Health Canada has released a new consultation document looking at the potential regulatory path for CBD to be regulated as a natural health product. Feedback must be submitted by June 5, 2025.

The agency has been exploring the topic since 2018. Currently, Canadians can only access CBD products through Canada’s cannabis for medical use program, which only allows online sales, or through non-medical “recreational” stores where employees cannot discuss medical effects. 

While there is no current legal pathway for natural health products containing cannabidiol (NHPCCs), Health Canada is proposing amending existing regulations that could create a pathway as a highly-regulated medical ingredient that could be accessed without a prescription.

Health Canada also continues to explore regulating health products containing CBD under the Food and Drug Regulations as non-prescription veterinary drugs (more on this below).

If allowed, natural health products containing CBD could not contain more than 10 parts per million (ppm) THC and would be required to undergo a full safety and efficacy assessment, including phase 3 clinical trials.

Any activities with such products—from manufacturing, packaging, labelling, and importing natural health products containing CBD—would require a special licence. The import and export requirements of the Cannabis Act would apply also still to NHPCCs.

The consultation document also considers where such products could be sold, including pharmacies, health food stores, and online. Any advertising and promotion would need to be regulated by the FDA. 

Permitting CBD as a medicinal ingredient in natural health products would require amendments to Schedule 2 of the Natural Health Products Regulations and the Prescription Drug List.

The federal government’s external science advisory committee also identified what they say are several gaps in the scientific evidence that would need to be addressed in future product licence applications. Those gaps include long-term safety and any possible interaction with other drugs, as well as its impact on specific, under-studied communities like pregnant and breastfeeding individuals, older adults, Indigenous peoples, people with underlying medical issues, and more.

Health Canada also encourages the industry to continue more clinical research on cannabis-based products and their derivatives and notes that the approach to post-market safety monitoring of NHPCCs would be the same as for other similar risk NHPs.

For the potential for CBD as a product for pets, Health Canada is considering limiting veterinary drugs containing CBD (VDCCs) to an oral dose of CBD of 0.2 to 2 mg/kg twice a day for treating pain associated with osteoarthritis in dogs. The agency says it would also consider further amendments to the PDL for CBD if additional evidence supports a non-prescription status for that VDCC.

The federal health agency is asking for stakeholder feedback on several of the issues they highlight, which will be used to aid in their decision-making process.

Health Canada has released several updates on this ongoing process over the years to look at CBD as an NHP and/or as a non-prescription veterinary drug.

In 2022, Health Canada also released a report on health products containing cannabis. In their Forward Regulatory Plan: 2024-2026, released earlier this year, Health Canada also said it intends to create a regulatory pathway for health products containing cannabidiol that would not require practitioner oversight. 

The nine-person expert panel report in 2022 included recommendations for some very limited forms of therapeutic CBD use for both humans and some dogs. 

In 2018, Health Canada completed a scientific review to determine if cannabis and its associated phytocannabinoids, like CBD, could be identified for non-prescription status. At the time, the agency determined there was not enough scientific evidence to do so. 

The federal government’s five-year report on legalization, released in 2024, included a recommendation that Health Canada make it possible for people in Canada to access health products containing cannabis through standard drug approval pathways. 

The Cannabis Act review panel also recommended that the health agency prioritize the development of a pathway for health products containing CBD but noted the challenges around a lack of available research.

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