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Category: Around the Industry

  • FDA Rolls out New Features in CTP Portal to Assist Submission Process

    FDA Rolls out New Features in CTP Portal to Assist Submission Process

    Today (July 17), the U.S. Food and Drug Administration introduced new enhancements to its Center for Tobacco Products Portal NextGen, expanding its web-based submission system for premarket tobacco product applications and substantial equivalence (SE) reports. New features include the ability to upload folders and subfolders, label submission documents directly within the portal, and save contact information for future filings, reducing administrative burden and improving submission consistency. Based on user feedback, the updates are intended to streamline the application process for tobacco manufacturers and applicants.

    As part of the transition, the FDA will phase out eSubmitter for PMTA and SE submissions after Nov. 14, with applicants expected to use the web-based forms in CTP Portal NextGen. PDF forms will remain available for those unable to use the portal, while eSubmitter will continue to support other submission types, such as ingredient listings and harmful and potentially harmful constituent reports, until additional web forms are introduced. The agency said it plans to provide further training and guidance as it expands the portal’s capabilities.

  • Australia’s Tobacco Use Down, Pouches & Black Market Up: Survey

    Australia’s Tobacco Use Down, Pouches & Black Market Up: Survey

    Australia’s latest National Drug Strategy Household Survey shows daily smoking continues to decline, with the number of daily smokers falling by more than half since 2001 to about 1.3 million Australians, while 68.7% of people aged 14 and older report never having smoked. The 2025 survey also found daily e-cigarette use has largely plateaued since 2022, with frequent vaping among 18- to 24-year-olds dropping from 11.3% to 5.8%.

    However, researchers highlighted emerging challenges, including rising illicit tobacco use and nicotine pouches. The survey found one in three smokers now purchase black-market cigarettes — double the proportion reported in 2022 — while use of three or more nicotine products has tripled since 2019, signaling growing concern over poly-nicotine use despite overall declines in smoking.

  • Indian Consumer Group Calls for Illicit Trade Task Force

    Indian Consumer Group Calls for Illicit Trade Task Force

    India’s Consumer Online Foundation (COF) urged the Prime Minister’s Office to establish a National Task Force on Illicit Tobacco Trade under the Cabinet Secretariat or PMO to combat the growing market for smuggled cigarettes, counterfeit tobacco products, and illegal nicotine products. In a letter to the government, the consumer advocacy group said illicit trade is undermining India’s tobacco control efforts by eroding tax revenues, bypassing health regulations and age restrictions, and strengthening organized crime.

    The COF proposed a multi-agency task force involving the ministries of health, finance, home affairs, and commerce, along with customs and enforcement agencies, to develop a national anti-illicit tobacco strategy focused on intelligence-led enforcement, border security, counterfeit manufacturing, market surveillance, and consumer reporting. The foundation also called for a 100-day action plan and pointed to international experience, including Australia, arguing that tobacco taxation must be supported by robust enforcement to prevent consumers from shifting to illegal markets.

  • Minnesota AG Sues Local Company for Selling Flavored Vapes

    Minnesota AG Sues Local Company for Selling Flavored Vapes

    Minnesota AG Keith Ellison filed a lawsuit against local e-cigarette manufacturer Maduro Distributors, alleging the company sold banned flavored vape products under its The Loon brand that were marketed in ways appealing to youth. The complaint, filed in Ramsey County District Court, accuses the Fridley-based company of selling products with flavors including cotton candy and blue razz slushy, using “kid-friendly characters” in promotions, and falsely representing some products as FDA-approved.

    The Loon sells disposable and refillable vapes as well as nicotine pouches and previously received an FDA warning letter for marketing unauthorized products, according to The Minnesota Star Tribune. Maduro said it had changed flavor names before Minnesota’s 2024 ban took effect and removed the FDA approval claim from a third-party website, arguing it had cooperated with state officials.

  • Customs Joins Case Against Duty-Free Nicotine Sales in India

    Customs Joins Case Against Duty-Free Nicotine Sales in India

    India’s customs authorities joined the health ministry’s legal challenge against Adani Group’s sale of nicotine pouches at airport duty-free shops, arguing that duty-free status provides tax benefits but does not exempt retailers from broader regulatory requirements. In a filing to the Mumbai High Court, customs officials said goods being “outside customs frontiers” for taxation purposes do not grant immunity from other laws, rejecting Adani’s argument that international departure-area shops are beyond the reach of domestic regulations.

    The company has challenged a health ministry inspection that found nicotine pouch sales at Mumbai International Airport’s duty-free stores violated Indian law, arguing the products are legally sold under duty-free rules and sealed for use after passengers leave the country. The case is scheduled for its next hearing on July 28.

  • Cessation Trust Breaks from Health NZ Over Harm-Reduction Stance

    Cessation Trust Breaks from Health NZ Over Harm-Reduction Stance

    Wellington stop-smoking provider Takiri Mai Te Ata Trust ended its partnership with Health New Zealand after refusing to promote vaping as a smoking cessation tool. The trust, which has helped people quit smoking for more than 30 years, said it could not continue delivering services in a way that conflicted with its values. Regional manager Catherine Manning said the organization did not support helping people quit cigarettes by transitioning to another nicotine product.

    Health New Zealand said it worked extensively with the trust to find a solution that would allow the service to continue without directly supplying vapes, but no agreement was reached, and the contract ended by mutual consent. Health New Zealand maintains that vaping is less harmful than smoking and can help smokers quit, while stressing that non-smokers should not vape. Action for Smokefree 2025 director Ben Youdan said evidence shows vaping can be an effective cessation tool, adding that vaping is “not risk-free” but “dramatically” reduces the risk of death compared with smoking.

    Youdan said that while he recognized the trust’s concerns, many organizations have seen real benefits from using vaping as part of smoking cessation efforts.

  • Former CTP Toxicologist Accuses FDA of Approving Zyn Without Full Facts

    Former CTP Toxicologist Accuses FDA of Approving Zyn Without Full Facts

    A report published yesterday (July 14) by The Examination and STAT raised questions about the U.S. Food and Drug Administration’s review process for Philip Morris International’s Zyn nicotine pouches, alleging that agency scientists had unresolved concerns about the composition and potential health implications of the pouch material before the product was authorized for sale. The report said FDA toxicologist Christy Leppanen questioned whether regulators had adequately assessed possible microplastic exposure after conducting informal tests that found Zyn pouches did not dissolve when exposed to saliva or other conditions. Leppanen alleged that the FDA did not seek additional information from PMI about the pouch material before approving the product, while former FDA officials cited in the report questioned whether the agency fully evaluated all product components as required under federal law.

    The allegations come as nicotine pouches have become one of the fastest-growing segments of the tobacco and nicotine market. The U.S. nicotine pouch market is estimated to grow 37% in 2026 to $6.8 billion, according to TobaccoIntelligence, with companies promoting pouches as lower-risk alternatives to combustible cigarettes because they deliver nicotine without smoke exposure. The FDA has authorized certain nicotine pouches, including Zyn, based on a review of whether the products are appropriate for the protection of public health, weighing potential risks such as youth uptake against potential benefits for adult smokers transitioning away from cigarettes. PMI defended the authorization process, citing the FDA’s scientific review, while the FDA said its evaluation did not identify additional concerns regarding the ingredients or materials used in Zyn products. Concerns raised by Leppanen and other scientists center on whether pouch materials could release microscopic particles during use and what long-term effects those exposures may have. The FDA’s recent decision allowing PMI to communicate that Zyn use instead of cigarettes lowers the risk of certain smoking-related diseases represented a major regulatory milestone for the category, but, according to The Examination, the allegations in the report may fuel additional debate over product standards, disclosure requirements, and the depth of scientific reviews for emerging nicotine products.

  • Public Health Groups Sueing FDA Over New Vape, Pouch Stance

    Public Health Groups Sueing FDA Over New Vape, Pouch Stance

    A coalition of public health organizations, including the Campaign for Tobacco-Free Kids, American Academy of Pediatrics, American Heart Association, and American Lung Association, filed a federal lawsuit yesterday (July 14) challenging the U.S. Food and Drug Administration’s May 2026 enforcement guidance for e-cigarettes and nicotine pouches. The plaintiffs argue the policy unlawfully allows unauthorized products to remain on the market without the premarket scientific review required under the Tobacco Control Act, creating an enforcement safe-harbor for products that FDA has previously identified as posing significant youth appeal.

    Filed in the U.S. District Court for the District of Maryland, the lawsuit seeks to overturn the guidance, alleging it violates both the Tobacco Control Act and the Administrative Procedure Act, and could have significant implications for manufacturers and retailers by determining whether products with pending marketing applications can continue to be sold while awaiting FDA review.

  • Pakistani Growers Protest ‘Violation’ of Tobacco Purchase Agreement

    Pakistani Growers Protest ‘Violation’ of Tobacco Purchase Agreement

    Tobacco growers in Pakistan’s Khyber Pakhtunkhwa province accused the local management of a multinational tobacco company of failing to honor procurement agreements by refusing to purchase leaf that farmers say meets agreed quality standards. Protesting outside the Pakistan Tobacco Company’s depot in Charsadda, growers claimed the alleged refusal has left hundreds of farming families facing financial hardship during the marketing season and warned that continued purchasing delays could discourage future tobacco cultivation.

    Farmer representatives are calling on provincial and federal authorities to intervene, investigate the dispute, and ensure procurement contracts are honored, while threatening to escalate demonstrations if the company does not resume purchases.

  • New German Plan Would Raise Cigarette Packs to €12 by 2030

    New German Plan Would Raise Cigarette Packs to €12 by 2030

    DW Media reported that Germany’s coalition government is planning a steeper increase in tobacco excise duties than previously proposed, with draft Finance Ministry plans expected to raise the average price of a pack of cigarettes from about €8 to €12 by 2030, while also increasing taxes on fine-cut tobacco used for roll-your-own cigarettes.

    According to German media reports, the higher-than-expected tax increases are intended to help close a budget shortfall while supporting the government’s public health objective of reducing smoking rates among youth and adults. The proposed measures would further increase the tax burden on the tobacco industry in one of Europe’s largest cigarette markets, where roughly one-quarter of the population aged 15 and older are regular smokers.