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Category: Global Regulation

  • Korea Weighs Raising Cigarette Prices as Smoking Rates Fall

    Korea Weighs Raising Cigarette Prices as Smoking Rates Fall

    South Korea is considering higher cigarette prices as conventional smoking rates continue to decline, according to The Seoul Economic Daily. The share of adults who smoke cigarettes fell to 17% in 2025 from 23.9% in 2016, according to the 2025 National Health and Nutrition Examination Survey released Sept. 30 by the Korea Disease Control and Prevention Agency. The smoking rate was 28% among men and 5.5% among women. The decline accelerated after the government raised the price of a pack to 4,500 won ($3.33) in 2015 from 2,500 won ($1.85).

    South Korea’s Ministry of Health and Welfare has included raising cigarette prices toward the OECD average as a medium- to long-term goal in its 6th National Health Promotion Master Plan for 2026-2030. Analysts say cigarette prices have since failed to keep pace with inflation, with consumer prices rising 22.8% since 2015 while cigarette prices remained unchanged. The average cigarette price across the 38 OECD member countries was 9,869 won ($7.30) in 2023, more than twice South Korea’s price.

  • FDA Streamlines Tobacco Product Registration and Listing Process

    FDA Streamlines Tobacco Product Registration and Listing Process

    The U.S. Food and Drug Administration on Sept. 28 launched a redesigned Form FDA 3741 that consolidates establishment registration and product listing submissions for all regulated tobacco product categories, including cigarettes, e-cigarettes, smokeless tobacco, heated tobacco products, and oral nicotine products such as nicotine pouches. The change replaces two previously separate forms, Form FDA 3741 and Form FDA 3741a, and is intended to simplify the process for manufacturers by eliminating the need to determine which form applies to different product categories.

    The redesigned form includes a submission checklist that directs manufacturers to the sections relevant to their filing and allows companies updating existing registrations to change specific information without resubmitting unchanged sections. The FDA is also encouraging manufacturers to use the new Form FDA 3741b spreadsheet for initial product-list submissions or additions to existing product lists. Domestic tobacco product manufacturers must submit annual establishment registrations by Dec. 31, while product listings are due June 30 and Dec. 31 when manufacturers have made certain changes to their products or manufacturing operations.

    The FDA said manufacturers should submit the redesigned Form FDA 3741 electronically through its Tobacco Registration and Listing Module Next Generation (TRLM NG) system, although paper submissions remain available for companies unable to file electronically. Existing registrations and product listings will remain in TRLM NG, and manufacturers do not need to resubmit their entire registration because of the change. The previous versions of Forms FDA 3741 and 3741a have been retired, with existing TRLM NG users receiving prompts to update registration and product-listing information using the new format.

  • NZ Proposes Tougher Penalties for Tobacco Smuggling

    NZ Proposes Tougher Penalties for Tobacco Smuggling

    New Zealand is proposing tougher penalties for tobacco smuggling and excise evasion, including increasing the maximum prison term from six months to seven years. The government also plans to introduce new offenses and fines for selling tobacco that does not comply with the country’s packaging requirements, including a fine of up to NZ$2,000 ($1,120) and a strict-liability penalty of up to NZ$200,000 ($112,000) for manufacturers, importers, and distributors. The maximum penalty for an existing knowledge-based packaging offense would increase from NZ$50,000 to NZ$100,000 ($28,000 to $ $56,000).

    The changes would be introduced through amendments to the Smokefree Environments and Regulated Products Act 1990. The government said Customs seized 12 million cigarettes and 1.7 tons of loose tobacco at the border between January and Sept. 1. The proposals would also align penalties for selling small quantities of tobacco with those for packaging offenses and strengthen consequences for specialist vape retailers that breach regulations.

  • Italy’s New Cigarette Prices Take Effect

    Italy’s New Cigarette Prices Take Effect

    Beginning today (Sept. 28), Italy implemented another round of tobacco price increases, with updated Customs and Monopolies Agency (ADM) price lists covering about 75 products, including cigarettes, cigarillos, cigars, and fine-cut tobacco, according to La Sicilia. Increases are as much as €0.30 per pack, with several Japan Tobacco International brands affected, including Camel, Winston, and Benson & Hedges. Examples cited by La Sicilia include Camel hard packs at €6.30, Winston at €5.80, and Benson & Hedges Gold at €6.80.

    The latest increases follow adjustments in January that affected Philip Morris brands, including Marlboro. The price changes are linked to Italy’s revised tobacco excise structure, which raises the fixed component of the cigarette excise duty from €32 per 1,000 cigarettes in 2026 to €35.50 in 2027 and €38.50 from 2028. Minimum tax charges for fine-cut tobacco and cigarillos are also scheduled to increase through 2028.

  • Türkiye Drafting Tobacco Control Bill That Includes Generational Ban

    Türkiye Drafting Tobacco Control Bill That Includes Generational Ban

    Türkiye is preparing legislation that would prohibit people born after Jan. 1, 2015, from using or selling tobacco products throughout their lives, according to Professor Toker Ergüder, who is involved in drafting the proposal. The Health Ministry has been preparing the legislation for about a year and is expected to submit it to Parliament in October. The draft would also tighten smoking restrictions in indoor and outdoor public spaces, introduce new cigarette packaging rules, eliminate slim cigarettes, and prohibit smoking in restaurant areas, while designated smoking areas would be established in parks and public-building grounds. The proposal also includes a longer-term plan to prohibit tobacco production and sales in Türkiye from 2040. Ergüder said annual cigarette sales increased from about 91,000 tons, or 4.5 billion packs, in 2012 to approximately 160,000 tons, or 8 billion packs, in 2025.

  • Trump Administration Looking to Change PMTA Process

    Trump Administration Looking to Change PMTA Process

    The Trump administration is reportedly preparing changes to the FDA’s review process for new tobacco products that could make it faster and easier for products such as flavored vapes and nicotine pouches to receive marketing authorization, according to The Wall Street Journal. The FDA is expected to revisit requirements established in 2021 for Premarket Tobacco Product Applications (PMTAs), following years of industry criticism over lengthy reviews.

    Reuters reported it could not independently verify the report, but quoted an HHS spokesperson as saying, “The Trump administration is committed to keeping nicotine out of the hands of kids, getting ⁠counterfeit vaping products off the streets and providing safer alternatives for adults who want to quit smoking cigarettes.”

    Industry groups and companies welcomed the potential changes. Laura Leigh Oyler, vice president of regulatory affairs at Haypp Group USA, said the FDA has not met congressional review deadlines for noncombustible products and has authorized fewer than 100 reduced-risk products compared with thousands of combustible products. “An overhaul isn’t just welcome, it’s necessary,” Oyler said, adding that the current process has contributed to the influx of foreign, illicit products.

    Charlie’s Holdings also supported the reported changes, saying it has been seeking FDA authorization for certain tobacco-derived nicotine e-liquids since 2020 and hundreds of synthetic nicotine products since 2022. CEO Henry Sicignano said the PMTA process has imposed high costs on smaller U.S. businesses while illicit products have entered the market. Charlie’s said it currently retains 678 timely filed PMTA assets and expects a streamlined authorization process to increase the value of its portfolio.

  • Germany to Discuss Annual Tobacco Tax Increases

    Germany to Discuss Annual Tobacco Tax Increases

    Germany’s Bundestag is scheduled to hold a first reading Sept. 24 of a government bill that would raise taxes on cigarettes, heated tobacco, e-liquids, fine-cut tobacco, and other tobacco products annually from 2027 through 2030. The proposal would increase the weighted average retail price of a 20-cigarette pack from about €8.05 currently to €8.77 in 2027 and €11.36 by 2030. The bill is expected to move to parliamentary committees after the debate.

    The government estimates the changes would generate €756 million in additional tobacco-tax revenue in 2027, rising to €3.589 billion annually by 2030. The German Association of the Tobacco Industry and Novel Products (BVTE), backed by BAT, JTI, Philip Morris, Reemtsma, and tobacco trade associations, has launched a campaign calling for lower and more predictable increases, citing concerns about legal-market sales and illicit trade.

  • Taiwan to Raise Penalties for Bringing in E-cigarettes

    Taiwan to Raise Penalties for Bringing in E-cigarettes

    Taiwan’s Ministry of Finance announced plans to raise penalties for illegally bringing e-cigarettes, heated tobacco products, and related components into the country. Amendments to customs anti-smuggling rules will remove the existing exemption from fines for tobacco-related products with a customs value of NT$5,000 ($160) or less, while fines for violations involving these products will be higher than those for most other controlled goods.

    Customs data show 1,346 e-cigarette seizures last year involving about 120,000 devices and 33,000 bottles or cartridges of e-liquid. In the first eight months of 2026, authorities recorded 726 cases involving 35,000 devices and 40,000 bottles or cartridges of e-liquid. Seized products will be confiscated, and individuals may be referred to local health bureaus, which can impose fines of at least NT$50,000 ($1,600) under Taiwan’s Tobacco Hazards Prevention Act.

  • Germany Busts Ring that Imported 7.6M Illegal Vapes

    Germany Busts Ring that Imported 7.6M Illegal Vapes

    German customs investigators announced over the weekend that they are investigating an alleged international network accused of illegally importing nicotine-containing disposable e-cigarettes from China and selling them on Germany’s black market. Authorities said the manufacturer structure allegedly imported more than 7.6 million disposable vapes between January 2024 and March 2025, resulting in an estimated €33.3 million in unpaid excise taxes.

    The investigation covers 23 defendants, including four employees of a Chinese e-cigarette manufacturer and 19 Germany-based individuals allegedly involved in receiving and reselling the products. Authorities executed 13 arrest warrants and seized more than 100 pallets containing about 600,000 illegal vapes, with estimated tax losses of €4 million. Investigators also seized four properties, a vehicle, luxury watches, gold jewelry, gold bars, cash valued at more than €2.25 million, and 37 bank accounts. The investigation is being led by the Essen Customs Investigation Office on behalf of the Düsseldorf Public Prosecutor’s Office. All defendants are presumed innocent unless convicted.

  • Maldives’ Cigarette Imports Likely to Jump

    Maldives’ Cigarette Imports Likely to Jump

    Maldives Customs Service data show that 48,881,100 cigarettes were imported between January and July 2026, following a sharp decline in cigarette imports after the government raised import duties. Imports fell from more than 338 million cigarettes annually to 76.2 million between 2021 and 2025, when more than MVR 1 billion ($65 million) in duties was collected. The import duty was increased to MVR 8 ($0.52) per cigarette in November 2024 as part of efforts to encourage tobacco cessation, but the government subsequently reversed the increase, reducing the duty to MVR 4 ($0.26) from July 2026.