The directors unanimously approved consultation with the company for 60 days, but stressed that the new positions do not bind the agency to change the current rule, which prohibits
The collegial council of National Health Surveillance Agency (Anvisa) decided unanimously, in a virtual meeting that lasted more than 7 hours this Friday 1st, to open a public consultation to re-discuss the regulation of electronic cigarettes The current regulation (RDC 46), from August 2009, prohibits the production, sale, importation and advertising of any electronic smoking device (DEF).
In the public consultation, which will be open for 60 days, the company will be able to make suggestions and contributions through an electronic form on the Anvisa website in which the opinions of citizens, medical-scientific societies, companies and any other interested party will be collected. At the end of the process, contributions to the discussion on possible new regulations for e-cigarettes will be considered. At the end of the procedure, a new board meeting will be scheduled.
The opening of the public consultation and the discussion on a possible new regulation of e-cigarettes does not mean, however, that vaping will necessarily be allowed in Brazil. “The public consultation period is a period which, in absolute terms, links the Agency to what was shown and demonstrated in today’s meeting”, stated the director-president of Anvisa, Antônio Barra Torres, referring to the positions expressed during the meeting from different parties.
Before the vote of the five directors, more than 60 videos with different positions on the product were shown to the public attending the meeting. Former smokers, national and international researchers, doctors, leaders of health organizations such as the Pan American Health Organization, NGOs working in the field of public health, and members of the tobacco industry spoke.
Some participants defended the regulation, arguing that replacing regular cigarettes with e-cigarettes could be beneficial to smokers and that other countries have already regulated DEFs, which would also help reduce smuggling.
On the other hand, renowned doctors such as Drauzio Varella, Jaqueline Scholz (coordinator of the Tobacco Control Committee of the Brazilian Society of Cardiology) and Roberto de Almeida Gil (general director of Inca) have opposed the modification of the current legislation, which prohibits use, claiming that the product can cause addiction in non-smoking children and adolescents and that its harm is not yet fully known by science.
“Tobacco companies want to continue doing what they have always done: addicting our children and adolescents to the most ferocious addiction there is. It is easier to give up crack than to give up cigarettes. And that is why they want Anvisa to approve them use: broaden the market, and we cannot allow this”, defended Varella.
Councilors voted unanimously in favor of holding the public consultation, partly due to the widespread controversy on the topic. Despite being banned, e-cigarettes are used by more than 2.2 million Brazilians, according to the 2022 Ipec survey. Congress is also discussing bill 5008/2023, by Senator Soraya Thronicke (Podemos-MS).
Barra Torres said he had reproduced to the public the declarations, positions and analyzes received so far by Anvisa “in favor of transparency”. However, during his vote, he highlighted the lack of evidence on the possible benefits of e-cigarettes in reducing harm to traditional cigarette smokers, signaling that he may remain opposed to its marketing.
“We cannot ignore that the available scientific evidence does not yet demonstrate that DEFs could replace conventional cigarettes as they are less harmful. This is not scientifically proven,” he said.
Experts underline that, although public consultations are an important tool for social participation and are part of good regulatory practices, it is important that they are analyzed with caution, given that the lay population (and not even science) has complete knowledge of the possible harms of product.
“In this public consultation it is necessary to demonstrate the opinions, the scientific basis and also the social impact in an adequate and relevant way and not only with personal statements and absolutely devoid of any coherence”, he underlined at the Estadao the pulmonologist Margareth Doltremo, president of the Brazilian Society of Pneumology and Physiology (SBPT) and full member of the National Academy of Medicine (ANM).
“Regulation may give traditional cigarette smokers the false idea that by switching to e-cigarettes they will be more protected and prevent them from doing what is most important, which is treating themselves and quitting smoking,” said cardiologist Jaqueline Scholz. coordinator of the Smoking Control Committee of the Brazilian Society of Cardiology (SBC).
“When the tobacco industry defends liberalization as harm reduction, it is a completely wrong concept and cannot be applied in this situation. Nicotine addiction will be maintained with DEFs. E-cigarettes are not a transition, but rather l ‘start of a new legion of new nicotine addicts,’ says Margareth.
The industry argues that regulating e-cigarettes would provide a harm reduction option for tobacco smokers, provide greater safety for Brazilian consumers, and help prevent use of the product by people under 18 years of age.
Questioned by journalists on the necessary caution in analyzing unfounded contributions that could emerge in the public consultation, Barra Torres stated that “Anvisa has been carrying out public consultations since 1999? and that the non-technical contribution “has a certain facet, a certain content” and the contribution technical “has another content” and guarantees that everything will be “analysed, well processed and taken into consideration”.
He also said that Anvisa’s board does not yet have a position on whether to change the current rule. «In light of what emerges from the public consultation, any path can be adopted. What we read today is a series of documents and positions from different bodies and organizations that indicate directions. Now, in the public consultation, depending on what comes in it, on a new contribution, on a new fact, on a content deemed quite relevant, the initial orientation of a project can also be changed”, he declared.
Anvisa clarified that the public consultation form will be opened on the Anvisa website shortly after the publication of the decision in the Official Journal of the Union, which should take place tomorrow or in the next few days.
Source: Terra
Ben Stock is a lifestyle journalist and author at Gossipify. He writes about topics such as health, wellness, travel, food and home decor. He provides practical advice and inspiration to improve well-being, keeps readers up to date with latest lifestyle news and trends, known for his engaging writing style, in-depth analysis and unique perspectives.
