FLER at APE

A federal judge in Texas on Oct. 8 granted a joint request by the FDA and plaintiffs including Altria subsidiaries Helix Innovations and NJOY to stay litigation challenging the agency's 2021 PMTA rule. The court cited FDA's anticipated rulemaking concerning the regulation at issue. FDA announced on Sept. 28 that it intends to reassess the PMTA framework and could initiate new rulemaking to replace it. The parties must file a joint status report within 45 days and every 45 days thereafter. A motion by three Reynolds American companies to intervene remains pending.

Philip Morris Malaysia Managing Director Naeem Shahab Khan met Perlis Mufti Mohd Asri Zainul Abidin on September 17 and presented the company's shift from conventional cigarettes toward alternative products. The mufti said a product could be considered halal if it is clean, its side effects are not harmful or can be controlled, and it does not involve excessive waste. His remarks did not mention IQOS or any other specific PMI product and did not amount to a new product-specific religious ruling. It was at least the second publicly reported engagement between Philip Morris Malaysia and a Malaysian religious institution over cigarette alternatives within six months.

Japan Tobacco (JT) will launch MEVIUS Tropical Option, a new tobacco stick for Ploom, nationwide in Japan from October 6, 2026. The capsule-format product combines mango-oriented sweetness with menthol cooling, adding a tropical flavor to the MEVIUS Ploom tobacco-stick lineup for the first time. Each pack contains 20 sticks and will launch at JPY 590. The product is compatible with all Ploom devices, and its addition will expand the Ploom tobacco-stick portfolio to 32 variants.

Imperial Brands' acquisition of Swedish Helwit owner Yoik Group AB has highlighted the professional-services firms supporting cross-border oral nicotine M&A. Latham & Watkins and KPMG advised Imperial, while PwC and TM & Partners advised Yoik. KPMG also appeared on Imperial's acquisition of Black Buffalo earlier in 2026, while PwC played an extensive role in KT&G's acquisition of Swedish nicotine-pouch company Another Snus Factory. Imperial's public disclosures put the global modern oral nicotine delivery market at approximately £8.8 billion in retail sales and 23.5 billion pouches in 2024

Philip Morris Japan (PMJ) launched Bold Ruby as a new regular color for the IQOS ILUMA i and IQOS ILUMA i ONE in Japan on September 16, 2026, priced at JPY 6,980 and JPY 3,980, respectively. Initial sales began through IQOS online and physical channels, with convenience stores and selected tobacco retailers set to follow from September 29. Bold Ruby is a regular rather than limited-edition colorway and is available for the ILUMA i and ILUMA i ONE, but not the ILUMA i PRIME. The release does not involve changes to the devices' core hardware or functions.

The U.S. Department of Health and Human Services has named Bret Koplow permanent director of the FDA’s Center for Tobacco Products, ending his period as acting chief. Koplow has spent years working on tobacco regulation, law and policy inside the FDA and, while serving as acting director, pushed for faster PMTA reviews and nicotine pouch review pilots. HHS also said CTP will prioritize innovation and access to less harmful alternatives for adult smokers while continuing efforts to protect youth.