The U.S. Food and Drug Administration has denied marketing of two Vuse menthol e-cigarette products currently marketed by R.J. Reynolds Vapor Co. citing that they do not meet public health standard.
In a stament, the agency said it has issued marketing denial orders or MDOs for Vuse Vibe Tank Menthol 3.0% and the Vuse Ciro Cartridge Menthol 1.5%.
The company is urged to stop marketing or distributing these unauthorized products in the U.S. or face FDA enforcement action.
The FDA said the company may resubmit applications or submit new applications to address the deficiencies for the products that are subject to these MDOs.
After reviewing the company’s premarket tobacco product applications or PMTAs, the FDA agency 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. It is the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.
As per existing evidence, non-tobacco-flavored e-cigarettes, including menthol flavored e-cigarettes, have a known and substantial risk with regard to youth appeal, uptake and use.
Brian King, director of the FDA’s Center for Tobacco Products, said, “The applications for these products did not present sufficient scientific evidence to show that the potential benefit to adult smokers outweighs the risks of youth initiation and use.”
The agency noted that these products cannot be legally introduced into interstate commerce in the U.S. without risking FDA enforcement.
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.
Data from the 2022 National Youth Tobacco Survey found that Vuse was the second most common brand youth e-cigarette users reported “usually” using.
In October 2021, the FDA authorized the marketing of tobacco-flavored 3 e-cigarette products of R.J. Reynolds under the brand name Vuse. It was the first time that electronic cigarettes were officially allowed in the U.S for adult smokers.
The company then had told the FDA that the Vuse e-cigarettes were helpful in smokers quitting smoking or helped them bring down their use of cigarettes significantly.
To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. These are the only e-cigarette products that currently may be lawfully sold in the U.S.
The latest announcement is part of FDA’s actions to ensure any tobacco products that are marketed undergo science-based review and receive marketing authorizations.
In September 2020, the FDA had rejected applications for more than a million e-cigarettes and related products, as they could possibly harm underage teenagers.
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