company news about Trump Pressures FDA to Authorize Glas Flavors

Yesterday the FDA announced marketing authorization for four Glas G2 refill pods. The new pods include two menthol flavors, along with Gold and Sapphire, which are actually mango and blueberry flavors. All four pods are available in 50 mg/mL only.

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.

The pods are sealed and will only work with the Glas G2 device. The G2 device and a single tobacco-flavored pod were previously authorized by the FDA on March 18.

The G2 device uses age-gating technology that requires users to pair it with a Bluetooth-enabled smartphone, download an app, and upload a selfie and images of their drivers license. They then can then only use the G2 while it is in proximity to the phone, which, according to the FDA, "conducts random biometric check-ins to periodically confirm the registered user is the one using the device."

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

Has Trump “saved vaping”?

President Donald Trump was elected in 2024 after posting on his Truth Social platform: “I saved Flavored Vaping in 2019, and it greatly helped people get off smoking. I raised the age to 21, keeping it away from the ‘kids.’ Kamala and Joe want everything banned, killing small businesses all over the Country. I’ll save Vaping again!”

Unfortunately, the FDA commissioner he appointed, Martin Makary, disagreed on vaping. During his first year at the agency, Makary went out of his way to do the opposite of “saving vaping.” He made wild accusations about youth vaping rates and slammed vape shops, and his agency began issuing rounds of new marketing denial orders (MDOs) and conducting armed raids on vaping distributors. If anything, Makary has been even more of an anti-vaping zealot than his very zealous predecessors.

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.

That decision rankled members of Trump’s White House staff, who were acutely aware of Trump’s campaign promise, and wanted an American vape company to get a flavored vape authorization.

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.”

The FDA’s flavor problem

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.

The FDA’s own annual survey of youth tobacco use has repeatedly shown that the availability of flavored products was not a primary driver of teen uptake. But the agency has stood by its belief that flavored products—which are used by the vast majority of adult vapers—could not be allowed unless manufacturers could provide overwhelming scientific evidence that youth would be protected from them.

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.

In yesterday’s press release, the agency said its “rigorous, scientific review of these products found that the applicant sufficiently demonstrated that Glas’s device access restriction technology, combined with FDA-required marketing restrictions, is expected to effectively mitigate the ability of youth to use the product.”

If this is the standard, there is no hope for bottled e-liquids, open-system devices, or most other pod or disposable vapes.

Flavored vaping products should be allowed on the market without requiring consumers to jump through hoops to use them, and the authorization process shouldn’t require involvement by the President (or, for that matter, Senator Durbin or the Campaign for Tobacco-Free Kids).