- Robert Preidt and Robin Foster
- Posted October 13, 2021
FDA Authorizes First E-Cigarette
The U.S. Food and Drug Administration on Tuesday announced its first authorization of an electronic cigarette.
The permission to sell was granted to R.J. Reynolds for three of its Vuse tobacco-flavored vaping products.
"Today's authorizations are an important step toward ensuring all new tobacco products undergo the FDA's robust, scientific premarket evaluation. 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," Mitch Zeller, director of the FDA's Center for Tobacco Products, said in an agency news release.
The FDA added it had denied the company permission to sell 10 flavored vaping products, but did not say what they were. The three authorized products are less likely to appeal to children and teens. While the products can now be sold in the United States, the FDA stressed they are neither safe nor "FDA- approved," and that nonsmokers shouldn't use them.
"We must remain vigilant with this authorization and we will monitor the marketing of the products, including whether the company fails to comply with any regulatory requirements or if credible evidence emerges of significant use by individuals who did not previously use a tobacco product, including youth," Zeller added. "We will take action as appropriate, including withdrawing the authorization."
But anti-smoking advocates were not convinced.
"While it is a positive step that FDA denied applications for 10 flavored Vuse e-cigarettes, it is concerning that a product that has three times the nicotine concentration as legally permitted in Canada, the UK and Europe was authorized. Vuse products with this level of nicotine leaves our nation's youth at an undue risk of addiction," Matthew Myers, president of The Campaign for Tobacco-Free Kids, said in a statement.
The FDA acknowledged the issue of teen vaping in its statement.
"The FDA is aware that the 2021 National Youth Tobacco Survey (NYTS) found approximately 10 percent of high school students who currently used e-cigarettes named Vuse as their usual brand. The agency takes these data very seriously and considered risks to youth when reviewing these products," the agency said.
But, "the evidence also indicated that, compared to users of non-tobacco flavored [vaping] products, young people are less likely to start using tobacco-flavored [vaping] products and then switch to higher-risk products, such as combusted cigarettes," the FDA added. "The data also suggest that most youth and young adults who use [vaping] begin with flavors such as fruit, candy or mint, and not tobacco flavors. These data reinforce the FDA's decision to authorize the tobacco-flavored products because these products are less appealing to youth and authorizing these products may be beneficial for adult combusted cigarette users who completely switch to [vaping] or significantly reduce their cigarette consumption."
The FDA also noted that it has imposed advertising restrictions on the Vuse products, to minimize exposure to youth.
Still, there's been minimal U.S. government oversight or research on e-cigarettes, even though they've been available in the country for more than a decade, the Associated Press reported.
The FDA is facing a court deadline for regulating the products and has been conducting an extensive review to decide which ones it should permit to stay on the market.
In September, the agency said it had rejected applications for more than 1 million e-cigarettes and related products, mainly because they may appeal to teens, the AP reported.
Decisions on products from most major vaping products, including Juul, are still pending.
The most popular brand among teens is a disposable e-cigarette called Puff Bar that comes in flavors like pink lemonade, strawberry and mango, the AP reported. Disposable e-cigarettes are not subject to the tight flavor restrictions of products like Juul.
Visit the the U.S. Department of Health and Human Services for more on the dangers of vaping.
SOURCE: Associated Press, Oct. 13, 2021, news release, U.S. Food and Drug Administration
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