There are three authorized products and they 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.
Mitch Zeller said in a statement “Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation.”
“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 advocates from the Campaign for Tabacoo-Free Kids were not impressed and their group president said in a statement:
“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.”
At least one member of Congress also expressed concern.
Rep. Raja Krishnamoorthi, member of Congress said: “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.”
“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.
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.
