Author: Timothy Donahue

  • Burton: Menthol Marketing Orders a ‘Significant Step’

    Burton: Menthol Marketing Orders a ‘Significant Step’

    By Robert Burton

    Vapes are a powerful tool for adult smokers making the transition from cigarettes to reduced-risk products (RRP). The category is governed by market-specific regulation, often influencing public perception and, therefore, uptake.

    Last week, following an extensive scientific review, the U.S. Food and Drug Administration authorized the marketing of four menthol-flavored e-cigarette products for Altria-owned vaping company Njoy. This is a watershed moment for the sector and one which will have a huge and significant impact on the global RRP market.

    This announcement signifies the FDA’s acknowledgment that menthol vaping products have the potential to be an important and effective tool for adult smokers looking for reduced-risk alternatives. This is significant for the wider sector in a number of ways; above all, it sets a precedent for other markets, paving the way for other regulators, particularly those looking at bans, to consider flavors in the context of public health.

    Across the globe, we are seeing an increasing number of markets introduce bans on flavors on a precautionary basis in a bid to mitigate youth uptake. At Plxsur, we have long advocated against the ban of flavors on vape products, arguing that it has the potential to negatively impact those making the transition from conventional cigarettes, who often are drawn to vapes for their flavor, amongst other factors such as price and convenience. There are also arguments and emerging evidence that flavor bans drive the black market sale of unregulated, dangerous products.

    There will be many that, understandably, say this decision is “too little, too late,” but it is nonetheless encouraging to see the FDA, with its extensive science and evidence-based review, validating that with effective regulation and enforcement, flavored vape products are “in the interest of public health.” Those countries that have considered flavor bans should look to the U.S. and conclude that it can’t be justified from a scientific review perspective.

    While this is the first authorization of a “characterizing flavor” by the FDA for vaping products, two of the major regulatory influencing bodies, the FDA and the Medicines and Healthcare Products Regulatory Agency (MHRA), now acknowledge that there is value in non-tobacco-flavored vaping products.

    This decision has the potential to impact the world. The U.S. has long influenced international markets, so it sets a benchmark that we expect other, less vape-supportive governments and regulatory bodies will follow.  

    Rob Burton

    In Italy, tobacco-flavored vapes constitute 40% of the vape market, while menthol represents 21%.[1] This demonstrates the significance of flavored products in the market as a whole. If such flavors were to be banned, this would act as a barrier for smokers to move to reduced-risk alternatives and potentially lead vapers to return to cigarettes.

    In some geographies, it is great to see that vapes are being accepted as an effective alternative to conventional cigarettes, even this week’s news from Australia announcing that vapes – which until now have only been available through prescription – will soon be available for sale within pharmacies without the need for a prescription, offering an effective pathway to end the smoking epidemic in the country.

    As we anticipate the potential revision of the Tobacco Product Directive Review next year, the justification for banning flavors, from a scientific point of view, simply isn’t there. In the case of Njoy, this has been shown through closed-system pod-based devices, which offer a more cost-effective avenue for existing smokers and disposable systems while incorporating child lock systems that will restrict access to children, as is already applied by a Plxsur company, ProVape, in its SALT and KUBIK brands.

    While the FDA’s authorization is specific to these four products made and sold by Njoy and does not apply to any other menthol-flavored e-cigarettes, our expectation is this will open a channel for other such products to achieve authorization by providing the necessary framework and the potential for knowledge-sharing and guidance. With the weight of data-led evidence, the category can advocate for the democratization of this framework, enabling further regulatory authorizations for products produced by responsible vaping companies in the interest of the adult smoker.  

    At Plxsur, we have a clear purpose – to facilitate adult smokers to make positive health decisions by transitioning away from cigarettes to reduced-risk products. Flavor is a key factor in supporting smokers moving completely to such alternatives, and we look forward to seeing a more science and data-led approach being adopted across all markets as we work to save the lives of those impacted by smoking, mitigate the risk of youth uptake, and do so sustainably and responsibly.

    We view this FDA decision as a significant step forward in broadening the pathway for adult smokers, and previously lacking “off-ramp” for U.S. menthol smokers looking to make the switch, which, according to Public Health England, is 95% less harmful and, therefore, undeniably, “in the interest of public health.”[2]

    Robert Burton is Group Scientific and Regulatory director for Plxsur.

    [1] The Global Vaping Market: A Plxsur Snapshot

    [2] E-cigarettes: an evidence update: A report commissioned by Public Health England

  • Durbin Disappointed in FDA for Menthol Vape Order

    Durbin Disappointed in FDA for Menthol Vape Order

    Senator Dick Durbin
    Credit: Dick Durbin

    When the U.S. Food and Drug Administration authorized the marketing of four Njoy brand menthol e-cigarette products, Sentor Dick Durbin was disappointed. He said the agency should have done better. The move marks the first non-tobacco flavored e-cigarette products to be authorized by FDA.

    “Flavors like menthol are used by Big Tobacco companies to mask the harsh taste of their dangerous products. FDA knows this from its own experience seeking to ban the production of menthol cigarettes to protect the public health,” Durbin stated. “We’ve seen that children begin nicotine use with menthol. Today’s authorization of menthol-flavored vapes will create an opening for more children to become addicted to harmful products.”

    Earlier this month, Durbin, chair of the Senate Judiciary Committee, held a Committee hearing entitled “Combatting the Youth Vaping Epidemic by Enhancing Enforcement Against Illegal E-Cigarettes.” The hearing underscored the alarming level of youth e-cigarette use, the role that flavors—such as menthol—play in youth use of tobacco products, and examined how federal agencies have failed to enforce laws designed to protect children from a lifetime of nicotine addiction.

    Tony Abboud, executive director of the Vapor Technology Association, who also spoke at Durbin’s e-House cigarette hearing, said he applauds the FDA decision to “finally follow the massive body of science” that shows flavored e-cigarettes help people quit smoking. However, Abboud said the move does little to address the massive problems surrounding the regulatory agency’s authorization process.

    “The reality is that this news, while a tiny step in the right direction, again reveals a more troubling pattern – the FDA acting only in self-interest to quell political pressure rather than acting in the interest of the American people,” said Abboud. “The only vapes authorized today are all owned by the biggest cigarette companies.

    “Today’s authorizations once again demonstrate Brian King and the FDA’s hypocritical allegiance to those cigarette companies whose deadly cigarettes and other combustible products that the FDA continues to flood the market with at a record pace.”

  • Australia Softens Stance on Vaping Product Ban

    Australia Softens Stance on Vaping Product Ban

    Credit: Yavdat

    Australia will soften a proposed groundbreaking ban on vaping following opposition from the Greens party, leading the government to agree to revise a bill that would have limited vapes to those with a doctor’s prescription.

    The agreement between the ruling center-left Labor party and the Greens will lead to the passage of legislation later this week that restricts the sale of vapes to pharmacies and removes them from retail shelves. This move is aimed at curbing the rise in youth vaping.

    However, the bill falls short of the government’s initial ambition to restrict sales only to those with a doctor’s prescription, which would have been a world-first. The amended bill will take effect on 1 July, reports Reuters.

    Under the compromise deal, vapes will be moved “behind the counter” in October. Customers will need to have a conversation with the pharmacist before making a purchase, and under-18s will need a prescription.

    Health Minister Mark Butler said in a statement that the government “welcomed constructive engagement with the crossbench and secured the support of The Greens for our world-leading vaping laws.”

    The Labor party does not have a majority in the upper house and must negotiate with other parties and independent senators to pass legislation.

  • New York State Gets $112.7 Million From Juul Labs

    New York State Gets $112.7 Million From Juul Labs

    Credit: Standap

    New York State is set to receive $112.7 million from a multistate settlement with Juul Labs Inc. due to its involvement in the youth vaping epidemic, according to the Office of the Attorney General (OAG).

    Attorney General Letitia James announced on Friday that the Hudson Valley would receive over $13 million from the historic total of $462 million, to be divided among participating states,” according to media reports.

    “E-cigarette use among young New Yorkers shot up after JUUL flooded the market with advertising aimed at teenagers and lies about the safety of its products,” James said. “Now young people are suffering from physical and mental health issues fueled by vaping addiction.

    “This settlement puts new limits on JUUL’s marketing and will provide leaders in the Hudson Valley over $13 million to implement new anti-vaping programs to protect our kids.”

    The $112.7 million total going to New York State will reportedly be distributed among counties, the Board of Cooperative Education Services (BOCES), and the five largest cities in the state to support programs to reduce and prevent underage vaping.

  • EU-Wide Flavor Ban Debated by Health Ministers

    EU-Wide Flavor Ban Debated by Health Ministers

    EU health ministers on June 21 discussed proposals to restrict flavors in consumer nicotine products, such as vapes and nicotine pouches.

    The EU Employment, Social Policy, Health and Consumer Affairs Council will consider proposals from Latvia and Denmark to support an EU-wide flavor ban and a crackdown on cross-border sales, among other recommendations. 

    If the health ministers reach consensus support for these proposals, the next step would be to ask the European Commission to introduce draft legislation, which would eventually be voted on by the council and the European Parliament, according to Vaping360.

    Denmark, Estonia, Finland, Hungary, Lithuania, the Netherlands and Slovenia already ban vape flavors. Spain recently completed a public consultation on a proposed flavor ban while Latvia reportedly is in the process of introducing flavor restrictions.

    The Tobacco Products Directive allows the member states to set their own rules for flavors. The Latvian proposal asserts that individual bans don’t work due to cross-border sales, among other factors.

    Vaping activists have urged the EU to keep e-cigarette flavors legal.

    “By supporting a flavor ban, EU health ministers would push millions of adults back to smoking or into the black market, endangering lives and ignoring scientific evidence. A flavor ban would be a huge step backward for public health and harm reduction,” said Michael Landl, director of the World Vapers’ Alliance, in a statement.

    “Scientific research consistently shows that flavors play a crucial role in helping smokers quit. The endorsement of the flavor ban ignores those findings and the clear will of the people, opting instead for a policy that will cause more harm than good. The World Vapers’ Alliance will continue fighting for reasonable, evidence-based policies that truly protect public health.”

  • North Carolina to Vote on Vape Registry Law

    North Carolina to Vote on Vape Registry Law

    Credit: Katherine Welles

    A new bill in North Carolina, if passed, would require the state to certify vaping and other next-generation tobacco products for sale.

    The Senate Judiciary Committee approved the proposal Wednesday. It was slipped into HB 900, which deals with Wake County leadership academies and their ability to maintain state designations. The House passed it without objection.

    To become law, the bill would need to pass the Senate and then the House before the end of the session. Senate leaders have said they plan to complete their work by the end of the month, local media reports.

    The chambers, both controlled by Republicans, have been unable to come to an agreement on budget modifications for the fiscal year that begins July 1.

    A North Carolina lawmaker wrongly told others that the U.S. Food and Drug Administration regulates the products, but the regulatory agency does not have the ability to check which products are being sold.

    The bill would fine retailers who sell products that aren’t on the registry for initial violations. The legislation could also suspend or revoke the establishment’s license.

    Vaping industry representatives warned lawmakers that the bill will cost people jobs and money.

    PMTA registry laws are already being enforced in AlabamaLouisiana and OklahomaWisconsin passed a registry law in December and will become effective July 1, 2025. 

    Utah also passed a registry bill that included a flavor ban that will become active on Jan. 1, 2025, and Florida has a unique registry that also begins Jan. 1, 2025.

  • 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.

  • Havoc in Hemp

    Havoc in Hemp

    Credit: OceanProd

    The proposed Miller Amendment was designed to kill the hemp cannabinoid industry.

    By Rod Kight

    As everyone reading this article likely knows, the Miller Amendment unexpectedly passed a bloc vote in the U.S. House Committee on Agriculture on May 23. In a last-minute turn of events, chairman Glenn Thompson ordered an “en bloc” vote on all amendments rather than voting on them individually.

    This was presumably done because he knew that he did not have enough votes to pass the Miller Amendment on its own. Unfortunately, the tactic worked. This is especially frustrating given that the chairman has previously expressed interest in retaining the current definition of “hemp” for the next farm bill. 

    It is not an exaggeration to say that the Miller Amendment was specifically designed to kill the hemp cannabinoid industry. This is because the Miller Amendment:

    • changes the definition of “hemp” so that total THC must not exceed 0.3 percent;
    • expressly excludes viable seeds from a marijuana plant from the definition of “hemp” even though they contain almost no THC and the DEA itself considers them to be hemp;
    • expressly excludes cannabinoids that the plant produces but which are synthesized or manufactured outside the plant from the definition of “hemp” even if they are produced using cGMP or other internationally accepted quality control standards and are identical to the naturally occurring ones; and
    • expressly excludes “quantifiable amounts” of THC, including THCa, and “any other cannabinoids that have similar effects (or which are marketed to have similar effects) on humans or animals as THC” from the definition of “hemp.”

    Taken together, these provisions of the Miller Amendment strike a deadly blow to the entire hemp cannabinoid industry. If enacted into law, the hemp industry as we know it will no longer exist. If you read the provisions carefully, it should be clear that the Miller Amendment was not written by a hack or even someone who is simply concerned about so-called “intoxicating cannabinoids.”

    This amendment was written by insiders with a very specific agenda. Presently, the author is not known to me. Still, this policy has been the subject of a major lobbying push by a select group of major marijuana organizations to erase the hemp industry. 

    Chris Roberts, writing for MJBizDaily, reported that the“U.S. Cannabis Council—members of which include many multistate marijuana operators—circulated a letter asking lawmakers to exclude from the new Farm Bill any hemp-derived product with ‘detectable quantities of total THC and any other intoxicant that can be derived from hemp, including other forms of THC.’”

    The U.S. Cannabis Council is not the only villain in the war against hemp, but its members include some of the worst actors. It and its members actively advocate for cannabis policy that:

    • promotes the interests of a small handful of large corporate marijuana companies (i.e., marijuana monopolists) over the interests of small businesses;
    • advocates for limited licensure and vertical integration;
    • uses repurposed “Reefer Madness” fearmongering tactics about cannabis intoxication to further its cause; and
    • has initiated a “total war” against hemp with the express goal of completely destroying the hemp cannabinoid industry in what amounts to a bloody turf war.
    Rod Kight

    For anyone who did not previously believe that last point about Big Marijuana’s “total war” against hemp or who has ever asked “why can’t we all just get along?,” today’s congressional shenanigans should be ample proof of Big Marijuana’s end goal of completely eradicating the hemp industry. The Big Marijuana lobby and the monopolistic corporations it serves are willing to resort to backhanded political tactics and otherwise go the distance to take over the cannabis industry to the complete exclusion of the hemp sector. It is time to unite and fight back. This is our rallying cry: Hemp is cannabis. What is good for the hemp industry is good for the cannabis industry. 

    As I discussed in a recent keynote speech at Noco, the hemp industry is emerging as the paradigm for the future of cannabis. By defeating the Big Marijuana monopolists and promoting reasonable laws/regulations, such as the three-pillar approach (see below), we have an opportunity to rewrite the cannabis story and to create an industry where small businesses and farmers can thrive and consumers have access to a wide array of safe cannabis products through a variety of distribution channels.

    Rather than focusing on cannabis intoxication, vertical integration, expensive licensing, prohibiting home-grow, a zero-sum turf war or any other such nonsense, the three-pillar approach addresses three reasonable regulatory “zones” for consumer safety and a healthy industry: (1) age gating, (2) quality control for production and manufacturing, and (3) standardized and informative labeling and marketing. Read/listen to more on the three pillars here. I welcome your input.

    Fortunately, a lot of marijuana companies are beginning to see the “hemp light.” I regularly receive calls from marijuana companies who have decided to pivot to the hemp industry as the path forward for their businesses. They see hemp as a commonsense solution, not a “loophole,” and want assistance making the journey. Hemp is the great uniter, and we welcome anyone who believes in fair play, reasonable regulations and a healthy cannabis economy. 

    Here are some suggestions on how to join the fight and help hemp win the war against oppressive monopolistic interests:

    • Call your federal lawmakers today and let them know that you support hemp. Tell them to “vote no” to the Miller Amendment and to retain the current definition of hemp.
    • Support the organizations that are fighting for hemp with your donations: the American Healthy Alternatives Association, the Hemp Roundtable, the Midwest Hemp Council and the Hemp Industries Association. These organizations are leading the fight against a well-funded greed machine, and they cannot do it without your support. If you want the hemp industry to survive, then donate money to these organizations today! Don’t screw around. Do it now. 
    • Call “bullshit” on the organizations that purport to be pro-cannabis but advocate against hemp. Hemp is cannabis, and these organizations are working against your interests. Inform and educate your friends, colleagues, customers, competition, lawmakers, lobbyists, news media and anyone else who has any interest in cannabis that there is a war raging against hemp that will impact the future of cannabis. NOW IS THE TIME!
    • Stay up to date on news about the farm bill and state-level bills that deal with hemp. We are in a critical time for the industry, and things are moving very rapidly. You owe it to yourself and to the industry to stay informed.
    • Finally, set aside differences with your competition and focus instead on creating a united hemp industry that is dedicated to a positive future for cannabis. If we win, there will be plenty of time to compete, but if we lose, there will be no industry.

    The future of cannabis will be determined by what is happening right now. Act accordingly.

  • FEELM Showcases Several Systems at WVS Dubai

    FEELM Showcases Several Systems at WVS Dubai

    To address different consumer pain points in various markets, FEELM, an atomization innovator, highlighted several technologically advanced vaping solutions during the World Vape Show Dubai 2024.

    Under the theme “ALL ON,” the company officially launched its next-generation pod solution—FEELM Pro—in Dubai. “This solution meets consumers’ pursuit of explosive flavor by using the latest FEELM ceramic coil technology, featuring a thinner ceramic coil for explosive power. This ensures ample e-liquid supply with each puff, avoiding aroma loss during atomization and providing a higher, more stable flavor reproduction,” according to a press release.

    In addition to FEELM Pro, FEELM presented two different series of large puff solutions at the Dubai show: the TPD-compliant 5,000-puff disposable solution TANKER and the TPD-compliant 3,200-puff vape pod solution QUAD SHOT Pro. The former offers Balance and Turbo modes, allowing consumers to experience taste differences under different modes; the latter uses the FEELM Turbo solution, achieving a qualitative leap in flavor explosiveness compared to similar products, being both smooth and sweet, according to the release.

    “Under compliance, we strive for technological innovation in flavor explosiveness, flavor reproduction, human-machine interaction, and playability,” said Rex Zhang, assistant president for FEELM. “We hope to collaborate with more customers in the future, rooted in the TPD market, to meet the personalized needs of different consumers and help the industry accelerate into a new stage of development.”

    The company also brought six different series solutions, covering all the current innovative elements on the market and achieving different combinations of elements and experience upgrades through technological upgrades.

    “For example, the world’s first 30,000 puffs disposable with four-sided surround screen and ultra-high wattage solution ‘Galaxy Display + Quattro Mesh’ brings a high-configuration combination of a 4.8-inch four-sided surround screen and quad mesh combined with high wattage of 40W + 6 modes of different puffs,” the release states. “With this device, you can experience all the cutting-edge technological innovations, instantly falling in love with it.”

    Additionally, the world’s first 18,000-puff multifunctional modular design solution, “Off Charge,” was showcased. It strives for ultimate playability, bringing new ideas with a modular design and adding a smart screen display. Press a button to experience different flavors. After disassembling the module, you can smoke the pod while charging your phone with the EPS.

    Additionally, the world’s first 20,000-puff double-burst power ceramic coil solution, “FEELM Turbo DUO,” continues the high explosiveness of the FEELM Turbo series, doubling the flavor explosiveness with dual ceramic coils.