FDA Issues Marketing Denial Orders for Vuse Alto E-Cigarette

According to an announcement from the US Food and Drug Administration (FDA) on October 12th, the FDA has issued marketing denial orders (MDOs) for six flavors of e-cigarette products under the Vuse Alto brand, a subsidiary of British American Tobacco (BAT) company, RJ Reynolds Vapor. The flavors affected include three mint and three blueberry varieties, prohibiting the company from marketing or distributing these products in the United States. Failure to comply may result in enforcement actions by the FDA. However, the company has the option to submit new applications for a reevaluation of these denied products.

The FDA has evaluated pre-market tobacco product applications (PMTAs) based on a public health standard that considers the risks and benefits of the products for the entire population. After reviewing the PMTAs from these companies, the FDA has determined that these applications lack sufficient evidence to demonstrate that allowing these products to be marketed adequately protects the public health. This standard is required by the 2009 Family Smoking Prevention and Tobacco Control Act. Specifically, the evidence submitted by the applicants did not prove that mint and blueberry flavored products provide additional benefits to adult smokers, in terms of either quitting smoking altogether or significantly reducing their smoking, compared to tobacco-flavored products known to pose risks to youth.

Dr. Matthew Farrelly, Director of the Office of Science at the FDA Center for Tobacco Products (CTP), stated:

We conduct reviews based on each application, and applicants have the responsibility to provide sufficient scientific evidence to support their product seeking approval. If an application includes sufficient scientific evidence to meet the necessary public health standards, including non-tobacco flavored products, we will authorize that product.

According to the FDA, Vuse is the most prevalent e-cigarette brand in the United States, with its sub-brand Vuse Alto being the top-selling variant. Furthermore, results from the National Youth Tobacco Survey (NYTS) in the US indicate that Vuse e-cigarette products have consistently ranked as the second most commonly used brand among young people since 2021. These products belong to the category of cartridge-based devices, utilizing replaceable pods.

According to a Reuters report, British American Tobacco company has issued a statement on their official website regarding this matter. Kingsley Wheaton, the Chief Strategy and Growth Officer of British American Tobacco, stated that...

According to the FDA, the sole reason for making this arbitrary decision is the lack of long-term consumer conversion data for these products. This decision appears inconsistent, considering the submission of a year-long data package at the Food and Drug Law Institute Tobacco and Nicotine Regulatory Product Science Workshop attended by the FDA on March 30, 2023. A summary of this data will be posted on our website in the coming days.

The British American Tobacco Company released a statement expressing its intention to challenge these rejections and promptly seek a stay of execution on the ban of menthol flavor.

The company immediately expressed their doubts about the Marketing Denial Order (MDO) issued by the FDA and is seeking a stay in its implementation. The FDA's decision denies American adult smokers access to low-risk products, going against validated science and the FDA's own goal of reducing the health impacts of tobacco use. The 250,000 pages of scientific materials submitted to the PMTA were arbitrarily rejected. However, Vuse Alto Rich Tobacco and Golden Tobacco are still undergoing FDA PMTA review.

In 2017, British American Tobacco acquired Reynolds American Inc. for $49.4 billion, marking its entry into the US market after a long absence since 2004.

It has been reported that the products mentioned in the FDA's rejection order cannot be legally marketed in the United States. If these products have already been released, they must be removed from the market or face enforcement action by the FDA. Up until now, the FDA has approved 23 e-cigarette products and devices with tobacco flavors, which are currently the only e-cigarette products that can be legally sold or distributed. These approvals include other products under the Vuse brand, such as the Vuse Vibe and Vuse Ciro devices, along with their accessories. The application for six tobacco-flavored Vuse Alto products is still under FDA review.