FLER at APE

The U.S. FDA has announced the agency-wide deployment of new agentic AI capabilities, providing all employees with an optional multi-step task automation tool. Building on the broad adoption of its earlier large-language-model system, Elsa, the FDA aims to use this next-generation AI workflow to accelerate product review, regulatory oversight, and internal operations, while maintaining strict human supervision and data security.

PMI Japan unveils limited edition IQOS ILUMA i in Galaxy Blue, inspired by the universe, set to launch on October 29.

The California DOJ issued Information Bulletin No. 2025-DLE-17 on November 10, 2025, providing an update on the state’s flavored tobacco enforcement. The Attorney General’s office is set to launch the Unflavored Tobacco List (UTL) by December 31, 2025, identifying tobacco products without characterizing flavors that may legally be sold in California. Enforcement will continue to focus on “obviously flavored” products, while unregistered products remain subject to seizure and penalties.

British American Tobacco (BAT) acquires state-owned shares of UZBAT, a joint venture in Uzbekistan, for $22.3 million.

NEXA has introduced a disposable e-cigarette, NEXA FLEX, which is promoted as “Built in the USA,” highlighting domestic production and flavors developed for adult U.S. vaping consumers. The device retains features such as a transparent e-liquid chamber, Normal/Turbo dual modes, and up to 40,000 puffs, and is scheduled to launch in late November in Texas. Other brands, including SKE and FASTA, have also recently released products labeled as “Made in the USA” or “U.S.-assembled.”

Philip Morris Japan has announced the launch of a new SENTIA Icy Red tobacco stick for its IQOS ILUMA i and IQOS ILUMA heated tobacco devices, featuring an intense menthol profile with red fruit notes. The new product will roll out in stages from December across physical IQOS outlets, online channels and tobacco retailers nationwide in Japan, priced at 530 yen (approx. USD 3.4) per pack.