The Food and Drug Administration issued marketing granted orders for seven e-cigarette products from R.J. Reynolds Vapor Co. They are the Vuse Alto Power Unit and six Vuse Alto tobacco-flavored pods, which are sealed, pre-filled and non-refillable.
The pods have varying nicotine strengths. Those authorized are:
- 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 move allows the products to be legally sold in the United States; however, it does not mean the products are safe or FDA approved, the agency said.
“We welcome the FDA’s decision to authorize RJR Vapor’s Vuse Alto device, as well as Golden Tobacco and Rich Tobacco flavors,” said Tadeu Marroco, chief executive of British American Tobacco (BAT), the parent company of Winston-Salem, North Carolina-based R.J. Reynolds Vapor Co. “With authorizations for Alto, Vibe, Ciro and Solo, all in tobacco flavors, BAT now has the largest portfolio of vapor market authorizations provided to any U.S. organization for premarket tobacco product applications (PMTAs).”
Marroco said the success of these legal products is dependent on the FDA “doing more” to combat the illicit marketplace of vapor products.
“By creating a future where a wide range of potentially reduced-risk products is accessible to adult smokers, we are taking a meaningful step towards building a smokeless world,” Marroco said.
The tobacco company said it continues to challenge the FDA’s marketing denial orders issued in October 2023 for Alto’s Menthol and Mixed Berry flavors.
The PMTAs submitted by R. J. Reynolds Vapor Co. in 2020 included “rigorous scientific studies for Vuse Alto,” the company said. “These build on the science submitted in the U.S. business’s earlier PMTA submission to FDA with respect to Vuse Solo, Vuse Vibe and Vuse Ciro, which were granted marketing authorization in original flavors in October 2021 and May 2022 respectively.”
“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,” the FDA said in a statement.
The agency 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.
BAT, London, owns brands including Vuse vapor products, Velo modern oral nicotine products and Pall Mall, Lucky Strike, Camel, Natural American Spirit and Newport cigarettes. Reynolds American is among it subsidiaries.
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