FDA Authorizes E-Cigarette Products For First Time
At the same time that the Food and Drug Administration eyes regulations on the vaping industry to curtail youth addiction, the agency has approved three Vuse products, saying that "the potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth."
The Hill:
FDA Authorizes An E-Cigarette For First Time, Citing Benefit For Smokers
Federal health regulators Tuesday for the first time authorized the legal marketing of an electronic cigarette, saying the product from RJ Reynolds could help addicted adult smokers. The Food and Drug Administration (FDA) said the company's refillable Vuse Solo closed device and tobacco-flavored e-liquid pods could benefit addicted adult smokers who switch by reducing their exposure to harmful chemicals. (Weixel, 10/12)
Bloomberg:
BAT’s Vuse Gets FDA Nod Amid Broad Review Of E-Cigarettes
The U.S. Food and Drug Administration authorized British American Tobacco Plc’s e-cigarette Vuse and its tobacco-flavored pods, the first major e-cigarette products cleared in a sweeping review of whether millions of cigarette alternatives have a public-health benefit. Vuse is the first vape-type product from a major company to win FDA backing to continue U.S. sales, with the agency saying it can help users reduce exposure to harmful chemicals. The FDA is working through millions of applications -- including some from BAT competitors such as Juul Labs Inc. While the products under review have already been sold in the U.S., the companies need the FDA’s approval to keep marketing them. A denial by the agency would mean companies could face enforcement action if they try to continue sales. (Kary, 10/12)
The New York Times:
F.D.A. Authorizes E-Cigarettes To Stay On U.S. Market For The First Time
“The authorized products’ aerosols are significantly less toxic than combusted cigarettes based on available data,” the F.D.A. said in a statement announcing the decision. The statement concluded, “The F.D.A. determined that the potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth.” (Richtel and Kaplan, 10/12)
The Wall Street Journal:
FDA Authorizes Tobacco-Flavored Vuse E-Cigarette, Rejects Its Fruity Versions
In an effort to curb youth vaping, the FDA last year temporarily halted the sale of sweet and fruity e-cigarette refill cartridges. Manufacturers were allowed to submit those products for the agency’s permission to resume their sales. The FDA rejected five flavors Reynolds had submitted under the Vuse Solo brand, the company said. The agency said it is still reviewing Vuse Solo’s menthol refill pods. Before the federal flavor restrictions took effect last year, the company sold Solo refills in flavors such as melon, chai, mint and berry. The FDA hasn’t yet ruled on the company’s most popular model, Vuse Alto, or two other Vuse devices. (Maloney, 10/12)
