March 17, 2023: “The U.S. Food and Drug Administration issued marketing denial orders (MDOs) for two menthol e-cigarette products currently marketed by R.J. Reynolds Vapor Company under the Vuse Solo brand.
The currently marketed products include the Vuse Replacement Cartridge Menthol 4.8% G1 and the Vuse Replacement Cartridge Menthol 4.8% G2.
The company must not market or distribute these products in the U.S. or they risk FDA enforcement action. The company may resubmit applications or submit new applications to address the deficiencies for the products that are subject to these MDOs.
The FDA evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the risks and benefits of the product on the population as a whole.
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, which is the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.
Specifically, evidence submitted by the applicant did not demonstrate that its menthol-flavored e-cigarettes provide an added benefit for adult smokers relative to tobacco-flavored e-cigarettes.
“The FDA is a data driven agency and science remains the cornerstone of our tobacco product regulatory activities,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products.
“The science has guided – and will always guide – the FDA’s decision making on premarket tobacco product applications, including today’s marketing denial orders.”
Existing evidence, including data from the 2022 National Youth Tobacco Survey (NYTS), shows 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. NYTS data also found Vuse to be 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.
Today’s actions are just one of many the FDA has taken to ensure any tobacco products that are marketed in the U.S. undergo science-based review and receive marketing authorizations by the agency.
To date, the agency has received applications for more than 26 million deemed products and has made determinations on 99% of these applications.
To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices, which are the only e-cigarettes that currently may be lawfully sold or distributed in the U.S.; this includes the Vuse Solo e-cigarette device and two accompanying tobacco-flavored e-liquid cartridges.
The FDA has also denied marketing applications for millions of products that did not meet the requirements in the law, including ten non-tobacco-flavored e-liquid cartridges under the Vuse Solo brand, Vuse Vibe Tank Menthol 3.0% and the Vuse Ciro Cartridge Menthol 1.5%.”