(CNN) — The US Food and Drug Administration (FDA) reported Tuesday that it licensed e-cigarette products for the first time, giving RJ Reynolds approval to sell three of its Vuse vaping products.
“While today’s action allows tobacco products to be sold in the United States, this does not mean that they are safe or ‘FDA approved’. All tobacco products are harmful and addictive and those who do not use them should not start [a usarlos]”the FDA said in a statement.
The FDA said it had denied the company permission to sell 10 flavored products, but did not say what they were. The three licensed products are all flavored tobacco, and the FDA said they were less likely to appeal to children and teens, and more likely to be used by smokers to reduce their risk of harm.
“Today’s authorizations are an important step in ensuring that all new tobacco products undergo robust scientific evaluation by the FDA prior to marketing,” said Mitch Zeller, who directs the Center for Tobacco Products in the United States, in a statement. the FDA.
“The manufacturer’s data shows that its tobacco-flavored products could benefit addicted adult smokers who switch to these products, either completely or with a significant reduction in cigarette use, by reducing their exposure to harmful chemicals.” Zeller added.
“We must remain vigilant with this authorization and will monitor the marketing of the products, even if the company violates any regulatory requirement or if credible evidence emerges of significant use by people who were not previously using a tobacco product, including young people. We will take the appropriate measures, including the withdrawal of the authorization “.
The FDA action restricts digital, radio and television advertising of products, the FDA said.
“These products were found to meet this standard because, among several key considerations, the agency determined that study participants who used only licensed products were exposed to fewer harmful and potentially harmful components in aerosols compared to cigarette users. combustion, “the FDA said.
“The FDA is aware that the 2021 National Youth Tobacco Survey found that approximately 10 percent of high school students currently using e-cigarettes named Vuse as their regular brand. The agency takes this data very seriously and considered the risks to young people when reviewing these products, “he added.
“The data also suggests that the majority of youth and young adults who use electronic nicotine delivery systems (ENDS) start out with flavors such as fruit, caramel, or mint, rather than tobacco flavors. These data reinforce the FDA’s decision. to authorize tobacco flavored products because these products are less attractive to young people and the authorization of these products may be beneficial to adult users of combustion cigarettes who switch completely to ENDS or significantly reduce their cigarette consumption. “
E-cigarette products have been on the market for years, despite the fact that none had received the official green light from the FDA. Manufacturers had until September 9 of last year to submit requests for authorization from the agency to remain in the market.
The FDA said in September that it needed more time to decide on the applications.