Tobacco Products
Registration of Tobacco-Derived Smoking Products
All tobacco-derived smoking products, whether manufactured in Brazil or imported, must be registered with Anvisa in order to be sold in the country.
Each product must be registered by the interested company, which must be either the Brazilian manufacturer or an importer legally established in the country.
A product can only be sold after the registration approval has been published in the Federal Official Gazette. The registration is valid for one year from the date of publication. Therefore, for the company to maintain the right to continue selling the registered product, it must renew the product registration annually. It should be noted that the registered product does not have a registration number. The sanitary status of the product can be verified on Anvisa’s website.
To register a tobacco product with Anvisa, the interested company (manufacturer or importer) must submit a dossier containing various information about the product. The submission is made electronically, and the Inspection and Health Surveillance Fee must be paid. In 2012, Brazil banned the use of additives that enhance the sensation of use or make the products more attractive, such as flavoring agents.
The main information that the dossier must contain includes:
- List of tobacco types and parts of the plant used;
- List of all compounds used in the manufacture of the product and their respective purposes and quantities, i.e., the product’s composition;
- Physical and chemical parameters of the filter and wrappings (length, circumference, ventilation, pressure drop, chemical composition, weight, and permeability), in the case of products with filters;
- Analytical report on the substances and parameters present in the total tobacco. For cigarette-type products, primary and secondary stream analyses (Hoffman List) are also required. For cigars, analyses of nicotine, carbon monoxide, and tar (TNCO) in the primary stream are required;
- Product packaging layout.
The registration of tobacco-derived smoking products aims to:
- Establish minimum parameters to be followed by such products;
- Ensure the availability of essential information about products marketed in Brazil;
- Monitor products and any changes made to their composition through registration renewal;
- Gather information on product composition (total tobacco composition), enabling regulatory improvements and the adoption of health measures that contribute to tobacco control and reduce product attractiveness;
- Provide a framework for determining product regularity, ensuring that any unregistered product is deemed irregular.
The registration of tobacco-derived smoking products complies with Articles 9 and 10 of the WHO Framework Convention on Tobacco Control (FCTC) (Decree No. 5,658/2006), which address knowledge of the composition and emissions of tobacco products. The FCTC also establishes that the public must be informed about product composition, which is done within the limits of confidentiality requirements, through publication in the Product Consultation.
Health Warnings
All tobacco products sold in Brazil must bear health warnings covering 100% of the back, 100% of one side, and 30% of the front of the package. Health warnings have been mandatory for over 25 years, and pictorial warnings were introduced in 2002 and have been mandatory ever since.
Anvisa is responsible for periodically publishing the health warning images and messages. In 2024, Anvisa published the images and messages to be used between November 2025 and November 2027.
Compliance with the health warning requirements for the product to be registered is verified during the analysis of the registration dossier.
Electronic Smoking Devices
Since 2009, the sale, advertising, and importation of electronic smoking devices have been prohibited. In 2024, after a robust regulatory impact assessment based on scientific evidence, new regulations were published maintaining the ban on any type of commercial activity related to electronic smoking devices.
The 2024 regulation classifies electronic smoking devices into:
- Liquid-based products, which include electronic cigarettes;
- Solid-based products, which include heated tobacco products; and
- Hybrid-based products, which use both liquid and solid refills, including leaves.
Regardless of the type of matrix used, all electronic smoking devices are prohibited in the country.
Participation in International Forums
WHO Framework Convention on Tobacco Control (WHO FCTC) – The FCTC is the first international treaty negotiated under the auspices of the WHO, aiming to protect people from the health, social, environmental, and economic consequences of tobacco consumption and exposure to tobacco smoke. The treaty sets out general measures to reduce tobacco use and exposure. Anvisa participates in groups that discuss key aspects of regulations and practices to ensure the best possible implementation of FCTC articles within its scope, considering national realities and existing regulations.
Conference of the Parties and Meeting of the Parties (COP and MOP of the WHO FCTC) – Anvisa regularly participates in the Brazilian delegation to the COP and MOP, providing technical support for discussions and decisions related to the FCTC articles and the Protocol that fall within Anvisa’s jurisdiction.
Additionally, Anvisa participates in the expert group on Articles 9 and 10 of the WHO FCTC (contents and emissions of tobacco products and disclosure of this information) and provides technical support to other countries on specific topics such as registration of smoking products, regulation of additives in tobacco products, regulation of electronic smoking devices, and enforcement actions, among others.
Global Tobacco Regulators Forum (GTRF) – The GTRF is a WHO-linked group comprising the world’s leading tobacco control regulatory authorities. Anvisa is one of the founding and longest-standing members and currently serves on its management committee. During its meetings, regulators discuss topics related to tobacco products, particularly the implementation of Articles 9 and 10 of the FCTC, enforcement challenges, and emerging issues. The GTRF conducts studies and research at the request of its members or the WHO. An Anvisa staff member currently coordinates research on policies related to the use of additives in tobacco and nicotine products.
WHO Study Group on Tobacco Product Regulation (TobReg) – TobReg is composed of international experts from various fields. Anvisa’s participation aims to contribute the expertise accumulated by the agency over the years. The group advises the WHO by providing scientifically sound and evidence-based recommendations on the regulation of tobacco products and by addressing knowledge gaps in the regulation of nicotine and tobacco products. These recommendations are published in the Technical Report Series (TRS), with the objective of reducing tobacco demand and protecting public health.
Applicable Regulations
These are the main regulations applicable relating to tobacco and smoking products exported to Brazil:
- Resolution RDC 195/2017: Packaging and advertisement
- Resolution RDC 14/2012: Regulation of brand names, allegations in the packaging, addictives
- Law 12.546/2011: Limitations to the advertisement of tobacco products
- Resolution RDC 304/2002: Prohibits the sale of food products that simulate tobacco products or their packaging
- Resolution RDC 226/2018: Online requirement for market authorization of tobacco products