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Category: Global Regulation

  • 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.

  • FDA Tightens Oversight on Vape, Pouch Imports

    FDA Tightens Oversight on Vape, Pouch Imports

    The FDA has updated import alerts 98-07 and 98-06 to strengthen the regulation of unauthorized e-cigarettes and other tobacco products entering the country. The changes clarify that all new vapor products must have FDA authorization to be marketed legally in the U.S. Under Import Alert 98-07, unauthorized vapor imports may face detention or refusal of entry without physical examination. The update also provides clearer guidance for importers, customs brokers, and federal partners, including links to the FDA’s searchable database of authorized tobacco products.

    Import Alert 98-06 focuses on non-e-cigarette tobacco products, including smokeless tobacco and nicotine pouches such as NOIS, LYFT, and SKRUF. These products, like vapor products, may also be detained if unauthorized. The FDA emphasized that mis-declared products remain a key focus, citing the seizure of three million units of unauthorized vapor products worth $76 million in collaboration with U.S. Customs and Border Protection. To date, the FDA has authorized only 34 vapor products and devices, underscoring its commitment to enforcing compliance and preventing illegal products from entering the market.

  • Latvia: Tobacco Sellers Look for Loopholes in New Regulations

    Latvia: Tobacco Sellers Look for Loopholes in New Regulations

    Tobacco sellers in Latvia are reportedly looking for loopholes in the new regulations that go into effect this month, according to Euro News.

    Beginning January 2025, tobacco products, including disposable vapes, refillable e-cigarettes, and nicotine pouches, cannot be sold to individuals under 20 years old, and vaping products can no longer have flavors other than tobacco. The amount of nicotine in nicotine pouches will also be reduced.

    According to Latvijas Televizija, a Latvian public television channel, companies selling refill cartridges are looking for ways to circumvent the new rules and continue selling the same products—some are planning to sell separate bottles of flavoring and nicotine that customers can mix themselves.

    “Certainly, after the new year, there will be alternatives that can be offered to the client, but they will not have such a wide range. Let’s increase the range bit by bit and, after some time, it will definitely be bigger,” said Jakaterina Smirnova, representative of e-cigarette company Ecodumas.

    “I assume that, similarly to other products, relatives and friends who travel will be able to bring them [the banned products] from abroad. Like all illegal things, Telegram trading will probably also develop. And it’s hard to stop,” said Anrijs Matiss, a board member of the Traditional and Smokeless Tobacco Products Association.

    The association estimates a state budget loss of €10 million annually following the new laws.

    The nicotine pouch industry expects that products will disappear from retail shelves, at least temporarily.  

  • Milan Bans Outdoor Smoking

    Milan Bans Outdoor Smoking

    Milan has banned smoking in outdoor and public areas, effective Jan. 1, 2025, reports Euro News.

    The ban includes “all public spaces, including streets” but provides an exception for isolated spaces as long as smokers maintain a distance of at least 10 meters from other people. Those caught violating the ban face fines ranging from €40 to €240.

    The ban aims to improve the city’s air quality and protect the health of citizens from secondhand smoke. Milan is one of Europe’s most polluted cities in terms of air quality.  

    The new law does not apply to electronic cigarettes, however.

  • Iowa Vape Companies Sue to Block Registry

    Iowa Vape Companies Sue to Block Registry

    A group of e-cigarette and vaping product distributors and retailers is suing the state of Iowa to block enforcement of a new law set to take effect in February.

    Alternatives to Smoking and Tobacco Inc., Global Source Distribution, Triton Distribution, Smokin Hot, Central Iowa Vapors WDM, and Route 69 Vapor filed the lawsuit in the U.S. District Court for the Southern District of Iowa.

    The companies allege that House File 2677 violates the supremacy clause and equal protection clause of the U.S. Constitution as well as the equal protection clause of the Iowa Constitution.

    State records show House File 2677 was introduced on March 27, 2024, with backing from lobbyists for R.J. Reynolds and other tobacco companies. Lobbyists for the American Cancer Society Action Network declared their opposition to the bill within two days, according to Iowa Capital Dispatch.

    The bill was approved in the Iowa House on April 3, 2024, and in the Iowa Senate on April 19, 2024. Governor Kim Reynolds signed it into law on May 17, 2024.

    The law stipulates that manufacturers whose electronic nicotine-delivery systems—more commonly known as electronic cigarettes, e-cigarettes, and vaping products—are sold in Iowa must certify that their products “have received a marketing authorization” from the Food and Drug Administration or that their applications for authorization were filed by September 2020 and are still under review.

    The Iowa Department of Revenue is then tasked with producing a publicly accessible directory listing all certified vaping products—at which point any retailer selling products not on the registry is subject to fines or other enforcement action.