Author: Timothy Donahue

  • 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.

  • GSTHR Report Finds Vapes Help Smokers Quit

    GSTHR Report Finds Vapes Help Smokers Quit

    The latest Briefing Paper from the Global State of Tobacco Harm Reduction (GSTHR), a project from public health agency Knowledge·Action·Change (KAC), focuses on Aotearoa New Zealand’s remarkable journey towards “smokefree” status.

    “Pro-consumer laws and an endorsement for vaping: why smoking is disappearing in Aotearoa New Zealand” tells the story of the country’s rapid and growing embrace of vaping, which overtook smoking in 2022, and provides another vital case study showcasing the potential of tobacco harm reduction through the adoption of safer nicotine products (SNP), following recent GSTHR Briefing Papers on Japan and the United Kingdom. This country profile also features in The Global State of Tobacco Harm Reduction 2024: A Situation Report published last month.

    While Aotearoa, New Zealand, had been experiencing falling smoking rates for the last 50 years, this decline gathered pace following the widespread adoption and, in 2018, the legalization of nicotine vaping products. Thanks to the Government’s step change in vaping policy, Aotearoa New Zealand now has a considerable chance of reaching its “Smokefree 2025” goal, a designation indicating that smoking prevalence has been reduced to below 5%.

    David MacKintosh, a director for KAC, said the Briefing Paper explores the rapid trajectory of Aotearoa New Zealand’s progress in reducing smoking, the approaches that have underpinned this, and the lessons that can be learned.

    “By embracing vaping as a tool for smoking cessation, policymakers are accelerating the transition away from cigarettes and their associated harms,” he said. “More needs to be done in addressing high smoking rates in some groups, notably among Māori communities, which contributes significantly to health disparities in the country. However, the experiences and success of Aotearoa New Zealand provide food for thought for many other countries seeking to tackle smoking.”

    This would be a remarkable achievement given the smoking rate in 1976 was 40% for men and 32% for women. This has now fallen to the point where only 8.3% of adults smoked in 2023. In the same year 11.9% of adults vaped in the country, up from 1.4% in 2016. But while the overall smoking figures are low, they mask much higher rates within some communities. Daily smoking prevalence for Maori, who make up 16% of the country’s population, was 17.1% in 2022/2023, which is in stark contrast to the 6.1% rate for people of European descent.

    Alongside regulatory oversight of vaping products to ensure quality and safety, a key factor has been the proactive encouragement of vaping as a tool for smoking cessation by the Government. The Ministry of Health has provided official resources for people looking to stop smoking with the help of vaping. Smokefree New Zealand, a smoking cessation resource run by the country’s publicly funded healthcare service Health New Zealand, has stated that “using vaping products is a legitimate option for those people who are trying to quit smoking”.

    Through the Vaping Facts website, the Ministry of Health of New Zealand and Health New Zealand have also emphasized the Cochrane Review’s position that vaping is significantly safer than smoking.

    Aotearoa New Zealand’s attitude to vaping is in direct contrast to its neighbor Australia, which has heavily restricted the availability of SNP by making nicotine available only in pharmacies. Australia has sought to reduce significantly the availability of safer nicotine products, which has led to the proliferation of a thriving black market in the absence of a legal market. Meanwhile, with its broadly supportive public health messaging, Aotearoa New Zealand has enabled consumers to make positive changes in their own volition, enabling them to switch from smoking to safer products.

    These differences in approach have resulted in a marked difference in smoking rates between the two countries, with Australia’s smoking prevalence plateaued in recent years after many years of steady decline. Indeed, the current smoking prevalence for Australians aged 14 and over has only fallen slightly in the last five years, from 12.8% in 2018 to 11.8% in 2023.

    It should be noted that Aotearoa New Zealand’s attitude towards vaping is not mirrored for all SNP. While heated tobacco products are also legal, the sale of both snus and nicotine pouches is banned. Still, as this Briefing Paper shows, Government and public health organizations in Aotearoa, New Zealand, working with consumers, have highlighted the crucial role that vaping can play in reducing smoking.

    The country has demonstrated its ability to enact pro-consumer legislation effectively, and its consistent endorsement of some safer nicotine products has been a key component of its stop-smoking strategy. Central to this has been consumers, who have established a demand for safer products and proven to the Government that these products can and will exist despite initial legislative opposition.

  • 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.

  • EU Pushing Again for Stricter Smoking Rules

    EU Pushing Again for Stricter Smoking Rules

    Credit: Doganmesut

    EU countries agreed Tuesday on a push for stricter anti-smoking rules, backing bans on smoking and vaping in many outdoor areas, including playgrounds and cafe patios.

    Health ministers from the bloc’s 27 nations meeting in Brussels adopted a recommendation inviting member states to crack down on secondhand smoke and vapor.

    “Today’s agreement is a crucial step towards our goal of a tobacco-free generation in Europe and is critical in protecting our children and young people from the harmful effects of second-hand smoke,” said the EU’s health commissioner, Oliver Varhelyi.

    The recommendation is non-binding, as health is the responsibility of individual member states. However, it indicates the policies governments could pursue in the future as they seek to reduce smoke-related deaths and ailments.

    It passed with all countries voting in favor apart from Germany and Greece, which abstained, underscoring some political divisions. Last week, the European Parliament voted against a similar text, according to media.

    The document approved on Tuesday calls on EU countries to extend restrictions in place for cigarettes to cover “emerging products”, such as heated tobacco devices and electronic cigarettes that are increasingly popular with young people. Governments should “provide effective protection” from aerosols emitted by these in indoor environments such as offices and public buildings.

    Following an initial proposal put forward by the European Commission in September, the text says such protection should also be granted in some outdoor areas. This, in practice, entails that all smoking should be banned in locations including swimming pools, beaches, zoos, rooftop bars, and restaurant terraces.

  • 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.” 

  • Wild Bill’s Tobacco Buys 34 Cheap Tobacco Shops

    Wild Bill’s Tobacco Buys 34 Cheap Tobacco Shops

    Credit: Wild Bill’s Tobacco

    Wild Bill’s Tobacco has acquired all 34 locations of Cheap Tobacco, including 33 in Central and Eastern Ohio and one in West Virginia, according to a press release from Wild Bill’s Tobacco. The deal was finalized in early November, allowing Cheap Tobacco’s Founder and CEO, Dennis Harper, to retire after “celebrating his 30th year with the company.”

    Harper stated, “We’re confident that Wild Bill’s Tobacco will continue to provide amazing products and service you’ve come to expect while adding even more options to enjoy. We wouldn’t have passed the torch to anyone else but the Wild Bill’s family. Their reputation as a leader in our industry can’t be understated. We are proud to have served you over the years and know you will enjoy the added benefits of this transition.”

    Prior to this deal, Wild Bills’s Tobacco had over 200 stores in Michigan, Indiana and Ohio and celebrated its 30th anniversary this year, according to the release. Wild Bill’s said it is “thrilled” to add its first store in West Virginia with this acquisition. Wild Bill’s said it is the second largest tobacco retailer in the United States and continues to grow its brand rapidly as the premier tobacco retailer in the world.

    “This acquisition allows us to serve a broader customer base and be a part of new communities across the Midwest,” said Jon Welzel, chief marketing officer at Wild Bill’s Tobacco. “Guests will still experience the competitive pricing that became synonymous with Cheap Tobacco, but the store design that is brought to life and streamlined for customer needs, selection, and speed at checkout, as well as the expanded product offerings and premium customer experiences, will create a unique experience for these new members of our family.”

    The retailer plans to renovate and provide a facelift to all 34 Cheap Tobacco stores within six to nine months. Walk-in humidors will be added to each location, featuring cigars from around the world.

    Through this acquisition, Wild Bill’s Tobacco “has retained all Cheap Tobacco store-level employees, from district managers down, and plans to offer additional benefits for Cheap Tobacco staff members.”

  • 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.”

  • Supreme Court Won’t Hear Graphic Warning Challenge

    Supreme Court Won’t Hear Graphic Warning Challenge

    The U.S. Supreme Court won’t hear a challenge to a federal requirement that cigarette packages and advertising include graphic images demonstrating the effects of smoking.

    The nation’s top court declined to hear the case in a brief written order handed down Monday.

    R.J. Reynolds appealed to the high court after the 5th U.S. Circuit Court of Appeals found the warnings do not violate the First Amendment, the AP reports.

    They include pictures of smoke-damaged lungs, feet blackened by diminished blood flow and a picture of a woman with an immense growth on her neck and the caption “WARNING: Smoking causes head and neck cancer.”

    Nearly 120 countries worldwide have adopted more prominent, graphic warning labels. Studies from those countries suggest that image-based labels are more effective than text warnings at publicizing smoking risks and encouraging smokers to quit. The U.S. has not updated its labels since 1984.

    It’s not clear when new labels might appear. Some legal claims remain, and the FDA has said it doesn’t plan to enforce any new requirements until at least December 2025.

  • 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.

  • Research: THR Plan May Save 400,000 Nigerian Lives

    Research: THR Plan May Save 400,000 Nigerian Lives

    Credit: Rawpixel

    New research by leading international health experts has found that more than 400,000 Nigerian lives could be saved if policymakers adopt a progressive approach to tobacco harm reduction (THR).

    The report, released on Nov. 19, outlines how integrating alternative nicotine products such as vapes and nicotine pouches into Nigeria’s tobacco control framework could dramatically reduce the nation’s smoking-related death toll.

    According to the report, Saving 600,000 Lives in Nigeria and Kenya, 3.5 million Nigerians currently smoke, and each year 26,851 Nigerians die from smoking-related illnesses. While the World Health Organization (WHO) projects that smoking-related deaths will drop to 18,000 annually by 2060, experts argue that the number remains far too high.

    By adopting THR strategies, the researchers estimate that the annual smoking-related death toll could be reduced to 7,600 by 2060, saving over 416,000 lives in the process.

    Derek Yach

    “We have a clear opportunity to reduce the burden of smoking-related diseases in Nigeria significantly,” said Derek Yach, one of the report’s authors and former leader of the Foundation for a Smoke Free World. “By embracing safer alternatives like vapes and nicotine pouches, Nigeria can drastically lower smoking-related deaths and help people who smoke quit more effectively. Tobacco harm reduction is the key to saving lives and improving public health in Nigeria.”

    The use of THR products has already been proven to reduce smoking rates in countries such as the UK, Sweden, Japan and New Zealand. In these nations, the widespread adoption of e-cigarettes and other nicotine alternatives has led to a marked decline in cigarette consumption, the leading cause of smoking-related diseases, according to an emailed press release.

    Delon Human

    “The success stories from other countries are undeniable,” said Dr. Delon Human, co-author of the report and founder of the African Harm Reduction Alliance. “In nations where tobacco harm reduction is embraced, smoking rates are dropping, and lives are being saved. Nigeria can achieve similar results by adopting a more inclusive tobacco control policy incorporating standard measures and access to these life-saving alternatives.”

    The report calls on Nigerian policymakers to take bold steps in reducing smoking-related harm by considering the introduction of safer nicotine products into the national health strategy. Nigeria could make significant progress toward its public health goals by offering people who smoke alternatives that are far less harmful than combustible cigarettes.

    “As Nigeria’s leaders continue to refine tobacco control measures, they have a unique opportunity to reduce smoking-related harm while empowering people who smoke with the tools to quit,” Yach added. “With the right policy choices, Nigeria can not only improve the health of its citizens but also set an example for the rest of Africa.