The FDA could authorize additional vaping products in the near future, according to comments made today by the acting director of the FDA Center for Tobacco Products (CTP).
According to an X (Twitter) thread from longtime tobacco control leader Cliff Douglas, CTP Acting Director Bret Koplow told attendees at a Food and Drug Law Institute (FDLI) tobacco and nicotine policy conference that he supports “promoting a tobacco harm reduction approach to reduce cigarette smoking.”
A “remarkable change” in FDA tone
Koplow, according to Douglas, even “carefully supports the potential for increasing the range of flavored e-cigs that could be authorized for sale.”
The tiny list of FDA-authorized vaping products includes no products in flavors other than tobacco and menthol, and no bottled e-liquids at all. During Trump’s time in office, the CTP has authorized only one vaping device, the JUUL, and refills in tobacco and menthol.
“Koplow,” wrote Douglas in his X thread, “also emphasizes the need for a ‘legal marketplace’ with only authorized reduced-risk products available, supported by strong enforcement. The challenge is that to actually make this work effectively for public health purposes, [the FDA] must dramatically streamline, simplify and accelerate the review and authorization process and provide for a truly robust marketplace. Otherwise, an unregulated marketplace will thrive and these will end up being hollow words.”
It’s unclear which of these words belong to Koplow and which to Douglas, who supports allowing adult access to a variety of vapes. Nevertheless, the fact that an FDA official was dispatched to a conference with any kind of pro-vaping message marks a potential change of course.
Other FDLI conference attendees have confirmed that the acting director exhibited a “remarkable change in tone.”
However, it’s important to remember that vaping consumers and small businesses have been burned before by Trump administration promises of a “streamlined” FDA authorization process. Until we see these policies in action, it’s wise to assume that changes—if they come at all—could be a long way off.
Does Commissioner Makary support vape policy changes?
The words seem entirely at odds with those of FDA Commissioner Martin Makary, who has spread misinformation about youth vaping prevalence and vape shops, and encouraged an all-out assault on the independent vaping industry. In his Senate confirmation hearing, he promised that “people with guns” would address the problem of illegal vapes, and since being approved he has been true to his word.
Trump promised during his presidential campaign to “save vaping,” but his FDA commissioner has done everything possible to turn that promise on its head.
Since Donald Trump was sworn in as President, the FDA hasissued at least 40 marketing denial orders (MDOs) to U.S. companies, denying them permission to sell e-liquids and other vape products. The agency may have issued even more than 40 MDOs, but we can't be sure. Since Aug. 19, the FDA has stopped publishing a public list of MDOs, which it previously maintained on a CTP website page.
Vaping industry insiders say that the Trump administration’s war on “illegal Chinese vapes” has long since expanded into a war on all Chinese vaping devices. Customs and FDA border agents have begun seizing any kind of vaping product coming from China, including refillable tanks and mods used to vape American e-liquids.
In September, Makary approved raids on five vape distributors and six retailers in seven states, during which the FDA, Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), and U.S. Marshals seized more than 2.1 million supposedly “illicit” products.
The seizures included not just unauthorized Chinese disposable vapes—which Makary and U.S. Attorney General Pam Bondi have described as a "national security threat"—but also bottled e-liquid made by small American manufacturers, including some products with pending premarket tobacco applications (PMTAs).
Makary says those raids are just the beginning.
“We have to do everything,” he told the National Desk. “We have to go after the distribution networks.”
After months of bizarre anti-vaping zealotry, it’s almost impossible to imagine Makary flipping 180 degrees and signing off on streamlined reviews for flavored vape marketing applications.