The US Food and Drug Administration said Tuesday it had authorized e-cigarette products for the first time ever, giving permission to R.J. Reynolds to sell three of its Vuse vape products.
“While today’s action permits the tobacco products to be sold in the U.S., it does not mean these products are safe or ‘FDA approved.’ All tobacco products are harmful and addictive and those who do not use tobacco products should not start,” 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 authorized products are all tobacco flavored, 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 toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation,” Mitch Zeller, who heads FDA’s Center for Tobacco Products, said in a statement.
“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,” Zeller added.
The Campaign for Tobacco-Free Kids, which advocates for the abolition of tobacco products, was not impressed.
“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,” the group’s president, Matthew L. Myers, said in a statement.
At least one member of Congress also expressed concern.
“FDA has turned its back on the public health by approving a high-nicotine e-cigarette. Many countries around the world have capped the amount of nicotine allowed in e-cigarettes, which allowed them to avoid a youth vaping epidemic,” Rep. Raja Krishnamoorthi (D-IL), chairman of the House Oversight Committee’s Subcommittee on Economic and Consumer Policy, said in a statement.
“I’ve been pushing to lower nicotine levels in the United States for years. FDA has ignored the data and missed another opportunity to address the youth vaping epidemic.”
The FDA said it would keep an eye on the marketing of the products.
“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.”
The FDA’s action restricts digital, radio and television advertising for the 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 the authorized products were exposed to fewer harmful and potentially harmful constituents from aerosols compared to users of combusted cigarettes,” the FDA said.
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“The FDA is aware that the 2021 National Youth Tobacco Survey found approximately 10 percent of high school students who currently used e-cigarettes named Vuse as their usual brand. The agency takes these data very seriously and considered risks to youth when reviewing these products,” it added.
“The data also suggest that most youth and young adults who use ENDS (electronic nicotine delivery system products) 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.”
E-cigarette products have been allowed to remain on the market for years, even though none has been given the official green light by the FDA until now. Manufacturers were given until September 9 of last year to submit applications for the agency’s authorization to remain on the market.
The FDA said in September it needed more time to decide on the applications.
It has yet to decide on the biggest players in the e-cigarette market, including Juul.