Category: This Issue

  • The 6-Methyl Solution

    The 6-Methyl Solution

    Credit: Alexey Stiop

    There’s a new synthetic product that some brands are using to replace nicotine in flavored vapes.

    By Timothy S. Donahue

    This story is based on a chemical reaction. When 6-methyl nicotine products hit the market last year, no one gave them much attention. After all, flavored nicotine products are readily available in most markets. This may not always be true. With strict flavor bans already in states like California, Massachusetts and New Jersey, many others want to join the flavor-ban train. Retailers in all states also know a potential federal ban is on the horizon.

    Today, there is at least one vaping product and several modern oral nicotine products using some derivative of 6-methyl nicotine. Some of its supporters are saying it’s a billion-dollar market. Two industry financial analysts said the number seemed unlikely. Many retailers, manufacturers and industry-interested parties have recently learned about the presence of 6-methyl nicotine products and question the safety and market viability of the new nicotine analog.

    Using 6-methyl nicotine is said to give users the same satisfaction that nicotine products offer. It also comes with a lower price point and isn’t hindered by the U.S. Food and Drug Administration’s authority over nicotine products. Brands using 6-methyl nicotine don’t (currently) have to go through the rigors of the FDA’s premarket tobacco product application (PMTA) process that nicotine products must.

    That doesn’t mean that 6-methyl nicotine products behave any differently than traditional nicotine products. They are not in the same “family,” but according to consumer research, the sensory effect and experience effects seem to be the same for the user. The 6-methyl nicotine molecule isn’t nicotine and doesn’t have any association with nicotine; however, its advocates say it does offer a user experience indistinguishable from nicotine.

    The creation of synthetic nicotine analogs isn’t new. One of the earliest patents can be traced back to 1961 for a 6-methyl nicotinic acid registered by Phillips Petroleum Company. In the late 60s and early 70s, many of the major tobacco companies at the time were interested in developing a product that could potentially separate many of the negative health impacts of nicotine, such as its effects on blood pressure, that come along with the satisfaction of smoking.

    According to Ed Carmines, chief scientific officer for Chemular, a regulatory consulting group, researchers attempted to discover the structural features of the nicotine molecule that were responsible for its various pharmacological properties. This led Philip Morris to discover one chemical, CR-1542, which appeared to show increased activity when compared to S-nicotine (the active molecule of nicotine).

    The chemical was identified as (S) 6-methyl nicotine (6-MN). Scientists at R.J. Reynolds seemed to have a similar program, eventually forming Targacept, which later became an independent pharmaceutical company. “Early on in the research program at Philip Morris, before receptors were really known and understood, Philip Morris scientists were trying to figure out whether they could separate the good feeling you get from smoking from the increase in heart rate caused by nicotine.

    “And they took the nicotine molecule, and they started changing it. And they changed it in about 80 different ways,” said Carmines. “Then they ran it through tests that responded to nicotine. There are some chemical assays and some biological assays. They basically found that 6-methyl nicotine was equally potent or potentially more potent than nicotine in these assays. The scientists were unable to separate this increase in heart rate from the good feeling you get from nicotine, and Philip Morris basically dropped the program.” The programs were dropped due to fears of added industry regulation at the time, according to records. Later, 6-methyl nicotine was rediscovered, and several companies began researching its current market potential.

    Credit: Natali

    Easy explanation

    There are a few different brands of 6-methyl nicotine analogs on the market, including Imotine and Metatine. Carmines explained that the Imotine brand of 6-methyl nicotine is sold by a company called Novel Compounds based in Southern California. The brand is used in some 6-methyl nicotine modern oral products.

    Charlies Holdings has exclusive rights to the chemical for vape products in the U.S. and sells 6-methyl nicotine under the brand Metatine. A limited survey of the current market only turned up one vaping device that offers 6-methyl nicotine, Spree Bar, owned by Charlie’s, which is a disposable flavored pod product line launched late last year.

    Henry Sicignano, president of Charlie’s Holdings, parent to Spree Bar, speaking at an education seminar sponsored by Chemular at the Total Products Expo 2024 held in Las Vegas from Jan. 30 to Feb. 2, explained that, when vaped, Metatine provides the same sensations as traditional combustible tobacco products and nicotine vaping products.

    “But because Metatine is not made or derived from tobacco, and because Metatine does not consist of or contain nicotine from any source, Spree Bar is not subject to FDA PMTA requirements,” said Sicignano. “This offers retailers an excellent vehicle for providing adult consumers with flavored vapes that do not violate federal regulations.

    “Metatine is a synthetic molecule. It’s an analog that very closely resembles nicotine, but it is definitely not nicotine. Metatine has demonstrated no toxicity other than oral toxicity, very, very similar to nicotine. There are no additional side effects. The sensory experience is indistinguishable from that of nicotine vapes.”

    There is a CAS Registry Number for 6-methyl nicotine. That means it is unique and specific to only one substance regardless of how many other ways it can be described, as far as regulators are concerned. Novel Compounds became interested in 6-methyl nicotine and asked Chemular and Carmines to help research alternatives that have been created to replace nicotine. After all, he was a tobacco scientist with nearly 30 years of experience in the industry.

    Carmines said that there are several compounds that people have tried to market or bring to market. However, until 6-methyl nicotine was found, nothing really piqued his interest. “Metatine and Imotine, they both have the same genesis. In a nutshell, he said that both Novel Compounds and Charlie’s developed proprietary e-liquid bases that can serve in a one-to-one swap out for standard nicotine solutions in conventional vape and oral nicotine products,” he said.

    Other than wanting to know if 6-methyl nicotine is safe, some other major industry concerns surrounding the molecule are its potency and its addictive properties. Nicotine mainly shows its action through specific nicotinic acetylcholine receptors located in the brain. It stimulates acetylcholine receptors, thus enhancing dopamine release in the brain, producing the feeling of pleasure.

    “There are different kinds of receptors. The nicotine from a tobacco plant worked pretty well. So, tobacco companies never took it any further. But it turns out that for the receptor in the brain, there could be something that actually fits the receptor better. If you think about a key going into a lock, 6-methyl may fit it a little bit better than nicotine,” explains Carmines. “In truth, it is not clear whether 6-methyl nicotine ‘fits the lock better’ or if it simply gets absorbed a little bit better and gets to the brain a little bit faster because 6-methyl may be more soluble.”

    The Spree Bar website states, “Metatine has been tested for tobacco-specific nitrosamines (TSNAs), degradants, chemical impurities, and other volatile organic compounds. The results indicate that Metatine likely poses no additional risk compared to additives found in conventional vape products currently on the market.”

    A research paper presented at the 2023 Tobacco Science Research Conference states, “Imotine has been tested for tobacco-specific nitrosamines, degradants, chemical impurities and other volatile organic compounds. The results indicate that Imotine poses no additional risk than current vape and pouch additives on the market.”

    Concerning the addictive properties of 6-methyl, Carmines said that the addictive properties should be nearly identical to nicotine (see “First Impression,” page 42). Even though 6-methyl nicotine is more powerful, in a vaping product, “strength” is regulated through dosage, much like traditional nicotine. With 6-methyl nicotine vaping products, the consumer gets the same impact that they get from vaping a 50 mg salt or a 5 percent salt nicotine product (such as a Bidi Stick).

    “Adult consumers feel exactly the same. There’s less Metatine there,” he explains. “In terms of addiction potential, the addiction is really based on someone feeling good because they get nicotine in the brain. And 6-methyl nicotine is likely going to do exactly the same. It is not going to be less addictive. It’s not going to be more addictive. It’s going to interact with the same receptor and produce the same reward that people seek when they use nicotine.”

    Credit: CymitQuimica

    Retailer reasoning

    There are several advantages to a retailer selling 6-methyl products. Carmines said that Novel Compounds had multiple law firms look at 6-methyl nicotine and concluded that Imotine does not fall under the authority of the Tobacco Control Act. It could be surmised that that applies to most 6-methyl nicotine products. The FDA also cannot designate 6-methyl nicotine as a drug if a manufacturer doesn’t make any health claims or imply the chemical is intended for use in the “cure, mitigation, treatment or prevention of disease,” according to the agency.

    At some point, as the products grow in popularity or if they are misused, there is the potential for Congress to act to give the FDA authority over products containing 6-methyl nicotine. Synthetic nicotine had a similar experience. The FDA could have gone after synthetic nicotine as a drug, but it didn’t. Instead, the agency asked Congress to incorporate synthetic nicotine into the definition of a tobacco product under the Tobacco Control Act.

    The FDA knows 6-methyl nicotine products are on the market. How the agency will react in the future is unknown. There are rumors that the agency considered adding nicotine substitutes/alternatives to the deeming rule but decided against it.

    Many retailers are questioning why they should sell a nicotine substitute when traditional nicotine products are so readily available. Carmines said 6-methyl nicotine products may not fit into every market. Regulations for the vaping industry can change from state to state in the U.S. How flavor ban rules are worded and what products are impacted can also vary dramatically from state to state.

    Depending on state legislation, several states ban electronic nicotine-delivery systems (ENDS), and some states write flavor laws differently. Some states specifically state “vaping products” while others may say “nicotine vaping products.” The regulations usually differ because they are meant to include cannabis vaping products.

    “In California, Massachusetts, Rhode Island, two or three others that I can’t think of right now, [Spree Bar is] not legal because it’s a flavored vape device,” explains Sicignano. “In New York state, we are legal all across the state except the five boroughs of Manhattan. But by and large, I believe 44 states, we have a legal product because we are not an electronic nicotine-delivery system.”

    For retailers in areas in states that have strict flavor bans, 6-methyl nicotine products can offer consumers more choices. Many retailers do not want to run afoul of the law and risk getting a warning letter or civil money penalty from the FDA. The single question remains: Why would a retailer sell 6-methyl nicotine products?

    “Why would somebody use this product [Spree Bar]? I think it’s the availability of legal flavors and price. Flavors aren’t always available where consumers are purchasing. I think from a retailer perspective, it’s not taxed for the most part,” said Carmines. “So, you most likely have no federal or state excise tax on this since it is not a tobacco product. That is a big advantage for the consumer. Consumers can purchase a 6,000-puff Spree Bar refill for just $9.95. That is less than half the price of most nicotine vape products.”  

    Because it isn’t a tobacco product, 6-menthyl nicotine products have an advantage over traditional nicotine products. Flavored 6-methyl nicotine products can cost a lot less because it isn’t subject to skyrocketing nicotine taxes. In Washington, D.C., which has the second-highest tobacco tax rate at $5.03 per pack of 20 combustibles and vapor products are taxed at 80 percent of the wholesale price, 6-methyl nicotine products can easily be offered at a much lower price point.

    “In approximately half the states in the (U.S.) that charge a nicotine tax, half, not all, but in about half of the states that charge a nicotine tax, [a 6-methyl nicotine product] is exempt,” said Sicignano. “It’s not nicotine. Minnesota, for example, has the highest nicotine vape tax rate at 95 percent; [6-methyl products are] not subject to the Minnesota tax. The product’s half as expensive before you start and is currently exempt from regulation …. I think that’s compelling.”

  • Cannabis Conundrum

    Cannabis Conundrum

    South Carolina retailers are cautioned after recent hemp comments from a state solicitor.

    By Rod Kight

    “You can turn hemp into a THC product by adding an acid into a compound. Well, that creates the THC level increase to the point where it gives you that high, euphoric feeling. At the end of the day, if it gets you high, it’s illegal in South Carolina. Bottom line.” —Walt Wilkins, 13th Circuit Solicitor of South Carolina

    Say what?

    As reported in the Post and Courier in Greenville, South Carolina, prosecutor Wilkins went on to state: “It doesn’t matter to us if it’s delta-8 or delta-9 or delta-10 or delta-22. If the THC level is above (0.3 percent), it’s a Schedule I drug, and it’s illegal in South Carolina.”

    Despite Wilkins’ strong rhetoric, South Carolina law provides no support for any of the above comments. Much like hemp laws throughout the country, the state defines hemp with respect to its concentration of delta-9 THC, not with any other cannabinoids or forms of THC or with the effect it produces when consumed.

    The South Carolina Hemp Farming Act (HFA) broadly legalized hemp, the definition of which specifically includes, “the plant Cannabis sativa L. and any part of that plant, including the nonsterilized seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts and salts of isomers, whether growing or not, with the federally defined THC level for hemp” (emphasisadded). Of course, the “federally defined THC level for hemp” is currently 0.3 percent delta-9 THC on a dry weight basis.

    Additionally, the HFA created a category of lawful “hemp products,” which it defines as “all products with the federally defined THC level for hemp derived from, or made by, processing hemp plants or hemp plant parts, that are prepared in a form available for commercial sale, including, but not limited to, cosmetics, personal care products, food intended for animal or human consumption, cloth, cordage, fiber, fuel, paint, paper, particleboard, plastics and any product containing one or more hemp-derived cannabinoids, such as cannabidiol” (emphasis added).

    In other words, South Carolina law governing hemp does not define or limit any isomers or forms of THC other than delta-9. Lawful hemp and hemp products are distinguished from unlawful marijuana products solely by virtue of their concentrations of delta-9 THC, which cannot exceed 0.3 percent. All other cannabinoids, extracts, derivatives, acids, etc. are exempt from both the federal laws regulating controlled substances, regardless of their intoxicating effect.

    Unfortunately, and as addressed in prior articles, South Carolina law enforcement, including the state attorney general, regularly twists the law into a word salad in order to enforce its priorities. One might assume those priorities are standard-issue prohibitionist in nature. However, I cannot fail to notice that Wilkins’ comments were almost immediately followed by news articles about a new South Carolina medical marijuana bill.1

    As I have discussed on numerous occasions, new marijuana legislation is often accompanied by bills and law enforcement actions aimed at eliminating hemp, thus “clearing the field” for marijuana monopolies (e.g., the terrible hemp bill2 currently being proposed in the Florida legislature as the state considers legalizing recreational marijuana).

    In a similar vein, the South Carolina Department of Health and Environmental Control (DHEC) recently released a memo stating that the following are not approved to be added to food or beverage products:

    • pure CBD isolate;
    • delta-8 THC, delta-9 THC or delta-10 THC; and
    • “full spectrum” whole-plant extract (i.e., “full spectrum hemp oil/extract” from biomass) if it includes health claims or bears any sort of declaration of THC or CBD.

    In support of the memo, the DHEC leans heavily on the U.S. Food and Drug Administration’s well-known but rarely enforced position that CBD and THC cannot be added to food, an issue I testified to the FDA about during its hearing on cannabis. Leaving aside the fact that the FDA’s position is overbroad for the reasons I discussed in my testimony, its position has been widely known for almost a decade.

    The DHEC’s letter was probably in response to South Carolina’s burgeoning hemp-derived beverage industry. The DHEC appears to have gotten word that intoxicating hemp beverages were being manufactured and distributed in the state and quickly whipped up a letter to stop them. As with Wilkins’ press conference, it seems more than coincidental that a new medical marijuana bill is being considered at the same time that the DHEC issues a letter that effectively shuts down the state’s hemp beverage industry.

    As a South Carolina native who moved away after law school (Wilkins was in my law school class), I continue to be disappointed in my home state’s backward cannabis policies and priorities. Hopefully, legal action and/or a proper hemp bill will move things in the right direction. Until then, South Carolina is a bad place for hemp. This harms farmers, small businesses and consumers in the state. 

    Note: This article is commentary. It is not intended to be legal advice and should not be construed or relied upon as such.

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

    1 www.marijuanamoment.net/south-carolina-senate-continues-debate-on-medical-marijuana-bill-with-lawmakers-clashing-over-changes-from-earlier-version/

    2 https://floridapolitics.com/archives/658369-hemp-bill-banning-some-cannabinoids-headed-to-senate-floor-advancing-in-house/

  • Irrational Math

    Irrational Math

    Credit: Pavel Kant

    The portrayal of tobacco mathematics is often guided by unreasonable theories.

    By George Gay

    When, toward the end of last year, I was invited to attend the preview of a documentary titled How Sweden Quit Smoking, it struck me that the title was rather odd because Swedish people had not quit smoking tobacco nor, as far as I was aware, had they stopped inhaling any of the other forms of smoke that are produced in that country.

    The documentary’s title was, I guess, based on the odd notion put about in recent years that 5 percent, or thereabouts, equals 0 percent. Once smoking rates come down to about 5 percent, they might as well be regarded as being 0 percent. This, to me, is irrational, but it seems to have been generally accepted, so I shall move on—reluctantly.

    After the showing of the documentary, which was directed by Tomasz Agencki on behalf of We Are Innovation and which explored the success that the use of snus had had in replacing smoking in Sweden, thereby hugely reducing cancer rates, a few invited speakers expressed incredulity that, given this success, snus and its derivatives were not being promoted more widely in the world and, indeed, were banned in many places. I, on the other hand, was incredulous at the incredulity expressed because we do not live in a rational world.

    Look at it this way: If you are willing to accept the irrational notion that 5 percent equals 0 percent, you should not be surprised when others also hold irrational beliefs. If you live irrationally, you will possibly die that way. Or perhaps not, given that many tobacco commentators believe that certain deaths are “preventable.” Welcome to life through the looking glass.

    During the event, hope was expressed that the documentary, which was undoubtedly well made, would change the minds of those in authority opposed to promoting or even allowing the use of snus to help smokers quit their habit. I share that hope, but I have one reservation.

    If the documentary does change minds, what does it say about the people, for instance, those in authority in the EU where snus is banned outside Sweden, who were deaf to previous evidence-based approaches around the efficaciousness of snus but were swayed by a documentary, no matter how good? That they are irrational people driven by their passions?

    The irrationality that surrounds discussions about smoking and vaping was in full flow today, Jan. 29, as I was listening to Today, one of BBC Radio’s main morning news programs. A story was introduced announcing how the U.K. government intended to bring in a blanket ban on the sale of single-use vapes, purportedly mainly for the sake of protecting young people.

    The person who introduced the item said that within months, the sale of single-use vapes to anyone of any age in England, Wales and Scotland should be impossible because of what the government was announcing.

    Let’s unwrap that a little. Although it is illegal already in the U.K. to sell vapes to those under 18 years of age and though the story was devoted almost entirely to the issues raised by single-use vapes being sold willy-nilly to young people, the interviewer did not seem to be interested in delving into the reasons why this illegal activity was occurring. And no question was raised as to why, when the law banning the sale of single-use vapes to young people was apparently being flaunted, it was believed that another law would stop sales to young people—and to all and sundry.

    Once again, we were being asked to accept the irrational. The news item, as many before it, did all it could to blame vape manufacturers for the sales illegality. It was because the manufacturers were making the packaging of single-use vapes attractive to young people. But it doesn’t take a second’s thought to realize that it doesn’t matter whether the manufacturers paint their packaging sky-blue with pink polka dots, it is illegal to sell those packages to young people. The problem must lie elsewhere.

    And, of course, it does. It lies with successive Conservative governments. What we have at present is a proposal that is based on a moral panic stirred up by the media and used by a grateful government that, in an election year, is desperately trying to win kudos and votes by acting to reverse the problems it has created during the past 13 years, one of which is down to its having slashed the budgets of the agencies charged with policing the import and retail sale of vapes.

    The four-minute to five-minute BBC item included a one-minute statement by John Dunne, director general of the U.K. Vaping Industry Association, who warned that the proposed ban on single-use vapes would simply drive the business underground, exposing young people to unregulated products. The rest of the time was allocated to an interview with Glyn Potts, the head teacher of Newman Catholic College at Oldham, which has more than 1,500 pupils aged 11 to 16.

    In answer to a question, Potts said he believed about 10 percent of the school’s students had tried vapes but that fewer than 30 of them vaped regularly, which could mean that none of them did. But let’s take it that the upper figure of 30 is correct and the school has exactly 1,500 pupils: Now children, 30 divided by 1,500 and multiplied by 100 equals two: 2 percent.

    Two percent is less than 5 percent, and 5 percent is 0 percent. Therefore, 2 percent is less than 0 percent. The interviewer, feeling perhaps that the item wasn’t going to plan, chimed in with what appeared to me to be a less than objective observation, saying, “It’s 30 sets of young lungs, isn’t it?” Hmm. Perhaps mention could have been made about the air quality or lack of it outside the school gates.

    Two percent is hardly the “youth vaping epidemic” The Guardian newspaper referred to on the same day when writing about the same story, a piece of about 600 words that included the words “youth” three times, “children” five times, “underage” once and “young people” once, all references being to the same group of people as far as I could tell.

    But then I should add that the paper said 9 percent of 11-year-olds to 15-year-olds were now vaping, and the proportion of 11-year-old to 17-year-old vapers using single-use vapes had increased almost ninefold during the past two years. How could one take a rational account of the situation from these figures, the only vaping figures presented?

    Without details, the second statement is meaningless to the point of being misleading. We are not told how a “vaper” is defined and, often, those opposed to vaping will count young people who have tried to vape just once. Additionally, we cannot tell what the starting point was two years ago. Were there just two vapers and now there are 18? And notice how with the 9 percent figure, we are faced with the opposite problem because we are not told whether that figure has been on the rise or is going down.

    If I were feeling really cheeky, I would point out, too, that 9 percent is less than twice 5 percent and therefore less than twice 0 percent, making it 0 percent. Come on, keep up.

    Neither does 2 percent reflect the concern about vaping’s becoming “endemic,” apparently expressed by the prime minister, Rishi Sunak. “As any parent or teacher knows, one of the most worrying trends at the moment is the rise in vaping among children, and so we must act before it becomes endemic,” The Guardian quoted Sunak as saying.

    Well, a lot of financially well-off parents might feel that way and so might some moderately well-off parents, but the increasing number of parents impoverished by the Sunak and previous Conservative governments probably have more pressing worries.

    Kamila Hawthorne, chair of the Royal College of General Practitioners, was quoted in a Dec. 22 front-page story in The Guardian, headed “Revealed: Huge rise in hospital admissions with malnutrition,”as saying: “As a nation, we shouldn’t be having malnourished children. We shouldn’t be having children with rickets. We should not be having people with iron deficiencies or low folic acid …. There’s that sense of this isn’t right; what’s happening here.”

    Later in the story, it was said that nutritional deficiencies are particularly concerning in children, with iron and B12 being critical for brain development, which may be compared with the vape story that said only that “doctors are concerned about the unknown [my emphasis] long-term health impact of vaping on young people and their developing respiratory systems, including nicotine addiction, which can cause anxiety and withdrawal headaches.”

    The Guardian’s malnutrition piece bled to inside pages, where another story was headed “‘Heartbreaking’: Teachers tell of children with bowed legs and no winter coat,” and where a pull quote had a head teacher saying, “One child came in so malnourished, I had to carry them to the doctor myself.”

    Despite such shocking news, the malnutrition story did not quote Sunak as saying this was a most worrying trend and, indeed, he might not have been asked to comment. But it is clear that the Conservative government, which has been in power since 2010, has a chilling record on child poverty and owns this state of affairs. It certainly seems not to be intent on bringing in quick-fired legislation on nutrition as it is in the case of single-use vapes. 

    Further, it seems that consecutive Conservative administrations, having disabled the U.K.’s ambulance service and most other public services with its backward-focused austerity program, are now relying on head teachers to carry or otherwise get patients to hospitals. It seems that the head teacher who carried the child too weak to walk was not alone.

    Potts had his own story to tell after he was asked the somewhat leading question: “Have you seen any serious complications or problems arising from the use of vaping, because there have been children, haven’t there, who’ve been hospitalized?” Fortunately for the interviewer, Potts has a good memory. He said that two and a half years ago, a pupil entering the school grounds on a bus, egged on by friends, took a huge “gulp” on a vape he had “stolen” from an older brother and, on leaving the bus, collapsed and was taken to the hospital.

    Two children collapse at different schools, and the reasons behind those collapses provoke different reactions from the government. In one case, indifference; in the other, panic. What is going on here? Well, this is an election year in the U.K. I would speculate that the parents of the 18 young people spluttering over their vapes could well be persuaded to vote for Sunak’s party. In contrast, the parents of the young people without enough to eat have possibly been disenfranchised by the government’s recent changes to electoral requirements.

    The term “moral panic” is bandied about often, but I think it is not without justification in this case. Let me return to the school where less than 2 percent of students are said to vape and where, by the way, none are said to vape at school because of the sophisticated fire alarm system and CCTV. Potts said it was known that vapes, particularly disposable vapes, were being repurposed to contain cannabis derivatives and even spice and sold to young people. If something were not done, young people could die, he added. Now I looked online at his school, and it seems to be the sort of establishment where many parents would aspire to send their children and where those children would have the opportunity to develop their various talents.

    It did not look like the sort of establishment that would be twinned with a crack den. So even if he were also talking about the school’s environs, an area that I do not know, I cannot help thinking that his comments, in this instance, were over the top and, therefore, unhelpful.

    Some people might think it strange that, given the above, I am not necessarily opposed to a ban on single-use vapes, but if such a ban is to be imposed, I believe that it should be based on a rational, quickly performed analysis of the pros and cons of these products, especially as they relate to the environment, and then only with guarantees that the necessary policing of the ban will be fully funded. It should not be the result of preconceived ideas, anecdotal evidence, dodgy data, moral panic and political shenanigans.

    ARAC ad
  • Solid Expectations

    Solid Expectations

    Credit: TAW4

    ECigIntelligence predicts that the global vaping market grew by almost $2 billion last year.

    By Freddie Dawson

    Further regulatory restrictions on e-cigarettes are expected, but these will not prevent the global vaping market from continuing to grow in 2024, ECigIntelligence predicts. The trend is distinctly toward tightening controls on vaping products. Just eight of the nearly 60 countries and regions tracked by ECigIntelligence’s Policy Radar have a positive outlook on the political climate when it comes to alternatives to conventional cigarettes.

    Yet despite this, ECigIntelligence sees the overall vaping market still growing by almost $2 billion between 2023 and 2024.

    So notwithstanding increased regulation in many markets, there is still enough demand for alternatives to traditional cigarettes to fuel growth. Perhaps it is important to put that growth into context. An increase of just under $2 billion (from $26.4 billion to a predicted $28.3 billion) is the smallest rise not impacted by Covid-19 in the overall global market since the increase from 2016 to 2017.

    The much newer, less established heated-tobacco market is now expected to overtake vaping with our sibling site TobaccoIntelligence predicting the heated-tobacco market will reach an estimated $28.6 billion in 2024.

    So while there is still growth in vaping, it is by a lesser amount than it has been (particularly when viewed as percentage growth of the existing market). And other alternatives fueled by the seemingly limitless resources of Big Tobacco companies are quickly overtaking.

    This makes 2024 something of a pivotal year for vaping, with important elections coming up in existing markets—such as those for members of European Parliament (MEPs) as well as contests in Belgium, India, Indonesia, Mexico, South Africa, South Korea and Taiwan—two of which could potentially be crucial for the future of the global vaping market.

    Europe: Elections, Directive Revisions and Developments

    Clearly, EU elections, covering the majority of European markets as they do, could have a massive impact on the future of vaping. However, their very multi-country nature makes them difficult to predict and influence—particularly on issues such as tobacco control, which would be a relatively minor campaigning point for the vast majority of politicians running.

    Nevertheless, there is a chance a milder outlook on alternatives to conventional cigarettes will emerge, with right-wing/centrist parties such as the European People’s Party, European Conservatives and Reformists Party, and Identity and Democracy Party polling well.

    These groups are less likely to support strict regulation, which would—at the least—maintain the status quo at a significant time for nonsmoking nicotine products as both the EU Tobacco Products Directive (TPD) and Tobacco Excise Directive (TED) will be revised.

    For example, ECigIntelligence believes it unlikely a centrist/right-leaning EU would support a policy like banning all nontobacco flavors in vaping products. But given the MEP elections, ECigIntelligence does not believe much progress will be made on advancing policies in the TPD and TED.

    Outside of elections, there are also a variety of other proposals expected to see significant developments through 2024, particularly in the areas of flavor bans and plain packaging as—in a continuation from 2023—fears over youth uptake of e-cigarettes continue to rise in more jurisdictions.

    Focus on Australia Under Labor Government

    In Australia, an overall new tobacco plan is also being drafted with the recently elected Labor government now taking control. Labor is thought to have a more skeptical view on the benefits of nonprescription nicotine products in smoking cessation, which could change how the country’s already delayed tobacco plan tackles these products.

    This means that new regulations, such as a proposal to bring in plain packaging and a flavor ban for vaping products (regardless of nicotine content) as well as heated-tobacco products, could be adopted. Health warning requirements for vaping products are envisaged as well, and a ban on disposable vaping products is also expected to be in the bill.

    Further measures could also be taken, such as a prohibition on the import of nicotine-free e-cigarettes (and limiting their sale to pharmacies only). However, there may be a chance conditions for prescribing e-cigarettes are eased—though that would be poor solace in comparison to the stringency of the other proposals. 

    Flavor Bans and Other Global Regulations

    We could also see other countries enacting their own flavor bans. For example, Slovenia is expected to make such a move in 2024 while a proposal is under discussion in Canada that would limit e-liquid flavors to tobacco, mint and menthol.

    ECigIntelligence thinks it is very likely that the Canadian ban will be approved, given it is government-backed and the measures proposed would not be considered controversial among the wider voting population. However, as it is still early stages in the formulation of the proposal, a date for when it would come in is not yet predictable.

    Dutch authorities could move to introduce plain packaging—though it is unlikely the measure would enter into force in 2024 as it currently is only an adopted motion to take action.

    The Netherlands is also looking at implementing retail regulations such as a registration obligation for all points-of-sale, which would be introduced in 2024. And, eventually, a generational ban on vapor products could be brought in.

    A proposal to ban the sale of tobacco and related products, including e-cigarettes, in supermarkets as of July 2024 is expected. Sales will still be allowed after that at fuel stations, in convenience stores and in specialist shops. An effective date for the measure is not yet final. Entry into force is subject to its passing through the upper and lower houses of Parliament, which has not happened yet but is thought to be likely.

    Ireland is also looking to limit the sales of vaping products. There, government officials will consider a ban on disposable vaping products in 2024. Results of a consultation showed almost 85 percent of participants supporting a ban. Such a move also appears to enjoy some government backing, with ministers expressing lukewarm support. However, such a move would have to be agreed on by government coalition members, and it may run into hurdles from EU single-market rules.

    It will be interesting to see how these measures impact 2024 market estimates, such as those in Australia (expected to increase around $72 million to $478 million), Canada (expected to rise $50 million to $757 million), Ireland (only growing $4 million to $128 million) or the Netherlands (expected to fall $17 million to $160 million)—if they do indeed go forward in 2024.

    Disposables are Still Big, China Losing Ground

    It should be noted that disposables are the primary—and sometimes sole—category driving growth, so how regulation goes in 2024 is crucial to how growth in the overall vaping market develops. Intense media coverage of youth uptake and environmental issues is expected to continue and probably increase in most cases—also doing the market few favors.

    Already, two major markets have announced bans on disposable products with both France and the U.K. moving forward with the intention to enact regulations to prohibit their sale.

    Details on how the bans will be implemented as well as exact timescales remain light. In the U.K., the intention is for a ban to come into effect in 2025. But with an unpopular government, looming elections and other priorities, whether such a deadline will be made—or any deadline at all for that matter—is open to speculation.

    In France, more details are clear as a bill has been approved by the country’s senate. Vaping products that cannot be refilled or are powered by a nonrechargeable battery would be prohibited under the new law, although no date for when the ban will come into effect has yet been announced. And the law must still face EU scrutiny on issues such as freedom of movement of goods.

    A 2021 attempt by Belgium to ban disposables was met with a negative opinion from the European Commission. This was because the EU TPD—still in force, although currently under revision—prevents member states from prohibiting or restricting “the placing on the market of tobacco or related products, which comply with this directive.”

    It seems unlikely that the European Commission could come up with a different opinion on a disposable vape ban in France, putting the plan still in the realms of uncertainty.

    Nonetheless, ECigIntelligence expects to see a significant increase in the number of pre-filled and open pod category product launches as companies start to develop pod versions of disposable devices in line with incoming regulations in areas such as battery waste.

    This will lead to some growth in user numbers in these categories—though the majority of that will only be down to cannibalizing off existing disposable category numbers.

    Regulations are also likely to have an impact on the supply side of the market in 2024, with countries like Indonesia, Vietnam and Malaysia gaining importance in the area of hardware manufacturing.

    This could potentially lessen the reliance of the sector on Chinese manufacturing—though it should be noted that the opinion of Chinese industry members is that such growth is more overspill from a crowded Shenzhen manufacturing scene rather than wholesale relocation of business to other markets due to factors like increased domestic regulations and duties in China.

    Freddie Dawson is the managing editor for news at ECigIntelligence, a provider of detailed global market and regulatory analysis, legal tracking and quantitative data.

  • Northern Exposure

    Northern Exposure

    Credit: Matthieu

    Vape and modern oral sales are rising, but combustibles remain king of the North American market.

    By Timothy S. Donahue

    It’s constant but unknown. While the nicotine market remains profitable, it is changing. As more major tobacco companies embrace next-generation products, combustible sales will suffer. The evolving regulatory environment will also continue to play a major factor in the North American nicotine market.

    According to Statista, in 2024, revenue in the U.S. nicotine market will reach $107.5 billion. It is projected to experience a compound annual growth rate of 0.62 percent between 2024 and 2028. The largest segment in the market remains combustible cigarettes, with an expected value of $82.7 billion in 2024. The Marlboro brand continues to dominate U.S. cigarette sales with a 50 percent market share.

    E-cigarette revenues are projected to reach $8.8 billion. Statista expects the vape market to experience an annual growth rate of 3.24 percent from 2024 to 2028. Retail sales of nicotine pouches are also seeing unprecedented growth. According to Euromonitor, the U.S. pouch market generated $8.58 billion in 2023 compared to $7.23 billion in the previous year. The U.S. modern oral nicotine market is expected to reach $11.03 billion by 2027.

    The Canadian tobacco market is much smaller than the U.S., reflecting that country’s lower population. Nicotine sales in Canada are projected to generate a revenue of $12.3 billion in 2024. The market is anticipated to experience a compound annual growth rate of 1.10 percent between 2024 and 2028. In Canada, too, combustible cigarettes continue to account for the majority of tobacco sales. The traditional cigarette market is expected to reach a volume of $10.6 billion this year. In 2024, the revenue in the e-cigarette market in Canada is estimated to reach $1.4 billion.

    Nicotine pouches were approved for sale in Canada on July 18, 2023, as a natural health product. Modern oral nicotine pouches are currently outside the scope of the federal Tobacco and Vaping Products Act and the provincial Smoke-Free Ontario Act 2017, which regulate tobacco and vaping products by restricting their advertisement, display and public use. However, that is expected to change soon.

    During an education seminar at the Total Products Expo (TPE) that took place in Las Vegas Jan. 30 to Feb. 2, 2024, Brad Seipel, executive vice president at MARC Research, noted that many of the next-generation tobacco products disrupting the market today have been on the market for over a decade. Innovation in the industry, he said, is being driven with a focus on tobacco harm reduction and a move away from traditional tobacco. “We are now living in a post-tobacco market. It is a nicotine market,” Seipel said.

    Bonnie Herzog

    Bonnie Herzog, an analyst with Goldman Sachs, observed in an industry report that retailers are seeing customers making fewer trips to the store, which is being driven by consumers switching to alternative nicotine products like modern oral. These products often last longer than a typical pack of combustibles. She also explained that the illicit market for disposable vape products continues to be a growing concern for the nicotine industry and retailers alike as the U.S. Food and Drug Administration’s crackdown on flavors and noncompliant products has driven traffic to the gray/black market or retailers willing to sell unauthorized vaping products.

    She said a broad majority of retailers believe the situation is worsening with the impact felt strongest in urban areas and states with the strictest flavor bans. “Many retailers highlighted that the illicit disposable [e-cigarette] market is impacting cigarette volume, and [Altria] estimates the growth of these illegal products contributed to cigarette industry declines in the range of 1.5 percent to 2.5 percent over the last 12 months,” she said. “Retailers don’t believe the situation will change without more enforcement and are broadly pessimistic given the ubiquity of the offering, tracking/enforcement difficulty and relatively light penalties reducing deterrence.”

    One respondent to the survey pointed out that enforcement fines issued by the FDA are manageable ($19,192 per violation), and the extent of policing hasn’t resolved the issue. Others noted that retailers selling these products (i.e., on the gray market) are making hefty margins on those sales, which are helping them offset losses on (cigarette) sales.

    Brian King

    During Keller and Heckman’s E-Vapor and Tobacco Law Symposium, held Jan. 29–30 in Las Vegas, Brian King, head of the FDA’s Center for Tobacco Products, said his agency carried out a series of coordinated blitzes against Elf Bar and other “illicit” brands at several retailers that resulted in warning letters. The agency then issued civil money penalties following subsequent reinvestigations against retailers found to still be selling illegal products. Many of the recipients of these penalties were small businesses.

    “We do know that we need that comprehensive approach,” said King. “And so, we’ve also taken action on the borders, particularly for products that are coming in internationally. We do have import alerts in place. Those do address products that have been accurately declared. Of course, we know that there are entities that are misdeclaring products as well. Towards that end, we work very closely with colleagues at Customs and Border Protection. We did have an operation that was conducted earlier this year where we seized over $18 million worth of products, including Elf Bar, Funky Republic and several others. It was about 1.4 million units of illegal e-cigarettes. Ultimately, this is one example of ongoing activities. There will be more.”

    Tim Philipps

    Also speaking at TPE, Tim Philipps, with Tamarind Intelligence, said that a major issue is enforcement. While the FDA’s premarket tobacco product application (PMTA) process is expensive and onerous, it also seems pointless because there is little effort to stop products that skip the regulatory process from being marketed. According to Phillips, even the FDA’s current blitz barely skims the surface of the deepening gray/black markets.

    “The products that you’re getting offered in retail environments, they haven’t gone through a regulatory process, and there’s no signs of that happening, frankly,” he said. “The FDA is stepping up some of its enforcement activity. We’ve seen more and more of this happening, and I think it will keep increasing. But the reality is the market’s not being regulated at all. The same is happening, by the way, in the U.K. and all across Europe. We’re seeing a lot of products come in. The reason is that a lot of these products are being distributed directly to retailers or directly to consumers (from the manufacturer). And that’s been a great success.”

    A looming federal menthol ban could also boost the gray/black markets for nicotine products. The FDA has submitted proposals to the White House Office of Management and Budget (OMB) to ban the use of menthol in cigarettes and other tobacco products and prohibit all nontobacco flavors in cigars. The FDA is also expected to definitively define a “characterizing flavor.” The OMB is currently reviewing these proposals. Before the product standards can be implemented, the OMB must review their potential economic impact.

    The FDA has stated that it expects to announce the final ruling on the menthol ban in March. However, with the U.S. presidential election approaching this November, many industry experts are uncertain if any action will be taken at all. Unsurprisingly, several respondents to Herzog’s retailer survey expressed fatigue with ongoing uncertainties related to the potential federal menthol ban, the FDA’s efforts to enforce bans on illegal disposable vape products and flavors and the agency’s slow progress in completing PMTA reviews. The rapid growth of local flavor bans is also an expanding concern.

    “A number of retailers who are currently not subject to [local] flavor bans anticipate the potential in the near future given rapidly evolving legislative agendas,” Herzog stated. “The looming decision by the FDA on a federal menthol ban on (cigarettes) has also led many retailers to take a wait-and-see approach on carrying gray market vapor products, which are higher margin and more affordable for consumers.”

    The future of nicotine products still holds promise. Seipel said that the dissolvable and heat-not-burn segments have plenty of room for growth as the awareness and usage of those products haven’t yet gotten traction in the North American market. Seipel said as long as there are combustible smokers, there is going to be room for innovative products that help them switch to less harmful alternatives.

    “There’s also [an] opportunity in innovation for helping female smokers …. We have to remember that there are way more people out there that need help [quitting smoking],” he said.

  • Vaping in Vietnam

    Vaping in Vietnam

    E-cigarettes continue to compete in Vietnam, but combustible smoking remains popular.

    By Norm Bour

    Vietnam may not be your traditional “tobacco-growing country.” The country has less than 15,000 hectares (37,000 acres) under cultivation while neighboring China produces almost 40 percent of the world’s tobacco. However, the tobacco industry in Vietnam does employ about a quarter million people. In 2022, market research company Euromonitor International estimated the Vietnamese tobacco industry to be worth an estimated $4.4 billion, approximately 1 percent of the country’s GDP.

    Like other countries in Asia, many more men than women in Vietnam smoke combustible cigarettes. According to the World Health Organization, the current smoking rate among men is a staggering 42.3 percent, and the rate for women is only 1.7 percent. Prices for cigarettes are also low by international standards, with a 20-stick pack costing less than $2.00. My wife is not an avid smoker, but she likes her occasional clove, and that set us back $1.80.

    A 2021 report on tobacco taxes by the Southeast Asia Tobacco Control Alliance said tobacco prices in Vietnam were getting cheaper and cheaper when compared to the nation’s per capita income. Revenue in the cigarette segment in Vietnam is projected to reach $7.1 billion in 2024. Like many Asian countries, offering cigarettes as a display of good manners has long been a social convention among Vietnamese men.

    Along with the cheap price, rules and laws don’t seem to apply here, as I watched teens who were surely under 18 years old buy cigarettes on the street. And there are street vendors on almost every corner in the larger cities. But the good news is that underage smoking overall is declining in Vietnam.

    On top of that, Vietnam is a country full of contradictions. On one hand, it is quite militant and strict with laws, and law enforcement people are everywhere. Yet, on the other hand ….

    Gambling is illegal, but they build multibillion-dollar casinos, which can legally be used only by foreigners. Obtaining an entry visa is easier than it used to be, but they are very controlling regarding access and departure points, and they allow no latitude to change them.

    Motorbikes are ubiquitous in this Asian country, and bike traffic is as bad as everywhere else in this part of the world. Though helmets are required, many shun them. Families of four, including infants, ride down the street helmet-free as well as preteens who have not reached puberty. The government generally outlaws indoor smoking unless you are in one of many exempted areas, but, in my mind, it is not smoking that should be regulated—it’s traffic laws that make crossing a major street a life-threatening endeavor.

    The e-cigarette industry in Vietnam is currently experiencing a surge in popularity among younger people as they seek out a modern and trendy option to traditional smoking. As of now, Vietnam has not implemented any regulations regarding vaping. However, the government has stated that it is working toward introducing a new law regulating its usage and distribution.

    The e-cigarette market in Vietnam is projected to generate revenue of $23.9 million in 2024 and to grow at a rate of 1.27 percent annually between 2024 and 2028, according to Statista. When compared globally, the United States generates the highest revenue in the vaping segment, with a projected revenue of $8.8 billion in 2024.

    In Ho Chi Minh City, which was previously known as Saigon, I visited several vape shops, and, as has been the case in all my worldwide visits, some look decrepit and uninviting, and some feel like a modern shop in America or England.

    One of the busiest streets in Saigon is Bui Vien Street, which is filled with hundreds of different bars and eateries (imagine Bourbon Street in New Orleans) and is called a “walking street” since it’s so popular for tourists and locals. As you might expect, with so much street traffic, I found three vape shops in close proximity.

    Vaping Venom offered an inviting modern concrete decor look and offered very little in the way of liquids but instead had a decent display of disposables. It also sold liquor, a nice surprise whenever I encounter a vape shop that does both.

    When I asked the counter girl which was more expensive, vaping or cigarettes, she confirmed that vaping was more costly. She also shared that the store caters more to tourists, and since customs in Vietnam can be more troublesome than in other countries, tourists only want disposables, which are cheap if they need to toss them.

    Vaping Venom’s offerings included Waka, manufactured by Shenzhen Yuxi Electronic Technology. While still more expensive than tobacco, the product is reasonably priced, perhaps due to the proximity of China to Vietnam. Locals usually buy and Wake vapes. And they are cheaper over the long term.

    Vaping 24h was around the corner (with no sign in front), and though the curb appeal was not as good, its inventory was more robust, with a significantly larger supply of liquids, though also dominated by Waka juice. In broken English, the counterman at Vaping 24h verified: “We sell more to locals.”

    Viet Vape was my last visit of the day, and I chuckled when I passed a large school letting out their students for lunch. Even though Vietnam forbids under-age-18 tobacco sales, within a five-minute walk of the school were three vape shops. The legal distance from schools for tobacco sales is 100 meters, which is less than a two-minute walk. Other countries are similar and restrict sales within 1,000 feet (almost 305 meters), which is common in the U.S.

    I was reading a report of a woman selling cigarettes in front of a local high school. The penalty for this is a fine of VND3 million ($123) to VND5 million, along with forfeiture of the delinquent’s tobacco selling license for up to three months and the confiscation of their products.

    The counter guys at Viet Vape were a bit suspicious of my inquiries, but since they had impressive displays of liquids, my assumption of catering more to locals was confirmed by them. And since Vietnam—and Asia in general—offers exotic fruits less known by American vapers, this is a great place to experiment. As we have seen over the past decade, flavor choices, especially fruits, keep people vaping.

    Dragon fruit, lychee, and kiwi combinations are abundant here while grapefruit, mango and papaya are available worldwide. Plus, since Vietnam is the second-largest exporter of tobacco in the world, tobacco vape is also a big seller.

    “Tourists only want disposables,” Viet Vape verified, “and they want to be discreet since they get looked at more closely than locals.”

    Vaping bans are a worldwide trend, and while many Asian countries ban vapes and e-cig outright,* Vietnam is still pretty lax, as is Malaysia, our next stop on our Asian report series.

    Norm Bour is the founder of VapeMentors and works with vape businesses worldwide. He can be reached at norm@VapeMentors.com.

    * https://tobaccoreporter.com/2023/10/24/vapes-banned-in-half-of-southeast-asia/#:~:text=The%20sale%20and%20use%20of,regulate%20vapes%20and%20e%2Dcigarettes

  • Looking Back: Vapor 2023

    Looking Back: Vapor 2023

    Credit: Yury Zap

    Regulatory challenges and misinformation continued to test the vaping industry in 2023.

    By VV staff

    It remains a frustrating business environment. The vaping segment has survived despite setbacks in 2023 and continues growing as a global market. However, divergent regulatory perspectives on vaping’s harm reduction potential continue to hinder its uptake by cigarette smokers. The past 12 months could also be labeled the year of the great exodus as several vaping retailers and manufacturers went out of business. Despite the challenges, more and more former smokers continue to switch.

    While several countries banned, enacted regulations or continued heavily regulating vaping products, the United States’ denials of numerous premarket tobacco product applications (PMTAs) had the greatest impact on the industry this year. The U.S. Food and Drug Administration’s ban on most products has allowed a black market of disposable vapes to become a multibillion-dollar industry. Disposable e-cigarettes account for almost 40 percent of the global vape sector, according to ECigIntelligence.

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

    Disposable e-cigarettes currently account for about 53 percent of the multibillion-dollar U.S. vaping market, according to the Centers for Disease Control and Prevention, more than doubling in size since 2020. Several states, including New York and California, have extended product responsibility laws in place for computers and other electronics, but those rules don’t apply to vaping products. At the federal level, there are no regulations specifically for the disposal of vaping products. Without action, some experts say the devastating environmental impact could last for centuries.

    Misinformation surrounding the vaping industry also continued to spread in 2023. Nearly half of cigarette smokers and young adult nonsmokers think that nicotine-based e-cigarettes have the same amount or even more harmful chemicals than regular tobacco-based cigarettes, according to a Rutgers study.

    Another study found that there are also a lot of exaggerations and misinformation about vaping on social media. Some tweets exaggerate or distort claims about nicotine and addiction while others misinterpret scientific studies to promote vaping. There are also tweets that downplay the harmful effects of nicotine and promote its benefits, which are potentially problematic. Below is a month-by-month recap of the vaping industry’s biggest headlines in 2023.

    January

    Credit: Cerib

    The upscale U.K.-based grocer Waitrose halts sales of single-use vaping products due to environmental concerns. The FDA says it will “decide within months” how to regulate legal cannabis (it still hasn’t). Vaporesso becomes the first open-system vaping device brand to obtain the ability to sell in the United Arab Emirates. The Netherlands bans flavors, and Belgium says it plans to restrict flavor names and vape devices. A 2022 article that claimed e-cigarette users faced the same cancer risk as combustible cigarette smokers is retracted by the World Journal of Oncology. Lawmakers in Taiwan ban vaping products. A U.S. district judge preliminary approves a $255 million settlement resolving consumer claims that Juul Labs deceptively marketed e-cigarettes.

    February

    FDA
    Credit: Adobe

    Hong Kong begins enforcing its ban on CBD, labeling it as a “dangerous drug” and imposing harsh penalties for its possession. Bloomberg Philanthropies commits $420 million over four years to the Bloomberg Initiative to Reduce Tobacco Use. Australia reschedules the psychedelics psilocybin and MDMA to provide access to people with post-traumatic stress disorder. Connecticut sues five companies for selling delta-8 products. Alex Norcia resigns from Filter for a job at Altria. RAI Services Co. submits a citizen petition asking the FDA to adopt a new enforcement policy directed at “illegally marketed disposable electronic nicotine-delivery system [ENDS]” products. Matthew Farrelly, former chief scientist and director of the Center for Health Analytics at RTI International, is named director of the FDA’s Center for Tobacco Products’ (CTP) Office of Science. The FDA files the first civil money penalties for illicit sales of ENDS products.

    March

    Credit: Ascannio

    Altria Group exchanges its entire investment in Juul Labs for a nonexclusive, irrevocable global license to certain of Juul’s heated-tobacco intellectual property. Altria also agrees to acquire Njoy Holdings for approximately $2.75 billion and asks the U.S. Federal Trade Commission (FTC) to drop its 2020 challenge to the company’s 2018 acquisition of a 35 percent share in Juul Labs. The FDA proposes new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of vaping and other tobacco products. RLX Technology reveals that its 2022 financial performance was heavily impacted by new industry regulations and e-cigarette taxes, along with Covid-related disruptions, in China. A U.S. federal judge throws out a tobacco industry lawsuit against California’s statewide ban on the sale of flavored vaping and other tobacco products. The FDA updates its definition of “tobacco products” to include nontobacco nicotine products. Two menthol Vuse flavors that received a marketing denial order (MDO) can continue to be marketed by R.J. Reynolds Vapor Co. after the federal 5th Circuit Court of Appeals issues a stay. Argentina bans imports and sales of ENDS products. Former CTP Director Mitch Zeller joins the advisory board of Qnovia, a “platform pharmaceutical” company that is developing a prescription inhaled smoking cessation therapy.

    April

    Credit: Jo Panuwat D

    Malaysia removes e-liquid containing nicotine used in e-cigarettes and other vaping products from the country’s Poisons List of controlled substances. Greentank Technologies closes a Series B financing round worth $16.5 million with a “strategic investor group” that includes BAT-funded Canadian cannabis producer Organigram Holdings. Vuse’s U.S. market share rises from 41.5 percent while Juul’s declines to 26.1 percent. Altria’s youth marketing suit in California begins. The U.K. announces plans to give 1 million smokers free vaping starter kits to encourage them to give up tobacco products. Juul Labs settles youth marketing lawsuits with six states, bringing the total of state settlements to 45 states, with a combined price tag of more than $1 billion. Panama rejects a proposal to regulate vaping products. The High Court of Justice in London rules that Philip Morris Products’ patents protecting its tobacco-heating technology are valid. Delaware becomes the 22nd U.S. state to pass a recreational marijuana bill. Altria’s youth marketing suit in California begins.

    May

    Credit: MdIqbal

    Australia announces that it will ban the importation of all nonprescription vaping products, including those that do not contain nicotine. R.J. Reynolds sends letters to several small vape shops threatening to sue them if the shops do not stop selling flavored vaping products. A U.K. report shows inmates are spending more than £7 million ($8.5 million) a year on e-cigarettes. Logic Technology challenges the FDA’s marketing denial of its menthol vape products. Altria strikes a $235 million deal to end a California lawsuit alleging that the company marketed vaping products to youth. Flonq launches the world’s first fully recyclable vape device—the Flonq Plus-E. Yolonda Richardson succeeds Matthew Myers as president of Tobacco-Free Kids. The FDA issues “Import Alert 98-06” detaining new tobacco products such as e-cigarettes without marketing authorization at the border. Altria completes its purchase of Njoy.

    June

    Credit: Timothy S. Donahue

    Hawaiian law makes shipping of vaping and other tobacco products valued at more than $10,000 a misdemeanor. ANDS launches Slix, a disposable vape that it says is 99.29 percent recyclable.

    Bidi Vapor sends the initial shipment of Bidi Sticks to over 900 Kwik Trip and Mapco locations.

    A federal appeals court rules that the FDA acted reasonably in denying Magellan Technology’s application to market flavored vaping products.

    The FDA issues warning letters to 189 retailers for selling unauthorized tobacco products, specifically Elf Bar and Esco Bars brands. Zanzibar bans the use and imports of vape products. The CTP announces that it has made significant strides in putting its Reagan-Udall Foundation recommendation-based plan for improvement into action.

    July

    Credit: Ascannio

    Juul Labs asks the U.S. International Trade Commission (ITC) to block sales and imports of the Njoy Ace vapor device, claiming that the product infringes several Juul patents. The FTC dismissed the complaint against Njoy parent Altria Group for its purchase of a 35 percent stake in Juul Labs after Altria’s pullout. New York City accuses Magellan Technology Inc., Ecto World LLC (Demand Vape), Mahant Krupa 56 LLC (Empire Vape Distributors) and Star Vape Corp. of racketeering for selling illegal flavored vapes. Jason Carignan moves to Chemular. The FDA gives the Ohio State University Comprehensive Cancer Center a $3.9 million grant to evaluate the effects of e-cigarette flavors on the smoking behaviors of current adult smokers. Philip Morris International acquires Syqe Medical, an Israeli company, for an estimated $650 million. Juul Labs submits a PMTA to the U.S. FDA for the Juul2 system. China’s State Tobacco Monopoly Administration releases the guidelines for vape exports. A study linking nicotine vapes to liver disease was retracted from Gastroenterology Research. The FDA sends more warning letters for Esco Bars and Elf Bar sales. China vape exports top $3.36 billion for the first half of 2023.

    August

    Credit: Natanaelginting

    Ukraine imposes a consumption tax on disposable vapes. Venezuela bans all vaping products. The Philippines passes a law forcing importers of raw materials for vaping products to seek special clearances to release shipments. High Light Vape, which sells a vape pen disguised as a highlighter, is lambasted by the media. Njoy asks the ITC to ban the import and sale of certain Juul products. New Zealand imposes new regulations to limit youth vaping. The Coalition of Asia Pacific Tobacco Harm Reduction Advocates launches its shadow report on the World Health Organization’s failing tobacco harm reduction strategy. Juul Labs announces a company restructuring aimed at reducing operating costs. Romania bans flavors for heated-tobacco products. Suriname bans the sale of all vaping products. The U.S. Court of Appeals for the D.C. Circuit sides with Fontem U.S. in a ruling that the FDA failed to conduct a proper analysis before rejecting some vaping product marketing applications.

    September

    Credit: Gevorg Simonyan

    The U.K. Vaping Industry Association announces that it will exclude tobacco companies from its membership. Indonesia legalizes vaping. Esco Bars’ manufacturer files a lawsuit challenging the FDA’s import ban of its products. Vaporesso becomes the first licensed company to sell open systems in the UAE. New York opens state cannabis licensing to the public. The FDA sends warning letters to 15 companies that market products under the brand names Elf Bar, EB Design, Lava, Cali, Bang and Kangertech. A massive fire destroys U.K. e-liquid and hardware brand Dinner Lady’s factory. Ispire announces that its fiscal year 2023 saw a 100.4 percent and a 10.9 percent surge in cannabis and tobacco vaping product revenues, respectively. Healthier Choices Management Corp. sues R.J. Reynolds Vapor Co. seeking royalties from sales of its Vuse Alto vape pens, chargers and pre-filled liquid pods, alleging the products infringe a patent. The FDA imposes civil money penalties on 22 retailers for the illegal sale of Elf Bar/EB Design products.

    October

    Credit: Maurice Norbert

    Philip Morris International unveils LEVIA, a zero-tobacco stick for use with its IQOS heat-not-burn device. A new study, E-Cigarette Flavor Restrictions’ Effects on Tobacco Product Sales, finds that flavor bans boost sales of traditional combustible cigarettes. U.K. Prime Minister Rishi Sunak proposes a tobacco endgame plan. The U.S. Supreme Court declines to hear Avail Vapor’s arguments against the FDA’s regulatory authorization process. ECigintelligence reports that disposable e-cigarettes account for almost 40 percent of the global vape sector. The American Vaping Association ends operations; Greg Conley joins the American Vaping Manufacturers Association. The FDA declines to issue a marketing order for flavored Vuse Alto pods. Elf Bar changes its name to defy a U.S. import ban. Njoy files lawsuits against 34 foreign and domestic manufacturers, distributors and online retailers of illicit disposable vaping products. Logic Technology Development loses a court appeal to halt the FDA’s ban on the company’s menthol-flavored pods. Czechia bans flavors for heated-tobacco products. Altria says a booming illegal disposable flavored vape market is causing a major decline in the sales of its authorized vaping products.

    November

    Credit: Chetroni

    Italy’s Regional Administrative Court of Lazio (TAR) suspends a decree that would make CBD oil a narcotic substance until Jan. 16, 2024. The global vaping market will reach $93.94 billion in value by 2030, registering a CAGR of 16.27 percent from 2022 to 2030, according to Straits Research. BAT announces a $90.5 million investment in Organigram. Ohio becomes the 24th U.S. state to allow adult marijuana use for nonmedical purposes. Research from the United Nations suggests that toys are a much larger contributor to electronic waste than vaping products. The FDA again sends warning letters to online retailers for selling disposable products marketed under the brand names Elf Bar, EB Design, Bang, Cali Bars and Lava. The 10th Conference of the Parties (COP10) to the World Health Organization Framework Convention on Tobacco Control is postponed, officially due to unrest in the host nation, Panama.  

    Louisiana’s state Office of Alcohol and Tobacco Control releases a list of nearly 400 approved vape products for legal sale in the state. Juul Labs raises an estimated $1.3 billion in funding. Ispire Technology reports revenue of $42.9 million and gross profit of $6.9 million in the quarter that ended Sept. 30. The FDA increases the penalties for violations of federal nicotine product laws. PMI expands IQOS Iluma in the Middle East. New Zealand’s new coalition government announces a cancelation of the country’s controversial generational tobacco ban. The Foundation for a Smoke-Free World, which was originally funded by PMI, says it will no longer accept any monetary support from the nicotine industry. The WHO announces the dates for the resumed in-person sessions of COP10 for February 2024. Australia will ban imports of disposable vapes beginning Jan. 1, 2024. France plans to ban disposables by 2025.

    December

    Credit: Oleksii.

    (Editor’s Note: This magazine went to press in December, so the month may be incomplete.) The FDA announces that it is now estimating that completion of PMTA reviews may be delayed as the agency considers the D.C. Circuit’s opinion in Fontem U.S. v. FDA, affirming in part and vacating and remanding in part MDOs for certain vaping products. U.S. House lawmakers demand information from federal officials on what they are doing to stop the influx of kid-appealing electronic cigarettes from China. Mexico’s Supreme Court of Justice rules that the presidential decree banning the sale of e-cigarettes is unconstitutional. The FDA announces that it has filed civil money penalty complaints against 25 brick-and-mortar and online retailers for selling unauthorized Elf Bar, EB Design and other e-cigarette products. France’s National Assembly unanimously approves a bill to ban single-use electronic cigarettes. Vuse’s market share rose from 41.5 percent to 42 percent, surpassing No. 2 Juul which dropped from 24.7 percent to 24.3 percent. Guam proposes rules to stiffen the fees and penalties for vape sales to minors.  

    Looking ahead

    It’s impossible to predict what the vaping industry will look like by the end of 2024. Industry insiders expect regulators to crack down on disposable vaping products, and misinformation will likely continue to run wild.

    The U.S. will probably see a decline in product variety because the FDA is unlikely to approve many devices. However, globally, especially in the EU and the U.K., the industry should continue to thrive and expand. More importantly, innovation should continue to thrive outside the U.S.

    Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers Association, predicted at the end of 2022 that the FDA’s policy on vaping products would continue to be characterized by regulatory paralysis and the search for the least politically controversial regulatory option, and the industry wouldn’t hear rulings on many PMTAs until 2024 or later. He was correct on both counts.

    Looking forward to 2024, Conley told Vapor Voice that the vaping industry should expect a turbulent ride, particularly in the United States. He predicts that the most significant hurdle remains the FDA’s CTP.

    “Under the current leadership of Brian King, the agency’s stance toward vaping products has become even more antagonistic despite a drop in youth vaping to its lowest levels in a decade,” said Conley. “This tension is heightened by ongoing court cases that might force reforms within the CTP, but these changes are likely to be met with considerable internal resistance and intransigence.

    “Those in the industry should not be naive. The regulatory landscape in the U.S. for vaping businesses, regardless of their size, is likely to get worse before it gets better. This is a hard truth we need to brace for.”

    Beyond the federal level, a critical challenge will continue to come from state governments and major tobacco companies like Altria and R.J. Reynolds. The rise of synthetic nicotine-containing disposable vaping products, which are impacting cigarette sales and the vapor market shares of the major tobacco companies, is leading to a push for state-level PMTA registries, according to Conley.

    “In essence, these bills seek to deputize state regulatory agencies to behave as mini-PMTA enforcement divisions. The true effect of these registries is to ban all products that submitted their PMTAs after September of 2020. In plain English, this means nearly every disposable vaping product on the market becomes illegal to sell,” Conley explains. “Such measures have already been implemented in Alabama, Oklahoma and Louisiana, leading to a disruption in the market dynamics. Law-abiding retailers and average adult consumers are suffering as a result.”

    Globally, Conley predicts that the vaping industry will continue to go up against well-funded prohibitionist campaigns spearheaded by organizations bankrolled by Michael Bloomberg. However, there’s a silver lining: The evidence supporting regulation over outright bans continues to grow.

    “I’m cautiously optimistic that we’ll see countries in Latin America and Southeast Asia begin to revisit their previous, misguided policies. Regrettably, however, the anti-disposable furor is likely to get even more heated in Europe,” said Conley. “For adult consumers looking for hassle-free nicotine consumption, there’s never been a better time than now. The market has evolved tremendously in terms of product quality and variety. However, the picture is starkly different for businesses in the vaping industry. Until there is real reform that regulates the products adults want, like flavored disposables, being successful in this industry may require risking your livelihood and potentially your freedom.”

    Conley said the industry must remain vigilant because regulatory challenges, particularly in the U.S., coupled with global policy shifts and market dynamics suggest that the industry’s path will be rocky in the short term. “The hope is for a future where nicotine control policies are grounded in harm reduction principles rather than mirroring a drug war,” he said. “However, we’re currently seeing a trend that veers toward the latter.”

  • Delayed Response

    Delayed Response

    Credit: F Armstrong Photo

    The U.S. Food and Drug Administration is considering court opinions before finalizing PMTA reviews.

    VV staff

    The U.S. Food and Drug Administration stated in prior status reports for its premarket tobacco product applications (PMTAs) that the agency would complete a review of 100 percent of the applications by the end of 2023.

    The agency is now estimating that completion of the reviews may be delayed as the regulatory agency considers the D.C. Circuit’s opinion in Fontem US v. FDA, affirming in part and vacating and remanding in part marketing denial orders for certain vaping products. Fontem US, a subsidiary of Imperial Brands PLC and parent to Fontem U.S., owns the global e-cigarette brand blu. In August, the court found that the FDA failed to justify its denial of Fontem U.S.’ unflavored vape products on public health grounds.

    “As to Fontem’s flavored products, the FDA reasonably found a lack of evidence that the benefits of such products to adult smokers sufficiently outweighed the potential risks to young nonsmokers. As to Fontem’s unflavored products, however, the FDA acted unlawfully by failing to engage in the holistic public health analysis required by the statute,” the opinion states. “The agency did not take into account the potential benefits of unflavored products or weigh those benefits against risks to the public health.”

    The original PMTA completion date was Sept. 9, 2021; however, the FDA stated it was unable to meet that goal due to the extremely large number of PMTAs filed by manufacturers.

    The FDA is under a Maryland Federal District Court order to file regular status reports on the agency’s review of PMTAs. The court case that ended in a court-imposed deadline for the FDA was filed by health groups seeking a timeline for the review of the PMTAs that were filed with the agency by Sept. 9, 2020.

    The court order stems from litigation filed by health groups against the FDA seeking a court-imposed deadline for finalizing the review of the PMTAs that were filed with the agency by Sept. 9, 2020.

    The court-imposed deadline to complete the agency’s review was originally Sept. 9, 2021, which the FDA was unable to meet due to the extremely large number of PMTAs filed by manufacturers.

    The most recent and the FDA’s seventh status report was filed on Oct. 23, 2023, according to media reports. Specifically, in these reports, the FDA provides an update on the progress of finalizing the agency’s review of pending PMTA “covered applications.”

    In the order requiring the FDA to submit status reports, the Maryland court stated that “covered applications” are limited to applications for products that are sold under the brand names Juul, Vuse, Njoy, Logic, blu, Smok, Suorin or Puff Bar. Additionally, any product with a reach of 2 percent or more of total “Retail Dollar Sales” in Nielsen’s Total E-Cig Market and Players or Disposable E-Cig Market and Players’ reports.

    For such new tobacco products to be lawfully marketed in the United States, the Family Smoking Prevention and Tobacco Control Act requires the FDA to complete a substantive review of the PMTA for each new tobacco product and issue a marketing granted order authorizing the sale of the product. According to the FDA’s Oct. 23 status report, the agency has completed its review of 69 percent of the 186 pending covered applications.

    The FDA states that it will file the next status report with the court by Jan. 22.

  • Into the Unknown

    Into the Unknown

    Credit: Tori

    Control of the U.S. cannabinoid market will be fueled by lobbying and lawsuits in 2024.

    By Rod Kight

    During the past six months, I have repeatedly been asked to predict what will happen with the U.S. Farm Bill. This is because the Agriculture Improvement Act of 2018, better known as the “2018 Farm Bill,” expired at the end of September. “Will it change?” “Will hemp be outlawed?” “Will I still be able to sell [insert THCa, delta-8 THC, D9 gummies, etc.]?” “What can we do to ensure that hemp remains legal?” Although I routinely discuss this with lobbyists and associations, the fact is that no one knows what will happen with the next Farm Bill.

    Fortunately, that issue will not be decided for almost another year, which is plenty of time for the rapidly expanding hemp industry to grow even bigger.

    Congress recently passed the Further Continuing Appropriations and Other Extensions Act, 2024. Included within this act is Section 102, which states:

    (a) Extension.—Except as otherwise provided in this section and the amendments made by this section, notwithstanding any other provision of law, the authorities (including any limitations on the authorities) provided by each provision of the Agriculture Improvement Act of 2018 (Public Law 115–334; 132 Stat. 4490) and each provision of law amended by that act (and for mandatory programs at such funding levels), as in effect on Sept. 30, 2023, shall continue, and the authorities shall be carried out, until the later of—(1) Sept. 30, 2024; or (2) the date specified in the provision of that act or the provision of law amended by that act.

    President Biden is expected to sign the act.

    This means that we will not likely have a new Farm Bill until the fall of 2024. Given that the 2018 Farm Bill is the basis for the hemp cannabinoid market, which Whitney Economics recently reported has a demand of $28.4 billion (more than the marijuana industry and on par with the craft beer industry), maintaining status quo for another year is a good thing for the industry.

    Rod Kight

    In addition to an additional window of time to continue its progress of bringing cannabis to people in the U.S., the extension will allow hemp companies to expand their sales and operations internationally. This is because hemp can cross borders, and many current hemp products meet the emerging standards set by countries who are creating cannabis programs.

    This does not mean that the hemp industry will take a break from politics. In fact, the reality is quite the opposite. There is a growing dispute, known as the “Cannabis Civil War,” between the hemp and marijuana industries. At stake is control over the rapidly expanding and lucrative market in cannabinoids and cannabis products. I use the term “cannabis” in this context as a generic botanical term to encompass both federally legal hemp and federally illegal marijuana. In addition to intensive lobbying efforts by both sides of the cannabis industry, there have been a number of important decisions in recent lawsuits. 

    For this reason, I will spend the rest of this article discussing important rulings in four recent lawsuits filed by hemp companies and hemp organizations against various states regarding laws and rules that they contend violate state and/or federal law. My firm has worked with the hemp plaintiffs in some of these lawsuits.

    Additionally, I will discuss the landmark ruling in a trademark dispute between two private parties that addressed the legal status of delta-8 tetrahydrocannabinol (D8 THC) and a decision by the Georgia Court of Appeals regarding D8 THC in the context of a criminal seizure. These cases appear to be the tip of the proverbial iceberg in the Cannabis Civil War, and I anticipate several more to follow.

    BioGen v. State of Arkansas. In this case, several Arkansas hemp companies filed a lawsuit against the state, seeking an injunction prohibiting enforcement of Senate Bill 358, enacted on April 11, 2023, as “Act 629” (the Act). This bill criminalized all hemp products “produced as a result of a synthetic chemical process” and “[a]ny other psychoactive substance derived therein.”

    The hemp companies argued that the Act is preempted (i.e., superseded) by the federal 2018 Farm Bill and that its provisions are unconstitutionally vague and thus void. The U.S. District Court agreed and entered an injunction barring enforcement of the Act. In its ruling, the court made three important findings: (1) the Act is preempted by federal law under the principle of “conflict preemption,” (2) the Act is preempted by federal law under the principle of “express preemption,” and (3) the Act is unconstitutionally vague and thus void.

    Maryland Hemp Coalition Inc. v. Moore. The Maryland hemp industry sought an injunction prohibiting the enforcement of Maryland Code Ann. Alc. Bev. §36-1102, known as the Cannabis Reform Act (CRA), “against any person who was already lawfully in the business of selling hemp-derived products prior to July 1, 2023.”

    In an expansive ruling in favor of the Maryland hemp industry, the Washington County Circuit Court found that “the interests of [the hemp industry] plaintiffs are not ‘merely academic, hypothetical or colorable,’ but rather, they are interests of survival, prosperity and, indeed, of life, liberty and property.”

    In its ruling, the court addressed the issue of “whether the strict and exclusive licensing scheme under the CRA and as applied to the hemp industry is a valid exercise of legislative prerogative.” In finding it is not a valid exercise, and thus prohibiting enforcement of the CRA against the state’s hemp industry, the court ruled that the CRA “creates a monopoly that unfairly excludes many from their right to continue, or enter, a profession of their choosing, all to the detriment of the public.”

    The Washington County Circuit Court went on to state that “[b]ased on the evidence and argument offered thus far, the court cannot find a rational basis to support the exclusive and exclusionary licensing scheme that has put plaintiffs out of their legitimate businesses.”

    In short, the court found that the CRA creates an illegal monopoly, it unlawfully puts legitimate hemp companies out of business, and it is a “severe” and “Draconian” licensing scheme that fails to “actually benefit the communities found to have been impacted.” It also noted that the plaintiffs were not challenging the health and safety portions of the CRA.

    Northern Virginia Hemp and Agriculture LLC v. the Commonwealth of Virginia. Several Virginia hemp companies sought an injunction prohibiting enforcement of SB 903, which state lawmakers enacted “in response to the growing concerns regarding delta-8 and other adulterated hemp products on the market.” The restrictions placed on hemp products by SB 903 are dramatic enough to destroy most of the state’s hemp industry.

    The hemp company plaintiffs argued that SB 903 was preempted by federal law, namely the 2018 Farm Bill. The hemp companies made two preemption arguments. The first was based on federal and state definitions of hemp, and the second was related to the ability of Virginia hemp processors to ship or transport hemp through the commonwealth. The U.S. District Court found that these arguments failed, and the court denied the request for an injunction. Consequently, SB 903 is currently in effect.

    Sky Marketing Corp. dba Hometown Hero v. Texas Department of State Health Services. Several Texas hemp companies filed a lawsuit and sought an injunction prohibiting the Department of State Health Services (DSHS) from enforcing a rule it promulgated that made D8 THC a controlled substance.

    The Travis County District Court ordered the DSHS to “remove from its currently published Schedule of Controlled Substances the most recent modifications of the definitions to the following terms: ‘*(31) tetrahydrocannabinols’ and ‘*(58) marihuana extract’ and any subsequent publications of the same (if any) until further order of this court.”The court further “enjoin[ed] the effectiveness going forward of the rule stated on DSHS’s website that delta-8 THC in any concentration is considered a Schedule I controlled substance.” Consequently, D8 THC is not a controlled substance in Texas.

    AK Futures LLC v. Boyd Street Distro LLC.Unlike the cases summarized above, this case did not arise from a lawsuit filed by hemp companies. Rather, it arose in the context of an intellectual property dispute between the two private parties. The plaintiff, AK Futures (AK), makes vaping products. It sued Boyd Street Distro (Boyd) for infringing on its trademark and copyright rights by selling a fake version of its “Cake”-branded vaping products that contain D8 THC.

    In an unusual defense, Boyd argued that AK’s case should be dismissed because its trademark rights were unenforceable based on its position that D8 THC is illegal under federal law. In ruling for AK, the U.S. Court of Appeals for the 9th Circuit upheld the injunction issued by the lower court, ruling the 2018 Farm Bill legalized the D8 THC products. Specifically, the 9th Circuit held that D8 THC is not a controlled substance under the plain and unambiguous text of the 2018 Farm Bill and that it fits within the legal definition of “hemp.”

    The court also found that the method of manufacture is irrelevant. Since most D8 THC is produced through an isomerization of cannabidiol rather than an extraction from the plant, this portion of the ruling is particularly notable.

    Elements Distribution v. State of Georgia. This case arose out of a criminal seizure in which the plaintiff, Elements Distribution LLC (Elements), sought the return of business records, money and products from law enforcement. In February 2022, Gwinnett County, Georgia, law enforcement officers executed a search warrant upon a warehouse owned by Elements and seized business records, currency and edible and nonedible products containing D8 THC and D10 THC.

    The warrant was issued based on the affidavit of a law enforcement officer that Elements had violated OCGA §16-13-30(b), which prohibits the possession of a controlled substance with the intent to distribute by possessing and selling products containing D8 THC and D10 THC. In ruling that Elements was entitled to a return of the seized items, the Georgia Court of Appeals found that the warrant authorizing the seizure was not supported by probable cause.

    The state argued that even though D8 THC and D10 THC are not themselves controlled substances, edible products containing them are controlled substances unless those products also meet the definition of “hemp products” under OCGA §2-23-3 of the Georgia Hemp Farming Act. The court found the state’s argument to have “no merit” and ordered the state to return the items it seized from Elements.

    As the cases above demonstrate, there is a growing body of case law regarding the legal status of hemp and hemp products, particularly D8 THC. Of note is an emerging trend by hemp companies to sue state agencies regarding laws and regulations that severely restrict distribution of the products they sell.

    The 2018 Farm Bill, which is the foundational federal law regarding the legal status of hemp, has just been extended to Sept. 30, 2024. Meanwhile, the Whitney Economics report discussed at the beginning of this article found that total demand for hemp-derived cannabinoid products exceeds that of the marijuana industry and is on par with the craft beer industry.

    The latter report and extension of the 2018 Farm Bill means we can expect to see the Cannabis Civil War—and lawsuits regarding hemp products—continue in 2024.

    Based in Asheville, North Carolina, USA, Rod Kight is a world-renowned attorney in the cannabis industry.

  • Lack of Enforcement

    Lack of Enforcement

    The UKVIA forum offered insight into the most significant threats to the U.K. vaping industry.

    By George Gay

    The U.K. vaping industry, which has benefited from some progressive government policies in the past, nevertheless found itself with the sword of Damocles hanging over its head as participants met in London for the annual forum of the U.K. Vaping Industry Association (UKVIA) on Nov. 10. And I am not being overly dramatic here.

    As part of his forum presentation, the Conservative Member of Parliament Adam Afriyie warned attendees that the U.K. “could go the way of Australia in the blink of an eye”—and he wasn’t talking galahs and wombats; he was referring, I assume, to a generally very restrictive vaping environment, though not necessarily to the specific prescription-based medicalization of vaping in that country.

    What was at the back of everybody’s mind on Nov. 10 was a government consultation on smoking and vaping issued in October and due to end on Dec. 6, which made the theme of the forum, “Accelerating action: Securing a world without smoking,” something of an object lesson in being careful what you wish for.

    The consultation includes a proposal to make it an offense to sell any product containing tobacco to those born on or after Jan. 1, 2009, which would raise the legal smoking age by a year annually until it applies to the whole population. The government claims this has the potential to almost completely phase out tobacco smoking among young people by 2040.

    Worryingly for the vaping industry, some might suggest this policy would be a way of single-handedly ensuring a U.K. without tobacco smoking, eliminating the need for products that can substitute for combustible cigarettes, such as vapes. And for those wedded to the idea that vapers should be drawn only from the ranks of smokers, it would mean the vaping industry had a limited future, one where, within a predictable timeframe, it would simply be managing decline.

    On the other hand, some might argue that with one of the UKVIA’s goals being to support the government in reaching its 2030 smoke-free target, and given the government’s claims about the damage caused by tobacco smoking being so alarming, timing is of the essence and that vaping can help things along, though the idea that it is necessary to act speedily is perhaps undermined by the facts that the risk of cigarette smoking has been known about for more than half a century, and substitute products have been around for even longer.

    Credit: Fotolia Premium

    On the other hand, if I haven’t run out of hands, the future might not look this bleak because there is the usually unspoken argument, with which I would agree, that vapers need not be recruited only from the ranks of smokers. We must be grown up and realize that some people will, for the foreseeable future, seek recreational drugs, and nicotine delivered through vaping must be a better, less risky candidate than many others on offer, especially alcohol, which surely must be the subject of the next government consultation.

    But I digress. There are proposals in the consultation that forum participants will likely have considered to be more directly threatening than a creeping tobacco smoking ban. “The U.K. government and devolved administrations [those in Northern Ireland, Scotland and Wales] have a duty to protect our children from the potential harms associated with underage vaping while their lungs and brains are still developing,” the consultation says in part. “So, the U.K. government and devolved administrations are consulting on several proposals on youth vaping, including restricting flavors, regulating point-of-sale displays, regulating packaging and presentation, considering restricting the supply and sale of disposable vapes, whether regulations should extend to non-nicotine vapes and taking action on the affordability of vapes.

    What I find a little concerning about the above is that, unless the consultation document was put together by people who started messing with nicotine before their brains had fully developed, it seems to have been written in something of a rush. The fourth proposal is apparently about “consulting on … considering restricting,” which seems a mite convoluted. And the fifth proposal goes into passive mode whereby the regulations might extend, seemingly of their own accord. That is creepy.

    These might seem to be minor semantic matters, but I’m not sure they are because they reflect on how much time and effort went into producing the consultation document and, more worryingly perhaps, suggest that not enough time will go into examining the submissions. Afriyie, who is the vice-chair of the All-party Parliamentary Group for Vaping, suggested the U.K.’s civil servants were well informed and committed to the U.K.’s principle of harm reduction and would make a good job of reviewing the consultation, ensuring submissions were evidence based and making pragmatic recommendations to ministers. I wish I were so confident.

    Civil servants presumably wrote the consultation, which is not in my view objective but comes with an agenda. The sixth paragraph kicks off with an almost meaningless statement: “No other consumer product kills up to two-thirds of its users.”

    Glossing over the fact that no “product” had been identified by this stage of the text and that, therefore, to refer to “no other product” was meaningless, it is the case that “up to two-thirds” could mean none, which was perhaps not what the writers had in mind. And the word “kills,” though almost universally used, is clearly misleading. This is not to denigrate civil servants, just to point out that they are probably too few in numbers fully to perform the tasks assigned to them.

    Credit: WavebreakMediaMicro

    I worry the government believes that what it is dealing with here is not a health matter but a political one, especially given that a general election is likely to be called next year. Addressing the attendees about vaping by those underage, Afriyie, who is not standing at the next election, said, “… if any of your products, I mean any of them, have fancy colors or have packaging or have names or have flavors with names that would even vaguely appeal to young people, can I just say, just stop.

    Because if next year I come to this conference and we’ve gone the route of Australia, do you know, it will be your fault. It will be your fault for not policing the industry and ensuring that you are absolutely responsible in your new role of healthcare.”

    Of course, the UKVIA has no powers to police the industry. The association can encourage and cajole its members to ensure their products do not specifically appeal to those underage, but then it is unlikely that its members will be the ones to step out of line.

    There is no doubt that vapes are getting into the hands of those who are too young legally to buy them, but, for a long time, the UKVIA has been telling the government about this trend and suggesting remedial actions that could be taken, including the licensing of retailers and heavy fines for those who recklessly sell vapes to those underage. Not only have such suggestions fallen on deaf ears, but successive Conservative governments have run a ruthless and reckless decade-long program of austerity that has, in part, decimated the organizations charged with policing retail activities.

    According to a press note issued by Arcus Compliance on Nov. 9, the day before the forum was held, a leading academic at Imperial College London had reported that the budgets of one of those organizations, Trading Standards, had been halved: cut by an estimated £200 million ($254.04 million) since 2010.

    Data gathered through Freedom of Information requests by Arcus Compliance reportedly showed that across 11 major provincial U.K. cities, which have a shared population of more than 5.5 million people, just 21 successful prosecutions had been made against retailers for underage/illicit sales between 2021 and early 2023. Further, the total amount of fines handed down across these cities over the same period was £2,188.

    The managing director of Arcus Compliance, Robert Sidebottom, who was co-chair of the forum, said the concerning lack of enforcement in the form of prosecutions and penalties demonstrated the system was in serious distress.

    “The government has now pledged £30 million to help intercept illegal tobacco and vaping goods at the border and to tackle youth access,” he was quoted in the press note as saying. “While this is a welcome development, we can’t just slap a multimillion-pound Band-Aid on the issue of underage and illicit vape sales and call it a day—especially if parliamentarians move on considerations to restrict the sale of disposable vapes.”

    This was a theme addressed by John Dunne, the UKVIA’s director general, in his forum presentation. While acknowledging that it was necessary to urgently address what he described as the unintended consequences of sales to those underage, the sale of illicit products and the environmental damage caused by vapes, he pointed out that while current regulations were not being enforced, it made no sense to add further punitive regulations to the industry’s operations.

    John Dunne

    Dunne, whose job must have been made hugely more difficult in recent times by the almost constant churning within ministerial departments caused by the unstable, almost unhinged, turmoil within the ruling Conservative Party, expressed concern that the contents of the vaping consultation had been swayed by the court of public opinion, driven in turn by click-bait journalism, and therefore threatened “to undo all of the good work that our sector has done in being the most disruptive force in history in addressing the most preventable cause of death, which is smoking.”

    The forum, which apparently is now the biggest business-to-business event in the U.K., was well organized and held within a comfortable, well-run venue, the QEII Centre in Westminster, London. There was a program of practical panel discussions and presentations, which included an address by Weinuo Ao, the secretary general of the China Electronic Chamber of Commerce, which, in cooperation with the UKVIA, organized the first trade delegation of Chinese companies to attend a UKVIA forum.

    There was a panel session on the thorny, seemingly unresolvable, problem of trying to change public perceptions about vaping for the better and one on the equally thorny and divisive subject of addressing the environmental impact of vapes. It is almost painful to see how both of these issues, like the enforcement issue, are largely out of the industry’s hands.

    Enforcement is in the hands of the government, and changing perceptions would require those currently spreading misleading information about vaping to stop what they are doing, while it is consumers who should, in their own interests, take the environmental issue in hand by not carelessly discarding their vapes.

    One panel discussed the future of vaping, another looked at the future of retailing and yet another examined whether in the future it would be possible or even desirable to take harm reduction to a new level—perhaps beyond the 95 percent less risky figure normally quoted in the U.K.

    Alongside the forum was a mini-exhibition, and an awards dinner followed, co-compared by Marina Murphy, senior director of scientific and medical affairs at ANDS, and Sairah Salim-Sartoni, founder of Salim-Sartoni Associates. Sixteen awards were up for grabs, including one for most supportive parliamentarian, which went to Afriyie.

    Finally, whereas my take on the forum was that the most significant threats to the vaping industry in the U.K. were being caused by a lack of enforcement of current regulations, there was hope. For instance, from my observations, the government could take its enforcement activities to a new level simply by taking some lessons from Sidebottom and his co-chair, Jeannie Cameron, the CEO of JCIC International and the first woman to chair a UKVIA forum.

    Sidebottom, who is ex-military, and Cameron ran the show like a military operation, and I don’t mean a retreat. Presentation timings were policed strictly with Sidebottom threatening stragglers with being grasped in a headlock and dragged from the stage and Cameron saying something about a whip. Unless I was mistaken, at least one participant was stopped mid-sentence …