Update: On Friday, the U.S. Court of Appeals for the Fifth Circuit granted R.J. Reynolds Vapor Co.’s emergency motion for an administrative stay of the FDA’s MDO for Vuse Alto menthol products. The FDA cannot enforce its denial order on menthol flavored Vuse Alto until the court resolves the company’s motion for a stay pending judicial review, R.J. Reynolds Vapor Co. said in a statement to CSP Daily News.
The Food and Drug Administration issued marketing denial orders (MDOs) to R.J. Reynolds Vapor Co. Thursday for six flavored e-cigarette products under its Vuse Alto brand—one of the best-selling vapor brands in the convenience-store industry.
The denial includes three menthol-flavored and three mixed berry-flavored products, with each flavor being offered in three nicotine strengths, the FDA said. R.J. Reynolds Vapor Co. cannot distribute or market the products listed in the MDO or it risks enforcement action, the FDA said. However, the company may submit new premarket tobacco product applications (PMTAs) for the products subject to these MDOs.
British American Tobacco (BAT), of which R.J. Reynolds Vapor Co. is an indirect subsidiary, said it would immediately be seeking a stay of enforcement on the MDOs for the menthol products from the FDA. If granted, it would allow retailers to keep the denied products on shelves for now. Vuse Alto Rich Tobacco and Golden Tobacco products remain under review with the FDA, BAT said in its statement.
“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,” said Kingsley Wheaton, chief strategy and growth officer at BAT. “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.”
Vuse is the most commonly sold e-cigarette brand in the United States, with Vuse Alto being its most popular sub-brand, the FDA said. Vuse Alto is a large capacity pod-based system with a ceramic wick and alloy heating element. Its counterparts, Vuse Vibe, Vuse Ciro and Vuse Solo, have been authorized by the FDA in original flavors.
Evidence submitted by the applicant did not demonstrate that the menthol- and mixed berry-flavored products provided an added benefit for adults who smoke cigarettes—in terms of switching or significant smoking reduction—relative to that of the tobacco-flavored products that is sufficient to outweigh the known risks to youth, the FDA said. Vuse e-cigarettes have been the second most commonly reported e-cigarette brand used by youth in the United States since 2021, the FDA said, citing the National Youth Tobacco Survey.
“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, 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.”
The FDA has authorized 23 tobacco-flavored e-cigarette products and devices to date. It has made determinations on 99% of applications for more than 26 million deemed tobacco products that it received through the PMTA process.
Wheaton called the agency’s decision on its latest MDOs arbitrary and said its sole grounds for the decision was the absence of long-term consumer switching data for these products. He said the PMTAs submitted by R.J. Reynolds Vapor Co. in 2020 included rigorous scientific studies for Vuse Alto that demonstrated that it is appropriate for the protection of the public health.
“We also remain deeply concerned that the FDA continues to allow the proliferation of youth-appealing vapor products like Cotton Candy and Peanut Butter Cookie which are flooding U.S. retail shelves. Companies in open defiance of the agency must be held accountable. BAT believes FDA should be employing its most powerful enforcement tools on the worst offenders without delay,” Wheaton said.
The Vuse Alto 5.0 Menthol four-pack was the top selling UPC for vapor pods in 2022, follow by Juul Classic Menthol four-pack, according to c-store shipment data from McLane Co. The Vuse Alto Kit Blue was the second most shipped vapor kit and device in 2022, McLane said, second to Juul Device Slate.
Members help make our journalism possible. Become a CSP member today and unlock exclusive benefits, including unlimited access to all of our content. Sign up here.