In a first, FDA authorizes fruit-flavored vapes for adults

The Food and Drug Administration on Tuesday authorized the first fruit-flavored vapes for adults 21 and over amid President Donald Trump’s previous vows to “save” vaping.

The agency green-lit electronic cigarettes from Los Angeles-based Glas in mango, blueberry and two varieties of menthol. The news came hours after the Wall Street Journal reported that Trump pressed FDA Commissioner Marty Makary to approve flavored vapes.

The approval marks a shift after the FDA for years worked aggressively to regulate flavored vapes, rejecting more than 1 million fruit-, candy- and dessert-flavored products, according to court filings. Nicotine companies had sued the FDA saying it unfairly shifted its standards for authorizing electronic cigarette liquids popular with teens. The Supreme Court last April unanimously backed the agency.

In the run-up to the 2024 election, Trump offered support for vaping and promised to protect the industry after a private meeting with a leading vaping lobbyist, The Washington Post reported. On Truth Social, Trump at the time wrote that he “saved Flavored Vaping in 2019” and would “save Vaping again!” But the rhetoric came after his first administration moved to crack down on vapes amid youth use and Trump signed legislation raising the age of tobacco sales to 21.

The Campaign for Tobacco-Free Kids, an advocacy group, panned the decision, saying it risks a resurgence of youth electronic cigarette use.

“Today’s decision puts at risk the progress our nation has made in reducing youth e-cigarette use,” Yolonda C. Richardson, president and CEO of Campaign for Tobacco-Free Kids, said in a statement. “It conflicts with overwhelming scientific evidence and the FDA’s own repeated conclusions that flavors pose a substantial risk to young people.”

Electronic cigarettes or vapes are generally considered less harmful than traditional cigarettes but still carry health risks. The battery-powered devices heat nicotine-infused liquid that turns into a vapor that is inhaled.

In a news release, the FDA said a “rigorous, scientific review” found a technology referred to as “device access restriction” combined with FDA’s restrictions around marketing would “effectively mitigate the ability of youth to use the product.” The technology requires the users to verify their age and identity with government-issued identification and pair the device with a smartphone via Bluetooth. The agency is requiring the company ensure its advertising is targeted to adults ages 21 and older.

“By helping to prevent youth use, device access restrictions are a potential game changer,” Bret Koplow, acting director of the FDA’s Center for Tobacco Products, said in a statement.

This is the first time the agency has authorized a fruit-flavored electronic cigarette product. The agency had previously green-lit tobacco and menthol-flavored vapes.

Kathy Crosby, CEO and president of the nonprofit Truth Initiative, called the FDA’s move a “a key test case.”

“The FDA has a responsibility to ensure that products meet a rigorous public health standard that considers both the potential benefit for adults who smoke and the risks to youth,” she said in a statement. “With these products now authorized, the agency must closely monitor how they are marketed and used to confirm that they continue to meet that high bar - and take swift action if they don’t.”

The move to allow the first menthol-flavor electronic cigarettes in 2024 drew swift criticism from some public health groups, though it signaled the agency believes the products could help adult smokers quit smoking tobacco. Meanwhile, the FDA has faced consternation on Capitol Hill for several years over the proliferation of illegal flavored electronic cigarette products, many of which are manufactured in China.

The Department of Health and Human Services did not immediately respond to a request for comment on the timing of the decision.

Lena H. Sun and Justin Jouvenal contributed to this report.