The decision is certain to be opposed by health groups and parent organisations that have long pointed to flavours as the driver behind underage vaping in the U.S. But the federal action comes as teen vaping rates have dropped to a 10-year low and manufacturers have pushed the Republican administration to loosen restrictions on their products.
Vaping companies have long made the case that their products can help blunt the toll of smoking among adults, which is blamed for 480,000 US deaths annually due to cancer, lung disease and heart disease. The battery-powered devices have been sold in the US since 2007, but their potential benefits have been overshadowed for years by uptake among middle and high school students.
The newly authorised e-cigarettes come in mango, blueberry and two varieties of menthol. Los Angeles-based vaping company Glas Inc. plans to market the flavours under the names Gold, Sapphire, Classic Menthol and Fresh Menthol, according to the FDA release.
Previously, the FDA had only granted permission to tobacco or menthol-flavoured vaping products. Most e-cigarettes OK’d by regulators come from large manufacturers, including Juul and Altria.
Tuesday’s announcement is not an approval or endorsement, and the FDA reiterated that the Glas vapes are only intended for adults interested in quitting or cutting back on cigarettes.
The FDA suggested the company’s digital age-verification system makes it unlikely the products will be picked up by underage users. Users must first verify their age with a government ID on their cellphone. The e-cigarettes can then only be used when connected via Bluetooth to the phone of the verified user.
The FDA’s OK of the new fruity products will be “a key test case,” said Kathy Crosby of the Truth Initiative, an anti-tobacco nonprofit.
“Ultimately, it’s critical that we remain vigilant in protecting young people, including closely monitoring the use of authorized products,” Crosby said in an emailed statement.
As a presidential candidate, Trump vowed to “save” vaping and won backing from e-cigarette companies, shop owners and vaping enthusiasts.
Under President Joe Biden, the FDA denied more than a million marketing applications for candy- or fruit-flavoured products, part of a wider crackdown that is credited with helping drive down teen vaping after a surge in 2019. During his first administration, Trump put in place the first flavour restrictions on e-cigarettes and raised the age for purchasing all tobacco products from 18 to 21.
But action on vaping and other tobacco policies has largely taken a backseat under FDA Commissioner Marty Makary, who has focused on a slate of other priorities, including restricting COVID-19 vaccines, phasing out artificial food dyes and speeding up approval of some innovative drugs.
Groups such as the Vapor Technology Association have met with administration officials in recent weeks, calling for more action on flavours.
In March, the FDA released its first-ever guidance to industry on flavours, stating that menthol, coffee, mint and spice flavours could have a role in appealing to adult smokers. The same document also reiterated the risks of sweeter flavours that tend to appeal to teens, such as fruit, candy and dessert flavours.
The vast majority of US teens who vape continue to use unauthorised fruit- and candy-flavoured products, according to the latest government data. Those products are technically illegal but remain widely available in cheap, disposable brands typically imported from China.
