Today, 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. The currently marketed products include 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 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.
“Consistent with the authorities granted by Congress, the FDA remains committed to evaluating new tobacco product applications based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “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.”
When reviewing premarket tobacco 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, which is 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 a complete switch 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.
“Today’s decision pertains to the specific application submitted for review by FDA,” said Dr. King. “It is the responsibility of the applicant to provide sufficiently robust scientific evidence to demonstrate that the necessary public health standard has been met. In this case, the presented evidence did not meet that standard.”
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 issuance of these MDOs is just one of the many actions the FDA has taken to ensure any tobacco products that are marketed undergo science-based review and receive marketing authorizations by the FDA. The agency has completed the review of and made determinations on more than 99% of the nearly 6.7 million deemed products for which applications were submitted by a court-ordered Sept. 9, 2020, deadline. 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 FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.