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Category: Global Regulation

  • U.K. Stores Debate Definition of “Tobacco Product”

    U.K. Stores Debate Definition of “Tobacco Product”

    Sainsbury’s and Morrisons, the second and fifth largest supermarket chains in the U.K. respectively, are being accused by the Chartered Trading Standards Institute (CTSI) of displaying ads for “tobacco products” in their stores, a violation of a law passed in 2002.

    Video screens and posters at the stores promote devices that deliver nicotine by heating tobacco rather than burning it, products that the two stores say are not covered under the advertising law.

    Previously, Japan Tobacco International, which makes heated devices, said the 2002 law defines a tobacco product “as something that is smoked, sniffed, sucked, or chewed,” and because heated tobacco products do not produce smoke, they aren’t covered by that definition. The supermarkets used the same argument, with a statement from Morrisons saying, “On that basis, we are comfortable that it is legal for heated tobacco products to be advertised in store.”

    CTSI says the issue has never been tested in court, so it cannot say conclusively that running the ads is illegal.

    “The only people who can definitively test it are the courts,” said Kate Pike, lead officer for tobacco and vaping at CTSI. “Now the courts are chocka. Trading Standards is very stretched, and I think that’s probably the reason why you’re seeing more and more of these ads.”

    A spokesperson for the government would not weigh in on the current debate but said a forthcoming bill would expand the ban to all advertising of nicotine and tobacco products including nicotine pouches and vapes.

    “This government’s landmark Tobacco and Vapes Bill will enhance existing legislation, including on advertising, and put us on track for a smoke-free UK,” the spokesperson said.

  • Denmark Goes All-In on Action Plan

    Denmark Goes All-In on Action Plan

    Health concerns are growing in Denmark as a reported 36% of people between the ages of 15 and 29 use at least one tobacco or nicotine product. To combat this, Denmark has enacted the entirety of a 30-point action plan aimed at protecting youth from using nicotine products and alcohol. The original plan was proposed in November 2023 and implementation of about half its point began in April 2024. The final 16 measures were recently approved and are beginning to be implemented.

    Some of the new measures include:

    • Penalties for selling tobacco and nicotine products that are illegal to market in Denmark and for selling tobacco, nicotine products, and alcohol to minors are being increased, with fines starting from €6,700.
    • The Danish Safety Technology Authority can permanently confiscate illegal tobacco and nicotine products without a court order.
    • In some situations, the authority can temporarily deprive retailers of the right to market tobacco and nicotine products.
    • The authority can use fictitious profiles and go undercover to search for sellers or ads marketing illegal goods on social media.
    • Beginning in July, appealing flavors—defined as tobacco or menthol—and scents in tobacco substitutes, such as nicotine pouches, will be banned.
  • FDA Tobacco Case Heads to Supreme Court

    FDA Tobacco Case Heads to Supreme Court

    The Supreme Court will hear oral arguments on Tuesday in a clash between RJR Vapor and the U.S. Food and Drug Administration (FDA) centered around the rules in which the FDA can be challenged in court. The FDA argues that the Tobacco Control Act allows cases to be argued in one of three areas: in the D.C. Circuit, in the place where the plaintiff resides, or in the place where it has its principal place of business. RJR Vapor, a subsidiary of British American Tobacco based in North Carolina, however, is trying to challenge the FDA in the conservative U.S. Court of Appeals 5th Circuit based in Louisiana.

    RJR Vapor filed a petition for review along with Avail Vapor, a Texas retailer, and by a trade association for Mississippi gas stations and convenience stores that sell RJR Vapor’s products— states that reside in the 5th Circuit. RJR’s North Carolina home resides in the 4th Circuit, which had previously turned their appeal against the FDA denial of applications aside. The 5th Circuit, however, previously ruled against the FDA denials, saying the government agency was sending companies on “a wild goose chase.”

    RJR Vapor and the retailers argue the law states “any person adversely affected” can challenge the FDA, to include retailers within the 5th Circuit trying to sell RJR Vapor’s popular menthol-flavored Vuse brand e-cigarettes who could potentially go out of business. In 2016, the FDA rejected RJR Vapor’s application, saying the product would not be “appropriate for the protection of the public health.”

    The FDA argues that its rulings are “always or nearly always” regulating the manufacturer and that any effects on retailers are indirect and thus irrelevant, and that allowing this case in the 5th Circuit would allow “ready evasion” and create incentives for “forum-shopping.” The FDA contends the stakes are high in this case, as the 5th Circuit’s previous ruling would allow manufacturers to get around federal restrictions and cherry-pick the courts where its cases would be heard.

    The FDA approached the Supreme Court, and in October 2024, it agreed to hear the case. RJR Vapor argues the Supreme Court doesn’t have the authority to rule over “non-final” cases like this one to begin with, and wants the case dismissed without decision.

  • FDA Authorizes 20 ZYN Pouch Products

    FDA Authorizes 20 ZYN Pouch Products

    Today, the U.S. Food and Drug Administration (FDA) authorized the marketing of 20 ZYN nicotine pouch products through the premarket tobacco product application (PMTA) pathway following an extensive scientific review. This is the first time the agency has authorized products commonly referred to as nicotine pouches, which are small synthetic fiber pouches containing nicotine designed to be placed between a person’s gum and lip. 

    The FDA determined that the specific products receiving marketing authorization met the public health standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. This standard considers the risks and benefits of products to the population as a whole.

    “As a public health scientist and former Director of the Office of Science at FDA’s Center for Tobacco Products, I couldn’t be more excited for public health with FDA’s decision today,” Matt Holman, vice president of U.S. Scientific Engagement and Regulatory Strategy at PMI said on X. “Authorizing products that can help the nearly 30 million smokers in the United States switch to a better form of nicotine has the potential to save countless lives.”

    Among several key considerations, the agency’s evaluation showed that, due to substantially lower amounts of harmful constituents than cigarettes and most smokeless tobacco products, such as moist snuff and snus, the authorized products pose a lower risk of cancer and other serious health conditions than such products. The applicant also provided evidence from a study showing that a substantial proportion of adults who use cigarette and/or smokeless tobacco products completely switched to the newly authorized nicotine pouch products.

    “To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks,” said Matthew Farrelly, Ph.D., director of the Office of Science in the FDA’s Center for Tobacco Products. “In this case, the data show that these nicotine pouch products meet that bar by benefiting adults who use cigarettes and/or smokeless tobacco products and completely switch to these products.”

    Additionally, the FDA found that the applicant showed these nicotine pouch products have the potential to provide a benefit to adults who smoke cigarettes and/or use other smokeless tobacco products that is sufficient to outweigh the risks of the products, including to youth. As part of its evaluation, the FDA reviewed data regarding youth risk and found that youth use of nicotine pouches remains low despite growing sales in recent years. For example, the 2024 National Youth Tobacco Survey showed that 1.8% of U.S. middle and high school students reported currently using nicotine pouches.

    “It’s critical that the manufacturer market these products responsibly to prevent youth use,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “While current data show that youth use remains low, the FDA is closely monitoring the marketplace and is committed to taking action, as appropriate, to best protect public health.”

    While today’s actions permit these specific tobacco products to be legally marketed in the U.S. to adults 21 and older, it does not mean these tobacco products are safe, nor are they “FDA approved.” There is no safe tobacco product; youth should not use tobacco products and adults who do not use tobacco products should not start. 

    The FDA will closely monitor the marketing and use of these products. To reduce the potential for youth exposure to advertising of these products, the authorizations impose stringent marketing restrictions for digital, television, and radio, including measures to ensure ads are carefully targeted to adults ages 21 and older and the demographics of the audiences reached by the ads are tracked and measured by the manufacturer. The company also stated that they intend to implement additional measures to restrict youth access, reduce youth appeal, and limit youth exposure to their labeling and advertising, such as: not using mass-market advertising on radio and TV; employing actors/models for marketing that are no younger than 35 years old, or styled to appear under 35; and avoiding any content designed to target youth, including characters, images or themes. The agency may suspend or withdraw a marketing granted order issued under the PMTA pathway for a variety of reasons if the agency determines the continued marketing of a product no longer meets the necessary public health standard, such as if there is a notable increase in youth initiation.

    The products for which the FDA issued marketing granted orders are the following, each with two nicotine strengths (3 milligrams and 6 milligrams): ZYN Chill, ZYN Cinnamon, ZYN Citrus, ZYN Coffee, ZYN Cool Mint, ZYN Menthol, ZYN Peppermint, ZYN Smooth, ZYN Spearmint and ZYN Wintergreen. Importantly, today’s actions are specific to these products only; the authorizations do not apply to any other nicotine pouch or other ZYN products. Additionally, the authorization does not allow the company to make reduced-risk claims about the authorized products, which would require a modified-risk tobacco product application.

    Today’s actions are the latest of many the FDA has taken to ensure all new tobacco products marketed in the U.S. undergo science-based review and have received marketing authorizations by the agency. To date, the FDA has received applications for nearly 27 million products and has made determinations on more than 26 million of those applications. This includes authorization of other flavored oral tobacco products, including nicotine mints and chews in 2021 and mint smokeless tobacco in 2015. To find a list of tobacco products that may be legally marketed and sold in the U.S., visit the FDA’s Searchable Tobacco Products Database.

  • FDA Proposes Limiting Nicotine Levels

    FDA Proposes Limiting Nicotine Levels

    The U.S. Food and Drug Administration (FDA) today issued a proposed rule that, if finalized, would make cigarettes and certain other combusted tobacco products minimally or nonaddictive by limiting the level of nicotine in those products. If finalized, the United States would be the first country globally to take such a stand. The FDA first announced its intent to propose such a rule in 2018, and now intends to seek input on the proposal, including through public comment and the FDA’s Tobacco Products Scientific Advisory Committee.

    Nicotine is the primary addictive chemical in tobacco products that keeps people using the products. In the case of combusted products, such as cigarettes, nicotine addiction leads to users being repeatedly exposed to a toxic mix of chemicals in the smoke that cause disease and death. Based on the scientific evidence outlined in the proposed rule, the proposed nicotine level for cigarettes and certain other combustible tobacco products would be low enough to no longer create or sustain addiction. Importantly, a large body of research also shows that reduced nicotine content cigarettes do not lead smokers to compensate for lower nicotine by smoking more.

    “Multiple administrations have acknowledged the immense opportunity that a proposal of this kind offers to address the burden of tobacco-related disease,” said FDA Commissioner Robert M. Califf, M.D. “Today’s proposal envisions a future where it would be less likely for young people to use cigarettes and more individuals who currently smoke could quit or switch to less harmful products. This action, if finalized, could save many lives and dramatically reduce the burden of severe illness and disability, while also saving huge amounts of money. I hope we can all agree that significantly reducing the leading cause of preventable death and disease in the U.S. is an admirable goal we should all work toward.”

    Based on the FDA’s population health model, by the year 2100, this nicotine product standard could prevent approximately 48 million U.S. youth and young adults from starting smoking. The model also projects that more than 12.9 million people who smoke cigarettes would stop doing so one year after the rule becomes effective, including those who would completely switch to noncombusted tobacco products; this estimate increases to 19.5 million people within five years of the rule being finalized. Additionally, the model estimates that by the year 2060, the product standard would result in 1.8 million tobacco-related deaths averted, rising to 4.3 million deaths averted by the end of the century.

    The proposed rule would not ban cigarettes or any other tobacco products. The FDA is proposing to cap the nicotine level at 0.7 milligrams per gram of tobacco in cigarettes and certain other combusted tobacco products, which is significantly lower than the average concentration in these products on the market today. The FDA’s proposal would apply to cigarettes, cigarette tobacco, roll-your-own tobacco, most cigars (including little cigars, cigarillos, and most large cigars), and pipe tobacco. The proposed rule does not include e-cigarettes, nicotine pouches, noncombusted cigarettes (such as heated tobacco products that meet the definition of a cigarette), waterpipe tobacco (hookah), smokeless tobacco products, or premium cigars.

    “Today, we’re taking a critical step in the rulemaking process by providing the public with a proposal they can review and engage on,” said Brian King, Ph.D., director of the FDA’s Center for Tobacco Products. “This proposal allows for the start of an important conversation about how we meaningfully tackle one of the deadliest consumer products in history and profoundly change the landscape of tobacco product use in the United States.”

  • Taiwan: Legislator Criticizes Enforcement of E-Cig Ban

    Taiwan: Legislator Criticizes Enforcement of E-Cig Ban

    Since the March 2023 amendment to Taiwan’s Tobacco Hazards Prevention Act, which prohibits the sale, demonstration, and use of e-cigarettes, enforcement has been notably insufficient, according to one Taiwanese legislator. Chinese Nationalist Party (KMT) Legislator Wan Mei-ling highlighted that out of 500,000 e-cigarette-related cases, only 1,247 resulted in fines—a mere 0.25%.

    The fines issued include 251 for selling e-cigarettes, 619 for selling heated tobacco devices, and 404 for illegal use. Additionally, between July and September 2024, authorities confiscated 681 “zombie vapes” containing the anesthetic etomidate, averaging 227 per month. Etomidate, classified as a Category 2 narcotic, poses significant health risks, including adrenal insufficiency and impaired concentration, potentially leading to accidents.

    Wan[MM1]  emphasized the health dangers of e-cigarettes, particularly for adolescents, citing risks to brain development, lung damage, and increased cancer susceptibility. She called for enhanced inspections and public awareness campaigns to mitigate the societal impact of e-cigarettes and associated substances.

    In response, the Executive Yuan [MM2] reported that the High Prosecutors’ Office convened meetings with relevant ministries to discuss e-cigarette prevention and control. Efforts include intensified investigations into e-cigarettes laced with illegal drugs, collaboration with e-commerce and social media platforms to identify sellers, suspension of illegal websites, and tracking financial transactions to enforce the ban more effectively.

     [MM1]Is that the proper way to do the name?

     [MM2]Who? IS that a full name?

  • Ireland Introduces Licensing Fees to Combat Illicit Vape Sales

    Ireland Introduces Licensing Fees to Combat Illicit Vape Sales

    Starting February 2, 2025, Ireland will implement a new licensing system requiring retailers to pay annual fees to sell vaping and tobacco products. Retailers must pay €800 annually to sell vaping products and €1,000 for tobacco products, with tobacco-free nicotine pouches currently excluded from this regulation.

    The Health Service Executive will oversee compliance, conducting inspections to ensure adherence to the new rules. Licenses are subject to annual renewal, and retailers found in violation risk losing their ability to sell these products. Previously, selling tobacco required a one-time €50 fee, and no license was needed for vaping products.

    David Melinn, Country Manager at BAT Ireland, supports the licensing system, stating it will aid in enforcing the under-18 vape sales ban and prevent illegal vape sales. However, he expressed concerns over the exclusion of tobacco-free nicotine pouches from the legislation, hoping future amendments will address this oversight.

    The introduction of these fees is part of the Public Health (Tobacco Products and Nicotine Inhaling Products) Act 2023, reflecting Ireland’s commitment to regulating nicotine product sales and reducing underage access. The government anticipates that this measure will enhance public health by curbing the availability of illicit vaping products, particularly among youth.

  • FDA Proposes Landmark Rule to Limit Nicotine Levels in Cigarettes

    FDA Proposes Landmark Rule to Limit Nicotine Levels in Cigarettes

    The FDA is preparing to propose a rule to cap nicotine levels in cigarettes and certain other tobacco products to make them minimally or non-addictive. This effort aligns with the Biden administration’s broader public health goals to significantly reduce smoking rates, particularly among youth, and to curb tobacco-related illnesses and deaths. Tobacco use remains the leading cause of preventable death in the U.S., accounting for approximately 480,000 deaths annually.

    The proposed rule, part of the FDA’s comprehensive tobacco control strategy, is expected to face strong opposition from the tobacco industry and some policymakers. Critics argue that the move could unintentionally boost the black market for cigarettes and may not address existing addiction among smokers. Proponents, however, emphasize the measure’s potential to save millions of lives and reduce healthcare costs in the long term.

    This regulation, if implemented, would mark a historic step in tobacco control, as no other country has yet enforced nicotine limits in cigarettes to this degree. The FDA has been exploring such measures since 2009 when Congress gave it authority to regulate tobacco products under the Family Smoking Prevention and Tobacco Control Act. While the proposal is still in its early stages, public health advocates view it as a critical milestone in reducing the public health burden of smoking.

  • FDA Rule on Nicotine Content Clears OMB

    FDA Rule on Nicotine Content Clears OMB

    The Biden administration has moved closer to implementing a rule that would limit nicotine levels in cigarettes, with the proposal clearing an Office of Management and Budget review on Friday.

    Public health experts are optimistic about the potential impact. Studies suggest significantly reducing nicotine—by as much as 95%—could render cigarettes non-addictive, prompting many smokers to quit or transition to less harmful alternatives like e-cigarettes or nicotine pouches. Dorothy Hatsukami, a tobacco policy researcher, noted that minimally addictive cigarettes have shown promise in helping people quit smoking.

    However, critics warn of unintended consequences. Guy Bentley of the libertarian Reason Foundation argued that restricting nicotine levels could effectively ban cigarettes, fueling a black market and benefiting foreign entities.  “Biden’s ban is a gift with a bow and balloons to organized crime cartels with it, whether it’s cartels, Chinese organized crime, or Russian mafia. It’s going to keep America smoking, and it’s going to make the streets more violent,” said Rich Marianos, former assistant director of the U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives and the current chair of the Tobacco Law Enforcement Network.

    The future of the rule remains uncertain given the upcoming change of administration and the likelihood of litigation by industry.

  • FDA Issues Final Guidance on Testing Methods

    FDA Issues Final Guidance on Testing Methods

    The FDA has published final guidance for the tobacco industry on the “Validation and Verification of Analytical Testing Methods Used for Tobacco Products.” This guidance provides recommendations for tobacco manufacturers on how to generate validation and verification data for analytical methods supporting regulatory submissions, including Substantial Equivalence (SE) reports, Premarket Tobacco Product Applications (PMTA), and Modified Risk Tobacco Product Applications (MRTPA). It also applies to testing and reporting harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke.

    The updated guidance finalizes the draft issued in December 2021, incorporating comments received from stakeholders. Key changes include updates reflecting recent statutory revisions, such as the inclusion of synthetic nicotine under the definition of tobacco products, and clarifications on alternative validation procedures. The guidance also supports the use of national and international standard test methods and provides detailed recommendations on laboratory accreditation, statistical methods, and analytical test method validation, helping the industry produce more reliable and consistent data for regulatory purposes.