Today, the U.S. Food and Drug Administration (FDA) authorized the marketing of seven e-cigarette products in the United States through the premarket tobacco product application (PMTA) pathway. Following an extensive scientific review, FDA issued marketing granted orders to R.J. Reynolds Vapor Company for the Vuse Alto Power Unit and six Vuse Alto tobacco-flavored pods, which are sealed, pre-filled, and non-refillable:

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%

While FDA is authorizing the marketing of these tobacco products in the United States, it does not mean these tobacco products are safe nor are they “FDA approved.” Additionally, this action is not an authorization or indication of appropriateness to market these products as modified risk tobacco products. All tobacco products are harmful and potentially addictive. Those who do not use tobacco products, especially young people, should not start.

FDA evaluates PMTAs based on a public health standard that considers, among other things, the risks and benefits of the product to the population as a whole. After reviewing the company’s applications, FDA determined there was sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act. Specifically, the applicant showed that these tobacco-flavored products have the potential to provide a benefit to adults who smoke cigarettes that is sufficient to outweigh the risks of the products, including to youth.

While FDA remains concerned about the risk of youth use of all e-cigarettes, youth are less likely to use tobacco‐flavored e-cigarette products compared to other flavors. According to the 2023 National Youth Tobacco Survey, Vuse was among the most commonly reported brands used by middle and high school students currently using e-cigarette. However, only 6.4% of students who currently used e-cigarettes reported using tobacco‐flavored products. To further mitigate youth use of these products, FDA has placed stringent marketing restrictions on the new products in an effort to prevent youth access and exposure, as it has with previously authorized products. FDA will closely monitor how these products are marketed and will act as appropriate if the company fails to comply with any applicable statutory or regulatory requirements. The agency may suspend or withdraw authorization if the agency determines that continued marketing is no longer appropriate for the protection of the public health, including if there is a notable increase in use of the products among youth or former cigarette users, or a decrease in patterns of complete switching by current cigarette users to the new products.

Today’s actions are the latest of many FDA has taken to ensure all new tobacco products marketed in the United States undergo science-based review and have received marketing authorizations by the agency. FDA has received applications for nearly 27 million deemed products and has made determinations on more than 26 million of those applications. To date, FDA has authorized 34 e-cigarette products and devices, including the seven authorized today. The agency maintains a printable one-page flyer of all authorized e-cigarette products; these are the only e-cigarette products that currently may be lawfully marketed and sold in the United States, and those manufacturing, importing, selling, or distributing e-cigarettes without the required premarket authorization risk enforcement. Those seeking a list of tobacco products—including e-cigarettes—that may be legally marketed in the United States, can visit FDA’s new Searchable Tobacco Products Database.