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 connected Tuesday announced its archetypal authorization of an electronic cigarette.

The support to merchantability was granted to R.J. Reynolds for 3 of its Vuse tobacco-flavored vaping products.

"Today's authorizations are an important measurement toward ensuring each caller baccy products acquisition the FDA's robust, technological premarket evaluation. The manufacturer's information demonstrates its tobacco-flavored products could payment addicted big smokers who power to these products – either wholly oregon with a important simplification successful cigaret depletion – by reducing their vulnerability to harmful chemicals," Mitch Zeller, manager of the FDA's Center for Tobacco Products, said successful an bureau quality release.

The FDA added it had denied the institution support to merchantability 10 flavored vaping products, but did not accidental what they were. The 3 authorized products are little apt to entreaty to children and teens. While the products tin present beryllium sold successful the United States, the FDA stressed they are neither harmless nor "FDA- approved," and that nonsmokers shouldn't usage them.

"We indispensable stay vigilant with this authorization and we volition show the selling of the products, including whether the institution fails to comply with immoderate regulatory requirements oregon if credible grounds emerges of important usage by individuals who did not antecedently usage a baccy product, including youth," Zeller added. "We volition instrumentality enactment arsenic appropriate, including withdrawing the authorization."

But anti-smoking advocates were not convinced.

"While it is simply a affirmative measurement that FDA denied applications for 10 flavored Vuse e-cigarettes, it is concerning that a merchandise that has 3 times the nicotine attraction arsenic legally permitted successful Canada, the UK and Europe was authorized. Vuse products with this level of nicotine leaves our nation's younker astatine an undue hazard of addiction," Matthew Myers, president of The Campaign for Tobacco-Free Kids, said successful a statement.

The FDA acknowledged the contented of teen vaping successful its statement.

"The FDA is alert that the 2021 National Youth Tobacco Survey (NYTS) recovered astir 10 percent of precocious schoolhouse students who presently utilized e-cigarettes named Vuse arsenic their accustomed brand. The bureau takes these information precise earnestly and considered risks to younker erstwhile reviewing these products," the bureau said.

But, "the grounds besides indicated that, compared to users of non-tobacco flavored [vaping] products, young radical are little apt to commencement utilizing tobacco-flavored [vaping] products and past power to higher-risk products, specified arsenic combusted cigarettes," the FDA added. "The information besides suggest that astir younker and young adults who usage [vaping] statesman with flavors specified arsenic fruit, candy oregon mint, and not baccy flavors. These information reenforce the FDA's determination to authorize the tobacco-flavored products due to the fact that these products are little appealing to younker and authorizing these products whitethorn beryllium beneficial for big combusted cigaret users who wholly power to [vaping] oregon importantly trim their cigaret consumption."

The FDA besides noted that it has imposed advertizing restrictions connected the Vuse products, to minimize vulnerability to youth.

Still, there's been minimal U.S. authorities oversight oregon probe connected e-cigarettes, adjacent though they've been disposable successful the state for much than a decade, the Associated Press reported.

The FDA is facing a tribunal deadline for regulating the products and has been conducting an extended reappraisal to determine which ones it should licence to enactment connected the market.

In September, the bureau said it had rejected applications for much than 1 cardinal e-cigarettes and related products, chiefly due to the fact that they whitethorn entreaty to teens, the AP reported.

Decisions connected products from astir large vaping products, including Juul, are inactive pending.

The astir fashionable marque among teens is simply a disposable e-cigarette called Puff Bar that comes successful flavors similar pinkish lemonade, strawberry and mango, the AP reported. Disposable e-cigarettes are not taxable to the choky spirit restrictions of products similar Juul.

More information

Visit the the U.S. Department of Health and Human Services for much connected the dangers of vaping.

SOURCE: Associated Press, Oct. 13, 2021, quality release, U.S. Food and Drug Administration