FDA Authorizes 7 Tobacco-flavored Vuse E-cigarettes For Sale in The U.S., Bringing The Number Of Authorized Products To 34

FDA authorizes 7 tobacco-flavored Vuse e-cigarettes for sale in the U.S., bringing the number of authorized products to 34

The U.S. FDA has approved seven Vuse Alto e-cigarette products from Reynolds Tobacco for sale in the United States. Currently, the FDA has authorized 34 e-cigarette products and devices, including the seven products authorized today.

 

On July 18, the U.S. Food and Drug Administration (FDA) official website announced that seven e-cigarette products were authorized for sale in the United States through the Premarket Tobacco Product Application (PMTA) path.

 

After an extensive scientific review, the FDA issued marketing authorization to R.J. Reynolds Vapor Company for the Vuse Alto Power Unit and six enclosed, prefilled, 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%

The FDA emphasizes that while the FDA authorizes these tobacco products for sale in the United States, this does not mean that these tobacco products are safe or that they are "FDA-approved." Additionally, this action does not mean that these products are appropriate for marketing as reduced-harm tobacco products. All tobacco products are harmful and potentially addictive. The FDA reminds people who do not use tobacco products, especially young people, that they should not start using them.

 

The FDA evaluates PMTAs based on public health criteria, which considers the risks and benefits of the product to the population as a whole. After reviewing the company's application, the FDA determined that there is sufficient evidence to show that allowing these products to be marketed will help protect the public health, a standard required by the Family Smoking Prevention and Tobacco Control Act of 2009. Specifically, the applicant showed that these tobacco-flavored products have the potential to provide sufficient benefits to adults who smoke that outweigh the risks of the products, including risks to youth.

 

While the FDA remains concerned about the risks of all e-cigarette products to youth, youth are less likely to use tobacco-flavored e-cigarette products than other flavors. According to the 2023 National Youth Tobacco Survey, Vuse is one of the brands most commonly reported by middle school and high school students. However, only 6.4% of students who currently use e-cigarettes report using tobacco-flavored products. To further reduce the risks of youth use of these products, the FDA has imposed strict marketing restrictions on the new products to prevent youth access and use, just as it did for previously authorized products. The FDA will closely monitor the marketing of these products and will take appropriate action if the company fails to comply with any applicable legal or regulatory requirements. This includes the possibility of suspending or revoking the authorization if it finds a significant increase in the use of these products by youth or former cigarette users, or a decrease in the full switching pattern of current cigarette users to the new products.

 

This action is one of many steps the FDA has taken to ensure that all new tobacco products sold in the United States undergo scientific review and receive marketing authorization. The FDA has received nearly 27 million applications for deemed products and has made decisions on more than 26 million applications.

 

On June 21, the FDADA issued a marketing authorization order 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%.

 

To date, the FDA has authorized 34 e-cigarette products and devices, including the seven products authorized today. The FDA maintains a one-page printable flyer of all authorized e-cigarette products; these are the only e-cigarette products that can be legally sold and distributed at this time, and those who manufacture, import, sell, or distribute e-cigarettes without premarket authorization face enforcement risks.

 

List of the only e-cigarette products authorized by the FDA for sale in the United States as of July 2024:

List of the only e-cigarette products authorized by the FDA for sale in the United States: Source: FDA official website