FDA Denies Marketing of Two Vuse Menthol E-Cigarette Products

VIEW TODAY’S NEWS RELEASE HERE

FDA announced the agency has issued marketing denial orders (MDOs) for two menthol e-cigarette products currently marketing by R.J. Reynolds Vapor Company – the Vuse Vibe Tank Menthol 3.0% and the Vuse Ciro Cartridge Menthol 1.5%.  The company must not market or distribute these products in the U.S. or they risk enforcement action by the FDA.

When reviewing premarket product applications (PMTAs), the agency evaluates, among other things, a tobacco product’s components, ingredients, additives, constituents, design, harmful and potentially harmful constituents, and health risks, as well as how the product is manufactured, packaged, and labeled.  After reviewing the company’s PMTAs, the FDA determined that the applications lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health, the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.

Existing evidence demonstrates that non-tobacco-flavored e-cigarettes, including menthol flavored e-cigarettes, have a known and substantial risk with regard to youth appeal, uptake, and use; in contrast, data indicate tobacco-flavored e-cigarettes do not have the same appeal to youth and therefore do not pose the same degree of risk.  Given these existing differences in youth risk, applicants need to provide robust evidence to demonstrate that using their menthol flavored e-cigarette products are likely to promote complete switching or are likely to significantly reduce combustible cigarette use in adult smokers beyond that facilitated by tobacco-flavored e-cigarettes products.  Data from the 2022 National Youth Tobacco Survey found that Vuse was the second most common brand youth e-cigarette users reported “usually” using.

These products cannot be legally introduced into interstate commerce in the U.S. without risking FDA enforcement.  In addition to ensuring that the manufacturer complies with this order, as with unauthorized products generally, the FDA intends to ensure compliance by distributors and retailers.  Retailers should contact R.J. Reynolds Vapor Company with any questions about products in their inventory.

VIEW TODAY’S NEWS RELEASE HERE

×

Upcoming Events

Attending any of these upcoming events? Have other events to share? Let us know! Email us at NNN@ITCMI.ORG to share your event information or to get on our list serve for event updates.

 

NIHB presents National Tribal Health Conference | Sheraton Grand at Wildhorse Pass in Chandler, Arizona | LEARN MORE AND REGISTER

75 Years Later:  The Impact of the 1950 Papers on Smoking and Lung Cancer | This symposium will celebrate the achievements that have occurred over the past 75 years in the fields of tobacco control, lung cancer epidemiology and causal inference.  Two seminal papers on lung cancer and smoking initiated these three areas of scholarship in 1950.  Since then, significant public health, policy, and research contributions have been made by scholars around the world.  In this symposium, speakers will highlight such accomplishments and present their current research in these fields. | DOWNLOAD FLIER | REGISTER HERE

Association of American Indian Physicians 53rd Annual Meeting | Hyatt Regency Seattle in Seattle, Washington | LEARN MORE AND REGISTER

National Lung Cancer Screening Day | Now in its fourth year, this initiative is kpowered by a dynamic collaboration among the American Cancer Society's National Lung Cancer Roundtable, GO2 for Lung Cancer, the Radiology Health Equity Coalition, and the American College of Radiology. | LEARN MORE