On July 18th, the U.S. Food and Drug Administration (FDA) announced on its official website the authorization of seven electronic cigarette products for sale in the United States through the Premarket Tobacco Product Application (PMTA) pathway.
Following extensive scientific review, FDA granted marketing authorization to R.J. Reynolds Vapor Company for the Vuse Alto Power Unit and six closed, pre-filled, and non-refillable Vuse Alto tobacco-flavored pods:
- Vuse Alto Pod Golden Tobacco 5%
- Vuse Alto Pod Rich Tobacco 5%
- Vuse Alto Pod Golden Tobacco 2.4%
- Vuse Alto Pod Rich Tobacco 2.4%
- Vuse Alto Pod Golden Tobacco 1.8%
- Vuse Alto Pod Rich Tobacco 1.8%
FDA emphasized that while these tobacco products have been authorized for sale in the U.S., this does not mean they are safe or FDA-approved. Furthermore, this action does not indicate that these products are endorsed as reduced-risk tobacco products. All tobacco products are harmful and potentially addictive. FDA reminds individuals, especially young people who do not use tobacco products, not to start using them.
FDA evaluated PMTA applications based on public health standards, considering the risks and benefits to the overall population. After reviewing the company’s application, FDA determined there was sufficient evidence to support allowing these products to be sold, which meets the standards required by the Family Smoking Prevention and Tobacco Control Act of 2009. Specifically, the applicant demonstrated that these tobacco-flavored products may benefit adult smokers enough to outweigh the products’ risks, including risks to youth.
Despite ongoing concerns about youth use of all e-cigarette products, the likelihood of youth using tobacco-flavored e-cigarette products is lower compared to other flavors. According to the 2023 National Youth Tobacco Survey, Vuse is one of the most commonly reported brands among middle and high school students, but only 6.4% of current e-cigarette users reported using tobacco-flavored products. To further mitigate the risk of youth using these products, FDA has imposed strict marketing restrictions on new products to prevent youth exposure and use, similar to previously authorized products. FDA will closely monitor the marketing of these products and take appropriate action if companies fail to comply with any applicable laws or regulatory requirements. This includes potentially suspending or revoking authorizations if there is a significant increase in use among youth or former cigarette users or if current cigarette users switch completely to new products.
This action is one of many measures FDA has taken to ensure all new tobacco products marketed in the United States undergo scientific review and receive marketing authorization. FDA has received nearly 27 million applications for deemed products and has made decisions on over 26 million applications.
On June 21st, FDA also issued marketing authorizations to NJOY LLC for four menthol e-cigarette products: NJOY ACE Pod Menthol 2.4%, NJOY ACE Pod Menthol 5%, NJOY DAILY Menthol 4.5%, and NJOY DAILY EXTRA Menthol 6%.
As of July 2024, FDA has authorized a total of 34 e-cigarette products and devices, including the seven products authorized today. FDA maintains a printable list of all authorized e-cigarette products, which are
