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FDA authorizes first e-cigarette product

Says benefits in helping smokers quit outweighs risk to youth

On Oct. 12, for the first time ever, the Food and Drug Administration authorized an electronic cigarette to be sold in the U.S., saying it believes the help the vaping device provides to smokers who want to quit combustible cigarettes outweighs the risk of hooking a new generation of smokers.

The agency approved Vuse’s Solo Power Unit e-cigarette and two tobacco-flavored replacement cartridges marketed by R.J. Reynolds, while denying applications for 10 flavored Vuse e-cigarettes. 

“The authorized products’ aerosols are significantly less toxic than combusted cigarettes based on available data,” the FDA said in a statement announcing the decision. The statement concluded, “The FDA determined that the potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth.”

The approved replacement cartridges each have around 5% nicotine. That is three times the nicotine concentration legally permitted in many countries. In its announcement, the FDA noted that it was aware of the heavy use of Vuse products by youth, but that it was approving “tobacco flavors,” which are less appealing to teenagers.

Hundreds of more applications are pending, and it's possible the decision could open the door for other electronic cigarettes to stay on the market. For more than a year, the manufacturers of e-cigarettes have been in a holding pattern — most of their products on the market but awaiting official authorization — as the FDA investigated whether they were a benefit or a danger to public health. As part of its review, the agency earlier ordered thousands of vaping products off the market, including a brand that has surpassed Juul as a favorite among teenagers for their fruity and candy flavors, Puff Bars. 

A statement from American Cancer Society and American Cancer Society Cancer Action Network (ACS CAN) CEO Karen E. Knudsen, MBA, PhD, follows:

“While we acknowledge the rigorous scientific process undertaken by the Food and Drug Administration to evaluate these products against the public health standard, we remain concerned about the potential implication for youth initiation and lifelong tobacco addiction to high nicotine concentration products.

“The American Cancer Society strongly recommends against dual use where consumers still use some amount of combustible tobacco alongside e-cigarettes. Tobacco use remains the leading cause of preventable cancer death. Any amount of tobacco use is dangerous. To maximize public health, it is critical to prevent youth from starting any form of tobacco including e-cigarettes and to support all those who use tobacco products in quitting.

“While the FDA has issued strict marketing restrictions in an effort to prevent youth exposure, the manufacturer of these authorized products, R.J. Reynolds, has an established track record of circumventing regulation to addict generation after generation of new customers. Continued post-market surveillance will be imperative to ensure the company complies with the regulation and further monitoring of extended use of these nicotine-containing products will be crucial to understand potential long-term health implications.

“We call on the FDA to continue to prohibit all flavors in all tobacco products to prevent additional youth – and anyone else - from starting and encouraging those who use tobacco to quit for good.”


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