The Food and Drug Administration authorized three electronic cigarette products by Vuse Solo on Tuesday, citing benefits to adult smokers who are trying to quit tobacco.
Why it matters: It’s the first such move by the agency in its effort to regulate new tobacco products. While e-cigarette manufacturers have touted the vape products as safer, the FDA has previously cracked down on them amid high rates of use among teens.
- Products must be approved by the FDA to claim they help users quit smoking, according to an FDA press release.
Details: In the first greenlight since the FDA pushed e-cigarette makers to apply for approval, the agency approved Vuse Solo brand devices, which are distributed by R.J. Reynolds, a division of British American Tobacco.
- Only tobacco-flavored pods were given the go-ahead.
- The FDA also denied applications for 10 flavored Vuse Solo products.
- Tuesday’s action imposes tight marketing restrictions aimed at curbing “youth exposure to tobacco advertising,” the FDA said in a statement announcing its decision.
Of note: The FDA said the authorized products’ aerosols “are significantly less toxic than combusted cigarettes based on available data.”
What they’re saying: “Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products in a statement.
- “The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products — either completely or with a significant reduction in cigarette consumption — by reducing their exposure to harmful chemicals,” Zeller added.
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