Compliance and Enforcement Policy for the Tobacco and Vaping Products Act

Table of contents

• Disclaimer
• 1.0 Introduction and purpose
• 2.0 Scope
• 3.0 Guiding principles
  • 3.1 Accountability
  • 3.2 Fairness, consistency and impartiality
  • 3.3 Transparency
  • 3.4 Targeted and outcomes focused
  • 3.5 Evidence based
  • 3.6 WHO Framework
• 4.0 Roles and responsibilities
  • 4.1 Health Canada
  • 4.2 Regulated parties
  • 4.3 Consumers
  • 4.4 Provincial, territorial, and local governments
  • 4.5 Law enforcement
  • 4.6 Information sharing
• 5.0 Compliance and enforcement activities
  • 5.1 Compliance Promotion
  • 5.2 Compliance Monitoring
  • 5.3 Enforcement
• 6.0 Appeals
• 7.0 Openness and transparency
• 8.0 Contact us

Disclaimer

This document does not constitute part of the Tobacco and Vaping Products Act (TVPA) or its associated Regulations. In the event of any inconsistency or conflict between that TVPA or its Regulations and this document, the TVPA or its Regulations take precedence. This document is an administrative document that is intended to facilitate compliance with the TVPA, 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 TVPA or its Regulations. If a regulated party has questions about legal obligations or responsibilities under the TVPA or its Regulations, they should seek their own legal advice.

1.0 Introduction and Purpose

Health Canada is one of the federal organizations responsible for compliance and enforcement activities for tobacco and vaping products. The purpose of this policy is to describe Health Canada's compliance and enforcement approach under the Tobacco and Vaping Products Act (referred to herein as "the TVPA") and its Regulations. It is intended to promote a consistent and transparent approach to compliance and enforcement. Please note that other legislation, such as the Canada Consumer Product Safety Act (CCPSA) and the Excise Act, 2001, may apply to products regulated under the TVPA. This policy does not apply to those legislations.

The TVPA regulates the manufacture, sale, labelling and promotion of tobacco and vaping products. The purpose of this Act is to provide a legislative response to a national public health problem of substantial and pressing concern and to protect the health of Canadians in light of conclusive evidence implicating tobacco use in the incidence of numerous debilitating and fatal diseases.

2.0 Scope

A number of organizations are responsible for administering and enforcing different parts of the TVPA and its Regulations. This policy applies to the compliance and enforcement approach undertaken by Health Canada and not to other responsible authorities under the TVPA. The section on roles and responsibilities provides more information on the role of Health Canada and of other organizations.

To support the compliance and enforcement objectives of the TVPA, Health Canada collaborates with other federal partners, including the Canada Border Services Agency, the Canada Revenue Agency, and law enforcement agencies. Health Canada also works closely with provincial and territorial governments.

In addition to the requirements of the TVPA and its Regulations, other legislation may apply to some products, including but not limited to, labelling requirements for vaping products under the Canada Consumer Product Safety Act (CCPSA) and the Excise Act. It is the responsibility of the regulated parties to be aware of all applicable requirements.

The TVPA regulates a number of activities, including, but not limited to, activities related to promotions and advertising including broadcasting and publishing, and packaging and labelling of tobacco and vaping products.

3.0 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.

3.1 Accountability

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

• the Department's mandate, values, policies and legal and operational frameworks
• the public interest
• applicable international requirements

3.2 Fairness, consistency and impartiality

Health Canada's legislation 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.

3.3 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 method to achieve this is by publishing data through regulatory transparency and openness initiatives.

3.4 Targeted and outcomes focused

Health Canada's compliance and enforcement actions are targeted to have the most positive impact on 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.

3.5 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.

3.6 WHO Framework

In response to the health risks associated with the tobacco epidemic, the Framework Convention on Tobacco Control (FCTC) is the first treaty negotiated under the auspices of the World Health Organization (WHO). The WHO FCTC came into force in February 2005 and Canada was amongst the first 40 signatory countries.

4.0 Roles and responsibilities

Many parties have a role in advancing the objectives of the TVPA and its Regulations.

4.1 Health Canada

As outlined in this policy, Health Canada develops and implements compliance and enforcement policies and undertakes compliance and enforcement activities to ensure that regulated parties are complying with the TVPA and its Regulations.

4.2 Regulated parties

Regulated parties have mandatory responsibilities under the Act. Any party conducting a regulated activity can be inspected. During an inspection, a regulated party is required to provide all reasonable assistance and information necessary for the inspector to perform their duties. An inspector may request that a regulated party provides evidence that its facility, equipment, practices, and procedures meet the applicable requirements. Obstructing or hindering an inspector who is carrying out their duties or functions is an offence under the Act.

Regulated parties are expected to

• understand the law and their obligations with respect to all regulated activities, and
• ensure their products, activities and processes comply with applicable laws.

Regulated parties should

• be aware of the ethical obligations that govern the actions of Health Canada inspectors as set out in the Values and Ethics Code for the Public Sector

4.3 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 tobacco and vaping products in their possession, including respecting the prohibition of providing tobacco or vaping products to young persons. Consumers are encouraged to report any issues with respect to the quality of tobacco and vaping products directly to the retailer and/or manufacturer.

4.4 Provincial, territorial, and local governments

Provincial, territorial, and local governments may enact their own tobacco and vaping legislation, and corresponding compliance and enforcement programs. Their legislation may duplicate, enhance, or be more restrictive than the requirements of the TVPA, and they may have compliance and enforcement policies that apply to the activities they regulate.

4.5 Law enforcement

Law enforcement plays a critical role in directly supporting the purposes of the TVPA and in working with departments and agencies, where appropriate. Law enforcement has the authority to take action against illegal tobacco and vaping product activity and against those who operate outside of the legal framework.

4.6 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 TVPA and its Regulations, during compliance and enforcement activities, to other parties such as provincial or territorial governments or law enforcement.

5.0 Compliance and enforcement activities

Health Canada enforces the TVPA through a variety of compliance and enforcement activities, including:

• Compliance promotion
• Compliance monitoring
• Enforcement actions

It is the responsibility of the regulated party to be aware of all applicable requirements.

5.1 Compliance promotion

Health Canada believes that compliance promotion is an effective tool in facilitating compliance with the TVPA 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 legislative and regulatory requirements and their responsibilities.

5.2 Compliance monitoring

Health Canada monitors the activities of regulated parties to verify they are complying with the TVPA 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, which may involve actions such as:

• Visually examining a retail or manufacturing facility, inventories, equipment, packaging, labelling, and websites
• Collecting, copying and reviewing documents and records
• Taking samples for laboratory analysis or for compliance assessment

Health Canada uses information from internal and external sources to identify possible non-compliance. When Health Canada identifies a product or activity that may not be compliant with the TVPA 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 the public, a company within a supply chain, and/or federal, provincial, territorial and international partners.

5.3 Enforcement

When non-compliance is identified, there are a number of options to support achieving compliance.

5.3.1 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. These could include consent to seizure and product disposal.

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

5.3.2 Measures initiated by Health Canada

When a regulated party is unable or unwilling to take action, Health Canada may take enforcement action to address non-compliance. Health Canada's actions are targeted to have the most positive impact on 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 a number of enforcement actions to address non-compliance, depending on the circumstances. These may include, but are not limited to:

• Publishing advisories on non compliant products
• Issuing warning letters to non-compliant regulated parties
• Seizure of products
• Prosecution

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

• 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
• The likelihood that the same problem will recur
• The expected impact of compliance and enforcement actions
• The need to maintain public confidence in the integrity of the regulatory regime

6.0 Appeals

Under the TVPA, regulated parties have the right to request a review of decisions relating to certain compliance and enforcement measures undertaken by Health Canada, such as an Order of Restoration for seized products. These review processes involve individual(s) other than the decision maker that imposed the compliance and enforcement measure. They will also occur in a manner that prioritizes on-going compliance and enforcement actions and does not compromise Health Canada's compliance and enforcement efforts

7.0 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, available to the public via its website, such as vaping compliance and enforcement reports: https://www.canada.ca/en/health-canada/services/smoking-tobacco/vaping/compliance-enforcement.html#a1

8.0 Contact us

For more information about this policy, email Health Canada: tcp.questions-plt@hc-sc.gc.ca

Effective Date: January 31, 2024