HEALTH: FDA Authorizes First E-Cigarette

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dWeb.News Article from Daniel Webster dWeb.News


By Robert Preidt and Robin Foster
HealthDay Reporter

WEDNESDAY, Oct. 13, 2021 (HealthDay News) — 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 shows that its tobacco-flavored products can benefit addicted adult smokers who switch, either completely or with significant reductions in cigarette use – by reducing their exposure of harmful chemicals,” Mitch Zeller (director of the FDA’s Center for Tobacco Products) stated in a news release.

The FDA added it had denied the company permission to sell 10 flavored vaping products, but did not say what they were. These three products are less likely than the others to be popular with teens and children. The FDA has approved the products for sale in the United States. However, they are not safe or FDA-approved and should not be used by non-smokers.

“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 appropriate action, including revocation of 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. These data are very important to the FDA and they were considered when reviewing these products.

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 FDA also stated that the majority of youth and young adults who start using [vaping] flavors are fruit, candy, or mint flavors and not tobacco. These data support the FDA’s decision that tobacco-flavored products should be authorized. This is because they are less appealing to youth. Authorizing these products may also benefit adult combusted cigarettes users who switch to [vaping], or drastically reduce their cigarette intake. “

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 has been reviewing the applications and is currently deciding which products it should allow to remain 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. The strict flavor restrictions for Juul products are not applicable to disposable e-cigarettes.

More information

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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