Tag: PMTA

  • 5th Circ. Grills FDA on PMTA Rules

    5th Circ. Grills FDA on PMTA Rules

    A Fifth Circuit panel questioned the U.S. Food and Drug Administration this week, raising doubts about whether it properly considered the impact of its 2021 rule requiring premarket authorization for new tobacco products on small businesses. According to Law 360, the judges questioned whether the agency complied with the Regulatory Flexibility Act, which mandates that regulators assess how new rules affect smaller firms. Vape companies argue the FDA relied on outdated economic data and imposed disproportionate costs that could drive many small manufacturers out of the market.

    During oral arguments in New Orleans, the panel pressed the FDA on its shift in position between 2016 and 2021, when the agency moved from a more flexible approach to requiring extensive scientific evidence for new products. The judges also asked whether the health risk information requirements were discretionary or mandated by the Tobacco Control Act. The skepticism suggests the court is weighing whether the FDA’s rulemaking process adequately accounted for the realities faced by small vape businesses.

    The case comes amid broader challenges to the FDA’s handling of Premarket Tobacco Product Applications (PMTAs), including disputes over flavored e-cigarette denials. If the Fifth Circuit finds the FDA violated the Regulatory Flexibility Act, the agency could be forced to revisit its rulemaking, potentially easing compliance burdens for smaller companies.

  • FDA Deploys Agentic AI to Assist Regulatory Reviews

    FDA Deploys Agentic AI to Assist Regulatory Reviews

    The U.S. Food and Drug Administration today announced the deployment of agentic AI capabilities to all agency employees, a move expected to streamline complex, multi-step regulatory tasks — including pre-market reviews, post-market surveillance, inspections, and compliance activities that would be of interest to those in the tobacco and nicotine industries.

    The new systems allow staff to build multi-model AI workflows capable of planning, reasoning, and executing tasks under human oversight. The tools are optional and operate within a secure GovCloud environment, with no training on industry-submitted data.

    In an email to StatNews, an FDA spokesperson called the tool “exploratory” and said that the AI agents do not make regulatory decisions. “All outputs from AI are reviewed and validated” by FDA staff “before being incorporated into any official regulatory action, ensuring that the AI remains a support tool rather than a decision maker,” he wrote.

    The deployment follows the success of Elsa, an internal LLM tool launched in May and now used by more than 70% of FDA personnel. The agency is also launching a two-month Agentic AI Challenge, with selected projects to be showcased in January 2026.

    FDA Commissioner Marty Makary said the upgrades mark a major step in modernizing regulatory operations, while Chief AI Officer Jeremy Walsh highlighted the potential to accelerate and validate safety assessments across all FDA-regulated sectors — including tobacco.

  • FDA Schedules TPSAC Review of ZYN Applications

    FDA Schedules TPSAC Review of ZYN Applications

    The U.S. Food and Drug Administration announced a January 22, 2026, virtual meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) to review modified risk tobacco product (MRTP) applications submitted by Swedish Match USA for 20 ZYN nicotine pouch products. These products—already authorized for sale through the PMTA pathway in January 2025—include flavors such as Cool Mint, Citrus, Coffee, Peppermint, and Wintergreen, each in 3 mg and 6 mg strengths. The company is seeking permission to market the pouches with the claim: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

    Under federal law, MRTP applications must demonstrate that a product, as actually used by consumers, reduces individual health risks and benefits overall population health. TPSAC’s review will focus on scientific evidence regarding ZYN’s relative health risks, consumer comprehension of the proposed claim, and the potential public health impact of granting a modified risk order. The meeting will be held virtually, open to the public, captioned, and recorded.

    Public comments may be submitted to Docket No. FDA-2025-N-0835 through January 21, 2026, with comments received by January 7 provided directly to TPSAC. The FDA is also inviting individuals to request oral presentation slots during the meeting’s public comment period. Redacted MRTP application materials are available on the FDA’s website, and the agency will consider all public input and TPSAC recommendations before issuing a final decision.

  • Swedish Innovator Eyes U.S. Launch with Fast-Acting Nicotine Pouch

    Swedish Innovator Eyes U.S. Launch with Fast-Acting Nicotine Pouch

    As nicotine pouch use soars in the United States, Swedish biotech firm Emplicure AB announced plans to seek U.S. regulatory approval for its patented nicotine delivery system, Seratek. Designed to deliver nicotine more rapidly at lower strengths, the company says the technology could mark a new chapter in smokeless alternatives for adult nicotine users.

    According to a 2025 pharmacokinetic study, Seratek released 80% of its nicotine within five minutes under controlled conditions, outperforming existing pouch brands even at lower strengths. In a consumer taste test in Sweden, 123 adult pouch users preferred Seratek over international leaders for flavor, comfort, and discretion. Emplicure says it will file a Premarket Tobacco Application (PMTA) to authorize sales in the U.S.

    Emplicure CEO Mattias Josander, a former executive at Swedish Match, Red Bull, and L’Oréal, said the company’s goal is to “accelerate the transition to a smokeless world.” He added, “If vaccines were the breakthrough of the 20th century, nicotine pouches could represent the public-health breakthrough of the 21st.”

  • Midwest Goods Responds to FDA Seizure, Says Actions are ‘Troubling’

    Midwest Goods Responds to FDA Seizure, Says Actions are ‘Troubling’

    Following yesterday’s (September 10) news that federal officials seized $86.5 million worth of illicit vapes in Chicago, Midwest Goods confirmed that agents from the Food and Drug Administration (FDA) and U.S. Marshals executed a civil seizure warrant at its facilities, targeting more than 75 brands of bottled e-liquids used in refillable vaping devices. The company said it is fully cooperating with authorities.

    In a statement, Midwest emphasized that the products cited in the warrant are manufactured in the U.S. by companies employing “hundreds, if not thousands,” of American workers. Many of the e-liquids, the company said, are tied to premarket tobacco product applications (PMTAs) that have been pending with the FDA since as far back as September 2020, despite a statutory requirement for review within 180 days. Midwest noted that the FDA has previously allowed these products to remain on the market during the prolonged review process.

    “Midwest has always attempted to work cooperatively with FDA,” the company said in its statement. “After a recent FDA inspection in August, we advised FDA that we had removed from our product catalog and inventory several ENDS products about which FDA inspectors had inquired. We also offered to remove other ENDS products from our product catalog if FDA was concerned about our continuing to offer them for sale. FDA acknowledged receipt of our correspondence, but did not request that we stop selling any other products.”

    The company called the enforcement action “troubling,” particularly in light of reports that FDA is preparing to expedite reviews of products tied to larger companies with more recent applications, while seizing long-pending independent products. It pledged to continue cooperating with federal authorities while reserving the right to challenge the seizure in court.

    Read the full statement here.

  • Tariffs, Executive Orders and Cuts: The Trump Administration’s First Six Months

    Tariffs, Executive Orders and Cuts: The Trump Administration’s First Six Months

    By Freddie Dawson, Senior editor, Tamarind Intelligence

    The first six months of the second Trump administration can be defined by tariffs, executive orders and no further action on reforming the issues facing the American vaping market.

    President Donald Trump embarked on his second term as president having promised to “save flavored vaping” in the U.S. in the lead up to the election. This has not yet happened despite a flurry of executive orders – at least 157 that have been published in the U.S. Federal Register as of May 23. (More have been announced but that was the date of the last one published at the time of writing.)

    Many vaping advocates had hoped he might use an executive order to reset or reassess the U.S. Food and Drug Administration (FDA) Pre-Market Tobacco Application (PMTA) process. Thus far this has not happened and, instead, there have been some comments that could be construed as concerning.

    There was the U.S. Supreme Court decision in the long-running case with the vaping company Wages and White Lion Investments – doing business as Triton Distribution – and the vaping company Vapetasia. The Supreme Court unanimously decided to vacate and remand the appealed Fifth Circuit Court decision that had been in favor of the companies over whether the FDA had been right to issue market denial orders (MDOs) to the them.

    This was a disappointment for vaping advocates. The companies had argued the FDA had been arbitrary and capricious in the changes it made to PMTA requirements while also being unclear about those changes and what minimum requisites would need to be included to successfully be granted a market authorization and be considered a legal product able to be sold in the American market. Advocates hoped a decision in favor of the vaping companies would confirm the FDA approach had been wrong and pave the way for the new administration to implement a new policy.

    Instead, the Supreme Court mostly rejected the vaping companies’ arguments. It did not arbitrate on all issues presented and returned the case to the lower court for further work, making the decision not a total defeat. However, it was a pretty galling blow for those wanting to see a change. Many of them hoped the Department for Health and Human Services (HHS) – now under new management – would even decline to continue to argue the case following the change in leadership.

    Instead, they appeared to fully embrace the prior approach. A HHS spokesperson welcomed the Supreme Court decision. They said it represented confirmation that the approach taken by the FDA – including under the administration of former Democratic president Joe Biden – was the correct one. “The recent Supreme Court ruling supports the FDA’s efforts to regulate e-cigarette products in line with the standards outlined in the Tobacco Control Act,” a spokesperson said.

    Beyond this, comments by the new HHS secretary – Robert Kennedy Jr and head of the FDA – Marty Makary could also be construed to be viewed as negative takes on vaping from major administration figures.

    Both have been questioned by Florida Republican Senator Ashley Moody on what they will do to combat Chinese vaping products illicitly on the U.S. market. Makary told Moody he agreed that vaping products were proliferating on the American market and that this was due to the Chinese flooding it with cheap supplies.

    He said public health research would never be able to properly study them as the market moved faster than the science could but that the FDA could collaborate with other U.S. government departments to increase enforcement actions. “The Office of Inspections and Investigations has a lot of people with guns, and they do enforcement and raids,” he said.

    Several vaping commentators did not react well to this – particularly on the semi-serious threat of armed enforcement raids. However, it could also be theoretically read that Makary was implying the enforcement action would be directed at imported Chinese vaping products and that emphasis was placed on revamping the FDA’s approach to PMTAs.

    Kennedy Jr’s later comments in answer to questions from Senator Moody could potentially support such a reading. He told her that the FDA had created its own backlog and had deliberately dragged its feet on approvals for American vaping companies, which had been acting responsibly by putting age verification chips in vaping devices, providing information on addiction and were making labels not attractive to children.

    Chinese products had flooded the opening in the market provided by them obeying the law and that these were the products that were responsible for youth attraction issues with flavors, colors and youth-aimed enticements such as cartoon like imagery as well as features such as gaming capabilities on devices. He told Senator Moody that he promised to “wipe them out”.

    Despite being a complete misreading of the nicotine alternatives history – and almost certainly being a ‘barn door shut after the horse has already bolted’ sort of promise, it does at least show some favor for American vaping companies and a potential desire to address issues facing it in the future.

    That marks something of a change from Kennedy Jr’s initial nomination hearings where vaping did not come directly come up. However, his potential use of an Alp nicotine pouch during the sessions did draw a few headlines and suggested the new secretary may have a sympathetic stance on nicotine alternatives.

    But although the administration has not addressed the U.S. vaping regulatory situation through any means – such as the use of executive orders – it has taken other actions through those means that have had an impact on the industry.

    This includes several orders trimming resources for government entities that have some impact on vaping and other nicotine alternatives – including the HHS, the Center for Tobacco Products (CTP) itself and aspects of the Centers for Disease Control (CDC) such as the Office on Smoking and Health (OSH). This has resulted in redundancy or resignation for myriad groups of former federal employees in these organizations up to and including the former head of the CTP, Brian King and – allegedly – the entirety of the OSH.

    The impact of these actions will likely take some time to properly be felt. In the short term it presumably has increased the disorder and delay already present in organizations such as CTP that would have had primary responsibility for PMTA assessment. Further in the future the decisions could potentially benefit vaping and other nicotine alternatives – depending how important intervening steps turn out.

    For example, significantly more will be revealed on the future direction of PMTA assessment by who becomes the next head of CTP. A new head and new staff could perhaps be more efficient in assessing and processing PMTAs – though it is hard to see where new staff with the requisite expertise will suddenly materialize from. Similarly, much will be implied about the administration’s opinion of, and the potential future of, nicotine alternatives by what is done with the former activities of the OSH. For example, maintaining the collection and publication of smoking-related datasets but dropping things like preferential access to data or provision of OSH opinions on issues could create a more vaping-amenable atmosphere in the U.S..

    Setting that aside, more immediately, the action taken through executive orders that has had the most impact on vaping and other nicotine alternatives has been the imposition of tariffs on goods imported into the U.S. from China. Primarily this has affected vaping hardware – though has also had an impact on other product which rely on specialist or mass-produced items that are hard to find from other sources at economically viable prices.

    Theoretically this activity could be considered taking action against the proliferation of illicit Chinese vaping products on the market – as promised by Kennedy Jr and Makary. There is some evidence this is happening with reports of limits placed on maximum purchase numbers for disposable vaping products from wholesalers and decreases in registered imports of vaping products from China.

    Data from the FDA showed only 71 shipments this May, compared to 996 in January 2025, before the additional new Trump tariffs started to be announced. It also compares to the 1158 shipments recorded last May.

    But without a viable domestic vaping manufacturing sector in the U.S., the move risks worsening public health. There previously was little evidence of other nicotine alternatives leaching numbers away from vaping. There is perhaps a little more of that – primarily through dual use driven by situational advantages. This, for example, could be using pouches in scenarios where more discretion is required. But primarily the trend appears to still be for dual or poly use of products rather than switching entirely.

    If vaping products continue to be limited by supply constraints brought about by tariffs, this trend may increase, or people may instead choose to move back to conventional cigarettes. There is little evidence domestic vaping will be able to spring up to fulfil the need. A couple of companies have announced they were transferring manufacturing capacity to the U.S. Many more are moving capacity out of China to third-party countries partly at least to get around U.S. tariffs.

    But there will be no major transference of vaping capacity to the US simply because of the continuing PMTA situation. No company will take the time, effort, and capital it would require setting up manufacturing in the U.S. with no guarantee the product would ever be approved to be sold on the domestic market.

    Meanwhile it is also unclear whether there has definitely been a reduction in Chinese vaping imports. Several manufacturers were already in the process of moving vaping manufacturing capacity out of the Shenzhen region in China due to rising costs driven by competition. Tariffs will have accelerated that trend – though President Trump’s “Liberation Day” spread of tariffs will have gone some way to reducing the advantage such a move would gain in terms of exports to the USA.

    But it has been noted that imports of vaping products from countries such as Indonesia have already outstripped their totals for the entirety of last year (3,139 thus far this year compared to 3,102 for all of 2024). And there remains significant speculation that the vast majority of Chinese vaping imports – particularly for disposable vaping products – do not enter the U.S. under the proper registration. U.S. officials have alleged that they are often deliberately labelled as products such as shoes to get around restraints. Though this claim has been repeated many more times than evidence backing it has been produced.

    One potential support of vaping products entering the U.S. market through some means aside from in registered shipments is the 90% discrepancy between the reported value of Chinese vaping exports to the U.S. ($3.6bn for 2024) and Chinese vaping imports registered with U.S. authorities ($333m for the same time period).

    So thus far there has not been much help for vaping in the first six months of the second Trump administration. But there is the potential of future promise. Appointments and reassignments for the OSH and – primarily – the CTP could theoretically change the approach to vaping regulation in America. Further policing of illicit vaping products entering the market could lead to domestic uptake – if PMTA conditions were first sorted. So not much for vaping or wider nicotine alternatives in the first six months. But perhaps the groundwork for something more to be built later.

  • FDA Updates Tobacco Application Forms; Effective Immediately

    FDA Updates Tobacco Application Forms; Effective Immediately

    Today (June 6), the FDA posted six updated or new forms that are required for submitting new tobacco product applications under the premarket tobacco product application (PMTA) and Substantial Equivalence (SE) pathways. Starting July 6, 2025, applicants must use these forms in their PMTA and SE Report submissions. If applicants do not use the latest version of the forms or do not complete them properly, FDA generally intends to refuse to accept the application.

    The updated forms reflect public comments and are part of FDA’s work to promote efficiency, effectiveness, and transparency to improve its tobacco product application review process. The latest versions of the forms offer new instructions and additional details on the information applicants are required to include. Ultimately, these forms can help applicants submit higher-quality applications to facilitate FDA’s review.

    A list of the updated forms is below. Use of old versions of the forms will no longer be accepted after the 30-day notice period.

    Updated PMTA forms:

    • Form FDA 4057 – Premarket Tobacco Product Application (PMTA) Submission
    • Form FDA 4057a – Premarket Tobacco Product Application Amendment and General Correspondence Submission
    • Form FDA 4057b – PMTA Unique Identifying Information for New Tobacco Products (formerly referred to as a grouping spreadsheet)

    Updated or new SE forms

    • Form FDA 3965 – Tobacco Substantial Equivalence Report Submission
    • Form FDA 3965a – Tobacco Substantial Equivalence Report Amendment and General Correspondence Submission (formerly Form FDA 3964)
    • Form FDA 3965b (NEW) – SE Unique Identifying Information for New Tobacco Products

    To assist applicants’ proper use of Form FDA 4057b and Form FDA 3965b, FDA is releasing version 2.0 of its Product Form Validator Tool. Applicants may use the tool for both forms to validate the data and confirm if a completed form is consistent with FDA ingestion requirements before submission.

    If applicants have questions about the forms, they can email AskCTP@fda.hhs.gov or call 1-877-287-1373 between 9 a.m. and 4 p.m. EST. Additionally, applicants can explore FDA’s PMTA tips

  • Don’t Gamble Your PMTA: Bet on Your Quality System

    Don’t Gamble Your PMTA: Bet on Your Quality System

    By: Gabriel Muñiz

    The recent leadership changes and staffing reductions at the FDA’s Center for Tobacco Products (CTP) have created a moment of uncertainty, but also opportunity, for the tobacco and nicotine industry. With shifting priorities and new leadership on the horizon, some manufacturers see a chance to reset the regulatory conversation. While some companies are using this moment to tighten up operations and reinforce compliance in order to have a better chance at a favorable premarket tobacco product application (PMTA) outcome, others are taking a gamble, scaling back on quality systems and asking themselves, “Do we really have to keep doing all of this?”

    The question often centers around the expectations outlined in 21 CFR Part 1114 and the commitments companies made in their PMTAs. In a push to save costs, some manufacturers are reportedly reducing quality oversight, cutting corners in documentation, and stepping away from key controls they originally described in their PMTAs. The rationale? If enforcement is slowing down, maybe the FDA won’t notice or maybe it won’t matter.

    That’s a risky assumption.

    A PMTA is more than a regulatory formality. It’s a company’s game plan. A commitment to how the product will be manufactured, tested, controlled, and distributed. If your application included a robust quality management system (QMS), specific product testing protocols, or detailed supplier qualification processes, you’re expected to follow through. Along with the science, those commitments were the basis on which the FDA evaluated whether your product was “appropriate for the protection of public health.”

    Under Section 910 of the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA has the authority to withdraw or suspend a marketing granted order (MGO) if it determines that a tobacco product is no longer “appropriate for the protection of public health,” the standard upon which PMTAs are evaluated and approved. If an inspection or oversight activity reveals that a company has significantly deviated from the manufacturing methods, testing protocols, or quality systems described in its PMTA, the FDA may conclude that the product no longer meets the criteria for market authorization. While there hasn’t yet been a public case of an MGO being rescinded solely for failure to follow internal PMTA commitments, the legal basis for such action is clear. An MGO is conditional—it depends on a company continuing to manufacture its product as promised. Deviating from that blueprint introduces real regulatory risk.

    While some in the industry viewed the Fifth Circuit’s ruling in Bidi Vapor v. FDA as a signal that the tide was turning in manufacturers’ favor, the outcome in FDA v. Wages and White Lion Investments LLC made it clear: Companies are still expected to meet regulatory requirements and support their products with quality data and compliance. The courts may question FDA procedures, but they won’t eliminate the work required to maintain market authorization.

    Even in a more industry-friendly political environment, the responsibility to protect public health isn’t going away. The current administration may support regulatory efficiency and streamlined processes, but not at the expense of consumer safety. Companies that ignore or scale back their quality systems risk finding themselves unprepared when FDA inspections or compliance reviews resume in full force.

    Now is the time for manufacturers to take stock of their internal systems and ensure alignment with their PMTAs. This includes verifying that quality controls, personnel training, document management, complaint handling, and supplier oversight are functioning as described. A comprehensive, well-maintained QMS doesn’t just satisfy regulatory requirements; it builds trust and stability, especially in a time of change.

    This transition at CTP represents a golden opportunity, but only if companies take the right approach. Cutting corners today to save money may end up costing you far more if it puts your MGO at risk. Regulatory clarity, product stability, and long-term market access depend on more than a favorable headline—they depend on daily operational integrity.

    The FDA may be shifting, but its core mandate remains. This is the moment for responsible manufacturers to lead by example, double down on quality, and show that this industry can thrive without sacrificing quality or consumer trust. For those willing to roll the dice, just remember, being the first company to lose an MGO over PMTA noncompliance isn’t the kind of milestone you want your brand remembered for.

    Gabriel Muñiz, an independent consultant with EAS Consulting Group, is a regulatory compliance expert with extensive experience in the tobacco industry. Muñiz’s tenure at the FDA, particularly as a director within the Office of Regulatory Affairs (ORA), involved leading compliance and enforcement activities for the agency’s tobacco program. His work in building the tobacco operations program and shaping tobacco regulatory policy was instrumental in the development of key compliance strategies and regulatory frameworks, including the proposed tobacco product manufacturing practices. After his FDA career, Muñiz further honed his skills at Juul Labs, where he played a key role in developing premarket tobacco product applications and ensuring alignment with evolving federal regulations. His deep expertise in tobacco regulation will be invaluable to EAS’ clients seeking strategic compliance advice and navigating tobacco-related regulatory challenges.

    About EAS Consulting Group

    EAS Consulting Group, a member of the Certified family of companies, is a global leader in regulatory solutions for industries regulated by the FDA, USDA, and other federal and state agencies. As part of Certified Group, EAS Consulting Group delivers expert regulatory solutions our customers can feel confident in—so the world can trust in what it consumes. Our network of over 200 independent consultants enables EAS to provide comprehensive consulting, training, and auditing services, ensuring proactive regulatory compliance for food, dietary supplements, pharmaceuticals, medical devices, cosmetics, tobacco, hemp, and CBD.

  • Iowa Judge Halts Law that Would Pull Vapes from Shelves

    Iowa Judge Halts Law that Would Pull Vapes from Shelves

    A Federal District Court for the Southern District of Iowa sided with e-cigarette industry plaintiffs in a preliminary ruling against the state, temporarily halting the enforcement of the state’s PMTA registration law. On May 3, Chief Judge Stephanie Rose issued a temporary stay on HF 2677, which would have required vape products to have marketing authorization from the Food and Drug Administration between 2016 and 2020 in order to be sold in Iowa.

    “As the plaintiff alleges, Congress intended to concentrate enforcement authority on the FDA in Section 337(a) of the FDCA, aiming to prevent states from adopting inconsistent enforcement methods that would undermine the federal regulatory system,” Rose said in the ruling. “Iowa acknowledges that the legislative motive is the ‘absence of federal enforcement,’ which reflects why Congress has granted such enforcement powers to the federal government.”

    The bill was passed by the state legislature in April 2024 and signed by the governor in May, with an effective date set for February 2025. The Attorney General of Iowa agreed to temporarily pause enforcement of the law, awaiting the court’s decision on the preliminary injunction after the Iowa State E-cigarette Industry Association filed a lawsuit in December, which claimed the state’s policy would hurt local businesses and lead to vaping products being pulled from the shelves.

    The court ruled that the Iowa law “impermissibly intrudes upon the federal government’s exclusive authority” to enforce the Food, Drug, and Cosmetic Act, which ensures that food, medicine, cosmetics, and medical devices are safe and properly labeled.

    “It’s definitely a win in the right direction,” said Ashley Hartman, chief strategy officer for Central Iowa Vapors. “It essentially would have shut our stores down. There’s only 26 products that are currently approved on the registry federally and so that would have completely wiped away everything in our stores.”

    The ruling holds extra significance in that the Vapor Technology Association plans to apply for a preliminary injunction next week in a similar registration bill in North Carolina. The Iowa ruling could provide a legal precedent for other states facing similar lawsuits regarding PMTA registration laws.

  • Charlie’s Holdings Receives PMTA Acceptance Filings for 11 Products

    Charlie’s Holdings Receives PMTA Acceptance Filings for 11 Products

    Charlie’s Holdings, Inc. announced today that it received acceptance filings for 11 of its best-selling flavored PACHA Disposables brands from the Center for Tobacco Products of the U.S. Food and Drug Administration. Charlie’s has received more than 700 acceptance filings for its PMTA submissions.

    The FDA has received PMTAs for nearly 27 million electronic nicotine delivery system products and has made determinations on more than 99% of the applications. However, the FDA has authorized fewer than three dozen tobacco- and menthol-flavored e-cigarette products and devices. To date, no company in the world has received an FDA marketing order for a flavored (non-tobacco or non-menthol) disposable vape product.