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 of the public health, FDA should reconsider its Vuse marketing order as statutorily required and not use it as a template for other e-cigarette PMTAs. Policymakers outside the USA should anticipate that tobacco companies will use FDA’s decision to try to weaken tobacco control regulation of e-cigarettes and promote their products.
- non-cigarette tobacco products
- public policy
- tobacco industry
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Contributors SG wrote the first draft. LKL expanded that draft, focusing on regulatory issues as well as contributing to the technical analysis. Both authors contributed to revising the paper.
Funding This research was supported in part by the National Heart, Lung, and Blood Institute of the National Institutes of Health and the FDA’s Center for Tobacco Products (award number: U54HL147127).
Disclaimer The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or the Food and Drug Administration.
Competing interests SG serves as a consultant to the World Health Organization.
Provenance and peer review Not commissioned; externally peer reviewed.