FDA Authorizes First E-Cigarette

By Robert Preidt and Robin Foster
HealthDay Reporter

WEDNESDAY, Oct. 13, 2021 (HealthDay News) — The U.S. Food and Drug Administration on Tuesday introduced its first authorization of an digital cigarette.

The permission to promote was granted to R.J. Reynolds for 3 of its Vuse tobacco-flavored vaping merchandise.

“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, stated in an company information launch.

The FDA added it had denied the corporate permission to promote 10 flavored vaping merchandise, however didn’t say what they have been. The three approved merchandise are much less more likely to attraction to kids and youths. While the merchandise can now be bought within the United States, the FDA harassed they’re neither secure nor “FDA- approved,” and that nonsmokers should not 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 weren’t satisfied.

“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, stated in a statement.

The FDA acknowledged the difficulty of teenybopper vaping in its assertion.

“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 company stated.

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 additionally famous that it has imposed promoting restrictions on the Vuse merchandise, to attenuate publicity to youth.

Still, there’s been minimal U.S. authorities oversight or analysis on e-cigarettes, regardless that they have been out there within the nation for greater than a decade, the Associated Press reported.

The FDA is going through a courtroom deadline for regulating the merchandise and has been conducting an intensive evaluation to resolve which of them it ought to allow to remain available on the market.

In September, the company stated it had rejected purposes for greater than 1 million e-cigarettes and associated merchandise, primarily as a result of they could attraction to teenagers, the AP reported.

Decisions on merchandise from most main vaping merchandise, together with Juul, are nonetheless pending.

The hottest model amongst teenagers is a disposable e-cigarette referred to as Puff Bar that is available in flavors like pink lemonade, strawberry and mango, the AP reported. Disposable e-cigarettes aren’t topic to the tight taste restrictions of merchandise like Juul.

More data

Visit the the U.S. Department of Health and Human Services for extra on the dangers of vaping.

SOURCE: Associated Press, Oct. 13, 2021, information launch, U.S. Food and Drug Administration

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