August 2026: FDA Authorizes Marketing of Next-Generation JUUL2 E-Cigarette System
The U.S. Food and Drug Administration (FDA) authorized the marketing of JUUL Labs Inc.’s next-generation e-cigarette system, the JUUL2, along with its tobacco- and menthol-flavored pods. The decision, delivered through the agency’s premarket tobacco product application (PMTA) pathway, approves three new products: the redesigned JUUL2 device, a tobacco-flavored pod, and a menthol-flavored pod. Both authorized pod varieties feature a nicotine strength of 18 milligrams per milliliter, equivalent to approximately 1.5% to 1.6% nicotine concentration.
Under federal regulatory standards, the agency evaluated whether the new products offer a net benefit to overall public health, balancing potential risks such as youth appeal against potential benefits for adult smokers transitioning away from combustible cigarettes. FDA scientific reviews indicated that a substantial proportion of adult smokers completely gave up traditional cigarettes after adopting the JUUL2 system. Within six weeks, complete smoking cessation reached 19.9% to 34.6% among adults using the tobacco-flavored pods, and 28.4% to 49.3% among those using the menthol-flavored pods.
The agency determined that individuals who made a complete transition to the authorized JUUL2 products experienced significantly lower exposure to harmful chemicals than those who continued smoking cigarettes. Consequently, regulators concluded that the public health gains for adult smokers outweighed potential risks associated with youth appeal. Public health officials emphasized, however, that adult smokers must switch completely to e-cigarettes to gain meaningful risk reduction, cautioning that dual use of both traditional cigarettes and e-cigarettes does not offer equivalent health benefits.
This action follows previous marketing authorizations granted to JUUL Labs in July 2025 for original JUUL products containing higher nicotine concentrations of 3% and 5%. To date, the FDA has authorized 48 e-cigarette products for sale in the United States.
August 2026: FDA Authorizes 11 New ZYN Nicotine Pouch Products
The U.S. Food and Drug Administration has authorized the marketing of 11 new nicotine pouch products under the ZYN ULTRA brand, manufactured by Swedish Match USA, Inc. subsidiary of Philip Morris International (PMI). The authorization covers ten varieties in 9 mg nicotine strength along with an 11 mg Smooth (unflavored) option: ZYN ULTRA Chill 9 mg, ZYN ULTRA Citrus 9 mg, ZYN ULTRA Cool Mint 9 mg, ZYN ULTRA Deep Freeze 9 mg, ZYN ULTRA Menthol 9 mg, ZYN ULTRA Peppermint 9 mg, ZYN ULTRA Spearmint 9 mg, ZYN ULTRA Wintergreen Chill 9 mg, ZYN ULTRA Wintergreen 9 mg, ZYN ULTRA Smooth 9 mg and ZYN ULTRA Smooth 11 mg.
Granted through the agency’s premarket tobacco product application pathway, the decision follows a scientific review evaluating overall population health risks and benefits. The FDA determined that the products contain substantially lower levels of harmful and potentially harmful constituents compared to traditional oral and smokeless tobacco products. Additionally, agency review indicated that the nicotine delivery of these higher-dose products is sufficient to reduce cravings and withdrawal symptoms, helping adult smokers completely transition away from more harmful tobacco products.
The evaluations were conducted under an FDA pilot program designed to increase efficiency and streamline the review process for nicotine pouches. With today’s authorizations, the FDA has authorized a total of 43 nicotine pouch products for the U.S. market, 23 of which were processed through the pilot program.
August 2026: FDA Authorizes Four New ‘on!’ Nicotine Pouches, Bringing Total to 30
The U.S. Food and Drug Administration (FDA) has authorized the marketing of four new nicotine pouch products under the “on!” brand, manufactured by Altria subsidiary Helix Innovations LLC. The newly authorized flavors and strengths – Rich Berry (2 mg), Cappuccino (2 mg and 4 mg), and Autumn Spice (2 mg) – bring the total number of FDA-authorized nicotine pouch products to 30.
The agency’s scientific review found that these new products contain significantly lower levels of harmful and potentially harmful constituents (HPHCs) than traditional oral and smokeless tobacco products, with many toxic chemicals falling below quantifiable limits. For adult tobacco users aged 21 and older, completely switching from cigarettes or smokeless tobacco to these pouches can substantially reduce chemical exposure and downstream health risks. However, the FDA noted that dual use – using pouches alongside cigarettes – fails to provide the same risk-reduction benefits.
The applications were evaluated through the FDA’s nicotine pouch pilot program, an initiative designed to streamline the Premarket Tobacco Product Application (PMTA) pathway. By improving review efficiency, reducing applicant response times for deficiency letters, and expediting scientific evaluations, the pilot successfully accelerated product decisions. The FDA has already begun applying lessons learned from the pilot to refine PMTA reviews across other tobacco product categories.
June 2026: FDA Defends Approval of Fruit-Flavored Vapes Despite Limited Smoking-Cessation Advantage
The FDA is facing criticism over its authorization of Glas fruit-flavored pods after internal review documents indicated that the products were not shown to be significantly more effective at helping adult smokers quit cigarettes than tobacco-flavored alternatives. The decision has prompted questions from public health groups and lawmakers about whether the agency has softened its approach to flavored vaping products.
However, the FDA’s rationale extended beyond a direct comparison of smoking-cessation rates between flavored and tobacco-flavored products. According to the agency, the evidence showed that the authorized products could provide a meaningful benefit to adult smokers when evaluated as part of the broader tobacco harm reduction landscape. The FDA concluded that some adult smokers who would otherwise continue smoking cigarettes may prefer non-tobacco flavors and could switch completely to the authorized products, even if the overall cessation advantage versus tobacco-flavored e-cigarettes was not statistically significant.
The agency also emphasized that its assessment was based on the statutory “appropriate for the protection of public health” (APPH) standard, which requires weighing potential benefits to adult smokers against risks to youth. In this case, the FDA determined that the risk of youth uptake was sufficiently mitigated by the products’ access-control technology. The authorized devices require users to verify their age through a smartphone application and connect to the device via Bluetooth before use, a feature designed to restrict access by underage users. The FDA concluded that this user-verification mechanism, together with other marketing and distribution controls, could substantially reduce youth access and experimentation compared with conventional vaping products.
In its review, the FDA reportedly moved away from relying solely on evidence showing that flavored products outperform tobacco-flavored products in smoking cessation. Instead, it considered a broader body of evidence, including consumer behavior data, switching patterns among adult smokers, toxicological assessments, and the effectiveness of technological safeguards intended to prevent youth use.
Critics argue that this interpretation represents a significant shift from the agency’s earlier decisions, in which numerous flavored vaping applications were denied because applicants failed to demonstrate that their products offered a sufficiently strong benefit to adult smokers to offset youth-use risks. Supporters of the FDA’s decision, meanwhile, contend that the agency is recognizing both the potential role of flavors in helping some smokers transition away from cigarettes and the emergence of new technologies that may reduce youth access to vaping products.
The controversy has been heightened by the brevity of the FDA’s publicly released review memorandum, which spans only six pages, leading some observers to call for greater transparency regarding the scientific basis for the decision.
May 2026: FDA Authorizes Fruit-Flavored Vape Pods, Marking Policy Shift with Age-Gated Technology
The U.S. Food and Drug Administration (FDA) authorized four new pod-based e-cigarette pods from Glas Inc. – Classic Menthol, Fresh Menthol, Gold, and Sapphire – in a decision that marks a significant turning point in U.S. vaping regulation. The authorization represents the first time the agency has cleared non-tobacco, non-menthol flavors under the Premarket Tobacco Product Application (PMTA) pathway, bringing the total number of authorized vape products for marketing in the United States to 45.
Gold and Sapphire correspond to fruit flavors – reported as mango (Gold) and blueberry (Sapphire) -making this the first explicit entry of fruit-flavored vape products into the FDA-authorized category. At the same time, the authorized pod names deliberately avoid explicit flavor descriptors, relying instead on abstract branding. This appears to be an effort to reduce youth appeal by removing direct references to fruit or sweet flavors from product labels.
Crucially, the newly authorized pods are designed exclusively for use with Glas’s age-gated device, which incorporates multiple layers of access control. According to the FDA’s review, the system combines hardware and software safeguards intended to limit youth use. Users must verify their age and identity using a government-issued ID and pair the device with a smartphone via Bluetooth. Once activated, the device will not function if it is separated from the verified phone. In addition, the companion app performs random biometric check-ins to confirm that the authorized adult user remains the one operating the device. The FDA concluded that this combination of device-level restrictions and mandated marketing controls is expected to meaningfully mitigate youth access.
The timing of the authorization is also notable. The move comes amid reports of President Trump’s frustration with FDA delays over the authorization of flavored vapes, adding a political backdrop to a clear policy shift toward controlled expansion.
The FDA has framed the decision as a controlled and conditional expansion, arguing that the potential benefit for adult smokers – particularly those seeking alternatives to combustible cigarettes – may outweigh the risks, provided strict safeguards remain in place. However, public health groups have already raised concerns that authorizing fruit flavors – even under neutral naming conventions and technological restrictions – could complicate efforts to reduce youth vaping.
Glas is a California-based, independent U.S. vaping company specializing in closed pod systems and design-focused devices within the broader Electronic Nicotine Delivery Systems (ENDS) category. The company has built its positioning around regulatory compliance, controlled distribution, and device-based access restrictions, investing heavily in the scientific and regulatory work required for the FDA’s PMTA process to demonstrate its products meet the “appropriate for the protection of public health” standard.
In summary, the move signals a measured recalibration of U.S. vaping policy. After years of limiting authorizations largely to tobacco and menthol products, the FDA is now cautiously opening the door to flavor diversity beyond those categories, anchored in tighter technological controls, restrained branding, and a heightened level of political and regulatory scrutiny.
March 2025: FDA Authorizes Glas G Device and Tobacco Pod, Expanding List of Authorized Vapes to 41
The U.S. Food and Drug Administration (FDA) has authorized the marketing of the Glas G device and a Blonde Tobacco 50 mg/ml pod, marking a notable development in the tightly regulated U.S. vaping market. The authorization was granted through the agency’s Premarket Tobacco Product Application (PMTA) pathway, which companies must successfully complete before new tobacco products can be legally marketed in the United States.
With the addition of the Glas products, the total number of electronic nicotine delivery systems (ENDS) authorized by the FDA now stands at 41 products, according to the agency’s official list. These include: JUUL (5 products), Logic (Japan Tobacco, 8 products), NJOY (Altria, 10 products), Vuse (British American Tobacco,16 products), and Glas (2 products).
These represent the only e-cigarettes that may currently be legally sold in the U.S. market under FDA authorization. The decision is significant because it represents the first authorization for a vaping product outside the major tobacco companies and JUUL. Until now, nearly all FDA-authorized ENDS products have been associated with large tobacco manufacturers or JUUL Labs, reflecting the significant scientific and financial burden required to complete the PMTA process. Glas’s entry suggests that smaller independent manufacturers can still navigate the regulatory pathway successfully.
The FDA granted marketing orders specifically for the Glas G device and a tobacco-flavored pod, rather than any non-tobacco flavors that had been expected in the industry. The continued restriction of authorizations primarily to tobacco and menthol flavors reflects the agency’s cautious approach to flavored vaping products, which regulators believe may increase youth appeal.
Glas Inc. is a California-based vaping company known for developing premium vaping hardware and e-liquids. Unlike many authorized competitors, the company operates independently of the major global tobacco groups. Glas gained recognition within the industry for focusing heavily on regulatory compliance and preparing its products for the FDA’s PMTA process, investing in the scientific and regulatory work required to demonstrate that its products are “appropriate for the protection of public health,” the standard required for authorization.
Following the authorization, the President and CEO of Glas underlined that the company expects further approvals for its broader product lineup. “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 menthol and flavored pods,” the executive said. “FDA completed scientific review of these products in the fourth quarter of 2025, and the scientific evidence included in the Glas G2 applications aligns with the standards outlined in the FDA’s recent draft guidance for flavored ENDS PMTAs.”
The company also emphasized the role that regulated flavored products could play in addressing the illicit market. “FDA-authorized, age-gated flavored products are one element of the solution to combating the proliferation of illicit, youth-appealing flavored vapes that now account for nearly 70 percent of the e-cigarette market,” the CEO said, adding that stronger enforcement across the supply chain is also needed.
The authorization of the Glas G system represents both an expansion of the FDA’s authorized product list and a rare example of a smaller independent vape manufacturer successfully navigating the U.S. regulatory framework.
E-cigarettes Authorized by the U.S. FDA:
December 2025: FDA Authorizes Six on! PLUS Nicotine Pouch Products
The U.S. Food and Drug Administration (FDA) authorized the marketing of six on! PLUS nicotine pouch products through the premarket tobacco product application (PMTA) pathway. These authorizations represent the first decisions issued under the expedited review process launched in September 2025. By implementing several changes to its review procedures – including real-time communication with the applicant – the FDA completed its scientific review within three months while maintaining rigorous scientific standards.
The six authorized on! PLUS nicotine pouch products are manufactured by Altria subsidiary Helix Innovations LLC and are available in three flavors and two nicotine strengths (6 mg and 9 mg):
| on! PLUS nicotine pouches Mint, 6 mg | on! PLUS nicotine pouches Mint, 9 mg |
| on! PLUS nicotine pouches Wintergreen, 6 mg | on! PLUS nicotine pouches Wintergreen, 9 mg |
| on! PLUS nicotine pouches Tobacco, 6 mg | on! PLUS nicotine pouches Tobacco, 9 mg |
Based on its scientific review, the FDA determined that the on! PLUS nicotine pouch products:
– Contain lower levels of most harmful and potentially harmful constituents (HPHCs) compared with other oral and smokeless tobacco products, with many constituents present at levels too low to be quantified
– Do not contain measurable levels of several carcinogenic HPHCs, including those identified as key drivers of excess oral cancer risk among adult smokeless tobacco users
– Have the potential to provide a net benefit to adult smokers and/or users of other smokeless tobacco products that is sufficient to outweigh the risks of the products, including risks to youth.
Primary packaging will consist of a certified child-resistant can with a safety lid. The FDA has previously urged manufacturers to adopt child-resistant packaging or other measures to reduce the risk of accidental nicotine poisoning in young children.
While on! PLUS nicotine pouch products may now be legally marketed in the United States to adults aged 21 and older, this authorization does not mean the products are safe, nor does it mean they are “FDA approved.” The authorizations apply only to these six specific products and do not extend to any other products produced by Helix Innovations LLC.
With the addition of the six on! PLUS variants, the total number of FDA-authorized nicotine pouch products has increased to 26 – including 20 ZYN variants (Swedish Match USA, Philip Morris International) and six on! PLUS variants (Helix Innovations, Altria).
December 2025: FDA launches web-based Tobacco Premarket Application forms
U.S. FDA launched web versions of four forms (FDA Forms 4057, 4057a, 3965, and 3965a) in CTP Portal NextGen for applicants submitting and amending premarket tobacco product applications (PMTAs) and Substantial Equivalence (SE) reports. The web forms allow applicants to create, validate, and submit PMTA and SE report submissions directly online, further enhancing the application submission process by making it more integrated and efficient. FDA encourages applicants to use the online versions of the forms which feature step-by-step instructions, an interface that helps guide applicants through the submission process, ability for multiple users to work on a submission and real-time, automatic submission validation.
July 2024: Authorization of tobacco-flavored Vuse Alto products
US FDA issued marketing orders to BAT’s Vuse Alto device and six Vuse Alto tobacco-flavored pods (sealed, pre-filled and non-refillable) through the pre-market tobacco product application (PMTA) pathway. Authorized products include 3 Golden Tobacco (5%-2.4%-1.8%) and 3 Rich Tobacco (5%-2.4%-1.8%) variants.
After reviewing the BAT’s applications, FDA determined there was sufficient evidence to determine that permitting marketing of the products would be appropriate for the protection of the public health. Specifically, BAT demonstrated that these tobacco-flavored products have the potential to provide a benefit to adults smokers that is sufficient to outweigh the risks of the products, including to youth.
While FDA remains concerned about the risk of youth use of all e-cigarettes, youth are less likely to use tobacco‐flavored e-cigarette products compared to other flavors. According to the 2023 National Youth Tobacco Survey, Vuse was among the most commonly reported brands used by middle and high school students currently using e-cigarette. However, only 6.4% of students who currently used e-cigarettes reported using tobacco‐flavored products. To further mitigate youth use of these products, FDA has placed stringent marketing restrictions on the new products in an effort to prevent youth access and exposure, as it has with previously authorized products. FDA will closely monitor how these products are marketed and will act as appropriate if the company fails to comply with any applicable statutory or regulatory requirements. The agency may suspend or withdraw authorization if the agency determines that continued marketing is no longer appropriate for the protection of the public health, including if there is a notable increase in use of the products among youth or former cigarette users, or a decrease in patterns of complete switching by current cigarette users to the new products.
FDA has received applications for nearly 27 million e-cigarette products and has made determinations on more than 26 million of these applications. To date, FDA has authorized 34 e-cigarette products and devices, including the seven authorized today. Following the authorization of Vuse Alto pods, Altria’s NJOY is no longer the only pod-based product with marketing order granted (- yet, it is still the only menthol product authorized). Going forward, it is critical to watch whether the menthol-flavored Vuse Alto pods will be eventually authorized.
June 2024: Authorization of menthol-flavored NJOY products
Following an extensive scientific review, the US FDA authorized the marketing of four NJOY e-cigarette products in the US through the pre-market tobacco product application (PMTA) pathway1. The FDA issued marketing granted orders to NJOY LLC, part of Altria Group, for four menthol-flavored e-cigarette products: NJOY ACE Pod Menthol 2.4%, NJOY ACE Pod Menthol 5%, NJOY DAILY Menthol 4.5%, and NJOY DAILY EXTRA Menthol 6%. The two authorized ACE products are sealed, pre-filled, non-refillable pods that are used with the previously authorized ACE device and the two authorized DAILY products are disposable e-cigarettes with a pre-filled, non-refillable e-liquid reservoir.
These authorization mark the first non-tobacco flavored e-cigarette products to be authorized by the US FDA. As each application is reviewed on a case-by-case basis, these authorizations are specific to the four NJOY products and do not apply to any other menthol-flavored e-cigarette products.
After reviewing the NJOY’s applications, the US FDA determined that there was sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of the public health. Specifically, the evidence submitted by the applicant showed that these menthol-flavored products provided a benefit for adults who smoke cigarettes relative to that of the applicant’s previously authorized tobacco-flavored products – in terms of complete switching – that is sufficient to outweigh the risks of the product, including youth appeal.
The US FDA has received PMTAs for nearly 27 million deemed products and has made determinations on more than 26 million of these applications. To date, the US FDA has authorized 27 tobacco- and menthol-flavored e-cigarette products and devices, including the four mentioned-above.
June 2024: FDA Rescinds Marketing Denial Orders for JUUL Vaping Products, Returning Applications to Pending Review
The U.S. Food and Drug Administration (FDA) has revoked the Marketing Denial Orders (MDOs) issued to JUUL Labs in June 2022, placing the manufacturer’s products back under substantive scientific review. The agency clarified that the rescission does not constitute a product authorization or a denial, nor does it signal whether the applications will ultimately be approved. Instead, the action returns JUUL’s Premarket Tobacco Product Applications (PMTAs) to pending status while regulators re-evaluate the submissions in light of additional information provided by the company and evolving legal precedents.
The FDA originally blocked JUUL’s entire U.S. product lineup in June 2022, citing insufficient and conflicting data regarding the products’ toxicological profiles – specifically concerns surrounding genotoxicity and potentially harmful chemicals leaching from proprietary e-liquid pods. However, the agency administratively stayed its denial orders in July 2022 after determining that unique scientific issues warranted further review. Since that time, a series of federal court rulings in lawsuits brought by other e-cigarette manufacturers has established new case law, prompting the FDA to adjust its regulatory framework to ensure all final decisions align with both scientific merits and prevailing legal standards.
April 2024: FDA Denies Marketing Applications for 65 MNGO Disposable E-Cigarettes
The U.S. Food and Drug Administration (FDA) has issued Marketing Denial Orders (MDOs) to Shenzhen Yibo Technology covering 65 disposable e-cigarettes marketed under the “MNGO Disposable Stick” brand. Following a scientific review of the company’s Premarket Tobacco Product Applications (PMTAs), regulators determined that the submissions lacked adequate evidence regarding manufacturing processes, product design features, and product stability. The agency also concluded that Yibo failed to demonstrate that its flavored e-cigarettes offer an added benefit to adult smokers that outweighs the risks posed to youth.
Significantly, the FDA’s decision targeted several “Clear” variants that were marketed as flavorless or unflavored. Scientific evaluation revealed that these products contained flavor enhancers designed to impart a menthol or mint cooling sensation. Determining that the overall sensory effect constitutes a characterizing flavor, the FDA signaled that it evaluates products based on user sensation rather than formal ingredient labels – a precedent with broad implications for products utilizing synthetic cooling agents and future flavor regulations.
February 2024: FDA Issues Marketing Denial Orders for Fontem US Vaping Products
The U.S. Food and Drug Administration (FDA) has issued Marketing Denial Orders (MDOs) to Fontem US, a subsidiary of Imperial Brands, covering five e-cigarette products across its blu and myblu lines. The action affects a 1.2% menthol myblu pod alongside four blu disposable e-cigarettes offered in menthol, mint, vanilla, and cherry flavors at a 2.4% nicotine concentration.
According to agency findings, Fontem failed to submit sufficient scientific evidence in its Premarket Tobacco Product Applications (PMTAs) to justify market authorization. The FDA highlighted missing aerosol safety data regarding Harmful and Potentially Harmful Constituents (HPHCs) for one product, as well as incomplete battery safety evaluations for several others. Additionally, regulators determined that Fontem did not demonstrate that the potential benefit to adult smokers – through complete switching or significant reduction in cigarette consumption – outweighed the documented appeal to youth. The agency noted that according to the 2023 National Youth Tobacco Survey, 6% of middle and high school e-cigarette users reported using blu brand products.
Under the order, Fontem US must immediately pull the targeted products from U.S. retail channels and halt further distribution. While the current products can no longer be legally sold, the FDA noted that Fontem remains eligible to submit new applications addressing the scientific deficits identified in the agency’s review.
January 2024: FDA Targets June 2024 to Complete PMTA Reviews Following Delays and Legal Shifts
The U.S. Food and Drug Administration (FDA) has updated its court-ordered status report, indicating that it now expects to complete its review of remaining Premarket Tobacco Product Applications (PMTAs) for deemed products on the market prior to August 8, 2016, by June 30, 2024.
Agency officials noted that the remaining submissions present complex scientific evaluations that demand extensive review. Furthermore, the FDA is recalibrating its review criteria to align with recent judicial rulings, including a unanimous decision by the U.S. Court of Appeals for the D.C. Circuit in Fontem v. US FDA, which upheld the agency’s marketing denials for flavored vapes while striking down denials for unflavored variants. The review timeline has been further extended by manufacturers filing post-litigation amendments to their pending applications, with some submissions arriving as recently as December 2023.
The agency originally missed its court-mandated September 9, 2021 deadline – set for one year after the initial application cutoff – due to the overwhelming volume of millions of PMTAs submitted by industry manufacturers. Now required to submit regular progress updates to the court, the FDA projects taking regulatory action on 94% of the covered pending applications by March 31, 2024, with its next formal status report scheduled for April 22, 2024.
January 2024: FDA Issues Marketing Denial Order to Bidi Vapor
FDA issues a marketing denial order (MDO) to Bidi Vapor LLC for its Bidi Stick – Classic e-cigarette. This product is a closed-system, disposable, tobacco-flavored e-cigarette device. Bidi Vapor may submit a new application to the US FDA addressing the scientific deficiencies.
Since June 2022, Kaival Brands, the US distributor of all products manufactured by Bidi Vapor, has in place an international licensing agreement with Philip Morris International for the development and distribution of its e-cigarettes (known as the Bidi Stick) outside the US.
January 2024: FDA Blocks Sale of 22 SMOK Vaping Products; Manufacturer Appeals to Fifth Circuit
The U.S. Food and Drug Administration (FDA) has issued Marketing Denial Orders (MDOs) for 22 SMOK brand e-cigarette products manufactured by Shenzhen IVPS Technology, prompting the Chinese company to launch an immediate appeal in federal court. The denied products encompass open-system devices, pods, atomizers, and cartridges designed to be used with separately purchased e-liquids.
According to the FDA, IVPS failed to provide sufficient scientific data demonstrating that permitting the sale of these products would be appropriate for the protection of public health. The agency noted that the applications lacked adequate characterization of constituent delivery, product stability, and abuse liability. Regulators also emphasized that because the open-system hardware is sold without e-liquid, consumers could pair the products with any tobacco- or non-tobacco-flavored liquid on the market.
In response, Shenzhen IVPS Technology filed an appeal with the U.S. Court of Appeals for the Fifth Circuit in New Orleans. The manufacturer pushed back against the FDA’s conclusions, stating that it invested over $30 million in its Premarket Tobacco Product Applications (PMTAs), which comprised more than 600,000 pages of data. The company stressed that its submission included comprehensive harmful and potentially harmful constituent (HPHC) aerosol testing, in vitro toxicology analysis, 24-month storage stability studies, and clinical pharmacokinetic trials evaluating abuse liability profiles.
The legal challenge comes as the Fifth Circuit recently vacated two separate 2021 MDOs issued to e-liquid manufacturers, adding further momentum to the growing wave of judicial pushback against the FDA’s premarket review decisions.
January 2024: FDA Denies Marketing Applications for Suorin and blu PLUS+ Vaping Products
The U.S. Food and Drug Administration (FDA) has issued Marketing Denial Orders (MDOs) to Chinese manufacturer Shenzhen Youme Technology Co. and Imperial Brands’ subsidiary Fontem US LLC, barring the companies from marketing or distributing select e-cigarette products in the United States. The orders cover two Suorin brand products – a device and an empty, refillable cartridge – from Shenzhen Youme, alongside Fontem’s blu PLUS+ product lineup, which includes a battery, seven pre-filled tobacco and menthol e-liquid cartridges, and additional variants not currently marketed in the U.S.
The FDA rejected Shenzhen Youme’s applications after determining that consumers could fill the empty Suorin cartridges with unvetted e-liquids purchased separately, and noted that the submissions lacked sufficient evidence evaluating the products’ abuse liability, or risk of promoting addiction. Fontem’s applications were denied due to several deficiencies, including inadequate ingredient reporting, insufficient harmful and potentially harmful constituent (HPHC) yield data, and missing abuse liability information. Furthermore, Fontem failed to provide sufficient evidence demonstrating that its flavored products offer adult smokers a benefit that outweighs the potential risks to youth.
Since 2020, the FDA has received Premarket Tobacco Product Applications for more than 26 million products and has reached decisions on 99% of those submissions. To date, the agency has authorized a total of 23 tobacco-flavored e-cigarette products for legal sale in the U.S. market.
October 2023: FDA Issues Marketing Denial Orders for BAT’s VUSE Alto products
The FDA issued marketing denial orders (MDOs) to BAT for six flavored e-cigarette products under its Vuse Alto brand after determining that the applications lacked sufficient evidence to demonstrate that marketing of the products would be appropriate for the protection of the public health (i.e. added benefit for smokers relative to the known risks to youth). The denied products include three menthol-flavored and three mixed berry-flavored pods, with each flavor being offered in three nicotine strengths. US FDA requests BAT to stop marketing these products in the US in order not to risk facing FDA enforcement action. However, BAT may submit new applications for the products that are subject to these MDOs. Moreover, we expect BAT to win a temporary stay order from Appeals Court, pending the court review of the US FDA decision.
Vuse is now the most commonly sold e-cigarette brand in the USA, with Vuse Alto being its most popular sub-brand. Vuse Vibe and Vuse Ciro devices and the accompanying tobacco-flavored cartridges are approved for marketing by the FDA. Applications for six tobacco-flavored Vuse Alto products remain under the FDA review.
BAT generated 60% of the global Vuse revenue in the US in H1 2023 and menthol variants account for ~75% of Vuse consumables (i.e. ~45% of global Vuse revenue is associated to the menthol variants sold in the US).
July 2023: Juul Labs Submitted PMTAs for JUUL2 system
Juul Labs submitted PMTA to the US FDA for JUUL22. The submission includes JUUL2 device, tobacco-flavored pods (18 mg/mL) and information on novel, data-driven technologies to restrict underage access. JUUL2 System was initially launched in the UK in 2021. FDA issued Marketing Denial Orders (MDO) for the currently-marketed JUUL System in June 2022 (- for further details, see the “High-profile cases: JUUL” section below).
Background Information
A Premarket Tobacco Product Application (PMTA) is submitted to obtain an FDA marketing order. A PMTA must provide scientific data demonstrating that a product is appropriate for the protection of public health3. The FDA required all new (i.e., non-pre-existing) tobacco products that were on the market as of August 8, 2016, to submit a PMTA by September 9, 2020, as required by court order. A new tobacco product that was not on the market as of August 8, 2016, must submit a PMTA and receive authorization before marketing the product. Products commercially marketed as of February 15, 2007, are considered pre-existing tobacco products and do not require premarket applications.
As of May 2026, the FDA has received nearly 27 million Premarket Tobacco Product Applications (PMTAs), an unprecedented volume driven primarily by the agency’s order requiring all new tobacco products – such as e-cigarettes and nicotine pouches – on the market as of the August 8, 2016 cutover date to submit applications by September 9, 2020. An overwhelming 99.95% of accepted applications pertained to e-cigarettes, compared to just 458 smokeless and 52 heated tobacco product submissions. However, administrative hurdles eliminated the vast majority of filings before full evaluation: the agency refused to accept almost three-quarters of all submitted PMTAs, and roughly 94% of total submissions failed to reach substantive scientific review due to refusal-to-accept or refusal-to-file determinations.
| Marketing Orders Granted | Nicotine Pouches | Vaping Products | Heated Tobacco | Total MGOs |
| Philip Morris International | 20 | — | 10 | 30 |
| Altria | 10 | 10 | — | 20 |
| British American Tobacco | — | 16 | — | 16 |
| Japan Tobacco | — | 8 | — | 8 |
| Glass Inc. | — | 6 | — | 6 |
| JUUL Labs | — | 5 | — | 5 |
| Total | 30 | 45 | 10 | 75 |
For the few applications that advanced, approval remained exceptionally rare, yielding a conversion metric of approximately three marketing orders per million submitted PMTAs and leaving only 75 authorized products to date. Among the applications that actually underwent substantive scientific review, the FDA denied 99.995%. It took the agency more than five years to resolve the initial application backlog, a delay that severely constrained legal product expansion and inadvertently fueled a thriving illicit e-cigarette market in the U.S. As a result of these strict benchmarks and procedural delays, the FDA’s review standards and speed have become the focus of widespread litigation.
The FDA’s widespread issuance of Marketing Denial Orders (MDOs) to major e-cigarette manufacturers – including Juul Labs, Imperial Brands’ myblu portfolio, and menthol products from BAT and JT – sparked immediate legal pushback that created significant regulatory uncertainty. Following a June 2022 MDO against Juul, a federal appeals court granted a temporary stay to keep the products on shelves pending review, prompting the FDA to administratively suspend its order to re-evaluate “unique scientific issues”. Juul then sued the agency in September 2022 under the Freedom of Information Act for withholding supporting decision documents. Similar judicial stays were granted to other major brands like Vuse (BAT) and Logic (JT), while an August 2022 Eleventh Circuit ruling vacated MDOs for six smaller e-cigarette companies, forcing the FDA to conduct fresh evaluations.
This wave of court challenges placed substantial operational strain on federal regulators. By May 2023, the FDA Commissioner publicly acknowledged that the agency was drained by more than 40 active lawsuits from e-cigarette companies disputing their marketing denials, while also hinting at upcoming discussions with the Department of Justice regarding PMTA enforcement strategies. The ongoing legal resistance highlights the deeply contested nature of the FDA’s review standards, and various cases remain ongoing in federal court today.
References:
- https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-four-menthol-flavored-e-cigarette-products-after-extensive-scientific ↩︎
- https://www.juullabs.com/next-generation-platform-pmta ↩︎
- https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/premarket-tobacco-product-applications ↩︎
