Tag: e-cigarettes

  • 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.

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  • 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

  • Georgia Seeking to Create Vape Safety Committee

    Georgia Seeking to Create Vape Safety Committee

    Local legislators in Georgia are sponsoring a Georgia House resolution that would create a new study committee on the safety and consumer protection of nicotine vapor products.

    “Within the nicotine vapor product industry there is no current directory of products that have been vetted and approved by the (U.S.) Food and Drug Administration for consumer safety and consumption,” the text of the resolution reads. “Further study needs to be had on the consumer safety of refillable liquid vapor products that are produced from the small businesses within the nicotine vapor product industry.”

    The resolution was introduced to the Georgia General Assembly on Feb. 27, according to media reports.

    “A study is needed to develop potential legislation or other action that would help prevent incidents leading to consumer harm or injuries in the nicotine vapor industry and protect the health and safety of those consuming the products,” the resolution continues.

    The proposed House study committee would be made up of five Georgia House members appointed by the speaker of the House.

    “In the event the committee adopts any specific findings or recommendations that include suggestions for proposed legislation, the chairperson shall file a report of the same prior to the date of abolishment specified in this resolution,” the text reads. “No report shall be filed unless the same has been approved prior to the date of abolishment specified in this resolution by majority vote of a quorum of the committee.”

    Per the resolution, the proposed committee would officially disband on Dec. 1. “Until such products from small business manufacturers are adequately regulated by the federal government, it is important to study all of the issues surrounding electronic cigarettes, e-liquids and other nicotine vapor products while at the same time encouraging economic development in this state,” the resolution text reads.

  • New Virginia Vape Rules, Tax Likely to Become Law

    New Virginia Vape Rules, Tax Likely to Become Law

    Credit: TS Donahue

    Virginia’s 2024 legislative session is likely going to send two bills regulating vaping and a new vaping tax to the governor’s desk.

    Among the bills with a presumably higher impact is one that would create a new state registry that would limit sales to only FDA-approved products.

    “It’s an important step to address childhood vape use,” said Rodney Willet, a cosponsor of the registry effort, according to media reports. The Henrico-based delegate says it would still open the door to sell plenty of vape products for consumers, but Midgette said the trendiness of the industry makes it hard for any one brand to stay popular.

    “It’s an evolving business. There’s one brand everyone wants, then a few months later people want a different one,” Midgette said.

    Midgette also pushed back on the FDA approval requirement, suggesting the products the federal government had approved represent a small and low-quality collection of brands.

    Another bill would block any new shops from opening within 1000 feet of a school or daycare center.

    But the business owner also noted a carve out made in Lopez’s bill for convenience stores and gas stations.

    Last on the list is a new six-cent-per-mil of nicotine tax on vape products currently in the Senate budget.

    “Six cents? That’s nothing,” Midgette joked, noting North Carolina added a five-cent tax already, and it’s handled by his distributors before being passed down to consumers.

  • UKVIA Seeking Clarity on Vape Advertising Notice

    UKVIA Seeking Clarity on Vape Advertising Notice

    Photo: New Africa

    The U.K. Vaping Industry Association (UKVIA) is seeking clarification following the recent Committee of Advertising Practice (CAP) enforcement notice on the prohibition of vaping ads on social media.

    The UKVIA is particularly concerned that “factual (nonpromotional) information” should only be made available to those who have “actively and specifically sought it out,” which would limit such content to social media accounts set to “private.”

    The industry group is especially worried that this means factual posts, such as repeating evidence-based statistics such as vaping is 95 percent less harmful than smoking, for its annual VApril Vape Awareness Month will now be deemed unlawful.

    “Around 40 percent of U.K. smokers wrongly believe that vaping is at least as harmful as, or even more harmful than, cigarettes, which suggests we need more evidence-based vaping facts on social media, not less,” the UKVIA wrote in a statement.

    One of the main aims of VApril is to use both paid and organic posts on LinkedIn, X and Facebook to give facts to smokers to help them make informed decisions over how they consume nicotine.

    The CAP says that after March 28, it will enforce restrictions under the Tobacco and Related Products Regulations 2016, which prohibit “ads that have the direct or indirect effect of promoting nicotine-containing electronic cigarette products” from being shown in most social media.

    The Enforcement Notice says: “Electronic cigarette ads are prohibited in any online media where content is shared to users who have not specifically sought it out.

    “This means paid-for display ads in all online space are prohibited, but it also means that regular, non-paid-for posts and content in social media, which might get shared by an algorithm to users, are prohibited too.”

    The Advertising Standards Authority will hold a webinar on March 21 where the rules on social media vape ads will be explained.

  • U.S. Trade Commission to Probe ALD and Stiizy

    U.S. Trade Commission to Probe ALD and Stiizy

    Credit: Ascannio

    The U.S. International Trade Commission (ITC) will investigate oil vaporizing devices, components and products manufactured and sold by ALD Group and Stiiizy in response to patent violation complaints filed by Pax Labs.

    Pax Lab has asked the ITC to issue a limited exclusion order and a cease and desist order.

    In a note on its website, the ITC stressed that is has not yet made any decision on the merits of Pax Lab’s complaint. The ITC’s chief administrative law judge will now assign the case to one of the ITC’s administrative law judges, who will schedule and hold an evidentiary hearing. That judge will make an initial determination as to whether there is a violation of section 337 of the Tariff Act; that initial determination is subject to review by the Commission.

    The ITC said it will make a final determination in the investigation at the earliest practicable time. Within 45 days after institution of the investigation, the ITC will set a target date for completing the investigation. ITC remedial orders in section 337 cases are effective when issued and become final 60 days after issuance unless disapproved for policy reasons by the U.S. Trade Representative within that 60-day period.

  • FDA Urged to Follow the Science for Vaping Rules

    FDA Urged to Follow the Science for Vaping Rules

    Photo: Pixel-Shot

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) should open the marketplace for electronic nicotine delivery systems to products with varied characteristics so that those interested in alternative nicotine products can access them, according to R Street resident senior fellow Jeffrey Smith.

    In a recently published analysis, Smith critiques the FDA’s disregard for the current research on ENDS, diving into new data that he says represents a “tectonic-shift in the academic medicine community” regarding the safety of ENDS for smoking cessation. 

    ”As evidence grows for the utility of ENDS and other potentially life-saving alternative products, the CTP continues to limit Americans’ access to these products,” writes Smith.

    “Though the CTP has received millions of applications for ENDS products, it has only allowed a few to be marketed legally in the United States. Of those that have received marketing clearance, only older closed systems have been approved—with tobacco as the only permitted flavor.”

    Arguing that a diverse range of ENDS products available to those who smoke and want to quit is critical to reducing the health burdens associated with smoking, Smith urges the CTP to revise its processes and procedures, and allow more cigarette alternatives on the market. Continued delay by the CTP, he says, will only lead to more unnecessary deaths and disease in the United States.