FLER at APE

According to VitalLaw on August 27, 2026, the U.S. Court of Appeals for the Fifth Circuit vacated an FDA marketing denial order (MDO) against NicQuid LLC, ruling that the agency’s comparative-efficacy standard for electronic nicotine delivery system (ENDS) applications had become a substantive rule requiring notice-and-comment rulemaking under the Administrative Procedure Act (APA). The court did not reject FDA’s authority to compare the public health benefits and risks of flavored vapes, but held that the agency could not establish a broadly binding standard through informal adjudications. The case was remanded to FDA for further proceedings.

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.

Mesa Underwriters Specialty Insurance Company has asked a federal court in Washington to declare that it has no duty to defend or indemnify vape distributor i5 Distribution in a product liability case involving an Elf Bar BC5000. The plaintiff alleges that the disposable vape caught fire and exploded in his pocket, causing severe burns and ultimately requiring an above-the-knee amputation of his left leg. MUSIC is relying on a tobacco, nicotine or nicotine replacement products exclusion and a premises limitation endorsement. The court has not ruled on the coverage dispute.

A U.S. federal court upheld Pennsylvania's vape directory law on October 14, rejecting a challenge brought by Nova Distro, 101 Distributors and companies operating Tobacco Hut retail stores. Court records show that vaping accounts for about 60% of Tobacco Hut's profits and that the chain held approximately $2 million in inventory potentially subject to seizure under the law as of June 2. Pennsylvania began enforcement on October 19. The ruling follows similar appellate decisions in other states, even as new research shows that unlisted vaping products continue to account for substantial sales in states with established directories.

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.

At the 2026 New Approaches Summit in New York, former FDA Center for Tobacco Products Director Mitch Zeller called for the tobacco harm reduction debate to shift from the traditional “end game” toward defining a desired “end state.” He also highlighted unresolved concerns around dual use, argued that biomarkers of exposure may be more meaningful than cigarettes-per-day in assessing risk reduction, and said nicotine misperceptions remain a major barrier to public health progress.