Tag: vaping

  • 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!”

  • Greece to Boost Penalties for Youth Vape Sales

    Greece to Boost Penalties for Youth Vape Sales

    Credit: Lefteris Papaulakis

    Greece is set to introduce a new bill in its Parliament that would impose stricter penalties for businesses supplying alcohol, electronic cigarettes, and vaping devices to minors in the government’s efforts to revamp alcohol laws in the country.

    This is a joint decision made by the ministries of Citizen Protection, Justice, and Health, and it comes after repeated incidents of selling alcohol to under-aged individuals.

    According to sources, violators who sell these harmful products to minors could be punished with imprisonment, financial fines, and other administrative penalties, including the immediate closure of the business involved, media reports.

    Ministerial officials report that past oversights have also been identified regarding the access minors have to these harmful products. Specifically, under the previous government, the number of police officers assigned to enforce the anti-smoking law, for example, had been drastically reduced, penalties had been minimized, and there was also a decision allowing for the use of alcohol by minors at private events.

    The Minister of Justice Giorgos Floridis commented on the new law, “Everything is now becoming stricter for the protection of minors, with increased enforcement.”

  • FDA Warns Companies For Selling ‘Smart’ Vapes

    FDA Warns Companies For Selling ‘Smart’ Vapes

    The U.S. Food and Drug Administration issued warning letters to nine online retailers and one manufacturer for selling or distributing unauthorized disposable e-cigarettes designed to resemble smart technology, including smartphones and gaming devices.

    The products mentioned in the warning letters are promoted as having various designs and functions that might attract young people, according to an agency press release. These include features like playing games, connecting to smartphones, receiving text or call notifications, playing music, and customizing products with personalized wallpaper.

    “These products may resemble smart devices, but there’s nothing smart about them,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “They’re illegal to sell and a flagrant attempt to target kids.”

    The agency states that the designs of the unauthorized products cited in the warning letters are likely to appeal to youth because they help conceal the nature of the products as tobacco products from parents, teachers or other adults. Example images of unauthorized products cited in the warning letters compared to electronic devices on the consumer market, such as smartphones and gaming devices.

    “The firms receiving these warning letters sold and/or distributed e-cigarettes in the United States that lack authorization from FDA to legally market a new product, which is in violation of the Federal Food, Drug and Cosmetic Act,” the release states.

    In addition to the violations mentioned in the warning letters, the retailers and manufacturer were warned to address any violations that are the same as, or similar to, those stated in the warning letter and promptly take any necessary actions to comply with the law. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure and/or civil money penalty.

    “FDA is steadfast in our commitment to enforce the law,” said John Verbeten, director of the CTP’s Office of Compliance and Enforcement. “We will continue to take appropriate measures, working hand in hand with our federal enforcement partners, to address unauthorized tobacco products, especially those most appealing to youth.”

  • U.K. County Installs Vape Waste Bins for Recycling

    U.K. County Installs Vape Waste Bins for Recycling

    In North Yorkshire County in the United Kingdom, vape recycling bins have been installed at all 20 household waste recycling centers to prevent vapes from ending up in curbside bins.

    Materials used in single-use vapes can harm the environment and must be disposed of separately.

    Once collected at the recycling centers, they are transported to the recycling facility to be dismantled, and the lithium-ion battery is removed for processing while the metals and plastics are recycled.

    Lithium-ion batteries can cause fires if discarded in curbside recycling or waste bins. These batteries cause most fires in the waste collection and recycling industry.

    “This exciting new initiative has the aim of ensuring that people who use vape devices know how to dispose of them in the right way,” said the county’s executive member for waste services, Cllr Greg White. “Vapes are not safe to be recycled or disposed of in curbside bins or boxes at home. One incorrectly discarded vape could cause huge damage or serious injury.

    “In August, we also introduced coffee pod bins at our recycling centers as we aim to continue expanding what we accept at our recycling centers. These initiatives demonstrate our commitment to responsible recycling and reducing our carbon footprint.”

    Research released this year from Material Focus found that, in the U.K., the public is buying 7.7 million single-use vapes per week, which has doubled compared to 2022.

    People are also throwing away 5 million single-use vapes per week, or eight per second, which has quadrupled compared to 2022.