Menthol-flavoured vapes have been approved by the Food And Drug Administration (FDA) in the U.S. for the first time.
The move supports the vaping industry’s assertion that vapes can drastically reduce the harms of smoking, which kills eight million people a year - including 480,000 in the U.S.
To legally market a new tobacco product in the U.S., a company must receive a written marketing order from the FDA.
Four approved menthol products
The new approval includes two disposable vapes and two pre-filled vape pods manufactured by NJOY, a subsidiary of tobacco giant Altria Group, which makes Marlboro and some menthol-flavoured cigarettes.
Matthew Farrelly, a top science official with the FDA’s Centre for Tobacco Products, said in a statement that “after rigorous scientific review,” the agency concluded that the benefit of adult smokers switching to vapes outweighed the risks to young people.
He said: “.. evidence submitted by the applicant showed that these menthol-flavoured products provided a benefit for adults who smoke cigarettes relative to that of the applicant’s previously authorised tobacco-flavoured products - in terms of complete switching - that is sufficient to outweigh the risks of the product, including youth appeal.”
He added that Altria’s data showed NJOY vapes helped smokers to reduce their exposure to the harmful chemicals in traditional cigarettes.
In recent years, the FDA has cited public health risks in denying marketing approvals for thousands of vapes - until Friday, it had approved just 23 tobacco-flavoured products.
An ‘important option’ for adult smokers
The Altria Group said in a statement that the FDA’s latest action provides an important option for adults looking to lessen the health consequences of tobacco use.
“We believe that, for tobacco harm reduction to succeed, adult smokers must have access to a robust marketplace of FDA-authorised smoke-free alternatives,” said Paige Magness, senior vice president of regulatory affairs for Altria Client Services.
“FDA authorization of NJOY menthol e-vapour products provides adult smokers and vapers with regulated alternatives to the illicit flavoured disposable e-vapor products on the market today.”
Reviews of other decisions
The U.S. Supreme Court is currently weighing up whether to review conflicting lower-court decisions regarding FDA regulation of vapes.
In January, a divided U.S. Court of Appeals for the 5th Circuit ordered the FDA to reconsider its decision prohibiting two companies from marketing their vape products.
In a stinging decision, the majority said the agency’s application process sent manufacturers on a “wild goose chase” of requirements.
The FDA is under mounting pressure to finish reviewing applications from companies seeking to market vape products. During a Senate Judiciary Committee hearing this month, senators ripped into the FDA over delays in reviewing company applications. They said it had caused a proliferation of illegal flavoured vape products, many manufactured in China.
Days before the Senate hearing, the FDA and federal law enforcement announced the creation of a task force to crack down on the flood of illegal vapes in tobacco shops and online marketplaces.
The FDA also recently reversed a decision to ban vape products made by Juul Labs.
