WASHINGTON, D.C. — The Food and Drug Administration recently authorized the marketing of seven e-cigarette products in the United States through the premarket tobacco product application pathway. Following a thorough scientific review, the FDA granted marketing orders to R.J. Reynolds Vapor Company for the Vuse Alto Power Unit and six Vuse Alto tobacco-flavored pods. These products are sealed, pre-filled, and non-refillable, available in the following varieties:
- 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 the FDA has allowed these products to be marketed in the U.S., this does not mean they are safe or “FDA approved.” The agency emphasizes that all tobacco products are harmful and potentially addictive. Non-users, especially young people, are advised not to start using tobacco products.
The FDA evaluates premarket tobacco applications (PMTAs) based on a public health standard. This considers the overall risks and benefits of the product to the population. After reviewing R.J. Reynolds’ applications, the FDA found enough evidence to show that marketing these products would protect public health. Specifically, the company demonstrated that these tobacco-flavored products could benefit adults who smoke cigarettes more than they pose risks, including to youth.
The FDA remains concerned about youth use of e-cigarettes. However, youth are less likely to use tobacco-flavored e-cigarettes compared to other flavors. According to the 2023 National Youth Tobacco Survey, Vuse was one of the most commonly reported brands used by middle and high school students who currently use e-cigarettes. Only 6.4% of students reported using tobacco-flavored products.
To mitigate youth use, the FDA has imposed strict marketing restrictions on these new products to prevent youth access and exposure. The agency will closely monitor how these products are marketed and will take action if the company fails to comply with regulatory requirements. The FDA may suspend or withdraw authorization if marketing is deemed no longer appropriate for public health protection, especially if there is an increase in youth usage or a decrease in cigarette users switching to these products.
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