company news about FDA Tobacco Director Says Agency Could Authorize Flavored Vapes

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). 

The marketing granted orders (MGOs) for the Glas mango and blueberry flavors mark the first FDA authorizations for any vaping products in flavors other than tobacco or menthol. 

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 Glas authorizations reportedly happened after President Donald Trump pressured FDA Commissioner Martin Makary to act.

“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.” 

Last month, the Wall Street Journal reported that Makary himself was responsible for blocking authorization of Glas’ age-gated flavored pods. The commissioner had apparently rejected the recommendation from the Center for Tobacco Products (CTP) scientific staff and decided on his own to keep the flavored products in regulatory limbo while CTP okayed the G2 device and Blonde Tobacco pod.

Does Commissioner Makary support vape policy changes?

The issue apparently boiled over last weekend, when Trump and Makary spoke directly. According to the Wall Street Journal, Trump’s advisers had counseled the President that Makary is “a problem for the administration”—partly because of the vaping issue—and Trump had “upbraided” the FDA boss.

Tuesday the FDA announced the Glas authorizations.

Tufts University School of Medicine professor Michael Siegel summed up the events nicely in a STAT News article: “I think the overall result is a good one. I’m not sure that the process by which it occurred is necessarily a good thing.”

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.

The FDA has long been opposed to allowing legal vape products in flavors other than tobacco and menthol—a stance that aligned the agency with anti-vaping tobacco control groups. In the draft of the FDA’s Deeming Rule submitted to the Obama White House in early 2016, the FDA called for removal of all flavored vape products from the market 90 days after the rule’s August 2016 implementation. That proposal was rejected by the Office of Management and Budget, and the FDA was left to find scientific excuses for what would be a de facto10-year flavor ban.

Since it began issuing marketing decisions on vaping products in 2021, the agency’s position has been that non-tobacco/non-menthol flavors pose a unique risk of creating new users, especially among youth. It has maintained this stance while youth vaping first grew to a peak and then declined to its lowest level in more than a decade. Throughout that time, flavored products have been widely available.

Makary says those raids are just the beginning.

But age-gating technology has changed that—at least a little. It seems to have given the FDA enough political cover to authorize a few flavored products, while also putting a gigantic wall between the vast majority of vapes and authorization.

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.