The U.S. Food and Drug Administration has denied marketing of two Vuse Solo brand menthol e-cigarette products currently marketed by R.J. Reynolds Vapor Co. The agency said the company must not market or distribute these unauthorized products in the U.S. or they risk FDA enforcement action.
The marketing denial orders or MDOs were issued against the Vuse Replacement Cartridge Menthol 4.8 percent G1 and the Vuse Replacement Cartridge Menthol 4.8 percent G2.
After reviewing the company’s premarket tobacco product applications or 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.
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.
Based on evidence including data from the NYTS 2022 National Youth Tobacco Survey, the FDA noted 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.
The NYTS data also found Vuse to be the second most common brand youth e-cigarette users reported “usually” using.
Meanwhile, data indicate tobacco-flavored e-cigarettes do not have the same appeal to youth and therefore do not pose the same degree of risk.
The agency noted that applicants need to provide proper 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.
These products cannot be legally introduced into interstate commerce in the U.S. without risking FDA enforcement. The FDA also intends to ensure compliance by distributors and retailers.
R.J. Reynolds may resubmit applications or submit new applications to address the deficiencies for the products that are subject to these MDOs.
To date, the agency has received applications for more than 26 million deemed products, and it 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.
Previously, the FDA has denied marketing applications for millions of products, including ten non-tobacco-flavored e-liquid cartridges under the Vuse Solo brand, Vuse Vibe Tank Menthol 3.0 percent and the Vuse Ciro Cartridge Menthol 1.5 percent.
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