Tag: FDA

  • FDA Authorizes Juul E-Cigarettes in Tobacco and Menthol Flavors

    FDA Authorizes Juul E-Cigarettes in Tobacco and Menthol Flavors

    Today (July 17), the U.S. Food and Drug Administration (FDA) issued marketing granted orders (MGOs) for Juul Labs’ original e-cigarette device and refill cartridges in tobacco and menthol flavors.

    As part of its 2020 application, Juul submitted over 110 scientific studies to FDA covering nonclinical, clinical, and behavioral science. Following rigorous evaluation of the data, FDA decided that an MGO for the Juul System was “appropriate for the protection of public health” – the standard required by statute for authorization.

    “Today’s FDA authorization of Juul products marks an important step toward making the cigarette obsolete,” company CEO K.C. Crosthwaite said in a statement. “More than 2 million adult Americans have switched completelyaway from deadly cigarettes using Juul products. Meanwhile, underage use of our products is down 98% since 2019, to one-half of one percent of youth. 

    “We strongly support FDA’s role in regulating tobacco and nicotine products. Americans who use nicotine deserve an orderly, reliable market in which they can confidently choose from a wide array of smokefree nicotine products that are high-quality, innovative, backed by rigorous research, made in FDA-inspected manufacturing facilities, and marketed and sold responsibly.”

    The approval marks a major reversal after the FDA banned Juul’s products in 2022, citing concerns over public health. That decision was quickly stayed following an appeal by the company and formally rescinded in June 2024. During this time, Juul products remained on the market.

    “The decision follows wider expectations in the industry that the Trump Administration would ease regulatory hurdles for launching new vapes and other smoking alternatives,” Emma Rumney wrote for Reuters. “Some companies have seen FDA applications for new nicotine products languish for years or, like Juul, faced rejections that were challenged in court.”

    The approval breathes new life into Juul, which had faced regulatory roadblocks and financial turmoil after the initial ban. It also potentially signals a broader shift in FDA oversight, as the agency faces growing pressure over delays in product reviews and the proliferation of unauthorized nicotine products in the market. Juul’s authorization is seen as a potential bellwether for other pending applications in the vaping industry, the WSJ suggested.

  • Wisconsin Vape Law Sparks Federal Lawsuit Over FDA Authority

    Wisconsin Vape Law Sparks Federal Lawsuit Over FDA Authority

    A Wisconsin trade group filed a federal lawsuit aiming to block a new state law regulating vape product sales, claiming it oversteps federal authority and threatens thousands of small businesses. Wisconsinites for Alternatives to Smoking and Tobacco (WiscoFAST) filed the suit in the U.S. District Court for the Western District of Wisconsin, challenging Wisconsin Statute 995.15, which took effect July 1.

    The law empowers the Department of Revenue to fine sellers and manufacturers $1,000 per day starting September 1 if they sell vape products not authorized by the FDA. So far, only 34 e-cigarette products have FDA marketing approval.

    WiscoFAST is seeking a preliminary injunction, arguing the law violates the Supremacy Clause of the U.S. Constitution by encroaching on the FDA’s exclusive authority under the Federal Food, Drug, and Cosmetic Act (FDCA). They also say it breaches the Equal Protection Clause of the 14th Amendment by unfairly banning some non-tobacco nicotine products.

    “[The law] will strip Wisconsinites of their right to purchase the vaping products they use to stay smoke-free, while threatening to shutter 3,000 small businesses that are vital to our state’s economy,” said Tyler Hall, president of WiscoFAST. “This law disregards the FDA’s careful approach to regulating ENDS and could push former smokers back to deadly combustible cigarettes. We’re fighting to protect consumer choice and the livelihoods of thousands of Wisconsin workers.”

    The American Lung Association (ALA) also disagrees with the new law, saying it likely won’t improve public health. Molly Collins, the ALA’s Wisconsin advocacy director, argued that raising the purchase age and increasing vape prices would be more effective.

  • FDA Embraces “Radical Transparency” by Publishing CRLs

    FDA Embraces “Radical Transparency” by Publishing CRLs

    On July 10, the U.S. Food and Drug Administration (FDA) published more than 200 decision letters, known as complete response letters (CRLs). The CRLs were issued in response to applications submitted to the FDA for approval of drugs or biological products between 2020 and 2024, marking a significant step in the Agency’s broader initiatives to modernize and increase transparency.

    By making the CRLs available, the public now has significantly greater insight into the FDA’s decision-making and the most common deficiencies cited that sponsors must address before their application is approved.

    “For far too long, drug developers have been playing a guessing game when navigating the FDA,” said FDA Commissioner Marty Makary. “Drug developers and capital markets alike want predictability. So today we’re one step closer to delivering it to them, with an ultimate goal of bringing cures and meaningful treatments to patients faster.”

    “Because the FDA has historically refrained from publishing CRLs for pending applications, sponsors often misrepresent the rationale behind FDA’s decision to their stakeholders and the public,” the press release said. “According to a 2015 analysis conducted by FDA researchers, sponsors avoided mentioning 85% of the FDA’s concerns about safety and efficacy when announcing publicly that their application was not approved. Moreover, when FDA calls for a new clinical trial for safety or efficacy, that critical information is not disclosed approximately 40% of the time. Lessons learned from non-approvals are also not shared within the industry, leading companies to repeatedly make similar mistakes.”

    This initial batch of published decision letters associated with since-approved applications is now accessible to the public at openFDA. The Agency is in the process of publishing additional CRLs from its archives and is continuously exploring ways of providing the public with greater transparency into its decision-making process.

    On the surface, this all sounds like good news for companies that have spent years frustrated by FDA backlogs. What actually changes remains to be seen.

    “Commissioner Makary’s announcement raises questions about whether this effort is truly ‘radical transparency’ or just a repackaging of existing requirements,” Sarah Wicks and Michelle L. Butler wrote for FDA Law Blog. “The key difference may lie in timing and ease of access; despite the statutory requirement under FDAAA, action packages are often slow to appear on FDA’s website, especially following staffing disruptions at FDA.

    “It is currently unclear whether FDA intends to publish CRLs close in time to their issuance or for applications that are not subsequently approved. The prospect of publication of such CRLs would likely be of great concern to many applicants and of great interest to their competitors. Regardless, we will be watching to see how this radical transparency initiative unfolds.”

  • 22nd Century Advances FDA Renewal for VLN

    22nd Century Advances FDA Renewal for VLN

    22nd Century Group, Inc. announced that it is proceeding with the Modified Risk Tobacco Product (MRTP) renewal process for VLN, its flagship line of reduced-nicotine content cigarettes.

    First authorized by the FDA in December 2021, VLN remains the only combustible cigarette with MRTP designation, permitted to market key reduced-harm claims such as “95% less nicotine” and “Helps you smoke less.” The renewal, due in December 2026, comes as the company expands its VLN portfolio through partnerships and patented low-nicotine plant varieties.

    “Our MRTP authorization for VLN cigarettes stands apart as one of the most unique and innovative tools in the tobacco industry, leading the fight in Tobacco Harm Reduction to reduce the health harms of smoking,” said Larry Firestone, Chief Executive Officer of 22nd Century Group. “Our VLN cigarette is the only product that meets the FDA’s guideline for low nicotine based on its proposed low-nicotine mandate issued in January 2025.

    “While the FDA’s mandate has not yet become a final ruling, we expect that the FDA will fully support our MRTP renewal for VLN.”

  • Makary Updates First 100 Days Leading FDA

    Makary Updates First 100 Days Leading FDA

    FDA Commissioner Marty Makary issued a statement today (July 10) to update the work that has been accomplished in his first 100 days leading the organization and create a roadmap for future objectives.

    “The FDA regulates products that account for 20% of all U.S. consumer spending, and our work impacts the lives of every American,” he said. “Over the past 100 days, we’ve launched dozens of key initiatives across the full range of the FDA’s purview to help make food healthier for children and families, accelerate meaningful cures and treatments, and modernize the agency with transparency, gold-standard science, and common sense.”

    The statement then listed dozens of bullet points highlighting the work being done, the majority of which focused on pharmaceuticals and food manufacturing. Under the heading “Administration – Gold-Standard Science & Common Sense,” Makary said the FDA was protecting American consumers by combating illegal vapes. “In collaboration with U.S. Customs and Border Protection, seized nearly $34 million worth of illegal, youth-appealing e-cigarette products originating in China,” it said.

    Makary also pointed to the FDA’s implementation of AI to assist all departments in reviewing products, of particular interest to the nicotine industry that has dealt with years of little to no movement regarding vapes and alternative products.

    “Completed a successful first AI-assisted scientific review pilot, demonstrating that internal AI tools can greatly reduce the time reviewers spend on mundane tasks or non-productive busywork,” the statement said. “Launched Elsa, a generative AI tool designed to help all FDA employees – from scientific reviewers to investigators – work more efficiently. Elsa is just an initial step in the FDA’s larger plans to integrate AI into agency processes.”

    “I’m excited by what the talented FDA team have been able to achieve in 100 days by embracing gold-standard science, radical transparency, and common sense,” Makary said. “This is just the beginning. We’ll continue to introduce initiatives to modernize the agency.”

    Read the entire press release 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: New PATH Study Data Files Available for Researchers

    FDA: New PATH Study Data Files Available for Researchers

    The Population Assessment of Tobacco and Health (PATH) Study released two new data sets today (July 1), including an innovative data type for researchers on locale that can provide a fresh resource for research questions.

    The Wave 7.5 Special Collection Public-Use Files are now available from FDA’s Center for Tobacco Products and NIH’s National Institute on Drug Abuse. These Wave 7.5 files contain questionnaire data from youth (12-17 years old) and young adults (18-22 years old) collected between April 2023 and December 2023. Adult and youth/parent Location Characteristics Restricted-Use Files from Wave 6 (2021) and Wave 7 (2022–2023) have also been released. These variables characterize a respondent’s neighborhood of residence as one of four basic locale types: city, suburban, town, or rural. Providing an enhanced measure of a respondent’s location improves the ability of researchers to understand relationships between tobacco use behaviors and community characteristics. Researchers are encouraged to submit a request to obtain data access.

    In addition to these newly released data files, the Wave 7.5 Special Collection Restricted-Use Files were also made available in April 2025. Researchers may continue to request access to the Wave 1-Wave 7 Restricted-Use Files and Biomarker Restricted-Use Files. Data and documentation from the Public-Use Files are also available for download with updated Master Linkage Files.

    The PATH Study is a household-based, nationally representative, longitudinal study of youth (12-17 years old) and adults in the United States. The study was launched in 2011 to inform FDA’s regulatory activities under the Family Smoking Prevention and Tobacco Control Act.

    Questions about the collection, content, weighting, documentation, or structure of PATH Study data may be submitted to PATHDataUserQuestions@Westat.com.

  • FDA Issues Reminder to Update Tobacco Product Listings

    FDA Issues Reminder to Update Tobacco Product Listings

    Twice every year – by June 30 and Dec. 31 – registered tobacco product manufacturers are required to report to the U.S. Food and Drug Administration their tobacco product listings if they have made certain changes, the FDA reminded in a statement.

    If a manufacturer made any of the following changes, they must be reported:

    • Introduced any tobacco products for commercial distribution that were not included in a previous listing;
    • Discontinued manufacturing, preparation, compounding, or processing any tobacco products for commercial distribution;
    • Resumed manufacturing, preparation, compounding, or processing any tobacco products previously listed as discontinued; or
    • Made any required or voluntary material change to any listing information previously submitted, such as a name, labeling, consumer information, or advertisement changes.

    Information previously submitted to FDA should not be resubmitted.

    Updates can be submitted using the new “Tobacco Registration and Listing Module Next Generation (TRLM NG).”  If you are unable to submit online using TRLM NG, you can mail the appropriate Registration & Listing PDF form (FDA Form 3741) or, for deemed establishments, (FDA Form 3741a) to CTP’s Document Control Center.

    For resources on product listing submissions, go to the Tobacco Registration and Product Listing – Next Generation (TRLM NG) Instructions page. Manufacturers can also read the Registration and Product Listing for Owners and Operators of Domestic Product Establishments page for more information. 

  • U.S. Supreme Court Backs RJR, Broader Legal Challenges to FDA

    U.S. Supreme Court Backs RJR, Broader Legal Challenges to FDA

    The U.S. Supreme Court ruled 7–2 in favor of R.J. Reynolds Vapor Company, allowing it to challenge FDA denials of e-cigarette marketing applications in the Fifth Circuit, even though the company is based in North Carolina.

    The decision effectively expands who can file lawsuits under the 2009 Family Smoking Prevention and Tobacco Control Act, now including retailers and trade groups affected by product bans, not just manufacturers. This enables tobacco companies to approach conservative-leaning courts like the Fifth Circuit, which has frequently ruled against FDA vaping restrictions.

    The FDA argued that retailers were never meant to be included under the legislation, and that 75% of e-cigarette appeals were being filed in the Fifth Circuit through strategic partnerships with local vape shops and trade groups, undermining consistent enforcement.

    Justice Amy Coney Barrett, writing for the majority, said that retailers are “adversely affected” because they lose potential sales or risk penalties by selling unapproved products. Justice Ketanji Brown Jackson, in dissent, warned the ruling contradicts Congress’s intent, allowing companies to bypass venue restrictions meant to streamline regulation.

    The case specifically involved menthol-flavored Vuse vapes, which the FDA had denied for failing to meet public health standards. The ruling now returns the case to the Fifth Circuit for further review.

  • FDA Begins Review of Zyn’s Modified Risk Claim

    FDA Begins Review of Zyn’s Modified Risk Claim

    The U.S. Food and Drug Administration (FDA) has officially begun its scientific review of modified risk applications for 20 Zyn nicotine pouch products, submitted by Swedish Match USA, Inc.

    Already authorized for sale in January 2025, the company is now seeking permission to market Zyn with a health-related claim: “Using Zyn instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

    FDA’s review will assess whether this claim is scientifically and legally justified under the Modified Risk Tobacco Product (MRTP) process. The agency will issue a final decision after reviewing scientific evidence, public comments, and recommendations from its Tobacco Product Scientific Advisory Committee (TPSAC).

    “It is a positive development that FDA is progressing the MRTP applications and we hope for an expeditious review,” a PMI spokesperson said. “Swedish Match has presented the agency with a substantive scientific package that the company believes supports authorizing ZYN as appropriate to promote public health. Providing accurate information on the relative risk of different nicotine products to America’s 45 million legal-age nicotine consumers will help accelerate switching to better alternatives than continued cigarette use—the most harmful form of nicotine consumption.”

    Public comments open June 18 at regulations.gov under docket FDA-2025-N-0835. The comment period will remain open for at least 180 days after publication of the Federal Register notice.

    TPSAC meeting details and redacted application materials will be released on a rolling basis at the FDA’s Center for Tobacco Products website.