FDA Authorizes First E-Cigarette – WebMD

Written by Robert Pridet and Robin Foster
HealthDay reporter

WEDNESDAY, Oct. 13, 2021 (HealthDay News) — The U.S. Food and Drug Administration on Tuesday announced its first authorization to use an electronic cigarette.

Permission to sell has been granted to RJ Reynolds for three Vuse tobacco flavored products.

“Today’s permits are an important step toward ensuring that all new tobacco products undergo robust, scientific premarket evaluation from the Food and Drug Administration. Manufacturer data demonstrates that their tobacco-flavored products can benefit addicted adult smokers who switch to these products—either fully or with a significant reduction In an agency news release, Mitch Zeller, director of the Food and Drug Administration’s Center for Tobacco Products, said in an agency news release, cigarette consumption — by reducing their exposure to harmful chemicals.

The Food and Drug Administration added that it refused to allow the company to sell 10 flavored e-cigarette products, but did not say what they were. The three approved products are unlikely to be attractive to children and teens. While the products can now be sold in the United States, the Food and Drug Administration has confirmed that they are neither safe nor “FDA approved,” and that non-smokers should not use them.

“We must remain vigilant about this mandate and will monitor the marketing of the products, including whether the company is not complying with any regulatory requirements or if credible evidence of significant use by individuals who have never used a tobacco product, including young adults, has emerged,” Zeller added. “. We will take appropriate action, including withdrawing the authorization.”

But anti-smoking advocates were not convinced.

“Although the FDA’s refusal of 10 orders for Vuse flavored e-cigarettes is a positive step, it is about a product with three times the concentration of nicotine as legally allowed in Canada, the UK and Europe,” he said. Matthew Myers, president of Campaign for Tobacco Free Kids, said in a statement that nicotine is leaving our nation’s youth at risk of addiction.

The US Food and Drug Administration (FDA) acknowledged the issue of teen vaping in its statement.

“The FDA is aware that the 2021 National Youth Tobacco Survey (NYTS) found nearly 10 percent of high school students who currently use e-cigarettes called Vuse as their regular brand. The agency takes this data seriously and considers the risks to Young when auditing agency said.

But “evidence has also indicated this, compared to non-tobacco flavor users.” [vaping] Products, young people are unlikely to start using tobacco flavor [vaping] The products then switch to high-risk products, such as burning cigarettes. “The data also indicates that most young people and young adults who use [vaping] Start with flavors like fruit, candy, or mint, not tobacco flavors. This data reinforces the FDA’s decision to license tobacco-flavored products because these products are less attractive to young people and authorization of these products may be beneficial for adult users of burning cigarettes who are completely converting to tobacco. [vaping] or drastically reduce cigarette consumption.

The FDA also noted that it has restricted advertising on Vuse products to reduce exposure to young adults.

Still, there is minimal oversight or research by the US government about e-cigarettes, even though they have been available in the country for more than a decade, News agency mentioned.

The Food and Drug Administration is facing a court deadline to regulate products and has conducted a comprehensive review to determine which products should allow them to remain on the market.

In September, the agency said it was rejecting applications for more than 1 million e-cigarettes and related products, mainly because they might appeal to teens. AP mentioned.

Product decisions for most major vaping products, including Juul, are still pending.

The most popular brand among teens is the disposable e-cigarette called Puff Bar which comes in flavors like pink lemonade, strawberry and mango, AP mentioned. Disposable e-cigarettes are not subject to the strict flavor restrictions of products like Juul.

more information

Visit the US Department of Health and Human Services to learn more about the dangers of vaping.

Source: News agency, October 13, 2021, press release, US Food and Drug Administration


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