Rule Reset | FDA Signals Major Overhaul of PMTA Process | RegWatch
October 09, 2026 by regulatorwatch.com
Rule Reset | FDA Signals Major Overhaul of PMTA Process | RegWatch
A reset of the FDA’s PMTA process is overdue if regulation is meant to guide the market rather than paralyse it. The current pathway has left many smoke-free products trapped in uncertainty while cigarettes remain legally available and illicit alternatives gain space. A better system should be rigorous, transparent and fast enough to distinguish responsible products from those that do not meet standards. Harm reduction depends on regulation that can make timely decisions, not one that delays safer options out of reach.
14.10% of the adult population are current smokers. There are approximately 39.8 million current smokers in United States 17.10% of men are current smokers but only 11.10% of women.
SOURCE: GSTHR
