TobaccoReporter logo

Blog

  • South Korea Tightening Tobacco Enforcement After Compliance Failures

    South Korea Tightening Tobacco Enforcement After Compliance Failures

    The Seoul Metropolitan Government launched tighter enforcement of South Korea’s revised Tobacco Business Act after inspections found widespread compliance failures among liquid e-cigarette retailers and significant weaknesses in vending machine age-verification systems. Between April 24 and June 23, authorities inspected 666 retailers and found that 28.5% operated vending machines. Of 415 machines examined, 339 used ID-based age verification, but 168 accepted forged or altered identification during testing, while 112 recognized every fake ID used.

     Inspectors also found inadequate youth warning signage and advertising violations, with many in-store advertisements visible from outside. The city said it will push for stronger ID verification requirements, require retailers to improve age-checking systems, distribute compliant warning labels, and continue inspections as liquid e-cigarette use continues to rise, particularly among adolescents, whose 2025 vaping rate exceeded conventional cigarette smoking for the first time.

  • Russia Adds New Laws for Tobacco Licensing

    Russia Adds New Laws for Tobacco Licensing

    Russian President Vladimir Putin signed legislation introducing a licensing system for the wholesale and retail sale of tobacco and nicotine products, with separate licenses required for each retail outlet and delivery vehicle. The new laws also clarify the method for determining exclusion zones around educational institutions where tobacco and vape sales are prohibited, while introducing criminal penalties that include fines and forced labor for large-scale wholesale or retail sales conducted without a license.

    The legislation also gives Russia’s regions the authority to ban the retail sale of vapes, e-liquids, and other electronic nicotine delivery systems under a five-year pilot program running from March 1, 2027, through March 1, 2032. Regions choosing not to participate will continue operating under the existing national regulatory framework, with the results of the pilot expected to inform future policy decisions.

  • Proposed UK Vape Rule Would Add £5 Deposit

    Proposed UK Vape Rule Would Add £5 Deposit

    A UK council backed a proposal to introduce a refundable deposit on vape devices sold in the city, aiming to improve disposal rates and reduce fires caused by discarded lithium-ion batteries. Under the plan by the Norwich City Council, consumers would pay an additional £5 when purchasing a vape and receive the money back upon returning the device. Council members said the scheme would help reduce cleanup costs, recycling contamination, and fire risks, while Norfolk Fire and Rescue Service said it supports measures that encourage the safe disposal of vapes and other lithium battery-powered products.

  • Maldives Reduces Cigarette Duty

    Maldives Reduces Cigarette Duty

    The Maldives Parliament approved government legislation cutting the import duty on cigarettes from MVR 8 to MVR 4 ($0.52 to $0.26) per cigarette, with the bill passing unanimously on July 1 without amendments. The measure was approved by 68 MPs after advancing through the Committee of the Whole Parliament, despite earlier heated political debate over the government’s reversal of the duty increase introduced in November 2024. Government lawmakers said the reduction reflects evidence that the country’s vape ban did not lead to a significant increase in cigarette smoking and supports its broader tobacco control strategy.

    The government said the duty reduction follows recommendations from the World Health Organization and forms part of a longer-term approach to sustainable tobacco control. Officials have indicated they will continue to review cigarette duty rates based on future research while maintaining other tobacco control measures introduced in recent years.

  • Cambodia’s NACD Calls for Shisha, Vape Suppression

    Cambodia’s National Authority for Combating Drugs (NACD) called for stronger enforcement against student use of vapes and shisha, with Chairman and Deputy Prime Minister Neth Savoeun directing authorities to eliminate gatherings where young people use the products in coffee shops and around schools. Speaking at the National Day Against Drugs last week, Savoeun urged provincial governors to take immediate action, warning that such activities threaten the future of Cambodia’s youth.

    Savoeun also emphasized the importance of education and prevention alongside law enforcement, encouraging students to reject drugs, e-cigarettes, and other harmful products while promoting anti-drug awareness in their communities. He further instructed authorities to respond more quickly to drug-related reports submitted through the government’s “No Drug” mobile application as part of broader efforts to combat drug crime.

  • Cyclone Publishes Nicotine-Free Vape, Pouch Data

    Cyclone Publishes Nicotine-Free Vape, Pouch Data

    Cyclone Pods published complete third-party laboratory test results for its nicotine-free vape and botanical pouch product lines, including the testing laboratories, analytical methods, and individual sample findings rather than summary data. The company said its Gust Pro and Lightning vape products were tested by ISO 17025-accredited Legend Technical Services using LC-MS/MS, with nicotine, diacetyl, and vitamin E acetate reported as not detected in 15 of 16 samples at the stated detection threshold. The company also disclosed the one sample in which a trace amount of nicotine was detected.

    Its Focus Pouches were tested by A2LA-accredited Certified Laboratories using ICP-MS and HPLC methods, with all pesticides and residual solvents reported as not detected, heavy metals measured at trace levels, and caffeine testing at 113% of the labeled amount. Cyclone Pods said the publication of complete laboratory reports, including methodologies and sample-by-sample results, is intended to provide greater transparency for retailers and consumers regarding its nicotine-free product portfolio.

  • Latvian Authorities Bust Illicit Cigarette Ring

    Latvian Authorities Bust Illicit Cigarette Ring

    Latvian authorities have dismantled an organized illegal cigarette operation, seizing 12.8 million counterfeit cigarettes, raw materials, manufacturing equipment, firearms, and luxury assets in raids centered in the Zemgale region. The cigarettes, packaged under brands including Marlboro, Winston, and NZ, were allegedly intended for the Latvian market. Police estimate the group’s activities resulted in more than €5 million in unpaid taxes. Two men have been arrested, a third suspect remains at large, and a pretrial investigation is ongoing.

    Source: Latvian Public Media

  • FDA Finally Issues Proposed Rule to Require Foreign Tobacco Manufacturers to Register Facilities and List Products

    FDA Finally Issues Proposed Rule to Require Foreign Tobacco Manufacturers to Register Facilities and List Products

    By Dean R. Cirotta, President EAS Consulting Group

    On June 29, 2026, the FDA published a proposed rule in the Federal Register – “Establishment Registration and Product Listing for Tobacco Products” (Docket No. FDA-2025-N-7130, RIN 0910-AH59). https://www.federalregister.gov/documents/2026/06/29/2026-13047/establishment-registration-and-product-listing-for-tobacco-products

    The proposed rule would add a new a new part (21 CFR Part 1108) that would specifically prescribe the format, content, and procedures for establishment registration and tobacco product listing for both domestic and foreign manufacturers of tobacco products.  The FDA based many of the requirements in this proposed rule on the recommendations and interpretations originally outlined in an FDA guidance for industry entitled “Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments” which was finalized and first issued on November 12, 2009.

    This rule would allow FDA to further protect the public health by helping to ensure that owners and operators of domestic and foreign establishments that manufacture tobacco products sold in, distributed in, and/or imported into the United States, are complying with Federal law, including FDA’s premarket authorization requirements. Information that would be required by the rule would enable FDA to better pursue enforcement actions against non-compliant tobacco products that have entered commercial distribution or await entry into commercial distribution, at the border.

    The FDA feels the proposed rule would offer the following benefits:

    • It would close a regulatory gap by requiring foreign tobacco manufacturers to register with FDA and list products intended for U.S. distribution.
    • It would improve FDA’s ability to identify manufacturers and products in the marketplace.
    • It would provide additional information to support enforcement actions against non-compliant and unauthorized tobacco products.
    • It would help combat the importation of illegal or unauthorized tobacco products.
    • It would create a more level regulatory playing field between U.S. and foreign manufacturers.
    • It would provide FDA with greater visibility into the global tobacco supply chain. 

    The primary driver of this rulemaking is a longstanding regulatory gap. Under the Family Smoking Prevention and Tobacco Control Act, domestic owners and operators of tobacco product manufacturing establishments are already required to register their establishments and submit product listings with FDA. However, foreign owners and operators are not subject to these requirements unless FDA issues specific regulations — which it has not done until now. This gap has left FDA without visibility into the foreign manufacturers supplying tobacco products to American consumers, including electronic nicotine delivery systems (ENDS) and e-cigarettes.

    Key Takeaways from the Proposed Rule:

    • The proposed rule would extend facility registration requirements to foreign establishments that engage in the “manufacture, preparation, compounding, or processing” of a tobacco product.
    • Foreign establishments would be subject to FDA inspection, a significant new compliance obligation for overseas manufacturers.
    • Foreign establishments would be required to submit product listing information identified for each tobacco product manufactured, prepared, compounded, or processed for commercial distribution.
    • The rule explicitly expands the definition of “manufacturer” to include specification developers (entities that design and control product specs), third-party/contract manufacturers, bulk tobacco product manufacturers, and repackagers/relabelers — meaning entities that outsource physical production, but control product design are not exempt.
    • Manufacturers would be required to submit information electronically through FDA’s online system, enabling them to register more quickly. Paper submissions would only be permitted via a formal waiver.
    • Domestic manufacturers must register within five business days of first engaging in manufacturing operations. Foreign manufacturers must register before any tobacco product manufactured at their establishment is imported or offered for import into the United States. Annual re-registration is required by December 31 of each year, with product listing updates required in both June and December.
    • Each listed product must include uniquely identifying information — brand and subbrand name, product category and subcategory, package type and quantity, characterizing flavors, nicotine source (tobacco-derived vs. non-tobacco derived), and nicotine concentration. ENDS products must also include e-liquid volume, battery capacity, and wattage.
    • The rule would require all manufacturers to maintain product labeling, advertising, and consumer information records for at least four years after their use, enabling FDA to verify compliance with labeling rules and check for marketing that targets youth or makes unauthorized health claims.

    For tobacco manufacturers, importers, and distributors, the proposed rule signals FDA’s continued focus on supply-chain transparency, imported product oversight, and enforcement against products that have not met applicable tobacco regulatory requirements.  

     Owners and operators of foreign facilities should consider the following:

    • Which sites and products will fall under this new rule
    • Are the sites prepared to host an FDA inspection
    • How will this affect the sites and the products they manufacture for the US market
    • Do they have all the product-specific information required by the new rule.
    • Do they have all the historical labeling, advertising and consumer information readily available
    • How will this affect their supply chain and importation of products into the US

    This proposed rule is clearly a priority, not only for the FDA, but also the administration, as the proposed rule references Executive Order 14212 and the Make America Healthy Again Commission’s 2025 strategy report, positioning the rule as part of broader administration efforts to crack down on illegal ENDS products and protect public health.

    The agency is asking for specific feedback and is accepting public comments before determining whether to issue a final rule. Therefore, companies should consider submitting comments. The public comment period closes on September 14, 2026. Comments can be submitted at Regulations.gov at

    Federal Register: Establishment Registration and Product Listing for Tobacco Products

    __________________________

    Dean Cirotta
    President, EAS Consulting Group

    Dean Cirotta serves as President for EAS Consulting Group, with management responsibility for all technical aspects of the company, including client relations and personnel. Prior to EAS’ acquisition by the Certified Laboratories family of companies, Dean served as Partner and President/COO of EAS from 2012-2019.

    Cirotta is a highly accomplished executive in the pharmaceutical and dietary supplement industries, including executive management roles overseeing regulatory affairs, compliance, quality assurance/control, operations, manufacturing, laboratory operations and financial and corporate management. Additionally, he has been actively involved in tobacco regulatory requirements for over 15 years, expanding EAS client services and cementing EAS’ reputation in the tobacco industry through the assessment of quality systems, implementation of quality systems in preparation for FDA Inspections and the anticipated TPMPs.

    Cirotta has over 35 years of experience in the FDA regulated industries. Prior to joining EAS, Mr. Cirotta was President and COO of UPM Pharmaceuticals, Leitner Pharmaceuticals and he served as Vice President of Global Regulatory Affairs for the pharmaceutical division of Bausch & Lomb.

  • FDA Issues MRTP Orders for 20 Zyn Products

    FDA Issues MRTP Orders for 20 Zyn Products

    The U.S. Food and Drug Administration issued Modified Risk Tobacco Product orders for 20 Zyn nicotine pouch products manufactured by Swedish Match USA, making Zyn the first nicotine pouch brand authorized to market reduced-risk claims compared with cigarettes. The FDA-authorized claim states that using Zyn instead of cigarettes lowers the risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis. The authorization applies to 10 Zyn flavors in both 3 mg and 6 mg nicotine strengths and builds on the products’ January 2025 authorization for sale through the FDA’s premarket tobacco product application pathway.

    The FDA said its decision followed an extensive scientific review of the products’ relative health risks, consumer understanding of the claim, youth use data, and overall population health impact. The agency concluded that the modified-risk claim is scientifically supported, that consumers understand its meaning, and that allowing the claim is expected to benefit public health. The authorization requires Swedish Match USA to conduct post-market surveillance and behavioral studies, and the orders will expire after five years unless renewed. The FDA also noted it retains the authority to withdraw the orders if continued marketing no longer benefits public health, including if youth uptake increases.

    Separately, Philip Morris International said the decision expands its portfolio of FDA-authorized modified-risk products, which also includes IQOS heated tobacco products and General snus. PMI U.S. CEO Stacey Kennedy said the authorization provides adult nicotine consumers with FDA-reviewed, science-based information about the health benefits of switching completely from cigarettes to Zyn.

  • DEA Backs Cannabis’ Medical Utility at Hearings

    DEA Backs Cannabis’ Medical Utility at Hearings

    Today (June 29), the U.S. Drug Enforcement Administration administrative law judge opened formal hearings to determine whether cannabis should be moved from Schedule I to Schedule III under the Controlled Substances Act. The proceedings, scheduled to run through July 15 with a brief Independence Day recess, stem from President Donald Trump’s December 2025 executive order and will determine whether Schedule III status should be extended to all cannabis, building on an April 2026 interim order that reclassified only FDA-approved cannabis products and state-licensed medical marijuana. A final rule extending Schedule III to all cannabis would provide broad tax relief to state-licensed operators by exempting them from the Section 280E federal tax provision.

    The hearings have drawn criticism from cannabis reform advocates, who protested outside DEA headquarters after the agency limited participation to organizations and individuals opposed to rescheduling, arguing that supporters did not meet the legal definition of an “interested person.” Advocacy groups, including Students for Sensible Drug Policy and NORML, criticized the exclusion of medical experts, legal cannabis businesses, and reform organizations, while also objecting to the DEA’s decision not to livestream the proceedings. Although the agency said it will publish transcripts after the hearings conclude, critics argued that the lack of real-time public access undermines transparency.