Author: Timothy Donahue

  • Iowa Vape Companies Sue to Block Registry

    Iowa Vape Companies Sue to Block Registry

    A group of e-cigarette and vaping product distributors and retailers is suing the state of Iowa to block enforcement of a new law set to take effect in February.

    Alternatives to Smoking & Tobacco Inc., Global Source Distribution, Triton Distribution, Smokin Hot, Central Iowa Vapors WDM and Route 69 Vapor filed the lawsuit last week in U.S District Court for the Southern District of Iowa.

    The companies allege that House File 2677, signed into law earlier this year, violates the supremacy clause and equal protection clause of the U.S. Constitution, as well as the equal protection clause of the Iowa Constitution.

    State records show House File 2677 was introduced on March 27, 2024, with backing from lobbyists for R.J. Reynolds and other tobacco companies. Lobbyists for the American Cancer Society Action Network declared their opposition to the bill within two days, according to media.

    The bill was approved in the Iowa House on April 3, 2024, and in the Iowa Senate on April 19, 2024. Gov. Kim Reynolds signed it into law on May 17, 2024.

    The law stipulates that manufacturers whose electronic nicotine delivery systems — more commonly known as electronic cigarettes, e-cigarettes and vaping products — are sold in Iowa must certify that its products “have received a marketing authorization” from the Food and Drug Administration or that its application for authorization was filed by September 2020 and is still under review.

    The Iowa Department of Revenue is then tasked with producing a publicly accessible directory listing all the certified vaping products — at which point any retailer selling products not on the registry is subject to fines or other enforcement action.

  • 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.”

  • Look Back: Vapor in 2024

    Look Back: Vapor in 2024

    In 2024, regulatory challenges and misinformation continued to test the vaping industry.

    By VV staff

    There is positivity surrounding the nicotine industry. With the Trump administration set to take power in January, many believe it will take a softer stance on flavored nicotine products than the Biden team. The vaping industry continues to survive despite setbacks experienced in 2024, and it continues to grow globally. However, divergent regulatory perspectives on vaping’s harm reduction potential continue to hinder its uptake by cigarette smokers.

    The past 12 months could also be labeled “the year of the registry” as several product registry bills were enacted, the most interesting of which was in Florida. Florida’s governor, Ron DeSantis, signed legislation intended to crack down on the sale of unauthorized vapes that the state deems attractive to children. The new law (HB 1007), however, only targets disposable vaping products not authorized by the U.S. Food and Drug Administration. The rules will be enforced beginning Oct. 1.

    Unlike other state registry lists, Florida is the first state in the U.S. to include a carve-out for refillable pod systems, open-system vaping products, and bottled e-liquids. Florida Smoke Free Association President and entrepreneur Nick Orlando was a driving force behind getting the open-system exemption. In its original form, the bill would have prohibited sales of any vape products that had not yet received FDA approval.

    Orlando said that if any area of the vaping industry genuinely needs reform, it is at the federal level and within the FDA review and approval process. “The FDA’s Center for Tobacco Products [CTP] is supposed to comply with a statutory, 180-day deadline to review new tobacco product applications, many of which are potentially less harmful than combustible cigarettes,” said Orlando. “However, as Florida’s vape manufacturers have experienced, working through this process is often a painstaking, costly and onerous ordeal that has resulted in a backlog of thousands of applications that have sat with the CTP for years.”

    Also this year, the FDA approved menthol vapes for the first time. The regulatory agency authorized four Njoy products through the premarket tobacco product application (PMTA) pathway. The FDA issued marketing granted orders to Njoy, an Altria subsidiary, for two pods for its Ace closed e-cigarette device, which was authorized in April of 2022, and two disposable e-cigarettes—Njoy Daily Menthol 4.5 percent and Njoy Daily Extra Menthol 2.4 percent.

    The two authorized Ace pods are the Njoy Ace Pod Menthol 2.4 percent and the Njoy Ace Pod Menthol 5 percent. All four of the newly authorized products are prefilled and nonrefillable. The decision is significant because it is the first nontobacco-flavored vapor product to be authorized by the FDA. In his TPL review, Office of Science Director Matthew Farrelly said that Njoy had “demonstrated the potential for these new products to benefit adults who smoke [combustible cigarettes] as compared to those who continue to use [combustible cigarettes] exclusively” and that the company had “also proposed robust marketing plans that include restrictions beyond those required with PMTA authorization.” Farrelly also highlighted data from a longitudinal cohort study that Njoy submitted with its application, which pointed to “robust absolute switching rates” and a higher rate of complete switching than tobacco-flavored Njoy Daily.

    Another pressing issue in 2023 is that critics continue to accuse the vaping industry of avoiding responsibility for the environmental damage caused by disposable vaping products. Federal regulators have failed to pass measures that would make vaping components easier to recycle or more eco-friendly. Some regulations have been proposed to lessen the products’ environmental impact. For example, standards could be put in place requiring them to be reusable or mandating that manufacturers fund collection and recycling programs.

    According to the Centers for Disease Control and Prevention, disposable e-cigarettes account for about 53 percent of the multibillion-dollar U.S. vaping market, which has more than doubled in size since 2020. Several states, including New York and California, have extended product responsibility laws for computers and other electronics, but those rules don’t apply to vaping products. At the federal level, there are no regulations specifically for the disposal of vaping products.

    Some experts say that the devastating environmental impact could last centuries without action. Ultimately, 2024 witnessed significant milestones in combustible smokers making the switch to less risky nicotine-delivery systems. That trend is expected to continue into next year. Looking back on this year, below is a month-by-month recap of the vaping industry’s most prominent headlines of 2024.

    January

    A group of Juul Labs investors challenged a November 2022 financial bailout by directors Nick Pritzker and Riaz Valani, alleging that the deal benefited insiders at the expense of other investors. Jan. 1, 2024, marked the official launch of McKinney Specialty Labs, a scientific organization with expertise in testing nicotine and other aerosolized products.

    On Jan. 3, the U.S. Court of Appeals for the 5th Circuit ruled that the FDA acted “arbitrarily and capriciously” in rejecting the premarket tobacco product applications of Wages and White Lion Investments, doing business as Triton Distribution, and Vapetasia for approval to sell their products in the United States. The Supreme Court of the United States rejected R.J. Reynolds Tobacco Co.’s bid to challenge a voter-approved ban on flavored vaping and other tobacco products in California, the most populous state in the U.S.

    February

    Philip Morris International and BAT settled their ongoing intellectual property disputes relating to heated-tobacco and vapor products. The U.S. Food and Drug Administration continued its de facto flavor ban. It issued marketing denial orders to Fontem US for four Blu disposables and one Myblu brand e-cigarette product. The attorney general for North Carolina announced the launch of an online, searchable public depository containing nearly 4 million documents from the state’s lawsuit against e-cigarette manufacturer Juul Labs.

    R Street Institute released a report that explores how flavors can influence behavior and why well-intentioned efforts to ban flavored tobacco and nicotine products can have unintended consequences. BAT’s Italian division was fined €6 million ($6.4 million) for “misleading advertising of a heated-tobacco product.” Amazon was fined €1 million for the same reason.

    March

    Belarus’ State Committee for Standardization banned 47 types of electronic cigarettes from sale because they contained unlawful levels of nicotine. The highest court in Massachusetts ignored objections from vape shop owners and tobacco retailers and upheld the legality of a novel bylaw in the town of Brookline that bars cigarette sales to anyone born after Jan. 1, 2000. The chairmen of five key Senate committees warned the chief executives of major convenience stores and wholesalers to stop selling illicit flavored vaping products.

    A federal judge approved the final part of a class action settlement with Juul Labs and its parent company Altria, bringing the settlement total to just over $300 million. The Office of the Solicitor General filed a petition for certiorari in the case of the FDA v. Wages and White Lion Investments, asking the Supreme Court to review the U.S. Court of Appeals for the 5th Circuit’s en banc decision concluding that the FDA’s denial of some premarket tobacco product applications was arbitrary and capricious. The global vaping company Plxsur reached its goal of reaching $1 billion in consolidated revenues from its partners in just two years.

    April

    The governor of Vermont, Phil Scott, vetoed legislation banning the sale of flavored vaping and tobacco products in the state. New York City Mayor Eric Adams and New York City Corporation Counsel Sylvia O. Hinds-Radix announced that the city of New York filed a lawsuit against 11 wholesalers for their part in the illegal sale of flavored disposable e-cigarettes.

    Kentucky Governor Andy Beshear signed House Bill 11 into law, making Kentucky the sixth state in the U.S. with a registry law. Lawmakers approved British Prime Minister Rishi Sunak’s plan to ban anyone aged 15 and under from ever buying cigarettes. Kazakhstan’s President Kassym-Jomart Tokayev signed a bill banning the sale and distribution of vaping products.

    The U.S. Marshals Service seized more than 45,000 unauthorized e-cigarette products valued at more than $700,000 in California. Florida is the first state in the nation to include a carve-out in vape registry for refillable pod systems, open-system vaping products and bottled e-liquids. The board of directors for the Brazilian Health Surveillance Agency (Anvisa) voted unanimously to maintain a ban on the sale of e-cigarettes and other vaping products.

    May

    The U.S. Drug Enforcement Administration asked the White House for permission to reclassify marijuana as a less dangerous drug. The Oregon Court of Appeals upheld a Washington County ban on flavored tobacco sales. The FDA uploaded the first update to its Searchable Tobacco Products Database, which provides an overview of tobacco and vapor products that may be legally marketed in the United States. Filtrona launched a series of new filters for heated-tobacco products, the Boreas range.

    The FDA filed several modified-risk tobacco product renewal applications submitted by Philip Morris Products for several IQOS products for scientific review. A study published in Thorax found associations between the use of social media platforms and the risk of combustible cigarette smoking and vaping among youth. A judge in Ohio ruled that the state law that prohibits cities from banning flavored tobacco is unconstitutional. The Supreme Court of Justice in Panama ruled unanimously that Panama’s ban on the sale of all vaping products is unconstitutional. The FDA announced that it is seeking civil money penalties from nine brick-and-mortar retailers and one online retailer for selling Elf Bar products.

    June

    The FDA updated its import alert, which includes a “red list” of manufacturers, distributors and brands of vapor products that may be detained “without physical examination.” The FDA reversed a marketing denial order issued to Juul Labs for its vaping products. Governor DeSantis vetoed a bill that aimed to ban delta-8 and other cannabis products. U.S. Senators criticized top health and law enforcement officials for their failure to tame the rapidly growing illicit e-cigarette market.

    The FDA authorized four menthol Njoy products through the PMTA pathway. This was the first time a flavored vaping product was authorized. Romania’s Chamber of Deputies adopted a bill banning advertising of electronic cigarettes and nicotine pouches. Philip Morris International halted sales of Zyn nicotine pouches on its U.S. website as Washington, D.C., officials investigate the company’s compliance with the district’s ban on the sale of flavored tobacco products.

    Altria Group submitted PMTAs to the FDA for its “On! Plus” oral nicotine pouch products. New York state received $112.7 million from a multistate settlement with Juul Labs Inc. due to the vaping company’s involvement in the youth vaping epidemic. The Supreme Court of the United States ruled 6-3 to overturn the “Chevron deference,” a backbone principle for how the federal government keeps corporations in check.

    July

    R.J. Reynolds Vapor Co., an operating company of Reynolds American Inc., the BAT Group’s U.S. subsidiary, announced that it is expanding its vapor portfolio with SENSA, a zero-nicotine vapor product. Australia became the first country to restrict the sale of vapes to pharmacies when its laws surrounding vaping products went into effect. The U.S. Supreme Court agreed to hear the FDA’s defense of the agency’s rejection of Triton Distributing’s PMTAs.

    North Carolina Governor Roy Cooper signed into law a vape registry bill. The U.K.’s Labour government will propose a bill to gradually raise the legal age for purchasing cigarettes and impose restrictions on the sales and promotion of vaping products, as confirmed by King Charles III in a speech. Philip Morris International said that it will invest $600 million in a factory in Aurora, Colorado, to help meet U.S. consumers’ growing appetite for the company’s Zyn nicotine pouches.

    The Italian government placed CBD on the country’s list of narcotic drugs in defiance of a regional administrative court ruling and in contravention of European Union law. The Philippine government halted the sale, advertising and distribution of vape products online. The Cook Islands banned the manufacture, importation, sale, distribution and advertising of cigarette alternatives such as e-cigarettes. PMI postponed the test launch of its IQOS heated-tobacco device in the U.S. to the fourth quarter.

    August

    Costa Rica banned vaping in public places such as restaurants, offices and educational institutions. The Haypp Group, the world’s largest online retailer of nicotine pouches, reported net sales of SEK942.8 million ($89.66 million) for the second quarter of 2024, up 23 percent over the comparable 2023 period. RLX Technology reported net revenues of RMB627.2 million ($86.3 million) in the second quarter of 2024, up 66 percent from the comparable 2023 quarter.

    The FDA and the Department of the Treasury announced a proposed rule that would require an importer to submit the FDA-issued Submission Tracking Number ENDS products into the electronic imports system operated by U.S. Customs and Border Protection. New data from Action on Smoking and Health U.K. found that more than half of ex-smokers in Great Britain who quit in the past five years—amounting to 2.7 million adults—used a vape in their last quit attempt. VPR Brands reported revenues of $1.77 million for the second quarter of 2024, down from $1.9 million in the comparable 2023 quarter. Gross profit was $451,469 compared with $1.1 million in the second quarter of 2023.

    Illinois lawmakers decisively passed a law that forbids vaping companies from targeting teens with their advertising, particularly by promoting electronic cigarettes that resemble school supplies such as highlighters, markers or erasers. Smoore International Holdings reported revenue of RMB5.04 billion ($705.4 million) for the six months that ended June 30, down 1.7 percent from the comparable 2023 period.

    An administrative law judge of the International Trade Commission recommended a ban on importing Njoy Ace products into the United States following a patent infringement claim filed by Juul Labs. Philip Morris International’s Swedish Match affiliate announced an investment of $232 million to expand the production capacity of its manufacturing facility in Owensboro, Kentucky. The Kurdistan Regional Government intensified efforts to crack down on the use of e-cigarettes, with both the Ministry of Health and the Ministry of Interior enforcing a decision to ban their import and sale.

    September

    Illinois Senator Dick Durbin condemned top health and law enforcement officials for their, in his eyes, inadequate efforts in combating the surge of illegal disposable e-cigarettes among young people in the U.S. Representatives from PMI began pitching the benefits of its IQOS heated-tobacco device to Nevada state lawmakers. Police in Allen, Texas, secured evidence and marched out business owners in handcuffs for selling what attorneys for the vape shops say were legal cannabis products.

    The FDA announced a final rule raising the minimum age for certain restrictions on tobacco product sales. A review of evidence by a team of scientists found that e-cigarettes are among the top 3 most effective tools to stop smoking. Accorto Regulatory Solutions joined the Global Institute for Novel Nicotine, an organization dedicated to advancing tobacco harm reduction through supporting the research and development of nonvaporized tobacco alternatives for adult smokers. The Great Smoky Cannabis Dispensary opened in North Carolina for its first recreational marijuana sales for anyone over the age of 21.

    Irish Health Minister Stephen Donnelly proposed bans on nontobacco vape flavors and advertising in nonspecialized shops. The FDA issued six warning letters to manufacturers and retailers for selling or distributing unauthorized e-cigarette products promoted at an industry trade show. PMI recorded a record loss of about £220 million ($198 million) on the sale of its inhaled-therapeutics Vectura Group unit to Molex Asia Holdings in the third quarter.

    Tucker Carlson announced plans to introduce a nicotine pouch brand called ALP in November. U.S. President-elect Donald Trump said he will save flavored e-cigarettes. The European Commission approved France’s bid to ban disposable vapes. The U.S. Department of Health and Human Services updated its regulations to reflect the required annual inflation-related increases to civil money penalties, consistent with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015.

    October

    The FDA cleared an Investigational New Drug application for Qnovia’s RespiRx nicotine inhaler (QN-01). According to Qnovia, the RespiRx is the first truly inhalable nicotine-replacement therapy to assist smokers attempting to quit smoking. PMI pulled its IQOS tobacco-heating device from New Zealand store shelves after a new law took effect requiring vaping devices to have removable batteries. French consumer vaping organization SOVAPE announced that it will dissolve. The group had been active since 2016.

    The JT Group completed the acquisition of Vector Group on Oct. 7, following a tender offer. Ispire Technology, a company that develops and commercializes vaping technology products, announced a five-year master distributor agreement with ANDS, a Dubai-based distributor in the Middle East, North Africa region specializing in combustion-free nicotine-delivery solutions. Amazon agreed to pay Vermont $400,000 and improve its vetting practices to settle claims that it failed to stop online vendors from selling e-cigarettes. Jamaica supported an updated strategy to accelerate action to meet tobacco control targets in the Americas region.

    The minister of mental health and addictions says the federal government will ban most vape flavors across Canada. Guam’s governor, Lou Leon Guerrero, vetoed a bill that seeks a 10 percent tax on vaping and electronic nicotine products. Elf Bar and Lost Mary created a board in the U.K. to provide strategic advice for the brands. The Oregon Court of Appeals struck down a law restricting the packaging of vape and cannabis products on the grounds that the legislation unconstitutionally restricts free speech.

    The FDA 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. French Health Minister Genevieve Darrieussecq said in an interview with the newspaper Le Parisien that nicotine pouches “are dangerous products because they contain high doses of nicotine” and added that a ban will be announced.

    November

    The U.K. government introduced its Tobacco and Vapes Bill, which involves some of the world’s strictest anti-smoking rules. A jury trial commenced for a lawsuit filed by the state of Alaska against Juul Labs and Altria Group that alleges that the companies played a significant role in the rising use of e-cigarettes among young people. A survey found that one year after Quebec banned nontobacco-flavored vapes, most vapers are buying such products illegal in the province.

    Altria Group beat market expectations for third-quarter revenue and profit as robust demand for its nicotine pouches and vaping products helped soften the blow to its combustible cigarettes category. After a scientific review, the FDA issued a renewal of modified-risk granted orders to Swedish Match for eight General Snus products. A court in The Hague ruled that the Netherlands was allowed to introduce a ban on flavors in e-cigarettes to protect public health. Tobacco stocks rose in the wake of Trump’s victory in the U.S. presidential election.

    Ispire Technology reported revenue of $39.3 million for the first quarter of 2025, down from $42.9 million in the comparable 2024 quarter. Mayor Adams and New York City Acting Corporation Counsel Muriel Goode-Trufant announced that the city of New York filed a federal lawsuit against a major distributor of disposable flavored e-cigarettes. Mexico’s top court ruled that a ban on imports of e-cigarettes and related products was unconstitutional. Tucker Carlson launched his own nicotine pouch brand, ALP, which the conservative American commentator touted as “the first nicotine pouch brand made by and for adults who unapologetically love nicotine.”

    Trump nominated Robert F. Kennedy, Jr. to serve as the new secretary of the Department of Health and Human Services. The Swedish government released data showing that Swedes made history by officially becoming the first country to be “smoke-free.” President Sadyr Japarov signed a law prohibiting the import, circulation and use of electronic cigarettes.

    A report from the CDC Foundation and Truth Initiative showed that from 2019 to 2023, there was a 47 percent increase in e-cigarette unit sales at U.S. retail outlets. The Surgeon General of the United States released a report on health disparities related to tobacco use. Imperial Brands reported a dip in revenue despite double-digit growth in its electronic cigarettes division and growth in its traditional tobacco division. Spain began a public consultation on new rules for vaping devices. A landmark bill in the United Kingdom to ban its younger generation from smoking cleared its first hurdle in the House of Commons.

    December

    (Editor’s Note: This magazine went live in December, so the month may be incomplete.) Tobacco Reporter, after 150 years of nicotine industry news, ended the publishing of its magazine. Vietnam’s National Assembly approved a measure to prohibit the production, sale, import, storage, transportation and use of e-cigarettes starting in 2025. The United States Supreme Court heard oral arguments in FDA v. Wages and White Lion Investments LLC, a pivotal case concerning the FDA’s rejection of applications to market flavored nicotine vaping devices. The U.S. Drug Enforcement Administration began sharing details about its long-anticipated hearings on its cannabis rescheduling publicly.

    A survey by online retailer Nicokick finds more than 86 percent of current U.S. nicotine pouch users say they are likely to switch to Tucker Carlson’s recently launched Alp brand. Smoking rates in Spain dropped to a record low. The FDA issues warning letters to 115 brick-and-mortar retailers for selling unauthorized e-cigarette products. The warning letters cite the sale of disposable e-cigarette products owned by Chinese manufacturers and marketed under popular brand names, including Geek Bar Pulse, Geek Bar Skyview, Geek Bar Platinum, and Elf Bar.

    Looking ahead

    Predicting what the vaping industry will look like by the end of 2025 is impossible. Industry insiders expect regulators to crack down on disposable vaping products, and misinformation will likely continue to run wild. Many in the industry believe Trump will change how the FDA regulates vaping products. The sale and use of single-use disposable vapes will be banned in England from June next year, and many other countries are expected to follow suit.

    From Feb. 2, 2020, to June 16, 2024, U.S. disposable e-cigarette sales increased by 201.3 percent (4.1 million units to 12.3 million units); their unit share increased from 26 percent to 58.1 percent of total e-cigarette sales, according to the CDC Foundation. France began the process of banning disposable vapes in December 2023. The National Assembly and Senate approved the ban in February 2024, and the European Commission approved it in September 2024.

    Additionally, the U.S. will probably see a decline in product variety because the FDA is unlikely to approve many devices. However, the industry should continue to thrive and expand globally, especially in the EU and the U.K. More importantly, innovation should continue to thrive outside the U.S. That could all change, however, as a new president takes office in January in the U.S.

    In September, Tony Abboud, executive director of the Vapor Technology Association (VTA) said he had the opportunity to meet with Trump, where Abboud had a wide-ranging conversation, including praising the then President for taking “two bold and decisive actions” in 2019: preventing a ban on flavored vapes for adults and protecting youth by raising the age to purchase nicotine products to 21.

    “Since then, youth vaping has dropped to an all-time low, and many adults have used flavored vaping to quit smoking. VTA’s meeting with President Trump represents a great day for small businesses across America who fear the Biden-Harris administration’s efforts to shut down small businesses and deprive adults who smoke of their flavored vaping products,” said Abboud. “We are pleased that [Trump] is continuing to fight for vapers.”

    Trump’s nomination of Kennedy to head the Department of Health and Human Services, which oversees the FDA, which regulates vaping, nicotine pouches, and all other nicotine and tobacco products through its Center for Tobacco Products, is also a wild card for the nicotine industry. Kennedy’s position on vaping, nicotine, and tobacco harm reduction remains unknown, making anything a possibility in 2025.

  • The Golden Age

    The Golden Age

    Killing THCa will end a renaissance of cannabis reform, access and business opportunity.

    By Rod Kight

    As I write this, I sit in the Charlotte airport awaiting a flight to Las Vegas, where I will speak at MJBizCon on a panel about rescheduling.

    As I prepare for the panel and think about the implications of rescheduling, it’s impossible to ignore a fundamental reality, namely that “cannabis” is already mostly descheduled. Cannabis and all its cannabinoids, including delta-9 THC in concentrations up to 0.3 percent by dry weight, were completely descheduled at the end of 2018, when the current Farm Bill was enacted.

    In other words, we simultaneously watch the Drug Enforcement Agency (DEA) rescheduling saga play out in the hope that marijuana and its cannabinoids will eventually be downgraded to schedule 3, while we live in a world where cannabis and all its cannabinoids were removed from the Controlled Substances Act (CSA) six years ago. Of course, I’m referring to hemp.

    We Are Living in a Cannabis ‘Golden Age’

    Amidst the high drama of the “cannabis civil war,” it is easy to overlook the fact that we are living in a cannabis “Golden Age”—a renaissance of cannabis reform, access and business opportunity. There’s never been a time in history when you could legally order cannabis flower to your front door (not to mention a host of other cannabis products, including THC beverages, gummies and vapes).

    It’s been almost 100 years since an individual or a small company could legally grow, manufacture and/or sell cannabis and cannabis products across state and international lines. Today, cannabis consumers have a wealth of product choices that are sold by a wide array of distribution outlets, from dispensaries to grocery stores and consumption lounges to e-commerce websites. At the same time, cannabis entrepreneurs have more options to enter the industry than ever before.

    Over the past six years, cannabis rapidly expanded across the country, resulting in normalization in ways most people did not anticipate. This trend continues to grow.

    Killing THCa Ends This Golden Era

    Killing THCa ends this Golden Era. As most people who read my blog know, “THCa flower” is just “cannabis flower” that complies with the Farm Bill’s current legal definition. It’s not new. It’s not synthetic. It’s the same thing we’ve been smoking for thousands of years, and, as I write this, it is still federally lawful.

    Despite all the amazing cannabis form factors to which we have access, flower remains “ground zero,” the mother of every cannabis product. For many, smoking or vaping cannabis flower is the go-to method of use. If we kill THCa, we effectively “reschedule” cannabis and eliminate billions of dollars of legal cannabis flower from the market.

    Closing this so-called “loophole” in the next Farm Bill ends an unprecedented era of massive cannabis reform, normalization, business growth and consumer choice. The idea of rescheduling cannabis that was legalized in 2018 should be sinful to anyone who truly believes in and cares about the plant. Regardless of Congressional intent, the 2018 Farm Bill is unambiguous. It offered an opportunity to the cannabis industry.

    Rather than working to undo this windfall based on presumptions about what Congress did or did not want, we should embrace and expand on it. This is particularly important as we watch the DEA drag its feet by simply moving marijuana to schedule 3, a move that is important but not nearly as powerful as saving THCa and preserving the definition of “hemp.” Even better, we should expand the definition of “hemp” as proposed in Rand Paul’s hemp bill, which increases the delta-9 THC limit to 1 percent without any reference to THCa.

    Let’s Regulate Hemp Properly

    I’ll close this article by stating the obvious—hemp needs to be regulated properly. This is not the article to discuss regulatory issues, but those who were involved in the early days of cannabis reform remember that it took time to get regulations worked out. (Most people would argue that California and many other states went overboard in their efforts, but that’s also better suited to another article.) The point is that the hemp industry is young, and regulating any new industry takes time.

    Importantly, though, the hemp industry is actively pushing to be better regulated. I contend we need a structure focused on the “Three Pillars”: age-gating, safe manufacturing and standardized labeling. To that end, the U.S. Hemp Authority expanded its certification program to include intoxicating hemp products, and other organizations, such as the American Healthy Alternatives Association, lobby for reasonable regulations. The National Cannabis Industry Association has made positive moves for hemp. It will take some time, but rather than throwing the baby out with the bathwater, we should focus on working out proper regulations.

    Conclusion

    Killing THCa will end the cannabis Golden Age, will set cannabis reform back in a way that may take decades to recover from, will push billions of dollars of cannabis back onto the black market and will restrict access to millions of people. Let’s not do that.

    Rod Kight is an international cannabis lawyer who represents businesses throughout the cannabis industry.

  • Don’t be Alarmed

    Don’t be Alarmed

    Media outlets often decry vaping while promoting other unhealthy activities.

    By George Gay

    The Guardian newspaper on Oct. 3 pressed ahead with its apparent campaign to undermine vaping whenever possible with a story headlined “Alarm at rise in vaping among nonsmokers.” This is the first paragraph from Health Editor Andrew Gregory:“One million people in England now vape despite never having been regular smokers, a sevenfold increase in just three years, according to research that has alarmed health experts.”

    The research was attributed to a Lancet study led by University College London (UCL) and published in The Lancet Public Health journal.

    The first point to make is a minor one but one that is worth mentioning because it crops up in a lot of news stories that would claim to be objective in reporting only the facts but in my view are not. Indeed, The Guardian is published under a banner stating that comment is free while facts are sacred—so what is the word “just” doing in that first paragraph? To my way of thinking, it introduces an opinion into the sentence; it says that the writer believes three years is a short period, but, just in case the reader has different ideas, this “just” is just to put the record straight.

    Another point to bear in mind is that we are not told in the story how a vaper is defined, though the study no doubt does give such a definition. In the story, the closest we come to a definition is where it is said that “most [my emphasis] of the people now using e-cigarettes who had never been regular smokers were vaping daily and over a sustained period.” So, insofar as the story is presented, it could be the case that almost half of the 1,006,000 who have taken up vaping after not having been regular smokers might vape once every two days, once every week, once every month ….

    More importantly, I read the article and was unable to detect a sense of alarm in what was said by the health experts quoted. Indeed, what is striking about the story is that all the health experts take the opportunity to mention the good that vaping has done in helping smokers quit their habit. One of those experts, Nick Hopkinson, a respiratory physician and chair of Action on Smoking and Health, was quoted as saying also that high levels of vaping among young people and the growing use of vaping among never-smokers was a “concern,” but concern doesn’t come close to alarm in my book. I would feel concern if I had invited four people over for dinner and found at the last minute that I might not have provided enough food for that number. I would feel alarm, however, if I realized that the food I had provided had been contaminated with an emetic, especially if there were only one bathroom in the house.

    Beyond that, eagled-eyed readers will have noticed that whereas Hopkinson talks of “never smokers,” the writer is concerned with people who have never been “regular smokers.” These categories are clearly not the same. Indeed, given what we are told about smoking, it is difficult to understand how there could exist smokers who do not indulge their habit regularly. We are told that smoking comprises an addiction so overwhelming that it is more compelling than taking heroin, so how could it be that people can smoke or not smoke as their fancy takes them?

    The next thing to note is that the writer is claiming that alarm is being raised over vaping, something that has not, as far as I am aware, killed anybody in England and raises only potential risks at this stage. In what seemed to me to be a fair and balanced statement, the study’s lead author, Sarah Jackson, of the UCL Institute of Epidemiology and Health Care, was quoted, in part, as saying that vaping regularly over a sustained period posed more risk than not vaping. Fair enough, but then crossing the road regularly over a sustained period poses more risk than not crossing the road, and regularly eating sticky buns over a sustained period poses more risk than not eating them, etc., etc.

    But let’s look at this another way. The Guardian, which claims to offer a high level of journalism and often does, has for a long time campaigned against vaping while promoting alcohol. Indeed, it has railed in tabloid-type pieces against the use of cartoons on vaping products as being a lure to those underage while on one occasion devoting three quarters of a page to the promotion of a wine that boasts a cartoon character on its label. And it has railed in badly presented stories against the uptake of vaping by the young but has promoted the launch of a wine especially aimed at the young. It promotes alcoholic drinks in its weekly food supplement and runs advertisements for alcoholic drinks.

    And while The Guardian raises alarm about people coming to vaping for the first time, it is not alarmed at people who don’t usually drink alcohol getting into it in a big way. On Oct. 16, it ran a story that, for all intents and purposes, was an advertisement for a supermarket wine. Hannah Crosbie wrote in part that the wine was so sweet that she thought it would appeal to people who didn’t particularly like wine. And this was not a story about “sensible drinking,” the usual cop-out used by people in favor of alcohol consumption but against tobacco or nicotine consumption. She promoted the idea of guzzling the wine without thinking about it too much, and later, she asked a question about whether the taste of the wine needed to offer complexity when it was £6.50 ($8.25) a bottle: “Ask me again after my fourth glass,” she signed off.

    So I suppose I shouldn’t be surprised that I cannot remember ever having seen in The Guardian a story about alarm being raised about the number of people in England who previously didn’t drink alcohol but now do. And yet, 40 percent of adults in England drink more than 14 units of alcohol a week when previously they drank no alcohol. That’s about 16 million people while the figures for those who drink at all are about 80 percent and 32 million.

    So, alarm is being raised over 1 million people who have taken to a habit that poses a potential risk whereas no alarm is being raised about 16 million people who have taken to drinking alcohol that poses risks known to be serious. According to the Alcohol Change U.K. website, alcohol is a causal factor in more than 60 medical conditions, including mouth, throat, stomach, liver and breast cancers, high blood pressure, cirrhosis of the liver and depression. Alcohol misuse is the biggest risk factor for death, ill-health and disability among 15-year-olds to 49-year-olds in the U.K.*

    And according to the Drink Aware website, in 2022, 16 percent of U.K.* adults (about 6.4 million), defined as those older than 16 years of age, reported binge drinking in the previous week while 19 percent (about 7.6 million) did not drink alcohol.

    One of those 6.4 million is likely to have been the U.K.’s secretary for health and social care, Wes Streeting, who, in 2023, told The Guardian during an interview: “If I’m going out, I’m a binge drinker—terrible messaging for the shadow health secretary [as he was at that time]!” This was typical of the jokey blokey way in which alcohol is portrayed generally in the U.K. But it is inconceivable that Streeting would have said, or The Guardian would have reported, that he binge smoked or binge vaped during a night out.

    But then binge smoking or binge vaping are of course impossible, and, anyway, smoking or vaping doesn’t lead to all those fun memories of alcohol-induced assaults, vomiting in the street, vehicle accidents, arrests, visits to the accident and emergency departments of under-pressure hospitals and the beating of partners and children on arriving home. Memories for those who still have recollections the following day and those who make it home, of course.

    Streeting is said to be keen on preventing ill-health as a way of reducing the burden on the U.K.’s National Health Service, though while he seems bent on targeting vaping, I have not seen any move on his part to reduce the level of alcohol consumption, which many people believe would be a good idea. According to Alcohol Change, from 2009 to 2019, the price of alcohol decreased by five percent relative to retail prices and became 13 percent more affordable than in 2008. Alcohol is 74 percent more affordable than it was in 1987.

    In relation to the prevention of ill-health, on Oct. 15, there was an excellent debate on the BBC’s Today news program in which two well-informed people who were clearly concerned with doing the right thing spoke about his suggestion that obese people should be given weight reduction injections to help them and help them back into the workforce.

    One of those debating this idea mentioned, almost in passing, that while such an idea had merit, it might raise ethical issues. Immediately, the presenter interrupted with a question about why it would raise such issues, which I found strange. You don’t have to be a philosopher—and I am not—to know that one of the basic principles of ethics is that you should treat other people as ends in themselves, not as a means to an end. Providing people who wish to lose weight for the good of their health with the means to do so safely is right and proper, but we surely cross an ethical line when we do so to make them into more productive work units. And a few seconds’ thought about what use weight-loss injections and other medical interventions might be put to, and possibly are being put to, in one of the world’s increasing number of authoritarian regimes is enough to set alarm bells ringing.

    And yet we in the U.K. long ago started to move in this direction, in line with neoliberal capitalist ideas. For instance, many years ago, people were redefined as human resources with little pushback. And one of the “problems” with smoking has often been defined as a problem with productivity loss, real or invented by the fevered imaginations of those who simply oppose smoking.

    But I digress. I wrote above that Jackson had delivered what I thought was a fair and balanced statement, and this is what else she was quoted as saying: “The public health impact of this substantial rise in vaping among people who have never regularly smoked will depend on what these people would otherwise be doing. It is likely that some would have smoked if vaping were not an available option. In this case, vaping is clearly less harmful.”

    And you can take this idea further. Might they, for instance, have taken to drink if not to vaping? Gregory says in his story that, according to the researchers, the “dramatic increase” has been largely driven by young adults, with one in seven 18-year-olds to 24-year-olds (14 percent) in England who had never regularly smoked now using e-cigarettes. It might be coincidental, but anecdotal data seems to indicate that young people are drinking less alcohol than previous generations of young people.

    If there is a correlation here, I think it is to be welcomed. In my opinion, the cause of ill-health prevention will be better served if younger generations take to vaping rather than drinking. The message I would take from all this is don’t panic, don’t be alarmed. Try to keep an open mind and seek out the facts.

    *I realize that using figures for England and the U.K. is not entirely satisfactory, but it proved impossible to obtain all the figures used only for England. I have mitigated against this problem by not directly comparing figures for England and the U.K. England accounts for about 85 percent of the U.K.’s adult population of about 40 million.

  • 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.

  • Routine Failure

    Routine Failure

    The US Supreme Court to decide if a failed routine drug test amounts to racketeering.

    By Timothy S. Donahue

    The U.S. Supreme Court has been busy this session. The court has heard several cases dealing with the nicotine and cannabis industries. Among them is the case of a truck driver who was fired from his job after a CBD wellness product marketed as THC-free caused him to fail a routine drug test. Douglas Horn sued the maker of the CBD product he took for chronic pain under a federal racketeering law for economic harm.

    A decision in the case, expected next year, could determine the ability of Americans to collect substantial damages under an anti-mob law if they lose their job after being injured by consumer products.

    The companies that manufacture the product argued to the justices that Horn’s injuries were personal rather than related to any harm to his business or property. Therefore, they contended that his case did not fall under the Racketeer Influenced and Corrupt Organizations Act (RICO). This federal law, originally enacted to combat organized crime, establishes the right for individuals who suffer injuries to their business or property due to racketeering activity to seek triple damages.

    A longtime trucker, Horn had an unblemished record over his decades of service. Like many truckers, Horn’s job required frequent drug testing to ensure compliance with federal regulations, particularly given the risks associated with operating heavy machinery on the nation’s highways. A single failed drug test could cost him his commercial driver’s license and, consequently, his livelihood.

    In 2020, Horn began experiencing chronic pain due to the physical demands of his job. After researching various treatments, he turned to CBD products for relief. CBD, or cannabidiol, is a nonpsychoactive compound derived from the cannabis plant and is widely marketed for its potential therapeutic benefits, such as pain relief and reduced anxiety. Significantly for Horn, the CBD products he chose were advertised as containing no THC—the compound in cannabis that is responsible for its intoxicating effects.

    Relying on these assurances, Horn began using CBD products regularly. While CBD is entirely legal, THC remains illegal in certain contexts. However, during a routine drug test, he tested positive for THC. Despite his protests that he had only used CBD products labeled as THC-free, Horn was promptly suspended and later terminated from his job. Unable to find another position due to the failed drug test, Horn faced financial ruin.

    Horn filed a lawsuit, claiming that the producers of Dixie X committed mail and wire fraud that resulted in harm to his “business or property.” A federal district court ruled against Horn, but the New York-based 2nd U.S. Circuit Court of Appeals allowed his suit to move forward. The company appealed to the Supreme Court a year ago, arguing in part that the RICO Act never contemplated “garden-variety products-liability” suits. The justices agreed to hear the case, recognizing its broader implications not only for the CBD industry but also for the interpretation of federal law and consumer protection standards.

    The CBD companies argued that they were operating within the bounds of federal law, particularly under the 2018 Farm Bill, which legalized hemp-derived CBD products with THC levels below 0.3 percent. They contended that any trace amounts of THC in their products were legal and that they had not intentionally deceived consumers. The companies also asserted that RICO was not the appropriate vehicle for this type of claim, arguing that it was intended to address criminal enterprises, not businesses engaged in legal commerce.

    However, Horn’s legal team countered that the companies’ actions constituted a pattern of fraudulent activity, directly causing harm to consumers like Horn. They argued that RICO could be applied in this case because the companies knowingly misled consumers about the contents of their products, thereby violating federal laws and causing tangible damages.

    Lisa Blatt, representing the manufacturers, stated during the hearing that Horn’s unwanted ingestion of THC constituted an injury to his body—essentially a “personal” injury—and not an injury to his “business or property.” She argued that Horn’s economic losses were the “damages he sustained” due to that injury.

    Easha Anand, representing Horn, argued that the lost employment is an injury to “business” that should bring the case within the wheelhouse of RICO. The lower court agreed with Horn, permitting his suit to proceed before the companies took the case to the Supreme Court. The American Association for Justice agreed with Anand and urged the Supreme Court to side with the trucker.

    Unlike its criminal counterpart, the companies contend that the civil RICO statute explicitly states that a plaintiff must be “injured in his business or property.” They argued that this wording indicates an intent to exclude the other primary type of injury recognized by the law —injury to the person—typically the basis for hiring “personal injury” lawyers.

    Horn’s premise—that civil RICO is available if the “personal” injury leads to “business or property” damages—would have sweeping implications, the companies argued, making RICO available to any tort plaintiff who can produce a receipt for lost wages or other economic loss. And the Clayton Act, a critical antitrust statute, Blatt told the justices, limits private suits to plaintiffs with injuries to “business or property,” for which the Supreme Court routinely has rejected personal injury claims. The same result, she argued, should apply here.

    For Horn, though, “injured” is the same thing as “harmed,” and the harm he suffered to his business (loss of employment) is a classic injury to business of the type that the civil RICO statute reaches. Anand also emphasized that in RICO, Congress made clear that the act “shall be liberally construed to effectuate its remedial purposes.” That rule of construction, she said, suggests that in the event of any doubt, the court should permit Horn’s suit to proceed.

    After more than an hour of argument, it appeared that the case could divide the court’s conservative justices, some of whom seemed sympathetic to Horn’s position and others wary of opening up the ability for people to seek significant awards for run-of-the-mill injury claims. During Anand’s presentation, Chief Justice John Roberts stated that the limitation on “business or property” is intended to be a significant constraint on the scope of RICO, which he views as central to the law’s purpose. He suggested that Anand’s position could undermine this important limitation.

    Justice Brett Kavanaugh was even more pointed, criticizing the idea that Horn could “get around that limitation … by characterizing the lost wages or medical expenses as separate injuries to your business or property.” And Horn’s position, Kavanaugh warned, would create “a dramatic, really radical shift in how tort suits are brought throughout the United States.”

    Justice Elena Kagan challenged Blatt’s reading of the text. Kagan pushed Blatt to assist her in figuring out “the most normal, natural reading” of the statutory language.

    “If you’re harmed when you lose a job, then you’ve been injured in your business, haven’t you?” Kagan asked the lawyer for the companies. The law, Kagan said, “just says if you’ve been injured by a RICO violation in your business, which includes your employment, then you’re entitled to threefold damages.”

    The Supreme Court’s decision in the Horn case could significantly impact both the trucking and cannabis industries. If the court rules in favor of Horn, it may lead to an increase in lawsuits against CBD companies, potentially changing the legal landscape for the industry, according to legal experts. Furthermore, such a ruling could prompt Congress to reconsider the 2018 Farm Bill and related legislation to establish clearer CBD product guidelines.

    If the court rules in favor of the CBD companies, it may enhance the current regulatory framework and limit the use of RICO in cases involving cannabis products that are legal under state law. This outcome could provide some reassurance to the cannabis industry, which has frequently encountered legal uncertainty due to the conflicting laws between federal and state regulations.

    The case not only affects the parties directly involved but could also establish a precedent for how courts manage disputes in industries where state and federal laws conflict. Additionally, it may shape how companies address advertising and product labeling in sectors with new and changing regulatory frameworks.

    Consumer protection advocates have also commented on the case, arguing that companies should be held accountable for their claims, particularly in industries where health and safety are at stake. They see the case as a critical test of whether existing laws are sufficient to protect consumers in the rapidly evolving cannabis market.

    The Horn case touches on fundamental issues of federalism, consumer protection and the intersection of law and commerce in a rapidly changing industry. For Horn, the case represents a fight for justice after a devastating blow to his career. For the CBD companies, it is a battle to protect their business practices and the legitimacy of an entire industry.

    Regardless of the outcome, the decision will likely have a lasting impact on the legal and regulatory landscape for CBD products, the trucking industry, and beyond. The Supreme Court’s ruling will not only decide the fate of one trucker but could also shape how emerging industries are regulated and held accountable under U.S. law.

  • Licensed to Sell

    Licensed to Sell

    The 2024 UKVIA forum focused on the UK’s proposed Tobacco and Vapes Bill.

    By George Gay

    As many people have noted, it seems odd that after decades of handwringing over the negative health consequences of tobacco smoking, the health community has been at best lukewarm and at worse fundamentally opposed to the introduction of new-generation nicotine products. After all, these products are significantly less risky than combustible cigarettes, and they have been more effective at helping smokers quit their habit than any of the products or strategies previously used. The health community seems to have been intent, and largely successful, on reviving the tobacco wars as the nicotine wars—this time, with it comprising the bad guys.

    The health community has obstructed the introduction of these new products, which it generally recognizes as being less risky than cigarettes, partly on the grounds that, since they are relatively new, it is not known what negative health effects they might cause in the future, after prolonged use. This, of course, is to misapply the precautionary principle given that the new products are being used to replace combustible cigarettes, which the health community likes to describe as comprising a consumer product that will kill you when used in the way it is designed to be used. Since humans are unable to predict the future with certainty, such an approach comprises an ideology that rules out change, including progress, of any kind.

    The health community has resisted the introduction of less risky products also on the grounds that they are used by those too young to buy them legally. Consumption by those underage is often described as comprising an epidemic, but this is hyperbole, often used, apparently unashamedly, by people who put themselves forward as scientists. It has also been used by U.K. politicians who, while saying that nobody wants children to come to harm, vote against providing meals to young people from financially impoverished families.

    It seems that many in the health community and many politicians prefer to stick their heads in the sand when it comes to the rising level of child poverty in the U.K. and prefer to remain in that rather uncomfortable—not to say undignified—position rather than admit that many underage vapers are the risk-takers who, if they had not been vaping, would have been smoking.

    Nevertheless, it cannot be denied that if some of those who are too young to buy vapes legally are vaping regularly, then somewhere along the line, the law has probably been broken, and this law-breaking should not be allowed to continue to happen with impunity. Indeed, this is something the U.K. Vaping Industry Association (UKVIA) has recognized for a long time. For years, it has called for the introduction of a retail licensing scheme that would allow sanctions to be imposed on retailers who sold vapes to the underaged and indulged in other illegal activities.

    And from this point of view, one provision of the U.K. government’s much-trailed Tobacco and Vapes Bill (T&V) 2024, which was published 10 days before the UKVIA held its annual forum in London on Nov. 15, drew a cautious welcome from participants. In part, the bill provides for the introduction of a licensing scheme* for the retail sale of vapes and nicotine products as well as tobacco products, herbal smoking products and, somewhat bizarrely, cigarette papers (but not cigarette lighters). The welcome was cautious because a few flies could drop into the ointment, one of which could be a lack of enforcement, a problem that was given a new-to-me angle during the forum.

    In the past, it has been said that government austerity measures had left Trading Standards (TS) with inadequate resources to fully carry out its responsibilities, which, among many others, include enforcing compliance with retail laws as they apply to tobacco and nicotine products. But a forum presentation by Kate Price, the lead officer for vaping at the Chartered Trading Standards Institute, seemed to cast doubt on whether this lack of TS funding was the most significant issue and, therefore, on whether an increase in funding would make a great deal of difference.

    The forum was told that TS teams worked for local authorities that also had seen their funding slashed, leaving them needing to control their budgets tightly. The implication seemed to be that these authorities, with responsibilities that include the protection of vulnerable children and older people, might not see retail offenses as a high priority for prosecution through the courts, which anyway were suffering from backlogs caused by their own funding issues.

    Neither, it seemed, would it make much difference if, as some have suggested, the revenue from licensing fees were to be ringfenced for use by TS because, presumably, this would do nothing to relieve the bottlenecks further down the line that lead to court appearances. One other provision in the T&V bill might be more positive in that, if enacted, it would give TS powers to issue on-the-spot fines, but the industry seems to believe, not without justification, that the level of fines being discussed would not present much of a deterrent given the profits that can be made by retailers who sell illicit products and/or licit and illicit products to those underage.

    I shouldn’t give the impression that Price is against further funding for TS; she isn’t. In fact, she made the point that it was difficult for TS to cover the 60,000 premises from which vapes are sold, and, because of this, she asked industry players to report whenever they came across rogue retailers. This was all well and good and in line with the industry’s desire to work closely with TS, but later in the forum, retail representatives seemed to suggest that many reports were made, but few seemed to be acted upon. It was said that there were few prosecutions, and those prosecutions attracted low penalties.

    It was said too that the system of enforcement needed to move from reactive to proactive, using, among other things, a system of regular test purchases, and I got the impression that there was a need for a complete rethink because the whole system of retail oversight and enforcement seemed far too cumbersome to produce timely prosecutions. The industry is aware that this is the most important issue that it needs to address because the retail sale of illicit products and the sale of all products to the underaged are two big sticks with which its opponents can keep beating it. On the positive side, the government says that it intends to strengthen enforcement activity to support the implementation of the measures outlined in the T&V, but, with government coffers hardly overflowing, the industry would be unwise to hold its breath on this one.

    Price’s presentation, informative and useful as it was, rather put me in mind of some of the wise words of the late JJ Cale on his Grasshopper album, where he laments that “Prop up the front, the back falls down.” In fact, come to think of it, those words might comprise a suitable theme for the 2025 UKVIA forum.

    This year’s forum, which was held under the theme “The Changing Vaping Environment— Succeeding in a New Policy Landscape,” comprised a packed program of practical presentations and panel discussions that, along with a modest exhibition space, embraced nicotine pouches as well as vapes.

    In opening remarks, forum participants were told that the vaping industry faced an unprecedented period of change but that it could succeed and even thrive in the new policy landscape. The industry, the government, regulators and the public health community could work together to ensure that vaping could achieve its full potential—a smoke-free U.K. and the health benefits that would flow from such an outcome.

    John Dunne, the director of the UKVIA, said, however, that the industry had to deal with the issue of youth uptake and, in this regard, he expressed delight that the government had reintroduced its T&V bill and added a provision to include a vaping licensing scheme. The industry supported evidence-based and well-balanced regulation aimed at addressing the issues of packaging, product design and flavor descriptions that young people might find overly appealing, he added. But he issued a word of warning in asking the government to oppose any measures that could equate vaping with smoking because far too many people still believed that vaping was as harmful or more harmful than smoking.

    I’m afraid this is a plea destined to fall on deaf ears. In fact, if the T&V bill goes through in anything close to its present form, which seems likely, I think the equating horse will have already bolted. You only have to look at the name of the bill to see that smoking and vaping are being lumped together, and many of the bill’s provisions, as they stand, give the idea that cigarettes and vapes need to be dealt with in lockstep. Unfortunately, smokers are likely to interpret this as meaning that there is no point in switching.

    The only way in which it would be possible to view this bill as having been put together by people who intended to engage the full potential of vaping to reduce the incidence of smoking would be to assume they were suffering from a nasty case of cognitive dissonance. I think the bill indicates that the U.K. is on the cusp of throwing away its previous positive approach to tobacco harm reduction.

    How else is it possible to explain how a country that has stated officially that vaping is 95 percent less risky than smoking and that has been operating a “swap (vapes for cigarettes) to stop” scheme is now proposing that the advertising and sponsorship of nicotine products be banned, putting them into the same basket as cigarettes? In a bill factsheet, the government states unequivocally that its intention is to equate nicotine products with tobacco products in this respect. “The bill will ban the advertising and sponsorship of all vapes and other nicotine products (such as nicotine pouches), mirroring impactful restrictions on tobacco [my emphasis],” it says. This seems to me to be the exact opposite of what is needed, which is the vigorous promotion of the advantages of smokers switching to vapes and other nicotine products.

    There is much more that is of concern too. “The bill also provides powers to make places vape-free and heated-tobacco-free, insofar as they are smoke-free places,” the factsheet states. “Vape usage is already prohibited in many places, and, as with smoke-free places, proposals for any restrictions will be subject to full public consultation.” Once again, the government is implying that there is no difference between smoking and vaping, without having rescinded its 95 percent less risky stance. This is cognitive dissonance on stilts.

    Although it is not necessarily relevant here, it is worthwhile examining the government’s thinking on tobacco smoke in outdoor settings. “Secondhand smoking poses a risk to your health even outdoors,” it states in the “Rationale for Intervention” section of its factsheet. “It is particularly dangerous for vulnerable people like children, pregnant women and those with preexisting but usually invisible health conditions such as asthma and heart disease.

    In some public settings, exposure can be high—if you can smell smoke, you are inhaling it.” Of course, it could have added: If you can smell e-cigarette vapor, you are inhaling it. And it could have further added for those who enjoy being frightfully continental and sitting at pavement cafes with diesel traffic chugging by that the opposite is not true, so you can inhale a busload of toxic fumes that your olfactory system has not warned you about. The truth is that you can get up and move away from tobacco smoke, which, like e-cigarette vapor, is also visible, but even if you detected it, you would have to move to the Outer Hebrides to get away from vehicle pollution. But then who is interested in the truth when half-truths and hypocrisy will win the argument?

    The bill will also provide ministers with powers to regulate the flavors, packaging and display of all vapes and other nicotine products, which, as Dunne indicated, are not issues that would necessarily concern the industry. But the sweeping powers are surely of concern, if for no other reason than that they leave the industry at the mercy of the whims of ministers, who come and go. This is a difficult position in which to leave an industry that runs on costly innovation and therefore needs stability.

    As was said often during the forum, the devil is in the detail, which is currently out for “consultation.” The trouble here is that there are consultations and consultations, and if the tobacco industry’s experience is anything to go by, this consultation will be between the government and those who support the government’s position or want its interventions to be more draconian than those proposed.

    This is not to suggest that the industry and its supporters should not interact with the consultation, especially if they are the sorts of people who find comfort in whistling Dixie. But my guess would be that many of the most popular flavors among adult consumers will be junked. And in further measures that will emphasize in the minds of consumers the idea that smoking and vaping are the same, packaging will be tightly regulated, possibly with the inclusion of unfounded health warnings, and vapes will be regulated out of sight in retail outlets.

    What is probably the standout provision of the T&V will make it an offense to sell tobacco products, herbal smoking products and cigarette papers—what has the government got against small pieces of paper?—to anyone born on or after Jan. 1, 2009. This provision seems to be supported by the vaping industry, but for the life of me, I cannot see why. In the unlikely event that this measure is made to work, and the industry sticks to its position that vapes should be used only by cigarette smokers to quit their habit, all the generational tobacco sales ban will do is ensure that the industry runs out of potential customers faster than it would do otherwise.

    In addition, you have to wonder whether the industry really believes that, having been successful with its generational tobacco sales ban, a future government won’t turn its sights on a generational nicotine ban. The signs are there for those who look, not the least of which is the fact that heat-not-burn products are to be included in the tobacco sales ban. The best way to encourage smokers to quit their habit is to offer them a range of alternative low-risk products, and heat-not-burn systems have proved that they should be part of the range. The government should take cognizance of the fact that while you can kick logic out the door, it will come back at you through the window.

    Surely, a better industry approach would be for it to oppose the generational tobacco sales ban on the grounds that, since so-called smoking-related diseases take decades to manifest themselves, such an ungainly policy will take far too long to show any significant effects. It could argue, rightly, that a much faster route to a healthier population is available and is one that will not involve the government in spending huge sums on enforcement, that will not require it possibly getting bogged down in issues of identity cards and that will not involve it getting into a fight with libertarians and others concerned with individual rights.

    All the government has to do is bring in an effective vaping product registration scheme, which anyway is one of the provisions of the T&V, stop equating vaping with smoking and start promoting the health benefits of smokers switching to vaping. What is a highly innovative industry will do the rest.

    Innovation was to the fore during the forum, and one session looked at “How vape technologies are evolving as we approach a post-disposables future and a new era of responsible vaping.” Although what was an interesting but shortened session ranged much wider than the title suggests, it is to be welcomed, I think, that the title, with its “new era of responsible vaping,” seemed to suggest that the industry has come to terms with the ban on disposables that will come into effect at the beginning of April next year. There are some fights worth engaging in, but they don’t include those that are difficult to win because they are ethically suspect at a time of environmental breakdown.

    Of course, some will say that the ban won’t work. The phrase “bans have never worked and never will work,” rang out often at the forum. But this simply isn’t true. There are a huge number of bans that work under any reasonable definition of the word “work” in this context, car speed limits comprising one. Only if you apply to the word “work” the unreasonable definition that brooks no or few contraventions can it be claimed that bans don’t work. This is not to say that all bans are a good idea, of course.

    In fact, there is widespread tacit approval of bans within the vaping industry, though these industry-friendly bans are supported because they operate under the cover of being positive developments, as well they might be, rather than negative ones. Look at the title of this session: “From licensing to product and regulatory compliance—killing the black market, not the consumers.”

    The licensing scheme referred to here will ban all those who cannot obtain a license for selling vapes while the regulatory compliance scheme will ban any product that doesn’t conform. And, of course, it goes without saying that the black market is banned. Those who don’t believe in bans should come out against the licensing proposal, they should come out against the regulatory compliance proposal, and, in fact, they should agitate to make everything legal. Such a position, if enacted, would at least save a fortune on enforcement.

    And such a position would save another fortune on lawyers. But for the time being, at least they are involved, as was made obvious by an informative presentation on“A case for vaping —What legal recourse does the industry have against misinformation, infringement, bad regulation and the illicit market?”This was an interesting presentation in line with the UKVIA forum’s emphasis on the practical, including as it did a look at patent infringements and anti-competitive practices, among other topics.

    Meanwhile, there were presentations on “Politics in the spotlight—Working with a new government and understanding the vaping products duty.” The latter presentation was interesting, not least because it highlighted a measure brought in by the new government that clearly is another way in which smokers might be persuaded that the consumption of vapes is as harmful as smoking. Looked at in a more positive light, however, Price mentioned in her piece that the application of duty would drag into the vapes enforcement arena bodies with more powers than TS has—HMRC (revenue and customs) and Border Force.

    It is worth mentioning that the duty issue comprised a positive example of the industry’s being able to use the consultation process. It wasn’t able to dissuade the government from applying a duty, but it was able to persuade it to bring in a flat rate rather than the tiered system that had been proposed. In fact, the forum was told that the Labour government had proved more approachable and receptive than the previous Conservative government had proved more approachable and receptive. The industry had been able to have a good level of engagement with the government, TS and HMRC.

    The forum included a couple of sessions focused on the truth, or lack of it, within the vaping sphere: “Closing the trust gap—How public education campaigns can be critical to correcting the vape narrative” and “Taste of truth—Understanding the key role of flavors in harm reduction.” One session looked at “The balancing act—What is the best route to further unlock vaping’s potential to improve harm reduction while also protecting young people?,” and the final session gave the floor to consumers by “Adding consumers to the conversation—A live focus group with the industry’s biggest stakeholders.”

    *Health issues are generally the responsibility of the U.K.’s devolved governments and administrations in Northern Ireland, Scotland and Wales, but, in this instance, the licensing scheme will apply in England, Wales and Northern Ireland while the bill will expand the scope of Scotland’s existing retail register to include herbal smoking products and nicotine products.

  • 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.