FDA vaping policy blindsided regulators; staffers say memo eased market rules

The Associated Press reported that senior officials in the FDA’s tobacco center were caught off guard by a recent decision that changes how the agency handles certain nicotine-based products on the U.S. market. The guidance, posted in the days before former FDA Commissioner Marty Makary resigned, would allow companies to launch some products before regulators fully vet them, staffers told the AP.

Staffers described the internal reaction as confusion about how the policy was developed and who authorized it. According to two FDA staffers who spoke to the AP on condition of anonymity to discuss confidential agency matters, some staff tasked with enforcing vaping regulations were not consulted on the changes. They said those enforcement officials learned about the guidance only the night before it was published earlier this month.

The AP reported that the FDA later convened hourslong meetings as officials tried to figure out how to carry out the six-page memo. Staffers said the memo breaks with longstanding FDA policy that has required scientific verification of health benefits for smokers before introducing new products. “It begs the question of whether the true subject matter experts may have actually opposed this policy and were ordered to do it anyway,” said Mitch Zeller, who retired as the FDA’s tobacco director in 2022.

The AP reported that the guidance did not follow a federally required public-comment period that typically allows for public feedback and revisions. Instead, the FDA published the finalized guidance hours after media reports surfaced that President Donald Trump had approved a plan to fire Makary, and Makary resigned following months of complaints from industry lobbyists close to the White House, according to the AP.

In a written statement, a Health and Human Services spokesperson did not address the guidance’s origins but said the agency’s approach would strengthen youth protections. Andrew Nixon 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.”

The AP also described a broader context in which the U.S. vaping debate has shifted in recent months. Under the FDA’s prior approach, it has struggled to police a market where unauthorized vapes were widely available. Most health researchers agree that e-cigarettes can be less harmful than traditional cigarettes, the AP reported, and the agency had authorized products from five companies while rejecting millions of applications, in large part because flavored products with fruit or candy appeal were seen as attractive to children.

The AP said that underage vaping among U.S. teenagers has fallen to its lowest level in more than 10 years, following pandemic-related disruptions and new state and federal restrictions. It also reported that Trump campaigned on saving the vaping industry after taking power last year, and that major tobacco companies such as Reynolds American and Altria have contributed financially to political action committees backing Trump and administration priorities, including his inauguration and a proposed White House ballroom.

The AP reported that vaping issues took a back seat at the FDA during Makary’s tenure, with Makary expressing skepticism about data showing declining underage use when he addressed e-cigarettes. The AP said Makary and other agency leaders nonetheless intervened on flavors: in February, it reported that Makary’s deputy blocked an FDA decision that would have authorized the first fruit-flavored vapes, citing internal memos later released by the agency.

By the final week of Makary’s leadership, the AP said FDA approved mango- and blueberry-flavored products. It reported that the agency’s new enforcement approach is designed to publish a list of e-cigarettes and pouches that are not yet authorized but will fall under “enforcement discretion,” meaning they can be sold without regulators targeting them for removal. While the AP said there is no public list of which products could qualify, it reported the policy is expected to allow for new flavors that regulators had previously blocked.

Even if the guidance changes enforcement, it may not quickly alter what consumers can already buy. The AP reported that the U.S. market has long included unauthorized disposable vapes with flavors such as mango, gummy bear and strawberry. It reported that Juul’s high-nicotine flavored products became ubiquitous in U.S. schools beginning around 2017 before Juul pulled those products from the market, and it said Juul now sells FDA-authorized e-cigarettes only in tobacco and menthol flavors.

The AP reported that the policy could create winners and losers among vaping companies, including multinational tobacco firms with more resources to reach later stages of FDA review and smaller companies that sell imported devices from China. Brian King, former FDA tobacco director and now with the Campaign for Tobacco-Free Kids, said the guidance suggests only e-cigarettes that are under scientific review would qualify to launch without FDA authorization, and he said relatively few applications reach that stage because it requires detailed health data on smokers who switch to the new product.

King said the approach could benefit larger tobacco companies. “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,” he told the AP. Tony Abboud of the Vapor Technology Association said lobbyists for smaller companies were watching closely, saying it was too early to tell whether the policy would help or hinder them.

Robyn Gougelet, a Juul vice president, said in response to the enforcement and regulation questions that flavored vaping products are already sold in the U.S. “The choice we face is not whether flavored vaping products should be sold in the U.S. They already are,” Gougelet said. “The choice is whether those products should be regulated and responsibly marketed — or illegal, untested, and smuggled into the country.”

The AP reported that FDA says it will focus enforcement not on flavors alone but on vapes with youth-appealing features, such as designs that resemble children’s toys. Jonathan Foulds, a tobacco-addiction specialist at Penn State University, said the agency is responding to a supply of illegal products. “The reality is they’re just deluged by illegal products coming across the border,” he said.