Vuse Solo e-cigarettes do not provide net benefits to public health: a scientific analysis of FDAs marketing authorisation

In October 2021, the US Food and Drug Administration (FDA) authorised marketing of RJ Reynolds Vapor Company’s (RJR) Vuse Solo e-cigarette through FDA’s Premarket Tobacco Product Application (PMTA) pathway. FDA concluded that RJR demonstrated Vuse products met the statutory standard of providing a net benefit to public health. A review of FDA’s scientific justification reveals deficiencies: (1) not adequately considering Vuse’s popularity with youth and evidence that e-cigarettes expanded the nicotine market and stimulate cigarette smoking; (2) trading youth addiction for unproven adult benefit without quantifying these risks and benefits; (3) not considering design factors that appeal to youth; (4) not addressing evidence that e-cigarettes used as consumer products do not help smokers quit and promote relapse in former smokers; (5) not discussing evidence that dual use is more dangerous than smoking; (6) narrowly focusing on the fact that e-cigarettes deliver lower levels of some toxicants without addressing direct evidence on adverse health effects; (7) downplaying significant evidence of other substantial harms; (8) not acting on FDA’s own study showing no all-cause mortality benefit of reducing (but not stopping) cigarette use; and (9) improperly considering e-cigarettes’ high abuse liability and potential for high youth addiction and undermining tobacco cessation. Because marketing these products is not appropriate for the protection o...
Source: Tobacco Control - Category: Respiratory Medicine Authors: Tags: Special communication Source Type: research