Tag: regulation

  • Sunak Asked to Reconsider UK Disposables Ban

    Sunak Asked to Reconsider UK Disposables Ban

    Photo: Lumos sp

    The U.K. Vaping Industry Association sent a letter to U.K. Prime Minister Rishi Sunak to “express profound dismay and disappointment” that the government decided to proceed with a disposable vape ban.

    “This decision jeopardizes the significant progress made in reducing smoking rates in the U.K. and poses a threat to the well-being of millions of adults who have successfully quit smoking with the help of vaping,” the letter reads.

    “We urge the government to reconsider the ban on disposable vapes and adopt a more balanced approach that prioritizes effective enforcement over draconian bans,” the letter says. “A distributor and retailer licensing scheme, as proposed to government repeatedly by the UKVIA, would achieve such an outcome without any cost to the taxpayer.”

  • FDA Issues Civil Penalties to 21 Small Business Owners

    FDA Issues Civil Penalties to 21 Small Business Owners

    Credit: Valiantsina

    The U.S. Food and Drug Administration has issued complaints for civil money penalties (CMPs) against 21 brick-and-mortar retailers for selling unauthorized Esco Bars e-cigarettes.

    In a press release, the agency stated that it had previously issued each retailer a warning letter for their sale of unauthorized tobacco products. However, follow-up inspections revealed that the retailers had failed to correct the violations.

    The agency now seeks the maximum penalty of $20,678 from each retailer.

    The complaints announced today represent the first set of CMPs FDA has filed for the sale of unauthorized Esco Bars e-cigarettes. “These retailers were duly warned of what could happen if they continued selling these unauthorized e-cigarettes,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “They should have acted responsibly to correct the violations, but they chose not to do so and now must face the consequences of that decision. FDA won’t sit back and tolerate inaction to comply with the law.”

    Currently, $20,678 is the maximum civil money penalty amount FDA can seek for a single violation from each retailer, consistent with similar CMPs sought against retailers for the sale of unauthorized Elf Bar products in Sept., Nov., and Dec. of 2023.

    The retailers can pay the penalty, enter into a settlement agreement based on mitigation factors, request an extension of time to file an answer to the complaint, or file an answer and request a hearing. Retailers that do not take action within 30 days after receiving a complaint risk a default order imposing the full penalty amount, according to the release.

    “Today’s CMP actions are just the latest in the continued, comprehensive push by FDA to take action across the supply chain to remove unauthorized e-cigarettes, particularly those that are popular among youth, from the marketplace,” the release states. “As of Jan. 30, 2024, FDA has issued more than 440 warning letters and 88 CMPs to retailers, including brick and mortar and online retailers, for selling unauthorized tobacco products.

    “In addition to actions involving retailers, FDA has issued more than 660 warning letters to firms for illegally manufacturing and/or distributing unauthorized new tobacco products, including e-cigarettes.

    “The agency has also filed civil money penalty complaints against 48 e-cigarette firms for manufacturing unauthorized products and sought injunctions in coordination with the U.S. Department of Justice against seven manufacturers of unauthorized e-cigarette products.”

  • Kaival Brands Appeals MDO of Tobacco Bidi Stick

    Kaival Brands Appeals MDO of Tobacco Bidi Stick

    A recent marketing denial order issued for a tobacco-flavored Bidi Stick only applies to one Bidi device. The company, Bidi Vapor, currently has 10 other flavors still in the U.S. Food and Drug Administration’s premarket tobacco product application (PMTA) process.

    Bidi Vapor’s “Classic” tobacco-flavored Bidi Stick ENDS device is the only product affected. Kaival Brands, parent to Bidi Vapor, holds the worldwide license to distribute products made by Bidi Vapor.

    In response to the MDO, Bidi Vapor filed a petition requesting that the U.S. Court of Appeals for the 11th Circuit review the MDO, which Bidi Vapor believes was, among other things, “arbitrary and capricious, in violation of the Administrative Procedure Act.” Bidi Vapor will also be seeking a stay of the MDO pending the outcome of the litigation.

    “Bidi Vapor disagrees with the FDA’s decision and is taking immediate action accordingly,” said Niraj Patel, the founder and CEO of Bidi Vapor and Chief Science Officer and founder of Kaival Brands. “In the meantime, it is important to note that the decision only affects the ‘Classic’ or tobacco-flavored Bidi Stick. The remaining ten Bidi Stick flavors are still under FDA scientific review and remain in distribution in the United States through Kaival Brands, subject to the FDA’s enforcement discretion.”

    Bidi Vapor has a history of successful outcomes when contesting adverse FDA decisions, having received a favorable 11th Circuit ruling in August 2022 that set aside the original MDOs received for its 10 non-tobacco flavored products, according to a press release.

    “While we are disappointed with the FDA’s decision, we are in close contact with Bidi Vapor and laser-focused on selling the Bidi Vapor products that we are permitted to,” said Barry Hopkins, executive chairman of Kaival Brands. “Like Bidi Vapor, we are fully committed to the legal and responsible use of our products. Moreover, we are committed to increasing Kaival Brands’ revenues by strengthening our existing business and also diversifying our product portfolio, as evidenced by the intellectual property we acquired in May 2023 from GoFire, Inc.”

  • New United Kingdom Vape Rules to Ban Disposables

    New United Kingdom Vape Rules to Ban Disposables

    Photo: Mikhail Reshetnikov

    The U.K. will ban disposable e-cigarettes, the government announced today.

    According to the government, disposable vapes have been a key driver behind the rise in youth vaping, with the proportion of 11 to 17-year-old vapers using disposables increasing almost ninefold in the last two years.   

    As part of the package, the government will also acquire new powers to regulate vape flavors, e-cigarette packaging and product presentation in stores to ensure that they don’t appeal to underage users. Additionally, the government will bring in new fines for shops in England and Wales that sell vapes illegally to children. Vaping alternatives, such as nicotine pouches, will also be outlawed for underage consumers.

    In its announcement of the new measures, the government also reiterated its commitment to a generational tobacco ban. To help implement the new rules, government agencies such as the Border Force, Revenue and Customs and Trading Standers will receive £30 million ($38.1 million) in new funding a year.

     “As prime minister I have an obligation to do what I think is the right thing for our country in the long term. That is why I am taking bold action to ban disposable vapes—which have driven the rise in youth vaping—and bring forward new powers to restrict vape flavors, introduce plain packaging and change how vapes are displayed in shops,” said ,” said Prime Minister Rishi Sunak.

    “Alongside our commitment to stop children who turn 15 this year or younger from ever legally being sold cigarettes, these changes will leave a lasting legacy by protecting our children’s health for the long term.”

    While action to prevent youth access to vaping is critical, this move smacks more of a desperate attempt by the government to sacrifice vapers for votes ahead of the upcoming general election.

    Public health officials welcomed the government’s decision. “We’re delighted that the Westminster government has heard our calls and is rightly prioritizing the health and well-being of our children and the planet,” said Mike McKean, vice president for policy at the Royal College of Pediatrics and Child Health. “Bold action was always needed to curb youth vaping and banning disposables is a meaningful step in the right direction. I’m also extremely pleased to see further much needed restrictions on flavors, packaging and marketing of vapes.”

    Representatives of the vape industry, by contrast, were dismayed, pointing to significant role disposable vapes have played in bringing the U.K.’s smoking rates down to a record low.

    “While action to prevent youth access to vaping is critical, this move smacks more of a desperate attempt by the government to sacrifice vapers for votes ahead of the upcoming general election,” said John Dunne, director general of the U.K. Vaping Industry Association (UKVIA), in a statement.

    “If the government thinks banning disposables will help protect young people, they are completely misguided. This counterproductive legislation will sooner put children at greater risk by turbo-charging the black market and, in turn, making it easier for them to access illicit and noncompliant vapes.”

    Pointing to recent research from University College London, the UKVIA said the answer to youth vaping doesn’t lie in counterproductive bans and restrictions, but rather in effective and proactive enforcement of the law which states that it is illegal for vapes to be sold to minors.

    We can’t have a two-tier society in which some adults are permitted to buy tobacco and others are denied the same opportunity.

    The government’s continued commitment to a generational tobacco ban, meanwhile, prompted a strong response from smokers’ rights activists, who said the plan infantilizes adults.

    A new poll for the smokers’ lobby group Forest found that almost two thirds (64 percent) of adults in Britain say that when people are 18 and legally an adult, they should be allowed to purchase cigarettes and other tobacco products.

    “As soon as you are legally an adult you should be treated like one and allowed to buy tobacco, if that’s your choice,” said Simon Clark, director of Forest.

    “We can’t have a two-tier society in which some adults are permitted to buy tobacco and others are denied the same opportunity.”

    Urging Downing Street to step back from the policy, he added:  “Law-abiding retailers will have the difficult job of enforcing this absurd policy that also drives a stake into the heart of traditional Conservative values such as freedom of choice and personal responsibility.”

     

  • Chemular, IGEN Team up to Streamline Compliance

    Chemular, IGEN Team up to Streamline Compliance

    Chemular and IGEN have formed a strategic alliance to create a new Compliance as a Service (CaaS) platform focused on streamlining the burden of compliance to small-sized and medium-sized companies who need turnkey solutions for Prevent All Cigarette Trafficking (PACT) Act, excise tax reporting and registration services.

    “The time and effort required to stay compliant with federal, state and local laws is increasingly burdensome for small-[sized] to mid-sized companies in regulated categories,” said Jason Carignan, chief commercial officer of Chemular, in a statement. “Except for larger players, most companies don’t have a dedicated compliance officer who can ensure every regulatory detail is addressed so their products can stay on the market—especially in industries like ours, where the rules change rapidly. Chemular, now powered by the IGEN backbone, will be able to significantly scale its turnkey compliance service offering to a growing portfolio of tobacco manufacturers and distributors.”

    In addition to saving time, utilizing the new CaaS platform can provide regulated companies with many other benefits, according to a company press release, including: streamlined remittance and reporting for excise tax, PACT Act, state registrations, and license capture; optimized growth opportunities by allowing employees and leadership to focus on what they do best: developing products and services; avoiding penalties with scaled compliance efforts that easily adapt to new markets with potentially different laws and regulations as the company grows; and reducing risk by monitoring real-time data and evolving regulations while establishing automated procedures that can minimize errors and detect fraud.

    Failure to adhere to compliance guidelines can be costly for companies, leading to large fines and expensive sanctions, regulatory scrutiny and loss of trust in the marketplace. In some cases, noncompliant companies can have their products removed from store shelves, giving space to competitors who were able to better adjust to changing regulations.

    “Compliance can be a long-term strategic advantage, yet most emerging businesses don’t have the resources and expertise to keep up with the growing complexity in regulatory requirements,” said Ryan Padget, president of IGEN. “We’re excited to bring our technology to Chemular, whose clients are regularly faced with regulatory hurdles, like PACT and excise tax reporting. This is just the beginning for our partnership—one that we see as a win for the industry as a whole.”

    Along with this announcement, the Chemular and IGEN teams will be appearing at the tobacco industry’s largest trade show, TPE24, providing resources and education to the show’s retail attendees. Chemular will be hosting the “Fortify Your Future” educational sessions of the show from Jan. 30, 2024, to Jan. 31, 2024, and will be available to speak with attendees at their second-floor meeting room located next to the educational session.

    Companies interested in becoming compliant or streamlining their current processes can visit www.chemular.com for more information.

  • Disposables Ban Could Thwart Cessation: Study

    Disposables Ban Could Thwart Cessation: Study

    Image: Viktoria Ostroushko

    A ban on disposable vapes, currently being considered by the U.K. government, could discourage the use of e-cigarettes among people who are trying to quit smoking, according to a new study led by researchers from University College London (UCL) and funded by Cancer Research U.K.

    Published in the journal Public Health, the study looked at survey responses from 69,973 adults in England, Wales and Scotland between January 2021 and August 2023.

    The researchers found the proportion of adults using disposable e-cigarettes rose from 0.1 percent to 4.9 percent during that period. The increase was particularly pronounced among 18- to 24-year-olds, with 14.4 percent using disposable vapes in 2023, as well as among smokers (16.3 percent) and people who had stopped smoking in the past year (18.2 percent).

    Use among people who had never regularly smoked was relatively rare (1.5 percent) but was higher among 18- to 24-year-olds, of whom 7.1 percent used disposable e-cigarettes and had never regularly smoked tobacco.

    “Our study suggests a ban on disposable e-cigarettes would affect an estimated 2.6 million people in England, Wales and Scotland,” said lead author Sarah Jackson, of the UCL Institute of Epidemiology & Health Care, in a statement.

    “This group includes about 316,000 18- to 24-year-olds who currently use disposables but who have never regularly smoked tobacco. However, it also includes 1.2 million people who currently smoke and would benefit from switching to e-cigarettes completely, and a further 744,000 who previously smoked and may be at risk of relapse.

    “While banning disposables might seem like a straightforward solution to reduce youth vaping, it could have substantial unintended consequences for people who smoke.

    “In the event of a ban, it would be important to encourage current and ex-smokers who use disposables to switch to other types of e-cigarettes rather than going back to just smoking tobacco.

    “In addition, we found disposable use to be particularly prevalent among recent ex-smokers with a history of mental health conditions. This group may require targeted support to help them avoid relapse.”

    While banning disposables might seem like a straightforward solution to reduce youth vaping, it could have substantial unintended consequences for people who smoke.

    The research team used data from the Smoking Toolkit Study, in which a different sample of 2,450 adults in Great Britain (who are representative of the general population) are interviewed each month.

    They found disposable e-cigarette use was significantly higher among adults living in England than Wales or Scotland (5.3 percent vs. 2 percent and 2.8 percent at the end of the study period) and among those from less (vs. more) advantaged social grades (6.1 percent vs. 4.0 percent), those with (vs. without) children (6.4 percent vs. 4.4 percent), and those with (vs. without) a history of mental health conditions (9.3 percent vs. 3.1 percent).

    Until recently, the researchers noted, very few adult vapers in Great Britain used disposables, but in 2021 new disposable e-cigarettes entered the market with designs and branding that appealed to young people, causing use of disposables to quickly rise in the U.K. and elsewhere. These products are available widely, for instance in corner shops, and are sometimes promoted via colorful in-store displays.

    While they are convenient to use, with a very low upfront cost, they have also become an environmental problem, with millions of the devices reportedly thrown away in the U.K. each week.

    A ban may discourage use of e-cigarettes among people trying to quit smoking and may induce relapse among those who have already used disposables to quit.

    “There is a need for action to reduce disposable vaping among young people who have never smoked,” said senior author Jamie Brown, a professor at the UCL Institute of Epidemiology & Health Care. “However, trade-offs need to be carefully considered. A ban may discourage use of e-cigarettes among people trying to quit smoking and may induce relapse among those who have already used disposables to quit. Cigarettes are far more harmful to our health and are not currently banned and a ban on disposable e-cigarettes may signal to large numbers of people that these products are worse for our health or that their harm is comparable to that caused by smoking tobacco. I favor a range of alternative policies, in the first instance, allied with rapid evaluation to judge whether these are sufficient to achieve reductions in youth vaping.”

    In the paper, the researchers outlined other measures to strengthen the regulation of disposable vapes that had a reduced risk of unintended consequences, such as causing relapse among ex-smokers.

    These included prohibiting branding with appeal to children (e.g., bright colors, sweet names and cartoon characters), prohibiting promotion of e-cigarettes in shops, putting e-cigarettes out of sight and reach of children, and putting an excise tax on disposables to raise the price to the same level as the cheapest reusable e-cigarettes. Defining disposables may prove problematic so a minimum unit price may be more a straightforward alternative to reduce their affordability and is something that could be implemented quickly.

    The researchers noted that their data might underestimate prevalence of disposable vape use. This is because survey respondents were asked which type of e-cigarette they mainly used, so people who used disposables as a secondary product were not captured.

    In addition to Cancer Research UK, the study received support from the U.K. Prevention Research Partnership.

  • Schumer Wants Crackdown on Zyn Nicotine Pouches

    Schumer Wants Crackdown on Zyn Nicotine Pouches

    Image: Tobacco Reporter archive

    U.S. Senate Majority Leader Chuck Schumer is calling for a crackdown on Zyn nicotine pouches, arguing that the product will be the next “trend in addiction for teens,” according to USA Today. He has asked the U.S. Food and Drug Administration and the Federal Trade Commission to take action on the company’s marketing practices and the product’s health effects.

    “Amid federal action against e-cigs and their grip on young people, a quiet and dangerous alternative has emerged, and it is called Zyn,” said Schumer. “I am delivering a new warning to parents because these nicotine pouches seem to lock their sights on teens and use social media to hook them.”

    “The amount of nicotine is highly addictive, and much more needs to be done to understand and communicate the health risks for young people,” Schumer said.

    Zyn’s parent company said that it both meets and exceeds industry regulations.

    “The FDA remains concerned about any tobacco product that may appeal to youth,” said Brian King, director of the FDA’s Center for Tobacco Products, in response. “The FDA uses a variety of surveillance tools to monitor the evolving tobacco product landscape and to identify emerging threats to public health.”

    King noted that the FDA closely monitors “those in the supply chain for compliance with federal law.”

    “As always, we are committed to holding those accountable who sell unauthorized tobacco products, including those labeled, advertised and/or designed to encourage youth use,” said King.

    The Federal Trade Commission did not comment, noting that it “does not publicly speculate on external requests for investigations or comment on letters from member[s] of Congress,” according to USA Today.

  • Juul Labs Supports Tighter Rules on Youth Access

    Juul Labs Supports Tighter Rules on Youth Access

    Credit: Piter2121

    Juul Labs wants tighter e-cigarette regulations to help stave off youth demand while also making the industry safer overall.

    In a recent open letter addressed to the Florida House of Representatives and Senate, the maker of JUUL vaping products urged lawmakers to endorse SB 1006 and HB 1007, legislative proposals to regulate the marketplace for legal nicotine vaping products in Florida.

    The Senate and House versions of the bill both require state regulators to develop a directory listing of certified nicotine products manufacturers and certified nicotine products. They also subject retail and wholesale nicotine products dealers to inspections or audits; prohibits sale, shipment, or distribution of certain nicotine products into this state; provides criminal penalties; requires entities that seek to sell nicotine products or dispensing devices to obtain wholesale nicotine products dealer permit; provides permit holders must consent to inspections and searches without warrant; provides for seizure and destruction of unlawful nicotine products, according to Florida’s Senate.

    In the letter, Juul Labs said it “is on a mission to transition the world’s billion adult smokers away from combustible cigarettes, eliminate their use, and combat underage usage of our products,” according to media reports.

    The letter highlighted what the company described as extensive efforts to ensure product quality and compliance with regulatory standards. The letter also emphasized significant investments in product development, regulatory science, and manufacturing quality controls.

    Penned by Juul Labs’ regional director for State Government Affairs, Jennifer Cunningham, the letter states that the company wants a better-regulated market. Cunningham cited measures implemented by Juul Labs, including supporting “Tobacco 21” laws to raise the legal age for tobacco product sales to 21, restricting vaping flavors to tobacco and menthol, limiting product purchases per transaction, and promoting retail partner compliance through ID checking and technology advancements.

    However, despite these efforts, the letter points out the challenges posed by a burgeoning illegal vape market in Florida, with the state being the primary destination for sales of illicit vapor products in the U.S. The vape maker also expressed readiness to assist Florida legislators in formulating policies that foster a well-regulated market for legal vapor products.

  • FDA Issues MDO for Tobacco-Flavored Bidi Stick

    FDA Issues MDO for Tobacco-Flavored Bidi Stick

    The U.S. Food and Drug Administration has issued a marketing denial order (MDO) to Bidi Vapor LLC for its Bidi Stick classic e-cigarette. The Bidi Stick is a closed-system, disposable, tobacco-flavored vaping device.

    “FDA has a key role to protect the public from the dangers of tobacco use,” said Matthew Farrelly, director of the Office of Science within FDA’s Center for Tobacco Products (CTP). “Integral to that role, our tobacco application review process relies on scientific evidence that demonstrates a product provides a net benefit to public health that outweighs the known risks. The science in this application did not show that.”

    The company must not market or distribute this product in the United States or they risk FDA enforcement action. The company may submit a new application to the agency for review that addresses these deficiencies.

    After reviewing the company’s PMTA, the FDA determined that the application lacked sufficient evidence to demonstrate that permitting marketing of the product would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act, an FDA press release states. Specifically, evidence submitted by the applicant did not demonstrate an overall net benefit to people who use tobacco products and lacked sufficient evidence to address health risks.

    “The Center has made considerable progress in reviewing the massive volume of tobacco product applications submitted to the agency, thanks to the tireless efforts of our dedicated legion of civil servant scientists,” said Brian King, director of the CTP. “The Center remains committed to processing submitted applications as expeditiously as possible while ensuring the utmost scientific integrity of the reviews.”

    Kavial Brands, the manufacturer of Bidi Stick, is expected to appeal the decision.

    China-based Shenzhen IVPS, the parent to SMOK brand vaping devices, filed an appeal with the New Orleans, Louisiana-based U.S. Court of Appeals for the Fifth Circuit after it received an MDO and was joined in the suit by a Dallas, Texas-based distributor of the SMOK products that were denied marketing.

    on Jan. 3, the U.S. Court of Appeals for the Fifth Circuit ruled that the FDA acted “arbitrarily and capriciously” in rejecting the premarket tobacco product applications (PMTA) of Wages and White Lion Investments, doing business as Triton Distribution, and Vapetasia for approval to sell their products in the United States.

    The 9-5 decision by the New Orleans-based 5th U.S. Circuit reversed a July 2022 decision by a three-judge panel of that court.

    The agency “sent manufacturers of flavored e-cigarette products on a wild goose chase,” telling them what would be needed to approve their products, and then denying all applications, the court said in an opinion by Judge Andrew S. Oldham. The FDA “never gave petitioners fair notice that they needed to conduct long-term studies on their specific flavored products,” Oldham wrote.

  • COP Must Respect Science, Consumers: Tax Group

    COP Must Respect Science, Consumers: Tax Group

    Martin Cullip

    The Taxpayers Protection Alliance’s (TPA) Consumer Center accused the World Health Organization Framework Convention on Tobacco Control of ignoring science and the rights of consumers in its pursuit of restrictive tobacco control measures, as the global body prepares for its 10th Conference of the Parties (COP10) this year.

    Martin Cullip, an international fellow at TPA issued the statement criticizing the WHO FCTC’s focus on policies known as MPOWER, which rely solely on restrictions on the supply and demand of tobacco products while ignoring other proven measures to help smokers quit.

    “While the WHO has had some success in the past, it is far from effective,” Cullip said. “Twenty years ago, when the FCTC treaty was first implemented, there were around 1 billion smokers worldwide and this number is not changing meaningfully.”

    Cullip said that despite decades of WHO’s restrictive tobacco control policies, most countries are not reducing smoking fast enough and will miss the WHO’s target to reduce smoking rates by 30 percent.

    He said the current approach focusing on control and restrictions, hasn’t delivered on its intended outcomes. “International treaties should have three main aims: grow global membership, encourage parties to implement measures consistent with the aims of the treaty, and measure outcomes as a result of its actions,” he said. “The WHO FCTC does the first two effectively, but not the third one at all.”

    “It is the lack of regard for outcomes which has led to many, including former WHO health directors, to declare that its approach is ‘not fit for purpose,’” he added.

    Cullip said the WHO’s focus had shifted from tackling the harms of tobacco smoke to fighting nicotine itself. “It seems that reducing death and disease is not an objective for them,” he said. “Their approach has changed to an attack on nicotine, which on its own, causes very little harm, instead of combustible tobacco, which kills.”

    He blamed the WHO’s “anti-scientific position” for the rise in global smoking rates, which leave smokers confused and more likely to carry on smoking rather than considering safer products that don’t burn tobacco.

    Cullip also criticized the WHO’s alleged disregard for harm reduction strategies, which seek to reduce harm for those who won’t abstain from tobacco use.

    He said the WHO has consistently failed to respect article 1(d) of the FCTC which includes “harm reduction strategies” as one of the main pillars of tobacco control.

    “Instead, the WHO promotes prohibition. Despite the abject failure of the war on drugs and any other prohibition in modern history, the WHO chooses to wage the war on nicotine. These recommendations distract countries from implementing measures that can improve the lives of their populations,” he said.

    Cullip said the WHO’s process excludes public participation and disregards consumer rights, violating the spirit of the Ottawa Charter which emphasizes individual control over health choices.

    “It is well past time the WHO FCTC process listened to the public it is supposed to serve,” he said. “The evidence in favor of harm reduction is increasing, and the WHO cannot ignore stakeholders who are central to the debate forever.”

    Cullip called on the WHO FCTC to embrace all approaches in its policy discussions, honestly assess evidence and allow for greater public participation to achieve effective tobacco control strategies.

    He also suggested that countries explore alternative methods beyond those dictated by the WHO to address their individual smoking challenges.

    “Keeping doing more of the same and hoping for a different outcome is insanity. The number of smokers won’t go meaningfully down unless the WHO recognizes that a change is needed. Safer nicotine products are not the enemy, it is smoked tobacco,” he said.