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.

Swedish nicotine pouch brand Kelly White is building its strategy around adult female consumers. Founder and CEO Sophia Wilsby told 2Firsts that women accounted for around 70% of the brand’s repeat customers on HAYPP in Sweden in 2025. The interview explores female consumer segmentation, product and design differentiation, gender stereotypes, packaging regulation, and how independent brands can compete with global players such as ZYN and VELO while considering funding, partnerships and future ownership options.

The UK High Court has ordered Chinese vape manufacturer Shenzhen SKE Technology to provide £569,039 ($776,000) in security for costs in its design infringement proceedings against Vapepen London and other defendants over its Crystal Bar vape product. The court did not accept the defendants’ main argument that recovering costs from a China-based company would face significant enforcement obstacles, but found that SKE had not sufficiently disclosed its own financial position. The order is procedural and does not determine the underlying infringement claims.

Cochrane’s 2026 update of its living review on electronic cigarettes for smoking cessation included 80 randomized controlled trials involving 29,861 adult smokers, with nine trials added in this update. The review retained its high-certainty conclusion that nicotine e-cigarettes increase smoking cessation rates compared with nicotine replacement therapy. In absolute terms, about 10 in 100 people using nicotine e-cigarettes may quit smoking for at least six months, compared with about 6 in 100 using NRT. The review found no clear difference in serious adverse event rates between the two groups, while longer-term safety and the relative effectiveness of newer device types remain less certain.

FDA CTP Director Bret Koplow used his FDLI keynote in Washington to outline how the agency is rethinking the PMTA framework. He discussed category-specific review, nicotine pouch and sPMTA pilots, AI-assisted review, a 70% reduction in pending applications, and a major staffing constraint: CTP currently has only nine scientific review teams. He also reaffirmed tobacco harm reduction while stressing youth protection, flavored products, risk communication, and the challenge of unauthorized e-cigarettes.

JAMA has published a Special Communication offering systematic recommendations for U.S.-based clinicians on the use of nicotine e-cigarettes in adult smoking cessation. Developed by the Harm Reduction Workgroup of the Society for Research on Nicotine and Tobacco’s Treatment Research Network, the paper recommends including e-cigarettes alongside FDA-approved cessation medications in risk-benefit discussions. It cites high-certainty evidence that nicotine e-cigarettes achieve higher quit rates than nicotine replacement therapy and evidence suggesting efficacy comparable to highly effective medications such as varenicline and cytisine. For adults who choose vaping to quit, the authors recommend FDA-authorized products, sufficient nicotine delivery and a rapid, complete transition away from cigarettes rather than prolonged dual use.