NEWS AND PUBLICATIONS

ANVISA maintains ban on electronic smoking devices in Brazil.

by | May 3, 2024 | Client Alert

On April 19, ANVISA upheld the ban on electronic smoking devices (ESDs). ESDs involve different equipment and technologies, mostly consisting of a rechargeable battery and refills for use and are known by different names such as electronic cigarettes, e-cigarettes, unheated tobacco, pods, among others.

In 2003, when they first appeared in the market, ESDs underwent several changes, including as disposable products, single-use products, refillable products, open or closed refills, among other variations, and since 2009 they have been banned in Brazil by ANVISA.

The matter was included in the 2017–2020 Regulatory Agenda, to promote a wide-ranging debate and gather up-to-date scientific information on the potential health risks and the possibility of reducing the risks associated with ESDs. In 2022, ANVISA approved the Regulatory Impact Analysis Report (RIA) on Electronic Smoking Devices (ESDs).

The approved technical report indicated the need to maintain the ban on electronic smoking devices, which includes all types of electronic cigarettes, and to adopt additional measures to prevent the irregular trade in these products, such as increased enforcement actions and educational campaigns.

Therefore, during the last Collegiate Board Meeting, the regulation (RDC) to maintain a ban on electronic smoking devices in Brazil was unanimously approved. As a result, the use of any electronic device for smoking in a closed collective environment is prohibited by law.  The import of ESDs, by travelers, in any form, including accompanied baggage is also prohibited.

Failure to comply with the resolution constitutes a health infraction and can lead to the application of penalties under Laws 9.294, of July 2, 1996, and 6.437, of August 20, 1977, which include a warning, interdiction, recall, and fine, among others.

ANVISA will periodically review the literature on the subject, whenever there is a technical-scientific justification. Interested parties may file toxicological studies, specific scientific tests, and peer-reviewed scientific articles, published in indexed journals, proving the alleged purposes of any electronic smoking device, which will be submitted to ANVISA for technical analysis. The RDC was published on the Federal Official Gazette on April 24 and will come in force on May 2.

We will be glad to assist you in case you have any doubts on the matter.

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