On 19 April 2024, the Board of Directors for the Brazilian Health Regulatory Agency (ANVISA) unanimously voted to uphold a ban on electronic smoking devices. The new regulation, RDC 855/2024 prohibits the manufacture, import, commercialization, distribution, storage, transportation and advertising of electronic smoking devices. The new regulation maintains RDC 46/2009, which banned electronic smoking devices in 2009.

In addition, the previous regulation is further strengthened and RDC 855/2024 covers the following key aspects:

• defines products covered, including, parts and refills, as well as heated tobacco products (Article 2);
• specifies the prohibition of entry of products into the country by travellers by any form of import, including in the accompanied luggage (Article 3);
• reiterates that use of any electronic smoking device in enclosed public places is prohibited by law (Article 4);
• stipulates that ANVISA will periodically conduct systematic literature reviews when there is a technical-scientific justification for such studies (Article 5); and
• provides for penalties in case of infractions (Article 6).

Leading up to the decision, a regulatory process was conducted involving a public consultation and a review of the current scientific evidence.

ANVISA published a document with questions and answers about the regulation. Following the new regulation, the Ministry of Health of Brazil has launched a campaign to inform the population about electronic smoking devices.

For more information, please contact the National Commission for the Implementation of the WHO FCTC - CONICQ in Brazil (conicq@inca.gov.br).