Reynolds Files Pre-Market Application for Vuse

Reynolds American, Inc. Files PMTA for E-Cigarette VUSE

The U.S. Food and Drug Administration (FDA) has begun reviewing R.J. Reynolds Vapor Co.’s Vuse e-cigarette to determine whether or not the company can use a modified risk claim on its products.

Reynolds submitted Vuse for FDA review on Oct. 11, 2019 with the hopes of gaining premarket approval for several Vuse e-cigarette products. As part of the review process, the FDA will consider the product’s existing risks and benefits to the general population, including non-users, as it compares to traditional cigarettes. If deemed to present fewer risks than the traditional cigarette, the company will be able to market Vuse with modified risk claims. Vuse is the second best-selling e-cigarette in the U.S., marketed to adult consumers.

Reynolds American is said to have submitted more than 150,000 pages of documentation to support its pre-market application. As part of the review, the FDA will also conduct inspections of the company’s manufacturing sites and any site and entity it sees as being involved in the clinical and non-clinical studies associated with the Vuse product.