Health

This Is the First E-Cigarette to Get an Official FDA Authorization

For the first time, the Food and Drug Administration (FDA) has authorized the marketing of e-cigarette products. The agency concluded that the three newly authorized products, all from R.J. Reynolds Vapor Company, reduce smokers’ exposure to harmful chemicals found in traditional cigarettes.

Those three products include the Vuse Solo electronic nicotine delivery system (e-cigarette) and the Vuse Solo tobacco-flavored cartridges. The Vuse cartridges contain 4.8% nicotine, which is in the moderate-to-high range. (Juul pods, for instance, come in 3% and 5% strengths, while other brands start as low as 1% and can exceed 5%.) However, along with this authorization, the FDA also denied 10 other marketing applications from R.J. Reynolds Vapor Company for flavored vape products. And the FDA is still evaluating the company’s application for its Vuse Solo menthol flavor. Cartridges with flavors other than tobacco, like candy or fruit, may be more appealing to young people.

“Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation,” Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products, said in a press release. “The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products—either completely or with a significant reduction in cigarette consumption—by reducing their exposure to harmful chemicals.”

But Zeller noted that this authorization comes with continued monitoring to make sure the company complies with these regulatory requirements. The FDA will also be on the lookout to make sure that a large number of people who never smoked previously don’t suddenly start using Vuse Solo devices and that the e-cigarettes don’t find their way to young people. If that starts happening, Zeller said, “we will take action as appropriate, including withdrawing the authorization.” (As of December 2019, you have to be at least 21 years old to buy any tobacco product—including e-cigarettes—according to federal law.) 

Vaping products like these have been available for years in the U.S. with little to no regulation. But after reports of rising rates of e-cigarette use and nicotine addiction among kids and teens, the FDA recently started reviewing the products on the market and cracking down on companies marketing their devices to young people. Ultimately, for the Vuse Solo products, the FDA found that the potential benefits to adult smokers outweigh the potential risks to kids and teens. 

And the decision confirms what many addiction specialists and harm reduction experts have said previously: While it would be ideal for people to neither smoke nor vape, e-cigarettes are the decidedly healthier option and may help some people curb their exposure to the dangerous chemicals in combustible cigarettes. There are other nicotine replacement options that are proven to help people quit smoking, like patches and lozenges, which should still be the first choice for smoke cessation. But those don’t work for everyone, and not all smokers are ready to (or even want to) completely stop using nicotine. It’s those who’ve tried the other nicotine replacements options out there without success who may get the most benefit from switching to e-cigarettes, experts told SELF previously.

But without a ton of data on each and every e-cigarette product on the market, consumers haven’t had much guidance when picking a device. And it’s been challenging to balance the preferences of adult consumers with the need to keep vapes out of kids’ hands. These actions from the FDA, including the authorization of just tobacco-flavored cartridges, may pave the way forward for a better-regulated vape market.

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