FDA Rejects Non-Tobacco-Flavored Vuse Alto Vaping Devices, BAT Questions the Denial

The FDA has issued marketing denial orders (MDOs) for six flavors of Vuse Alto e-cigarette products under British American Tobacco (BAT). Vuse Alto is the best-selling sub-brand of VUSE. BAT stated that the company intends to challenge these denials and will immediately seek a stay of enforcement for the menthol flavor denial.

According to a news release from the U.S. Food and Drug Administration (FDA) on October 12, the FDA issued marketing denial orders (MDOs) for six flavors of Vuse Alto e-cigarettes produced by RJ Reynolds Vapor, a subsidiary of British American Tobacco (BAT). This includes three menthol flavors and three blueberry flavors, which means the company cannot market or distribute these products in the U.S., or it will face enforcement action from the FDA. However, the company can submit new applications to have these denied products reviewed again.

FDA Announcement | Image Source: FDA 

The FDA evaluates premarket tobacco product applications (PMTAs) based on a public health standard that considers the risks and benefits of the products to the entire population. After reviewing the company's PMTA, the FDA determined that these applications lacked sufficient evidence to demonstrate that allowing these products to be marketed would be appropriate for the protection of public health. This is based on the standards mandated by the Family Smoking Prevention and Tobacco Control Act of 2009. Specifically, the evidence submitted by the applicant did not demonstrate that the menthol and blueberry products provided additional benefits to adult smokers compared to tobacco-flavored products that sufficiently offset the known risks to youth.

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

“We review each application on a case-by-case basis, and it is the applicant's responsibility to provide sufficient scientific evidence to support their request for marketing. If an application contains sufficient scientific evidence to meet the necessary public health standards, including for non-tobacco flavored products, we will authorize that product.”

The FDA stated that Vuse is the most common e-cigarette brand in the U.S., and Vuse Alto is its best-selling sub-brand. Additionally, results from the National Youth Tobacco Survey (NYTS) show that since 2021, Vuse e-cigarette products have been the second most used e-cigarette brand among U.S. youth, and these products are based on replaceable pods.

According to Reuters, BAT released a statement on its website regarding this matter, with BAT's Chief Strategy and Growth Officer Kingsley Wheaton stating:

“The only reason given by the FDA for making this arbitrary decision is the lack of long-term consumer conversion data for these products. Given that a data package was submitted to the FDA at the Tobacco and Nicotine Regulatory Science Workshop on March 30, 2023, this is a capricious decision. In the coming days, we will publish a summary of this data on our website.”

BAT stated in its announcement that the company intends to challenge these denials and will immediately seek a stay of enforcement for the menthol flavor denial. 

• The company will immediately challenge the FDA's marketing denial order (MDO) and seek a stay of enforcement;

• The FDA's decision will deny adult smokers access to lower-risk products;

• This decision contradicts validated science and undermines the FDA's goal of reducing the health impacts of tobacco use;

• The 250,000 pages of scientific material submitted to the PMTA were arbitrarily dismissed;

• Vuse Alto Rich Tobacco and Golden Tobacco are still under FDA PMTA review.

In 2017, BAT acquired Reynolds American for $49.4 billion, entering the U.S. market, which it had long been absent from since 2004. #p#分页标题#e#

BAT Announcement | Image Source: BAT 

It is reported that the products in the FDA denial order cannot be legally marketed in the U.S. If the products are already on the market, they must be removed; otherwise, they will face FDA enforcement. So far, the FDA has approved 23 tobacco-flavored e-cigarette products and devices, which are currently the only e-cigarette products that can be legally sold or distributed. These authorizations include other products from the Vuse brand, including tobacco-flavored Vuse Vibe and Vuse Ciro devices and their accessories. The applications for the six tobacco-flavored Vuse Alto products are still under FDA review.

References:    【1】 BAT expresses disappointment at FDA Marketing Denial Order for Vuse Alto Menthol and Mixed Berry and will immediately seek a stay of enforcement   【2】 FDA Denies Marketing of Six Flavored Vuse Alto E-Cigarette Products Following Determination They Do Not Meet Public Health Standard      Related Articles:    【1】 U.S. Supreme Court rejects e-cigarette companies appeal FDA's strict regulation of flavored e-cigarettes   【2】 FDA cracks down on illegal e-cigarette sales: 22 retailers fined, 168 physical stores warned   【3】 CEO of FDA testing partner: Products with new technology are easier to pass PMTA applications   【4】 Exclusive interview with FDA Tobacco Center Director: "Submitting a PMTA application does not equate to legal sales"