On October 12th, the US Food and Drug Administration (FDA) issued marketing refusal orders (MDOs) for six flavored electronic cigarette products under the Vuse Alto brand of RJ Reynolds Vapor. RJ Reynolds Vapor is a subsidiary of British American Tobacco.
Electronic cigarette products have received a marketing refusal order from the FDA, which means they cannot legally enter interstate trade in the United States and cannot be marketed and sold in the US market. If these products have already been placed on the market, they must be removed from the shelves, otherwise they will face the risk of FDA enforcement actions.
The products banned this time include Vuse Alto, which has three menthol flavors and three mixed berry flavors. For banned products, RJ Reynolds Vapor can submit new PMTA applications for FDA review in the future.
The FDA stated that after reviewing the company's PMTA applications, it determined that they lacked sufficient evidence to prove that allowing the product to be marketed is suitable for protecting public health - a standard required by the 2009 Family Smoking Prevention and Tobacco Control Act.
That is to say, the FDA believes that for adult smokers who want to quit or reduce smoking, the evidence submitted by PMTA applicants does not prove that menthol and mixed berry flavored products can provide additional benefits compared to tobacco flavored e-cigarettes, and these flavors may pose more risks to minors compared to tobacco flavored e-cigarettes. Therefore, the application for these six flavored e-cigarette products is not approved.
Dr. Matthew Farrelly, Director of the Science Office of the FDA Tobacco Products Center, said, "We review each PMTA application based on its strengths. Applicants need to provide sufficient scientific evidence to support the product they are seeking to market. If the application materials contain sufficient evidence to meet the necessary public health standards, even seasoned e-cigarette products will be approved. However, this case lacks such evidence
According to the FDA, Vuse is currently the best-selling e-cigarette brand in the United States, and Vuse Alto is its most popular sub brand. The results of the National Teenager Tobacco Survey show that since 2021, Vuse, a pop-up e-cigarette brand, has become the second most commonly used brand among American teenagers.
The FDA has received over 26 million applications for certified products and has made decisions on 99% of them.
So far, the regulatory agency has only authorized 23 tobacco flavored e-cigarette products and devices to be legally sold or distributed in the United States. Authorized e-cigarettes include Vuse Vibe and Vuse Ciro devices and accessories for tobacco flavors under the Vuse brand. The application for six tobacco flavored Vuse Alto products is still under FDA review.