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

Correspondence to Professor Stanton Glantz, San Francisco, CA, USA; [email protected]

WHAT IS ALREADY KNOWN ON THIS TOPIC

• In October 2021, the US Food and Drug Administration (FDA) authorised marketing of RJ Reynolds Vapor Company’s Vuse Solo e-cigarette products through FDA’s Premarket Tobacco Product Application pathway, its first authorisation of an e-cigarette.

WHAT THIS STUDY ADDS

• A review of FDA’s scientific justification for this decision reveals many deficiencies, including that FDA did not demonstrate positive net benefits to public health.

• FDA did not adequately address youth issues, evidence that as consumer products e-cigarettes do not help smokers quit, dual use and the full range of literature on heath harms of e-cigarettes.

HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY

• Because these deficiencies suggest that the continued marketing of the product is not appropriate for the protection of the public health, FDA should withdraw the Vuse Solo marketing order as statutorily required and not use it as a template for other e-cigarette authorisations.

• 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 and not accept the FDA decision as justification for similar decisions in other countries.

On 12 October 2021, the US Food and Drug Administration (FDA) authorised the marketing of British American Tobacco’s US subsidiary RJ Reynolds Vapor Company’s (RJR) Vuse Solo e-cigarette products through the Premarket Tobacco Product Application (PMTA) pathway.¹ Similar to what happened following FDA’s authorisation of Philip Morris’ IQOS heated tobacco product,^{2 3} FDA’s decision was quickly promoted around the world as an endorsement of e-cigarettes, including in Egypt⁴ and China.⁵ By December 2021, Vuse brands moved into second place in the US e-cigarette market, with 34% market share (behind Juul’s 38%).⁶

To authorise the marketing of a product for which a PMTA has been submitted, FDA must determine that allowing its sale is ‘appropriate for the protection of the public health’⁷ (APPH). According to FDA:

FDA interprets the APPH standard to require a showing [by the applicant company] that permitting the marketing of a new tobacco product would have a net benefit to public health based upon the risks and benefits to the population as a...