For the first time, the Food and Drug Administration on Tuesday authorized an electronic cigarette to be sold in the United States, a significant turn in one of the most contentious public health debates in decades.
In greenlighting a device and tobacco-flavored cartridges marketed by R.J. Reynolds under the brand name Vuse, the agency signaled that it believed that the help certain vaping devices offer smokers to quit traditional cigarettes is more significant than the risks of ensnaring a new generation.
“The authorized products’ aerosols are significantly less toxic than combusted cigarettes based on available data,” the FDA said in a statement announcing the decision.
The statement concluded, “The FDA determined that the potential benefit to smokers who switch completely or significantly reduce their cigarette use, would outweigh the risk to youth.”
The watershed decision could pave the way for authorization of some other electronic cigarettes, including from the once-dominant maker Juul, to stay on the market. For more than a year, the manufacturers of e-cigarettes have been in a holding pattern — their products on the market but awaiting official authorization — as the FDA has investigated whether they were a benefit or a danger to public health.
Over the past few months, as part of that review, the agency ordered thousands of vaping products off the market, including a brand that has surpassed Juul as a favorite among teenagers for its fruity and candy flavors, Puff Bars. On Tuesday, the agency also ordered 10 other Vuse flavored products off the market but declined to say which products it rejected.
Condemnation of the decision to accept other Vuse products was swift.
“This throws young people under the bus,” said Erika Sward, national assistant vice president for advocacy at the American Lung Association. She said the concern was both with the broader logic endorsing these products but also with Vuse, which in the government’s most recent survey on youth tobacco use was found to be one of the most popular vaping brands with young people.
Vuse’s owner, R.J. Reynolds, is one of the world’s largest cigarette companies. Juul is owned by another, Altria. Sward said an industry that lied about hooking generations on a deadly product that killed millions was now positioned to control the next iteration of the nicotine market.
“The industry has been waiting for their next big thing, and they found it with e-cigarettes,” she said.
E-cigarettes first appeared in the United States around 2007 with the promise of providing smokers with a less harmful alternative to smoking traditional tobacco cigarettes. The devices heat a nicotine solution into 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 and Vuse.
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.
Kaelan Hollon, a spokesperson for Reynolds American, R.J. Reynolds’ parent, said Tuesday’s decision “represents an important moment for Reynolds” and it showed that the authorized products “are appropriate for the protection of the public health.”
The company said it is still awaiting an FDA decision on its more popular vaping device, Vuse Alto.
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.
Material from the Associated Press was used in this report.