The Food and Drug Administration on Tuesday authorized R.J. Reynolds Vapor Companies' Vuse e-cigarette and three tobacco-flavored e-liquid pods in its first e-cigarette authorization. File Photo by sarahjohnson1/Pixabay
Oct. 12 (UPI) -- The U.S. Food and Drug Administration on Tuesday authorized e-cigarette products for the first time in history.
The agency announced that R.J. Reynolds Vapor Companies' Vuse Solo e-cigarette and three tobacco-flavored e-liquid pods had been approved to be marketed and sold after demonstrating that marketing of the new tobacco product would be "appropriate for the protection of public health."
"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," said Mitch Zeller, director of the FDA's Center for Tobacco Products.
Zeller added the authorization was "an important step toward ensuring" all new tobacco products undergo FDA evaluation.
The FDA also denied RJR permission to sell 10 flavored products, acknowledging a 2021 National Youth Tobacco Survey that found approximately 10% of high school students who use e-cigarettes identified Vuse as their brand.
"The evidence also indicated that, compared to users of non-tobacco flavored [electronic nicotine delivery system] products, young people are less likely to start using tobacco-flavored ENDS products than switch to higher-risk products such as combusted cigarettes," the FDA said.
Additionally, the FDA noted that while the action allows tobacco products to be sold in the United States it does not mean they are safe or "FDA approved" noting that all tobacco products are "harmful and addictive and those who do not use tobacco products should not start."
Tuesday's action restricts digital, radio and television advertising for the products and the FDA said it will continue to monitor the products and may suspend or withdraw the marketing order if it determines the marketing is no longer appropriate for the protection of public health.
"We must remain vigilant with this authorization and we will monitor the marketing of the products, including whether the company fails to comply with any regulatory requirements or if credible evidence emerges of significant use by individuals who did not previously use a tobacco product, including youth," Zeller said.
The Campaign for Tobacco-Free Kids issued a statement Tuesday, saying that the FDA's decision leaves children at risk of addiction.
"While it is a positive step that FDA denied applications for 10 flavored Vuse e-cigarettes, it is concerning that a product that has three times the nicotine concentration as leally permitted in Canada, the U.K. and Europe was authorized," said Matthew L. Myears, the organization's president. "Vuse products with this level of nicotine leave our nation's youth at an undue risk of addiction."