Towards a pathway for health products containing cannabidiol: Overview

On this page

• Introduction
• Objective
• Context
• Engagement to date

Introduction

Health Canada is exploring a regulatory pathway for the authorization of health products containing cannabidiol (CBD) that could be accessed without a prescription. Our goal is to protect the health and safety of Canadians and enable access to safe, effective and high-quality products for human and animal use to treat specific or minor ailments that are supported by adequate evidence.

For human use, we are looking at amending the existing regulatory framework for natural health products (NHPs) to include CBD as a medicinal ingredient. The pathway would include additional premarket measures to support product quality and provide cohesion between the Food and Drugs Act and the Cannabis Act, given that CBD is a component of the cannabis plant.

Developing a regulatory pathway for health products containing CBD that would not require a prescription would:

• Regulate health products containing cannabidiol consistently with other health products that do not require a prescription;
• Provide consumers with access to high quality products that are authorized by Health Canada for sale without a prescription; and
• Continue to respect Health Canada's international treaty obligations including exportation and importation.

We are also considering burden reduction elements including not carrying over the cannabis drug and research licensing requirements when a regulated party is only handling CBD.

For animal use, we are exploring regulating health products containing CBD under the Food and Drug Regulations as non-prescription veterinary drugs.

Health Canada intends to use this discussion paper to gather stakeholder and consumer feedback on key policy considerations for health products containing CBD that do not require a prescription. This feedback will be considered during the policy development process.

Context

The Government of Canada published a report in March 2018, summarizing the input received during the public consultations on regulations under the Cannabis Act. In this summary report, the government indicated it would:

• maintain existing access to prescription drugs containing cannabis and medical devices for use with cannabis; and
• determine an appropriate regulatory approach for health products containing cannabis that do not require a prescription.

In 2018, Health Canada completed a scientific review to determine if cannabis and its associated phytocannabinoids (such as CBD) could be identified for non-prescription status. We concluded at this time that there was not enough scientific evidence on such factors as their pharmacological actions, therapeutic effectiveness and safety to make the shift. For this reason, we added all phytocannabinoids produced by and found in the cannabis plant to the Prescription Drug List (PDL).

Following this review, we established a Science Advisory Committee on Health Products Containing Cannabis (SAC-HPCC) for human use and a subcommittee dedicated to animal use. The committee provided independent scientific and clinical advice on the appropriate safety, efficacy and quality standards for both sets of potential products. We took this advice into consideration when proposing the potential pathways. This initiative is also outlined in the 2024-2026 Forward Regulatory Plan.

Our main goal in evaluating whether a drug would be better sold as a prescription or non-prescription product is to protect the health and safety of Canadian consumers and protect the health and safety of animals, and safety of the food supply.

The standard process for deciding whether a drug should be prescription or non-prescription involves considering the three principles listed in Section C.01.040.3 of the Food and Drug Regulations, as follows:

1. Supervision by a practitioner is necessary:
   1. for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in respect of which the drug is recommended for use, or
   2. to monitor a disease, disorder or abnormal physical state, or its symptoms, in respect of which the drug is recommended for use, or to monitor the use of the drug;
2. The level of uncertainty respecting the drug, its use or its effects justifies supervision by a practitioner; or
3. Use of the drug can cause harm to human or animal health or a risk to public health and the harm or the risk can be mitigated by a practitioner's supervision.

The way in which Health Canada interprets the principles, along with their associated factors, are explained in the guidance document, Determining Prescription Status for Human and Veterinary Drugs.

Generally, if any principle or factor applies to a drug, the drug is given prescription status. If none of the principles or factors apply, the drug is given non-prescription status. Each decision made is based on an assessment of high-quality evidence.

Engagement to date

In 2019, we consulted interested consumers and industry stakeholders on health products containing cannabis. We wanted to know if they would be interested in purchasing, manufacturing or selling these products if they were to be legally available in Canada without a prescription.

In September 2020, we published a "what we heard" report which noted that among consultation respondents many consumers (61%) and industry representatives (62%) are interested in these types of products for human and animal use.

Next, we committed to seeking external scientific advice. In 2020, we established a science advisory committee.

Learn more:

• Consultation on potential market for cannabis health products that would not require practitioner oversight
• Summary report on the consultation
• Science Advisory Committee on Health Products Containing Cannabis

Science Advisory Committee on Health Products Containing Cannabis

The SAC-HPCC provided independent scientific and clinical advice to Health Canada, basing its advice on appropriate safety, efficacy and quality standards for such products.

Early in its mandate, the committee looked at several non-intoxicating phytocannabinoids before focusing solely on CBD. The body of evidence for therapeutic applications of CBD is more advanced than for other non-intoxicating phytocannabinoids. Industry and consumers also identified CBD as the phytocannabinoid of most interest.

The committee concluded that low doses of CBD (a maximum of 200 mg a day) taken orally for a short period (a maximum of 30 days) are safe and tolerable for healthy adults. However, healthy adults should talk to their pharmacist about their medications and substance use to avoid any unintended interactions. The SAC-HPCC also noted that the recommendation on the amount of CBD that is safe without oversight from a doctor or nurse practitioner did not apply to vulnerable patient populations (such as pregnant people and those with underlying medical conditions).

One challenge for the committee was the lack of available high-quality research on the safety and efficacy of CBD when used to treat minor health problems. While CBD shows early therapeutic potential, much of the studies, clinical trials and evidence reviewed focused on the drug-resistant epilepsy population and other complex health care needs and did not focus on CBD used in a self-care context to treat minor health ailments and conditions.

The SAC-HPCC identified key evidence gaps on safety and efficacy of CBD when used to treat minor health problems. Gaps include a lack of information on potential interactions with other drugs and substances, as well as on its safety when used long term. Addressing these evidence gaps are important before any potential PDL switch for CBD to non-prescription status.

The subcommittee on animal use found that:

• 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.

The subcommittee also identified evidence gaps related to specific indications for CBD use in companion animals, such as for dogs and cats. The overall absence of research meant there was little information on possible side effects of CBD. Most of the available safety and efficacy information came from scientific studies and surveys of owners and veterinarians, where sedation was the most commonly reported side effect. Although no serious side effects were reported, the subcommittee said that further scientific information was needed.

The subcommittee did not make any recommendations for food-producing animals, such as livestock. Having acceptable maximum residue limits (MRLs) would help in the potential development of a health product containing CBD intended for food animals. However, little is known about how residues of cannabis compounds would impact the food chain.

Read the final report, published in July 2022:

• Review of cannabidiol: A report of the Science Advisory Committee on Health Products Containing Cannabis

Notice to stakeholders

Coinciding with the publication of the committee's report, Health Canada invited interested parties to provide input on market considerations, potential regulatory options and additional scientific evidence on the safety or efficacy of CBD for human and animal use that could address the safety and efficacy gaps identified by the SAC-HPCC. We received some evidence that had been previously submitted to Health Canada and heard from industry and consumers that there is interest in being able to access products containing CBD that would not require a prescription to treat specific or minor ailments and conditions.

Based on this feedback and discussions with key veterinary drug stakeholders, such as the Canadian Veterinary Medical Association (CVMA), it is clear that a solution for animal use of products containing CBD is of interest. CVMA did express concern about the marketing of unauthorized products and the lack of access to cannabis-based veterinary products for medical purposes.

Notice to stakeholders: Non-prescription health products containing cannabidiol (CBD)

Legislative review of the Cannabis Act

The final report of the legislative review of the Cannabis Act was tabled in Parliament in March 2024.

Stemming from its review of the medical access program for cannabis, the panel recommended that Health Canada make it possible for people in Canada to access health products containing cannabis through standard drug approval pathways. The panel also recommended that Health Canada prioritize the development of a pathway for health products containing CBD.

The panel also highlighted the lack of evidence for therapeutic applications of phytocannabinoids, such as CBD, and the need for additional clinical research to facilitate the approval of cannabis-based medicines. This is in line with the SAC-HPCC's findings.