FDA Issues Marketing Denial Orders for 6 Vuse Alto Flavored e-Cigarette Products

The U.S. Food and Drug Administration (FDA) recently issued marketing denial orders (MDOs) to RJ Reynolds Vapor Company for 6 Vuse Alto brand flavored e-cigarette products, prohibiting marketing or distribution of the products in the US pending FDA enforcement action.

The agency in a press announcement stated that the company's premarket tobacco product applications (PMTAs) for the affected products—3 menthol-flavored and 3 mixed berry-flavored products, each offered in 3 nicotine strengths—provided insufficient evidence that, should they be made available, the products would be offer protection of public health—a legally required standard.

Specifically, the documentation provided by RJ Reynolds Vapor Company failed to show that the 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."

Additionally, the FDA pointed to data from the National Youth Tobacco Survey indicating that cartridge-based Vuse e-cigarettes have been the second most commonly reported vape brand used by US youth since 2021. Vuse Alto is the most popular sub-brand.

The 6 products covered by the MDO "cannot be legally introduced into interstate commerce in the US," the FDA stated. Any product currently on the market must be immediately removed.

The FDA to date has authorized 23 tobacco-flavored e-cigarette products and devices. According to the agency statement, tobacco-flavored Vuse products are included among them. There are also applications for another 6 tobacco-flavored Vuse Alto brands under FDA review.

“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, PhD, 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.”

Source: FDA denies marketing of six flavored Vuse Alto e-cigarette products following determination they to not meet public health standard. Press release. US Food and Drug Administration. October 12, 2023. Accessed October 17, 2023. https://www.fda.gov/news-events/press-announcements/fda-denies-marketing-six-flavored-vuse-alto-e-cigarette-products-following-determination-they-do-not