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Compliance and enforcement policy for the Cannabis Act

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Disclaimer

This document does not constitute part of the Cannabis Act (the Act) or its associated regulations. In the event of any inconsistency or conflict between that Act or regulations and this document, the Act or the regulations take precedence. This document is an administrative document that is intended to facilitate compliance with the Act, the regulations and the applicable administrative policies by regulated parties. This document is not intended to provide legal advice regarding the interpretation or application of the Act or regulations. If a regulated party has questions about legal obligations or responsibilities under the Act or regulations, they should seek their own legal advice.

Scope

A number of organizations are responsible for administering and enforcing different parts of the Act and its regulations. This policy is intended to promote a consistent and transparent approach to compliance and enforcement. It applies to the compliance and enforcement approach undertaken by Health Canada and not to other responsible authorities under the Act. The section on roles and responsibilities provides more information on the role of Health Canada and of other organizations.

To support the objectives of the Act, Health Canada collaborates with other federal partners, including the Canada Border Services Agency, the Canada Revenue Agency, and law enforcement, and works closely with partners across the federal Health Portfolio, including the Public Health Agency of Canada, the Canada Food Inspection Agency and the Pest Management Regulatory Agency. Health Canada also works closely with provincial and territorial governments.

In addition to the requirements of the Act and its regulations, other legislation may apply to cannabis and any person conducting any activities with cannabis. It is the responsibility of the regulated parties to be aware of all applicable requirements.

The Act also regulates activities that may not necessarily require an authorization from Health Canada. These activities include, but are not limited to, activities related to promotion and advertising (including broadcasting and publishing), packaging and labelling of cannabis accessories, and additional activities related to cannabis accessories (such as display and sale). It is the responsibility of regulated parties to ensure they comply with all applicable requirements of the Act or its regulations.

Guiding principles

Health Canada's Compliance and Enforcement Policy Framework identifies the following principles that guide the department's compliance and enforcement activities. The following guiding principles are described in the framework and apply to all activities undertaken under this policy.

Accountability

Health Canada is accountable to Parliament and to Canadians to help ensure that the compliance and enforcement actions and decisions are consistent with:

  • its mandate, values, policies and legal and operational frameworks
  • the public interest
  • applicable international requirements

Fairness, consistency and impartiality

Health Canada's acts and regulations are applied in a fair, consistent and impartial manner. Qualified and authorized personnel carry out its compliance and enforcement activities in ways that are reasonable, professional, unbiased and unprejudiced.

Health Canada staff will act with the highest levels of integrity, as set out in the Values and Ethics Code for the Public Sector.

Transparency

Health Canada strives to make its compliance and enforcement actions and decision-making process clear and understandable to everyone. The department provides access to relevant, useful and timely information about compliance and enforcement while respecting privacy rights. One of the ways this is done is by publishing data through regulatory transparency and openness initiatives.

Targeted and outcomes focused

Health Canada's compliance and enforcement actions are targeted to have the most positive impact on health and safety outcomes based on the effective use of resources. The most appropriate actions and tools are used, based on the impact of non-compliance for each situation.

Evidence based

Health Canada's compliance and enforcement actions and decisions are based on the best available evidence, information and science.

Evidence is assessed objectively and is based on Health Canada's Decision-Making Framework for Identifying, Assessing and Managing Health Risks and other departmental risk frameworks.

Roles and responsibilities

Many parties have a role in advancing the objectives of the Act. One of those objectives is the protection of public health and public safety.

Health Canada

Health Canada is responsible for administering the federal regulatory program for cannabis production for commercial and medical purposes. This includes:

  • granting licences to individuals or entities that want to produce legal cannabis
  • setting and enforcing strict requirements for cannabis licence holders
  • maintaining a system for tracking and monitoring the high-level movements of cannabis through the supply chain from cultivator to processor to retailer to ensure that legally produced cannabis is not diverted to the illegal market

Health Canada facilitates access to cannabis for medical purposes by licensing and regulating federally authorized sellers and processing registrations for personal and designated production. These measures ensure that individuals authorized by their healthcare provider can obtain legal and quality-controlled cannabis in accordance with the Act.

Regulated parties

Regulated parties are expected to:

  • understand the law and their obligations with respect to all regulated activities, including those that do not require a licence or authorization
  • ensure their cannabis, activities and processes comply with applicable laws
  • treat Health Canada staff in a courteous and respectful manner
  • understand the role of an inspector
  • comply with provisions of the Act and its regulations that govern interactions with Health Canada, such as requirements to comply with orders and prohibitions on obstructing an inspector or providing false or misleading statements
  • submit reports and pay regulatory fees, as required

Health care practitioners

In the case of cannabis for medical purposes, health care practitioners must continue to meet the professional standards and obligations of their respective provincial or territorial licensing authorities.

To help protect the health and safety of Canadians, health care practitioners are encouraged to report any adverse reactions (side effects) related to the use of cannabis to the licence holder, and health care practitioners may also report these directly to Health Canada.

Consumers

Consumers are responsible for their health and the health of others in their care. Consumers are also responsible for the safe use and control of cannabis in their possession.

Consumers are encouraged to report any issues with respect to the quality or safety of cannabis products directly to the licence holder. Consumers are also encouraged to inform Health Canada about health- and safety-related concerns that they may have with cannabis products. This will help inform Health Canada's compliance and enforcement activities. A cannabis reporting form is available on the Health Canada website for this purpose.

In addition, consumers are encouraged to report any adverse reactions (side effects) related to the use of cannabis products to the licence holder, and consumers may also report these directly to Health Canada.

Provincial and territorial governments

Provincial and territorial governments share responsibility with the federal government for the oversight and licensing of the cannabis supply chain. The federal Minister of Health is responsible for licensing various aspects of the cannabis supply chain ( for example, cultivation, processing, sale for medical purposes, analytical testing, research and cannabis drug licences).

The provincial and territorial governments authorize and licence the retail sale of cannabis for non-medical purposes. In doing so, entities authorized by provincial and territorial governments:

  • may sell only cannabis that has been obtained from federally licensed cultivators and processors authorized under the Act
  • may not sell cannabis to young persons
  • maintain appropriate records in relation to the sale of cannabis
  • take adequate measures to reduce the risk that cannabis will be diverted to the illegal market

Local, provincial and territorial governments may also tailor certain rules in their jurisdictions and may have compliance and enforcement policies that apply to the activities they regulate. For example, provinces and territories may set a higher minimum age for the legal purchase, lower possession limits for youth, and restrictions on where cannabis may be consumed. Where necessary, Health Canada works with provincial and territorial authorities to support the Act's public health and public safety objectives.

Law enforcement

Federal, provincial, and municipal law enforcement agencies play a key role in enforcing the Act and addressing illegal cannabis activity. Their responsibilities may include:

  • enforcing possession and cultivation limits
  • investigating and taking action against criminal activity, including illegal cannabis sales and production
  • detecting and preventing the diversion of cannabis from the legal market
  • addressing illegal cross-border movement of cannabis
  • enforcing laws related to impaired driving
  • providing training to law enforcement officers on:
    • enforcing cannabis-related legislation
    • detecting and investigating drug-impaired driving

Health Canada works closely with law enforcement to promote, among other things, the integrity of the licensing system including appropriate personnel security screening and compliance with the provisions of the Act and its regulations, and may refer suspected illegal activity to law enforcement for further action.

Compliance and enforcement activities

Health Canada manages risks posed to public health and public safety in connection with cannabis through a variety of compliance and enforcement activities, including:

  • compliance promotion
  • compliance monitoring
  • enforcement actions

Other legislation and regulations may also apply to products that contain cannabis. It is the responsibility of the regulated party to be aware of all applicable requirements.

Compliance promotion

Health Canada believes that compliance promotion is an effective tool in facilitating compliance with the Act and its regulations.

Health Canada promotes compliance through educational activities and information sharing on legislative and regulatory matters. This includes policies and guidance documents intended to help regulated parties better understand the requirements and their responsibilities.

Health Canada also provides information to consumers to enable them to make appropriate, safe and healthy choices. Consumers should stay informed about the health risks of cannabis and understand their obligations, including personal possession limits.

Compliance monitoring

Health Canada monitors the activities of regulated parties to verify they are complying with the Act and its regulations and to prevent non-compliance. Compliance monitoring includes gathering and analyzing information, carrying out compliance verification activities and collaborating with other regulatory agencies as appropriate.

As part of monitoring and verifying compliance, Health Canada has the authority to conduct inspections. Inspections may involve actions such as:

  • visually examining a facility, inventories, equipment, packaging, labelling and websites
  • collecting and reviewing documents and records
  • taking samples for laboratory analysis

Health Canada uses information from internal and external sources to identify possible risks to public health and public safety. When Health Canada identifies a product or activity that may not be compliant with the Act or its regulations, it applies the guiding principles in this policy, including using a targeted, outcomes-focused and evidence-based approach to assess whether there is non-compliance. External sources may include consumers, a company within a supply chain, and federal, provincial, territorial and international partners.

Enforcement

When non-compliance is identified, there are many options to support achieving compliance.

Voluntary compliance measures initiated by the regulated party

It is always the regulated party's responsibility to take appropriate and timely action to meet all requirements of the legislation and regulations. In cases of non-compliance, the regulated party may voluntarily undertake one or more interventions based on the level of risk. These could include consent to forfeiture, product detention, product disposal, product stop-sale and product recall.

Voluntary actions by a regulated party may not preclude Health Canada from initiating other measures if they are appropriate in the circumstances.

Measures initiated by Health Canada

When a regulated party is unable or unwilling to act, Health Canada may take enforcement action to address non-compliance or mitigate risks to public health or public safety. Health Canada's actions are targeted to have the most positive impact on health and safety outcomes based on the effective use of resources. Health Canada uses the most appropriate actions and tools based on the impact of the non-compliance for each situation.

Health Canada may take enforcement actions to address non-compliance or to address an issue of public health, depending on the circumstances. These include:

  • issuing warning letters for non-compliant activities conducted by regulated parties
  • issuing public advisories or other forms of risk communication
  • seizure and detention
  • issuing administrative monetary penalties up to $1 million
  • using collection agencies or other legal means to recover outstanding fees
  • refusing to issue, suspending or revoking an authorization, including a licence or permit (including for non-payment of fees)
  • issuing a ministerial order to recall products from the market, conduct tests or studies, produce information or documents, or take other measures

Decision factors

Where relevant, Health Canada may consider many factors to inform its compliance monitoring and enforcement activities, and to determine the most appropriate level of intervention, including:

  • nature and severity of the contravention of the Act and its regulations
  • public health and public safety risk
    • The real or potential risk to public health or public safety
    • The risk of diversion of cannabis to an illegal market or the risk of inversion of illegal cannabis into the legal market
  • behaviour of the regulated party
    • Whether the regulated party acted with indifference, recklessness or premeditation
    • The degree of co-operation and responsiveness offered by the regulated party once non-compliance is identified
  • compliance history
    • Previous compliance issues
    • Actions taken by the regulated party to comply with the law
  • other factors
    • The likelihood that the same problem will recur
    • The expected impact and success of compliance and enforcement actions
    • The need to maintain public confidence in the integrity of the regulatory regime

Information sharing

Where the disclosure is necessary to protect public health or public safety, Health Canada may disclose relevant information collected under authorities in the Act and its regulations, during compliance and enforcement activities, to other parties such as provincial or territorial governments or law enforcement.

Openness and transparency

Health Canada proactively releases data and information in accordance with the open government plan. This includes making information about compliance and enforcement activities, such as inspection data, as well as issuing administrative monetary penalties and ministerial orders, available to the public via its website.

Contact us

For more information about this policy, email cannabis@hc-sc.gc.ca.

For all other Government of Canada contact information, refer to Cannabis and industrial hemp contact information for licence holders, applicants and industry.

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