Last updated: September 11, 2023


Enforcement Agency

Content regulation

Not Applicable

The law does not regulate the contents of cigarettes; therefore, there are no specified penalties.

To align with FCTC Art. 9 and the FCTC Arts. 9 & 10 Guidelines, the law should regulate the contents of cigarettes and impose sanctions for violations.

Disclosure requirement

Ministry of Health
Fine, Business License suspension or revocation, Other

(e.g., seizure of the product, publication of the violation/violator)

Entities that can be held responsible

Manufacturers, importers, exporters


The law establishes that violations of the disclosure requirements are punishable according to the precautionary measures and sanctions provided in Arts. 65, 66, and 67 of the Organic Law on Health.

The Organic Law on Health sets out the range of penalties applied to violations of any regulations adopted by the Ministry of Health. These penalties include: fines between 12 and 2500 tax units and temporary or permanent closure of the establishment.

The law also determines that in the case of repeat offenses, fines may be doubled, and the Ministry of Health may seize and destroy non-compliant products and/or order the closure of the establishment.

Moreover, Art. 65 also allows the Ministry to impose precautionary measures in case of imminent risk of damage to health. These measures include: inspection, suspension of promotion and sales, withdrawal from the market, seizure and destruction of products, and temporary closure for a period of 48 hours to two years.

Lastly, Resolution No. 109/2004 establishes that the National Institute of Hygiene "Rafael Rangel" determines the appropriate mechanisms for the analysis and verification of the disclosed information on tobacco products.

The law aligns with FCTC Art. 10 and the FCTC Arts. 9 & 10 Partial Guidelines in that the law imposes sanctions for disclosure violations.