The legal landscape shifted further when the Supreme Court decided FDA v. Wages and White Lion Investments, upholding the FDA's comparative efficacy framework for evaluating flavored ENDS PMTAs. This means the FDA's approach — comparing a new flavored product's youth risk against its adult-switching benefit relative to existing authorized products — was upheld as legally valid. This closes off a major legal challenge avenue for manufacturers seeking to overturn PMTA denials in court.

For context on how the FDA's enforcement has escalated, see our seize-and-destroy law guide covering Operation Red Mist (18M units seized, $175M in product).