Washington — The Food and Drug Administration on Tuesday announced its first authorization of fruit-flavored electronic cigarettes intended for adult smokers, a major policy shift that comes after months of appeals to President Trump from the vaping industry.
The decision is certain to be opposed by health groups and parent organizations that have long pointed to flavors 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 U.S. deaths annually due to cancer, lung disease and heart disease. The battery-powered devices have been sold in the U.S. since 2007, but their potential benefits have been overshadowed for years by uptake among middle and high school students.
The newly authorized e-cigarettes come in mango, blueberry and two varieties of menthol. Los Angeles-based vaping company Glas Inc. plans to market the flavors 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-flavored vaping products. Most e-cigarettes approved 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.
The FDA stressed in a press release that it “will closely monitor how these products are marketed and will act appropriately if the company fails to comply with any applicable statutory or regulatory requirements. The FDA may suspend or withdraw authorization if the agency determines that continued marketing of the authorized products is no longer appropriate for the protection of the public health, including if there is a notable increase in use of the products among youth, or evidence that the benefits of the products no longer outweigh the risks.”
As a presidential candidate, Mr. 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-flavored products, part of a wider crackdown that is credited with helping drive down teen vaping after a surge in 2019. During his first administration, Mr. Trump put in place the first flavor restrictions on e-cigarettes and raised the age for purchasing all tobacco products from 18 to 21.
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.
But groups such as the Vapor Technology Association have met with administration officials in recent weeks calling for more action on flavors.
The Wall Street Journal reports that the FDA approval came after Mr. Trump pressured Makary to approve the flavored vapes, which he’d been refusing to do.
In March, the FDA released its first-ever guidance to industry on flavors, stating that menthol, coffee, mint and spice flavors could have a role in appealing to adult smokers. The same document also reiterated the risks of sweeter flavors that tend to appeal to teens, such as fruit, candy and dessert flavors.
The vast majority of U.S. teens who vape continue to use unauthorized fruit- and candy-flavored products, according to the latest government data. Those products are technically illegal but remain widely available in cheap, disposable brands typically imported from China.
