FDA clears NJOY e-cigarette products after ‘extensive’ review
The FDA said marketing authorization does not mean an e-cigarette product is safe or “FDA approved.” Photo by kevsphotos/Pixabay
The U.S. Food and Drug Administration on Friday cleared four NJOY menthol-flavored e-cigarette products to be marketed in the United States.
The FDA in a statement said it issued marketing approval for NJOY Ace Pod Menthol 2.4%, NJOY Ace Pod Menthol 5%, NJOY Daily Menthol 4.5% and NJOY Daily Extra Menthol 6%, after “an extensive scientific review.”
They are the first non-tobacco flavored e-cigarette products to receive FDA marketing authorization. The two Ace products are pods that are used with another FDA-authorized NJOY device. The two Daily products are disposable e-cigarettes.
Marlboro parent company Altria Group acquired NJOY in March for $2.75 billion. The company at the time of the purchase said NJOY would enhance its “smoke-free portfolio.”
About 9.5 million adult tobacco users exclusively use e-vapor products such as NJOY, according to Altria, and e-vapor raked in about $7.5 billion in domestic sales in 2022.
The FDA said authorization does not mean the products are safe or “FDA approved,” but that NJOY simply has legal authorization to market the products in the United States.
“All tobacco products are harmful and potentially addictive,” the agency said in a statement. “Those who do not use tobacco products shouldn’t start.”
The agency said it evaluates all marketing authorization applications based on “a public health standard that considers, among other things, the risks and benefits of the product to the population as a whole.”
After reviewing NJOY’s application, the FDA said there was “sufficient evidence” that the products’ benefits to adults who use tobacco outweigh their risks.
The FDA said it remains concerned about e-vapor’s popularity among young people, and that NJOY can lose its marketing authorization if the agency finds a “notable increase” in the use of the products among youth or former smokers.
The FDA in 2020 ordered a ban on all flavored e-cigarette products, with the exception of tobacco and menthol flavors, arguing they are disproportionately marketed toward children and contribute to the “troubling epidemic” of youth e-cigarette use.