The marketing denial orders were due to what the FDA stated as insufficient data supporting the products' additional benefit for adults switching from smoking cigarettes to vaping or cessation.
The US Food and Drug Administration (FDA) has issued marketing denial orders (MDOs) for 6 Vuse Alto brand-associated flavored e-cigarette products after determining the products did not meet standards for public health benefits and risks.1
The MDOs, issued to RJ Reynolds Vapor Company, target the largest sold brand of e-cigarettes in the US, and ensures the 6 products cannot be introduced into interstate commerce nor marketed for sale.
“The Center for Tobacco Products continues to make meaningful progress in reviewing the unprecedented amount of premarket tobacco product applications that have been received,” Brian King, PhD, MPH, director of the FDA’s Center for Tobacco Products, said in a statement. “We’re committed to completing review of these applications as soon as possible while ensuring that they undergo a rigorous scientific review in accordance with the law.”
The FDA determined the company’s premarket tobacco product applications (PMTAs) for the impacted products—3 menthol-flavored and 3 mixed berry-flavored products, with each flavor being offered in 3 nicotine strengths—provided insufficient evidence toward the appropriate regulation of such products relative to the public health impact they would have.
“Specifically, 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 complete switching or significant smoking reduction—relative to that of tobacco-flavored products that is sufficient to outweigh the known risks to youth,” the FDA statement read.
The agency additionally cited data from the National Youth Tobacco Survey showing that cartridge-based Vuse e-cigarettes have been the second most commonly reported vape brand used by US youth since 2021. The MDOs come 2 weeks following the FDA’s issuance of civil money penalty fines against 22 retailers due to their illegal sale of an e-cigarette brand known to strongly appeal to US youth.2
The company may be able to submit new applications for regulated use in the US for these impacted products. To date, just 23 tobacco-flavored e-cigarette products and devices have been authorized by the FDA.1
“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 a statement. “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.”