An e-cigarette is authorized by FDA for first time as harm reduction product

The authorization of an e-cigarette device and two accompanying nicotine cartridge products under the brand name Vuse 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 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 New York Times informs.

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.

In August, the FDA ordered three small e-cigarette manufacturers not to sell their flavored products, saying that their applications to market their products did not provide “sufficient evidence” that the benefit to adult smokers outweighed the risk to young people.

Mitch Zeller, director of the FDA’s Center for Tobacco Products, said that the agency would monitor 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.

The FDA’s assessment found that the e-cigarettes’ aerosols are significantly less toxic than combusted cigarettes. But in a statement, it emphasized that “all tobacco products are harmful and addictive and those who do not use tobacco products should not start.”
Made on