FDA Issues First Authorization for a Vaping Product

The FDA has issued its first marketing authorization for a vaping product. Marketing Granted Orders (MGOs) for the first generation-style Vuse Solo e-cigarette and two tobacco-flavored replacement cartridges were published on the FDA Center for Tobacco Products website Tuesday afternoon.

Along with the authorizations, the FDA announced it has issued Marketing Denial Orders (MDOs) for 10 Vuse Solo refill cartridges in flavors other than tobacco—even more evidence that the agency has no intention of authorizing any flavored products except possibly menthol. It’s unknown if the FDA denied the PMTA for the Vuse menthol-flavored refill.

Premarket Tobacco Applications (PMTAs) for the Vuse Solo and refill cartridges in several flavors were submitted to the FDA in October 2019. The manufacturer of the Vuse brand is RJ Reynolds Vapor Company—a division of Reynolds American Inc., which is a subsidiary of British American Tobacco.

The Vuse Solo is a so-called cigalike—a small stick battery that uses prefilled, disposable cartomizers. The product resembles a cigarette, although the Solo battery is silver in color, and the cartridges are black. Vuse Solo cartridges use nicotine salt-based e-liquid, and are available only in 4.8 percent (48 mg/mL) nicotine strength.

The device is very low in power, and requires a high nicotine strength to provide a reasonable satisfying hit for users. It is considered less effective as a product for transitioning smokers than pod-based devices like the Vuse Alto, JUUL and NJOY Ace.

The Vuse Solo was among the first products to be submitted for review, but it is an extremely cautious choice by the FDA. Among mass market vaping products, cigalikes like the Solo are the least popular in 2021. The FDA probably chose the Solo to be the first authorized product to assess the reaction from the tobacco control and medical organizations that the agency always seeks to please.