Nearly fifteen years after the Brazilian National Health Surveillance Agency (ANVISA) implemented a ban on the sale, import, and advertising of electronic cigarettes, the debate over this policy is more relevant than ever. Although personal use and possession of these devices are not restricted, ANVISA’s decision to reaffirm this ban in 2022 has generated mixed opinions among the population after an exhaustive regulatory review process and public consultation. The latest Public Consultation data show that a growing number of consumers and a significant portion of civil society demand reevaluating the current strategy towards a more open and evidence-based regulation.
In 2009, the Brazilian National Health Surveillance Agency (ANVISA), exercising its regulatory function in favor of public health and based on the precautionary principle due to the lack of available evidence at that time on electronic cigarettes, established prohibitions on the sale, import, and advertising of such devices. However, the regulation did not extend the ban to personal use and possession of these products; if an individual purchased electronic cigarettes abroad, they did not incur any penalty or legal infringement.
Thirteen years later, in 2022, during a regulatory review process that had begun in 2019, the Agency evaluated whether to regulate electronic cigarettes or maintain the existing prohibition. This deliberation culminated in a unanimous decision by the Agency’s directors, who, after conducting an extensive public consultation, chose to preserve the restrictions previously established by ANVISA in 2009.
Additionally, it was decided to increase the rigor of the regulatory framework, complementing it with educational measures and awareness campaigns. According to the Agency, these initiatives, mainly aimed at children and young people, seek to inform about the risks associated with the use of electronic cigarettes. These efforts would be amplified through enhanced surveillance in digital media, at borders, and at points of sale, thanks to closer cooperation with the National System of Sanitary Surveillance and entities such as the Receita Federal (Brazilian Federal Revenue), the Federal Police, the Federal Highway Police, as well as the Public Ministry at both federal and state levels.
To substantiate the decision to preserve the ban in 2022, ANVISA undertook Public Consultations and required the analysis and perspectives of renowned external institutions and researchers, among them Johns Hopkins University, the University of California in San Francisco, the Centers for Disease Control and Prevention (CDC) of the U.S., the Pan American Health Organization, the University of São Paulo, and the Tobacco and Health Studies Center of the National School of Public Health of the Oswaldo Cruz Foundation.
It’s important to highlight that entities associated with the Bloomberg Initiative, such as The Union, the Campaign for Tobacco-Free Kids (CTFK), the InterAmerican Heart Foundation, and Corporate Accountability, had a significant presence throughout the process.
The 600% increase in electronic cigarette users in Brazil ignites the debate over their legalization
As the 15th anniversary of the Collegiate Board Resolution that banned smoking risk and harm reduction devices in the country approaches, public perception of the counterproductive effect of such prohibition strengthens, suggesting it is creating more problems than it aims to solve.
A prominent perception is that, by deciding to maintain the veto on the legal sale of electronic cigarettes and other non-combustible alternatives to traditional cigarettes, the agency neglects the protection of millions of citizens who already resort to these products through illicit channels, widespread throughout the Brazilian territory. Moreover, it overlooks the implications of indirectly fostering a vast illegal trade within the country and ensuring the healthiness of an extensive market controlled by organized crime.
Recent statistics indicate that the number of electronic cigarette users in Brazil has increased by nearly 600% over the last six years, reaching 2.9 million in 2023. The Telephone Survey on Risk Factors for Non-Communicable Chronic Diseases, Covitel 2023, revealed that the prevalence of electronic cigarette use is exceptionally high in the 18-to 24-year-old age group. However, it uncovered that within this age group, an estimated 17.3% have tried electronic cigarettes, 6.1% use them occasionally, and 0.5% consume them daily.
These figures suggest that approximately 4 million people in Brazil in the first quarter of 2023 have used electronic cigarettes at some point, whether currently or in the past. The primary motivation for using these devices was “to try them out of curiosity,” representing 20.5% of the users.
This situation has intensified the debate over the prohibition and use of tobacco harm reduction products, which regulators call “electronic smoking devices.” This topic remains intense, extensive, and controversial in Brazilian society. An indication of the persistent controversy around this matter was conducting a new public consultation focused on gathering new technical and scientific information about these devices, which concluded last February 9th.
According to data from the Brazilian National Health Surveillance Agency, most of the approximately 14,000 people who participated in this consultation hold a view contrary to the current legislation. 58.8% of participants expressed that seeking a different way to regulate these products is viable beyond their simple prohibition. In comparison, 57.7% consider that the ban on the sale and consumption of these devices in the country has negative impacts.
Moreover, the Consultation brought to light regional variations in perceptions about the consultation, observing that regions like the Northeast, South, and Midwest were more inclined towards regulation, unlike the North and Southeast, which seemed to favor the persistence of the prohibition. This variation could be due to various sociocultural, economic, and public health factors, which differ significantly from one region to another. For instance, the prevalence of smoking, a history of more progressive or interventionist policies in terms of tobacco and public health, and the influence of activist groups, both in favor of and against the regulation of electronic cigarettes, can vary regionally.
Okumura emphasizes that experts and citizens prefer regulation to prohibition in the debate on electronic cigarettes
In a recent conversation with Miguel Okumura, President of THR BRASIL, we discussed the outcomes of the Public Consultation No. 1,222/2023 conducted by Anvisa. Okumura highlighted how the consultation period, from December 5, 2023, to February 9, 2024, was marked by significant social participation, encompassing experts, national and international civil organizations, and citizens. This notable interest, according to Okumura, underscores the complexity and significance of the debate surrounding the prohibition of what regulators and some scientists in Brazil call electronic smoking devices.
Okumura shared important insights about society’s reception of Anvisa’s proposal. There was a clear trend against the suggested prohibition, with a majority speaking in favor of regulation that would facilitate the marketing of electronic cigarettes in Brazil. This stance indicates an increasing recognition of the potential benefits of harm reduction as a strategy to combat smoking, highlighting the deficiencies of a prohibition policy, concluded Okumura.
The Brazilian activist particularly emphasized the consumers’ response to Anvisa’s regulatory proposal, with about 61.5% expressing opposition. This reaction underlines the call for policies that offer less harmful alternatives than conventional tobacco. Similarly, the attitude of the scientific community, though divided, showed a slight preference for regulation, with 53.5% of researchers supporting this approach. This demonstrates an inclination to adopt harm reduction as a viable strategy in the fight against smoking.
On the other hand, health professionals showed reservations, with 64.9% in favor of maintaining the prohibition, reflecting valid concerns regarding public health impacts. In this context, Okumura emphasized the importance of increasing education and dialogue on harm reduction among these professionals.
In conclusion, Okumura reiterated the need for policies aimed at harm reduction and criticized measures focused exclusively on prohibition. He argued that such policies have already proven not only to be ineffective in addressing the smoking problem but can also exacerbate it by fostering a black market.
Regarding the complex web of opinions and evidence surrounding this debate in Brazil, Okamura points out the need for informed dialogue and nuances in public health policies. The situation, he said, underscores the urgency of an informed policy that considers both scientific evidence and the voices of society as a whole, paving the way for a more balanced and practical approach in the fight against smoking.