FLER at APE

2Firsts reviewed the original federal court complaint filed by Altria subsidiaries Helix Innovations and NJOY on Sept. 2 challenging FDA’s 2021 PMTA rule. The lawsuit questions whether FDA’s review process complies with the Tobacco Control Act’s 180-day timeline, even as the agency moves to accelerate PMTA reviews and issues more marketing orders. Drawing on the complaint, FDA records, government audits and recent court rulings, 2Firsts examines the legal arguments, supporting evidence and potential implications for the U.S. tobacco review system.

The U.S. FDA has consolidated two tobacco establishment registration and product listing forms into a redesigned Form FDA 3741 covering all regulated product categories, including e-cigarettes, heated tobacco products and nicotine pouches. The current requirements remain limited to domestic establishments. Separately, the FDA has proposed extending registration and product listing requirements to foreign manufacturers, signaling greater regulatory attention to manufacturing entities and product-level information across the tobacco and nicotine supply chain.

Dragos Constantinescu has officially taken up his role as Chief Financial Officer and Executive Director at British American Tobacco (BAT). He previously spent 16 years at BAT across finance and general management roles in Europe before joining Asahi in 2019 and becoming CEO of Asahi Europe & International in 2025. His return comes as BAT continues to advance its “A Better Tomorrow” transformation.

KT&G will launch the lil Tonino Lamborghini heated tobacco device in Seoul on September 15, 2026. The product introduces a new heating technology called Flashwave Heating, which uses microwaves to heat tobacco sticks internally and delivers a manufacturer-rated heat-up time of about three seconds. The device features an all-metal aluminum body, a color display and a dedicated GUI, and launches alongside a new line of NAU tobacco sticks that are incompatible with existing lil consumables. Korean media describe the product as KT&G's first new heated tobacco platform since lil AIBLE was introduced in 2022.

R.J. Reynolds Vapor Company has introduced Vuse Pro prefilled pods in Peach, Berry, Watermelon and Fresh Mint in selected U.S. states. Vuse’s U.S. website says the pods are intended for use with existing Vuse Alto devices. Each contains 2.0 mL of e-liquid at 5.0% nicotine by weight, uses nicotine salts and is offered in two- and four-pod packs. Reynolds said the rollout includes mandatory ID scanning for every purchase, purchase limits, stronger retailer-accountability requirements and strict age-restricted marketing standards. The four pods have not received marketing authorization from the U.S. Food and Drug Administration.

Japan Tobacco International (JTI) has introduced PERLZ nicotine pearls in the UK, expanding its oral nicotine portfolio beyond conventional nicotine pouches. The fully dissolvable, multi-layer pearls are placed under the tongue and come in Mint and Berry flavors at concentrations of 1mg/g and 2mg/g, equivalent to approximately 0.3mg and 0.5mg of nicotine per pearl. UK retailer Haypp published four 30-pearl dispenser listings on July 31, 2026, followed by three 10-pearl sachet products on August 17. The dispensers retail for £6.50, while the sachets cost £2.50.