Senior officials within the FDA’s tobacco center were caught off-guard by a recent decision permitting more unauthorized e-cigarettes and nicotine pouches into the U.S. market. These guidelines were posted just days before former FDA Commissioner Marty Makary resigned. They will enable companies to launch certain nicotine products before full regulatory evaluation.
According to two staff members, some FDA officials responsible for vaping regulations were unaware of these changes until they were published. The sudden update caused internal confusion, raising questions about the policy’s origin and authorization. Officials have since conducted lengthy meetings to address the six-page memo that counters the FDA’s longstanding policy, which mandates health benefit verification before new products are introduced.
It’s unusual for the FDA to introduce new policies without consulting staff overseeing them. “It raises the question of whether the real experts actually opposed this policy and were ordered to implement it regardless,” stated Mitch Zeller, who retired as the FDA’s tobacco director in 2022. This situation challenges public trust in institutions like the FDA.
The new vaping guidelines bypassed the federally required public comment period, being finalized just hours after reports of President Donald Trump’s plan to fire Makary surfaced. He resigned amidst complaints from industry lobbyists close to the White House. A spokesperson from Health and Human Services claimed the approach bolsters protections against youth nicotine addiction while supporting evidence-based alternatives for adult smokers. Messages to Makary were not returned.
In the U.S., the FDA has struggled to regulate the market for over a decade. It has authorized products from five companies while rejecting many due to appealing flavors like fruit and candy. Still, unauthorized vapes remain common. Recently, underage vaping reached its lowest level in over 10 years, attributed to pandemic disruptions and new laws. Trump, backed by major tobacco companies like Reynolds American and Altria, who have heavily invested in e-cigarettes, took office last year pledging to support the vaping industry.
FDA staff planned to change course on flavors, but Makary and leaders intervened. In February, one deputy blocked an FDA decision to authorize fruit-flavored vapes, even though technology could prevent use by minors. Mango- and blueberry-flavored products were approved during Makary’s last week at the FDA, just before the new guidelines were published.
The guidance states the FDA will list e-cigarettes and pouches not yet authorized but subject to “enforcement discretion,” allowing sales without regulatory removal threats. Though a public list does not exist, this policy likely enables new previously blocked flavors. Brian King, now with the Campaign for Tobacco-Free Kids, suggests the agency is more open to flavored products, both in terms of stronger authorization intent and reduced enforcement action.
The new FDA approach may have little impact on flavors already in stores. The market has been flooded for years by unauthorized vapes with flavors like mango and strawberry. These filled the gap after Juul withdrew its high-nicotine flavored products from schools. Juul sees an opportunity to compete directly with disposable Chinese vapes, dominating U.S. sales.
“The choice is not whether flavored vaping products should be sold. They already are,” said Robyn Gougelet, a Juul VP. “The choice is regulation and responsible marketing versus illegal, untested imports.” The FDA will focus on vapes with youth-appealing features, such as designs resembling toys.
Jonathan Foulds, a tobacco-addiction specialist, said, “They’re inundated by illegal products. Focusing on the worst actors is common sense.” It’s unclear if the new policy will be embraced by the larger vaping industry. The guidance suggests only e-cigarettes under “scientific review” qualify for launch without authorization. As Brian King noted, this stage requires extensive health data, benefiting larger tobacco companies with more resources.
Lobbyists for smaller firms fear potential disadvantages. “Big companies would love to see competitors disappear,” said Tony Abboud of the Vapor Technology Association.
_The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute and the Robert Wood Johnson Foundation. The AP is solely responsible for all content._