The Food and Drug Administration announced Tuesday that it has authorized for the first time an e-cigarette company to begin marketing its products in the United States.
The FDA announced that it would permit the sale of three e-cigarette products, all owned by the company Vuse in the U.S., a significant step in how the regulatory entity is approaching cigarette alternatives. The products in question include the Vuse Solo e-cigarette and three tobacco-flavored liquid pods. The decision could set the stage for other e-cigarette companies to have their products authorized as well.
“Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products, in a press release.
Zeller went on to say that the data provided by Vuse seem to confirm that e-cigarettes help adult smokers quit cigarettes. However, the director said that the agency must “remain vigilant” and monitor whether Vuse will comply with the regulatory requirements that the FDA has implemented.
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The FDA’s analysis found that “the authorized products’ aerosols are significantly less toxic than combusted cigarettes based on available data.”
However, some parties have expressed concern that availability of e-cigarettes could entice youths to take up smoking.
“The American Lung Association is dismayed that FDA will permit three Vuse products to remain on the market in the U.S., including products that contain almost 5% nicotine,” said ALA President and CEO Harold Wimmer in a press release. “The harm these products cause to youth shows that they fail to meet the Tobacco Control Act’s public health standard.”
The FDA said that it recognizes these risks, which Wimmer expressed. However, the FDA decided that “the potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth, provided [that Vuse] follows post-marketing requirements aimed at reducing youth exposure and access to the products.”
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The FDA also filed 10 denials for flavored Vuse products, noting that teenagers were less likely to use tobacco-flavored e-cigarette products than nontobacco-flavored tobacco products. The 2021 National Youth Tobacco Survey found that most youths using e-cigarette products start with fruity or minty flavors. By only allowing tobacco-flavored products, the FCC hopes to diminish the number of youths who take up tobacco while allowing cigarette users to wean themselves off of the more harmful products.
A federal court recently decided that September 2021 would be the deadline for e-cigarette product applications — any e-cigarettes intended to appear on the market after the date require FDA authorization or will be rejected.
The FDA failed to meet the deadline, although the agency did state that it has taken action on more than 90% of the tobacco products it was considering.
