FDA Authorizes First E-Cigarette, Cites Benefit for Smokers – NBC 5 Dallas-Fort Worth
For the first time, the Food and Drug Administration approved an electronic cigarette on Tuesday, saying RJ Reynolds’ vaping device can help smokers cut down on conventional cigarettes.
E-cigarettes have been sold in the United States for more than a decade with minimal government oversight or research. In light of a court deadline, the FDA has conducted a full review of vape products to determine which ones will be allowed to remain in the market.
The agency said in September it had turned down applications for more than a million e-cigarettes and related products, largely due to their potential appeal to underage teens. However, regulators delayed decisions on most of the major vaping companies, including the pending market leader Juul.
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 exposure to the harmful chemicals in traditional cigarettes.
Although the products are now legal to sell in the United States, the FDA stressed that they are not safe or “FDA Approved” and that people who do not smoke should not use them.
Vuse Solo was launched in 2013 and is a rechargeable metal device shaped like a traditional cigarette. The FDA said it declined 10 more requests from the company for other flavored products. The agency is still considering the company’s request to sell a menthol-flavored nicotine formula.
“Today’s approvals are an important step in ensuring that all new tobacco products undergo robust, pre-market FDA scientific evaluation,” Mitch Zeller, director of the FDA’s Tobacco Center, said in a statement.
“The manufacturer’s data shows that its tobacco-flavored products could benefit addicted adult smokers who switch to these products – either entirely or with a significant reduction in cigarette consumption.”
E-cigarettes first appeared in the US 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 is inhaled.
However, little research has been done on whether e-cigarettes actually help smokers quit smoking. And the FDA’s efforts to review vapor products and their claims have been repeatedly hampered by industry lobbying and competing political interests.
Over the past few years, the vape market has grown by hundreds of companies selling a range of devices and nicotine solutions in a variety of flavors and strengths. However, the vast majority of the market is controlled by a few companies, including Juul Labs, which is partially owned by Altria, and Vuse.
Vuse is the second largest vape brand in the US after Juul and accounts for about a third of all retail sales. Parent company RJ Reynolds sells Newport, Camel and other leading cigarettes.
A company spokesman said in a statement that the FDA’s decision confirms “that Vuse Solo products are suitable for protecting public health, which underscores years of scientific study and research.”
The company said it is still awaiting an FDA decision on its more popular Vuse Alto steamer.
To stay in the market, companies need to demonstrate that their products are good for public health. In practice, this means proving that adult smokers using the products are likely to quit or cut down on smoking, while teenagers are unlikely to get hooked.
Kenneth Warner, a tobacco expert at the University of Michigan’s School of Public Health, said the news was a positive step towards reducing the harm from smoking. But he complained that only a vaping device backed by a big tobacco company could win FDA approval.
“The requirements the FDA places on companies making these applications are so extraordinarily difficult to meet that only those with enormous resources and human resources – in terms of scientists, lawyers, researchers – can successfully apply,” said Warner .
He said smaller businesses and vape shops should have a separate path to get their products approved.
Declaring underage vaping an “epidemic” in 2018, the FDA has taken a series of measures targeting the small cartridge-based devices that first triggered the problem, including limiting their flavors to tobacco and menthol. Regardless of this, the congress raised the purchase age for all tobacco and steam products to 21.
Survey data collected earlier this year showed that Vuse was the second most popular e-cigarette brand among high school vaporizers, favored by 10%. Juul was the fourth most popular e-cigarette at less than 6%.
The FDA said it was aware of the data on Vuse’s popularity, but decided to approve its tobacco flavor “because these products are less attractive to teenagers and approval of these products may be beneficial to adult smokers”.
The most popular brand among teenagers was a disposable e-cigarette called the Puff Bar, which comes in flavors like pink lemonade, strawberry, and mango. Disposable e-cigarettes are not subject to the strict taste restrictions of products like Juul.
Overall, the survey showed a nearly 40% decrease in teenage vaping rates as many children were forced to study from home during the pandemic. Still, federal officials cautioned against interpreting the results, as it was the first time they were collected online rather than in classrooms.
___
The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
[ad_1]