Category: Regulation

  • Vietnam to Regulate Vape, H-n-B as Tobacco Products

    Vietnam to Regulate Vape, H-n-B as Tobacco Products

    Credit: Serenity H

    Several government agencies have confirmed that Vietnam will regulate e-cigarettes and heated tobacco products (heat-not-burn) the same as traditional tobacco products under the country’s Law on Prevention and Control of Harmful Effects of Tobacco, which has been in effect since 2012.

    The Ministry of Industry and Trade has been assigned the task of presiding and coordinating with ministries and ministerial-level agencies to develop appropriate regulations to manage these products.

    To effectively manage tobacco products, the parties are analyzing the Law on Prevention and Control of Harmful Effects of Tobacco to evaluate its correlation with each type of product, specifically electronic and heated cigarettes, according to media reports.

    The law’s Article 2.1 states: “Tobacco is a product produced from all or part of tobacco ingredients, processed in the form of cigarettes, cigars, tobacco, pipe tobacco or other forms.”

    Article 2.3 adds: “Tobacco raw materials are tobacco leaves in loose form, sheets that have been pre-processed and separated from stems, tobacco fibers, tobacco stems and other substitute materials used to produce cigarettes.”

    Thus, the law stipulates that only the ingredients of a product should be considered to determine it as a “cigarette,” not the production process or usage of different types of products, whether cigarettes, cigars, pipe tobacco, or other forms such as heated tobacco.

    Thus, heated tobacco and e-cigarettes fall under the scope of the Law on Prevention and Control of Harmful Effects of Tobacco, similar to cigarettes, cigars and pipe tobacco. Essentially, if it contains nicotine it is a tobacco product.

    In a seminar on new types of cigarettes, Le Dai Hai, vice director of civil and economic law department (Ministry of Justice) said: “For heated tobacco, we confirmed that it is a tobacco product because it is made from tobacco ingredients, then inserted into the device for smoking.”

  • Philippines: Momentum Building for Disposables Ban

    Philippines: Momentum Building for Disposables Ban

    Photo: Mihail Reschetnikov

    Momentum is building in the Philippines for a proposal by Finance Secretary Ralph Recto to ban disposable e-cigarettes, reports The Philippine Star.

    The Department of Health has indicated support for the proposal, just like some senators, but the Department of Trade and Industry, which enforces the country’s vape law, has yet to take a stand.

    Eric Singson, mayor of Candon in the tobacco-producing Ilocos Sur province in Northern Luzon, said he was open to the idea. “If it is really hazardous to a person’s health, then it’s OK with me, we will subscribe to regulation, just like the Tobacco Regulation Act,” he said.

    Both the Department of Agriculture and National Tobacco Administration have yet to communicate their respective positions.

    Several countries in Europe including the United Kingdom, Ireland and Belgium have announced disposable vape bans.

    “If that is the trend, then maybe there is a very good reason for banning it. If it’s something of a health concern to the users, especially the minors, then I’m open to it,” Singson told The Philippine Star in an interview in.

    In Asia, disposable vapes are already banned in Singapore, Thailand and Taiwan.

    Recto proposed the ban in response to the rise in youth vaping and the impact of disposable products on the environment, with illicit e-cigarettes further eroding tax revenues.

  • Britain’s Generation Nicotine Ban Passes First Vote

    Britain’s Generation Nicotine Ban Passes First Vote

    Credit: XY

    Lawmakers approved British Prime Minister Rishi Sunak’s plan to ban anyone aged 15 and under from ever buying cigarettes despite opposition from some prominent members of his Conservative party, reports Reuters.

    The bill passed a vote in Britain’s parliament with 383 in favor and 67 against.

    Fifty-seven Conservatives, including Business and Trade Secretary Kemi Badenoch, voted against the plan. Earlier, two former prime ministers, Liz Truss and Boris Johnson, had come out against the legislation, with Truss describing the draft legislation as “unconservative” and Johnson calling it “nuts.”

    The ban enjoys strong support among healthcare professionals, who say that smoking causes 80,000 premature deaths every year, along with many more smoking-related illnesses.

    In a recent YouGov poll, a third of voters supported the phased approach and 30 percent supported a ban for everyone at the same time. Only a quarter said there should be no ban.

    Badenoch said that while she agreed with Sunak’s intentions, she opposed the bill as she was concerned about its impact on people’s rights and difficulty in enforcing the policy.

    Earlier this year, New Zealand scrapped a similar law after a new coalition government took power in late 2023. The government said it favored a harm-reduction approach to discourage smoking, but critics accused it of succumbing to tobacco lobbying.

    Britain’s generational tobacco ban will now progress to the next stage in parliament, where it can be subject to amendment.

  • U.K. to Vote Tuesday on Tobacco Endgame Bill

    U.K. to Vote Tuesday on Tobacco Endgame Bill

    Vapor Voice archives

    On Tuesday, British lawmakers will vote on a generational smoking ban aimed at preventing young people from smoking.

    The bill, a key policy announced by Conservative Prime Minister Rishi Sunak last year, will make it illegal to sell tobacco products to anyone born after 2009, according to media reports.

    The proposal has the support of the opposition Labour Party and is expected to pass. However, some libertarian-minded members of Sunak’s party criticized the proposals as “unconservative.”

    Authorities say that if passed, the bill will create modern Britain’s “first smoke-free generation”.

    Supporting the ban, England’s chief medical officer, Professor Sir Chris Whitty, said once people become addicted to smoking, “their choice is taken away.”

    Under the Tobacco and Vapes Bill, children turning 15 this year or younger will never be legally sold tobacco. The legal age of sale that people in England can buy cigarettes will be raised by one year, every year, until it is eventually illegal for the whole population.

    The bill also includes measures to crack down on youth vaping, such as banning the sale of disposable vapes and limiting their flavors to prevent children from becoming addicted to nicotine.

    Opponents, such as Conservative lawmaker Simon Clarke, have said it is better to focus on education and the tax system to deter young people from smoking rather than enforcing an outright ban.

    “I think that an outright ban risks being counterproductive; I think it actually risks making smoking cooler; it certainly risks creating a black market,” he told the BBC.

  • FDA Denies Marketing of MNGO Disposable Vapes

    FDA Denies Marketing of MNGO Disposable Vapes

    Credit: Chase4Concept

    The U.S. Food and Drug Administration on April 15 issued marketing denial orders (MDOs) to Shenzhen Yibo Technology Co. for 65 disposable e-cigarettes marketed as “MNGO Disposable Stick.”

    The products involved include flavors such as tobacco, menthol, pink lemonade, strawberry mango, watermelon freeze, iced banana, and others, with each flavor offered in a range of nicotine concentrations from 2 percent to 6 percent.

    According to the 2023 National Youth Tobacco Survey (NYTS), disposable e-cigarettes were the most commonly used device among current e-cigarette users, and almost 9 out of 10 current e-cigarette users reported using flavored e-cigarettes with fruit flavors being the most popular.

    The MDOs also include several “Clear” flavor products that were described by the applicant as flavorless or unflavored. However, data submitted in the company’s applications showed these products contained ingredients that are flavor enhancers or are known to impart a menthol or mint flavor, according to the FDA. Based on the entirety of evidence, the agency determined that the products have a characterizing flavor.

    “The onus is on tobacco companies to provide the evidence demonstrating that the necessary public health standard has been met, and when they fail to do so, FDA will appropriately deny the marketing authorization of new tobacco products,” said Brian King, director of FDA’s Center for Tobacco Products, in a statement. “In this case, the applicant did not meet the necessary bar.”

  • Video: FDA Urged to Prioritize Access to Safer Alternatives

    Video: FDA Urged to Prioritize Access to Safer Alternatives

    Consumer advocates were planning to speak out against what they describe as the U.S. Food and Drug Administration’s “alarming neglect” in facilitating access to safer nicotine alternatives for millions of adult consumers during a House Oversight hearing scheduled for 1 pm today.

    “Despite the bipartisan mandate of the Tobacco Control Act of 2009, the FDA’s performance has fallen short of expectations, leaving countless individuals without viable options to effectively transition away from combustible cigarettes,” the Consumer Choice Center wrote in a press note.

    “With over 26 million premarket tobacco product applications (PMTA) languishing in bureaucratic limbo, the FDA has only authorized fewer than 50 granted to just a handful of firms, completely disregarding the 180-day review deadline set imposed by Congress,” said Consumer Choice Center US Policy Analyst Elizabeth Hicks.

    “Less than 10 unique devices are available on the regulated marketplace, all of which come from industry incumbents, not to mention the growing categories of nicotine alternatives such as heaters, pouches, toothpicks, and more.

    “This blatant failure highlights a systemic issue within the agency, where regulatory inertia trumps the urgent need to provide consumers with safer nicotine alternatives such as e-cigarettes which studies have shown to be 95 percent less harmful than combustible cigarettes. As a result, consumers are being pushed towards the illicit market, which does not adhere to regulatory standards, to find their preferred nicotine alternative products,” said Hicks.

    “Consumers are deeply troubled by the FDA’s abject failure to fulfill its obligations under the Tobacco Control Act. It is imperative that the FDA swiftly rectify this situation by implementing a transparent and expedited regulatory pathway that prioritizes access to scientifically validated, less harmful nicotine products,” she concluded.

  • Navigating the Fog: Brazil’s Battle Over Vaping

    Navigating the Fog: Brazil’s Battle Over Vaping

    Image: VlaDee/pavlofox

    Brazilian lawmakers mull regulation of e-cigarettes.

    By Claudio Teixteira

    In the face of growing concerns about public health, the expansion of the illicit market, and the persistent inaction of the Health Agency in assuming its regulatory responsibilities, the Federal Senate of Brazil has taken matters into its own hands with a bill for the regulation of electronic cigarettes in the country. This initiative, driven by Senator Soraya Thronicke, seeks to fill a legal loophole that has favored organized crime for over a decade and ensure adequate consumer protection. The bill under discussion in Brazil has the potential to mark a before and after in the vaping policy of the largest market in Latin America. Below, some fundamental aspects of this project are detailed, and the perspectives of experts on the subject are gathered.

    Nearly 15 years have passed since the Brazilian National Health Surveillance Agency (ANVISA) banned commercial activities related to electronic cigarettes, and the discussion about this measure remains as relevant as it was at the beginning.

    Although the current law does not restrict personal use or possession of vaping devices, the ANVISA’s decision in 2022 to maintain the ban, after an exhaustive review process and public consultation, has generated a polarized debate among the Brazilian population. The consultation conducted last February has revealed considerable interest from consumers and various social sectors in reviewing and softening the current rules, favoring a more open and evidence-based policy.

    The ANVISA’s decision not to engage in the regulation of vaping products has spurred a significant legislative reaction from the Federal Senate. This situation highlights a critical moment in Brazil’s public health policy, marking a possible turning point in how the country addresses the regulation of these contemporary and widely debated products.

    In this context, Bill No. 5,008 of 2023, promoted by Thronicke, emerges. This legislative initiative is proposed as a direct response to the ANVISA’s inaction and seeks to establish a comprehensive regulatory framework for electronic cigarettes and similar devices in Brazil. The project covers many aspects, including production, marketing, importation and exportation as well as the regulation and specific supervision of these consumer products.

    Intending to establish precise requirements for their control, this bill represents a comprehensive effort to manage the presence and distribution of vaping devices in the Brazilian market, ensuring proper regulation from their manufacture to their promotion.

    Benefiting Organized Crime

    The senator has expressed concern that Brazil, unlike 84 percent of Organization for Economic Cooperation and Development countries, lacks specific legislation to regulate electronic cigarettes. According to her, this omission leaves consumers vulnerable, facing a proven ineffective ban that does not align with the more advanced legal and regulatory standards adopted globally.

    Thronicke emphasizes that the protection of public health must be the priority, with a particular focus on the safety of young people. She proposes implementing strict regulations covering all aspects from production to marketing, promotion and consumption of these products. The senator maintains that adopting such measures is essential to minimize the risks associated with the use of electronic cigarettes and ensure a market supply that is responsible and regulated.

    The senator has expressed her deep dissatisfaction with Brazil’s current lack of regulation of electronic cigarettes. In an interview with Poder360, she pointed out how this legislative gap directly benefits organized crime. She highlighted the critical need to be held accountable for this omission and wondered who truly benefits from this legal void.

    “I wish those responsible for this omission face the consequences. I need to know who is behind this and who is facilitating organized crime operations. In this legal limbo scenario, the only beneficiaries are, without a doubt, criminal groups,” emphasized the senator, underscoring the importance of addressing and closing this legislative gap to combat the advancement of organized crime in this sector effectively.

    The senator’s concern extends to the quality and safety of vaping products in the Brazilian market. Many of these products evade regulations and contain components of unknown composition, posing a significant risk to public health. Furthermore, she criticizes the current prohibitive policies for their inconsistency, banning potential alternatives in favor of products whose dangers are already widely documented.

    Thronicke argues that if bans are to be implemented, they should be applied equitably, including traditional tobacco products. “If the decision is made to ban electronic devices, then conventional cigarettes should also face prohibition. It takes courage to do so, especially when nicotine is legal in Brazil, and electronic cigarettes represent just another way of consuming it.”

    These statements underline the urgency and complexity of formulating precise and compelling regulations for electronic cigarettes and other reduced-risk products in Brazil, focusing on safeguarding public health and combating illegality.

    Her concerns are evident when she points out how the absence of regulation benefits organized crime through the illicit trade of these products. She also highlights the risks of using unregulated devices and liquids whose ingredients are unknown and potentially harmful. “What is currently sold in Brazil evades any regulation. In Brazil, it’s simple to adulterate these products. The substances used for refilling or containing are made up of unknown ingredients, representing a serious health risk,” the senator emphasized.

    Knowing the Bill

    • The bill proposes that companies wishing to manufacture or import electronic cigarettes in Brazil register their products with the ANVISA. This process would include paying a “sanitary surveillance and inspection fee” set at BRL100,000 ($20,000) for each registration application or renewal.
    • Additionally, registering these products with the Brazilian Federal Revenue service will be required. As part of the process, interested parties must also submit a toxicological evaluation report to the ANVISA that should comprehensively analyze the additives and materials used in the products. This measure seeks to ensure rigorous control over the quality and safety of electronic cigarettes available in the Brazilian market to protect public health and ensure that only safe and regulated products are accessible to consumers.
    • The National Institute of Metrology, Quality and Technology and the National Telecommunications Agency will play crucial roles in establishing technical and safety criteria for the proper functioning of vaping devices. These guidelines will include regulations on safety in the charging process and standards for the wireless communication of devices, aiming to ensure that their use is safe and effective.
    • On the other hand, the bill introduces rigorous regulations for liquids containing nicotine, establishing a maximum volume limit of 22 mL and a maximum nicotine concentration of 35 mg per milliliter.
    • Additionally, the devices must be designed to prevent inappropriate tampering and ensure that they are inaccessible to children as part of a comprehensive effort to increase the safety of these products and primarily protect minors.
    • For heated-tobacco products and their respective packaging, the legislative project specifies that each package must contain 20 units, with a nicotine emission that does not exceed 1 mg per tobacco stick.
    • Product packages must include an informative leaflet covering essential aspects for the consumer, including instructions for use and storage, contraindications, possible adverse effects and warnings directed at at-risk groups.
    • The products must detail their ingredients, the nicotine concentration, the batch number and production and expiration dates. In addition, they must incorporate warning messages about health risks and the obligation to keep these products away from children and adolescents.
    • The products must display explicit warnings about several critical aspects of consumer safety and health. Firstly, they must prominently indicate the prohibition of their sale to minors under 18 years of age along with a strong recommendation against their use by nonsmokers. The need to keep the product out of reach of pets will also be emphasized.
    • Specific contraindications will be detailed to ensure that consumers are fully informed about situations in which the use of the product is not recommended or can be risky. This includes warnings focused on high-risk groups, such as pregnant women, people with diabetes and patients with heart conditions, reinforcing the project’s commitment to public health protection and the promotion of responsible consumption.
    • The product label must provide detailed information on the possible adverse effects of using the product and warnings about the risks of dependency and toxicity arising from its prolonged use.
    • The products will include detailed contact information, such as the company’s legal registry and the manufacturer’s or importer’s address, to ensure effective communication with consumers and facilitate the submission of complaints if necessary. According to the senator, this set of requirements promotes high transparency and accountability, encouraging these devices’ safe and informed use.
    • The packaging of electronic cigarette products must clearly and visibly display on their exterior a series of crucial information for the consumer. This includes a detailed list of ingredients, categorized explicitly and understandably by the type of additives and nicotine concentration. It is also crucial to include the batch identification, the production date and the product’s expiration date.
    • A prominent warning that the product must remain out of reach of children and adolescents is essential, along with a message about the health risks that must occupy at least 20 percent of the packaging surfaces most visible to the consumer.
    • Regarding the wording of the products, a specific prohibition will be implemented on using numbers, expressions or graphic elements that evoke flavors associated with desserts, sweets or any other element that may attract children and adolescents.
    • The ANVISA will determine the substances whose use will be prohibited, thus ensuring thorough control over the components of these products to safeguard public health.
    • The advertising of electronic cigarettes and related products will be subject to a rigorous ban in all media, including television, radio, billboards, print publications and digital platforms, such as social networks. The only exception allowed will be promoting these products within physical sales points or through e-commerce platforms, provided that strict age control is implemented to prevent minors from accessing them.
    • Expressly, any direct or indirect reference to youth culture is prohibited, including images of people who may be perceived as under 25 years of age, to deter interest in these products from this age group. These measures aim to reduce the appeal of electronic cigarettes and similar products among young people, safeguarding their health and well-being.
    • A robust age verification system will be required at the point of sale to confirm that the purchaser is over 18 years old, using biometrics or other equivalents.
    • Sales points must also comply with regulations prohibiting placing electronic cigarettes near products intended for children, such as candies and toys, thus avoiding any association that may be appealing to minors.
    • Furthermore, an explicit ban will be imposed on the free distribution of electronic cigarettes by manufacturers, importers or traders for promotional purposes to prevent encouraging consumption among new users, particularly young people.

    The regulations surrounding the consumption of harm reduction products will be established in line with the rules applied to traditional cigarettes, including restricting their use in enclosed spaces under existing legislation.

    The controversial prohibition of open-system devices is among the critical challenges to implementing and complying with the proposed regulation. These are characterized by a reservoir that can be refilled and generally offers the option to recharge. In contrast, closed systems comprise devices designed typically for single use, which are nonrechargeable and disposable after use.

    Such devices, due to their customization capability and low cost, present a significant alternative for those users looking to quit smoking by allowing them to adjust the nicotine concentration according to their specific needs.

    However, a critical limitation of the proposed law is that the prohibition significantly restricts the tools available for harm reduction and smoking cessation. This limitation to specific devices poses notable challenges in compliance and effective implementation of the regulation, implying the allocation of resources that could be used more effectively in other tobacco control strategies and in promoting awareness of the associated risks.

    ‘Chemical Weapons’

    The journey of the bill proposed by Thronicke in the Brazilian Senate is anticipated to be full of obstacles. One critic is conservative Senator Eduardo Girao, who has fervently defended the approval of his project, the PL 4.356/2023, which seeks to ratify the prohibitions already imposed by the ANVISA on electronic cigarettes, which he describes as “authentic chemical weapons with a technological varnish.”

    Girao argues that e-cigarettes are designed to attract new consumers, thus compensating for the loss of users that the tobacco industry has experienced in Brazil and globally over the last decades. During a plenary session of the Senate on March 11, he warned about the “serious health consequences in the short [term], medium [term] and long term” that an increase in the consumption of these devices could entail, especially among young people. Among these consequences, he mentioned an increase in the incidence of respiratory diseases, cardiovascular diseases and cancer.

    Despite this opposition, there are voices like that of Deputy Heitor Schuch suggesting that it’s unlikely any bill will succeed without explicit backing or a prior determination by the health agency.

    The scenario underscores the complexity of the legislative and regulatory debate around electronic cigarettes in Brazil, reflecting the divergence of opinions both within the political spectrum and in the academic and medical fields. The situation highlights the need for a deep and balanced analysis that considers both public health and the realities of nicotine consumption in the country. Amid this debate, various voices, including politicians, scientists and civil society representatives, urge Brazil to adopt a coherent and safe regulatory framework for nicotine products.

    With 22 million active smokers and about 3 million vapers, the lack of defined regulation and clear inequality in access to less harmful alternatives underline the urgency of establishing effective regulation through legislation. This measure is essential for promoting public health, social equity and economic stimulus. This raises the question of whether this will be the moment Brazil moves toward a more equitable and effective tobacco control policy.

    However, as several experts, including Schuch, have highlighted, the likelihood of any bill progressing without the endorsement or a preliminary determination by the health agency seems slim. This scenario highlights the complexities surrounding the formulation and implementation of public policies in tobacco control, emphasizing the importance of a consensus among the stakeholders involved to move toward solutions that adequately address the public health challenges in Brazil.

    Finding the Right Balance

    For professor Ingrid Dragan Taricano, a prominent toxicologist, regulating electronic cigarettes is at a decisive moment. Taricano identifies several aspects that underline the urgent need to regulate these devices, covering everything from public health and the protection of minors to environmental implications and risk and safety assessments from a toxicological perspective.

    Following the essential principle of toxicology, which holds that “every substance is toxic; it is the dose that makes the poison,” Taricano highlights the need to carry out rigorous health-risk assessments to establish safe exposure limits to any substance that comes into contact with humans. This approach emphasizes the importance of addressing concerns about toxic substances in electronic cigarettes and raises a crucial question: What is the safe dose for each component of these products?

    Bill PL 5008/2023 incorporates this vision by requiring the submission of toxicological evaluation reports for registering electronic nicotine-delivery devices with the ANVISA. Taricano views this proposal positively, highlighting its relevance within the regulatory framework to ensure a comprehensive evaluation considering the additives used, the manufacturing material and an objective toxicological comparison with traditional cigarettes.

    Taricano emphasizes the importance of toxicology as a cornerstone for developing policies and regulations regarding electronic cigarettes. This scientific discipline provides the foundation for establishing quality and safety criteria, restricting certain ingredients and flavors and adopting measures to prevent young people’s access to these products.

    In nations where effective regulation has been implemented, specific limits for nicotine concentration have been determined, and proven quality components of e-liquid have been required. This scenario contrasts significantly with deregulated markets, where devices can contain dangerous substances without supervision, as Taricano warns.

    She criticizes positions against regulation that focus solely on the presence of harmful elements in electronic devices, overlooking the fundamental toxicological principle that “every substance is toxic, and everything is a matter of dose.” According to Taricano, user safety can only be guaranteed through the appropriate regulation of the quantities and quality of the components.

    Taricano highlights the complexity of establishing balanced regulation that protects public health without inhibiting innovation or individual freedom. For her, it’s fundamental that regulatory decisions are supported by a solid scientific base, ensuring that both the risks and benefits of using electronic cigarettes are considered. In this sense, science must be the beacon that guides toward informed and effective regulation, always with consumer well-being as the highest priority.

    ‘An Obstacle to Quitting’

    Alexandro Lucian, a renowned expert in harm reduction associated with smoking and leader of the Directory of Information for Tobacco Harm Reduction, a nongovernmental organization dedicated to improving anti-tobacco policies, highlights the bill’s importance as an essential tool to address current issues of smuggling, tax evasion and the indiscriminate use of products attractive to young people.

    Lucian points out that this project seeks to ensure that consumers have access to products that comply with appropriate health regulations and are adequately informed about the risks involved in their use.

    However, Lucian emphasizes that the bill requires significant reforms. He criticizes the imposition of an annual registration fee of BRL100,000 and the misclassification of electronic cigarettes as tobacco derivatives, which could hinder the legalization of numerous existing initiatives, thus fostering the illegal market and posing a risk to public health. “This fee will prevent most of the initiatives already existing in the country from becoming legal, fueling illegal trade and bringing incalculable risks to public health,” he says.

    He also underscores the need to review the project section that suggests banning open systems, which many users prefer. He argues that restricting legal access to these systems could further stimulate illegal trade. Lucian highlights that these systems, by offering the possibility to adjust the nicotine dose, facilitate the process for traditional cigarette smokers to migrate to electronic ones and, over time, give up the smoking habit.

    ‘An Obstacle for Small Businesses’

    From the consumer’s perspective, Ignacio Leiva, leader of ASOVAPE Chile and coordinator of the “Vaping Is Not Smoking” campaign, is a recognized activist who has significantly contributed to formulating progressive vaping regulations in Chile. Sharing his vision of the situation in Brazil, Leiva considers that Thronicke’s project represents a notable advance for Brazilian legislation, which currently faces unfavorable conditions due to the total ban.

    According to him, this situation has fostered the rise of a black market that not only puts consumers’ health at risk due to the lack of control over product quality but also deprives the state of significant tax revenues in addition to benefiting marginal groups that trade in these products.

    Leiva expresses concern about the BRL100,000 required for product registration, which he sees as a particularly onerous barrier for small-sized and medium-sized enterprises, possibly favoring large corporations and potentially resulting in a monopoly in the sector.

    While he supports advertising restrictions for conventional tobacco, Leiva advocates for greater freedom in promoting harm reduction products. He highlights the need to inform society about less harmful alternatives. He argues that regulation facilitating access to safe and regulated options can motivate a positive change in consumption habits, reducing tobacco use and benefiting public health. Moreover, he defends adopting fair regulatory measures that do not unjustly favor large corporations to the detriment of smaller market players.

    Leiva emphasizes the importance of achieving a balance between offering less harmful alternatives to smokers and protecting minors. He positively values the measures included in Thronicke’s proposal to prevent minors from using electronic cigarettes. He applauds the initiative to restrict the sale of these products alongside items aimed at the child and youth audience. This approach reflects, in his opinion, a solid commitment to the protection of young people, ensuring that efforts to minimize the harms associated with tobacco do not increase the use of electronic devices among the most vulnerable population.

    Protecting Public Health and Promoting Equity

    The voices of politicians, civil society members and scientists urgently highlight the need for a more coherent and safer regulatory framework for managing nicotine products in Brazil. There is widespread agreement on the need to focus policies on protecting public health and combating illegal trade as well as addressing smoking-related complications.

    It is also recognized that adopting appropriate regulations in the country would benefit public health and boost the economy through job creation, increased revenues and significant fiscal contributions to the state. This perspective underscores the importance of a balanced approach that combines health objectives with economic incentives to positively impact the population’s well-being and the country’s economic development.

    Although Brazil records lower smoking rates compared to other nations, there remains a significant fraction of the adult population, approximately one in eight adults, who continue to smoke. This represents about 22 million people. This data, derived from national statistics on tobacco consumption, highlights the pressing need to implement effective public health policies.

    The prohibition of products recognized as harm reduction options in Brazil poses a severe challenge in terms of social justice. A higher incidence of smoking is observed in the lower socioeconomic classes compared to the ability of middle and high classes to access less harmful alternatives, which evidences an apparent disparity in access to healthier options.

    This inequality suggests that strategies to promote a healthier lifestyle are predominantly available to those with greater economic capacity, leaving people with fewer resources and limited options to quit or reduce tobacco use. This scenario underscores the need to adopt inclusive measures that allow all layers of society to benefit from safer and more effective alternatives for smoking cessation.

    The current prohibition becomes a significant obstacle to implementing public policies aimed at improving access to harm reduction methods in communities most impacted by smoking. In this context, adopting effective regulation emerges as a crucial element, with the potential to make harm reduction strategies accessible to all levels of society, thus helping to mitigate health inequality.

    The discussion on regulating less harmful alternatives, such as electronic cigarettes, becomes especially relevant, offering solutions to the adverse consequences of prohibition in Brazil’s social fabric. Furthermore, this debate opens a new avenue in the fight against smoking. Considering social justice issues, it is imperative to promote policies that foster equity and ensure fair access to safer options for all citizens.

  • Oversight Committee to Question FDA Commissioner

    Oversight Committee to Question FDA Commissioner

    Robert Califf (Photo: FDA)

    The U.S. House Oversight and Accountability Committee will question U.S. Food and Drug Administration Commissioner Robert Califf as part of an investigation into the agency’s handling of tobacco and nicotine products regulation, among other issues, according to a press release.

    Last year, the committee announced an investigation into the FDA Center for Tobacco Products (CTP). “We have deep concerns that the CTP’s decisions have been influenced by political concerns rather than scientific evidence,” wrote Oversight Committee chairman James Comer in a letter for Califf. “Comments from FDA staff to RUF [the Reagan-Udall Foundation] … reflect such concerns.”

    Other members of Congress have also questioned the FDA’s commitment to fair regulation, with a bipartisan group of senators asking Califf in 2023 to explain the FDA’s premarket tobacco product application process.

    The hearing is scheduled for April 11 at 1 p.m. EDT. It will be live streamed on the committee website and on YouTube.

  • Nepal Readies to Place Ban on Vaping Products

    Nepal Readies to Place Ban on Vaping Products

    Credit: Patryk

    Preparations are underway to ban e-cigarettes in Nepal. Information Officer of the National Health Education, Information and Communication Center, Bhakta Bahadur KC, said.

    He said that the use of e-cigarettes is increasing among the youth in Nepal, and said legislation is being created to ban e-cigarettes as “they are as harmful to health as cigarettes.”

    Numerous studies have shown vaping to be at least 95 percent less risky than combustible cigarette smoking.

    According to statistics, in the last fiscal year alone, Nepal imported 3.2 million e-cigarettes and the business is worth Rs 210 million ($1.5 billion). Hookah and vape devices cost between Rs 10,000 and Rs 13,000.

    The letter of intent to ban e-cigarettes has already been sent to the Ministry of Health and Population, according to KC.

  • Ireland to Consider Disposables Ban, 21 Minimum Age

    Ireland to Consider Disposables Ban, 21 Minimum Age

    The Minister for Health in Ireland wants to raise the minimum age for smoking to 21. He would also like to ban disposable vaping products.

    Stephen Donnelly said the Government is also looking at a range of legislative measures “to come down hard” on vaping.

    He made the remarks at an event to mark the 20th anniversary of the workplace smoking ban in Ireland, which prohibited smoking in indoor commercial spaces.

    The process for legislating new restrictions, which involves a public consultation, is complicated by Ireland’s inclusion in the EU single market, according to media reports.

    Donnelly said he would personally recommend raising the smoking age and that legislation was being prepared in the event it was agreed upon at the Government level.

    “It’s a measure aimed at people who are 15, 16, 17 years of age that – with a smoking age of 18 – they find it relatively easy to go to either buy the cigarettes themselves or get a friend or an older sibling to get them.

    “But if you move to 21, it makes it much more difficult.” The country raised the age to 18 last year.

    A public consultation will also examine issues such as banning disposable vapes and extending prohibited smoking zones to outdoor seating areas.