Tag: FDA

  • U.S. FDA Warns Retailers for Elf Bar, Esco Bar Sales

    U.S. FDA Warns Retailers for Elf Bar, Esco Bar Sales

    Credit: Pastel Cartel

    The U.S. Food and Drug Administration is continuing its crackdown on illegal disposable vape devices. The regulatory agency has issued warning letters to 189 retailers for selling unauthorized tobacco products, specifically Elf Bar and Esco Bars brands. 

    “The FDA is prepared to use all of its authorities to ensure these, and other illegal and youth-appealing products, stay out of the hands of kids,” said FDA Commissioner Robert M. Califf. “We are committed to a multipronged approach using regulation, compliance and enforcement action and education to protect our nation’s youth.” 

    The warning letters are the result of a nationwide retailer inspection blitz over the past several weeks cracking down on the sale of these unauthorized e-cigarettes.

    The FDA continuously monitors the marketplace and took these actions as emerging marketplace data led to concerns over their appeal and risks to young people, according to an FDA release. More specifically, the agency’s ongoing surveillance efforts helped FDA identify Elf Bar and Esco Bars as being among the most popular brands in the United States and having high youth appeal.

    “All players in the supply chain—including retailers—have a role in keeping illegal e-cigarettes off the shelves,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “This latest blitz should be a wake-up call for retailers of Elf Bar and Esco Bars products nationwide. If they’re waiting for a personal invitation to comply with the law, they might just get it in the form of a warning letter or other action from the FDA.”

    Last month, the FDA issued import alerts for all products under both the Elf Bar and Esco Bars brands. An import alert places these tobacco products on the red list, which makes them subject to Detention Without Physical Examination and allows the FDA to detain a product without physically examining it at the time of entry.

    Elf Bar and Esco Bars products do not have the required marketing authorization from the FDA.

  • Keller and Heckman Files Amicus Brief with SCOTUS

    Keller and Heckman Files Amicus Brief with SCOTUS

    Credit: Sean Pavone Photo

    Eric Gotting and Azim Chowdhury, partners at Keller and Heckman, filed an amicus brief with the Supreme Court of the United States (SCOTUS) in support of Avail Vapor’s writ of certiorari petitioning the SCOTUS to review the 4th Circuit’s decision to uphold the U.S. Food and Drug Administration’s marketing denial order of Avail’s premarket tobacco product application for its nontobacco-flavored e-liquids, according to a post on The Continuum of Risk.

    The brief, filed on behalf of a group of public health experts, is intended to provide relevant scientific background on comparative health impacts of electronic nicotine-delivery system (ENDS) products with combustible cigarettes.

    The brief argues that ENDS are, beyond a reasonable doubt, much safer than cigarettes; ENDS help adult smokers quit and can reach many adults who would not otherwise quit smoking; ENDS flavors are important to adults trying to quit smoking; youth vaping has declined markedly since 2019, with most youth vaping being infrequent, nonaddictive and temporary, and more frequent and intense vaping generally limited to adolescents who are otherwise likely to smoke.

    Youth do not generally use the refillable tank devices sold in vape shops but instead use more mass-market products; claims that vaping is a gateway to smoking are based on a misunderstanding of the evidence; and because smoking and vaping are linked, measures like e-liquid flavor bans can cause more smoking or other damaging unintended consequences.

    In its petition, Avail asks the Supreme Court to consider the lower court’s legal reasoning and decision.

    Among other things, Avail argues in its petition that the FDA’s decisionmaking was arbitrary and capricious; that another court sided with a different petitioner against the FDA on the same basic arguments; and that the case is significant not only for Avail but for the entire industry and its customers.

    The Supreme Court has not yet decided whether it will hear Avail’s case.

  • Second Circuit Appeals Court Rules in Favor of FDA

    Second Circuit Appeals Court Rules in Favor of FDA

    Credit: Brian Kinney

    A federal appeals court has ruled that the U.S. Food and Drug Administration didn’t change its position on admissible evidence and the agency’s failure to consider a marketing plan didn’t impact the outcome.

    The FDA acted reasonably in denying vapor maker Magellan Technology Inc.’s request for a marketing order for its flavored vaping products, the U.S. Court of Appeals for the Second Circuit ruled Friday.

    The court upheld the FDA’s finding that Magellan failed to show the product would provide a benefit to adult users that would outweigh the risks to youth.

    The agency found Magellan’s evidence—four non-clinical studies—was insufficient to establish that the flavored pods would be more effective than tobacco-flavored electronic nicotine delivery systems (ENDS) in helping smokers switch to e-cigarettes to stop smoking altogether, according to Bloomberglaw.

    The manufacturer of Hyde and Juno brand e-cigarettes sued the FDA and the U.S. Department of Health and Human Services claiming the agencies violated the Administrative Procedure Act.

    New York-based Magellan Technology accused the agencies of refusing to review the company’s premarket tobacco product applications (PMTAs) for 12 products, a process which cost the company $1 million. Magellan claims the FDA “arbitrarily” and “capriciously” rejected the applications.

    “Magellan had already spent over $1 million on the PMTAs at the time the RTA [refuse-to-accept] order [was] issued and plans to spend over $10 million on the PMTAs in total,” the suit states.

    Texas-based retailer Vapor Train 2 LLC is also a plaintiff in the suit. The companies asked a Texas federal court to temporarily stay the RTA order the FDA issued to Magellan, according to the lawsuit filed Thursday.

    “FDA acted arbitrarily, capriciously, and otherwise not in accordance with applicable law in issuing the [refuse-to-accept] order,” the lawsuit states. “The agency invoked regulations governing [premarket tobacco product applications] acceptance that do not apply to Magellan’s [applications] and failed to consider timely amendments containing required content that Magellan properly submitted.”

    The companies are expected to appeal the ruling. Magellan could now seek an en banc review of the case (a rehearing by the full Second Circuit) or could appeal to the Supreme Court of the United States. 

  • Criminal Reform Groups Push Back on Flavor Ban

    Criminal Reform Groups Push Back on Flavor Ban

    Image: Tobacco Reporter archive

    A coalition of more than 50 criminal justice reform groups sent a letter to U.S. President Joe Biden warning that the U.S. Food and Drug Administration’s proposed ban on flavored tobacco products will lead to overpolicing in communities of color, according to The Hill.

    Prohibition-style policies, like the one proposed, “have serious racial justice implications,” wrote the organizations, which include Blacks in Law Enforcement, the National Association of Criminal Defense Lawyers, the National Latino Officers Association and the Sentencing Project.

    “Banning the legal sale of menthol cigarettes through licensed businesses will lead—and, in fact, has already led in some states—to illegal, unlicensed distribution in communities of color while triggering criminal laws in all 50 states, increasing the incidence of negative interactions with police and ultimately increasing incarceration rates,” the letter said. “There are far better solutions for reducing menthol cigarette use than criminalizing these products and turning this issue over to the police.”

    The aim of the flavor ban is not only to make smoking less attractive but also to advance health equity, according to Health and Human Services Secretary Xavier Becerra

    “FDA has the power to provide smokers with less harmful options and information to help accelerate reductions in smoking,” the coalition wrote in its letter. “Rushing forward with a total ban without these alternatives in place contradicts everything we know—and everything the administration has been saying in other spheres—about why harm reduction works and criminalization doesn’t.” The coalition urged the FDA to reconsider the ban and find solutions opposed to criminalization.

  • Lawmakers Continue to Urge FDA to Finish PMTA Reviews

    Lawmakers Continue to Urge FDA to Finish PMTA Reviews

    Credit: Adobe

    U.S. lawmakers are urging the Food and Drug Administration to wrap up its review of pending e-cigarette premarket tobacco product applications, reports Law360.

    In a letter to FDA Commissioner Robert Califf, 50 members of Congress requested the agency finalize its review of pending applications for e-cigarette products; deny applications for all nontobacco-flavored e-cigarette products, including menthol; and utilize the enforcement tools that have been given to the agency to remove all synthetic nicotine products from the market, including those with pending applications.

    The lawmakers’ call comes after the FDA failed to meet a court-ordered deadline of Sept. 9, 2021, to complete its review of all pending e-cigarette applications submitted to the agency. In its most recent filings with the court, the FDA has indicated that it will not be able to finalize its review of products with the largest market share until December 2023.

    “FDA’s repeated delays in removing flavored e-cigarettes from the market is putting children’s health at risk,” said Colorado Representative Diana DeGette in a statement. “FDA needs to step up its enforcement of these harmful products and get them off our store shelves now. Every day that these products remain on the market, the more harm they cause to young people’s health.”

    While the FDA has completed its review of many e-cigarette products, it has not yet completed its review of thousands of pending applications—including those for popular products manufactured by Juul Labs, Reynolds Vapor Co. and Smok.

    The lawmakers urged the agency to complete its review of all its pending applications no later than Dec. 31, 2023.

  • Flavor Bans for Vapor and Heated Tobacco to Grow

    Flavor Bans for Vapor and Heated Tobacco to Grow

    man holding flavored vape products

    Bans on flavors in vapor and heated tobacco are likely to spread.

    By Barnaby Page

    Flavors are perhaps the biggest battleground of all in e-cigarette regulation—much more so than nicotine strength, for example. That may seem surprising on the surface given the widespread misperceptions of risk associated with nicotine itself (as opposed to smoking), but the underlying reason is revealing. Although occasionally there are other rationales associated with flavor bans (specific harmful ingredients, or a racial dimension in the case of menthol in the United States), nearly always the argument against flavors is a proxy for anxieties over youth vaping.

    To put it another way, if nobody thought that anyone other than adults would use mermaid-flavored caramel candy floss e-liquid, nobody would be very interested in banning it (and in fact, adult usage of these flavors is almost completely overlooked in the debate). It’s because kids use—or, more precisely, are perceived to be attracted by—these flavors that regulators, politicians, pundits and pressure groups pay so much attention to them.

    Underage vaping undoubtedly occurs; this is indisputable. Whether flavors (which in regulatory terms means nontobacco flavors) are in fact a significant driver of this is more debatable. It’s true that young people often use the more exotic flavors, but that doesn’t mean the nicotine users among them wouldn’t vape if those flavors weren’t available.

    Of course, those who are vaping nicotine-free flavored liquids presumably wouldn’t find nicotine-free tobacco-flavored liquid very appealing, and they probably wouldn’t vape at all if their favored flavors were unavailable. But these nicotine-free users are not the main concern.

    Similarly, it’s true that kids say they like the flavors they use. But this is hardly unexpected; nobody would use a flavor they don’t like. Again, it doesn’t conclusively point to what would happen in the absence of flavors, and this is an area where more research is needed—research that will become more viable on a large scale as more and more flavor bans are implemented.

    The results may prove to be unexpected: for example, work by Abigail Friedman at Yale suggests that the San Francisco flavor ban may have pushed young people not toward tobacco-flavored vapes but toward combustibles, and while one research project in one city is of course not the end of the story, it underlines the importance of looking at the real consequences of regulation in this area. If flavor bans do not keep kids away from nicotine, there is little purpose to them.

    For now, though, limiting flavors is rightly or wrongly seen as key to limiting youth vaping, and prohibitions are spreading worldwide—perhaps not as quickly as the heat of the conversation might suggest but steadily nonetheless.

    The United States is in an unusual situation here, partly because of the considerable autonomy enjoyed by sub-national levels of government compared with many other countries and partly because of slow movement by the Food and Drug Administration. There can be almost no doubt that the FDA would like to ban flavors; after all, it has even backed the idea of a menthol ban in combustibles, which is far more contentious than any restrictions on e-cigarette flavors, and seems likely to be preparing to finalize a rule to that effect this fall.

    Where vapor is concerned, there is no formal prohibition as such (though it is always conceivable that the anticipated combustibles ban could in fact cover all tobacco products), but a de facto ban on vapor flavors seems to have been in operation via the premarket tobacco product application (PMTA) process. To put it bluntly, flavored products don’t get through, and indeed this has been formally alleged by R.J. Reynolds Vapor Co. in a case against the FDA, as yet unresolved.

    In this context, it might seem odd that the FDA did grant modified-risk tobacco product (MRTP) status to menthol-flavored IQOS products from Philip Morris back in 2020—MRTP of course being an overt acknowledgment of reduced risk, not merely an authorization to sell like the PMTA. This might reflect the fact that youth usage is much less associated with heated-tobacco products like IQOS than with vapor; in fact, heated tobacco was barely known in the U.S. in 2020, has worldwide generally given rise to much less anxiety over underage use and is generally not found in the more unusual, supposedly youth-friendly flavors. Or it might simply be an anomaly. Either way, the IQOS decision seems unlikely to be any kind of precedent for a softening of FDA attitudes toward flavored vapor.

    In the absence of an official FDA rule, formal regulatory activity against flavored vape products in the United States has most significantly occurred at state level—for example, with bans in California, New Jersey, New York and Rhode Island, an almost complete prohibition in Massachusetts and heavy restrictions in Maryland and Utah. Some other states also instituted emergency bans in 2019 that have now ended. There has also been much activity at county and municipal level (most notably in California and Massachusetts and to a lesser extent in Minnesota).

    Elsewhere in the world, again partly reflecting the allocation of powers to national and sub-national governments, there are countrywide bans.

    Among those nations that allow e-cigarettes as a product category but ban flavors, China is potentially the most important given its sheer size. However, the Netherlands—a country where skepticism over vapor in official circles is high—has also received much attention, not least because it could pave the way for other European countries to follow suit. Finland has already passed a bill prohibiting flavors in all inhalable products, and we believe Norway is also likely to enact a vapor flavor ban; Belgium is another possibility, though one we consider less likely.

    Much of the forecasting in this article is drawn from the Tamarind Intelligence Policy Radar, which presents the regulatory situation in more than 50 markets for alternative tobacco products as it is today and as it is projected to be in five years. It monitors more than 150 bills and policies, many of which seek to substantially increase the regulatory burden on novel tobacco and nicotine products. Based on this, other countries where we see a vapor flavor ban as possible include Canada and Argentina, although the latter is a less likely contender.

    Other countries have taken steps toward banning flavors in all alternative products. Nations such as Spain, Belgium, Russia and the Czech Republic have raised concerns about flavors in new tobacco and nicotine products in their policies, which include, for example, national tobacco plans and health strategies. However, it should be noted that we forecast some of these first steps toward a flavor ban to have a low likelihood to medium likelihood of adoption. This may be because the measure has not been a pressing issue for a government faced with elections in the near future, as with Spain, or because the policy has remained stuck in the legislative process for years, as is the case with the bill in Belgium.

    Comprehensive bans like these could be expected to also cover heated tobacco. Some countries, however, may choose to treat it separately; among these, we think a ban is likely in Taiwan and possible in the United States.

    In terms of sheer number of countries, however, by far the most important limitation on heated-tobacco flavors is the European Union ban, which entered into force late last year via a European Commission directive.

    Such directives do not have automatic legal power in all 27 EU member states, but the individual countries are obliged to incorporate them into domestic law, a process known as “transposition,” which must in this case be completed by October (and which also applies to the European Economic Area members Norway, Iceland and Liechtenstein). When this is complete (and though the deadline could be missed in some cases, it will almost certainly be completed), heated-tobacco flavors will be banned across most of Europe, leaving the post-Brexit United Kingdom—the most friendly of all European nations toward reduced-risk nicotine products—as the major outlier where flavors are still permitted.

    In this context, the ongoing revision of the EU Tobacco Products Directive (TPD) itself is also noteworthy. It was the 2014 version of the TPD that laid the groundwork for the e-cigarette regulatory frameworks in all EU member states (at that point including the U.K.), for example with limitations on nicotine strength, and with the next incarnation of the directive currently being drawn up, there is at the very least a possibility that it could include a flavor ban for alternative products, including vapor.

    If that happens, it might well be enough to sway undecided countries outside the EU and persuade them to enact their own flavor bans—perhaps even the U.K. It is also possible that, amid environmental concerns about the sudden rise of disposables, “flavor” will become a proxy for “disposable” in exactly the same way it has been for “underage.”

    At the same time, it is always conceivable that some yet unknown nicotine-delivery technology might escape these prohibitions if there are no concerns about youth usage.

    But it is unlikely that bans that do come into force will be reversed, regardless of their outcomes; perception is often as important as reality in regulating this area. Though it hasn’t happened yet, the alternative nicotine products sector may be facing a flavorless future.

    Barnaby Page is the editorial director of Tamarind Intelligence, the publisher of ECigIntelligence, TobaccoIntelligence and CannIntelligence. As a journalist, he has been covering the worldwide reduced-risk nicotine sector since 2014, with a particular focus on public health and regulatory issues.In his current role, he manages Tamarind’s editorial and reporting teams, producing a wide range of nicotine-related content. He previously spent 30 years as a reporter and editor for newspapers, magazines and online services, specializing in technology and business. He is based near London, England.

    Tamarind Intelligence analysts Berta Camps Bisbal and Sergi Riudalbas also contributed research to this article.

  • Group: Debt Ceiling Could Limit U.S. FDA’s Budget

    Group: Debt Ceiling Could Limit U.S. FDA’s Budget

    Image: Tobacco Reporter archive

    The proposed debt ceiling budget could stress the U.S. Food and Drug Administration’s budget, according to Inside Health Policy.

    The legislation’s nondefense federal funding cap makes it harder for programs like the FDA’s budget to get funding increases, and it could threaten some agencies’ existing funds, according to Steven Grossman, director of the Alliance for a Stronger FDA. “This is never a good situation for agencies whose mission and responsibilities keep expanding each year, as is the case with FDA,” he wrote.

    The Fiscal Responsibility Act of 2023 caps nondefense federal spending at $704 billion for the next two years. According to Grossman, after taking out funding for Veterans Affairs medical care and appropriations adjustments, the remaining nondefense funds are about $637 billion, which is roughly unchanged from fiscal 2023.

    There is still room to determine how much funding can be specifically allocated to the FDA, though, according to Grossman, despite the FDA’s funding being limited by the macro-budgetary levels determined by the debt ceiling.

    “FDA’s mission and responsibilities are incredibly consequential and visible,” he wrote. “It needs resources to protect public health and safety and to set standards for products that encompass 20 percent of all consumer spending (about $2.7 trillion).”

    The House GOP’s FDA funding bill cleared the Appropriations FDA-agriculture subcommittee last month; it would provide $6.6 billion in total funding with $3.5 billion in flat discretionary funding.

  • Retailers Want FDA List of Legal Vaping Products

    Retailers Want FDA List of Legal Vaping Products

    Retail associations have asked the U.S. Food and Drug Administration to provide them with list of e-cigarettes and vape products that are legal to market, reports NACS.

    In October 2021, NACS and five other retail associations sent a letter to the FDA asking the agency to publish the names of vapor products for which it has taken action. In their letters to FDA, the associations expressed the critical nature of this list for their retail members who need to know which products are legal to sell and which are not.

    The FDA formally responded in January 2022, stating that it understands the retail groups’ request for specific names of products and that the agency is working on updating the list with final actions taken on individual products, including those that received marketing denial orders (MDOs).

    “Given the large number of products involved, sharing this information requires additional time and resources so that the Agency does not disclose confidential commercial information (CCI) about products that are not yet marketed,” stated the agency.

    In a more recent letter to the FDA, the associations said they “can appreciate the immense task of reviewing millions of applications. However, there remains widespread confusion in the marketplace as to which products can remain on shelves and which need to be removed.”

    “While Director Zeller encouraged retailers to contact manufacturers with any questions about products in their inventory, this is not an adequate or fair solution. It places the burden on retailers to verify the marketing status of ENDS and vape products with the manufacturers. Many of our members are small operators who do not have the resources or bandwidth to contact the manufacturers,” wrote the associations.

     “Moreover, manufacturers providing a list does not guarantee accuracy or give the assurance that a verified list from the agency would give. These retailers stand to face enforcement if they are out of compliance with the law and the only way to ensure they can comply is if they have a verified list from the agency.”

    Renewed support for a list of legal products come after the FDA issued warning letters to 30 retailers, including one distributor, for illegally selling unauthorized Puff Bar and Hyde disposable vaping products. The FDA typically sends warning letters to manufacturers, however, now retailers are facing stiffer scrutiny.

    FDA Commissioner Robert Califf said cracking down on disposable products most used by youth is a priority for the regulatory agency. “We’re committed to holding all players in the supply chain – not just manufacturers but also retailers and distributors – accountable to the law,” he said.

  • FDA, NIH Fund Center for Rapid Surveillance of Tobacco

    FDA, NIH Fund Center for Rapid Surveillance of Tobacco

    Credit: Onticello

    The U.S. Food and Drug Administration and the National Institutes of Health (NIH) have awarded funding for a new Center for Rapid Surveillance of Tobacco (CRST). Through rapid surveillance and reporting of information, CRST will enhance the Center for Tobacco Products (CTP) and the research community’s ability to understand, document and quantify changes in the tobacco product marketplace and tobacco use patterns.

    “Nothing like this has ever been attempted before now,” said Cristine Delnevo, director of the Rutgers Center for Tobacco Studies and principal investigator of the rapid surveillance center. “No one has collected such comprehensive information, let alone organized and disseminated it rapidly. We think it will provide the FDA with meaningful and timely data to inform their congressionally authorized regulation of the tobacco market.”

    Research results from the CRST are expected to generate findings and data that are directly relevant in informing the FDA’s regulation of the manufacture, distribution and marketing of tobacco products to protect public health. In particular, the CRST will support more time-sensitive data collection, analysis and reporting—making potentially actionable information available before more traditional data collection methods. 

    “Given the rapidly evolving tobacco landscape, it’s critical that we have nimble surveillance tools that can keep pace to best protect public health,” said Brian King, director of the FDA’s CTP. “This new center is another important addition to our surveillance toolbox to help identify emerging issues and to inform timely action.”

    The CRST is supported through the Tobacco Regulatory Science Program, an interagency partnership between the NIH and CTP to foster tobacco regulatory research.

    The work is led by Rutgers Center of Excellence in Rapid Surveillance of Tobacco with substantial involvement from a large collaborative network that triangulates multiple data sources, federal scientific staff at CDC, NIH and CTP as well as external advisors with relevant expertise.

    “The signals about JUUL’s popularity with youth were there as early as 2017, but without identifying early, meaningful signals and subsequently implementing nationally representative large surveys with appropriate measures, it took much longer to evaluate the problem,” Delnevo said. “Successful rapid surveillance will facilitate a comprehensive understanding of the problem in a timely manner.”

    The grant money will fund the Rutgers Center of Excellence in Rapid Surveillance in Tobacco, which officially began operations on June 1, pulling information from numerous data sources. Researchers will:

    • Collect information from marketing company databases, tobacco maker websites, social media and merchant outlets to spot new marketing strategies;
    • Analyze retail scanner data to track tobacco-product sales and spot trends involving new product characteristics such as innovative flavors or delivery mechanisms;
    • Triangulate responses from surveys of youth, young adults, and adults who use tobacco and nicotine products to understand preferences and behaviors;
    • Synthesize the data to identify meaningful trends early and provide the FDA with actionable information to improve its regulation of tobacco products.

    Another seven faculty members from the Center for Tobacco Studies will join Delnevo on the rapid surveillance project, as will 13 co-investigators from Roswell Park Cancer Institute, East Carolina University, Stanford University, the University of Kentucky, The Ohio State University, Columbia University, and Westat, Inc.

  • U.S. FDA Sends Warnings to Sellers of Puff Bar, Hyde

    U.S. FDA Sends Warnings to Sellers of Puff Bar, Hyde

    Credit: Hyde

    Warning letters have been issued to 30 retailers, including one distributor, for illegally selling unauthorized disposable vaping products. The FDA typically sends warning letters to manufacturers, however, now retailers are facing stiffer scrutiny.

    The U.S. Food and Drug Administration stated today that the unauthorized products were various types of Puff and Hyde brand disposable e-cigarettes, which were two of the most commonly reported brands used by youth e-cigarette users in 2022, according to the FDA.

    The “action underscores the agency’s unwavering commitment to addressing the role retailers and distributors of unauthorized tobacco products play in this concerning public health issue facing America’s youth.,” according to the release.

    FDA Commissioner Robert Califf said cracking down on disposable products most used by youth is a priority for the regulatory agency. “We’re committed to holding all players in the supply chain – not just manufacturers but also retailers and distributors – accountable to the law,” he said.

    The warning letters are a result of a nationwide blitz to crack down on the sale of unauthorized e-cigarettes that are popular with youth – specifically Puff and Hyde products. The blitz included investigations of hundreds of retailers and distributors across the country. All products cited in the warning letters are disposable e-cigarettes.

    “Since becoming director of CTP, I’ve been crystal clear that FDA will not stand by while retailers and distributors seek to profit off illegally selling products that are well-known to appeal to youth,” said Brian King, director of the FDA’s Center for Tobacco Products. “Retailers and distributors play a key role in keeping unauthorized tobacco products off the shelves, and if they fail to do so, we’re committed to taking appropriate action.”

    The FDA generally sends warning letters the first time an inspection or investigation reveals a violation of the law, and recipients are given 15 working days to respond with the steps they’ll take to correct the violation and to prevent future violations. A majority of recipients of warning letters voluntarily correct the stated violation.

    Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure and/or civil money penalties. In addition to today’s actions among retailers, the FDA issued a warning letter to an importer of Puff Bar in October 2022; that investigation remains ongoing.

    In February, FDA filed the agency’s first civil money penalty complaints against four e-cigarette manufacturers; to date, FDA has filed civil money penalty complaints against ten e-cigarette manufacturers.

    And in October 2022, the first complaints for permanent injunctions were filed against six e-cigarette manufacturers. From January 2021 through May 2023, FDA issued more than 560 warning letters. All of these actions are part of FDA’s standing compliance and enforcement portfolio, and the latest counts of these actions will continue to be reported on a routine basis.

    “FDA will continue to take action against anyone making, distributing, importing, or selling unauthorized e-cigarette products, especially those most used by youth,” the release states.