Legal Measures and Enforcement

Article 11 Guidelines (Paragraphs 47-65)

Legal Measures


In drafting legal measures with respect to tobacco product packaging and labelling, Parties should consider issues such as who will be responsible for their administration, the available approaches for ensuring compliance and enforcement, and the level or levels of government involved.


Parties should identify the authority or authorities responsible for overseeing implementation of tobacco product packaging and labelling measures. Parties should consider ensuring that the relevant authority responsible for tobacco control matters is the same as that which administers the legal measures. In the event that the administration is made the responsibility of another area of government, the relevant health authority should provide input into label specifications.


Parties should ensure that the packaging and labelling provisions related to Article 11 of the Convention apply equally to all tobacco products sold within the jurisdiction, and that no distinction is made between products that are manufactured domestically or imported or intended for duty-free sale within a Party’s jurisdiction. Parties should consider circumstances in which measures would apply to exported products.


Parties should ensure that the cost of placing health warnings and messages, as well as information on constituents and emissions, on tobacco product packaging is borne by the tobacco industry.


Consistent with Article 19 of the Convention, Parties should consider including provisions to make it clear that the requirement to carry health warnings and messages or to convey any other information about a tobacco product does not remove or diminish any obligation of the tobacco industry, including, but not limited to, obligations to warn consumers about the health hazards arising from tobacco use and exposure to tobacco smoke.

Specific Provisions

Parties should ensure that clear, detailed specifications are provided for in their legal measures in order to limit the opportunity for tobacco manufacturers and importers to deviate in the implementation of health warnings and messages, as well as to prevent inconsistencies among tobacco products. In drafting such measures, Parties should review, inter alia, the following list:

Source Document

Parties should consider providing a “source document”, which contains high-quality visual samples of how all health warnings and messages and other information are to appear on packaging. A source document is particularly useful in the event that the language used in the legal measures is not sufficiently clear.

Adhesive Labels and Covers

Parties should ensure that adhesive labels, stickers, cases, covers, sleeves, wrapping and tobacco manufacturers’ promotional inserts and onserts do not obscure, obliterate or undermine health warnings and messages. For example, adhesive labels might be allowed only if they cannot be removed and are used only on metal or wood containers that hold products other than cigarettes.

Legal Responsibility for Compliance

Parties should specify that tobacco product manufacturers, importers, wholesalers and retail establishments that sell tobacco products bear legal responsibility for compliance with packaging and labelling measures.


In order to deter non-compliance  with the law, Parties should specify a range of fines or other penalties commensurate with the severity of the violation and whether it is a repeat violation. Parties should consider introducing any other penalty consistent with a Party’s legal system and culture that may include the creation and enforcement of offences and the suspension, limitation or cancellation of business and import licenses.

Enforcement Powers

Parties should consider granting enforcement authorities the power to order violators to recall non-compliant tobacco products, and to recover all expenses stemming from the recall, as well as the power to impose whatever sanctions are deemed appropriate, including seizure and destruction of non-compliant products. Further, Parties should consider making public the names of violators and the nature of their offence.

Supply  Deadline

In order to ensure the timely introduction of health warnings and messages, legal measures should specify a single deadline by which manufacturers, importers, wholesalers and retailers must only supply tobacco products that comply with the new requirements. The time allocated need only be enough to allow manufacturers and importers to organize the printing of new packages. It has been considered that a period of up to 12 months from the enactment of the legal measures should suffice in most circumstances.


Parties should recognize that the drafting of legal measures for packaging and labelling of tobacco products is not a one-time exercise. Legal measures should be reviewed periodically and updated as new evidence emerges and as specific health warnings and messages wear out. When undertaking periodic reviews or updates, Parties should take into account their experience in using their packaging and labelling measures, the experiences of other jurisdictions, as well as industry practices in this area. Such reviews or updates can help identify weaknesses and loopholes and highlight areas in which the language used in the measures should be clarified.


Infrastructure and Budget

Parties should consider ensuring that the infrastructure necessary for compliance and enforcement activities exists. Parties should also consider providing a budget for such activities.


To enhance compliance, Parties should inform stakeholders of the requirements of the law before it comes into force. Different strategies might be required for different stakeholders, such as tobacco manufacturers, importers and retailers. Parties should consider using inspectors or enforcement agents to conduct regular spot checks of tobacco products at manufacturing and importing facilities, as well as at points of sale, to ensure that packaging and labelling comply with the law. It may not be necessary to create a new inspection system if mechanisms are already in place that could be extended to inspect business premises as required. Where applicable, stakeholders should be informed that tobacco products will undergo regular spot checks at points of sale.

Response to Non-Compliance

Parties should ensure that their enforcement authorities are prepared to respond quickly and decisively to instances of non-compliance. Strong, timely responses to early cases will make it clear that compliance is expected and will facilitate future enforcement. Parties should consider making the results of enforcement action public in order to send a strong message that non compliance will be investigated and action will be taken.


Parties should consider encouraging the public to report violations in order to further promote compliance with the law. It might be helpful to establish an enforcement contact point for reporting alleged cases of non-compliance. Parties should ensure that complaints are investigated and dealt with in a timely and thorough manner.