The US Food and Drug Administration (FDA) has authorized e-cigarette products for the first time ever, giving permission for the sale of three vape products by e-cigarette brand Vuse.
The FDA announced on Tuesday that it had given permission to R.J. Reynolds (RJR) Vapor Company for its Vuse Solo closed electronic nicotine delivery system (ENDS) device and accompanying tobacco-flavored e-liquid pods, specifically, Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8 percent G1, and Vuse Replacement Cartridge Original 4.8 percent G2.
The decision is part of the agency’s broader review of the vaping industry, following years of pressure from politicians and public health groups to regulate the segment as strictly as other tobacco products.
“Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption – by reducing their exposure to harmful chemicals.”
“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.”
“We will take action as appropriate, including withdrawing the authorization.”
FDA denies sales of 10 flavored products
The FDA said it had denied the company permission to sell 10 flavored products but did not say what they were. The three authorized products are all tobacco flavored, and the FDA said they were less likely to appeal to adolescents, and more likely to be used by smokers to reduce their risk of harm.
“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,” said Zeller, in the statement. “The agency takes these data very seriously and considered risks to youth when reviewing these products.”
“The evidence also indicated that, compared to users of non-tobacco flavored ENDS products, young people are less likely to start using tobacco-flavored ENDS products and then switch to higher-risk products, such as combusted cigarettes. The data also suggest that most youth and young adults who use ENDS begin with flavors such as fruit, candy or mint, and not tobacco flavors.”
“These data reinforce the FDA’s decision to authorize the tobacco-flavored products because these products are less appealing to youth and authorizing these products may be beneficial for adult combusted cigarette users who completely switch to ENDS or significantly reduce their cigarette consumption.”
Growing number of teenagers in UAE, GCC attracted to vaping products
Al Arabiya English reported this week how a growing number of teenagers across the United Arab Emirates and wider GCC are being attracted to vaping products as a “fashionable and attractive” alternative to cigarettes, according to experts.
Doctors in the UAE are warning that the flavored options are enticing many adolescents to try the battery-operated e-cigarettes, with many falsely believing vaping is a safe alternative to traditional nicotine products.
However, they warn that vapes – which have cartridges filled with a liquid that usually contains nicotine, flavoring and chemicals - are still harmful products for a user of any age.