Category: Global Regulation

  • NZ Minister Grilled Over Oral Nicotine Plan

    NZ Minister Grilled Over Oral Nicotine Plan

    Associate Health Minister Casey Costello faced sharp questioning at a select committee over the government’s proposal to allow oral nicotine products such as snus and pouches. Costello, who, according to Radio New Zealand, has had to repeatedly deny allegations of an overly cozy relationship with the tobacco industry, said the move is part of a harm-reduction approach and is still subject to safety controls and measures to prevent youth access.

    Labour’s Dr. Ayesha Verrall warned the products could fuel new addiction among young people, pressing Costello to accept expert advice to introduce them only if proven safer and effective at reducing smoking. Costello said the recommendations are still being considered. Public health researcher Dr. Jude Ball said there is no evidence oral nicotine products help smokers quit and warned that tobacco companies are aggressively pushing them to expand youth uptake.

  • We are no longer in the world of ‘unintended consequences’ – Why Restricting Vape Flavors Risks Driving Smokers Back to Cigarettes

    We are no longer in the world of ‘unintended consequences’ – Why Restricting Vape Flavors Risks Driving Smokers Back to Cigarettes

    By Markus Lindblad, Head of External Affairs, Haypp Group

    Across the world, governments are introducing increasingly tough policies to reduce smoking rates amongst adult populations and prevent young people from accessing nicotine products. 

    In the UK, we have the introduction of one of the strongest pieces of anti-tobacco legislation in the world with the Tobacco and Vapes Bill. This will introduce a generational smoking ban, making it illegal to sell tobacco products to anyone born after 1 January 2009. Other measures included in the bill include the introduction of a licensing scheme for the retail of tobacco and nicotine products and new limits on the advertising and promotion of nicotine products. 

    Many of the measures proposed in the bill will indeed help the UK make progress towards a smoke-free future, and prevent youth access to nicotine products, however, others are almost certain to be counterproductive and lead to bad outcomes. 

    Foremost among these is a clause granting the Secretary of State powers to restrict the flavor of tobacco and nicotine products. I believe that using these powers to ban flavors would be a mistake. There are legitimate concerns about youth access to vapes or nicotine pouches, and there is a consensus that this issue needs to be addressed, but the international evidence shows us that restricting flavors is not the way to go about it. 

    Over the past two years, we have seen the publication of results from a number of large-scale studies on the impact of flavor bans at the state level in the USA. The results should give policymakers pause. 

    A study published this year in the Journal of the American Medical Association examined how flavor bans in seven U.S. states affected tobacco use. Researchers looked at data from 2013 to 2023 and found that while flavor restriction policies were associated with some reductions in e-cigarette use, there were also increases in cigarette use. 

    A 2024 study from the USA examined a dataset of 376,963 young adults (age 18 to 29 years) and found that state restrictions on flavored vape sales were associated with a 3.6 percentage point reduction in daily vaping, but also a 2.2 percentage point increase in daily smoking among young people. This increase in smoking rates, the authors highlight, potentially offsets any public health gains that might have been achieved by the flavor ban.

    Additional research from the Yale School of Public Health paints a similar picture. Using retail sales data from 44 US states, researchers discovered that following the introduction of flavor restrictions, cigarette sales rose as vape sales declined. In other words, when states restrict the availability of flavored vapes, they inadvertently push some smokers back to cigarettes, a behavior that is much worse in terms of health outcomes. 

    In each case, the intended outcome was to reduce vaping, but there was an unintentional increase in cigarette smoking. This is not a hypothetical outcome; it is observable and measurable in the data in each of the studies.

    The public debate around vape flavors often focuses on youth appeal, but it overlooks a critical dimension: the importance of flavors in helping adult smokers quit and stay smoke-free. Flavors aren’t just a marketing tool; they are a behavioral and psychological aid that help smokers make the transition away from cigarettes. 

    Our own research at Haypp underscores this point clearly. In a recent survey of 500 UK vapers, nearly one-third (30%) said that taste is one of the main advantages of vapes compared with other nicotine products. 28% said that flavor is the most important factor they consider when choosing a vape. These are not marginal preferences; they are decisive drivers of behavior. When asked how they would respond if a flavor ban were introduced, only 26% of vapers said they would continue to vape, while almost as many, 24%, said they would switch back to cigarettes. This finding should alarm anyone concerned with public health. It suggests that for UK vapers, a flavor ban may push a significant proportion of them back to a much more dangerous habit.

    Flavors also play a deeper psychological role in the process of smoking cessation. They help define the difference between smoking and alternative nicotine use, providing a sensory boundary that supports behavioral change. When a smoker switches to vaping, the experience of flavor, combined with the absence of smoke and tar, creates a sense of progress and separation from the old habit. Removing that variety reduces satisfaction, increases relapse risk, and ultimately undermines harm-reduction goals.

    The challenge for policymakers, then, is not whether to act but how to act responsibly. Blanket bans may appear decisive, but they are blunt instruments that often produce counterproductive outcomes. Given the breadth of evidence now available, we are no longer speaking about unintended consequences. The data shows that a ban on flavors will most likely lead to an increase in smoking rates. A more effective approach would focus on strict enforcement of age-verification measures, strict rules on responsible marketing, and clear product labelling, measures that address youth access directly without depriving adult smokers of an effective tool to quit. Youth access needs to be tackled, but we need to remember that for a smoker trying to quit, flavors are not a loophole; they are a lifeline. 

  • FDA Launches Web-Based PMTA Forms

    FDA Launches Web-Based PMTA Forms

    Today (December 3), FDA launched web versions of four forms in CTP Portal Next Generation (CTP Portal NextGen) for applicants submitting and amending premarket tobacco product applications (PMTAs) and Substantial Equivalence (SE) Reports. FDA transitioned from CTP Portal to CTP Portal NextGen—a “new, improved web portal” for submitting tobacco product applications electronically—in early 2025. The web forms allow applicants to create, validate, and submit PMTA and SE Report submissions directly through CTP Portal NextGen.

    The web-based forms include Forms FDA 4057, 4057a, 3965, and 3965a. Industry stakeholders with active CTP Portal accounts had the option to test and provide feedback on the new web functionality of the forms during online development. Creating these web-based forms is part of FDA’s work to promote efficiency, effectiveness, and transparency to improve its tobacco product application review process.

    According to the FDA, the new portal includes step-by-step instructions on completing the forms; a more user-friendly interface that helps guide applicants through the submission process; the ability for multiple users to work on a submission at the same time and easily save drafts; and real-time, automatic validation, ensuring all required fields are completed before submission.

    PDF versions of FDA’s PMTA and SE Report forms will remain available for applicants who choose not to use the web-based versions. These PDFs can still be downloaded and submitted electronically through CTP’s Document Control Center or uploaded via eSubmitter. FDA has also released updated PDF versions of Forms 4057, 4057a, 3965, and 3965a, correcting minor technical issues since their original posting in June 2025. Beginning Jan. 2, 2026, applicants using PDF forms must use these updated versions. Failure to use the current forms — or to complete them correctly — will generally result in FDA refusing to accept the application.

  • 5th Circ. Grills FDA on PMTA Rules

    5th Circ. Grills FDA on PMTA Rules

    A Fifth Circuit panel questioned the U.S. Food and Drug Administration this week, raising doubts about whether it properly considered the impact of its 2021 rule requiring premarket authorization for new tobacco products on small businesses. According to Law 360, the judges questioned whether the agency complied with the Regulatory Flexibility Act, which mandates that regulators assess how new rules affect smaller firms. Vape companies argue the FDA relied on outdated economic data and imposed disproportionate costs that could drive many small manufacturers out of the market.

    During oral arguments in New Orleans, the panel pressed the FDA on its shift in position between 2016 and 2021, when the agency moved from a more flexible approach to requiring extensive scientific evidence for new products. The judges also asked whether the health risk information requirements were discretionary or mandated by the Tobacco Control Act. The skepticism suggests the court is weighing whether the FDA’s rulemaking process adequately accounted for the realities faced by small vape businesses.

    The case comes amid broader challenges to the FDA’s handling of Premarket Tobacco Product Applications (PMTAs), including disputes over flavored e-cigarette denials. If the Fifth Circuit finds the FDA violated the Regulatory Flexibility Act, the agency could be forced to revisit its rulemaking, potentially easing compliance burdens for smaller companies.

  • Korea Labels Synthetic Nicotine as ‘Tobacco’

    Korea Labels Synthetic Nicotine as ‘Tobacco’

    South Korea’s National Assembly passed a major amendment to the Tobacco Business Act yesterday (December 2), closing a long-criticized loophole by classifying liquid e-cigarettes that use synthetic nicotine as “tobacco.” The tobacco law change was part of a broader package of 79 livelihood-related bills and 16 budget measures passed during the session.

    Officials say the move addresses a regulatory blind spot that allowed widespread use of synthetic nicotine—which they said accounts for 95% of the market— without taxation or consistent public health controls. Lawmakers expect the change to generate roughly 930.1 billion won ($632 million) in new tax revenue once implemented. The measure had stalled repeatedly since 2016 “due to industry opposition,” but this time cleared the plenary session with bipartisan support.

  • EU Document Leak Raises Questions Over COP11 Push

    EU Document Leak Raises Questions Over COP11 Push

    According to The European Times, industry observers are questioning the EU’s conduct at the WHO’s COP11 meeting after a leaked document showed Brussels pushing for far stricter language on novel nicotine products than member states had approved.

    “A leaked internal document later revealed that EU officials had encouraged the delegation to support language promoting prohibitions or strict limitations on all novel nicotine products,” the article said. “Once the document circulated among delegations, several member states described the situation as a procedural breach and questioned whether the Commission and the Danish EU Council Presidency were attempting to secure outcomes in Geneva that lacked consensus among governments at home.”

    WHO officials and aligned NGOs advocated sweeping restrictions on vapes, heated tobacco, and nicotine pouches, including flavor limits, packaging rules, environmental mandates, and broader liability tools. According to the leaked text, EU officials privately urged support for prohibitions or severe limits on manufacturing, import, sale, and use of all emerging nicotine products—despite such wording having been removed from the EU’s formal mandate during internal negotiations.

    Many of the most restrictive COP11 proposals were ultimately scaled back or made voluntary, with broader measures postponed to COP12 in 2027. However, the controversy has intensified scrutiny over the EU’s role within WHO processes and the transparency of its negotiations on nicotine policy, according to The European Times.

  • Uzbekistan Imposes Harsh Criminal Penalties on E-Cigarette Trade

    Uzbekistan Imposes Harsh Criminal Penalties on E-Cigarette Trade

    Uzbekistan enacted strict amendments to its Criminal Code, introducing severe penalties for the import, export, production, and sale of e-cigarettes and other nicotine-containing devices, according to local media reports. The nationwide ban now criminalizes all forms of circulation, including purchase, storage, and transportation. Large-scale violations or repeat offenses after administrative penalties can result in fines, corrective labor, restrictions of freedom, or up to five years’ imprisonment.

    Authorities say individuals may avoid prosecution if they self-report and surrender prohibited products voluntarily.

  • India Proposes New Taxes on Tobacco and ‘Sin Goods’

    India Proposes New Taxes on Tobacco and ‘Sin Goods’

    India’s government introduced two new tax bills today (December 1) aiming to maintain high levies on tobacco and other “sin goods” after the Goods and Services Tax (GST) compensation cess expires next year. The Central Excise (Amendment) Bill 2025, proposes excise duties of 60–70% on such products, with cigarette taxes calculated by length and filter type. Finance Minister Nirmala Sitharaman said the GST compensation cess on tobacco will end once all related loan and interest obligations are cleared. A second bill would impose a fixed monthly levy on pan masala and other notified goods.

    The revenue is expected to fund health programs and national security while keeping high-risk products expensive to discourage consumption and reduce under-reporting. Both bills require manufacturer registration, including for small-scale and handmade producers.

    The legislation is part of a broader tax realignment and will next go to parliamentary panels for review before a likely vote in 2026.

  • Russian Deputies Call for Complete National Vape Ban

    Russian Deputies Call for Complete National Vape Ban

    A group of State Duma deputies proposed amendments to completely ban the sale of vapes and e-liquids in Russia, while also introducing stricter penalties for illegal trafficking and involving minors in nicotine use. The amendments, prepared by deputies led by Yaroslav Nilov, Yana Lantratova, and Nina Ostanina, have been submitted for consideration to relevant working groups and reviewed by RBC.

    The proposal is linked to the second reading of a bill on licensing the retail trade in tobacco and nicotine products. Deputies highlighted that the ban aligns with President Vladimir Putin’s call for radical measures to protect children and young people from vaping risks. The amendments were sent to multiple inter-factional working groups focusing on public health, moral education, and the protection of traditional Russian values.

    The initiative has been framed as a long-overdue measure to safeguard public health, according to Lantratova, who emphasized that partial restrictions are insufficient. The current bill, submitted by the government in September 2025, sets a licensing framework for retail sales of tobacco and nicotine products, with unlicensed sales prohibited from September 1, 2026, and a transition period until September 1, 2027. The Ministry of Finance has also proposed giving regional authorities the power to impose local bans on vape sales, notifying the Federal Service for Alcohol Tobacco Control accordingly.

  • Korean Lawmakers Advance Bill to Reclassify Synthetic Nicotine

    Korean Lawmakers Advance Bill to Reclassify Synthetic Nicotine

    South Korea’s National Assembly Judiciary Committee on November 26 approved an amendment to the Tobacco Business Act that would classify liquid and synthetic-nicotine e-cigarettes as tobacco, closing long-criticized regulatory gaps. The measure heads to a plenary vote on November 27 after nearly a decade of debate.

    The bill expands the definition of cigarettes to include products “manufactured from nicotine,” while excluding pharmaceutical nicotine products. To protect existing vape retailers from abrupt shutdowns, it grants a two-year suspension of distance rules for newly designated tobacco shops and urges government support for workers transitioning out of the sector.

    Lawmakers also recommended considering temporary tax relief as the new classification takes effect. Revisions made in committee shorten the rollout period to four months, require risk assessments for existing inventory, and set the taxable moment at manufacture or import.

    Finance Minister Koo Yoon-cheol said the government will begin risk assessments ahead of implementation to minimize disruption.