WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has issued marketing denial orders (MDOs) for two menthol e-cigarette products marketed by R.J. Reynolds Vapor Company under the Vuse Solo brand. The products include the Vuse Replacement Cartridge Menthol 4.8% G1 and the Vuse Replacement Cartridge Menthol 4.8% G2. The company is prohibited from marketing or distributing these products in the U.S. or they risk FDA enforcement action.
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 public health.
“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,” said the FDA’s Brian King, Ph.D., M.P.H.
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. To date, the FDA has received applications for more than 26 million deemed products and has made determinations on 99% of these applications. The FDA has also denied marketing applications for millions of products that did not meet the requirements of the law.
These products cannot be legally introduced into interstate commerce in the U.S. without risking FDA enforcement. Retailers should contact R.J. Reynolds Vapor Company with any questions about products in their inventory.
This is just one of many actions the FDA has taken to ensure any tobacco products marketed in the U.S. undergo science-based review and receive marketing authorizations from the agency.
