FDA issues marketing denial order for popular flavored e-cigarette products

The FDA moved to ban the sale of six flavored e-cigarette products sold under the Vuse Alto brand of R.J. Reynolds Vapor Company, according to a press release from the agency.

The products — which include three menthol-flavored and three mixed-berry flavored e-cigarettes each sold at three nicotine strengths — must not be marketed or distributed in the U.S., according to the FDA action. Data from the National Youth Tobacco Survey showed that the cartridge-based Vuse e-cigarettes are the second most commonly used e-cigarette brand among U.S. youth since 2021.

The FDA reviewed the company’s premarket tobacco product applications and determined they lack sufficient evidence that the marketing of these products would protect public health, as required by the 2009 Family Smoking Prevention and Tobacco Control Act, specifically as it relates to whether these products would benefit adults who smoke by helping them to switching from or significantly reduce their smoking of tobacco-flavored products.

“We review each application on its own merits, and it’s the responsibility of the applicant to provide sufficient science to support the product they’re seeking to market,” Matthew Farrelly, PhD, director of the FDA's Center for Tobacco Product’s Office of Science, said in the release. “If an application contained sufficient scientific evidence to meet the necessary public health standard, including a non-tobacco-flavored product, we’d authorize the product. But such evidence was lacking in this case.”

The FDA has authorized 23 tobacco-flavored e-cigarette products and devices, including other Vuse products, with six more tobacco-flavored Vuse Alto products still under FDA review.

According to a press release from British American Tobacco, the parent company of R.J. Reynolds, the company intends to challenge these denials and seek a stay of enforcement.

Reference:

• BAT expresses disappointment at FDA Marketing Denial Order for Vuse Alto Menthol and Mixed Berry and will immediately seek a stay of enforcement. https://www.bat.com/group/sites/UK__CRHJSY.nsf/vwPagesWebLive/DOCWJLYQ#. Published Oct. 12, 2023. Accessed Oct. 13, 2023.