FDA bans sale of popular vape products
Federal officials have banned the marketing and sale of a popular vaping product due to what was described as a failure “to meet the public health standard.”
The U.S. Food and Drug Administration’s marketing denial orders cover R.J. Reynolds Vapor Company for six flavored Vuse Alto e-cigarette products. The ban covers three menthol-flavored and three-mixed berry-flavored products, each of which comes in a variety of nicotine strengths.
Under the order, the company is prohibited from marketing or selling the products in the U.S. though it will allow the company to submit a new regulatory application. As for the flavored products, the FDA said makers didn’t “demonstrate that the menthol- and mixed berry-flavored products provided an added benefit for adults who smoke cigarettes—in terms of complete switching or significant smoking reduction—relative to that of tobacco-flavored products that is sufficient to outweigh the known risks to youth.
“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,” said Matthew Farrelly, Ph.D., director of the FDA’s Center for Tobacco Product’s Office of Science. “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.”
Tobacco-flavored Vuse products can remain on the shelves.
R.J. Reynolds said it would challenge the order.
“This decision flies in the face of proven science and is contrary to the FDA’s stated goal of reducing the health effects of tobacco use. This disappointing decision would harm, not benefit, public health. We believe appropriately regulated flavored vaping products—including menthol—are critical in supporting adult smokers migrate from combustible cigarettes,” the company said in a statement.
According to the FDA, Vuse is the most commonly sold e-cigarette brand in the U.S. with VUse Alto being its most popular sub-brand. Also, the National Youth Tobacco Survey shows that Vuse e-cigarettes are the second most commonly reported e-cigarette brand used by youth in the