By Timothy S. Donahue
Top Takeaways:
New PMTA authorization: The FDA handed Marketing Granted Orders to Glas G2 device and a Blonde Tobacco 50 mg/mL pod, bringing the total number of authorized ENDS products in the U.S. to 41.
Small manufacturer breakthrough: California-based Glas Inc. becomes the only independent vape company—not affiliated with major tobacco firms—to secure FDA authorization.
Flavor caution continues: Despite speculation, the agency authorized only a tobacco-flavored pod, reinforcing its cautious stance on flavored ENDS products.
The industry had an idea it might happen. The U.S. Food and Drug Administration has granted marketing orders to California-based vape manufacturer Glas Inc. for two of its vaping products. The device and pod were added to the agency’s list of authorized products.
According to the FDA’s updated database posted on March 12, 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.
“In light of the FDA’s decision, we remain confident that there is an imminent path to authorization for the full suite of Glas G2 products – including our menthol and flavored pods,” Sean Greenbaum, founder and President of Glas, told Nicotine Insider. “FDA completed scientific review of all of these products in the fourth quarter of 2025, and the robust scientific evidence and study data in the Glas G2 applications fully align with – and likely helped formulate – the standards outlined in the FDA draft guidance for authorization of flavored ENDS PMTAs released earlier this week.
“FDA-authorized, age-gated, flavored products are one element to the solution to combatting the rampant proliferation of illicit, youth-appealing, flavored vapes that dominate nearly 70 percent of the e-cigarette market. The other is stronger, effective FDA enforcement against these non-compliant, bad actors across all channels of the supply chain.”
The decision increases the number of FDA-authorized ENDS products in the United States to 41. The authorization represents the first addition to the FDA’s ENDS authorization list since July 2025, when the agency granted marketing orders to one device and four pods manufactured by Juul Labs.
Although the decision permits Glas to legally market its device and tobacco-flavored pod in the United States, the outcome fell short of industry expectations that the company might become one of the first manufacturers to receive approval for non-tobacco flavored vape products.
“We look forward to continued discussion and collaboration with the FDA, so that the full suite of Glas G2 products can be made available to adult smokers who are in need of alternatives to combustible cigarettes, while preventing youth initiation, access and use,” said Greenbaum.
The FDA has authorized only tobacco- and menthol-flavored e-cigarettes to date. Glas previously indicated it believed its technology platform could help address regulatory concerns about youth access. The FDA also recently released draft guidance for flavored ENDS products.
In earlier statements, Greenbaum said the company’s device platform was designed to incorporate identity verification and other safeguards intended to restrict youth use. Greenbaum said the company submitted its PMTA application in July 2021 and expected authorization once the review process was complete.
Unusually, the FDA has not yet issued a formal announcement. The FDA also did not provide additional details about whether those features were included in the specific device authorized. Nonetheless, the decision does address months of uncertainty regarding Glas’s regulatory status.
In its MGO letter to Glas, the FDA states that “the requirements in these orders are intended to help ensure that the marketing of your products will continue to be appropriate for the protection of the public health, taking into account, among other factors, initiation among non-users, particularly youth.
“However, compliance with these requirements alone is not a guarantee that the marketing of the products will remain appropriate for the protection of the public health, particularly if, despite these measures, there is a significant uptake in youth initiation, for example. FDA will continue to monitor the marketing of your products.”
Months ago, an image circulated online suggesting that the FDA had approved multiple Glas products. At that time, the agency’s official database had not been updated, and no announcement had been made concerning an authorization. Hours later, in a related update, the FDA clarified that a website error occurred, noting that it did not represent any new authorizations.
The product list finally authorized differs from the earlier image shared online, which referenced additional devices and pods. Industry observers say the Glas authorization has broader implications for the PMTA process. In recent years, many manufacturers have contended that the expense and complexity of FDA review have effectively restricted successful PMTA approvals to large multinational tobacco firms.
Glas, however, functions as an independent vape manufacturer and is not connected to a large tobacco company, making its authorization noteworthy for smaller firms navigating the regulatory process. The FDA has recently indicated increased engagement with smaller manufacturers.
On Feb. 10, 2026, the agency held a roundtable discussion on PMTA submissions for ENDS products, specifically inviting companies with fewer than 350 employees to discuss challenges in preparing applications. At the same time, the agency continues to signal caution regarding flavored vaping products.
Earlier this week, the FDA issued draft guidance titled “Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk,” detailing how regulators assess flavored products under the “appropriate for the protection of public health (APPH)” standard.
The document states that flavors such as fruit, candy, and dessert varieties may face a much higher evidentiary burden due to their potential appeal to youth. Although the guidance provides a process for flavored product submissions, the Glas authorization—limited to a tobacco flavor—indicates that the agency remains cautious about approving flavored ENDS products.
Industry attention to PMTA authorizations and the process to gain an MGO has intensified in recent weeks. According to regulatory filings, vape companies Breeze Smoke and Glas have each requested or had review meetings with the Office of Information and Regulatory Affairs (OIRA) from the White House concerning the FDA’s flavored ENDS draft guidance.
Dimitris Agrafiotis, a longtime vaping industry advocate, stated on LinkedIn that the biggest problem with current MGOs, including the recent Glas authorization, is that consumers do not want tobacco-flavored vapes.
“They have no impact on public health simply because they are not the desired product to allow smokers to switch. Flavors play the most crucial role in long-term switching from combustible to alternative nicotine solutions, including vaping,” he wrote. “As a result, these MGOs only strengthen the black market, which hurts companies investing in proper regulatory pathways, because they simply cannot compete.”
