Towards a pathway for health products containing cannabidiol: Veterinary drugs containing cannabidiol for animal use

On this page

• Background
• Interplay between associated Acts
• Policy considerations

Background

Currently, there are 2 regulatory pathways for veterinary products containing cannabis in Canada:

1. Prescription drugs containing cannabis, which are regulated under the Cannabis Act (CA) and Food and Drugs Act (FDA) and their regulations
   • any veterinary drug containing phytocannabinoids (including CBD) would be considered a prescription new drug (Division 8 of the Food and Drug Regulations (FDR)) and require review and approval by Health Canada
   • pre-market product review for safety, efficacy, and quality under the FDA
   • no restriction on product formats that may be authorized
   • veterinarian oversight required
   • manufacturing subject to quality and security requirements under the FDA (including Division 2 of the FDR) and CA, respectively
   • can make health claims, if authorized
2. Hemp-based veterinary health products (VHPs), which are regulated under the FDA and FDR
   • may only contain parts of the cannabis and hemp plants that are not considered cannabis under the CA (parts found on Schedule 2 to the CA) or that are excluded from the application of the CA through the Industrial Hemp Regulations
   • hemp seed derivatives with a THC concentration of 10 μg/g or less
   • permitted to make general health claims (no treatment, prevention or cure claims) as per the VHP Notification Program (Division 1 of the FDR)
   • pre-market product notification to Health Canada and available at retail
   • manufacturing subject to Part 3 (GMP) of the NHPR

Note: Currently, there are no authorized veterinary drugs containing cannabis (including CBD). There are notified VHPs in Canada containing hemp (refer to the List of Notified Products for details).

Within the existing framework of the FDA and FDR, a submission for a market authorization for cannabis must be supported by safety, efficacy and quality evidence.

In light of continued interest from stakeholders to include CBD in veterinary products, Health Canada is committed to exploring a regulatory pathway for veterinary drugs containing CBD (VDCC) that may be accessed without a prescription.

Interplay between associated Acts

The Cannabis Act (CA) and its regulations came into force in 2018. They 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 can, in some instances, also meet 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:

• the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals
• restoring, correcting or modifying organic functions in human beings or animals

Although cannabis meets the definition of a drug, it is only regulated under the FDA 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 under the authority of the FDA, the FDR outlines the requirements for manufacturing, packaging, labelling, storing, importing, distributing and selling of food and drugs (including veterinary drugs). The regulations are intended to provide people in Canada with access to products that are safe, effective, and of high quality.

Veterinary drugs that contain CBD must comply with the FDA and FDR. As CBD is regulated under the CA and its regulations, a VDCC would also have to comply with parts of the CA and the Cannabis Regulations depending on where it is in the lifecycle.

Policy considerations

To permit CBD as a medicinal ingredient in a non-prescription veterinary drug, an amendment to the PDL supported by scientific evidence would be the first step. Any changes to the PDL would involve a consultation process.

When Health Canada considers if a veterinary drug would be better sold as a prescription or non-prescription product, the intent is to protect human and animal health and the safety of the food supply. As outlined above, when deciding if a drug should be prescription or non-prescription, we consider the 3 principles listed in the FDR, along with the factors that apply to a particular drug. If any of the principles or factors applies, the drug is given prescription status. If none of the principles or factors apply, the drug is given non-prescription status.

Since all phytocannabinoids are listed in the PDL, changes to the PDL would be needed to enable a non-prescription VDCC pathway for veterinary drugs. Changes for phytocannabinoids must be supported by scientific evidence to show that they can be used safely as intended and for the end user without the oversight of a health care provider. This is a distinct and separate process from a pre-market drug submission and review.

If amendments are made to the PDL, Health Canada could regulate VDCCs under the FDR as non-prescription veterinary products containing CBD. Provided a market authorization application meets our standards and the authorization requirements, such products could then receive a drug identification number (DIN). This number indicates that Health Canada has reviewed and authorized a product.

Feedback

• Ongoing research and studies will continue to assist in the body of knowledge needed to support the market authorization of products in this area. The PDL may be amended as more evidence accumulates.
• Do you have or are you aware of scientific or clinical evidence, literature studies or other forms of quality information on the safety, efficacy and quality of cannabis (including CBD) for use in animals, for specific indications or uses at specific doses?

The following key 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

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

Health Canada:

• is not considering allowing CBD as a non-medicinal ingredient
• will not permit THC as an ingredient due to its intoxicating nature and unsuitable level of risk for a self-selection product.

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

VDCCs would be limited to an oral dose of CBD of 0.2 to 2 mg/kg twice a day for treating pain associated with osteoarthritis in dogs.

We would consider further amendments to the PDL for CBD if additional evidence supports a non-prescription status for that VDCC.

Safety and efficacy

All veterinary drugs are subject to a pre-market safety and efficacy review and must meet our standards before they receive market authorization under the FDR.

VDCCs would undergo a full safety and efficacy assessment if they are considered as non-prescription drugs. 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. Specific health claims would have to be substantiated by well-designed experimental studies and scientific evidence. General health claims (such as those for VHPs) are not permitted for VDCCs, and VDCCs would not be considered a VHP.

Pre-market evidence should:

• establish that the benefits outweigh the risks
• provide statistically significant and clinically meaningful outcomes relevant to the target species
• show that the product has an acceptable safety profile
• show consistent results for all comparable studies
• support the characterization of the disease or health condition

Establishment licensing, good manufacturing practices and product quality

Under the FDR, an establishment licence is required for activities such as facricating, packaging, labelling, importing and distributing drugs. Establishment licence (EL) 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 health products are safe, effective and of high quality. Following GMP standards and practices helps to ensure that finished products:

• include the medicinal ingredient (in this case, CBD) in the stated dose
• are free from microbial and chemical contamination and other impurities
• are viable and stable until their expiry date
• are processed by qualified personnel, using equipment in facilities that follow good sanitation practices

Learn more about good manufacturing practices for veterinary drugs

To permit products containing CBD as non-prescription veterinary drugs, it is critical that products are high quality. Rigorous quality oversight is necessary to ensure that VDCCs 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 and their animals 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, synthetic production, its packaging and labelling, import and export, and sale are licensed activities 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 non-prescription veterinary drugs, Health Canada is proposing that manufacturing, packaging, labelling, importing and selling VDCCs would require an establishment licence under the FDR. 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 an establishment licence holder under the FDR could operate; as well as how both could be obtained for the same site, for those wishing to process CBD and manufacture a finished VDCC. This includes looking at the stage at which the raw cannabis material intended for a VDCC could be permitted on a veterinary drug site to avoid risks of diversion.

Feedback

• New products such as VDCCs would normally be considered "new drugs" (Part C, Division 8 of the FDR). All new drug submissions need to supply data that ensures a drug is safe, effective and high quality (chemistry and manufacturing). This data is then carefully reviewed. Would a more streamlined regulatory approach be appropriate? If so, how could a regulatory approach be streamlined? Note that the VHP notification program is not an appropriate option, as treatment, prevention and cure claims are not permitted.
• What are your views regarding whether something like a Cannabis Drug Licence and specific physical and personnel security controls being required for VDCCs?
• For evidence on manufacturing processes and quality control, what level of evidence/scientific review would you expect for a CBD product? For example, would a summary of the chemistry and manufacturing data be sufficient, or would data/scientific evidence in line with, Part C, Division 8 of the FDR be more appropriate? Should the regulatory pathway include the submission of a certificate of analysis (CoA) or should such information be made readily available upon request? Please provide any comments related to the need for a certificate of analysis for CBD to support the quality of VDCCs licensed as non-prescription drugs.
• One approach proposes that the GPP requirements under the CA would apply if you were producing the raw material CBD and the GMP requirements (FDA and FDR) would apply if you are sourcing the CBD as the medicinal ingredient from a licensed producer. If a company produces the CBD and makes the VDCC, both would apply. Do you have any comments or information to share about these important practices that are in place to ensure product quality?
• Are additional raw material GMP standards or qualifications necessary for Cannabis Act licence holders supplying raw material for VDCCs, to ensure that CBD being used as an ingredient in VDCCs conforms with established standards for veterinary drugs?

Packaging and labelling

All veterinary drugs must comply with the packaging and labelling requirements set out in the FDR. These requirements provide key information to support the safe and proper use of veterinary drugs. They also identify the product and help consumers make informed purchasing choices. Labels must provide specific information on the product, for example: medicinal and non-medicinal ingredients, recommended dose, indications and risks. The FDA prohibits representing a drug "in a manner that is false, misleading, deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety." This covers logos or symbols, brand names, claims in text and any product-related information referred to on the product label.

It is our view that VDCCs should look and feel like other comparable veterinary drugs as much as possible; however, we are also looking at other unique requirements in addition to what is currently required by the FDR for veterinary drugs, such as requiring a statement that the product contains CBD on the principal display panel. In addition, the science advisory committee recommended that products should be sold in a box with an insert giving dosing details and other information, such as any contra-indications. Also, the subcommittee recommended that any CBD product intended only for dogs should have a confirmed diagnosis of osteoarthritis from a veterinarian and that pet owners consult a veterinarian before administering a VDCC.

Learn more: Guidance on veterinary drug labelling.

Feedback

• Given the potential for concurrent health product and prescription drug use, is there a need for VDCCs to include a warning statement on the principal display panel to inform the consumer that they contain CBD?

Experimental studies: Research using cannabis

Clinical research and studies are critical to developing health products that are safe and effective. An increased availability of health products that are safe and effective means that consumers have a greater selection of therapeutic options to meet the health needs of their pets or livestock animals. High-quality research also helps health care providers make evidence-based decisions for their patients.

Health Canada encourages research on cannabis-based products and their derivatives for market authorization as both prescription and non-prescription veterinary drugs.

Current state of experimental studies

Experimental studies using drugs containing cannabis for animal subjects must receive authorization under the FDR. Sponsors (for example, academia, veterinarians, research organization) must submit an experimental study certificate (ESC) application for certain veterinary research purposes.

At present, sponsors interested in conducting experimental studies with cannabis or its derivatives, including CBD, must also meet certain requirements under the Cannabis Act (CA) and its regulations. 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.

Health Canada is considering applying the same requirements to experimental studies for VDCCs as other studies involving veterinary drugs and animals. 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.

Learn about veterinary drug experimental studies.

Feedback

• Describe any barriers or concerns with research/studies that you are currently facing for products containing CBD or that you anticipate might impact your ability to produce evidence to support the safety or efficacy of VDCCs?

Place of sale

We are considering various options regarding where VDCCs could be sold. Veterinary drugs are sold in retail settings, such as veterinary clinics and pet stores, and through online retailers and digital shopping platforms. However, cannabis for adult use is required to be sold in licensed retail settings that are only accessible to adults (exceptions are cannabis for medical purposes and drugs containing cannabis).

The SAC-HPCC recommended the following:

• there should be a confirmed diagnosis of osteoarthritis before CBD is administered to a dog
• veterinarian oversight is important until more safety and efficacy information becomes available

We are looking to require that VDCCs are sold at veterinary clinics. While this may impact access to products for consumers, we are concerned that the products are used appropriately by the intended end user. We are considering how best to ensure that these products respect the objectives of the Cannabis Act.

The sale of VDCCs to the general public with no restrictions on where they're sold (such as at a pet store) would mean that consumers would not have access to a qualified veterinarian, who would have knowledge about potential interactions between a VDCC and other drugs their animals may be taking.

Feedback

• Based on the SAC-HPCC's recommendations and the objectives of the CA, the place of sale is proposed to be a veterinary clinic. Currently, only prescription veterinary drugs are required to be sold pursuant to a prescription by a veterinarian through their clinic. Any non-prescription product can be sold in other retail locations, such as pet stores and front of counter at veterinary clinics. Do you agree or do you have other considerations or concerns for the sale of VDCCs in a pet store or at retail?

Advertising and promotion

Like other authorized novel veterinary drugs, VDCCs would be assessed for safety, efficacy and quality under the FDR. Similarly, as a health product, VDCCs should align with other authorized health products and adhere to the restrictions under the existing authorities of the Food and Drugs Act (FDA). The FDA provides oversight to effectively regulate advertising and promotion for drugs, including non-prescription health products.

Maintaining advertising and promotion for VDCCs under the FDA promotes regulatory consistency across the veterinary drug 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, a VDCC 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.

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.

Feedback

• In contrast to natural health products containing CBD, what unique context or challenges should be considered for VDCCs?
• Are there any further considerations on advertising and promotion that Health Canada should contemplate?

Post-market safety monitoring of VDCCs

The approach to the post-market safety monitoring of VDCCs would be the same as for any other similar risk veterinary drugs authorized for sale in Canada.

Under the FDR, the decision to authorize a VDCC would be based on the safety, efficacy and quality 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, and use outside of the recommended conditions of use.

Once a VDCC is marketed, we would monitor any serious adverse reactions reported to Health Canada. On an annual basis, market authorization holders (MAHs) must prepare a summary report with a critical analysis of all adverse reactions that have occurred in 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.

Detecting safety signals of all veterinary drugs involves collecting and assessing information from all sources. This includes adverse reaction reports from consumers, health care providers and market authorization holders, and safety information from other regulators.

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

• As envisioned, VDCCs would have the same post-market requirements and obligations as other veterinary drugs. Do you agree or have a rationale to justify an alternate approach without compromising the importance of providing ongoing safety-related information throughout the product's lifecycle?
• Are there any further considerations on vigilance that Health Canada should contemplate?

Compliance and enforcement

Promoting, monitoring and verifying compliance helps to raise awareness among regulated parties of their responsibilities and helps 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 of 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, which could result in prosecution and fines.

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

Feedback

• Are there additional comments or suggestions you would like to share that could help in developing the regulatory pathway for VDCCs for animal use

Other Activities

Personal Possession Limits

In line with the exemptions for prescription drugs containing cannabis, we are considering excluding VDCCs 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 that the import/export requirements of the Cannabis Act apply to VDCCs. Consideration will need to be given as to how licence holders under the FDR 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.