FDA authorizes first e-cigarette, cites benefit for smokers

Photo: The Canadian Press

For the first time, the Food and Drug Administration on Tuesday authorized an electronic cigarette, saying R.J. Reynolds’ vaping device can help smokers cut back on conventional cigarettes.

E-cigarettes have been sold in the U.S. for more than a decade with minimal government oversight or research. Facing a court deadline, the FDA has been conducting a sweeping review of vaping products to determine which ones should be allowed to remain on the market.

The agency said in September it had rejected applications for more than a million e-cigarettes and related products, mainly due to their potential appeal to underage teens. But regulators delayed making decisions on most of the major vaping companies, including market leader Juul, which is still pending.

Tuesday's decision only applies to Vuse’s Solo e-cigarette and its tobacco-flavored nicotine cartridges. The agency said data from the company showed the e-cigarette helped smokers significantly reduce their use of cigarettes.

While the products can now be legally sold in the U.S., the FDA stressed they are neither safe nor “FDA approved,” and that people who don’t smoke shouldn’t use them.

Launched in 2013, Vuse Solo is a rechargeable metallic device that is shaped like a traditional cigarette. The FDA said it rejected 10 other requests from the company for other flavored products, but did not disclose details. The agency is still reviewing the company's request to sell a menthol-flavored nicotine formula.

“Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation," said Mitch Zeller, director of the FDA’s tobacco center, in a statement.

"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.”

E-cigarettes first appeared in the U.S. around 2007 with the promise of providing smokers with a less harmful alternative to smoking traditional tobacco cigarettes. The devices heat a nicotine solution in a vapor that’s inhaled.

But there has been little rigorous study of whether e-cigarettes truly help smokers quit. And efforts by the FDA to begin vetting vaping products and their claims were repeatedly slowed by industry lobbying and competing political interests.

In recent years, the vaping market grew to include hundreds of companies selling an array of devices and nicotine solutions in various flavors and strengths. But the vast majority of the market is controlled by a few companies including Juul Labs, which is partially owned by Altria, and Vuse.

To stay on the market, companies must show that their products benefit public health. In practice, that means proving that adult smokers who use the products are likely to quit or reduce their smoking, while teens are unlikely to get hooked on them.

Kenneth Warner, a tobacco expert at the University of Michigan’s school of public health, said the news was a positive step for reducing the harms of smoking. But he lamented that only a vaping device backed by a Big Tobacco company was able to win the FDA’s endorsement.

“The demands the FDA places on companies filing these applications are so extraordinary difficult to meet that only those with huge resources and personnel — in terms of scientists, lawyers, researchers — are able to file successfully,” said Warner.

He said smaller companies and vape shops should have a separate path to get their products authorized by regulators.

The FDA declared underage vaping an “epidemic” in 2018 and has taken a series of measures aimed at the small cartridge-based devices that first sparked the problem, including limiting their flavors to tobacco and menthol. Separately, Congress raised the purchase age for all tobacco and vaping products to 21.