Oral health: Vaping inflicts damage and can lead to ‘irreversible’ problems

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.

Australia’s tobacco excise debate is increasingly exposing differences within the governing Labor Party. New South Wales Labor Premier Chris Minns reaffirmed on September 8 that he supports reducing tobacco excise, arguing that current tax settings are pushing consumers toward cheaper black-market cigarettes. Federal Health Minister Mark Butler continues to oppose an excise cut, while Treasurer Jim Chalmers and Assistant Treasurer Daniel Mulino have recently stopped short of ruling out future changes. The divergence follows the opposition Coalition’s proposal to cut tobacco excise by 80%.

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.

Russia's digital labeling regime for reusable e-cigarettes and similar personal vaping devices entered its first mandatory phase in September 2026. From September 1, manufacturers, importers and other market participants must register with the national Chestny ZNAK tracking system. From December 1, newly manufactured and imported covered devices will be required to carry digital identification codes and be reported as entering circulation. Russia has also issued new operational guidance for imports, marking the transition from a voluntary pilot to phased mandatory implementation.

Private antitrust litigation stemming from Altria's 2018 $12.8 billion investment for a 35% economic interest in JUUL is advancing before the U.S. Court of Appeals for the Ninth Circuit. Direct purchasers, indirect purchasers and indirect resellers of JUUL products filed answering briefs this week seeking to preserve class certifications granted by a California federal court in February. Altria and JUUL argue that individual consumers and large distributors differ too much in purchasing terms to remain in a single direct-purchaser class, while a separate dispute concerns whether California antitrust law can apply to indirect purchasers across 27 jurisdictions. A September trial has been put on hold during the appeal.

Indiana's Alcohol and Tobacco Commission (ATC) ordered tobacco certificate holders in September to remove certain vaping products marketed under Elf Bar, Lost Mary, MR FOG, iJOY and other brands from inventory under the state's foreign-adversary product law. The agency later listed 257 MR FOG products and 77 Lost Mary product entries as lawful for sale. The Lost Mary revision expressly stated that compliance evidence had been received for 20 additional products. 2Firsts compliance expert Kurt said potential filings could include e-liquid and ingredient-origin records, U.S. nicotine-analog supply-chain documentation and FDA premarket application status.