By Timothy S. Donahue

Top Takeaways:

• Regulatory clash: FDA commissioner halts flavored vape authorizations despite internal scientific support
• Policy tension: White House backs expanding adult access while FDA leadership urges caution
• Market impact: Delay underscores ongoing gridlock as illicit flavored products dominate U.S. sales

A growing divide within the nation’s capital is spilling into the vape market.

The White House is pushing to expand access to flavored e-cigarettes for adults, but U.S. Food and Drug Administration Commissioner Marty Makary has blocked several pending authorizations—despite agency scientists supporting the products, according to people familiar with the matter.

At the center of the dispute is an application by Los Angeles-based vape company Glas, which has been seeking authorization for multiple flavored products for nearly five years, according to a Wall Street Journal report. FDA scientific reviewers had signed off on several flavors—including menthol, mango, and blueberry—but a memo from Makary’s office halted the approvals, citing the need for further review.

“The White House and FDA are completely aligned on expanding the availability of flavored vape products for adults, and adults only,” White House spokesman Kush Desai said, adding that the administration is working to reverse prior policies that restricted access. “The Biden administration completely disregarded evidence finding these products are beneficial for adults trying to quit smoking, and the Trump administration remains committed to rectifying this poor policymaking.”

That position reflects a broader shift under the current administration, which has signaled a more favorable stance on harm reduction and on vaping as an alternative to cigarettes. However, the FDA’s top leadership appears more cautious.

Makary intervened even after internal reviewers recommended authorization, thereby creating friction between political leadership and the agency’s scientific staff. “It appears that, for reasons unclear, FDA political leadership has overruled the expert scientific conclusions of its own tobacco scientists,” said Stacy Ehrlich, a partner at Kleinfeld, Kaplan & Beckeran, an attorney for Glas.

The delay leaves the company in what it described as “regulatory limbo,” despite submitting additional data requested by the agency—including a study of about 400 participants showing that flavored products were more effective than tobacco-flavored options at helping adult smokers switch.

In mid-March, the FDA granted marketing orders to Glas for two of its vaping products. The agency issued Marketing Granted Orders (MGOs) for the Glas G2 hardware and a Blonde Tobacco 50 mg/mL pod through the premarket tobacco product application (PMTA) pathway. Glas is the first company not owned by a major tobacco firm to receive authorization.

The dispute underscores a long-standing tension in U.S. vaping policy.

Federal regulators began cracking down on flavored e-cigarettes in 2019 amid a rise in youth use, effectively limiting the legal market to tobacco and menthol flavors. Since then, the FDA has largely declined to authorize flavored products beyond tobacco, even as industry groups argue that flavors are key to helping adult smokers transition away from combustible cigarettes.

At the same time, enforcement gaps have enabled a massive illicit market to flourish. Unauthorized flavored disposables—many imported from China—now dominate U.S. retail shelves, creating a disconnect between formal policy and market reality.

The White House appears to be working to address that imbalance. “We are doing everything we can now to get American vapes on the market,” Health and Human Services Secretary Robert F. Kennedy Jr. told lawmakers, adding that such products are being used by adults to quit smoking.

Still, internal resistance remains. “The holdup, quite frankly, is Marty Makary,” said former U.S. Senator Richard Burr, who retired from the Senate in 2023 and now leads the Coalition for Smarter Regulation of Nicotine (also known as Regulate Smarter). “We’ve hit a wall.”

The FDA has signaled potential flexibility in future policy. A draft guidance issued in March suggested the agency could consider authorizing certain flavors—such as mint or coffee—that may appeal more to adults, while continuing to avoid fruit and candy flavors more closely associated with youth use.

In a September 2024 post on Truth Social, President Donald Trump said he would “save vaping,” despite banning flavored vaping products during his first term. “I’ll save Vaping again!” Trump said in the post.

But for now, decisions remain stalled. The FDA said the flavored Glas applications are still under review, and officials emphasized that any authorization must meet the statutory standard of being “appropriate for the protection of public health.”