Health Canada Considers Possibilities for Non-Prescription CBD Products for Humans and Animals

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In a March 2025, health consultation, Health Canada explained how it would be exploring a potential way for certain health products containing CBD to be accessible to Canadians without a prescription (1). Additionally, it is seeking ways to regulate CBD health products as non-prescription veterinary drugs for animals. Ultimately, the goal is for humans and animals to receive effective, safe, and evidence-backed CBD products to treat minor health problems. Health Canada is currently gathering feedback from industry stakeholders to potentially be used in the development process of CBD products without a prescription.

In 2020 Health Canada published its report on consumer and stakeholder interest in purchasing, making, or selling cannabis products that would not require a prescription. Results indicated that 61% of consumers and 62% of industry representatives showed interest in the products.

The new regulatory pathway, the consultation explained, would require amending the current natural health products (NHPs) framework to incorporate CBD as a medicinal ingredient. Furthermore, because CBD is part of the cannabis plant, the Food and Drugs Act and the Cannabis Act would also need be considered. Health Canada's international treaty obligations, including exportation and importation, would also be required to be respected.

The consultation outlined the Food and Drug Regulations principles followed in the process of evaluating a drug for prescription or nonprescription use, including practitioner supervision for its use, the drug’s level of uncertainty justifies practitioner supervision, and the risks for harm can be mitigated by practitioner supervision. If any of the principles apply, the drug is given prescription status.

The Cannabis Act created the regulatory framework for access to cannabis products in Canada in 2018 (2). Also in 2018, Health Canada conducted a scientific review on cannabis and phytocannabinoids, ultimately determining that there was not enough evidence to shift them to nonprescription status and placing them on the Prescription Drug List (PDL). The Science Advisory Committee on Health Products Containing Cannabis (SAC-HPCC) was also created for more information on the safety and efficacy of cannabis products for human and animal use.

The SAC-HPCC found that a maximum of 200 mg of CBD orally per day for a maximum of 30 days was tolerated by healthy adults (excluding vulnerable populations), with guidance from a pharmacist on potential interactions. However, the committee found a lack of high-quality research on CBD used therapeutically for minor ailments in a self-care context. Most studies involved treatment for epilepsy and other complex health conditions. Furthermore, gaps in evidence on drug interactions and long-term safety of CBD were found and would need to be addressed in order for CBD to become a nonprescription drug.

For animals, the committee found (1):

• the safety evidence supported very low doses between 0.2 and 2mg/kg orally 2 times a day
• there is enough evidence on the efficacy of CBD for treating pain associated with diagnosed osteoarthritis
• veterinarian oversight is important until more safety and efficacy information becomes available

Gaps in evidence for possible side effects were found with companion animals, and maximum residue levels need to be established for food producing animals such as livestock to better understand the effect of cannabis in the food chain.

Feedback on CBD for human and animal use can be submitted here, with the deadline of June 5, 2025.

References

1. Health Canada. Towards a pathway for health products containing cannabidiol: Overview https://www.canada.ca/en/health-canada/programs/consultation-towards-pathway-products-containing-cannabidiol/overview.html (accessed Mar 10, 2025).
2. Health Canada. Cannabis Act legislative review https://www.canada.ca/en/health-canada/services/drugs-medication/cannabis/laws-regulations/cannabis-act-legislative-review.html (accessed Mar 10, 2025).