FDA Authorizes Glas Vape but Flavor Hopes Fall Short

Mar.13
FDA Authorizes Glas Vape but Flavor Hopes Fall Short
The FDA has added Glas products to its authorized electronic nicotine delivery systems (ENDS) list, granting Marketing Granted Orders (MGOs) to the Glas G DEVICE and a BLONDE TOBACCO pod. The decision expands the number of FDA-authorized ENDS products to 41, marking the first new authorization since Juul’s approvals in July 2025. However, widely anticipated non-tobacco flavored products were not approved.

Updated March 17, 2026

Glas has confirmed to 2Firsts that its G2 device, which received a FDA Marketing Granted Order (MGO), incorporates age-gating technology. Based on currently public information, this means the FDA has granted an MGO to the first ENDS product confirmed to incorporate age-gating technology, validating 2Firsts’ earlier inference.

2FIRSTS | Exclusive: Glas says FDA-authorized G2 vape includes age-gating technology
2FIRSTS | Exclusive: Glas says FDA-authorized G2 vape includes age-gating technology
Glas has confirmed to 2Firsts that its G2 device, which received a FDA Marketing Granted Order (MGO), incorporates age-gating technology. Based on currently public information, this means the FDA has granted an MGO to the first ENDS product confirmed to incorporate age-gating technology, validating 2Firsts’ earlier inference.
www.2firsts.com

 

The FDA has updated information related to the marketing granted order (MGO) for the Glas vape product, revising the device name from “Glas G Device” to “Glas G² Device” and releasing the product’s Order Letter. For further details, see the follow-up report by 2Firsts.

2FIRSTS | Special Report|FDA Revises Device Name in Glas Vape Authorization; Company Signals Optimism on Menthol, Flavored Pods
2FIRSTS | Special Report|FDA Revises Device Name in Glas Vape Authorization; Company Signals Optimism on Menthol, Flavored Pods
The FDA updated public records on the PMTA authorization of a Glas vape product, renaming “Glas G Device” to “Glas G² Device” and releasing the order letter detailing scientific review and marketing restrictions. Company disclosures suggest the platform may include age-verification technology. If confirmed, Glas G² could be the first vape with device-level age verification to receive an FDA MGO. Glas executives also said menthol and other flavored pods could gain authorization in the future.
www.2firsts.com

 


 

Key Points

 

  • New ENDS Authorization: The FDA granted Marketing Granted Orders (MGOs) to Glas G DEVICE and BLONDE TOBACCO 50 MG/ML Pod on March 12, 2026, bringing the total number of authorized ENDS products in the U.S. to 41.

 

  • Flavor Expectations Unmet: Despite earlier industry speculation that Glas could obtain authorization for non-tobacco flavored pods, the newly authorized product remains tobacco-flavored.

 

  • First Addition Since Juul: The decision marks the first expansion of the FDA’s ENDS authorization list since Juul’s approvals in July 2025.

 

  • Small Company Entry: Glas, a small vape manufacturer unaffiliated with major tobacco groups, joining the authorized list challenges the perception that only large tobacco companies can secure PMTA authorization.

 

  • Policy Signal on Flavor: FDA recently issued draft guidance on flavored ENDS, outlining a regulatory pathway for such products, but the absence of flavored approvals in the Glas decision highlights the agency’s continued caution toward non-tobacco flavors.

 


 

2Firsts

Shenzhen, March 13, 2026

 

The U.S. Food and Drug Administration (FDA) has granted marketing authorization to products from California-based vape manufacturer Glas Inc., expanding its list of authorized electronic nicotine delivery systems (ENDS) — though the decision fell short of industry expectations for a flavored approval.

 

According to an update postedon the FDA website on March 12, 2026 (U.S. Eastern Time), the agency granted marketing authorization to Glas G DEVICE and BLONDE TOBACCO 50 MG/ML Pod under the Premarket Tobacco Product Application (PMTA) pathway.

 

With the addition, the number of FDA-authorized ENDS products has increased to 41.

 

The decision marks the first addition to the FDA’s ENDS marketing granted order (MGO) list since July 2025, when the agency authorized one device and four pods from Juul Labs.

 

While the approval confirms Glas’s entry into the FDA-authorized market, the pod granted authorization is tobacco-flavored rather than a non-tobacco flavor. Prior to the decision, some industry observers had speculated that Glas could become one of the first companies to obtain authorization for flavored ENDS products beyond tobacco.

 

Earlier December Document Foreshadowed Authorization but Listed More Products

 

The authorization follows months of speculation surrounding Glas’s regulatory status.

 

On December 21, 2025, a screenshot circulated on social media suggesting that the FDA had granted marketing authorization to one Glas device and five pods. At the time, the FDA’s official database had not been updated and no formal announcement had been issued.

 

FDA Authorizes Glas Vape but Flavor Hopes Fall Short
List of Glas products rumored to have received marketing authorization circulating online in December 2025 | Source: Social media

 

Following the circulation of the image, 2Firsts conducted a technical reviewof FDA webpages and identified traces of a related authorization document hosted on the agency’s servers. The materials appeared to reference Glas products but could not be fully accessed.

 

2Firsts subsequently contacted the FDA regarding the document but received no response.

 

In its March 12 update, the FDA states that “on 12/20/25, FDA experienced a related web error that did not change this list but was corrected the same day.”

 

While the agency did not elaborate further, the timing appears consistent with the previously circulating authorization image.

 

The product list in the March update also differs from the earlier version shared online. The circulating document referenced a “Glas G2 device” and multiple pods, while the current authorization lists Glas G DEVICE and a single tobacco-flavored pod.

 

Glas Previously Positioned Age-Verification Technology as a Pathway for Flavored Products

 

Glas had previously expressed confidence that its products could obtain FDA authorization by combining flavored ENDS products with age-verification technology designed to limit youth access.

 

In an interview with 2Firsts in the third quarter of 2025, the company described its G2 platform as incorporating a technology system intended to address regulatory concerns about youth usage.

 

According to Glas, the system integrates smartphone-based identity verification, proximity restrictions, and anti-counterfeit protections. The company argued that such technology could allow flavored ENDS products to remain available to adult smokers while preventing underage use.

 

Glas founder and CEO Sean Greenbaum told 2Firsts that the company had submitted its PMTA application in July 2021 and believed its G2 device could be among the next ENDS products to receive authorization.

 

Greenbaum said at the time that the company expected marketing authorization “within the next months.”

 

It remains unclear whether Glas G DEVICE incorporates the same technology.

 

FDA Authorizes Glas Vape but Flavor Hopes Fall Short
At the time of publication, the Blonde Tobacco pod on the Glas website was shown as “Sold Out” | Source: Glas website

 

Small Company Approval Seen as Signal of a Broadening ENDS Authorization Pool

 

Although the authorization did not include non-tobacco flavored products, Glas’s entry into the FDA’s authorized list is still viewed by some industry observers as a positive signal.

 

In recent years, many in the industry have believed that the complexity and cost of the PMTA process effectively limited ENDS marketing authorization to large multinational tobacco companies and major industry players.

 

At the same time, the FDA has also signaled support for smaller companies navigating the PMTA pathway. On February 10, 2026, the agency convened a Roundtable on Premarket Tobacco Product Application (PMTA) Submissions for Electronic Nicotine Delivery Systems (ENDS) Products, inviting industry representatives to discuss the challenges companies face when preparing PMTA submissions. Glas sent a representative to attend the meeting.

 

According to the FDA’s participation criteria, the roundtable targeted small tobacco product manufacturers—defined as companies with fewer than 350 employees.

 

Against this backdrop, Glas—a small vape manufacturer based in California and not affiliated with any major international tobacco group—joining the authorized list may signal that the pool of companies capable of obtaining ENDS marketing authorization could gradually broaden.

 

FDA Signals Openness to Flavored ENDS — But Glas Decision Shows Continued Caution

 

This week, the U.S. vaping industry received two signals from regulators that pointed in different directions.

 

Earlier in the week, the U.S. Food and Drug Administration (FDA) released a draft guidance titled “Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk.”

 

The document outlines how the FDA evaluates flavored ENDS products under the Premarket Tobacco Product Application (PMTA) framework. It emphasizes that applicants must demonstrate that the benefits to adult smokers outweigh potential risks to youth.

 

The guidance also notes that flavors with stronger youth appeal—such as fruit, candy, dessert, or other sweet varieties—may face a higher evidentiary burden during PMTA review because of their potential to increase youth initiation and use.

 

Although the guidance is nonbinding, many industry observers interpret it as a sign that the FDA is continuing to clarify the regulatory pathway for flavored ENDS applications.

 

However, in the Glas authorization announced Thursday (U.S. Eastern Time), the FDA approved only a tobacco-flavored pod.

 

The absence of any newly authorized non-tobacco flavored products suggests that the agency remains cautious about approving flavored ENDS.

 

Taken together, the policy guidance and the authorization decision suggest that while the FDA may be continuing to move forward with PMTA reviews, it is maintaining a cautious regulatory stance toward flavored products.

 

Notably, 2Firsts reported earlier in March that vape companies Breeze Smoke and Glas had separately requested White House review meetings under Executive Order 12866 regarding the FDA’s draft flavored ENDS guidance (RIN 0910-ZC78). The meetings were requested with the Office of Information and Regulatory Affairs (OIRA), part of the Executive Office of the President.

 

The filings reflected growing industry attention to how the FDA will evaluate flavored products under the statutory “appropriate for the protection of public health” (APPH) standard, as companies seek greater predictability and transparency in the PMTA review process.

 

2Firsts will continue to monitor developments in the U.S. PMTA process.

 

Cover image: The FDA website shows two Glas products granted Marketing Granted Orders (MGOs) on March 12, 2026 (U.S. Eastern Time) | Source: FDA website

 


 

Further reading:

[card_172559_card]

2FIRSTS | 2Firsts Interview with Glas |Why a California ENDS Company Believes Its Age-gated Flavored Vape Could Be Next in Line for FDA Authorization
2FIRSTS | 2Firsts Interview with Glas |Why a California ENDS Company Believes Its Age-gated Flavored Vape Could Be Next in Line for FDA Authorization
As the FDA advances efforts to streamline its PMTA review process, including support for small businesses, expectations are rising that additional product authorizations may follow. Age-verification technology is emerging as a key consideration in future approvals.In this interview, California-based Glas discusses its G2 platform, integrating smartphone-based identity verification, proximity controls and anti-counterfeit systems, and outlines its positioning under the FDA’s PMTA framework.
www.2firsts.com

2FIRSTS | FDA PMTA Roundtable: Ongoing Comprehensive Coverage by 2Firsts
2FIRSTS | FDA PMTA Roundtable: Ongoing Comprehensive Coverage by 2Firsts
2Firsts is the world-leading new tobacco industry media and advisory platform, dedicated to providing global professional readers with exclusive reporting, in-depth perspectives, and visionary insights.
www.2firsts.com

2FIRSTS | Special Report | Breeze and Glas Seek White House Review as FDA Advances Flavored ENDS Guidance
2FIRSTS | Special Report | Breeze and Glas Seek White House Review as FDA Advances Flavored ENDS Guidance
Breeze Smoke and Glas, Inc. have separately requested White House review under Executive Order 12866 as the FDA advances draft guidance on flavored ENDS (RIN 0910-ZC78). The guidance aims to clarify evidentiary standards under the statutory “appropriate for the protection of public health” (APPH) framework. The parallel filings highlight industry concern over regulatory predictability, particularly as Glas’s PMTA review status has recently drawn market attention.
www.2firsts.com

Smoore International Q1 Results: Enterprise-Focused Business Up 48.6% Year-on-Year, Proprietary E-Vapor Brand Business Up 14.3%
Smoore International Q1 Results: Enterprise-Focused Business Up 48.6% Year-on-Year, Proprietary E-Vapor Brand Business Up 14.3%
Smoore International reported its Q1 financial results, with revenue for the period reaching RMB3.856 billion, up 41.7% year-on-year, and net profit (profit for the period) totaling RMB262.5 million, up 36.6% year-on-year. Revenue from its enterprise-focused business was RMB3.2674 billion, representing a 48.6% increase from RMB2.1989 billion in the same period last year. Revenue from its proprietary brand business was RMB588.6 million, up 12.6% from RMB522.6 million a year earlier.
Apr.10 by 2FIRSTS.ai
BAT Japan Announces McLaren Collaboration “glo Hilo Plus” Limited-Edition Set, Priced at About USD 200
BAT Japan Announces McLaren Collaboration “glo Hilo Plus” Limited-Edition Set, Priced at About USD 200
British American Tobacco Japan (BAT Japan) announced a collaboration with McLaren Racing to launch the “glo Hilo Plus・McLaren Racing Inspired Limited-Edition Set.” Sales begin on March 3 via the glo Store Ginza and the official glo online store. Based on the “glo Hilo Plus,” the set includes a limited-edition device and dedicated accessories, priced at JPY 30,000 (about USD 200).
Mar.03 by 2FIRSTS.ai
ZYN by IQOS to Roll Out Across Tokyo From May 11 Through IQOS Shops and Lawson
ZYN by IQOS to Roll Out Across Tokyo From May 11 Through IQOS Shops and Lawson
Philip Morris Japan announced on April 23 at a product briefing that ZYN by IQOS, an oral tobacco pouch previously launched in selected areas, will expand sales in Tokyo. The company said the product will be released progressively from May 11 through IQOS shops, Lawson and other outlets in the city. The launch will include four flavors, each offered in Low and Medium intensity levels, for a total of eight products.
Apr.27 by 2FIRSTS.ai
Reuters Exclusive: FDA’s Fast-Track Review of Nicotine Pouches Slows Over Youth and New-User Concerns
Reuters Exclusive: FDA’s Fast-Track Review of Nicotine Pouches Slows Over Youth and New-User Concerns
Reuters reported on April 1 that several popular nicotine pouch products still have not been cleared for sale in the United States despite a fast-track review pilot run by the U.S. Food and Drug Administration. Three sources said FDA reviewers have taken a cautious approach because of potential risks to youth and other non-tobacco users, including the possibility of driving nicotine addiction among adults who do not already smoke.
Apr.02 by 2FIRSTS.ai
Fontem Sues FDA Over Refusal-to-File Decision for Nicotine Pouch PMTAs
Fontem Sues FDA Over Refusal-to-File Decision for Nicotine Pouch PMTAs
According to a complaint filed on March 17 in the U.S. District Court for the Northern District of Texas, Fontem US, LLC and Texas retailer OM Investment, LLC sued the Food and Drug Administration and the Department of Health and Human Services over FDA’s refusal-to-file decision for certain Zone nicotine pouch PMTAs.
Mar.19 by 2FIRSTS.ai
FDA Issues Draft PMTA Guidance for Flavored E-Cigarettes, Maintaining Higher Evidence Bar for Fruit and Sweet Flavors
FDA Issues Draft PMTA Guidance for Flavored E-Cigarettes, Maintaining Higher Evidence Bar for Fruit and Sweet Flavors
The U.S. Food and Drug Administration (FDA) on March 9 released a draft guidance outlining its current thinking on premarket tobacco product applications (PMTAs) for flavored electronic nicotine delivery systems (ENDS). The document reiterates that fruit, candy, dessert, and other sweet-flavored e-cigarettes present a “significant public health risk” to youth and therefore face a higher evidentiary burden if manufacturers seek marketing authorization.
Mar.10 by 2FIRSTS.ai