FDA authorizes an e-cigarette for first time, saying benefit for smokers outweighs risk to youths

THE FDA AUTHORIZED ONLY TOBACCOFLAVORED NICOTINE CARTRIDGES.

The Food and Drug Administration authorized a set of e-cigarette products for sale in the United States for the first time on Tuesday after it concluded that the benefit to adult cigarette smokers outweighed the risk posed to young people.

The authorization of an e-cigarette device and two accompanying nicotine cartridge products, which are sold under the brand name Vuse by the R.J. Reynolds Tobacco Company, is a shift in the ongoing debate over e-cigarettes, fueled by criticism that tobacco companies are addicting another generation to nicotine under the guise of helping adult smokers quit.

The FDA authorized only tobacco-flavored nicotine cartridges and denied requests from R.J. Reynolds for 10 flavored products, saying that young people typically start e-cigarette use, often called vaping, not with tobacco but with flavors such as fruit, candy or mint.

A request for authorization of menthol-flavored Vuse products was still being evaluated, the FDA said.

E-cigarettes have been sold in the United States for more than a decade with little regulation, but the FDA has been conducting a major review of the products to determine which can remain on the market. Last year, it told manufacturers of e-cigarettes and other items that they would have to apply to the FDA for permission to continue selling their products. The review, covering about 2 million vaping and other noncigarette tobacco products, had a deadline of Sept. 9, after which companies were supposed to stop selling their wares or face possible FDA enforcement action, which could include fines or seizure.

In August, the FDA ordered three small ecigarette manufacturers not to sell their flavored products, saying their applications to market their products did not provide “sufficient evidence” that the benefit to adult smokers outweighed the risk to young people. It called out flavors such as Apple Crumble, Dr. Cola and Cinnamon Toast Cereal.

Since those orders, the FDA has issued denials on more than a million other flavored products, which it said similarly failed to provide evidence that the benefit to public health outweighed the risk.

Although the FDA on Tuesday said the e-cigarettes could help adult smokers reduce or eliminate their use of cigarettes, the agency also cautioned that its authorization for R.J. Reynolds to market the products in the United States hinged on the company’s adherence to requirements “aimed at reducing youth exposure and access to the products.”

Mitch Zeller, director of the FDA’s Center for Tobacco Products, said in a statement that the agency would monitor R.J. Reynolds’ marketing of the Vuse products and that if “evidence emerges of significant use” by people who had not previously used tobacco products, including young people, the FDA could withdraw its authorization.