Brazilian FDA calls for contributions on Regulation Upholding Ban on Electronic Smoking Devices

December 6, 2023

Brazilian FDA calls for contributions on Regulation Upholding Ban on Electronic Smoking Devices

On December 5, the Collegiate Board of Directors (DICOL) of the Brazilian Food & Drug Agency (called “Anvisa” in the Portuguese acronym) published a call for contributions (#1,222/2023), to receive suggestions on its proposal to maintain the ban on the marketing of Electronic Smoking Devices (“DEFs” in the Portuguese acronym), thereby revoking the current regulation, Anvisa’s Rule #46/2009.

DICOL unanimously approved the call for contribuitions during its 19th Public Ordinary Meeting held on December 1, 2023. According to the opinion of Director Rapporteur Antonio Barra Torres (Vote #459/2023), the proposal aligns with conclusions of the Final Regulatory Impact Assessment’s (AIR) Report, approved by DICOL in July 2022, which recommends the maintainance of the established bans.

In its general provisions, the draft rule included various definitions, including the meaning of Electronic Smoking Devices, referring to multiples examples of DEFs available today. Furthermore, beyond the bans on marketing, importation, and advertising already outlined in Rule #46/2009, the new rule’s draft also prohibits the manufacture, distribution, transportation, and storage of DEFs, thereby expanding the scope of activities subject to regulatory oversight and sanctions. The sole exception lies in the permission for importing these devices only for research purposes.

The draft rule subjected to public consultation also excluded the provision of Article 2 of Rule #46/2009, which theoretically allows companies to seek marketing approval for DEFs. The proposal is to from now on only allow interested parties to submit studies, tests, and scientific articles to Anvisa’s analysis, without being linked to marketing approval application. Additionally, to prevent any undue delays in revisiting the topic, the draft rule establishes that Anvisa shall conduct periodic “systematic reviews of the literature on the subject whenever there is technical-scientific justification”.

The Agency's decision to maintain such ban concerning DEFs was expected, given the approval of the Final AIR Report, which asserts that permitting the commercialization of these devices is "technically unfeasible and potentially harmful to public health." In the vote that sanctioned the call for contributions, the Rapporteur clarified that, notwithstanding the approval of the Final AIR Report, Anvisa scrutinized over 400 new studies on the subject since July 2022 but found them insufficient to warrant changes to the Report’s conclusions.

The challenges faced by countries that allowed commercialization of DEFs were also strongly emphasized in the Rapporteur's vote, notably the escalating prevalence of DEF use since the decision to allow, particularly among young pepople, as well as the challenges in combating illicit market.

The call will have a 60-day period from December 12, 2023, ending on February 9, 2024. Comments must be sent through an electronic form that will be available at the Agency’s website. Foreign companies may physically file their comments at Anvisa’s headquarters in Brasilia.

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