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FDA clears first electronic cigarette – WebMD


By Robert Preidt and Robin Foster
Health Day reporter

WEDNESDAY, October 13, 2021 (HealthDay News) – The United States Food and Drug Administration announced its first authorization for an electronic cigarette on Tuesday.

Sales authorization has been granted to RJ Reynolds for three of its Vuse tobacco flavored vaping products.

“Today’s approvals are an important step in ensuring that all new tobacco products undergo pre-market scientific evaluation by the FDA. cigarette consumption – by reducing their exposure to harmful chemicals, ”Mitch Zeller, director of the Center for Tobacco Products at the FDA, said in an agency press release.

The FDA added that it had denied the company permission to sell 10 flavored vaping products, but did not say what they were. All three licensed products are less likely to appeal to children and adolescents. Although the products can now be sold in the United States, the FDA has stressed that they are not safe or “FDA approved” and that non-smokers should not use them.

“We must remain vigilant with this authorization and we will monitor the marketing of products, including if the company does not comply with regulatory requirements or if credible evidence emerges of significant use by people who have not already used any tobacco product, including young people. “Zeller added.” We will take appropriate action, including revoking the authorization. “

But anti-tobacco advocates weren’t convinced.

“While it is a positive step that the FDA has turned down applications for 10 Vuse flavored e-cigarettes, it is of concern that a product with a nicotine concentration three times higher than legally permitted in Canada, the UK and the United Kingdom. Europe was cleared. Products seen with this level of nicotine puts our country’s youth at undue risk of addiction, ”said Matthew Myers, president of The Campaign for Tobacco-Free Kids, in a statement.

The FDA acknowledged the teen vaping problem in its statement.

“The FDA is aware that the 2021 National Youth Tobacco Survey (NYTS) found that approximately 10% of high school students currently use e-cigarettes named Vuse as their usual brand. The agency takes this data very seriously and took into account the risks to young people during the review. these products, ”the agency said.

But, “the evidence also indicated that, compared to users of non-tobacco flavored products [vaping] products, young people are less likely to start using tobacco [vaping] products and then switch to high-risk products, such as burnt cigarettes, ”the FDA added. “The data also suggests that most youth and young adults who use [vaping] start with flavors such as fruit, candy or mint, not tobacco flavors. These data support the FDA’s decision to allow tobacco flavored products as these products are less appealing to young people and the authorization of these products may be beneficial for adult users of burnt cigarettes who switch completely to. [vaping] or drastically reduce their cigarette consumption.

The FDA also noted that it has placed advertising restrictions on Vuse products, in order to minimize exposure of young people.

Still, there has been minimal U.S. government surveillance or research on e-cigarettes, even though they have been available in the country for more than a decade, the Associated press reported.

The FDA faces a legal deadline to regulate the products and has conducted a thorough review to decide which ones it should allow to remain on the market.

In September, the agency said it had rejected applications for more than a million electronic cigarettes and related products, mainly because they might appeal to teens, the PA reported.

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

The most popular brand among teens is a disposable e-cigarette called Puff Bar which comes in flavors like pink lemonade, strawberry and mango, PA reported. Disposable electronic 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.

THE SOURCE: Associated Press, October 13, 2021, press release, US Food and Drug Administration

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