Notice to Stakeholders: Non-Prescription Health Products Containing Cannabidiol (CBD)

Introduction

In 2019, Health Canada held a consultation to seek feedback from Canadians, as well as cannabis and health products industries, about the potential market for non-prescription health products containing cannabis. A summary of comments received was published on Canada.ca in September 2020.

One of Health Canada’s commitments during the 2019 consultation was to seek external scientific advice on the appropriate evidence standards for non-prescription health products containing cannabis. To fulfil this commitment, in November 2020, Health Canada established the Science Advisory Committee on Health Products Containing Cannabis to provide independent scientific and clinical advice to support the department’s consideration of appropriate safety, efficacy and quality standards for health products containing cannabis that would not require a prescription.

On July 28, Health Canada published the final report from the Science Advisory Committee. The report focuses on cannabidiol (CBD) for both human and animal use. The Committee made the decision to focus on CBD because there is more research and evidence about the safety and potential therapeutic uses of CBD and because CBD was identified as an ingredient of interest during Health Canada’s 2019 public consultation. The department is appreciative of the efforts required by members to conduct this work and is pleased to share the Committee’s expert advice with the Canadian public.

Health Canada is exploring a potential framework for non-prescription health products containing CBD. The Committee’s final report is one of many sources of input that Health Canada is considering as it continues to develop a potential framework for these types of products, including feedback from interested stakeholders and the public.

Seeking Input

Health Canada is inviting interested parties to provide input to support the development of a potential regulatory pathway that would permit CBD as a medicinal ingredient in certain health products for human use, regulated under the Food and Drugs Act, which would not require a prescription. This initiative is set out in Health Canada’s Forward Regulatory Plan. Any future regulatory proposals for health products containing CBD will follow regular consultation procedures.

Health Canada is also seeking input on products for animal use to help inform potential policy changes in this area.

To note, this notice relates specifically to potential non-prescription health products containing CBD. Other cannabinoids, including delta-9-tetrahydrocannabinol (THC), are not being considered for non-prescription use at this time.

Next Steps

As the department progresses in its efforts to develop a potential non-prescription pathway for health products containing CBD, there will be opportunities for stakeholders to share input and provide feedback on more specific policy as it is developed. This notice provides an early opportunity for interested parties to help inform three areas as the department continues the policy development process.

1. Market Considerations

   In the comments received during the 2019 consultation, Health Canada heard that there was an interest in both purchasing and manufacturing health products containing cannabis, primarily those containing CBD. At that time, respondents indicated that there was a strong interest for such products in a wide variety of types and formats.

   As the market for CBD continues to evolve, as does the science surrounding CBD and its uses, the department is seeking updated information on the types of health products containing CBD for which industry may wish to manufacture and market, and consumers may wish to purchase and use, should a legal pathway for these products be established. This can include the types of products, the intended uses, formats, dosages and any other considerations regarding the potential market for such products.

2. Regulatory Framework

   In determining the appropriate level of regulatory oversight for CBD health products, Health Canada is considering input from various sources, including the Science Advisory Committee’s report, to inform its approach. Should interested parties have key perspectives that could inform the development of this approach for health products containing CBD, on areas such as product labelling, point of sale, access, post-market oversight and others, the department welcomes input at this time.

3. Call for Evidence

   Stakeholders and consumers are also encouraged to submit additional scientific evidence pertaining to the safety and/or efficacy of CBD that may be suitable for human or animal use as a health product without practitioner oversight (such as relieving minor symptoms of stress and nervousness, promoting sleep, and relieving minor pain).

   Human Use:

   We are particularly interested in receiving scientific evidence (such as clinical studies, peer-reviewed scientific journal articles etc.) in the following areas identified as gaps by the Science Advisory Committee in their report, including:

   • Long-term safety;
   • Potential interactions (drug-drug, drug-NHP, drug-food and interactions with alcohol);
   • Understudied subpopulations (such as young adults, the elderly, Indigenous populations, people with underlying medical conditions, pregnant and lactating individuals, racialized populations, LGBTQS2+ etc.);
   • Effectiveness of CBD in treating specific conditions (such as relieving minor symptoms of stress and nervousness, promoting sleep and relieving minor pain);
   • Optimal dosing; and,
   • Effectiveness of CBD applied topically.

   Animal Use:

   For animal use, we are also interested in receiving scientific evidence in the following areas identified as gaps within the Science Advisory Committee report, including:

   • Long-term safety;
   • Potential interactions (drug-drug and drug-food);
   • Optimal dosing;
   • Species-specific evidence for use in animals; and,
   • Information on implications for human safety for use in food-producing animals.

Comments

Information provided in response to this notice will help inform Health Canada’s ongoing policy work.

Submissions should be sent to the Natural and Non-prescription Health Products Directorate during the next 70 calendar days ending October 6. Please send your comments by email to nnhpd.consultation-dpsnso@hc-sc.gc.ca stating the title of this notice in the subject line (Notice to Stakeholders: Non-prescription Health Products Containing CBD).