Matthew Perrone | Associated Press
WASHINGTON. The FDA approved e-cigarettes for the first time on Tuesday, saying RJ Reynolds’ vaping device could help smokers cut down on regular cigarettes.
E-cigarettes have been sold in the United States for over a decade with minimal government oversight or research. Faced with a court deadline, the FDA undertook a massive review of vaping products to determine which ones should be left on the market.
In September, the agency said it had turned down bids for more than a million e-cigarettes and related products, largely due to their potential appeal to underage teens. But regulators have delayed making decisions on most of the major vaping companies, including market leader Juul, which has yet to be decided.
Tuesday’s decision only applies to the Vuse Solo e-cigarette and its tobacco-flavored nicotine cartridges. The agency said the company’s data showed that the e-cigarette helped smokers significantly reduce their exposure to harmful chemicals found in traditional cigarettes.
Although these products can now be legally sold in the US, the FDA has emphasized that they are neither safe nor “approved by the FDA,” and that people who do not smoke should not use them.
The Vuse Solo, released in 2013, is a rechargeable metal device shaped like a traditional cigarette. The FDA said it turned down 10 more requests from the company for other flavored products. The agency is still considering a request from the company to sell a menthol-flavored nicotine blend.
“Today’s approvals are an important step towards ensuring that all new tobacco products pass the FDA’s rigorous scientific pre-market assessment,” said Mitch Zeller, director of the FDA’s Tobacco Center.
“The manufacturer’s data demonstrates that its tobacco-flavored products can 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 United States around 2007 with the promise of providing smokers with a less harmful alternative to smoking traditional tobacco cigarettes. The devices heat the nicotine solution to inhale vapor.
But so far, there has been no thorough research into whether e-cigarettes actually help smokers quit smoking. And the FDA’s efforts to begin validating vaping products and their requirements have been repeatedly slowed by industry lobbying and competing political interests.
In recent years, the vaping market has grown to include hundreds of companies selling a variety of devices and nicotine solutions with different tastes and strengths. But the vast majority of the market is controlled by several companies, including Juul Labs, which is partly owned by Altria, and Vuse.
Vuse is the second vape brand in the US after Juul, accounting for about a third of all retail sales. Its parent company, RJ Reynolds, sells Newport, Camel and other popular cigarettes.
A company spokesman said in a statement that the FDA decision confirms that “Vuse Solo products are suitable for protecting public health, highlighting years of research and development.”
The company said it is still awaiting an FDA decision on its more popular vaping device, the Vuse Alto.
To stay in the marketplace, companies must show that their products provide public health benefits. In practice, this means evidence that adult smokers who consume these products are more likely to quit or reduce their use, while adolescents are unlikely to be interested in them.
Kenneth Warner, a tobacco expert at the University of Michigan School of Public Health, said the news is a positive step towards reducing the harm from smoking. But he lamented that only a vaping device backed by Big Tobacco was able to get FDA approval.
“The FDA requirements for companies filing such applications are so difficult to meet that only those with huge resources and staff – in terms of academics, lawyers, researchers – can successfully apply,” Warner said.
He said small companies and vape shops should have a separate path to authorize their products.
The FDA declared juvenile vaping an “epidemic” in 2018 and took a series of measures aimed at small cartridge-based devices that were the first to cause the problem, including limiting their tastes to tobacco and menthol. In addition, Congress raised the age of purchase for all tobacco and e-cigarettes to 21.
Survey data collected earlier this year showed that Vuse is the second most popular e-cigarette brand among high school seniors with a 10% preference for e-cigarettes. Juul was the fourth most popular e-cigarette, with less than 6% of respondents.
The FDA said it was aware of the popularity data for Vuse, but decided to allow its tobacco flavor “because these products are less attractive to young people, and permission to use these products may be beneficial” for adult smokers.
The most popular brand among teenagers was a disposable electronic cigarette called Puff Bar, flavored with pink lemonade, strawberry and mango. Disposable e-cigarettes are not subject to the strict taste restrictions of products like Juul.
Overall, the study found that the number of adolescents who use vaping fell by almost 40%, as many children were forced to study at home during the pandemic. However, federal officials cautioned against interpreting the results because they were first collected online and not in classrooms.
The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.