Senior officials within the Food and Drug Administration’s tobacco center were reportedly caught off guard by a recent decision that could pave the way for a surge of unauthorized electronic cigarettes and nicotine pouches into the U.S. market.
The new guidelines, published online earlier this month before the resignation of former FDA Commissioner Marty Makary, permit companies to introduce certain nicotine-based products without full regulatory vetting.
Staffers responsible for enforcing vaping regulations were not consulted on these significant changes, learning of them only the night before the document’s publication, according to two anonymous agency employees who spoke to The Associated Press.
This sudden appearance triggered internal confusion regarding the policy’s origins and authorization.
Agency officials have since convened extensive meetings to grapple with implementing the six-page memo, which marks a departure from the FDA’s long-standing requirement for scientific verification of health benefits for smokers before new products are introduced.
Drafting new policies without input from the overseeing staff is highly unusual for the FDA. Mitch Zeller, who retired as the FDA’s tobacco director in 2022, questioned the integrity of the process.
“It begs the question of whether the true subject matter experts may have actually opposed this policy and were ordered to do it anyway,” Zeller stated. “And that goes to the ability of the public to have trust and faith in institutions like FDA.”
The vaping guidelines bypassed a federally mandated period for public comment and revisions. Instead, the FDA published the finalized policy following months of complaints about Makary from industry lobbyists with close ties to the White House. Makary resigned from the agency last week.
A Health and Human Services spokesperson did not address the guidance’s origins in a written statement. Andrew Nixon, a spokesperson, said: “This approach strengthens protections against youth nicotine addiction while supporting evidence-based alternatives for adult smokers seeking to move away from combustible tobacco products.”
Messages seeking comment from Makary were not immediately returned.
For over a decade, the FDA has grappled with policing the U.S. e-cigarette market.
While most health researchers agree e-cigarettes are significantly less harmful than traditional cigarettes and are promoted as alternatives for smokers in the U.K. and other European countries, the FDA has authorized vaping products from only five companies, rejecting millions of other applications, primarily due to fruit, candy, and other sweet flavors deemed appealing to children.
Despite these rejections, unauthorized vapes remain widely available.
Recent shifts in Washington and across the U.S. reflect a changing landscape, with underage vaping among U.S. teenagers falling to its lowest level in over 10 years.
President Donald Trump came to power after vowing to “save” the vaping industry, and major tobacco companies like Reynolds American and Altria have contributed millions to political action committees supporting Trump and other administration priorities.
Despite this influence, vaping issues often took a backseat at the FDA under Makary, who, on rare occasions, voiced skepticism about data showing declining underage use.
Even as FDA staffers were prepared to shift course on flavors, Makary and other agency leaders intervened. In February, one of Makary’s deputies blocked an FDA decision that would have authorized the first fruit-flavored vapes, according to internal memos.
FDA reviewers had determined these products were unlikely to be used by children when combined with digital age-verification technology.
The mango- and blueberry-flavored products were finally approved during Makary’s last full week at the FDA, just days before the agency posted the new guidelines allowing unauthorized nicotine products.
Under the new guidance, the FDA is expected to publish a list of e-cigarettes and pouches that, while not yet authorized, will be subject to “enforcement discretion,” meaning they can be sold without regulators targeting them for removal.
While no public list of qualifying products exists, the policy is anticipated to permit new flavors previously blocked by regulators. Brian King, former FDA tobacco director now with the Campaign for Tobacco-Free Kids, observed: “What we’re seeing is a broader opening up and responsiveness to flavored products by the agency both in terms of a stronger appetite for authorization but also less appetite to take enforcement action against flavored products.”
While the FDA’s new approach breaks with precedent, its impact on the flavors already prevalent in gas stations, vape shops, and convenience stores may be limited.
The U.S. market has been inundated for years with unauthorized vapes featuring mango, gummy bear, strawberry, and dozens of other flavors. These disposable e-cigarettes filled the void left when Juul withdrew its high-nicotine flavored products from the market after their widespread use in U.S. schools around 2017. Juul now sells only FDA-authorized e-cigarettes in tobacco and menthol flavors.
Juul and other companies now see an opportunity to directly compete with disposable Chinese vapes, which some estimates suggest account for 80% of U.S. sales. Robyn Gougelet, a Juul vice president, articulated the dilemma: “The choice we face is not whether flavored vaping products should be sold in the U.S. They already are.
The choice is whether those products should be regulated and responsibly marketed — or illegal, untested, and smuggled into the country.” The FDA stated its new enforcement approach will target vapes with specific youth-appealing features, such as designs resembling children’s toys, rather than solely focusing on flavors.
Jonathan Foulds, a tobacco-addiction specialist at Penn State University, commented: “The reality is they’re just deluged by illegal products coming across the border. So they’re making it clear what should be common sense: ‘We’re going to focus on the worst actors.’”
It remains unclear whether the FDA’s new approach will be embraced by the entire vaping industry, which includes multinational tobacco companies alongside hundreds of smaller firms importing devices from China.
The guidance suggests that only e-cigarettes undergoing “scientific review” will qualify for launch without FDA authorization. Brian King noted that only a small number of applications typically reach this stage, which demands detailed health data on smokers who switch to the new product.
“This is certainly going to benefit the larger tobacco companies, which have the resources to get far enough into the application review process and thus won’t be prioritized for enforcement,” King said. Lobbyists for smaller companies express concern about being left behind. Tony Abboud of the Vapor Technology Association remarked: “The big companies would love nothing more than to see their largest swath of competitors out of the marketplace.”