Health Canada has launched a consultation on a proposed regulatory pathway for health products containing cannabidiol (CBD) that would allow access without a prescription. This marks a significant step in the evolving regulatory landscape for CBD products, which are currently governed under the Cannabis Act.
If implemented, the new framework would regulate CBD-containing products similarly to other non-prescription health products, potentially reducing regulatory burdens for industry stakeholders while maintaining high standards for safety, efficacy, and quality.
For businesses in the CBD space, understanding this consultation and its potential impact is crucial. In this blog, we outline the key takeaways, how this could affect the industry, and what steps companies should take to provide input on this proposal.
Scope & Purpose
Health Canada’s discussion paper, Towards a Pathway for Health Products Containing Cannabidiol, outlines a regulatory approach aimed at:
- Aligning CBD regulations with other non-prescription health products while ensuring consumer safety.
- Providing market access clarity for CBD health products without requiring oversight under cannabis-specific regulations.
- Gathering stakeholder input to shape a regulatory framework that balances accessibility and risk management.
- Defining safety and efficacy requirements for human and veterinary CBD products based on scientific evidence.
This consultation is part of Health Canada’s 2024-2026 Forward Regulatory Plan and follows previous reviews assessing CBD’s safety profile and therapeutic potential.
What You Need to Know
Potential Regulatory Changes:
- CBD could be classified as a Natural Health Product (NHP) – requiring premarket quality measures and aligning with NHP regulations.
- Cannabis-specific licensing requirements may be removed for companies handling CBD-only products.
- Veterinary CBD products would be regulated as non-prescription veterinary drugs under the Food and Drug Regulations.
- International treaty obligations will still apply, meaning restrictions on import/export may remain.
Scientific & Industry Insights:
- A Science Advisory Committee on Health Products Containing Cannabis (SAC-HPCC) previously found that low doses of CBD (up to 200mg/day for 30 days) are safe for healthy adults but highlighted research gaps on long-term use and drug interactions.
- The Canadian Veterinary Medical Association (CVMA) supports regulated CBD access for animals but emphasizes the need for more safety and efficacy data.
- A 2019 consultation found strong market interest, with 61% of consumers and 62% of industry representatives supporting a non-prescription CBD pathway.
How to Get Involved
Health Canada is actively seeking feedback from:
- Industry stakeholders (manufacturers, distributors, retailers)
- Health professionals (human and veterinary)
- Researchers and academia
- Indigenous partners
- Consumer organizations and the general public
To participate, stakeholders should:
- Review the Discussion Paper: Towards a Pathway for Health Products Containing Cannabidiol.
- Consider the discussion questions at the end of the paper.
- Submit comments via the online feedback form or email at nnhpd.consultation-dpsnso@hc-sc.gc.ca.
The feedback received will help shape Health Canada’s policy development for CBD health products.
How This Affects Your Business
Companies currently navigating the Cannabis Act to market CBD products could see a shift toward NHP regulations—which may streamline compliance requirements. However, this consultation does not immediately change existing regulations, and businesses should remain compliant with current laws until further updates from Health Canada.
Understanding and engaging in this consultation is key for industry stakeholders who want to influence the final regulatory framework. If you require assistance interpreting regulatory changes or preparing submissions, dicentra’s team of experts can provide strategic guidance.
For more information on how these proposed changes could impact your business, contact us today.
