholders will help inform Health Canada’s ongoing policy work on CBD health products.
Key areas for input include:
- Regulatory requirements: Licensing, manufacturing practices, and quality control for human and animal CBD products.
- Packaging & labelling: Whether warnings about CBD content should be required.
- Sales & distribution: Where these products should be sold and how consumer safety can be ensured.
- Advertising & promotion: Considerations for responsible marketing.
- Clinical trials & research: Barriers to generating safety and efficacy evidence.
- Post-market monitoring: Vigilance measures for ongoing safety tracking.
- Other considerations: Any additional insights, evidence, or suggestions to help shape the regulatory framework.
Submissions should be sent to the Natural and Non-prescription Health Products Directorate before June 5, 2025 via the online feedback form or by email to nnhpd.consultation-dpsnso@hc-sc.gc.ca.
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