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GOAL: Clear, practical regulations that are enforceable.

A regulation (or rule, order, ordinance or guideline) is issued by an executive authority or regulatory agency of a government, indicating how to implement a specific law and the related penalties and sanctions.

Regulations are key to implementing legislation; the way they are drafted can significantly impact the effectiveness of the law and whether it can be enforced.

Recommendations on regulations

It is key to ensure that laws are not weakened through the regulatory process. Regulations can also be used to address weaknesses in the law.

Use the navigation below to explore this page and find guidance and top tips on tobacco control regulations.

Tobacco control regulations should:

  1. Assign legal duties of compliance with clear responsibilities 
  2. Outline what constitutes a violation and the associated penalties 
  3. Assign enforcement authority to the appropriate agencies
  4. Assign responsibility for coordination to the relevant agencies
  5. Include civil society and provide for a public complaint mechanism

Tips for regulations

  • Set up an implementation task force made up of relevant stakeholders early in the process
  • Be vigilant against tobacco industry interference throughout and prepare for the risk of litigation
  • Ensure penalties are significant enough to deter violations
  • Plan for implementation and enforcement during drafting
  • Strategise how and when to release the new or amended regulations, including all stakeholders in the planning
  • Protect against implementation delays which can weaken the impact of a new regulation
  • Continue to review; regulations are iterative and can incorporate feedback

Violations and penalties

Violations should be clearly defined, with effective and proportionate penalties listed for all types of violators, including both individuals and businesses as appropriate.

Three types of penalties can be utilised

  • Monetary: fines for individuals and businesses should be a deterrent but set at an appropriate level for the specific context and industry being targeted. Monetary sanctions can be increased for repeat offenses and funding of corrective or countermeasures may be included.
  • Administrative: suspension, limitation or revocation of business, trade, manufacturing or import and export licenses; seizure of tobacco product; removal of TAPS.
  • Judicial: criminal sanctions, often used as a last resort for persistent offenders.

A simple and clear system for collecting fines should be established. For laws enforced by inspectors, where appropriate they should have authority to issue fines on the spot with simple payment methods.

Assigning enforcement authority

Regulations should assign enforcement authority to the appropriate agencies with clear powers and duties.

The following elements should be clear and unambiguous in the regulations:

  • Authority for enforcing laws clearly assigned to the appropriate agency or agencies.
  • Duties of every agency to inspect, take corrective action, monitor and report.
  • Powers to inspect and take corrective action, including issuing penalties and initiating appropriate legal proceedings.

Where product seizures are allowed for, duties and responsibilities of the seizing authorities should be clearly outlined.

Coordination responsibility

Regulations should clearly assign responsibility for the coordination of multiple agencies to a lead authority.

Where multiple agencies are named in the regulation, responsibility for coordination should be assigned to a lead agency. The best agency or body for this role will depend on the law and the local context.

Responsibilities and requirements for the lead agency should be clear and appropriate.

Involving civil society

Regulations should include civil society and provide a mechanism for public complaints.

Civil society and citizens play an important role in effective monitoring and enforcement of tobacco control laws, particularly smokefree, TAPS, packaging and labelling and sales to minors. Civil society can also play an important role in education in their communities, coordinating stakeholders and bringing legal action. 

Where appropriate, regulations should outline a toll-free complaints mechanism for the public to inform authorities of violations.

Implementation Areas


Category: GIH Basic page

Tobacco control law compliance increases the percentage of the population that is protected from tobacco harms.