By Timothy S. Donahue

Top Takeaways:

• Internal split: FDA scientists backed authorization for Glas’s age-gated flavored pods, but senior leadership stopped the orders
• Public health clash: Glas says its PMTA showed adult switching benefits and 100% effective youth-access controls in testing
• Regulatory limbo: The company’s flavored pods remain pending nearly five years after filing, despite internal recommendations to grant them

A small California vape maker is accusing the U.S. Food and Drug Administration of sidelining its own science after newly released internal records showed agency reviewers backed authorization for several flavored Glas products that were later blocked by senior leadership.

The story centers on Glas Inc.’s premarket tobacco product application (PMTA) for its G2 system, submitted July 21, 2021, covering an age-gated device and eight pod products. Company emails and FDA memos obtained through a Freedom of Information Act request show that the Center for Tobacco Products’ (CTP) Office of Science (OS) initially advised granting marketing orders for all eight SKUs on Dec. 18, 2025.

Then, on Feb. 17, 2026, OS Director Matthew Farrelly signed off on authorizing six items: the device, four flavored (two menthol-flavored) pods, and one tobacco-flavored pod, while pausing two other tobacco-flavored pods for more review tied to cancer-risk calculations.

That track didn’t last. In a separate memo dated March 11, Acting CTP Director Bret Koplow wrote that Principal Deputy Commissioner Sara Brenner had instructed the agency on Feb. 19 (scroll down) to “refrain from issuing” marketing granted orders (MGOs) for the four flavored pod products: Gold, Sapphire, Fresh Menthol, and Classic Menthol. The result was that FDA issued marketing granted orders only for the Glas G2 device and the Blonde Tobacco pod on March 12.

From Glas’s point of view, what looked like a slow review process became a test of whether the PMTA system was being run consistently. “Glas is concerned that the Brenner Memo does not fully account for the science and evidence in the record,” the company wrote in an April 7 letter to FDA Commissioner Marty Makary, Koplow, and agency counsel.

It added that the outcome was “difficult to reconcile with both the FDA’s own review process and the fulsome analysis and recommendations of the agency’s scientific staff.” The internal documents suggest the disagreement wasn’t about clearing everything at once. Farrelly’s Feb. 17 memo separated the products, six he believed should be authorized, and two tobacco-flavored pods, Blue Tobacco and Signature Tobacco, that he said should be examined longer because of higher estimated cumulative excess lifetime cancer risk values.

He also made clear he didn’t want the two to delay the rest: “I do not want to hold up authorizations for the other products.” Those “other products” included the four pods later blocked by Brenner’s directive. The FDA records describe them as Gold 50 mg/mL (mango), Sapphire 50 mg/mL (blueberry), Fresh Menthol 50 mg/mL, and Classic Menthol 50 mg/mL. In that group, Blonde Tobacco was the only pod that ultimately received an order.

Glas argues the pause is hard to square with what it says is the core point of the G2 system. For years, the company has pitched it as a response to the FDA’s concerns around youth access and counterfeit products in the electronic nicotine delivery system (ENDS) space. In letters to Secretary of Health and Human Services(HHS) Robert F. Kennedy Jr. and FDA officials, Glas described embedded age and identity verification before first use, continued user authentication, counterfeit cartridge detection, cartridge identification to prevent unauthorized reuse, and the ability to deactivate the device remotely. Glas also says FDA placed the product in an expedited lane as a “product with merit” because of these access controls.

In its April 7 letter, Glas also claims its application fits with the framework that the FDA later described in the March 2026 draft guidance on flavored ENDS and youth risk. The company says the FDA asked for proof that the products could help adult smokers switch or reduce cigarette use, and that its PMTA included a three-month randomized switching study of 400 exclusive heavy smokers.

According to Glas, after three months, 13% to 21% of participants using Glas products quit smoking entirely. It also reports that 45% to 46% cut daily cigarettes by at least half, and that 79% to 92% showed some degree of reduction when combined benefit measures were used. Glas says the largest gains appeared with menthol and flavored products.

The company points to another actual-use study, which it says showed smokers using Gold pods reduced daily cigarette use by 73%, while smokers using Sapphire pods reduced it by nearly 25%. It also cites a perception study it claims found interest among smokers who wanted to quit within 12 months, but little interest among youth, former smokers, and people who never smoked.

Glas says its population-health modeling predicted fewer deaths and fewer years of life lost if smokers switched from cigarettes to Glas G2 products, with extra public-health benefit attributed to the age-gating features compared with ENDS products that lack similar controls.

On youth access, Glas says the evidence is stronger still. The company told the FDA it ran multiple functional and age-verification tests where no underage participants could activate the device. In the April 7 letter, Glas quoted language it attributes to the FDA’s technical review, including that “the age-gating technology combined with the marketing restrictions … are expected to sufficiently mitigate the risk to youth,” and that “100% of youth and young adults below the minimum age of sale failed age-verification.”

Brenner’s memo, though, took a different stance. As Glas quotes it, Brenner wrote that the FDA has “very little experience evaluating device access restrictions in the context of ENDS” and needed “additional time to consider” the four non-tobacco products, directing CTP not to issue MGOs for them.

That split inside the agency is now feeding a larger political conflict over flavored vaping policy within the administration. A Wall Street Journal report claimed the White House has pushed to broaden access to flavored vape products for adults, while Makary has opposed authorizing new flavors and blocked that effort.

The same report said White House spokesman Kush Desai described the administration and the FDA as “completely aligned on expanding the availability of flavored vape products for adults, and adults only,” while Kennedy told lawmakers, “We are doing everything we can now to get American vapes on the market. People are using those vapes to quit smoking, which is something that we like.”

Glas attorney Stacy Ehrlich told the Journal, “It appears that, for reasons unclear, FDA political leadership has overruled the expert scientific conclusions of its own tobacco scientists.”

One thing that makes the Glas situation stand out is the amount of documentation available. In a March 23 letter to Kennedy, Glas says the FDA contacted the company on Dec. 17, 2025, to set up a teleconference for Dec. 19, but canceled it just hours before it was scheduled to take place. The next day, the FDA posted on its authorized products webpage several Glas products among “E-Cigarettes Authorized by the FDA,” including Blonde Tobacco, Classic Menthol, Fresh Menthol, the Glas G2 device, Gold, and Sapphire.

After Glas asked what was going on, Koplow replied: “The Glas products have not been authorized. The application remains pending. The website is being immediately corrected.” Glas says that sequence, scientific approval, a planned call, a public listing, then a reversal, shows the agency was ready to proceed, but something or someone was holding them back.

The company is now characterizing the continuing delay as more than bad decision-making, arguing it raises an Administrative Procedure Act problem. In its March 23 and April 7 letters, Glas argues the FDA missed the statutory 180-day PMTA deadline by years and then overrode scientific staff without a clear public explanation.

Glas says the application has been under review for almost five years, leaving its products, in the company’s words, in “regulatory limbo.”

Still, the broader stakes are obvious. Glas is a small, independent company that has poured millions of dollars into a vaping device designed to address the FDA’s concerns about youth access, only to have the flavored products central to its argument about adult switching halted after the scientific review appeared to be finished.

Whether FDA ultimately authorizes those pods, denies them, or leaves them pending, the internal records now sharpen the question hanging over the ENDS market: when flavored products reach the commissioner’s office, how much weight does the agency’s scientific review really carry?

This story was updated to add links to the memos and letters.