On October 12th, the US Food and Drug Administration issued a marketing refusal order (MDO) for six flavors of its Vuse Alto brand e-cigarette products to RJ Reynolds Vapor Co. This includes three menthol flavors and three mixed berry flavors, each offering three nicotine concentrations.



After reviewing the company's PMTA, the FDA determined that the application lacks sufficient evidence to prove that allowing the product to be marketed is suitable for protecting public health, which is a legal requirement under the 2009 Family Smoking Prevention and Tobacco Control Act.



Specifically, the evidence submitted by the applicant does not prove that menthol and mixed berry flavored products provide additional benefits for smoking cessation or significant reduction in smoking for adults compared to tobacco flavored products. The institution stated that this is sufficient to exceed the known risks faced by young people.



Matthew Farrelly, Director of the Office of the FDA Tobacco Product Science Center, said: "We review each application based on its strengths, and applicants have a responsibility to provide sufficient scientific evidence to support the products they seek to market." "If the application contains sufficient scientific evidence to meet necessary public health standards, including non tobacco flavored products, we will authorize the products. However, such evidence is lacking in this case



Vuse is the best-selling e-cigarette brand in the United States, and Vuse Alto is its most popular sub brand. In addition, the results of the National Youth Tobacco Survey (NYTS) show that Vuse e-cigarettes are a bomb based product that has become the second most commonly used e-cigarette brand among American teenagers since 2021.



These actions are one of the numerous actions taken by the FDA to ensure that any tobacco products sold in the United States undergo scientific review and obtain marketing authorization from the agency. The FDA has received over 26 million applications for certified products and has made decisions on 99% of them.



So far, the FDA has authorized 23 tobacco flavored e-cigarette products and devices, which are currently the only e-cigarettes that can be legally sold or distributed in the United States. These authorizations include other products under the Vuse brand, including tobacco flavored e-cigarettes. Vuse Vibe and Vuse Ciro devices, as well as the accompanying ink cartridges. The application for six tobacco flavored Vuse Alto products is still under FDA review.