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Towards a pathway for health products containing cannabidiol: Natural health products containing cannabidiol

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Background

Currently, there are 3 regulatory pathways that provide access to commercial products containing cannabis, including CBD in Canada, each subject to different regulatory controls (note the regulatory controls listed below are not exhaustive):

  1. Cannabis for non-medical purposes (Cannabis Act and its regulations)
    • fresh, dried, edibles, extracts, topicals, plus plants and seeds
    • health care practitioner authorization not required
    • no pre-market review for safety and efficacy
    • quality and security requirements under the Act
    • several controls to restrict youth access and prevent inducements for youth to consume cannabis (e.g. minimum federal age of 18 years, access through PT-licensed retail stores only, plain, child-resistant packaging)
    • restrictions on promotion, including cannot make health claims
  2. Cannabis for medical purposes (Cannabis Act and its regulations)
    • same classes as cannabis for non-medical purposes
    • health care practitioner authorization required
    • no pre-market review for safety and efficacy
    • quality and security requirements under the Act
    • access through HC-licensed commercial sellers (order online and delivered by mail)
    • plain, child-resistant packaging
    • restrictions on promotion, including cannot make health claims
  3. Prescription drugs containing cannabis (Cannabis Act, Food and Drugs Act and their regulations)
    • no restrictions on product formats that may be authorized
    • health care practitioner oversight required
    • pre-market review for safety, efficacy and quality under the FDA
    • manufacturing subject to quality and security requirements under the FDA and Cannabis Act
    • access through pharmacies only
    • can make health claims

Within these existing frameworks, there is no legal pathway to market a natural health product containing CBD (NHPCC).

There has been continued interest from stakeholders to include CBD in health products available without a prescription and consumers who want to access them. As a result, Health Canada committed to looking at a potential regulatory pathway for NHPCCs that may be accessed without a prescription.

Interplay between associated Acts

The Cannabis Act (CA) and its regulations came into force in 2018 and provide a legal framework for possessing, producing, distributing, selling, importing and exporting cannabis. Under the CA, cannabis is defined as a cannabis plant and anything referred to in Schedule 1 (for example, all phytocannabinoids, including CBD). It does not include anything referred to in Schedule 2 (for example, non-viable seeds).

Cannabis meets the definition of a drug under the FDA. In the definition, a drug includes any substance or mixture of substances manufactured, sold or represented for use in:

Although cannabis meets the definition of a drug, it is only regulated under the Food and Drugs Act in certain circumstances. These are outlined in the Cannabis Exemption (Food and Drugs Act) Regulations. Notably, these circumstances include when cannabis is "manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, or in restoring or correcting organic functions, in human beings or animals".

The FDA and its regulations regulate the safety, efficacy and quality of health products, such as prescription or non-prescription drugs, natural health products (NHPs) and medical devices. These products can only be sold if they have been authorized by Health Canada following a scientific review.

Established in 2004 under the authority of the FDA, the Natural Health Products Regulations (NHPR) outline the requirements for manufacturing, packaging, labelling, storing, importing, distributing and selling NHPs. The regulations are intended to provide people in Canada with access to NHPs that meet appropriate standards for safety, effective and high quality.

The definition of NHP has 2 components: a function component and a substance component. The function component relates to the intent of the definition, which is to capture those substances that are manufactured, sold or represented for use in:

The substance component refers to the ingredients that qualify as NHPs. An inclusion list (Schedule 1) sets out the substances that qualify as NHPs. An exclusion list (Schedule 2) indicates the substances that are not NHPs. Cannabis, as defined in the CA, is listed on Schedule 2 of the NHPR and is not currently an NHP.

With regulatory amendments, NHPCCs could be regulated under the FDA and the NHPR. However, as CBD is regulated under the CA and its regulations, its use as an ingredient in an NHPCC would mean that the product would also have to comply with parts of the CA and the Cannabis Regulations depending on where they are in the lifecycle.

Hemp-based NHPs

There are over 200 licensed NHPs containing hemp. Hemp-based NHPs include hemp seed oils and protein powders, among others.

Currently, NHPs may only contain parts of the cannabis and hemp plants that are not considered cannabis under the CA (noted in Schedule 2 to the Act). This includes plant parts such as:

Of note, these products cannot contain more than 10μg/g THC, an isolated or concentrated phytocannabinoid or a synthetic duplicate of that phytocannabinoid.

Policy considerations

To permit CBD as a medicinal ingredient in an NHP, amendments would be required to Schedule 2 of the NHPR and the PDL.

If these amendments are made, Health Canada would have the ability to regulate NHPCCs under the NHPR. Provided that a product licence application for an NHPCC meets the licensing requirements in the regulations, such products could then receive a natural product number (NPN). This number indicates that Health Canada has reviewed and authorized a product.

There may be some differences in the premarket regulatory oversight for NHPCCs compared to the oversight for existing NHPs. The differences would reflect the fact that they meet the definition of both a drug and cannabis.

The following key policy considerations are in line with the advice of our external science advisory committee and the feedback we received from previous consultations.

Scope

Medicinal ingredient: CBD

An expert committee of the World Health Organization (WHO) on drug dependance released a report confirming that CBD does not produce the psychoactive effects typically associated with addictive substances, such as tetrahydrocannabinol (THC). Furthermore, studies have shown that CBD does not lead to physical dependence or cravings.1 Given the minimal abuse potential of CBD and its non-intoxicating nature, there is a significantly reduced risk that health products containing CBD would be accessed by youth for non-medical purposes, or diverted to the illegal market.

In their report, the SAC-HPCC noted that it is unlikely that people would take CBD health products for an intoxicating effect; however, over-consumption of CBD could lead to unpleasant but minor side effects. It is our view that health products containing CBD can be appropriately regulated without practitioner oversight as natural health products – that is, subject to appropriate quality standards, thorough pre-market review, and post-market oversight.

Given the state of existing research, NHPCCs would be limited in scope to those containing CBD as a medicinal ingredient.

Health Canada:

We would maintain the established regulatory limit of 10 ppm THC (similar to natural health products containing hemp) for NHPCCs.

Safety and efficacy

All NHPs are subject to a pre-market safety and efficacy review and must meet the licensing requirements set out in the NHPR before they receive a market authorization.

As NHPs, NHPCCs would undergo a full safety and efficacy assessment. They would be authorized with a specific health claim, which requires scientific evidence with a direct link to the health claim, including evidence addressing safety and efficacy gaps identified by the committee. Evidence of traditional use would not be accepted and general health claims (those with low therapeutic value, such as an antioxidant claim) would not be permitted.

The type and amount of evidence depend on the proposed indication or health claim and the product's overall benefits and risks. However, NHPCCs are novel and fall into a higher risk category for self-care products. For these two reasons, we would require robust scientific evidence, such as that generated through phase 3 clinical trials. Evidence should:

Learn more about the pathway for licensing natural health products making modern health claims.

Note: The external science advisory committee identified several gaps in the scientific evidence (such as clinical studies, peer-reviewed scientific journal articles) that would need to be addressed in future product licence applications. There were gaps in:

Site licensing, good manufacturing practices and product quality

Under the NHPR, a site licence is required for manufacturing, packaging, labelling, or importing NHPs. Site licence holders are required to comply with good manufacturing practices (GMP), which refer to the regulatory requirements that are necessary to ensure product quality and risk management.

GMP requirements are designed to ensure that NHPs are safe, effective and of high quality. Following GMP standards and practices help to ensure that finished products:

Learn more about good manufacturing practices for natural health products.

To permit products containing CBD as NHPs, it is critical that products are high quality. Rigorous quality oversight is necessary to ensure that NHPCCs contain the ingredients on the label and do not pose risks of intoxication due to contamination with THC or other psychoactive compounds. Products that are not high quality would put consumers at risk and pose risks of diversion and youth access and, as such, are not appropriate as health products under the FDA.

Cannabis plant cultivation, CBD extraction and synthetic production, and its packaging and labelling, import/export, and sale are activities regulated under the Cannabis Regulations. Cannabis licence holders must comply with good production practices set out in the Cannabis Regulations, which are designed to ensure cannabis products are of high quality, free of contaminants, and appropriately labelled for THC and CBD content. In addition, cannabis licence holders must comply with a series of strict physical and personal security requirements that are designed to reduce the risk that legal cannabis is diverted to an illegal market or purpose.

Additionally, a Cannabis Drug Licence is required under the Cannabis Act for any Drug Establishment Licence holders who manufacture drugs containing cannabis. Cannabis Drug Licence holders must comply with physical and personal security requirements set out in the Cannabis Regulations, but not the good production practices (since the manufacture of drugs must comply with GMP requirements in the Food and Drugs Act).

As NHPs, Health Canada is proposing that manufacturing, packaging, labelling and importing NHPCCs would require a site licence under the NHPR. However, given the low risk of diversion of products containing CBD, it is not our intention to require a Cannabis Drug Licence or similar mechanism that would establish additional physical or personnel security requirements.

We are looking at how the sale of CBD between a licensed cultivator or processor under the Cannabis Act, and a site licence holder under the NHPR could operate; as well as how both licences could be obtained for the same site, for those wishing to process CBD and manufacture a finished NHPCC. This includes looking at the stage at which the raw cannabis material intended for an NHPCC could be permitted on an NHP site to avoid risks of diversion.

While it's expected that the requirements for handling materials and storage procedures and processes are in place for manufacturing NHPs, the NHPR do not include specific requirements for raw material controls. As CBD will be included as a medicinal ingredient and must be of sufficient quality and purity, Health Canada is considering measures, such as requiring a certificate of analysis for CBD as a raw material. Our goal is to ensure CBD meets quality standards and these standards remain strictly controlled throughout product development and manufacturing.

Feedback:

Packaging and labelling

All NHPs must comply with the packaging and labelling requirements set out in the NHPR. These requirements support the safe use of products and help consumers make informed purchasing choices. Labels must give specific information on the product, for example:

It is our view that NHPCCs should look and feel like other comparable NHPs as much as possible; however, we are also looking at other unique requirements in addition to what is required by the NHPR, such as requiring a statement that the product contains CBD on the principal display panel. In addition, the science advisory committee recommended that products carry statements or be packaged in boxes that contain informational inserts on the potential interactions between CBD and other drugs or alcohol. Risk information, such as cautionary statements for pregnant or breastfeeding individuals, are product-specific and already required on the label of NHPs.

Feedback

Clinical trials

Clinical research is critical to developing health products that are safe and effective. An increased availability of health products that are safe and effective means that individuals have a greater selection of therapeutic options to meet their health needs. High-quality research also helps health care practitioners make evidence-based decisions for their patients.

Health Canada encourages ongoing clinical research on cannabis-based products and their derivatives for market authorization or product licence as either prescription drugs or NHPs.

Current state of clinical trials

Clinical trials for human drugs containing cannabis using either human or animal subjects must receive authorization under the Food and Drug Regulations (FDR). Sponsors (for example, industry, academia, contract research organizations) must submit a clinical trial application to Health Canada. Sponsors are subject to the requirements of Part C, Division 5 of the FDR ("Drugs for Clinical Trials Involving Human Subjects") for all drugs for human use, including those containing cannabis.

Please read Health Canada's Notice to stakeholders – Clarification of requirements under the Food and Drug Regulations when conducting clinical trials with cannabis, for more information.

Sponsors interested in conducting clinical trials with cannabis or its derivatives, including CBD, must also meet certain requirements under the Cannabis Act (CA) and its regulations. They must apply for and obtain a federal cannabis research licence from the Controlled Substances and Cannabis Branch of Health Canada. They must also meet the terms and conditions specified in their licence.

The NHPR includes requirements that apply to clinical trials for NHPs, including those containing permitted parts of the cannabis plant that are not considered cannabis under the CA (as noted in Schedule 2).

Potential clinical trials for NHPCCs

Health Canada is considering that clinical trials for NHPCCs could have the same requirements as other clinical trials involving NHPs. Consideration will need to be given to whether sponsors would require a cannabis research licence under the CA and be required to meet the terms and conditions of that licence.

The scope of Part 4 of the NHPR is to ensure:

Feedback

Place of sale

We are considering various options regarding where NHPCCs could be sold. NHPs are sold in retail settings, such as local pharmacies, health food and specialty stores, and through online retailers and digital shopping platforms. However, cannabis products for adult use are sold in licensed retail settings that are inaccessible to young persons (exceptions are cannabis for medical purposes and prescription drugs containing cannabis). This is to protect young persons (people under 18 years of age) and minimize any inducement to use cannabis.

The science advisory committee recommended that consumers who wish to take CBD along with other medications and substances should consult their pharmacist. The pharmacist can provide information about potential interactions with other health products and flag any other potential concerns.

We are looking at pharmacy-only sale in either self-selection areas, like for other NHPs, or sales by pharmacists and staff working under a pharmacist's supervision. This may affect access to products for consumers, but our goal is to ensure that consumers use these products appropriately.

As NHPs can be sold by any retailer, including health food stores, we are also looking at allowing NHPCCs to be sold in this manner. This model would allow consumers to compare NHPCCs with other similar NHPs or non-prescription drugs on store shelves. In the 2019 survey, consumers expressed a preference for greater access to a wider variety of products without the need for a prescription to treat minor ailments. Approximately 40% of the consumers who responded said that NHPCCs should be sold in the same way that other NHPs are.

With no restrictions on place of sale, consumers would not have access to a qualified health care practitioner who would have knowledge about potential interactions between an NHPCC and other drugs, health products or substances.

Feedback

Advertising and promotion

Like other authorized novel NHPs, NHPCCs would be assessed for safety, quality and efficacy under the NHPR. Similarly, as a health product, NHPCCs should align with other authorized health products and adhere to advertising restrictions under the Food and Drugs Act (FDA). The FDA provides oversight to effectively regulate advertising and promotion for drugs, including NHPs.

Maintaining advertising and promotion for NHPCCs under the FDA promotes regulatory consistency across the NHP landscape. Although a more restrictive advertising approach exists under the Cannabis Act to protect youth from inducements to use cannabis, CBD is not habit-forming and not associated with abuse potential or intoxication. In our view, an NHPCC would not pose the same potential appeal as cannabis products might to young persons.

Under the FDA, health products must not be advertised in a false, misleading or deceptive manner and promotional materials must be consistent with the product's market authorization terms established by Health Canada. For example, a drug product cannot be advertised outside of its authorized indications or recommended uses. Health Canada will assess these existing restrictions to determine if they are sufficient to manage risks that could emerge from advertising of NHPCCs given the link to cannabis.

Consistent with the approach to other health products, Health Canada would take appropriate enforcement actions when non-compliance in advertising and promotion is identified. Generally, compliance is achieved voluntarily, although other existing measures may be used as needed.

We do not review or preclear advertisements but strongly encourage advertisers to consult an advertising preclearance agency (APA) for their preclearance services.

Feedback

Post-market safety monitoring of NHPCCs

The approach to the post-market safety monitoring of NHPCCs would be the same as for any other similar risk NHPs.

Under the NHPR, the decision to authorize an NHPCC would be based on the safety and efficacy information available at that time.

New safety information may become available during the post-market period, which could change what is known about the product's benefits and risks. For example, after a product is on the market, there may be more information about its long-term safety, interactions with other health products or substances, use outside of the recommended conditions of use and risks in certain vulnerable groups such as children, pregnant people or the elderly.

Once an NHPCC is marketed, we would monitor any serious adverse reactions reported to Health Canada. Market authorization holders (MAHs) are required to submit a case report for each serious adverse reaction to a NHP that occurs inside Canada, within 15 days after the day on which the MAH becomes aware of the reaction; and a case report for each serious unexpected adverse reaction to a NHP product that occurs inside or outside Canada, within 15 days after the day on which the MAH becomes aware of the reaction. Additionally, on an annual basis, MAHs must prepare a summary report with a critical analysis of all adverse reactions occurring inside Canada, as well as all serious, unexpected adverse reactions that have occurred outside Canada. We can request such reports to be submitted if there are reasonable grounds to suspect the product may no longer be safe when used under recommended conditions of use.

In addition to the adverse reaction reports we receive from consumers, healthcare providers and market authorization holders, we also monitor actions taken on NHPs by key regulatory counterparts and, depending on emerging safety concerns, we also monitor safety information provided in scientific studies.

When we identify a potential safety issue, we conduct a review of the available information and determine a strategy to mitigate the risk. This may, for example, involve more frequent monitoring, communicating the risks, requesting label changes or taking compliance and enforcement actions.

Feedback

Compliance and enforcement

Promoting, monitoring and verifying compliance help to raise awareness among regulated parties of their responsibilities and to ensure that they and their products comply with regulations. We educate regulated parties and other stakeholders, respond to consumer and trade complaints, and proactively inspect facilities, records and products.

To incite compliance with relevant legislation and regulations, we can take additional actions, such as directing the stop sale for a product, suspending a licence or requesting a voluntary recall.

We determine the most appropriate action and will escalate our response based on the severity of the risk posed by potential non-compliance and other factors, such as whether the regulated party has a history of non-compliance. In cases involving criminal activity, we may also refer to law enforcement.

Compliance and enforcement for NHPCCs would employ a risk-based approach that is comparable to other NHPs that have a similar risk profile.

Other Activities

Personal Possession Limits

In line with the exemptions for prescription drugs containing cannabis, we are considering excluding NHPCCs from the personal possession limits identified in the Cannabis Act

Importation and Exportation

Under the Cannabis Act, the importation and exportation of cannabis, (including CBD and drugs containing cannabis), requires an import or export permit issued by Health Canada, and may only be issued for a medical or scientific purpose. Moreover, only the holder of a licence under the Cannabis Act may obtain an import or export permit. As part of the permitting process, Health Canada monitors and reports on the quantity of cannabis being imported and exported. These requirements align with Canada's international treaty obligations (the United Nations Single Convention on Narcotic Drugs).

Given Canada's international obligations, it is proposed that the import/export requirements of the Cannabis Act apply to NHPCCs. Consideration will need to be given as to how site licence holders under the NHPR will be able to obtain an import or export permit under the Cannabis Act, given the proposal not to require a cannabis licence for activities related to these products.

Feedback

Table 1 shows some of the potential NHPCC requirements under the Cannabis Regulations and the Natural Health Products Regulations that would apply to the raw cannabis and the NHPCC finished product. As noted above, Health Canada is considering if any additional requirements may also be required.

Table 1: Potential NHPCC pathway - requirements under the 2 sets of regulations
CBD raw material requirements - under the Cannabis Regulations NHPCC Finished Products - requirements under the Natural Health Products Regulations
Good production practices (GPP) – quality control Good manufacturing practices (GMP) – quality control and risk management
Licences – cultivation, processing Site licence – manufacture, package, label and sale
Research licence Product licence
Physical and personal security Packaging and labelling
Record keeping and reporting Clinical trial
  Post-market – place of sale, advertisement, promotion, safety monitoring, reporting, compliance and enforcement

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