e-2450 (Health)

Cannabidiol (CBD) is a compound that is found in varieties of the cannabis plant, including industrial hemp plants. While it is non-intoxicating, CBD does have an effect on the body and brain. CBD is a controlled substance under a United Nations drug control convention to which Canada is a signatory. CBD is regulated in Canada under the Cannabis Act and its regulations, as well as the Food and Drugs Act and its regulations.

Internationally, CBD is listed under Schedule I and IV of the1961 Single Convention on Narcotic Drugs as amended by the 1972 Protocol. Based on this classification, the Government of Canada is required to:

• Limit possession except under legal authority;
• Limit production and imports to estimated needs;
• Licence and control production and distribution;
• Report on activities related to CBD; and,
• Establish strict restrictions for imports and exports.

Consistent with the controlled status of CBD internationally, CBD is a controlled substance in Canada. The Cannabis Act provides restricted access to CBD (along with other forms of cannabis) for both medical and non-medical purposes. The Act and its regulations establish a series of controls to mitigate against the public health and public safety risks posed by these substances. For example, the Act and regulations set out requirements for the production of products containing CBD to ensure that they meet quality standards and are tested and validated for CBD and tetrahydrocannabinol (THC) content. Similarly, persons wishing to produce, distribute or sell cannabis products, including those that contain CBD, must hold a licence or other form of authorization from the appropriate federal or provincial/territorial authority. Under the Cannabis Act, individuals who have the support of their health care practitioner may access cannabis for medical purposes from federally licensed sellers, including a range of cannabis products that contain CBD.

Operating alongside the regime established by the Cannabis Act, the Food and Drugs Act and its regulations provide a regulatory pathway for the manufacture and sale of prescription drugs that contain cannabis, including veterinary drugs. The Department added all phytocannabinoids (http://bit.ly/2TjG0JT), including CBD, to the Human and Veterinary Prescription Drug List (PDL) on October 17, 2018. This means that any drug containing a phytocannabinoid can only be sold in Canada on a prescription-only basis. The listing of all phytocannabinoids on the PDL reflects a current lack of clinical evidence supporting the safety and efficacy of the chemicals found in cannabis for therapeutic purposes. As experience grows and knowledge is gained (through robust scientific evidence), the prescription status of certain phytocannabinoids (for specific conditions of use) may no longer be necessary.

The Department is aware that some Canadians are interested in the potential therapeutic uses of cannabis for purposes such as pain relief, for human use and in animals, without the need for practitioner oversight. On June 19, 2019, Health Canada launched a consultation to seek feedback from Canadians and industry on the kinds of products they would be interested in purchasing, manufacturing or selling if such products were to be legally available in Canada. For more information, the report summarizing the feedback received is available online: https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/summary-report-consultation-potential-market-health-products-cannabis.html.

As part of this consultation, the Department made a commitment to seek external scientific advice regarding the appropriate evidence standards for non-prescription health products containing cannabis. On February 27, 2020, Health Canada also issued a call for nominations for a Science Advisory Committee on Health Products Containing Cannabis. The Committee will provide independent scientific and clinical advice to support the Department’s consideration of appropriate safety, efficacy, and quality standards for health products containing cannabis, including the conditions under which these products would be suitable to be used without practitioner oversight (e.g., dose and indication). 

The Committee will review available evidence regarding the use of cannabis and health products containing cannabis, address specific scientific questions, review current and emerging scientific and clinical issues, and provide evidence-based advice to help inform a potential regulatory path forward. For information pertaining to the Committee, please visit https://www.canada.ca/en/health-canada/corporate/about-health-canada/public-engagement/external-advisory-bodies/health-products-containing-cannabis.html.