Two Americas of FDA Tobacco Regulation
May 14, 2026 by substack.com
Two Americas of FDA Tobacco Regulation
Navigating the complex PMTA process involves years of compiling applications, paying for legal and compliance costs while facing state and local restrictions. Despite declining smoking rates, concerns arise over FDA authorizations, especially in cases like GLAS. Large tobacco companies invest billions in expansions, hinting at foreknowledge of regulatory outcomes. Small businesses are left waiting, contrasting with big corporations' bold moves. Doubts about regulatory coherence lead to skepticism, as concerns about regulatory personnel transitions and industry ties emerge. Uncertainty prevails for small businesses awaiting decisions, while larger corporations seem assured. The system's mixed messages raise questions about fairness and predictability in public health regulation.
