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Tag: e-cigarettes

  • FDA and CBP Seize $34M in Illegal E-Cigarettes in Chicago

    FDA and CBP Seize $34M in Illegal E-Cigarettes in Chicago

    The U.S. Food and Drug Administration (FDA) today (May 22) announced the seizure of nearly 2 million units of unauthorized e-cigarette products in Chicago, with an estimated retail value of $33.8 million. The seizures, which occurred in February of this year in collaboration with U.S. Customs and Border Protection (CBP), were part of a joint federal operation to examine incoming shipments and prevent illegal e-cigarettes from entering the country.

    During this operation, the team uncovered shipments of various illegal e-cigarette products, almost all of which originated in China and were intended for shipment to various U.S. states. FDA and CBP personnel determined that, in an apparent attempt to evade duties and the review of products for import safety concerns, many of these unauthorized e-cigarette shipments contained vague product descriptions with incorrect values. Upon examining shipments, the team found several brands of unauthorized e-cigarettes, including Snoopy Smoke, Raz, and others.

    “The FDA, working with our federal partners, can and will do more to stop the illegal importation and distribution of e-cigarette products in the United States,” said FDA commissioner Marty Makary. “Seizures of illegal e-cigarettes keep products that haven’t been authorized by the FDA out of the United States and out of the hands of our nation’s youth.”

    In the lead up to this operation, the joint FDA and CBP team identified potentially violative incoming shipments and completed other investigative work. The team was also able to successfully implement several new internal efficiencies and procedures, building off previous operations.

    “We continue to see an increased number of shipments of vaping-related products packaged and mislabeled to avoid detection,” said Bret Koplow, acting director of the FDA’s Center for Tobacco Products. “However, we have been successful at preventing these shipments from entering the U.S. supply chain – despite efforts to conceal the true identity of these unauthorized e-cigarette products.”

    Most shipments violated the FDA’s Federal Food, Drug, and Cosmetic Act, while some products were also seized for Intellectual Property Rights violations for unauthorized use of protected trademarks. All of the e-cigarette products seized in this operation lacked the mandatory premarket authorization orders from the FDA and therefore cannot be legally marketed or distributed in the United States.

    Standard practice for products forfeited to the government include disposing of the products in accordance with the law. In the case of unauthorized new tobacco products, including e-cigarettes, that generally means they will be destroyed.

    FDA also sent, for the first time, import informational letters to 24 tobacco importers and entry filers responsible for importing these illegal e-cigarettes. The letters advise the recipients that it is a federal crime to make false statements or entries to the U.S. government, and the FDA seeks information on the steps they have taken to ensure compliance with applicable federal tobacco laws and regulations. Specifically, the letters advise the firms to ensure their import entries contain complete and accurate information moving forward. Failure to do so may also be viewed as an intentional attempt to circumvent the FDA’s review of the shipment. Firms are requested to respond to the letters within 30 days with the requested information.

  • FDA Says it Prevented 444,000 Youth from Using E-Cigs Last Year

    FDA Says it Prevented 444,000 Youth from Using E-Cigs Last Year

    Today, a study co-authored by U.S. Food and Drug Administration scientists was released showing the agency’s youth e-cigarette prevention campaign, “The Real Cost,” successfully reduced e-cigarette use among youth. The campaign, which launched in 2018 under the leadership of President Trump, was found to have prevented an estimated 444,252 American youth (age 11 to 17 at study recruitment) from starting to use e-cigarettes between 2023 and 2024.

    Published in the peer-reviewed scientific journal American Journal of Preventive Medicine, the study found evidence that the campaign contributed to the nearly 70% decline in e-cigarette use among American youth that has occurred since 2019. According to the National Youth Tobacco Survey, the number of U.S. middle and high school students who currently use e-cigarettes has declined from 5.38 million in 2019 to 1.63 million in 2024, the lowest level in a decade.

    “As part of our work to Make America Healthy Again, we must ensure that children have a healthy start in life,” said Acting FDA Commissioner Sara Brenner, M.D., M.P.H. “This includes taking evidence-based actions to prevent youth tobacco product use.”

    Data from the evaluation, which followed a nationally representative sample of U.S. youth over time, showed that viewing ads from “The Real Cost” lowered chances that youth who had never used an e-cigarette would later initiate use. The survey collected information on how frequently youth were exposed to “The Real Cost” campaign and which youth went on to try e-cigarettes, among other variables.

    “Adolescence is a critical period for prevention efforts because most adults who use tobacco products begin using them in their teenage years,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “Youth tobacco prevention campaigns not only work, but they are also a cost-effective approach to protecting young people from a lifetime of nicotine addiction.”  

    “The Real Cost” Youth E-cigarette Prevention Campaign uses a variety of marketing tactics and creative advertising to reach youth. Advertising and prevention materials are delivered across communication channels relevant to teens, including digital and streaming platforms, social media and gaming platforms. The agency’s activities also include compliance and enforcement actions across the supply chain – in coordination with federal partners using their unique authorities – to ensure that those that make, distribute or sell illegal tobacco products are held accountable to the law.

  • Belgium First in EU to Ban Disposable Vapes

    Belgium First in EU to Ban Disposable Vapes

    Belgium will ban the sale of disposable electronic cigarettes as of Jan. 1 on health and environmental grounds in a groundbreaking move for European Union nations.

    Health minister Frank Vandenbroucke said the inexpensive e-cigarettes had turned into a health threat since they are an easy way for teenagers to be drawn into smoking and get hooked on nicotine.

    “Disposable e-cigarettes is a new product simply designed to attract new consumers,” he said in an interview, according to NPR.

    Because they are disposable, the plastic, battery and circuits are a burden on the environment. On top of that, “they create hazardous waste chemicals still present in what people throw away,” Vandenbroucke said, adding that he wants tougher tobacco measures in the 27-nation bloc.

    “We are really calling on the European Commission to come forward now with new initiatives to update, to modernize, the tobacco legislation,” he said.

    There is an understanding of Belgium’s decision, even in some shops selling electronic cigarettes, and especially on the environmental issue.

    Once the cigarette is empty, “the battery is still working. That’s what is terrible, is that you could recharge it, but you have no way of recharging it,” said Steven Pomeranc, owner of the Brussels Vapotheque shop. “So you can imagine the level of pollution it creates.”

    A ban usually means a financial loss to the industry, but Pomeranc thinks it will not hurt too much.

    “We have a lot of alternative solutions which are also very easy to use,” he said. “Like this pod system, which are pre-filled with liquid, which can just be clipped into the rechargeable e-cigarette. So we will simply have a shift of clients towards this new system.”

  • Wang: Global Trade Tariffs in Vaping

    Wang: Global Trade Tariffs in Vaping

    The vaping industry has always faced its share of challenges—from shifting regulatory landscapes to evolving consumer preferences. However, a few factors significantly threaten the industry’s future, such as the impact of global trade tariffs. With the United States set to increase tariffs on Chinese imports, companies that fail to adapt could face skyrocketing costs, disrupted supply chains, and a diminished ability to compete in one of the world’s largest markets.

    Trade tensions between the U.S. and China have been escalating for several years. The vaping industry, which relies heavily on hardware manufactured in China, is particularly vulnerable to these developments. Currently, vaping products imported from China face a 25% tariff, but there is a high likelihood that this could double or even increase to 100% under future U.S. administrations.

    For vaping companies, such tariff hikes mean the cost of importing devices could skyrocket. A 100% tariff would effectively double the cost of hardware produced in China, driving up retail prices for all such products in the U.S. market. This scenario threatens the financial viability of vaping companies and the availability of affordable, high-quality products for consumers.

    The Strategic Decision to Move Manufacturing to Malaysia

    Recognizing the potential for increasing tariffs and broader geopolitical challenges, some vaping manufacturers began shifting their operations from China to other countries. Such decisions were never made lightly. China has long been a global leader in manufacturing efficiency with a robust infrastructure and supply-chain network,, and moving away from such an established infrastructure posed significant logistical and operational challenges.

    Malaysia offered several key advantages to manufacturers. Firstly, Malaysia enjoys favorable trade agreements with the United States, the United Kingdom, and the European Union. For instance, starting in December 2024, a new free trade agreement between Malaysia and the U.K. took effect, eliminating tariffs on products moving between the two countries. Similar agreements are in place or in development with other major markets.

    Secondly, Malaysia’s robust manufacturing ecosystem and skilled workforce make it an ideal location for high-quality production. By establishing operations in Malaysia, companies can continue to deliver reliable, innovative hardware without the added burden of excessive tariffs.

    The Broader Impact on the Global Supply Chain

    The shift to Malaysia reflects a broader trend in global manufacturing. As trade barriers between the U.S. and China grow, a widespread redistribution of manufacturing operations is underway. Companies across industries—not just vaping—are reevaluating their supply chains to reduce dependence on any single country.

    This global redistribution of resources presents both challenges and opportunities. For manufacturers, the challenge lies in building new infrastructure, securing reliable suppliers, and maintaining quality control in unfamiliar territories. However, companies that successfully navigate these changes benefit from more resilient supply chains, reduced geopolitical risk, and greater flexibility in responding to market shifts.

    Maintaining Compliance and Quality Standards

    Shifting manufacturing bases also brings new compliance considerations. Regulatory bodies like the U.S. Food and Drug Administration (FDA) require Premarket Tobacco Product Applications (PMTAs) for vaping devices. These applications are tied to specific manufacturing facilities, meaning that changing production locations requires amendments to existing PMTAs or new submissions.

    Manufacturers must ensure that new facilities meet the highest quality and compliance standards. Proactively managing these regulatory requirements ensures that products remain market-ready even as production locations change.

    The Future of the Vaping Industry Amid Trade Challenges

    Looking ahead, it’s clear that trade tariffs and global manufacturing shifts are not short-term challenges. Regardless of who occupies the White House, protectionist trade policies are likely to persist or even intensify. The vaping industry must be prepared for this new reality.

    Companies that fail to diversify their manufacturing operations face mounting costs and increasing vulnerability to trade disruptions. On the other hand, those who invest in flexible, resilient supply chains will be well-positioned to thrive.

    The vaping industry is at a crossroads. Global trade tariffs pose a significant threat, but they also offer an opportunity for companies to rethink their supply chains and build more resilient operations. For manufacturers, shifting production from China to countries like Malaysia is not just a reactive measure—it’s a strategic move to secure long-term growth and competitiveness.

    As the industry moves forward, companies that adapt to these challenges will be the ones that lead the way. The ability to anticipate trade disruptions, embrace innovation and maintain rigorous quality standards will determine who succeeds in this ever-evolving market.

    As co-CEO of Ispire Technology Inc., Michael Wang is a leader in the development and commercialization of vaping technology and precision dosing. Previously, he served in executive roles at The Pharm/Sunday Goods, Onestop Commerce, Zazzle, and Honeywell.

  • FDA Warns 9 More for Illegal Vape Sales

    FDA Warns 9 More for Illegal Vape Sales

    The U.S. Food and Drug Administration issued warning letters to eight online retailers and one manufacturer for selling and/or distributing unauthorized flavored, disposable e-cigarettes.

    Some of the unauthorized products cited in the warning letters are marketed under brand names for disposable products, including Geek Bar and Lost Mary, according to the FDA. Other unauthorized products cited feature the names and/or images of celebrities.

    The firms receiving these warning letters sold and/or distributed e-cigarettes in the United States that lack authorization from FDA to be legally marketed in the U.S., which is in violation of the Federal Food, Drug, and Cosmetic Act.

    In addition to the violations mentioned in the warning letters, the firms were warned to address any violations that are the same as, or similar to, those stated in the warning letter and to promptly take necessary actions to comply with the law.

    Failure to promptly correct the violations can result in additional actions such as an injunction, seizure, and/or civil money penalty.

  • Justices Appear Divided on Triton’s PMTA Denials

    Justices Appear Divided on Triton’s PMTA Denials

    The hearing took just over an hour. Today, the United States Supreme Court heard oral arguments in FDA v. Wages and White Lion Investments, LLC, a pivotal case concerning the Food and Drug Administration’s rejection of applications to market flavored nicotine vaping devices.

    The case is about much more than saving the vaping industry; it is also a landmark case for regulatory accountability related to public health and consumer choice. A decision is expected by the end of the Supreme Court’s term in June.

    At issue is whether the FDA acted arbitrarily and capriciously when denying numerous premarket tobacco product applications (PMTA), as alleged by the manufacturers and affirmed by the U.S. Court of Appeals for the 5th Circuit, which accused the FDA of a “regulatory switcheroo”. 

    Elizabeth Hicks, US Affairs Analyst of the Consumer Choice Center, stated that the case underscores the need for “fairness and transparency” in regulatory processes. “The FDA’s blanket denials have placed enormous hurdles on firms providing harm-reduction alternatives, potentially decimating an industry that millions of adult consumers rely on to transition away from smoking traditional cigarettes,” she said.

    The court heard the FDA’s defense of the agency’s rejection of two companies’ premarket tobacco product applications (PMTAs) to sell flavored vape products that it has determined pose health risks for young consumers. The justices took up the FDA’s appeal filed after a lower court ruled that the agency had failed to follow proper legal procedures under federal law when it denied the applications to bring their nicotine-containing products to market.

    In January, the full slate of 5th Circuit judges ruled 10-6 that the FDA had been arbitrary and capricious, in violation of a federal law called the Administrative Procedure Act, by denying the applications without considering plans by the companies to prevent underage access and use.

    Associate Justice Clarence Thomas called the FDA guidance “a moving target” that shifted throughout the process. Also, Associate Justice Neil Gorsuch stated that applicants were not granted conditions for jury trials in administrative cases, as the court outlined in SEC v. Jarkesy. Gorsuch also wondered if the agency had failed to give applicants fair notice that the rules had changed.

    The court has a 6-3 conservative majority that is often skeptical of federal agency decision-making.

    Their lawyers argue that the FDA changed its standard for considering flavored vapes in the middle of the process without giving applicants adequate warning.

    Kavanaugh also seemed to have sympathy for the FDA’s case. He said it was clear from the outset what the FDA’s position on issuing denial orders was: a focus on the harm to young people that flavored vape products bring. He noted that under the Tobacco Control Act, the FDA has the power to regulate tobacco products, with a special focus on youth.

    If, after weighing the evidence, the FDA rejects an application, “It’s kind of the end of it, isn’t it?” Kavanaugh asked.

    Hicks said the FDA’s rejection of Triton and Vapetasia’s applications demonstrates a failure to balance or even understand public health priorities and opportunities provided by less harmful nicotine products.

    “While we all agree on the need to keep these products out of the hands of young people, denying adult smokers access to safer alternatives like flavored vaping devices could have dire consequences for harm-reduction efforts,” Hicks said in a press release. “Regulatory decisions should be evidence-based, not rooted in unachievable or shifting standards that are unreasonable to provide.”

     Justice Elena Kagan said that applicants know that the FDA believes that flavored vapes are especially appealing to children and that they would need to overcome that presumption in their PMTA submissions.

    “I mean, there’s just not a lot of mystery here about what FDA was doing. You might disagree with that, because you think that, in fact, the world of 40-year-olds really wants to do blueberry vaping, but you can’t say that FDA hasn’t told you all about what it’s thinking in this respect,” Kagan told the companies’ lawyer, Eric Heyer.

    Heyer told the justices that if his clients win the case, there could be a change in the FDA’s approach, citing comments Trump has made that he would “save vaping.”

    Just before the hearing began, Tony Abboud, executive director of the Vapor Technology Association. said the High Court has the opportunity to examine and critique the farcical “wild goose chase” manufacturers have been led on over the years due to the FDA’s illegal and bad faith actions.

    “While VTA eagerly awaits the SCOTUS decision, VTA knows that a favorable ruling will not fix the systemic and ideological failures at FDA. VTA will continue to work closely with the incoming Trump Administration, which can quickly and decisively end all current litigation – and all future litigation that will follow a SCOTUS decision favorable to industry – by implementing a new tobacco products standard which establishes clear scientific guidelines for the authorization of products and a real pathway to a broad and diverse U.S. vaping industry,” Abboud said. “Biden FDA’s illegal actions, which have deprived Americans of less harmful nicotine alternatives and are crushing an innovative industry, must be comprehensively addressed immediately through the bold and decisive leadership of President-elect Trump.” 

  • UK Generational Smoking Ban Clears First Hurdle

    UK Generational Smoking Ban Clears First Hurdle

    TR Archive

    A landmark bill in the United Kingdom to ban its younger generation from smoking has cleared its first hurdle in the House of Commons.

    If it becomes law, the legislation, backed by a 415 to 47 vote, would prevent anyone born after January 1, 2009, from buying tobacco.

    Before then, the bill must go through further parliamentary stages, with MPs able to suggest amendments to any aspects they don’t like.

    The legislation includes powers to introduce a licensing scheme for retailers to sell tobacco, vape, and nicotine products in England, Wales, and Northern Ireland.

    Other proposed measures include a total ban on vaping product advertising and sponsorship, with a possible ban on the sale of sweet vape flavors, subject to consultation.

    While the numbers indicate large cross-party support, there was strong criticism from Conservative, Liberal Democrat, and Reform UK MPs, who raised concerns about “civil liberties.”

    The division list showed Tory leader Kemi Badenoch voted against the measure, having previously said “people born a day apart will have permanently different rights,” reports Sky News.

    Former home secretary Suella Braverman, shadow immigration minister Robert Jenrick, and Sir Iain Duncan Smith were among the other high-profile Conservatives who didn’t back the bill.

    While most Liberal Democrats did vote to support the bill, the party’s health spokeswoman Helen Morgan said: “The introduction of a phased smoking ban is problematic and not because Liberal Democrats want to see people smoke themselves into an early grave – far from it – but because it raises issues of practicality and raises issues of civil liberties.”

  • Top Court to Hear Triton Vaping Case

    Top Court to Hear Triton Vaping Case

    The U.S. Supreme Court will next week hear the U.S. Food and Drug Administration’s defense of the agency’s rejection of two companies’ premarket tobacco product applications (PMTAs) to sell flavored vape products that it has determined pose health risks for young consumers.

    The live audio of the hearing can be found here.

    The justices took up the FDA’s appeal filed after a lower court ruled that the agency had failed to follow proper legal procedures under federal law when it denied the applications to bring their nicotine-containing products to market.

    The Supreme Court is due to hear the case in its next term, which begins in October, according to Reuters.

    Two e-cigarette liquid makers, Triton Distribution and Vapetasia, filed premarket tobacco product applications in 2020 for products with flavors such as sour grape, pink lemonade, and crème brulee and names such as “Jimmy The Juice Man Strawberry Astronaut” and “Suicide Bunny Bunny Season.”

    The FDA rejected the companies’ applications, along with more than 1 million other products.

    Triton and Vapetasia in 2021 asked the New Orleans-based 5th U.S. Circuit Court of Appeals to review the FDA’s denial of their applications.

    In January, the 5th Circuit ruled that the FDA had been arbitrary and capricious by denying the applications without considering plans by the companies to prevent underage access and use.

  • IKE Tech, Ispire to File PMTA for Age Gating Technology

    IKE Tech, Ispire to File PMTA for Age Gating Technology

    Ispire Technology and IKE Tech announced a successful pre-premarket tobacco product application (PMTA) meeting with the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) for their age verification technology for electronic nicotine delivery systems (ENDS).

    According to an e-mailed release, the technology aims to prevent youth access while expanding adult market access to flavored PMTA-authorized products. IKE Tech is a joint venture among three leading technology and research companies Ispire and Touch Point Worldwide d/b/a Berify and Chemular Inc.

    IKE Tech will submit a component PMTA, which would allow ENDS manufacturers to incorporate their blockchain-based age-gating solution if authorized. The FDA indicated potential priority review consideration and acceptance of a component PMTA. The company plans to complete the required studies in Q1 2025.

    This critical regulatory milestone marks an essential step in the journey to provide an innovative, secure universal solution aimed at preventing youth access to ENDS and expanding the market for adults who choose to use flavored PMTA-authorized products, according to the release.

    “The IKE Tech identity and age verification technology unlocks opportunities for adults who choose to use flavored vapor products while introducing a pioneering approach to reducing youth access and usage,” the release states.

    Due to its innovative design, reliance on blockchain technology, and partnership with leading identity and age verification providers, the IKE Tech system is an advanced component that could be used — in any ENDS device — to ensure only authorized adult users can access vaping products.

    FDA alignment on key points:

    • Component PMTA: IKE Tech will submit a PMTA for a component, as opposed to a finished tobacco product to be sold to consumers, and the FDA indicated it will accept such a component PMTA if all statutory requirements are met. Additionally, due to the fact this component employs novel point-of-use technology, the FDA indicated it will consider a request to grant the IKE Tech system priority review. If authorized, the component PMTA would allow ENDS manufacturers to use the IKE Tech system in their finished tobacco product PMTAs, as a plug-and-play age-gating solution, which may allow for the approval of a variety of flavored ENDS products.
    • Creation of Tobacco Product Master File (TPMF): IKE will create and file a TPMF for the IKE component. Once authorized, the component and TPMF can, subject to agreement, be available to ENDS device manufacturers for incorporation into products.

    IKE Tech anticipates completing the required studies for the component PMTA for the IKE Tech system, including the Identity and Age Verification component in Q1 2025.

    “Our commitment to harm reduction through innovation and our collaborative efforts with regulators are central to Ispire’s mission,” said Michael Wang, Co-CEO of Ispire. “We are proud to introduce technologies that are designed to responsibly support adult consumer choice while significantly reducing youth access. This technology represents our dedication to aligning with regulatory guidance and setting new standards for safer

     

  • Robert Kennedy, Jr. Tapped to Lead Trump’s HHS

    Robert Kennedy, Jr. Tapped to Lead Trump’s HHS

    President-elect Donald Trump has nominated Robert F. Kennedy, Jr. to serve as the new secretary of the Department of Health and Human Services (HHS). The effects Kennedy will have on the nicotine market remain unclear. Kennedy must still be confirmed by Congress.

    “For too long, Americans have been crushed by the industrial food complex and drug companies who have engaged in deception, misinformation, and disinformation when it comes to Public Health,” Trump posted. “The Safety and Health of all Americans is the most important role of any Administration, and HHS will play a big role in helping ensure that everybody will be protected from harmful chemicals, pollutants, pesticides, pharmaceutical products, and food additives that have contributed to the overwhelming Health Crisis in this Country.”

    As the leader of HHS, Kennedy will oversee the FDA, which regulates vaping, nicotine pouches, and all other nicotine and tobacco products through its Center for Tobacco Products.

    Kennedy’s position on vaping, nicotine, and tobacco harm reduction (THR) remains an unknown. During the presidential campaign, Trump promised that, if elected, he would “save vaping” after meeting with Tony Abboud of the Vapor Technology Association.

    “I saved Flavored Vaping in 2019, and it greatly helped people get off smoking,” Trump said on his Truth Social platform in September. “I raised the age to 21, keeping it away from the ‘kids.’ Kamala and Joe want everything banned, killing small businesses all over the country. I’ll save Vaping again!”