Health Canada seeks comments on regulating CBD as a natural health product

Health Canada has launched a new public consultation to explore potential regulatory pathways for the CBD as natural health product (PSN), a designation that covers and regulates low-risk products such as herbal remedies, certain sunscreens, and vitamins and minerals.

Stakeholders have until June 5, 2025 to share their comments on the proposed framework, which could allow Canadians to access CBD without a prescription and without necessarily having to go to a cannabis store.

A New Regulatory Path for CBD in Canada

From 2018, Health Canada is exploring the possibility of regulating cannabidiol (CBD) beyond its current status under Canada's medical and non-medical cannabis programs. Currently, the CBD products are available only through licensed online medical cannabis providers or recreational cannabis stores, where employees are not allowed to discuss the medical benefits.

As part of its Forward-Looking Regulatory Plan (2024–2026), Health Canada has committed to establishing a pathway for over-the-counter CBD-based health products. The ongoing review follows several previous assessments, including a 2022 report by a group of experts and the2024 Five-Year Review of the Cannabis Act, which recommended the development of a framework for accessible CBD-based health products.

The proposed amendments would establish a highly regulated environment allowing the sale of CBD as PSN, subject to rigorous safety and efficacy evaluations. The products should not contain more than 10 parts per million (ppm) of THC and should undergo rigorous clinical trials, including Phase 3 trials.

If implemented, this regulatory change will require amendments to Schedule 2 of the Natural Health Products Regulations and to the Prescription Drug List. It would also impose licensing requirements for the manufacture, packaging, labeling, and importation of these products, under the oversight of Health Canada and the Cannabis Act.

The Scientific Advisory Committee An external review by Health Canada highlighted several gaps in research that must be addressed before CBD can be fully integrated as a natural health product regulated. These gaps are as follows:

• the long-term safety of CBD use
• visit Drug interactions with CBD
• the effects on specific populations, including pregnant women, the elderly people, Indigenous communities, and people with pre-existing conditions.

The Federal Health Agency encourages the continuation of clinical trials on cannabis-based health products and specifies that post-market safety monitoring of CBD-based PSN will follow the same guidelines as other natural health products.

In addition to human use, Health Canada is also evaluating the The Potential of CBD for Pets. The consultation document suggests limiting the CBD-based veterinary medications at a dose of 0.2 to 2 mg/kg twice daily, particularly for treating the pain associated with osteoarthritis in dogs. Any extension beyond this scope would require scientific evidence additional items and any changes to the List of Prescription Drugs.