Category: This Issue

  • Going to the Extreme

    Going to the Extreme

    The 2024 InterTabac and InterSupply trade shows continue to go to the next level.

    VV staff and Wingle Group

    It’s big. With nine halls, the 2024 trade fair duo InterTabac and InterSupply, held at Messe Dortmund Sept. 19–21, was the largest show since InterTabac began more than 45 years ago. Event organizers at the time wanted to create a platform that provided the nicotine industry with comprehensive information on new products and improved purchasing opportunities in one centralized location.

    Today, the dual trade show encompasses the nine trade show halls as well as the CB Expo Hall (cannabis products) and PouchXchange Hall PA4. PouchXchange is a new, exclusive event that focuses on high-quality communication, networking, meetings with experts and entertainment. It was billed as a networking event for the nicotine pouch and snus industry experts. This event brought together manufacturers, suppliers, retailers and scientists from the industry and offered a platform for intensive dialogue.

    There were more than 800 exhibitors and 14,000 visitors, according to the organizers. Products presented at InterTabac range from cigarillos, cigars, cigarettes, pipes, smoking accessories, fine-cut tobacco and pipe tobacco to equipment, press products, e-liquids, e-cigarettes, modern oral products, heated-tobacco systems and sticks and more, according to Wingle Group, a consulting company focused on the personal electronics, innovative wellness and electronic consumer businesses.

    Some of the major insights in the vaping industry at the show included:

    • Smiss Technology is entering the connected devices segment with its own design of a connected pod system and e-cigarette that changes display indication according to the level of sound/voice (Smoore introduced a similar e-cigarette prototype earlier). The company’s portfolio now also includes disposables with removable screen modules.
    • Barong Elixir has started trial sales of its open-pod system with a heart rate sensor in the U.K. Shenzhen Future Tech Co. manufactures the device. It connects to a phone and has two versions of pods: one for e-liquid and one for CBD oil. The company plans to make it a universal pod system with a future software update.
    • China-based Flonq introduced the Flonq Meta (see “Vaping Under Control,” page 16), a smart pod vaping system with Bluetooth connectivity to an app. The app will provide vape usage statistics while the device’s display shows the consumed dosage. The application is expected to launch in November.
    • CIRAK Electronics GmbH announced the HQD Glaze Plus 12000 disposable e-cigarette, aimed at the U.S. and Russian markets. The device allows users to adjust the cooling agent in the vapor across 10 levels. It features two internal tanks: one for nicotine-flavored e-liquid and the other for a nicotine-free cooling agent. The output of the second tank is adjustable, enabling consumers to customize the level of coolness in the vapor.
    • Tesclacigs added a new disposable device to its portfolio, the Tesla Bar XT-26000. The booth also displayed the Vabeen Polar Beast 35000 disposable. Both devices are equipped with a large 3D curved screen and cooling level adjustment. The device consists of a 4 mL chamber with menthol and a 20 mL chamber with flavored e-liquid. The company plans to launch nicotine level adjustment disposables with the same design and construction.
    • Shenzhen ALD Technology Co. promoted its Fresor models. Recent products are the Fresor Nova Bar CR4 and the Fresor Click Turbo open pod systems with the Fresor Nova Dual flat mesh coil and the Fresor King disposable (also with the Fresor Nova).
    • Vaporesso presented the Dojo Sphere X 40000 disposable featuring a Quad Mesh heater inside.
    • Kiwi presented the Kiwi Go Plus pod system featuring a FEELM Max heater inside from Smoore. The device has the same design as the Kiwi Go 750 disposable pod.
    • Shenzhen Innokin Technology Co. presented pod systems with a removable battery design: the Innokin Trine and the Innokin Trine Q and a charging hub.
    • RELX launched the RELX Essential CR pod system with a removable battery design in New Zealand.
    • Golisi presented its Golisi Medo Q pod system, which has a modular design (removable battery) and is manufactured by Shenzhen Deyuan Electronic Industry Co. The device has a magnet child lock, where the user must rotate the cartridge three times to lock/unlock it.
    • NoNic by Aroma King showcased disposables with 6-methyl nicotine as an active ingredient. It is a nicotine derivative with a similar effect currently considered premarket tobacco product application-exempt in the U.S. Negotiations are ongoing in the Polish and U.S. markets.
    • Fumatul Distribution (Elf Bar’s distributor) launched the new TPD-compliant disposable Elf Bar EB6000 (same as the Lost Mary BM6000) and the Elf Bar 4-in-1 3200 revolver-like pod system, which was launched in the U.K., Canada and Ukraine in September.
    • Dongguan Hongyi Manufacture Co. promoted the “Nose Knows” brand of nasally inhaled vapes. The Nose Knows AT5000 disposable was launched in the U.S. in July.
    • PeakBar introduced its PeakBar Prestige pod system with a programmable remaining e-liquid mode: Smart mode. Smart mode is like the e-liquid indicator. When the users put the pod in, they can turn on Smart mode by pressing the button on two sides. When the e-liquid is used up, the screen will show a zero e-liquid level.
    • Alchem Europe promoted its Ivlac VI closed pod system prefilled with T-Max e-liquid (1,3-propanediol gives nicotine a more basic environment, ensuring a high level of freebase nicotine form, and potentially increases throat hit), with the total formula optimized for a stronger nicotine hit than the actual nicotine content.
    • Lovesticks brand introduced its new Lovesticks Luvx open pod system (identical to Elf Bar Elfx).
    • VGOD launched the new open pod system VGOD Pod Pro S.
    • The ENVA brand showcased its ENVA Prime pod system (RELX-compatible). The cartridges go with tobacco flavors made from natural tobacco.
    • Kanger promoted its brand Olit. It also presented the NOR TPD circumvent pod system.

    In addition, RELX released a TPD-compliant (2 mL tank + 10 mL bottle) disposable in the U.K. The user needs to press the bottom of the bottle to transfer e-liquid into the 2 mL tank. The RELX Essential Pro and the RELX Essential Plus are marketed in the U.K., and the RELX Diamond is marketed in Croatia.

    Reaching out globally, the RELX Essential 2 closed pod system debuted in Italy while an updated version of the RELX Essential CR launched in New Zealand, and the RELX Alpha-1 open pod system was introduced in Canada. Additionally, the RELX Creator 15000 disposable kit debuted in Malaysia, the RELX Novo 14000 disposable was launched in Thailand, and the RELX Prime open pod system was unveiled in Indonesia. Mongolia saw the launch of the RELX 12000 disposable.

    Two products showcased during InterTabac received additional coverage in this issue of Vapor Voice. Dekang Biotech Co. introduced its new DKiss 21 vaporless convection nicotine inhaler (see “Back to Basics,” page 38). A Nico capsule containing solid nicotine beads is clicked onto the device’s body to use the inhaler.

    The unique hot airflow system in the device separates the heating coil and ingredients, so no vaporization or chemical reaction occurs during use. The Nico capsule may deploy synthetic or tobacco-derived nicotine, meaning more market potential and better regulation compliance for this product format. A more compact version apart from the Dkiss Pen—the Dkiss 21 disposable—has a slightly different construction of its nicotine-containing chamber.

    Greentank (see “Heated Breakthrough,” Issue 3, 2024) is offering oil disposables and 510 cartridges with Quantum Vape heating technology—a unique flat atomizer design with the Quantum Vape Heating Chip. This technology can also be applied to e-liquid for vaping products. The claimed benefits include up to 52 percent cooler vapor compared to market-leading vapes, improved flavor consistency and prolonged lifespan. The materials are 100 percent biocompatible and free from heavy metals.

    Finally, this year’s shows featured a massive increase in the number of modern oral product (MOP) manufacturers exhibiting. Highlights include:

    • Nicotobacco, a Poland-based company, presented Cuba and Baron nicotine pouches. The can is child-resistant and is intended for the Swedish market only. For other countries, child-resistant packaging will be launched shortly.
    • House of Pouches manufactures a wide variety of products, in particular, nicotine pouches under the POKE and BLOW brands, energy pouches AMNESIA and CBD pouches SPIRIT OF NATURE.
    • The well-known vape brand Elux, known for its disposable pods, presented Elux slim nicotine pouches. The products have already been launched in the U.K. in 10, 17 mg/g strength varieties.
    • ALD Group promoted FLYTO nicotine pouches.
    • Philip Morris International showcased its Zyn nicotine pouches. PMI owns one of the most popular and recognizable players in the MOP market. In the first quarter, they were officially launched in Ukraine.
    • Shenzhen Zinwi Bio-Tech Co., a major e-liquid producer, introduced its ZNT nicotine pouches and lozenges.
    • The Tangshan Hancheng Technology Co. exhibited the equipment for filling nicotine pouches and the pouches used for filling: dry, wet, semi-dry and granular.

    One company that stood out was Chubby Gorilla. The California-based company is an established player in the consumer goods packaging solutions arena, serving clients in numerous industries, including the vaping and cannabis products industry. It is now also offering child-resistant packaging for MOPs—the Chubby Gorilla Pouch Container.

    Chubby Gorilla creates original (black, white, transparent and combinations of the aforementioned) and custom pouch cans. The can’s design can be transparent, translucent or opaque. To open the can, consumers turn the lid to align the arrows on the side point, then pull and turn slightly to the side.

    The 2025 edition of InterTabac and InterSupply will be held Sept. 18–20 at Messe Dortmund in Germany.

  • Ecological Impact

    Ecological Impact

    Credit: Mann888

    Finding solutions to hazardous waste from vaping products is a growing concern.

    By Timothy S. Donahue

    Disposing of vape waste is becoming an increasing environmental concern. The CDC Foundation, a nonprofit that supports the U.S. Centers for Disease Control and Prevention, estimates that each month in the U.S., consumers purchase 11.9 million disposable e-cigarettes.

    Based on that figure, a report from the U.S. PIRG Education Fund, a nonpartisan consumer-interest group, estimates that the disposable vapes sold annually would stretch longer than 7,000 miles if lined up, more than twice the width of the continental U.S.

    In addition to creating plenty of plastic waste, discarded e-cigarettes can be considered both e-waste (because of their circuitry and lithium-ion batteries) and hazardous waste (because they contain nicotine). E-cigarettes are also difficult to recycle, and many people don’t even try; garbology research has found evidence of plenty of vape litter. A 2022 survey found that just 8 percent of teen or young adult vapers sent their used disposable devices to recycling facilities.

    Within the e-cigarette category, disposables “pose the highest potential environmental costs,” according to a 2018 paper in the American Journal of Public Health, because they aren’t used as long as refillable models. A 2022 letter in the Lancet Respiratory Medicine called for tighter regulations on single-use vapes to prevent “environmental disaster.”

    In the meantime, the new report suggests that people who vape can make a simple switch to benefit the environment: choose reusable devices instead of those that go straight into the trash. “Nothing used for a day or two,” the report says, “should pollute our environment for hundreds of years.”

    Emma Shalaway, marketing director at Sauce Essentials, a California-based cannabis company, said that one of the biggest challenges brands like Sauce faces in implementing recycling programs, particularly across state lines, is the lack of specific legislation regarding the recycling of products.

    “For example, in California, there is really only legislation around the recycling of vape batteries, leaving a gray area for the complete recycling of all-in-one (AIO) vape products. This uncertainty makes it difficult for brands and retailers to navigate compliance when it comes to recycling programs even though we try to support by providing recycling bins in markets where initiatives like this are allowed,” explains Shalaway. “To push for better recycling infrastructure, we need specific legislation tailored to AIO cannabis vapes across state lines. Given the number of regulatory hurdles already present in bringing AIO cannabis vapes to market, it only makes sense to create clear guidelines for their proper recycling.”

    Credit: Benn Photo

    Douglas Dunlap, chief commercial officer at Greentank, a Canada-based atomization company, told Vapor Voice that recycling programs in the vaping industry are challenging due to the need for collaboration between hardware manufacturers, distributors, retailers and recycling services. Many brands lack control over the retail environment, which makes consumer education efforts on product recyclability difficult.

    “Establishing a consistent, user-friendly recycling initiative often requires buy-in from retail partners, including their willingness to promote and facilitate collection efforts at the point of sale. At Greentank, we’re constantly innovating to make our products cleaner and more environmentally friendly by sourcing sustainable materials and minimizing waste,” said Dunlap. “However, broader systemic changes are needed. State and local regulations often make recycling programs costly due to concerns about handling controlled substances. Reviewing these policies or specific recycling guidelines for vape products would significantly benefit brands, manufacturers and consumers, making it easier to create eco-friendly solutions.”

    According to the CDC Foundation, after the U.S. Food and Drug Administration’s February 2020 crackdown on flavored nicotine e-liquid cartridges for reusable vapes, sales of disposable brands increased 196.2 percent by March 2023. The FDA’s decision prohibited the sale of flavored prefilled nicotine vape cartridges exemplified by popular brand Juul but didn’t mention disposable vapes. This omission created a gray market, and by March, sales of disposable products increased to 11.9 million units a month and had overtaken the cartridges market share at 53 percent of vape sales. At this rate, consumers throw out 4.5 disposable vapes per second.

    This vape waste is becoming more common while cigarette butts become less common as the trash that litters our beaches and waterways. It seems we’ve gone from bad to worse. While cigarette pollution takes up to 10 years to degrade, disposable vapes are nonbiodegradable and “endanger ocean creatures that inadvertently consume the plastics.”

    Electronics often contain hazardous materials, such as the heavy metals lead and mercury. According to the U.N., “recycling activities are not keeping pace with the global growth of e-waste.” The agency’s report found that just 9.4 percent of e-waste is recycled in the Americas. It’s not just a capacity problem. We don’t have the technology to magically melt complex products such as disposable vapes back into their component parts.

    Disposable vapes are encased in plastic shells that never fully degrade. They follow in the footsteps of other environmentally harmful single-use pod products, such as coffee pods or even pod-using hair dye.

    Due to the nicotine e-liquid used in these products, vape waste can’t be recycled with other plastics because the Environmental Protection Agency defines the substance as an acute hazardous waste.

    Disposable vapes cannot be reused, recycled properly, or legally thrown in the trash. The lithium used in the batteries in disposable vapes sold yearly weighs 23.6 tons, equivalent to the lithium needed to create batteries for 2,600 electric vehicles.

    According to Dunlap, brands can play a key role by partnering with reputable hardware providers that prioritize safety and sustainability, like Greentank. When selecting hardware components, it’s important to consider eco-friendly materials such as wood, metal, ceramic, glass and PLA.

    “We encourage brands to think beyond the immediate product and consider the life cycle, including its environmental impact and long-term consumer experience,” he said. “[Marijuana] dispensaries have a unique opportunity to drive change by collaborating with recycling services and offering incentives for recyclable products.

    “Vape consumers often have strong loyalty to their local dispensaries and budtenders, making these locations ideal for education and promotion. With dispensaries empowering consumers to recycle, we could see a growing demand for sustainable products and more forward-thinking regulations.”

    Credit: Benn Photo

    While many states and cities have banned flavored vapes, few have wholly banned vapes, and none have explicitly targeted disposable products. Flavor bans, which replicate the same omission perpetrated by the FDA, have allowed the disposable gray market to thrive. More states and cities should follow their mandates to protect health and the environment by definitively banning disposables.

    Shalaway said that brands should take responsibility for the products they introduce to the market and advocate for local legislation that enables manufacturers to be accountable for this part of the supply chain.

    “We actively seek opportunities to engage with our communities through environmental initiatives like beach cleanups,” she said. “We are eager to collaborate with industry-focused organizations to help grow this side of the industry.

    “Recycling programs can often fail because consumers lack the motivation to participate—even with the convenience of a blue bin. To address this, our goal in the future is to reduce barriers by displaying recycling bins at retail locations and offer incentives, such as discounts on future purchases when consumers recycle a certain number of AIO vapes.

    “By making recycling more accessible and rewarding, we hope to encourage greater participation and accountability.”

  • Supreme Decision

    Supreme Decision

    Credit: Sean Pavone Photo

    The U.S. vaping industry is anxiously awaiting a decision from the highest court in the land.

    By Timothy S. Donahue

    The Supreme Court of the United States (SCOTUS) is poised to address a crucial case for the vaping industry that challenges the U.S. Food and Drug Administration’s decision to block the marketing of flavored e-cigarette products. The FDA is contesting a lower court ruling that favored two vaping companies, which argue that the FDA unjustly rejected over a million premarket tobacco product applications (PMTAs) to sell flavors other than tobacco or menthol.

    Under the agency’s PMTA pathway, companies must demonstrate that the marketing of a product would be appropriate for the protection of public health (APPH). When the FDA makes decisions about vaping products, it must take into consideration the risks and benefits to the entire population, not just users of the products.

    The case, Wages and White Lion Investments v. U.S. FDA, is compelling because a major factor in predicting how SCOTUS will rule in the first vaping case to be heard by the high court, and potentially at least three others, is that in the wake of another SCOTUS ruling, courts no longer need to defer to agency interpretation of the law simply because a statute is ambiguous (see “Principle Response,” page 22).

    Gregory Conley, an experienced industry attorney and director of legislative and external affairs at the American Vapor Manufacturers Association, said that the overturning of the Chevron deference could have a profound impact on the vaping and broader nicotine industries by reducing the deference courts previously granted to regulatory agencies like the FDA.

    “Judges will now critically evaluate the FDA’s regulatory processes and interpretations of ambiguous statutes rather than assuming the agency knows best,” Conley said. “In simpler terms, for the first time since its creation, the FDA’s Center for Tobacco Products will have to follow the law as written.”

    Vape companies secured a legal victory when the 5th U.S. Circuit Court of Appeals sided with Wages and White Lion (doing business as Triton Distribution) and Vapetasia when it overturned the orders denying the marketing of the companies’ flavored products. In its decision, the 5th Circuit condemned the FDA’s imposed requisites as “unfair,” noting that the agency “unexpectedly demanded” that the companies present studies demonstrating that flavored products would contribute to smoking cessation.

    In January, the en banc panel of the 5th Circuit voted 9-5 to grant the petitions for review. The judges ruled that the FDA had been “arbitrary and capricious,” in violation of a federal law called the Administrative Procedure Act (APA), by denying the applications without considering the companies’ plans to prevent underage access and use.

    “Over several years, the [FDA] sent manufacturers of flavored e-cigarette products on a wild goose chase. First, the agency gave manufacturers detailed instructions for what information federal regulators needed to approve e-cigarette products. Just as importantly, FDA gave manufacturers specific instructions on what regulators did not need,” Circuit Judge Andrew S. Oldham wrote in the majority opinion. “The agency said manufacturers’ marketing plans would be ‘critical’ to the success of their applications.

    “And the agency promulgated hundreds of pages of guidance documents, hosted public meetings and posted formal presentations to its website—all with the (false) promise that a flavored-product manufacturer could, at least in theory, satisfy FDA’s instructions. The regulated manufacturers dutifully spent untold millions conforming their behavior and their applications to FDA’s say-so.

    “Then, months after receiving hundreds of thousands of applications predicated on its instructions, FDA turned around, pretended it never gave anyone any instructions about anything, imposed new testing requirements without any notice, and denied all 1 million flavored e-cigarette applications for failing to predict the agency’s volte-face. Worse, after telling manufacturers that their marketing plans were ‘critical’ to their applications, FDA candidly admitted that it did not read a single word of the 1 million plans.”

    The case began when the FDA rejected 55,000 applications to market flavored e-cigarettes in August 2021, including Triton’s, and said applicants would likely need to conduct long-term studies establishing their products’ benefits to win approval. The Office of the Solicitor General asked the Supreme Court to review whether the 5th Circuit’s decision relied upon “legal theories that have been rejected by other courts of appeals that have reviewed materially similar FDA denial orders.”

    The regulatory agency’s “legal theories” in Triton are based on administrative fairness and regulatory consistency, not Chevron deference. In most vaping industry lawsuits, appeals courts have supported the FDA, and manufacturers have sought appeals. In the Triton Distribution case, however, the FDA had to petition the court to review the 5th Circuit’s decision, which was based more on APA violations. SCOTUS is scheduled to hear the case sometime during its new session, which begins in October.

    Conley explained that, while the end of Chevron signals a new openness by the Supreme Court to scrutinize federal agencies, the 5th Circuit’s opinion focused on matters of statutory interpretation, including procedural conduct and the FDA’s sudden imposition of new standards without proper notification.

    “With or without Chevron deference, we believe that the ‘switcheroo’ pulled by the FDA was arbitrary, capricious and not in line with the Administrative Procedures Act,” said Conley. “This stance aligns with the court’s broader view that agencies should not have unchecked power to interpret and enforce ambiguous statutes without clear congressional authorization.”

    Much of the lower court’s opinion is based on APA violations. The APA process for creating federal regulations has (typically) three main phases: initiating rulemaking actions, developing proposed rules and developing final rules. In practice, however, this process is often complex, requiring regulatory analysis, internal and interagency reviews, and opportunities for public comments.

    At its most basic level, the APA requires that an agency create a draft proposed rule, review/approve it, publish a notice of proposed rulemaking in the Federal Register and open a public comment period of at least 30 days. In a footnote to the Triton decision, the court characterized the FDA’s denial of all PMTAs for nontobacco-flavored e-cigarettes as a “de facto flavor ban” that circumvented the APA’s required notice-and-comment rulemaking process:

    “(5) FDA’s categorical ban has other statutory problems. For example, the TCA states that FDA must follow notice-and-comment procedures before adopting a ‘tobacco product standard.’ See 21 U.S.C. § 387g(c)–(d). And Congress specifically called a ban on tobacco flavors a ‘tobacco product standard.’

    “See id. § 387g(a)(1)(A) (referring to tobacco flavors, ‘including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke’); see also id. § 387g(a)(2) (cross-referencing notice-and-comment obligation to revise flavor standards). FDA unquestionably failed to follow § 387g’s notice-and-comment obligations before imposing its de facto ban on flavored e-cigarettes.”

    Attorneys from the U.S. Department of Justice told the justices that the 5th Circuit’s ruling “has far-reaching consequences for public health and threatens to undermine the TCA’s central objective of ‘ensuring that another generation of Americans does not become addicted’” to nicotine products.

    In court papers, Solicitor General Elizabeth Prelogar told SCOTUS justices that the FDA has never adopted a categorical ban on flavored e-cigarette products. “Rather, it has recognized that, because such products pose a ‘known and substantial risk to youth,’ applicants bear a particularly high burden of proving a potential for benefit to adult smokers that could justify the risk,” she wrote.

    Robert Burton, a longtime player in the U.S. vaping industry and current group scientific and regulatory director for the U.K.-based vaping company Plxsur, said that concerning the Triton case, decisions will now need to carry a significant weight of evidence on both sides.

     “Without the Chevron precedent, it may come down to a judgment based upon who knows the market and consumer best and who understands ‘best’ what is in the interest of public health, but based upon facts and data rather than a gray area deferral,” said Burton.

    Attorney Eric Heyer, who is representing Triton, expressed intense anticipation for the Supreme Court’s hearing of the case. He strongly criticized the FDA for imposing “surprise, after-the-fact … study requirements” and failing to adhere to the guidelines the agency itself had developed.

    It is unclear whether SCOTUS will hear the three other vaping-related cases, which are also before it (Magellan Technology Inc. v. Food and Drug Administration; Lotus Vaping Technologies LLC v. Food and Drug Administration; and Logic Technology Development LLC v. Food and Drug Administration). In these cases, vaping manufacturers seek a review of their losses in FDA-issued marketing denial order appeals handed down by various other circuit courts.

    Yolonda Richardson, president and CEO of the Campaign for Tobacco-Free Kids, has urged the high court to overturn the appeals court order, emphasizing that if allowed to stand, it could significantly harm public health, particularly that of children. Vaping companies have asserted that their products can mitigate the harm caused by smoking combustible cigarettes.

    When the Triton decision was announced, Tony Abboud, executive director of the Vapor Technology Association, welcomed the decision as a “blistering indictment” of the FDA’s Center for Tobacco Products for its “intentional misleading” of the U.S. e-cigarette industry.

    “The court was so stupefied by the FDA’s bad-faith efforts to reject all flavored e-cigarette products [that] it cited Shakespeare to illustrate the full extent of the FDA’s disingenuity, particularly after the court explained that the plaintiffs in that case provided scientific evidence that e-cigarettes ‘save lives,’” Abboud said. “The court also emphasized the dramatic and abrupt ‘FDA flip-flop,’ which led to the implementation of what the court called a ‘de facto ban’ on flavored e-cigarette products in the U.S.

    “This was in addition to the voluminous jurisprudence cited by the court laying bare just how egregious the behavior of the FDA administrative state has been toward e-cigarette products and the consumers that use them. As the court stated, ‘No principle is more important when considering how the unelected administrators of the fourth branch of government treat the American people.’”

    Triton Cited as Precedent by 5th Circuit

    The U.S. Food and Drug Administration is starting to see vapor on the horizon. The regulatory agency has been handed another brutal defeat by a federal court. The 5th Circuit Court of Appeals granted petitions for review to five vaping companies, citing its own decision in the Triton Distribution case as precedent.

    The court sent the company’s marketing denial orders (MDOs) back to the FDA for additional scientific evaluation. As a result, the manufacturers may keep selling their products until the agency completes new reviews of their premarket tobacco product applications (PMTAs) or until the Supreme Court takes action.

    “Specifically, the court determined that (1) FDA did not give e-cigarette manufacturers fair notice of the rule requiring long-term studies for PMTAs; (2) FDA did not acknowledge or adequately explain its change in position; and (3) FDA ignored reasonable and serious reliance interests that manufacturers had in the pre-MDO guidance,” the 5th Circuit wrote in its ruling.

    Five companies, Cloud House, Paradigm Distribution, SWT Global Supply, Vaporized and SV Packaging, first challenged their MDOs in court in October 2021. The court consolidated the five cases, and in November 2021, all petitioners were granted stays pending review.

    In January, the 5th Circuit found in favor of Wages and White Lion Investments (doing business as Triton Distribution) in the e-liquid manufacturer’s appeal of an MDO. The FDA later petitioned the Supreme Court to review the 5th Circuit’s ruling, and last month, the Supreme Court agreed to hear the agency’s appeal.

    The FDA challenged the Triton decision, and the U.S. Supreme Court agreed to hear that case. “But now, another panel of the 5th Circuit has applied the same rationale as in Triton to hold that these five, small-business manufacturers prevail for the same reason: FDA pulled a surprise switcheroo,” wrote the United States Vaping Association on X.

    “From 2018 to 2020, FDA provided a ‘dizzying’ array of detailed instructions explaining the requirements for PMTAs,” the opinion states. “But ‘[n]ever in this long, winding and byzantine regulatory process of meetings, PowerPoint decks, proposed rules, comment periods, guidance documents and enforcement priorities did FDA ever say that it was contemplating an across-the-board ban on flavored products. Nor did FDA ever give fair notice that flavored product manufacturers had to submit robust scientific studies on flavored e-cigarette products.’”

    The 5th Circuit found that the recent petitions posed the same issues as Triton’s. “Petitioners spent substantial time and resources preparing their PMTAs based on FDA guidance that they would not need to submit long-term clinical studies,” the court wrote. “Nevertheless, FDA rejected their PMTAs using the same boilerplate language it used for the Wages petitioners’ denials as well as those of thousands of other e-cigarette manufacturers.

    “Accordingly, for the reasons amply explained by the en banc court in Wages, we hold that FDA acted unlawfully here as well by denying petitioners’ PMTAs based on the absence of long-term clinical studies.”

    The FDA’s failure was not simply a failure to provide notice that a particular type of study was required (long-term studies) but a failure to provide notice of the substantive standard requiring comparison between the flavored products at issue and tobacco-flavored juices, according to the USVA.

    “USVA members have now won important legal precedent in the 11th and 5th Circuits,” the USVA posted. “Note that manufacturers who didn’t file a petition in a court of appeals to challenge their MDOs can still sue in district court, and if you’re in the 5th or 11th Circuit, you have binding precedent in place that should provide a solid prospect of securing a quick ruling vacating your MDO.”

  • Principled Response

    Principled Response

    VV Archives

    The end of Chevron deference could have ripple effects across the nicotine industry.

    By Timothy S. Donahue

    U.S. courts will no longer need to “humbly respect” how government agencies interpret the law. The end of Chevron deference means unelected officials will no longer have the leeway to subjectively decide what Congress intends when it passes regulatory legislation.

    The court’s ruling in Loper Bright Enterprises v. Raimondo and the related case Relentless v. Department of Commerce will likely have far-reaching impacts on nearly every action government agencies take. For the nicotine industry, it could change how courts view the U.S. Food and Drug Administration’s premarket tobacco product application (PMTA) process. It could also impact the agency’s efforts to regulate menthol and lower the levels of allowable nicotine in combustible cigarettes.

    “For far too long, unelected bureaucrats at the FDA have been making up the law to suit their ulterior agenda and … the Supreme Court has thankfully put a stop to it once and for all,” said Allison Boughner, vice president of the American Vapor Manufacturers Association, in a statement. “No longer will it be good enough for [prohibitionists] in Congress to write vague, Crayola language and then connive behind closed doors with FDA to impose arbitrary policies on the American public that could never withstand the light of day. [This] ruling is a stirring rebuke of FDA and, we hope, with more soon to follow in pending cases.”

    In declaring the doctrine’s demise, Chief Justice John Roberts wrote that agencies “have no special competence” in resolving statutory ambiguities—but courts do.

    “Chevron is overruled,” wrote Justice Roberts in the Loper Bright decision. “Courts must exercise their independent judgment in deciding whether an agency has acted within its statutory authority, as the APA [Administrative Procedure Act] requires. Careful attention to the judgment of the Executive Branch may help inform that inquiry.

    “And when a particular statute delegates authority to an agency consistent with constitutional limits, courts must respect the delegation while ensuring that the agency acts within it. But courts need not and under the APA may not defer to an agency interpretation of the law simply because a statute is ambiguous.”

    Agustin E. Rodriguez, a partner with Troutman Pepper, explained that “under the doctrine of Chevron deference, courts would defer to a federal agency’s interpretation of an ambiguous statute if the agency was charged with administering the statute in question and its interpretation was reasonable. However, the end of Chevron deference may alter that traditional thinking.”

    Bryan Haynes, also a partner at Troutman Pepper, added, “The Supreme Court’s decision overruling Chevron in the Loper Bright Enterprises v. Raimondocase could affect federal courts’ overall outlook on agency interpretations, possibly making courts hesitant to defer to agencies as a general practice.”

    The decision could potentially result in alterations to the FDA’s methods of regulating vaping products. The Supreme Court of the United States (SCOTUS) has agreed to hear its first-ever vaping case, Wages and White Lion Investments v. U.S. FDA, which is compelling because deferring to Chevron has been the standard for lower courts when deciding regulatory cases brought by manufacturers of nicotine products (the end of Chevron deference isn’t likely to directly impact the White Lion case, according to its attorneys).

    Robert Burton, an expert with more than 11 years of experience in the U.S. vaping industry and current group scientific and regulatory director for the U.K.-based vaping company Plxsur, said another general concern is that now, federal agencies may have to put more resources into the additional legal challenges that they will likely face and divert staff away from review/approval processes.

    “Agencies, such as FDA, may also have to look to improve their primary knowledge in those ‘gray areas’ to be able to demonstrate they actually have the knowledge and expertise rather than it being ‘assumed’ or deferred by judges based upon Chevron,” Burton explained. “I also can’t see anything changing soon; if anything, this will create a further backlog of court cases and delays in regulatory decisions based upon the potential for an agency to be challenged legally.”

    How it started

    The Chevron doctrine, based on the 1984 decision in Chevron v. Natural Resources Defense Council, held that courts should defer to the interpretations of “expert” federal agencies regarding ambiguous laws they are required to implement, as long as the agency interpretations are reasonable.

    In many cases, what would be considered “reasonable” was also left to government agencies to decide because nonelected bureaucrats were often considered “experts” even though they had little to no experience in the industries they were regulating.

    For 40 years, unelected officials were given latitude to decide on their own what Congress had intended when it wrote unclear laws—even if there were other sufficient interpretations that the courts could have considered. According to the New York Times, Chevron deference was applied in 70 Supreme Court decisions and 17,000 lower-court rulings during those years.

    The plea to overturn the Chevron doctrine came to the court in two cases challenging a rule issued by the National Marine Fisheries Service (NMFS) that requires the herring industry to bear the costs of observers on fishing boats. Applying Chevron, both the U.S. Court of Appeals for the District of Columbia Circuit and the U.S. Court of Appeals for the 1st Circuit upheld the rule, finding it to be a reasonable interpretation of federal law.

    The fishing companies brought their case to the Supreme Court, seeking the justices’ input on both the rule in question and the overruling of the Chevron doctrine. Roman Martinez, speaking on behalf of a group of fishing vessels, informed the justices that the Chevron doctrine undermines the courts’ responsibility to interpret the law and violates the federal law that governs administrative agencies, which calls for courts to independently review legal questions.

    Under the Chevron doctrine, he observed, even if all nine Supreme Court justices agree that the fishing vessels’ interpretation of federal fishing law is better than the NMFS’ interpretation, they would still be required to defer to the agency’s interpretation as long as it was reasonable. Such a result, Martinez concluded, is “not consistent with the rule of law.”

    Chris Howard, executive vice president of external affairs and new product compliance for Swisher, parent to the vaping company E-Alternative Solutions, welcomed the ruling, saying that federal agencies have had too much power for decades.

    “That ended with the Supreme Court’s decision overturning the longstanding Chevron doctrine,” said Howard. “The decision marks a significant shift in the judicial landscape, correcting the balance of power between federal agencies and the judiciary. It fundamentally alters how courts rule on agency statutory interpretation. As the majority states, courts will no longer be restrained by the need to provide deference.

    “Instead, ‘Courts must exercise their independent judgment in deciding whether an agency has acted within its statutory authority, as the APA requires.’ This transformation will likely lead to significantly less regulatory flexibility and increased judicial scrutiny. The implications of this decision will resonate across industries, including the tobacco industry, influencing regulatory practices and shaping the future of administrative law. Regulatory overreach will become the exception as opposed to the norm and enable courts to fulfill their duty to interpret the law.”

    Immediate uproar

    The end of Chevron deference is extremely far-reaching, with other industries, such as healthcare, likely to review previous decisions that have gone against them. Justice Elena Kagan, in her dissent, asserted that government regulators are best positioned to tackle highly technical subjects.

    “This court has long understood Chevron deference to reflect what Congress would want, and so to be rooted in a presumption of legislative intent,” Kagan wrote. “Congress knows that it does not—in fact cannot—write perfectly complete regulatory statutes. It knows that those statutes will inevitably contain ambiguities that some other actor will have to resolve and gaps that some other actor will have to fill.

    “Today, the court flips the script: It is now ‘the courts (rather than the agency)’ that will wield power when Congress has left an area of interpretive discretion. A rule of judicial humility gives way to a rule of judicial hubris. In recent years, this court has too often taken for itself decision-making authority Congress assigned to agencies. The court has substituted its own judgment on workplace health for that of the Occupational Safety and Health Administration, its own judgment on climate change for that of the Environmental Protection Agency and its own judgment on student loans for that of the Department of Education.

    “In one fell swoop, the majority today gives itself exclusive power over every open issue—no matter how expertise-driven or policy-laden—involving the meaning of regulatory law. As if it did not have enough on its plate, the majority turns itself into the country’s administrative czar. It defends that move as one (suddenly) required by the (nearly 80-year-old) Administrative Procedure Act. But the act makes no such demand. Today’s decision is not one Congress directed. It is entirely the majority’s choice. And the majority cannot destroy one doctrine of judicial humility without making a laughingstock of a second.”

    Several national healthcare groups made a joint statement expressing that Chevron deference protected the legal stability of public health programs such as Medicare and Medicaid. The groups claim that Chevron ensured that laws passed by Congress were interpreted and implemented by expert federal agencies such as the Centers for Medicare and Medicaid Services.

    “As our amicus brief noted, large health programs such as Medicaid and Medicare, as well as issues related to the Food, Drug and Cosmetic Act, are extremely complex, so it is key that decisions about how to interpret and implement relevant laws are made by experts at government agencies,” the statement reads. “Yet [this] majority opinion explicitly ends the use of this sensible doctrine.

    “As leading organizations that work on behalf of people across the country who face serious, acute and chronic illnesses and many people who lack access to quality and affordable healthcare, we will continue to work to ensure that healthcare laws are implemented in ways that benefit public health.”

    In its response to the Chevron ruling, the Public Health Law Center at the Mitchell Hamline School of Law stated that the Loper Bright ruling will “undoubtedly impact” the field of administrative law and implicate regulations that, in addition to promoting public health and safety, have served to protect consumers, workers, civil rights and the environment.

    “Legal experts differ on the degree to which Loper Bright may wreak havoc on the federal administrative state; however, the forceful dissent written by Justice Kagan in this case and its companion case, Relentless v. Department of Commerce, should not be ignored. The dissent expressed grave concern that these decisions ‘will … cause a massive shock to the legal system, cast doubt on many settled constructions of statutes and threaten the interests of many parties who have relied on them for years.’

    “In the absence of Chevron deference, the tobacco industry will doubtless feel emboldened to dispute any regulatory actions taken on its products. This includes e-cigarette manufacturers who will be eager for courts to undo FDA-issued premarket tobacco product application denial orders for many thousands of vape products.”

    The Biden administration called the Chevron decision “yet another deeply troubling decision that takes our country backward,” adding that President Biden’s legal team would work with federal agencies to do “everything we can to continue to deploy the extraordinary expertise of the federal workforce.”

    Reshma Ramachandran, a health policy expert and assistant professor at the Yale School of Medicine, said, “This term has been disastrous for public health in many ways.”

    In the vaping industry, however, Tony Abboud, executive director of the Vapor Technology Association (VTA), said that the decision clearly bolsters what the VTA has been saying for years: the FDA and, specifically, the Center for Tobacco Products overstepped their authority when they chose to implement a de facto ban on flavored e-cigarettes in their deeply flawed implementation of the PMTA process.

    “To be clear, it is [the] FDA’s responsibility under the law to create a regulation that clearly addresses the statutory standard of what is ‘appropriate for the protection of public health’ since the Tobacco Control Act is ambiguous on how that determination should be made. However, there is no question that the FDA violated the Administrative Procedure Act by implementing what the 5th Circuit Court of Appeals called ‘a de facto ban on flavored e-cigarettes’ through its shifty implementation of the PMTA regulation by imposing new requirements on products after applications were already filed, ultimately ensuring their application’s demise.

    “The Supreme Court’s decision elevates the importance of the Reagan-Udall Foundation’s findings after being convened at the request of the FDA commissioner, which specifically and clearly criticized the FDA’s Center for Tobacco Products for failing to inform companies what must be provided under the regulation to demonstrate APPH [appropriate for the protection of the public health] and, as importantly, for failing to inform the public on how FDA is applying this standard.”

    Beyond nicotine

    The cannabis industry also will likely be impacted by the Chevron ruling. Asheville, NC-based attorney Rod Kight, a global resource and expert in cannabis law, said that the recent ruling by the SCOTUS that Chevron deference is dead is welcome news to the cannabis industry. With respect to the hemp sector, the death of Chevron means that unofficial positions taken about various cannabinoids and processes to produce hemp products by both the U.S. Drug Enforcement Agency (DEA) and the FDA on their respective websites and in letters to stakeholders do not hold any weight, at least not with the courts.

    “In practical terms, this means that judges may not defer to federal agency positions and interpretations and, instead, must weigh their positions relative to the strength of the legal positions and interpretations put forth by the hemp industry,” explains Kight. “For instance, with respect to tetrahydrocannabinolic acid (THCA), the DEA has stated in two letters during the past year that ‘cannabis-derived THCA does not meet the definition of hemp under the CSA because upon conversion for identification purposes as required by Congress, it is equivalent to delta-9 THC.’

    “As I have discussed in several blog posts and interviews, this is partially incorrect and is not exactly what ‘Congress required.’ Rather, Congress requires a post-decarboxylation test for hemp production (i.e., cultivation) but not for harvested hemp or hemp products.”

    In the past, this type of unofficial guidance may have warranted a court’s deference to the DEA, even if an opposing position by a hemp industry participant was stronger and more well articulated. However, Kight said that, in the post-Chevron world, the DEA’s position will not hold any more weight with the court than a counter-position by an opposing litigant.

    “The same thing applies to any number of other issues, from vapes to synthetic cannabinoids,” said Kight. “Hopefully, this exciting legal development will curb the appetite for DEA and FDA to take strong positions that are often unwarranted while helping the hemp industry to carve out favorable judicial rulings based on the best and most well-articulated positions.”

    Abboud said the SCOTUS’ decision in Loperexposes the FDA’s improper regulation of flavored e-cigarettes. While the vaping cases that have gone before the SCOTUS were not explicitly decided on Chevron deference, it is hard to believe that the court will not look skeptically on the FDA’s prior “regulatory shenanigans and post-hoc justifications” laid bare by the 5th Circuit Court of Appeals in the White Lion case.

    “However, unlike the complete overturning of Chevron, it is likely that the court would issue a more limited ruling in the vape cases before it. That said, the real power of Loper is that it provides a template for new litigation against the FDA that is not limited to individual application decisions,” said Abboud. “This new regulatory challenge would reveal the full story of FDA’s tortured and disingenuous implementation of the ambiguous PMTA statutory provisions to ban flavored vaping products and possibly, as a result, spell the demise of the PMTA regulation.

    “VTA is once again calling for the FDA to immediately suspend any further denials based on its existing process and instead create a clear and streamlined tobacco product standard that will allow independent companies of all sizes to get less harmful nicotine alternatives on the market as it is required to do under the law.”

  • Industrial Sabotage

    Industrial Sabotage

    Credit: Stock Photo Pro

    The Mary Miller Amendment will kill the hemp industry, including its industrial sector.

    By Rod Kight, Jonathan Miller and Chris Fontes

    When the Mary Miller Amendment (MMA) passed the U.S. House Agriculture Committee, I wrote an article about how it is specifically designed to kill the hemp cannabinoid industry. Unfortunately, and even though this industry generated $28 billion in revenue last year, there are groups that want it dead, including a small cartel of marijuana corporate conglomerates who seek to destroy the hemp industry so they can control the entire cannabis supply chain to the exclusion of small hemp businesses.

    In addition to deploying millions of dollars into lobbying efforts to shut down the hemp industry, these conglomerates have launched a massive disinformation campaign about hemp products and child safety that is largely bereft of substantive factual support.

    But that’s not all. In addition to killing the hemp cannabinoid industry, the MMA will also kill the industrial hemp industry. Aside from the marijuana cartel, there are others who do not care about the hemp cannabinoid industry but who do care about industrial hemp. These groups are fine with the MMA because, to their understanding, it does not impact “industrial” hemp. This view is not only incorrect, but it is a direct result of the disinformation campaign referenced above. To be clear, the MMA will kill all hemp, including “industrial hemp.” This is because the MMA does the following:

    • It changes the definition of “hemp” so that total THC must not exceed 0.3 percent. Some people have argued that the MMA merely codifies current U.S. Department of Agriculture (USDA) policy in measuring THC in the field. That’s not true because the MMA goes well beyond measuring THC in the field to making a sweeping change to the current definition of “hemp” in the Farm Bill. Contrary to popular belief, THCa, the nonpsychoactive precursor to THC, is not mentioned in the Farm Bill’s definition of hemp. Importantly, it is not part of the legal “metric” for determining whether cannabis material is lawful “hemp.” In fact, the opposite is true. The current definition of hemp specifically includes its “acids.” (THCa is one of many acids the plant produces. The “a” in THCA stands for “acid.”) The only statutory reference to THCa in the Farm Bill is via an inference.

    The Farm Bill directs the USDA to use a “post-decarboxylation” method to test hemp in the field. This means that a hemp crop cannot be harvested unless it passes a total THC test, which accounts for the THCa concentration. In other words, even though THCa is never mentioned in the Farm Bill, it is implied by virtue of the required post-decarboxylation test that must take place before a hemp crop can be harvested. Once this test is passed, the hemp crop may be harvested. Thereafter, the concentration of THCa is irrelevant and, under the Farm Bill, the sole metric to distinguish between lawful hemp and unlawful marijuana is the concentration of delta-9 THC, not THCa. This is a critical point since most harvested hemp crops would fail if the THCa concentration was included as the compliance metric in defining harvested hemp, something that the MMA would require. Notably, grain crops require late flowering and will have no legal pathway if the MMA becomes law and “total THC,” rather than delta-9 THC, becomes the new legal compliance standard.

    • It excludes viable seeds from the definition of “hemp” when they come from a plant with total THC that exceeds 0.3 percent, even though cannabis seeds contain almost no THC, and the U.S. Drug Enforcement Administration itself considers them to be lawful. Notably, all grains, including hemp seeds, are “viable” before they are rendered nonviable.
    Credit: 24K Productions

    As discussed above, the MMA’s requirement that all post-harvest material pass a post-decarboxylation test would deem all hemp seeds from such plants to be Schedule 1 controlled substances. Given that as much as 88 percent of harvested hemp plants fail a total THC test and are illegal marijuana under the MMA, the grain market will collapse if the MMA is enacted into law. I should note that this specific provision has nothing to do with health, safety or anything else along those lines. Rather, it is solely about consolidating power in the hands of a few corporate marijuana conglomerates who perceive all competition, even from hobbyist home growers, as a threat to their bottom lines.  

    • It excludes “quantifiable amounts” of THC, including THCa, from the definition of “hemp.” Hemp is cannabis. It is not some other species of plant. One of the most notable and fundamental characteristics of the cannabis plant is that it expresses THC. By eliminating all THC, the MMA would render all hemp, including industrial hemp, a Schedule 1 controlled substance since ALL hemp plants express THC in quantifiable amounts.

    The founder of one of the top cannabis laboratories in the country informed me that his lab can detect THC at levels down to picograms per milliliter (0.0001). This roughly equates to a drop of THC in an Olympic-sized pool. Moreover, even if an industrial hemp plant could be grown with no quantifiable amounts of THC, the fiber market is not currently viable enough on its own to support an industry. It does not produce sufficient revenue to support testing labs, regulators’ budgets or the bottom lines of most businesses. Given time, this will change, but only if the entire hemp industry is allowed to survive and thrive.

    Rod Kight

    The MMA pulls the rug out from underneath the multibillion-dollar hemp industry that Congress created in 2018. This includes the grain and fiber sectors. Even though the MMA is promoted as an effort to close the so-called hemp loophole, what it will really do is kill the entire legal hemp industry while giving away billions of dollars to the illegal marijuana industry. If Congress truly believed that hemp products constitute a public health crisis, then it would have enacted legislation requiring the U.S. Food and Drug Administration or another federal agency to oversee it many years ago. The fact that it hasn’t done this belies the shrill cries of concern of the marijuana cartel’s disinformation campaign that mask its true intent to destroy its hemp competitor.

    Moreover, there are better ways to address safety than by killing the hemp industry, including by promulgating regulations that prohibit access by minors, mandating quality control in production and standardizing labeling so adults can make educated decisions about what products they choose to purchase. These three regulatory zones, what I call the “Three Pillars,” have been addressed in hemp industry-sponsored bills in state legislatures throughout the country, many of which have been defeated due to intense lobbying against them by the marijuana industry.

    Finally, for proponents of “industrial” uses for hemp who also think that it is OK to give the illegal corporate marijuana cartel a giveaway while destroying thousands of legal small businesses, be aware that MMA will kill the entire hemp industry, including the industrial sector that they purport to support. 

    Rod Kight is an attorney who represents businesses in the hemp industry.Jonathan Miller is general counsel to the U.S. Hemp Roundtable. Chris Fontes is president of the U.S. Hemp Authority.

  • A Cold Chill

    A Cold Chill

    Credit: Yusif

    While FDA menthol market authorizations are rightly seen as a victory, they may be pyrrhic.

    By Rich Hill

    The flavored electronic nicotine-delivery systems (ENDS) road has been a bumpy ride. Going back to pre-deeming days, flavored ENDS were ubiquitous, as were unquantified, anecdotal reports of their cigarette-smoking cessation efficacy. Following the accelerated premarket tobacco product application (PMTA) submission timeline, as everyone knows, the Center for Tobacco Products’ (CTP) decisions decimated flavored ENDS. Likewise, even the most sophisticated companies were receiving marketing denial orders (MDOs) for menthol ENDS. Throughout this bloodbath, the CTP oft repeated that flavored products need to demonstrate a cessation benefit to adult smokers weighed against the risk of youth initiation. Until recently, this had not played out.

    Njoy’s marketing granted orders (MGOs) for menthol Ace and Daily products was a watershed moment demonstrating that an ENDS product with a flavor other than tobacco could be granted marketing authorization status. However, the authorization does leave some questions unanswered.

    CTP’s Menthol Positioning

    In 2022, the CTP staked out its position on menthol in the cigarette context with the product standard prohibiting menthol in cigarettes. The center asserted that menthol reduces irritation and harshness of smoking, increases appeal and makes cigarettes easier to use—especially for youth, increases nicotine’s sensory effects in the brain and makes it more difficult to quit smoking. While the first points on irritation and harshness are unique to cigarettes, the CTP’s other points arguably apply to menthol and nicotine more generally—a dour omen for ENDS and other products.Given this position, particularly on youth initiation, it came as little surprise that several menthol ENDS products received MDOs over the past several years.

    An About Face?

    The Njoy Ace and Daily menthol product MGOs were a surprise considering the CTP’s menthol position and flavored vapor product denials. What was different about Njoy’s applications that tipped the scales?

    Beyond Njoy’s successful showing of product characterization, toxicology and abuse liability data, according to the Njoy Ace Technical Project Lead Review (TPLR), behavioral studies and marketing restrictions appear to have made the difference. Alongside other behavioral studies, Njoy simply did what the CTP required and conducted a longitudinal study comparing cigarette smoking cessation efficacy between tobacco and menthol ENDS products. Per the TPLR, “[t]he applicant’s findings and additional analyses conducted by statistics demonstrate a statistically significant added benefit of using menthol-flavored Njoy Ace compared to classic tobacco flavor … in achieving past-30-day [combustible cigarette] smoking cessation ….” Among other data in the TPLR, Table 3 reports that in the Intention to Treat Analysis, initial flavor at baseline analysis resulted in 26.6 percent past-30-day abstention rates for menthol versus 19.3 percent for tobacco at 6 months. When analyzed by flavor at time of switching, past-30-day cessation rates of 27.1 percent for menthol versus 19.3 percent for tobacco at 6 months were reported.

    Along with the adult cessation data, Njoy agreed to a long list of marketing restrictions—beyond what is observed in other applications. The restrictions included limitations on advertising means including no radio, television, outdoor, print, search engine advertising, social media promotions, product placements, engagements or activations or influencers, sponsors, etc., among others. Talent portrayals would be limited to models over 45 years of age. Njoy identified a range of sales restrictions as well.

    Ultimately, after assessing the youth data and risks, the TPLR executive summary states, “[t]he PMTAs contain sufficient evidence to show that the new products have the potential to benefit adults who smoke combustible cigarettes and who switch completely or significantly reduce their combustible cigarettes  use …. The applicant also proposed robust marketing plans that include restrictions beyond those required with PMTA authorization. The Office of Health Communication and Education has determined that these restrictions may help further limit youth exposure to the new product, the products’ labeling, advertising, marketing, and/or promotion, and the potential for youth initiation.”

    Questions Remain from the Njoy Decision

    The MGO, however, raises two interesting questions. First, how much adult benefit is enough to overcome youth uptake? And second, what impact do marketing restrictions have on marketing authorization decisions?

    The Math on Youth Use vs. Adult Cessation – How Much Differential is Enough?

    The TPLR reports youth Njoy use data from both applicant data and national surveys and concludes that “[w]hile ENDS with nontobacco flavors and high nicotine delivery may help adults who smoke switch from CC to ENDS, these same characteristics may facilitate initiation and continued nicotine use by youth.” The cost-benefit analysis is troubling because CTP provides no real quantitative measure comparing youth use rates to adult cessation rates. Rather than a numerical comparison, the analysis seems to rely upon the totality of the evidence. As the TPLR states, “the totality of evidence provided by the applicant suggests that the menthol-flavored [product] … is associated with significantly higher smoking cessation rates than tobacco-flavored Njoy Ace products, and epidemiology concluded that the new products are highly beneficial to adults who smoke CC.” The close of the TPLR user population synthesis states that menthol-flavored new products pose a risk to youth but went on to assert that the data “demonstrate added benefit of using menthol-flavored compared to classic tobacco-flavored … Njoy Ace in achieving past-30-day smoking cessation—a showing required to outweigh the risks associated with flavored ENDS among youth.”

    For some time, many in industry have wondered how much cessation difference between tobacco and flavored ENDS would be enough to outweigh risk to youth. While the balancing test is not numerically quantified, this marketing decision does provide some level by which to assess menthol products.

    Are Marketing Plans Back on the Table?

    In the White Lion Investments dba Triton Distribution v. FDA5th Circuit Court of Appeals decision from January 2024, the majority opinion found that the FDA ignored marketing plans in the Triton PMTAs: “[w]orse, after telling manufacturers that their marketing plans were ‘critical’ to their applications, FDA candidly admitted that it did not read a single word of the 1 million plans.”

    Njoy’s marketing plan, however, seems to have an effect on the outcome. Reviewers remarked that the Njoy plan was “robust and is expected to limit youth exposure” to marketing materials. Interestingly, the TPLR states that the marketing plan was “not considered in the APPH assessment,” but then goes on to refer to the plan positively, stating, “the applicant’s approach to marketing may help further limit youth exposure to the new products.”In Njoy’s case, the marketing plans may not have moved the APPH needle but were considered as a net positive in youth prevention.

    Are marketing plans important to your application? Beyond being a required part of the PMTA submission, it appears that in this case, the restrictions at least supplemented the adult benefit data to good effect.

    Will Menthol MGOs Have an Impact in This Market?

    While the menthol market authorizations are rightly seen as a victory, such a victory may be a pyrrhic one.

    The presence and consumer acceptance of flavored disposable ENDS products looms over this seminal marketing authorization. The fact is that many menthol-flavored ENDS products with pending PMTAs remain on the market. Even in the face of the availability of menthol ENDS, flavored disposable ENDS sales have skyrocketed.

    The Centers for Disease Control and Prevention published a Morbidity and Mortality Weekly Report (MMWR) in 2023 assessing e-cigarette unit sales across the various categories of products and flavors using scan data from brick-and-mortar retailers only. The MMWR reported that “the percentage of disposable e-cigarette sales more than doubled, from 24.7 percent in January 2020 to 51.8 percent in December 2022.” The predominant disposable flavors reported were “flavors other than tobacco, menthol or mint” (71.4 percent in 2020 and 79.6 percent in 2022). At the same time, menthol ENDS sales overall did not significantly change, while tobacco and mint flavors declined. With half of the market occupied by flavors that consumers clearly want, the growth space for a couple of menthol products seems limited.

    VV Archives

    While the FDA continues to publicize enforcement efforts, the flavored disposable ENDS trend will not abate anytime soon. Given that flavored disposables are crushing the category, it seems unlikely that the MGOs for Njoy’s menthol products will play a significant role in shifting market share in the near term.

    Where Does This Leave Us?

    Foremost, good on Njoy for cracking the code—most observers have been very skeptical that an ENDS product with any flavor would ever be granted marketing authorization. Ultimately, Njoy demonstrated what the industry knows to be true from ENDS consumers—flavors, including menthol, are a net positive for adults who smoke to transition away from higher-risk combustible cigarettes. However, questions remain about how the risk-benefit test will be applied—how that math actually works and who, other than the largest companies, can afford to produce such evidence.

    Rich Hill is senior director and new product compliance counsel at E-Alternative Solutions.

  • Power Moves

    Power Moves

    Credit: Bodu9

    Many in positions of authority ignore alcohol problems and exaggerate vaping issues.

    By George Gay

    The U.K. Vaping Industry Association (UKVIA) has welcomed, with a few reservations, the publication of a report by the Royal College of Physicians (RCP) that broadly supports vaping as an effective, less risky alternative to tobacco smoking.

    This is not surprising because much of what the RCP has to say is in line with what the UKVIA has been saying for some time. Still, it is good to have such a well-respected medical organization on your side, especially given the heft of its 267-page report, “E-cigarettes and harm reduction: An evidence review,” which was published on April 18.

    George Gay
    George Gay

    The report looks at several themes, including how e-cigarettes can be used to support more people to make quit attempts while discouraging young people and never-smokers from taking up e-cigarette use; trends in tobacco and vaping use; the effectiveness of e-cigarettes to treat tobacco addiction; the differences in health effects of vaping in people who smoke, vape or do neither; the role of the tobacco industry in the rising use of e-cigarettes; and the ethical dilemmas presented by e-cigarettes.

    In responding to the report on April 22, the UKVIA firstly warned the government “not to consider banning flavors as [to do so] would be going against the advice of one of the most eminent and respected medical bodies in the U.K.” I am not sure this is completely true because the report seems to leave enough wiggle room for the government to ban at least some flavors without flouting the RCP advice.

    My reading is that the RCP believes that to exploit fully the potential of vaping as a means of encouraging smokers to quit their habit it is necessary in part to allow consumers access to a “range” of flavors. But I think it is calling for more research to try to identify those flavors that are the most efficacious from the point of view of encouraging smokers to quit but also those, if any, that are off-the-scale attractive to the underage.

    This is one of the strengths of the report, I believe. For too long, it has been all too easy for commentators to say there is, in respect of vaping flavors, a need to balance the interests of smokers wanting to quit their habit who are attracted to certain flavors and those of the underage who should be discouraged from vaping by restricting the flavors available. Often, the flavors concerned are the same ones, and the commentators never put forward credible ways of finding this balance, which leaves policymakers and, therefore, policies in a state of limbo.

    The RCP, while, to some extent, dancing to the same tune about the need for balance, has at least come forward with some better steps, and it will be interesting to see if the government takes up the RCP’s advice or if it blunders on in the normal way. My concern is that with a problematic national election coming up this year or, at the latest, January next year, I cannot see it learning any new steps. More likely, it will continue to put its feet down like ready money.

    One reason the RCP can put forward a more credible idea for preventing underage use is that it seems to be aware that the flavors-and-the-underage issue is something of a red herring. It is aware that many underage people take to vaping because they can. As the UKVIA has been saying for a long time and as the RCP acknowledges, the government has slashed the funding for the main agency charged with policing the retailing of such products.

    At this point, I should declare that I have not read the RCP report, only the 13-page executive summary, which, as far as I can tell, includes all 54 recommendations of the full report. And there are limits. This brings me to one of my concerns. A 267-page report is impressive, but it is not going to get through to the average smoker, and smokers need to be addressed directly if they are going to be encouraged to quit.

    Credit: Pavel Kant

    The report will be addressed to other “experts” in the field and perhaps the government, which might or might not follow through on the recommendations, some of which are excellent. But there is no point in having, for instance, a recommendation that smokers be provided with accurate reduced-risk messages if that recommendation sits in a huge report on a shelf gathering dust.

    And it must be said that while there have been two previous RCP reports going back 17 years, the intellectual dial of vaping seems not to have been advanced very far. The first report was the 2007 252-page “Harm reduction in nicotine addiction: Helping people who can’t quit” while the second was the 2016 206-page “Nicotine without smoke: Tobacco harm reduction.” In total, with the latest report, that’s 625 pages.

    No doubt much of those 625 pages comprises repetition. Still, nevertheless, one wonders how come, with so much intellectual firepower aimed at the subject, U.K. vaping policies are still sometimes a muddle. After all, the RCP reports are just three of what must be a pile of reports that could usefully be used to support Lord Nelson should his current column, like much of the U.K.’s infrastructure, fall into disrepair.

    What smokers see by and large are not these reports but the sensational media pieces such as those aimed at stirring up a moral panic about vaping among the young. And unfortunately, such negativity is not confined to the imaginings of journalists. In a 700-word opinion piece in The Guardian newspaper on April 16, the chief medical officer of England, Chris Whitty, had two things to say about vaping.

    “In addition, the [tobacco and vapes] bill will substantially reduce the ability of vape companies to market to children, an utterly unacceptable practice.” And “It [the tobacco industry] tries to pass off new tobacco products as ‘safe,’ as it did with ‘low tar cigarettes’ and cigarette filters—but no tobacco products are safe.”

    Now I have a lot of time for Whitty, who I believe is a man of integrity, but I think he should reflect on the second of these statements. How does he think this statement will be interpreted by smokers, who are more likely to read it than the 267-page RCP report?

    To my way of thinking, many smokers will conclude that on the “evidence” he offers there is no point in switching from tobacco cigarettes to vapes or even nicotine pouches. Is that the message he wants to convey?

    He seemingly conflates tobacco products with nicotine products and says that no tobacco product is “safe,” which is true, but then no product is safe, especially alcohol, as I am sure he will be aware.

    As a heading in The Guardian had it on April 23, “Record level of alcohol deaths revealed after heavy drinking in pandemic.” “Years of inaction on alcohol harm has led to this, and the heartbreaking thing is these deaths were totally avoidable,” Richard Piper, the chief executive of Alcohol Change U.K., was quoted as saying in The Guardian article. “Our government has the responsibility and the power to put preventative measures in place, including proper regulation of alcohol marketing, clear alcohol labeling and a minimum price for a unit of alcohol.”

    But the government does not take such action because hypocrisy rules. The first of the major findings described in a press note announcing an April 25 report by the World Health Organization, “A focus on adolescent substance use in Europe, Central Asia and Canada,” stated, “Alcohol is the most frequently consumed [illicit] substance among adolescents, with 57 percent of 15-year-olds having tried alcohol at least once and nearly four in 10 (37 percent) indicating they’ve consumed alcohol in the past 30 days.”

    Credit: Viktor

    The press note goes on to say, “Roughly one in 10 (9 percent) adolescents across all age groups have experienced significant drunkenness—being drunk at least twice—in their lifetime, a rate that alarmingly climbs from 5 percent at age 13 to 20 percent by age 15, showcasing an escalating trend in alcohol abuse among youth.

    “Furthermore, recent patterns reveal that the incidence of drunkenness within the past 30 days also increases with age, jumping from 5 percent among 13-year-olds to an alarming 15 percent among 15-year-olds, highlighting an urgent need for targeted intervention strategies to curb this growing issue of underage drinking.”

    And just in case it is pointed out that the WHO report covers a wide geographical area that might not correctly represent the situation in the U.K., the report says, in part, that with respect to “lifetime” use of alcohol, the “United Kingdom (England) reported the highest prevalence for 11-year-olds (35 percent for boys and 34 percent for girls) and 13-year-olds (50 percent for boys and 57 percent girls).”

    With respect to current alcohol use, the report says that “At age 13, it ranged from under 1 percent of boys and girls in Tajikistan to 32 percent of boys in Bulgaria and girls in [the] United Kingdom (England).”

    But nothing will happen in the U.K., at least nothing that will be aimed at curbing alcohol use because most people are not interested in the health of young people to the extent that they would inconvenience themselves to help them. You will not find health advocates saying that a balance needs to be sought between allowing adults to get off their heads on alcohol and protecting young people from the harms caused by alcohol to developing brains.

    Moreover, in the U.K. in recent years, young people have been uncaringly plunged into poverty, hospitalized with malnutrition and forced to attend collapsing schools in areas with appalling levels of pollution. Hypocrisy rules.

    The government, which has been promoting alcohol through its taxation policies, is not alone. The Guardian, which is totally po-faced when it comes to smoking and vaping, also promotes drinking. On May 4, shortly after it had covered the WHO report, it carried a story taking up two-thirds of a page titled, “Sparkling form: Pet nat goes from hipster bars to M&S [a major, up-market food and beverage retailer].”

    I shall quote only the final sentence of the story, which was accompanied by a large picture of young people drinking and laughing, “The funky labels and crown caps have made Pet nat a hit with younger drinkers, and, according to Beames [a wine manager], opening a bottle of Pet nat is less formal, more fun.”

    What is meant by “fun” here, I wonder? Drinking alcohol can lead to mental and physical incapacities, fights, car crashes, pedestrian deaths, domestic abuse, crime in general, you name it—none of which can be laid at the feet of vaping.

    And it is clear the WHO is not interested in going after alcohol; it is on the trail of eliminating vaping. If you read its report, after the key findings and the introduction, you will see that the first of three quotes made hugely visible against brightly colored backgrounds has nothing to do with alcohol, even though alcohol is identified in the report as the main problem; it is about vapes: “I think the biggest health concern facing young people today is vapes. I think that they should either make vapes less accessible, take the nice flavors out of them or ban them (Girl, Ireland).”

    You will look through the report in vain for a highlighted quote on alcohol, but there is another on vapes and one on “addiction illnesses.”

    Why, I wonder, are so many people in authority seemingly willing to ignore the problems caused by alcohol while making up problems in respect of vaping? I am fast concluding that most of them have drunk too much and lost too many brain cells in the process.

    Finally, I think it is a shame that the RCP, in a report that, while somewhat repetitious, provides much food for thought, finds it necessary to attack the tobacco industry for being “self-serving,” an accusation that can be leveled at every industry, business, individual and organization—even, heaven forfend, the RCP and me.

    The 13-page executive report references “research” 20 times and 10 times to say that more of it is needed. And yes, I think each piece of research should be covered by a story in Vapor Voice written by me.

  • Playing with Numbers

    Playing with Numbers

    Photo: Hafiez Razali

    How research methods distort nicotine effects and risks

    By Cheryl K. Olson

    “The paper seems like a joke.” That’s what Harvard researcher Miguel Hernan said recently to the journal Science about a report linking e-cigarettes and strokes.

    The article was concocted by a dubious research group, founded to help young international medical school graduates get coveted authorship credits. Its analysis of U.S. government survey data claimed that respondents who vaped had a higher risk of stroke, at younger ages, than those who smoked. Its glaring flaws included inflating the number of survey takers by tens of thousands and failing to correct for the relative youth of vapers.

    Despite this, the 2022 paper’s findings found their way into media headlines and anti-vaping advertising. The Science article credits Gal Cohen and Floe Foxon with sounding the alarm on this appalling study.

    Subtler issues that affect research quality, and how research is perceived by the public, are harder to spot. Research methods may seem a dull or arcane topic. But a peek at how the research sausage is made reveals some simple yet surprising ways that the process can go wrong.

    Sometimes old habits or unquestioned assumptions are to blame. Just as typewriters affect how we text on our mobiles, legacy cigarette research methods and mindsets influence how we study noncombustible nicotine products.

    Hours of Vaping?

    Everyone understands cigarettes. When it comes to totting up use, cigarettes are easy. They come in standard units. You light, puff and extinguish. Not so for products such as vapes. How, then, do researchers compare smoking with these new nicotine-delivery systems?

    “There’s a lot of research showing that people who use e-cigarettes graze throughout the day,” says Arielle Selya, who conducts nicotine product research at Pinney Associates. “Unlike cigarettes, there’s no defined stopping and starting. They don’t have to finish a discrete unit; they just puff on and off.” Measuring this kind of variable, intermittent activity is a challenge.

    This problem is not unique to vaping. Studying nicotine pouch use, I found unexpectedly wide variations in what people did and what they thought was normal. Some tossed a pouch in the trash after 10 minutes or 15 minutes. Others kept one in their mouth for a couple of hours. A few sometimes reused a pouch they’d started earlier or cheeked pouches of two different flavors at once.

    As an example of what can go wrong, Selya pointed to a recent study of vaping and respiratory symptoms. To the authors’ credit, they tried to measure heaviness of e-cigarette use. The problem was the poor fit between their question and the behavior. They asked, “How many hours did you use electronic cigarettes per day?”

    “I’m not a vaper, but that seems like such a strange question,” says Selya. “Like asking how many hours do you spend drinking water?”

    Better approaches to measuring nicotine product use include writing down what you’re doing whenever a device pings you (ecological momentary assessment) or in a daily diary.

    Twisted Terminology

    Another holdover from cigarettes is the way tobacco is seen as the default flavor for all nicotine-containing products. “With e-cigarettes, you have to add a tobacco flavor,” notes Selya. “But researchers often say ‘flavored’ when they mean ‘non-tobacco flavored’–in some communications even the NYTS team does this–but tobacco itself is a flavor! This generates misunderstandings.”

    Nicotine research terminology can defy common sense. Consider the concept of “abuse liability.” In everyday English, abuse implies harm. When the U.S. Food and Drug Administration assesses new drugs, stricter regulation may be required if there’s abuse potential, defined as “intentional, nontherapeutic use” to “achieve a desired psychological or physical effect.” An effect like euphoria, hallucinations or distorted thoughts or perceptions. 

    When it comes to reduced-harm nicotine products, abuse potential becomes, weirdly, a plus. A backhanded compliment. If you want to attract someone away from cigarettes, features like rapid nicotine absorption, relaxation and relief of withdrawal encourage that transition.

    Abuse liability also illustrates another nicotine methodology vexation: there is no agreed-on way to measure it. One article looked at comments made by the FDA on manufacturers’ submissions for multiple types of nicotine products. Regulators considered a whole range of measures related to abuse liability, from product chemistry and pharmacokinetics to subjective factors. Of the latter, “liking” the product turned out to be the most reliable and sensitive abuse liability measure!

    Misleading Measures

    Again, cigarettes are simple and familiar. Novel nicotine products, by contrast, come in ever-evolving variations. U.S. government surveys, such as the Population Assessment of Tobacco and Health (PATH) and National Youth Tobacco Survey (NYTS), measure trends in who is using what products. The results are widely used and reported. However, for survey results to make sense, people must understand the questions.

    Discrepancies in results suggest that research participants often misunderstand nicotine products and/or the terms being used to describe them. For example, answers about vaping brands and device types often don’t match. In the NYTS, just two-thirds of teens who said they “usually” used a pod/cartridge brand of e-cigarette (such as Juul, Logic or Vuse) also said they “most often” used a pod/cartridge device. Almost one in five adults in the PATH study had these kinds of mismatched answers about their vaping behavior. 

    Some questions have even larger errors. “The NYTS asks whether your e-cigarette product contains nicotine salts,” says Selya. “And overall, about 50 percent said they don’t know.”

    This is also true for so-called “concept” flavors, she notes. “Not strawberry-banana, but something like cosmic fusion. When youth are asked about concept or ice flavors, they don’t know the characteristics of their product, or maybe don’t understand those words.”

    NYTS first asked youth about tobacco-free nicotine pouches in 2021. That year, just 1.9 percent of teens reported ever using one. Checking the details, I found a flaw: The questionnaire defined nicotine pouches as “flavored.” However, over a third of teen ever-users said the pouch product they used was unflavored. (Perhaps they confused pouches and snus?) 

    A further example: the 2023 NYTS found that 1 percent of youth—an estimated 370,000—had ever used a heated-tobacco product. At the time, that product category was not sold in the United States.

    As Ray Niaura of New York University told me, “That can’t be right. Literally, it’s impossible. So that means it’s measurement error.”

    This suggests young survey takers were befuddled. “Kids aren’t going to know,” says Niaura. “‘Heated tobacco: Yeah. I smoked a cigarette. It’s heated. I light it on fire.’”

    Yet the Centers for Disease Control and Prevention reported the result without comment or explanation.

    If a product is only used by a small percentage of people, these sorts of errors could create unreal changes in year-to-year trends. The reporting of those potentially misleading trends affect the perceptions of academics, regulators and the public. “With that amount of uncertainty and some of the low numbers, it’s hard to figure out what’s the signal versus the noise,” notes Selya.

    Questionable Choices

    Another seemingly simple but complicated issue: Who counts as a current product user? Youth surveys typically ask “have you used e-cigarettes at all, even a puff, in the last 30 days?” Surveys aimed at adults commonly ask, “Do you currently use e-cigarettes some days, every day or not at all?”

    If you assume capturing any youth e-cigarette use is important, then “even a puff” makes sense. But it also makes it difficult to separate teens who are briefly experimenting from teens at risk for problematic ongoing use.

    In studies that look at how using nicotine products affect some aspect of health, researchers choose what outcomes to measure. Their choices can suggest biases or suspicious holes in what’s reported.

    A recent study using PATH data tried to compare e-cigarette use and the age at which people developed asthma. “Why age of asthma onset rather than whether they developed asthma at all?” says Selya. “Often, I read a study and think, did you look at these other related outcomes? If so, why weren’t they published?” This issue of results that may exist but aren’t reported are known as the “file drawer problem.” Preregistering study plans would avoid this issue.

    Researchers, Meet Users

    Before I dove deeply into tobacco harm reduction, my research focused on the effects of violent video games on youth. Finding discrepancies between research reports and what teens told me, I realized that many of the field’s most-cited “experts” had never actually played or even observed the games they studied.

    Similarly, many nicotine researchers seem to have never held or used the noncombusted products they study. This leads to findings that don’t reflect real-world situations. One example is an article by Sebastien Soulet and Roberto Sussman on metal contents of e-cigarette aerosols. They found that researchers were overheating tank vaping devices, generating aerosols that would be “likely repellent to human users.”

    “I think there’s a big disconnect and abysmally low involvement of actual consumers, the people affected by policies,” says Selya. Partnering with people who actually know and use novel nicotine products would be a giant step toward improved research quality.  

    References

    Foxon F. (2023). Discordant device/brand reporting among adolescents who used e-cigarettes in the National Youth Tobacco Survey. Nicotine and Tobacco Research. https://doi.org/10.1093/ntr/ntad228

    Joelving F. (2024). Prescription for controversy. Science. https://www.science.org/content/article/questionable-firms-tempt-young-doctors-with-easy-publications

    Selya A, Ruggieri M, Polosa R. (2024). Measures of youth e-cigarette use: strengths, weaknesses and recommendations. Frontiers in Public Health. https://doi.org/10.3389/fpubh.2024.1412406

    Soulet S, Sussman RA. (2022). A critical review of recent literature on metal contents in e-cigarette aerosol. Toxics. https://www.mdpi.com/2305-6304/10/9/510

    Vansickel A et al. (2022). Human abuse liability assessment of tobacco and nicotine products: approaches for meeting current regulatory recommendations. Nicotine and Tobacco Research. https://doi.org/10.1093/ntr/ntab183

    Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors via McKinney Regulatory Science Advisors. She spent 15 years on the faculty of Harvard Medical School.
  • Registered Outcomes

    Registered Outcomes

    Credit: Jet City Image

    U.S. states are passing vape product registry bills to combat the FDA’s lack of enforcement.

    By Timothy S. Donahue

    Vaping product registry bills are gaining momentum in the U.S. This surge is a direct response to the perceived lack of action from the Food and Drug Administration in curbing the influx of illegal disposable vaping products. Currently, three states have successfully implemented registry rules, with four more set to follow suit in 2025. Notably, several other states are in the process of drafting similar bills.

    Critics claim that registry bills favor major tobacco companies, and many continue to condemn the premarket tobacco product application (PMTA) process as excessively onerous. They point out that it’s easier to bring new cigarettes to the market than it is to gain authorization for lower risk products such as e-cigarettes and vapes.

    According to Nick Orlando, an entrepreneur and president of the Florida Smoke-Free Association, if there is any area of the vaping industry that genuinely needs reform, it is at the federal level and within the failed 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.”

    Tony Abboud with the Vapor Technology Association said there are currently 13 million vapers across the U.S. Yet only six different types of FDA-authorized e-cigarettes are presently on the market. To date, the FDA has not authorized any nontobacco-flavored vaping products, rejecting millions of applications, which critics say amounts to a blanket anti-flavor policy.

    When speaking about a recent state registry proposal, Abboud said only the major tobacco companies that have FDA marketing authorizations reap the benefits from legislation created to limit the number of products available to consumers. He compared registry bills to a scenario in which all beer except for Bud Lite and Miller Lite are removed from stores. “Bud and Miller would love it, right, because they are definitely going to pick up some more customers,” Abboud said.

    Gregory Conley, director of legislative and external affairs at the American Vapor Manufacturers Association, said there is no need to guess why companies like Altria have dedicated massive resources toward passing PMTA registries. Altria has claimed in its investor reports that disposable vaping products are cutting into the company’s cigarette sales.

    “This is not about giving a competitive advantage to [Altria subsidiary] Njoy products; it’s about selling more combustible cigarettes, which kill over 400,000 people each year,” said Conley. “Fortunately, the more politicians learn about these bills, the less they like them, which is why most states that considered these bills in 2023 and 2024 have rejected them.”

    Alabama, Louisiana and Oklahoma already have PMTA registry bills in effect while laws in Kentucky, Utah, Virginia and Wisconsin are set to take effect in 2025. Many vape directories are very similar. Louisiana and Oklahoma, for example, nearly mimicked Alabama’s vaping registry rules. It should be noted that both the Alabama and Oklahoma registry rules, while technically in effect, are not currently being enforced. Bills to fund the enforcement of regulations in both states have been defeated by vaping industry advocates.

    The Louisiana Office of Alcohol and Tobacco Control (ATC) released the list of vape products that have been approved for sale. The VAPE Directory can be found on the ATC’s website. The law requires vape products sold in Louisiana to submit a certification form to the ATC. The directory list is updated every first of the month.

    If a product isn’t on the list, then it can’t be sold in the state. Some approved products on the list are Juul pods, Bidi Sticks and Vuse pods. Louisianna’s list contained less than 400 products when observed on June 1. In Louisiana, to be listed on the VAPE Directory, products must meet one of the following criteria:

    • Products must be on the U.S. market as of Aug. 8, 2016, and the manufacturer must have applied for a PMTA prior to Sept. 9, 2020, pursuant to federal law and the PMTA remains under review by the FDA;
    • Any vapor products or alternative nicotine products on the U.S. market that the FDA has issued a “no marketing order” but the agency or federal court has issued a stay order or injunction during the pendency of the manufacturer’s appeal or the order has been appealed and remains pending; or
    • The manufacturer has received a marketing order or other authorization under federal law for the vapor or alternative nicotine product from the FDA.

    Under the Louisiana rules, the commissioner may approve a vape or alternative nicotine product without a PMTA if a manufacturer can demonstrate that the FDA has issued a rule, guidance or any other formal statement that temporarily exempts product from federal PMTA requirements and provide sufficient evidence that the product is compliant with federal rule, guidance or other formal statements.

    To date, the FDA has authorized only 23 e-cigarette products, all of which are owned by major tobacco companies. The remaining brands on the market, such as the Elf Bar, Puff Bar and others, are considered unauthorized products. Limited FDA enforcement prompted states to step in with registry bills. One state, however, created a unique system for removing electronic nicotine-delivery system products from state shelves.

    Florida’s Fortune

    Florida has a reputation of doing things differently. The state’s creation of its vape registry rules was no exception. It didn’t start that way. The original version of Florida’s vape registry rule was like Louisiana’s. However, Orlando said that with Florida’s House Bill 1007, Governor Ron DeSantis and his team found a way to regulate the industry that would best serve the concerns of Florida’s attorney general while keeping vaping retailers in business.

    Unlike other state registries, Florida will not create a list of FDA products that have marketing authorization or are currently under PMTA review. Instead, Florida Attorney General Ashley Moody is tasked with creating a registry of products deemed illegal only after an administrative review process and a public comment period. The law focuses on disposable products and allows for the sale of most open system and pod system products.

    “The list does not currently have any products on it. The state must create a list, SKU by SKU, meeting specific criteria. The list and the products listed are then placed on a referral to a rules committee, which would then open up for public comment any items that made the ‘unauthorized’ list. There would also be mediation with the product owner,” explained Orlando. “The real benefit is that this process is very long, and it only deals with single-use products. You can keep a product on your store shelves until the entire process is completed.”

    HB 1007 requires the state’s attorney general to submit by Oct. 1, 2024, the rules by which Florida’s vaping products committee places products on the “illegal” list. The attorney general would then use those rules to put products on the list for review by the vaping committee, whose members are to be appointed by DeSantis.

    The law requires the state’s Department of Legal Affairs to create and keep a directory of all single-use nicotine vapes that it considers appealing to minors. This directory must be made accessible to the public by Jan. 1, 2025, and it should be updated regularly. Once a product is added to the list, retailers and wholesalers in Florida have 60 days to sell or remove it from their inventory. Any products left in circulation will be subject to seizure and destruction.

    Other states are responding to Florida’s legislative style for vaping product registration. Orlando said several state vapor associations are trying to figure out ways to tailor the Florida bill to their respective states. Due to varying administrative laws among U.S. states, Florida’s bill cannot be a “cookie-cutter” bill for different jurisdictions. Lawmakers cannot just copy language from Florida’s legislation.

    “State organizations have called me to ask how it all looks and how does this work. And when I’ve explained it, our lobby team has gotten on the phone with their lobby team, and they’ve helped draft some legislation similar to [Florida’s] where the industry can continue to operate,” said Orlando. “Nothing to report yet. We will have to wait and see if other states can recreate what has happened for Florida’s vaping industry.”

    Conley disagreed. While the Florida bill trumps an outright ban, politicizing vaping regulations is unnecessary. “While undoubtedly better than a full-blown ban on 98 percent-plus of the current vaping market, Florida’s bill should not be a model for other states,” said Conley. “Politicizing vaping by putting unilateral control into the hands of attorneys general does not make sense, particularly in light of the decline in youth usage we have seen since 2019 …. Adult use of vaping products has grown significantly since 2020 all while youth vaping has continued to fall. In any other reality, this would be celebrated as a significant public health victory.

    “On the plus side, Florida does have strong due process rights built into its administrative law statutes, so Florida businesses and consumers will have the opportunity to weigh in on future bans and potentially bring litigation.”

    Many manufacturers praised the Florida rules. Several companies said that the U.S. needs to address the flood of “illegal” vapes “entering the country from China.” Juul Labs (formerly an Altria subsidiary) stated in a release that illegal flavored disposable vaping products are produced by foreign manufacturers who “shirk U.S. laws while continuing to illegally target minors” with vape products that feature youth-appealing packaging and flavors.

    “Properly constructed and effectively enforced product directory laws can be an important supplement to federal enforcement against these illegal vapor products. We remain committed to upholding and participating in a well-regulated nicotine marketplace across the United States and in Florida,” Juul Labs stated. “We have invested significantly in product development, regulatory science, manufacturing quality controls, and compliance programs.

    “We believe all companies participating in the nicotine vapor market should be doing the same, to ensure that the products reaching consumers are of the highest quality and are reaching only intended users—adult smokers.”

    Disciplinary Reaction

    Another difference in Florida’s vaping rules is that the regulations have some teeth to combat underage retail sales. Any person who sells a nicotine product, including vapes, to someone under 21 for a third or subsequent time will face a third-degree felony charge, punishable by up to $5,000 in fines and five years in prison.

    Beginning March 1, 2025, manufacturers that sell prohibited products in the state will face a $1,000 daily fine for each such product until it’s removed from the market. This stricture will also apply to retailers, wholesalers and distributors who ship products into Florida.

    “That piece was in the original PMTA bill. We didn’t massage that one at all, but I think it does have a little more meat to it because there’s a third-strike rule that is substantial,” said Orlando. “Now, between you and me, I would go a little deeper than that, but they’re happy with what they wrote, so we’ll take it.”

    Orlando said retailers have embraced Florida’s new rules. The options were either an outright ban on all flavored vaping products or HB 2007, which allowed for adult vapers to have access to a variety of flavors and hardware options to help a broader swath of combustible smokers make the switch to vaping.

    “Once I explain to them what really happened and they understand the dynamics of it and what it takes, actually, to get something on the list and that open systems are totally excluded, they’re happy with it,” he said. “Because let’s remember, they had a choice: either be banned or be able to sell. I mean, it’s a pretty simple thing. There was no chance for a veto in this scenario.”

    Research has shown that flavors play a crucial role for individuals transitioning from cigarettes to vapes. Many ex-smokers report that they were only able to quit after discovering the specific vape flavor that suited them. Additionally, several studies have shown that many adult vapers prefer flavors other than tobacco.

    Regulations that specifically target THR products and raise their price or reduce their availability to adults not only threaten Americans’ health but also negatively impact state and federal budgets reliant on excise tax revenues, detrimentally impact 380,000 small businesses, encourage market consolidation in the tobacco industry and fail to target underage tobacco use, according to Citizens Against Government Waste. 

    “These regulations also push consumers and sellers into the unregulated black market for tobacco, putting consumers at risk of tainted products, many of which come from China. Responsible policymakers should acknowledge the benefits of THR products in mitigating the costly health impact of combustible cigarettes,” the group stated in a release. “Yet proposals to restrict the availability of THR alternatives relative to cigarettes continue to move through state legislatures, including Virginia and South Carolina.”

    Brandon Suriff, owner of Texas-based Create A Cig, said he once operated five thriving vape shops in Louisiana. However, the state’s PMTA registry forced Suriff to close two locations and lay off eight staffers. He says without action by the Louisiana lawmakers, the three remaining Create A Cig stores are struggling to survive.

    “The PMTA registry, while perhaps well-intentioned, has drastically limited the vaping products we can sell, cutting our sales in half and reducing our inventory selection by 90 percent. This change not only affects our bottom line but also drives our adult customers to seek products in neighboring states or through online vendors, inadvertently fostering an illicit market,” explains Suriff. “The enforcement of this registry by the Louisiana Office of Alcohol and Tobacco Control, which has just 30 agents to oversee the entire department, has proven to be a significant challenge. This has led to uneven enforcement and placed an undue burden on legitimate businesses like ours while doing little to curb underage vaping.

    “Legislators rushed into this registry without fully understanding its economic impact or its inefficacy in addressing the illicit market. It’s time for a reevaluation. Our aim has always been to offer a safer alternative to smoking, with strict measures to prevent sales to minors. If protecting our youth is the goal, there are better ways to achieve it without decimating local businesses and restricting adult consumers’ access to harm reduction products.”

    Orlando said that, at the end of the day, the vaping industry needs reasonable regulations and industry players need to be responsible. He believes the Florida regulations are a step in the right direction for THR.

    “Let’s get real. Let’s get accountable and start doing business like we should,” he said. “It takes people being engaged. It takes a great lobby team with a long history and be able to get those ears …. We’re lucky enough to have that. We’ve been doing this for 10 years nonstop, 365 days a year, volunteer efforts. The grassroots people help, too, because when we need them, they’re there.

    “Unfortunately, we can’t give up; otherwise, we’ll wind up like them. I advocate for tobacco harm reduction and vaping products because I saw the need for these products to stay on the market. It helped me quit smoking; I opened a shop because of it. It’s worth getting engaged. It’s definitely worth staying engaged before [anti-vaping legislation such as flavor bans and registry bills] comes up, so when it does, you can work through what the real challenges are and understand the root of the situation. Then fight the good fight.”

  • Thoughtful Reflection

    Thoughtful Reflection

    Speakers and panelists discussed the nicotine value chain during the InFocus virtual conference.

    VV Staff Report

    Participants in the May 22 InFocus virtual conference took a close look at the nicotine value chain, covering agriculture, synthetic nicotine products and innovation in tobacco harm reduction, among other topics. Below are some of the highlights of the event, which was sponsored by BAT, FEELM, Smoore, Alliance One International and Universal Leaf.

    Michael Strupp, professor of neurology at the Ludwig Maximilian University of Munich, addressed misconceptions about nicotine, stressing that it is not a nitrosamine and does not cause cancer. He emphasized the importance of distinguishing between the nicotine molecule and the substances produced by the combustion of tobacco. Strupp highlighted nicotine’s non-toxic nature and clarified that it is not a pesticide. He further explained that nicotine has potential therapeutic benefits, particularly in the treatment of neurodegenerative diseases such as Alzheimer’s and Parkinson’s as well as certain psychiatric disorders like schizophrenia.

    Strupp pointed out that nicotine can enhance attention and memory, improve mood by inducing euphoria and relaxation and indirectly influence body functions such as heart rate and blood pressure. Strupp discussed how nicotine’s mechanism of action has been well understood for decades, acting on nicotinic acetylcholine receptors in the brain. He explained that nicotine mimics acetylcholine, a neurotransmitter, and its interaction with these receptors can enhance learning, memory and attention.

    Concluding his keynote, Strupp emphasized the significance of understanding nicotine’s effects from a scientific perspective. He illustrated how the dopamine reward pathway is involved in nicotine addiction, with nicotine mimicking the effects of neurotransmitters like acetylcholine and dopamine.

    James Murphy, director of research and science at BAT, reflected on the remarkable transformation within the tobacco industry over his career, particularly with the development of three distinct noncombustible tobacco and nicotine product categories: heated products, vapor products and oral pouches.

    As a model for tobacco harm reduction, Murphy highlighted Sweden, where the widespread adoption of snus has led to a dramatic decline in smoking rates to just 5 percent. This shift has resulted in significantly better health outcomes compared to any other country in Europe, demonstrating the potential impact of noncombustible products on public health.

    Unfortunately, the promise of noncombustible combustible products is not reflected in consumer perceptions. Research findings indicated that a record percentage of consumers (90 percent in one survey) now believe that the risks associated with noncombustible products are equivalent to those of smoking.

    This misperception extends to medical practitioners as well, with a majority surveyed incorrectly attributing nicotine as a direct cause of cardiovascular disease, chronic obstructive pulmonary disease (COPD) and cancer. Murphy emphasized the need for education to correct these misconceptions and overcome barriers preventing adult smokers from switching to lower risk products.

    Murphy concluded by underscoring the importance of basing public health guidance on clear, rigorous science. He called for a unified commitment from all stakeholders to prioritize research and harm reduction strategies. A smokeless world, Murphy argued, is achievable through collaborative efforts focused on the well-being of millions worldwide. By dispelling myths and promoting evidence-based understanding of nicotine and noncombustible products, the industry can make significant strides in reducing smoking-related harm.

    Participants in the “Misperception of Nicotine” panel stressed the need for accurate information and education regarding nicotine, calling for global efforts to correct misconceptions and promote harm reduction strategies effectively. The panelists collectively highlighted the importance of engaging respectfully with all sides of the debate, basing policies on scientific evidence and ensuring transparency in public health communications.

    Moderator Jasjit S. Ahluwalia, professor of behavioral and social sciences and professor of medicine at the Center for Alcohol and Addiction Studies at the Brown University School of Public Health and Alpert School of Medicine, opened the panel by emphasizing the need to shift the narrative around nicotine. He pointed out that nicotine is often demonized despite scientific evidence suggesting that it is not the primary cause of smoking-related diseases.

    Ahluwalia highlighted a troubling public misconception that marijuana is safer than nicotine, which is not supported by science. He stressed that while nicotine will continue to be used, the focus should be on eliminating combustible tobacco products, which pose the greatest health risks. Ahluwalia also noted that e-cigarettes, though not without risk, are significantly safer than combustible cigarettes and do not cause cancer or COPD.

    Ahluwalia called for policies guided by science, advocating for accurate information to be provided to smokers about the benefits of switching to reduced-risk products (RRPs). Engaging with those who disagree is crucial, Ahluwalia argued, as there is much common ground and a shared purpose in harm reduction efforts. He also debunked the myth that nicotine use lowers IQs, stating that such misinformation undermines harm reduction efforts and that governments must play a role in correcting these misconceptions.

    Dave Dobbins, former chief operating officer at the American Legacy Foundation/Truth Initiative and consultant to Altria, underscored the importance of listening to all perspectives in the nicotine debate with kindness. He criticized the current tobacco control efforts, which he believes are often led by individuals who are not directly affected by nicotine use.

    Dobbins highlighted the severe health consequences of smoking, noting that cigarettes can reduce life expectancy by a decade and kill half of their users. He emphasized that nicotine delivery through RRPs is significantly safer than smoking.

    Dobbins called for clear, consistent communication with adult smokers, stressing the need to treat them with respect and provide accurate information about the benefits of vapes and pouches. He asserted that it is the duty of everyone, including cigarette companies, to disseminate accurate information about nicotine. Transparency in the origins and funding of scientific research is crucial to ensure trust and clarity in public health messaging.

    Delon Human, a specialist family physician and president of Health Diplomats, began by identifying himself as both a doctor and a consumer, emphasizing the human aspect of smokers. He expressed concern that a significant proportion of doctors (70 percent to 80 percent) incorrectly conflate smoking with nicotine consumption.

    Human criticized the World Health Organization for its inconsistent and unclear stance on nicotine, which also conflates tobacco use with nicotine use. He stressed the importance of the WHO and related agencies following scientific evidence. Human highlighted Sweden as an example of a country providing accurate information about nicotine use, resulting in significantly fewer cancer deaths due to the use of snus instead of cigarettes. He argued that scare stories about e-cigarettes need to be countered with scientific facts.

    Human pointed out that there is substantial opposition to nicotine within the WHO, which will take time to change. He also criticized Article 5.3 of the WHO Framework Convention on Tobacco Control (FCTC), which excludes the tobacco industry from discussions, arguing that this exclusion damages scientific progress and policy development and ultimately costs lives.

    Sudhanshu Patwardhan, nicotine expert and health tech entrepreneur, highlighted a study from the U.K. showing that 44 percent of doctors incorrectly believe nicotine causes cancer—a misconception common worldwide. He pointed out a significant gap between policy and medical understanding, which he said has real-world implications for smokers seeking healthier alternatives.

    Patwardhan called for a global nicotine literacy project to educate doctors and align public policies with scientific evidence. He emphasized the importance of making doctors champions of reason to communicate safer alternatives to cigarettes effectively.

    Patwardhan also stressed the need for sensible regulation that is supported by and encourages industry involvement. He concluded that educating healthcare providers around the world is key to promoting harm reduction.

    David Jones, a member of the U.K. All-Party Parliamentary Group for Responsible Vaping and deputy chair of the European Research Group, emphasized the critical role of tobacco harm reduction in public health policy, highlighting the U.K.’s pioneering “swap to stop” strategy, which provides vape starter kits to smokers to help them quit. He praised the U.K.’s evidence-based approach, which has significantly reduced smoking rates, but warned against recent proposals that could undermine these achievements.

    Jones argued against banning disposable vapes and flavored products, explaining that such measures could drive consumers to the black market and hinder smoking cessation efforts.

    Jones criticized the WHO for its opposition to RRPs, stating that its stance is not supported by scientific evidence. He called for greater accountability and transparency in international regulatory discussions, advocating for public and parliamentary scrutiny of decisions made by the FCTC.

    Highlighting the importance of flavors in vaping products for adult smokers, Jones cited research showing that nontobacco flavors are popular across all age groups. He argued that banning these flavors would be counterproductive and could lead to increased smoking rates as consumers turn to unregulated alternatives.

    Jones also addressed the potential of heat-not-burn products and nicotine pouches, urging the government to reconsider its stance on these alternatives and commission further research into their benefits. He emphasized that public health policies should provide smokers with accurate information about all nicotine products to support informed decision-making.

    In conclusion, Jones called for a continued focus on tobacco harm reduction, advocating for evidence-based regulations that support smokers in their efforts to quit. He stressed the need for the U.K. to maintain its leadership in this area and to hold international organizations accountable for their policies and decisions.

    Ramsey S. Lewis, Charles and Marilyn Stuber distinguished professor of plant breeding at North Carolina State University, delivered a detailed keynote on the complexities and challenges of developing low-nicotine tobacco varieties. He highlighted the increasing interest in these due to potential regulatory mandates that could require more than a 35-fold reduction in nicotine levels in conventional cigarettes. He emphasized that nicotine accumulation in tobacco plants results from complex interactions between environmental and genetic factors and asserted that genetic modification is the only viable method to achieve the stringent targets suggested by regulatory authorities.

    Lewis outlined the significant difficulties in achieving lower nicotine levels without negatively impacting other critical aspects of tobacco cultivation. He noted that reducing nicotine content often leads to undesirable reductions in yield, increased production costs and severe effects on leaf quality and other chemical properties of the tobacco. He warned against underestimating the complexity of biochemical pathways in living organisms, explaining that modifications in one area can lead to unexpected consequences in another.

    Furthermore, Lewis enumerated the numerous obstacles facing the development of low-nicotine tobacco. These include the feasibility of such projects, the limited availability of suitable varieties, susceptibility to diseases and insects, lower yields and higher production costs. Additionally, he highlighted the challenge of global acceptance of gene-editing techniques and the potential impact this may have on exports. Lewis underscored the need for extensive research and development to overcome these barriers and meet future regulatory requirements effectively.

    Participants in the “Nicotine – An Agricultural Approach” panel provided a comprehensive overview of the agricultural challenges and considerations associated with nicotine regulation. The discussions emphasized the need for continued research and development, thoughtful regulatory approaches and the importance of supporting both farmers and consumers in navigating these changes.

    Moderator Miranda Kinney, senior vice president of global communications and sustainability at Pyxus International, began the panel by delving into the agricultural aspects behind the tobacco products on today’s shelves, likening their personalized production journey to that of food products in supermarkets. She highlighted the importance of tobacco leaf, noting that it is the essential ingredient in most nicotine products and plays a critical role in supporting consumer satisfaction.

    Kinney emphasized that the tobacco industry supports millions of jobs globally, from farmers and processors to manufacturers, exporters, distributors and retailers, thereby enhancing livelihoods and supporting the economic viability of many developing countries.

    Kinney guided the discussion toward the intricate journey of the tobacco leaf, from the speck of a seed to a substantial industry contributor. She explained that the genetics and breeding of the seed, agricultural production practices, environmental factors and regulatory landscapes all impact the industry today and shape its future. She highlighted recent scientific advancements in genetics, cultivation practices and mechanization, noting their significant impact on farmers, particularly in developing countries where tobacco for novel nicotine products is often grown.

    Addressing regulatory challenges, Kinney pointed out that regulations, such as those proposed by the U.S. Food and Drug Administration on menthol and low-nicotine mandates, present key concerns for the industry. She discussed how potential regulations, particularly from influential regions like the EU and the U.S., could set trends globally. Kinney emphasized the importance of industry collaboration to anticipate and adapt to potential changes, ensuring that all parts of the supply chain are considered. She concluded by stressing the need for collective industry expertise to navigate the future, underlining that the agricultural aspects of tobacco production are intricately tied to the overall industry.

    George Cassels-Smith, chief executive of Tobacco Technology Inc., addressed the potential complications of mixed-crop standards, where only some plants meet lower alkaloid levels. He questioned the practicality and extensive testing required to manage such standards, particularly for plants that do not meet the set criteria.

    Cassels-Smith noted that synthetic nicotine gained a foothold in the U.S. market due to the stringent regulations on tobacco plants, although the regulations on synthetic nicotine have since been tightened. He pointed out that vaping products predominantly use synthetic nicotine, highlighting a significant shift in the industry toward these alternatives.

    He underscored the need for clear and feasible regulatory frameworks that consider the practical implications for producers and the broader industry.

    Lewis opened his remarks by clarifying that his expertise lies in plant breeding rather than addiction or behavior. He highlighted the significant challenges associated with modifying the nicotine content in tobacco plants without causing negative effects on the plants themselves.

    Lewis pointed out that if a regulatory mandate for low-nicotine tobacco were imposed today, the industry would struggle to comply due to the limited availability of viable low-nicotine varieties, which currently number around five and are associated with lower yields.

    He emphasized the complexity of biochemical pathways and the unintended consequences that can arise from genetic modifications, underscoring the need for extensive research and development to meet potential regulatory requirements.

    Carlos Pulcinelli, global project manager at Alliance One International, elaborated on the critical role of alkaloids in plant metabolism, with nicotine being the most significant alkaloid in tobacco. He asserted that it is currently impossible to control or modulate nicotine expression through agronomic practices alone, necessitating substantial investment in research and development.

    Pulcinelli stressed the increasing regulatory pressures facing the industry and the importance of developing the right plant varieties that meet the needs of farmers, regulators and consumers. He also highlighted environmental challenges such as extreme weather, droughts and floods, which complicate efforts to reduce nicotine levels.

    Despite potential changes in product formulations, he argued that the importance of plant alkaloids would remain paramount, calling for a balanced approach to meet these diverse challenges.

    Lea Scott, senior vice president of agronomy and agricultural sustainability for Universal Leaf Tobacco Co., discussed various agronomic practices, such as topping, used to manage alkaloid levels in tobacco plants. He emphasized the economic significance of tobacco farming, which generates approximately $944 million in revenue for the U.S. annually.

    Scott raised concerns about whether low-nicotine mandates might inadvertently encourage the growth of illicit trade, which already accounts for around 11 percent of the global tobacco market. He highlighted the substantial improvements in technology and the development of disease-resistant, high-yielding plant varieties. However, Scott noted that the transition to RRPs, such as heat-not-burn tobacco, would impact farmers by requiring less raw tobacco.

    He questioned whether lower nicotine levels might lead to increased consumption if consumers use more product to achieve their desired effect. Scott stressed that any shift to lower nicotine tobacco must be gradual and carefully managed, given its profound impact on farmers and communities worldwide. He also pointed out the trend of growing tobacco specifically for nicotine extraction into liquid forms, underscoring the importance of supporting both consumers and farmers.

    David Newns, entrepreneur and investor, chairperson and co-founder of Plxsur, highlighted the transformative potential of RRPs in global health outcomes. He noted that RRPs have evolved from a virtually unknown category to one now embraced by mainstream populations. This shift presents a significant opportunity to improve health outcomes worldwide by reducing the risks associated with traditional smoking. Newns emphasized that innovation cycles have been instrumental in driving the growth of the RRP category, transitioning vaping from a niche product to a globally recognized tool for harm reduction.

    Newns acknowledged the challenges associated with disposable vaping products but highlighted their crucial role in helping a large number of smokers switch to safer alternatives. These products have made it easier for smokers to incorporate vaping into their daily routines, facilitating a widespread transition from combustible tobacco. He also pointed out the collaborative efforts between academics and creatives in the vaping industry, dedicated to the mission of harm reduction. He reaffirmed that there is no one-size-fits-all solution, as different consumers have varying needs.

    Focusing on these needs, Newns explained that the universal demand from RRPs is for “more”—more convenience, flexibility, flavor, nicotine and personalization. This desire for “more” drives the continuous innovation within the industry. Looking ahead to GTNF 2024 in Athens this September, Newns expressed his enthusiasm over participating in “The Big Pitch” panel, which will invite innovators to present new and exciting nicotine products to industry leaders, fostering dialogue and shaping the future of RRPs.