Collegiate Council of National Health Surveillance Agency (Anvisa) reviewed and unanimously approved the Regulatory Impact Analysis (RIA) Report on Electronic Smoking Devices (DEF) or e-Sigs. This text specifies whether to keep the device ban. In addition, it is proposed to take additional measures to curb the illegal trade in these products, such as increased inspections and educational campaigns.
After the approval of the report, the development of a new regulatory text will begin. The proposal will then return to the Collegial Council, which will also decide whether there will be public consultations.
The General Directorate for Registration and Inspection of Tobacco Products Made or Not Made from Tobacco (GGTAB) also recommended a ban on the sale of e-cigarettes based on the report. Also according to GGTAB, there is no scientific evidence that currently indicates differentiated regulation of electronic smoking devices with liquid refills or heated tobacco.
Director Christiane Jourdan, head of the technical area and responsible for presenting the AIR report, stressed that the technical work carried out by Anvisa did not find support for adopting other regulatory alternatives other than maintaining a ban on these products. Alternative 2 AIR, which points to the continuation of the DEF ban with the adoption of non-regulatory measures to combat the illegal market and better inform the population, turned out to be the most technically supported.
Anvisa also clarified that countries where DEF is sold do not allow its use as “reduced harm products”, such as the US, Australia, Canada, New Zealand, the UK and the European Union.
“The FDA’s approval to sell e-cigarettes with liquid refills and heated tobacco refills came amid still-unknown product information.” says Anvisa.
Electronic cigarettes have been banned in Brazil since 2009, in accordance with Anvisa resolution (RDC 46/2009) on the subject. The ban covers the marketing, importation and advertising of this type of cigarette. As of 2018, the debate about the release of the use of these devices has returned to the country. Back in September 2019, Anvisa issued a warning about these products due to reports of adverse events among users, especially in the US.
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Via: Anvisa Source: G1