The U.S. Food and Drug Administration has authorized the sale of an electronic cigarette for the first time, approving its claim that it could help smokers cut back on using traditional cigarettes. The FDA approved Vuse's Solo e-cigarette brand and its separate tobacco-flavored nicotine cartridges.
Based on the data submitted by R.J. Reynolds, the company that manufactures the Vuse e-cigarettes, the FDA agreed that the product will help reduce the health risk of smokers by reducing their use of traditional cigarettes. The study found that health risks can be reduced when people also reduce their exposure to the harmful chemicals in inhaling smoke from traditional cigarettes.
The FDA said it had rejected 10 other products that were submitted for review by Vuse before it approved its Solo e-cigarette line. The agency said it is still in the process of reviewing Vuse's other applications, which includes a menthol-flavored nicotine cartridge.
Behind Juul, Vuse is the second-largest vaping brand in the county. The company's products account for about a third of all e-cigarette and vaping-related sales. So far, none of Juul's products have been approved by the FDA.
The FDA's director for its tobacco center, Mitch Zeller, said that the authorization is an important step in making sure that all new e-cigarettes and electronic tobacco products will be under the agency's scientific premarket evaluation.
Zeller said the manufacturer was able to prove through its own research and data that its product could benefit nicotine-addicted adult smokers in the country who switch to its e-cigarettes. He added that the product can benefit smokers by either reducing their cigarette use or completely switching away from them with Vuse's product.
The FDA's authorization was given more than a decade when e-cigarettes were first introduced into the country. Since then, there has mostly been no regulatory oversight on the use and distribution of these products. Over the last few years, regulators have attempted to control their distribution, particularly as cases of e-cigarette use amongst children and teens increased.
A recent court order has required e-cigarette and vaping product manufacturers to submit review applications to the FDA. To date, the FDA has rejected over a million vaping products and e-cigarette applications. Analysts said the FDA's vetting process has been slow due to increased lobbying and political interests over the issue.
