Author: Staff Writer

Into the Void

Credit: Billion Photos
In the wake of marketing denial orders, many U.S. e-liquid manufacturers are turning to synthetic nicotine.
By Timothy S. Donahue
In 2015, Mitch Zeller, the director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), was asked what the FDA’s position was on synthetic nicotine. “I’ll let you figure that one out for yourselves,” he said, hinting that the agency would regulate it as a drug. Today, vaping products, especially disposable devices, using tobacco-free nicotine (TFN) are one of the fastest-growing segments on the market.
After the FDA began issuing marketing denial orders (MDOs) to companies whose premarket tobacco product applications (PMTAs) failed to satisfy the agency’s concern about youth use, many rejected applicants hinted that they would start using synthetic nicotine—nicotine made in a lab and not derived from tobacco—in their flavored e-liquids.
Vapor Salon, for example, announced on Facebook that it would be switching to synthetic nicotine less than 24 hours after the FDA ordered the company to remove its products from the market.
“The main purpose of this is to be outside of the FDA’s regulations with their hefty PMTA requirement, which takes full effect on Sept. 9, 2021, with needing an approved PMTA or your product can no longer be sold,” the company wrote.
In July 2020, Puff Bar announced that it would cease all online sales and distribution in the U.S. until further notice after receiving a warning letter from the FDA. However, the brand resumed sales on its website in February of this year with an altered product. To get around the ban on its products, Puff Bar began using tobacco-free nicotine. As of this writing, Puff Bar continues to hawk its products both on its website and in convenience stores around the U.S.
Meanwhile, the popular online vaping retail website Element Vape.com has at least 11 brands offering several synthetic nicotine e-liquids in different flavors, including fruits, cereals and candies. Pioneer e-liquid manufacturer Five Pawns reformulated its vape juice using synthetic nicotine even before the Sept. 9, 2020, PMTA submission deadline.
“Synthetic nicotine products still must abide by nationwide age restrictions, but the Center for Tobacco Products lacks the ability to regulate them as ‘tobacco products,’” said Greg Conley, president of the American Vaping Association. “Unless and until the FDA authorizes a sufficient number of flavored products to keep current ex-smokers off of cigarettes, we will support efforts by small businesses to keep offering their products to adult customers.”
Tony Abboud, executive director of the Vapor Technology Association, said that synthetic nicotine has been available and on the market since as early as 2014, and while the FDA and U.S. Congress could have elected to regulate synthetic nicotine at any time, they have chosen not to confront the issue.
“If it wasn’t for the innovation of the vapor industry, cigarette companies would not today be saying, ‘We want to get rid of combustibles.’ Synthetic nicotine is simply the next level of innovation, and it’s not surprising the government is behind it. The [U.S.] government is always behind companies in any industry that is technological and that innovates,” explains Abboud. “There’s no surprise here. There’s no loophole here. There’s no evasion here. The marketplace is what the marketplace is. It’s up to the government to figure out if and how it wants to catch up.”
Credit: Myvisuals
Anti-tobacco groups, by contrast, vowed to halt the spread of synthetic nicotine. In a recent letter to the FDA, the Campaign for Tobacco-Free Kids (CTFK), the American Academy of Pediatrics and the American Lung Association, among other organizations, argued that e-cigarette manufacturers are using “a loophole” to avoid government regulations.
“As FDA denies marketing applications for e-cigarettes, manufacturers are exploring using synthetic nicotine in order to continue marketing their products while avoiding FDA regulation,” the letter states. “This development makes it even more imperative that FDA take immediate action against illegal, synthetic nicotine products.”
Matthew Myers, president of CTFK, said synthetic nicotine is not a safer product, and his organization has sent at least three letters since 2018 to the FDA concerning synthetic nicotine products, none of which has received a response from the regulatory agency. “It is totally designed to circumvent government regulation,” he said. “The companies that have used nicotine derived from tobacco to [now] nicotine made in a laboratory are the companies whose products have been denied because of their appeal to youth and their lack of evidence that they actually help smokers quit.”
Conley said that there is a reason the CTFK’s and other letters have gone unanswered through two different presidential administrations. “Tobacco-free nicotine was invented to eliminate trace levels of impurities that are present in traditional nicotine sources, not to evade regulation. Rather than expanding the futile war on drugs to nicotine, we believe all nicotine products should be regulated as consumer products and sold only to adult consumers 21 years and over.”
Defining tobacco products
Whether the FDA will allow products with synthetic nicotine to stay on the market remains to be seen. Despite its growing popularity, the category current operates in a regulatory void. Because the product is not derived from tobacco, it does not necessarily fall under the 2009 Family Smoking Prevention and Tobacco Control Act or meet the requirements of the Federal Food, Drug and Cosmetic Act’s definition of a tobacco product.
When synthetic nicotine first appeared on the market in 2016, the product was marketed as a way to circumvent the FDA’s proposed deeming rule for next-generation tobacco products by at least one company. The FDA’s definition of “tobacco product” includes any product made or derived from tobacco [that is intended for human consumption], including any component, part or accessory of a tobacco product. E-liquids that do not contain nicotine or other substances made or derived from tobacco may still be components or parts and, therefore, subject to the FDA’s tobacco control authorities, according to the agency.
“However, it’s possible that a disposable, closed system device that contains an e-liquid with truly zero nicotine (or synthetic nicotine) would not be regulated by the FDA as a tobacco product if it is not intended or reasonably be expected to be used in such a fashion,” the FDA states on its website. “[The] FDA intends to make these determinations on a case-by-case basis, based on a totality of the circumstances.”
In late 2016, Next Generation Labs (NGL), the maker of proprietary TFN Nicotine—nontobacco derived synthetic nicotine liquid and crystals—noted court statements made by the FDA in the NicoPure Labs LLC v. U.S. Food & Drug Administration that seemed to confirm that products not made or derived from tobacco fall outside of the FDA’s deeming rule.
Credit: NDABCREATIVITY
TFN claimed that in a response brief to the court dated Nov. 1, 2016, the FDA had stated that not all nicotine-free e-liquids (NFLs) were subject to the deeming rule. “Assuming an NFL is not made or derived from tobacco, it is subject to the rule only if it meets the definition of a ‘component or part’—that is, if it is ‘intended or reasonably expected’ either … (1) to alter or affect [a] tobacco product’s performance, composition, constituents or characteristics; or (2) to be used with or for the human consumption of a tobacco product; and is not an accessory,” the FDA was quoted as having said.
Experts have also said that the FDA could potentially assert jurisdiction over synthetic nicotine as a tobacco product and argue that, when the legislation was written, nobody had the foresight to think about synthetic nicotine. Eric Lindblom, a senior scholar at Georgetown’s O’Neill Institute for National and Global Health Law and a former director of the FDA’s Center for Tobacco Products Office of Policy, said that, in response to such moves by vapor companies, the FDA could either assert jurisdiction over synthetic nicotine as a tobacco product or push for synthetic nicotine to be regulated like any other drug.
Congress could eventually pass a nationwide ban on synthetic nicotine. A more likely scenario, however, according to industry insiders, is that individual states ban the sale of synthetic nicotine products. On May 17 of this year, the governor of Alabama signed into law Act No. 2021–453, which was backed by Altria, with that purpose in mind.
The legislation, which went into effect Sept. 1, states that “no e-liquid, e-liquid in combination with an electronic nicotine-delivery system, or alternative nicotine product that, in the case of any such product, contains synthetic nicotine or nicotine derived from a source other than tobacco may be sold or otherwise distributed” in Alabama if products have not been approved by the “FDA for sale as a drug, device or combination product.”
Abboud says vapor companies may not want to face the drug regulatory pathway. “Drug protocols are absurd, and if companies cannot even survive this PMTA process, then how would they ever possibly survive the other one?” he questioned. “Are you going to blame a company that spent millions of dollars trying to comply with [the] FDA’s opaque regulatory process, find that the FDA changed the rules at the last moment after the fact, and then and you’re going to criticize that company for doing something that’s currently lawful?”
For the time being, synthetic nicotine e-liquids will likely keep flavored e-liquids on the market despite the FDA’s efforts to remove them. However, Conley warned manufacturers against publicly advertising or celebrating their decision to switch to synthetic nicotine.
“A note to manufacturers planning to use TFN—don’t make public pronouncements about what you’re planning to do over the next month. Just do it,” he tweeted. “[The] FDA may have no respect for you, but there’s no need to blast them publicly. Plenty of harm reduction advocates can handle that.”
Sidebar
What is synthetic nicotine?
A major argument for synthetic nicotine is that it is safer than tobacco-sourced nicotine. The synthetic nicotine has no tobacco-specific nitrosamines (TSNAs), the harmful, cancer-causing chemicals found in combustible tobacco products. TSNAs are formed when tobacco leaves are grown, cured, aged and processed.
Research has shown that all nicotine is highly addictive, and regardless of the form, should be consumed with caution. However, the chemical does not directly cause cancer, which instead results from inhaling the byproducts of combustion.
Whether manufactured naturally or artificially, the nicotine molecule has the same chemical structure, C10H14N2, meaning that it comprises 10 carbon atoms, 14 hydrogen atoms and two nitrogen atoms. What makes it special, independent of its origin, is that it is a “chiral” molecule: It has two stereoisomers that are mirror images of each other.
The most prevalent form is (S)-nicotine, the physiologically active variant. Its mirror isomer, (R) nicotine, also occurs in plant-derived nicotine in small amounts but is considered physiologically ineffective. Synthetic nicotine is made with a combination of niacin, ethanol, sulfuric acid and a few other chemicals.
Traditionally, a problem for the producers of synthetic nicotine has been that the production process is both complicated and expensive. As a chiral molecule, nicotine is far easier to produce as a synthetic nicotine with equal amounts of both (R) isomers and (S) isomers compared to a nearly pure (S)-nicotine.
Naturally derived nicotine and synthetic nicotine are identical on a molecular level. The differences are the individual or potential impurities. Nicotine derived from tobacco can contain potentially harmful impurities. Purification can be difficult and costly because the impurities appear structurally very similar to the nicotine molecule itself. But synthetic nicotine is virtually free of any impurities from the beginning, and none of the impurities are carcinogenic.
Currently, two types of synthetic nicotine are on the market: an (S) only synthetic nicotine and a 50 percent (S) and 50 percent (R) synthetic nicotine. In the early years of the vaping industry, the cost of the process to produce synthetic nicotine was prohibitively expensive when compared to tobacco-derived nicotine extraction methods.
Today, that’s no longer the case. Synthetic nicotine can be purchased for nearly the same price as tobacco-derived nicotine and in some instances for even less. This is due to advancements in the commercially scaled bulk production of synthetic nicotine for use in the tobacco, vaping, pharmaceutical and scientific research industries.
In November 2020, eLiquiTech, a wholly owned subsidiary of Tobacco Technology Inc. (TTI), released its recently patented SyNic synthetic (S)-nicotine. Because SyNic has greater than 99.7 percent (S), an e-liquid needs only half the amount of SyNic to create the same effect for users as current 50/50 synthetic nicotine offerings on the market.

October 28, 2021
FDA Stays Bidi Vapor MDO Pending Review
The U.S. Food and Drug Administration has issued an administrative stay of its marketing denial order (MDO) for nontobacco flavored bidi sticks, pending the agency’s review of Bidi Vapor’s request that the MDO be rescinded based on product-specific scientific evidence in its premarket tobacco product applications (PMTAs).
Bidi Vapor’s flavored Bidi Sticks may remain on the market without the threat of enforcement while the FDA reviews the company’s request.
Bidi Vapor submitted PMTAs for all 11 flavor varieties of its Bidi Stick. The applications ran over 285,000 pages and contained information supporting the products as appropriate for the protection of the public health.
On Sept. 29, 2021, Bidi Vapor filed a Petition for Review with the U.S. Court of Appeals for the 11th Circuit, seeking judicial review of the MDO under the Tobacco Control Act, the Administrative Procedure Act as well as the U.S. Constitution.
“We appreciate FDA’s decision to stay, or put on hold, the MDO as it reconsiders its denial,” said Bidi Vapor Niraj Patel in a statement. “As we explained to the agency, Bidi Vapor submitted scientifically rigorous PMTAs that contained product-specific evidence demonstrating that the added benefit of our flavored Bidi Sticks to adult smokers outweighs any potential risks to youth, especially considering our stringent youth-access prevention measures and commitment to mature, adult-focused marketing.”
“That said, we are still seeking a formal, judicial stay from the appellate court pending the outcome of the lawsuit,” Patel noted.
The company has now filed a Motion for Stay Pending Review with the 11th Circuit Court of Appeals citing the “irreparable harm” it continues to suffer from the MDO.
Multiple companies have challenges their MDOs in recent weeks. In early October, the FDA rescinded MDOs it has issued to Turning Point Brands and Fumizer, placing their products back under review.
According to Filter, Triton, Bidi and Gripum recently received some temporary form of stay, and My Vape Order has demanded a recission due to the fact its PMTA includes some of the same data and studies that also appears in TPB’s applications.
October 28, 2021
Court: Triton Can Sell Flavored E-Cigs Pending MDO Review

Photo: kwanchaift
The 5^th U.S. Circuit Court of Appeals has ruled that Triton Distribution can continue selling its flavored e-cigarettes despite a decision to the contrary by the Food and Drug Administration, reports Reuters.
In a unanimous opinion on Oct. 26, the 5th U.S. Circuit Court of Appeals said that when the FDA last month denied the Texas company’s application to sell its products, the agency did not adequately consider Triton’s marketing plan to reduce the products’ appeal to youth.
The court found the FDA pulled a “surprise switcheroo” from earlier guidance stating that manufacturers would not need long-term studies to support e-cigarette applications.
The FDA initially said in guidance accompanying the deeming rule that it did not expect companies would need long-term studies to support their application. However, in an August announcement that it would deny a first batch of applications, the agency said that manufacturers would likely need studies that followed a cohort of people over time to show that their products’ use in helping adult smokers quit cigarettes outweighed the risk to youth.
Triton challenged the agency’s decision, saying it had relied on the earlier guidance in its application.
Multiple companies have challenged their MDOs in recent weeks. In early October, the FDA rescinded MDOs it has issued to Turning Point Brands and Fumizer, placing their products back under review.
More recently, the FDA issued an administrative stay of its MDO for nontobacco flavored bidi sticks, pending the agency’s review of Bidi Vapor’s request that the MDO be rescinded based on product-specific scientific evidence in its PMTAs.
According to Filter, Bidi and Gripum too recently received some temporary form of stay, and My Vape Order has demanded a recission due to the fact its PMTA includes some of the same data and studies that also appears in TPB’s applications.

October 28, 2021
Gay: Taxing Decisions

Credit: Orlando Bellini
Higher taxes and graphic warnings are not the best ways to encourage smokers to switch to ENDS.
By George Gay
Towards the end of August, the U.S. Food and Drug Administration announced that it had issued marketing denial orders (MDOs) in respect of about 55,000 flavored electronic nicotine-delivery system (ENDS) products. At about the same time, the FDA announced also that the deadline for combustible-cigarette manufacturers to print new health warnings on their products and product advertising had been delayed until October 11, 2022.
I think these two developments will strike you as odd if you subscribe to two almost universally-held ideas: that the consumption of combustible cigarettes kills and that graphic health warnings help to discourage people from such consumption; and if you subscribe to the idea that is less widely held: that ENDS are the most effective products for helping people quit smoking.
Indeed, to say that these two developments seem odd is something of an understatement. They represent a world turned upside down; a world in which the consumption of combustible cigarettes, which are regarded as deadly, is not discouraged, while the consumption of less-risky, cigarette-substitute products is discouraged.
Credit: Timothy S. Donahue
It is important to say, however, that what has happened is not entirely down to the FDA, which, in line with its obligations under the Tobacco Control Act of 2009, initially tried to bring in graphic health warnings on combustible cigarettes about 10 years ago, only to have them challenged in the courts and declared unconstitutional. The latest attempt at bringing in such warnings, the details of which became known in 2020, was similarly subjected to challenges, and to court-imposed delays.
However, it is reasonable, I think, to quarrel with the types of warnings proposed, which seem in large part to follow the same tired pattern of those used in other countries and regions. For instance, the proposed U.S. graphic warning pictures and captions, in line with those introduced elsewhere, do not tell the full story – that is, they don’t tell the whole truth.
Just to take one example; the caption on one picture reads, Warning: Smoking causes cataracts, which can lead to blindness. I don’t smoke, but I have cataracts forming; so obviously there are other causes of cataracts, the biggest of which I would say is probably, as in my case, getting old.
If there is to be an honest attempt at informing smokers, the cataracts warning needs to answer a lot of questions specifically aimed at people living in the U.S., questions that could be answered easily on a pack insert. Are there other causes of cataracts and what are they? At what age do smokers and non-smokers generally start to suffer from cataracts? Are cataracts more common in smokers than in non-smokers? Given that removing cataracts is one of the more common and more successful operations performed, how often do cataracts lead to blindness? Is the incidence of cataract-induced blindness more common among smokers than in the general population?
That the caption doesn’t answer these questions and the others that might rightly be raised by smokers, in my view is down to the paternalistic attitude of the FDA – and agencies in other countries that are in charge of determining the form of such warnings. Largely, I think, because smokers tend to be found in what are termed lower socio-economic groups, it is assumed they have to be told what is good for them without bothering their heads with details; whereas, in fact, some of them are rather smart.
Meanwhile, the FDA, while not being directly responsible for the delay in requiring health warnings on cigarette packs and advertising, is, in my view, more culpable in respect of the muddle over ENDS products. Basically, it has become hoist on its own petard – entrapped by its own propaganda about youth vaping.
In issuing its MDOs in August, the FDA said it had determined that the “applications for about 55,000 flavored ENDS products from three applicants lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products. The products from JD Nova Group LLC, Great American Vapes, and Vapor Salon subject to this action are non-tobacco-flavored ENDS and they include flavors such as Apple Crumble, Dr. Cola and Cinnamon Toast Cereal.”
This whole idea of considering public health, or population-wide health, rather than individual health, has its merits, but it is also flawed; as is the idea of utilitarianism on which it seems to be loosely based. If the idea is to bring about the maximum good for the maximum number of people, the calculations necessary become overwhelming and, in part, require the foretelling of the future.
As the FDA says, the applicant must demonstrate that the product is appropriate for the protection of public health. “This public or population health standard is quite high and requires considering the product’s risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account the increased or decreased likelihood that existing users of tobacco products will stop using such products, and the increased or decreased likelihood that those who do not use tobacco products will start using such products,” it says.
If a doctor you have consulted wants to prescribe for you an inhaler, is it incumbent upon her to take into account the fact that the production of that inhaler, and all the inhalers you will need for the rest of your life, will produce CO2 emissions that will exacerbate the existential climate crisis we have created and, therefore, the health of Joe Blow, who will then need an inhaler so that there are now two such devices being produced on a regular basis along with more CO2…?
To my way of thinking, it makes sense to consider population-wide health effects where there is a population-wide health threat, such as that caused by pollution, which is a far bigger killer than is tobacco smoking but which is largely consigned by those who should be tackling it to the too-hard drawer. But it seems to make little sense where what is in question comprises health threats to individuals and possible solutions for those threats.
Of course, what those who like to consider population-wide health benefits or threats will tell you is that there is no point in allowing the sale of vaping devices so that middle-aged Joe Blow can use such devices to quit smoking if young man John Doe takes up vaping and goes on to become a smoker, at least when this example is extrapolated across the population. I really don’t accept this argument because, to me, Joe and John are individuals, as are all the other people who make up the population and who make their own choices about what they do with their lives.
What has happened here is that, as mentioned above, the FDA has found itself hemmed in by its own propaganda. Take another look at that part of the FDA’s statement above where it tries to justify dumping 55,000 vaping products and where it talks of: ‘the public health threat posed by the well-documented, alarming levels of youth use of such products’.
To me, the use of the word “alarming” is an example of where the FDA’s claim to scientific rigor runs out of road. Compare what the FDA had to say with what was stated recently in a report entitled, Balancing Consideration of the Risks and Benefits of E-Cigarettes, which, I understand, was penned by 15 past presidents of the Society for Research on Nicotine and Tobacco.
Although the authors argue that the overwhelming focus of US policies and media attention on decreasing youth vaping has distracted from the goal of reducing smoking, they concede that: “Still, concerns emanating from substantial increases in youth vaping in 2018 and 2019 are readily understandable and important to address.”
It is also important to take note of something else that I think is significant. A contributor to the Global Forum on Nicotine held in the UK earlier this year explained how U.S. government policies were driven by the fears and wishes of the majority population, made up of the suburban, white, middle-classes. This was why tobacco smoking, a habit mainly of the financially less-well-off, had been largely tolerated [health warnings delayed again], while vaping, the subject of scare stories about an epidemic among the children of the middle class, had launched a moral panic [55,000 products dumped].
The Balancing Consideration report is indeed a model of balance; as can be glimpsed from this passage: ‘Smokers unable to quit smoking with evidence-based cessation methods should be well informed about the relative risks of vaping and smoking and vaping’s potential to help them quit smoking. They should understand that, while the long-term health consequences are unknown, completely substituting vaping for smoking likely reduces health risks, possibly substantially.
Dual use of cigarettes and e-cigarettes will not have a comparable beneficial effect. However, a period of dual use may be necessary for some smokers to transition from smoking. Because vaping itself poses some risk, the best advice is to eventually stop vaping as well.’
I find it impossible to argue with almost anything in this passage or in the objective of the authors, which is to encourage more balanced consideration of vaping within public health and in the media and policy circles. There is certainly a need for such balance. As the authors say in the introduction to the report: “Opponents focus on e-cigarettes’ risks for young people, while supporters emphasize the potential for e-cigarettes to assist smokers in quitting smoking.
Most U.S. health organizations, media coverage, and policymakers have focused primarily on risks to youths. Because of their messaging, much of the public – including most smokers – now consider e-cigarette use as dangerous as or more dangerous than smoking.”
The authors are correct; this is a situation that needs to be rectified.
And yet, I cannot go along with everything in the report, though it talks with empathy about smokers. “Today’s smokers come disproportionately from lower education and income groups, the LGBTQ (lesbian, gay, bisexual, transgender, and queer or questioning) community, and populations suffering from mental health conditions and from other drug addictions,’ it says. ‘Smoking accounts for a significant proportion of the large life expectancy difference between affluent and poorer Americans.”
And the report is right in making the point that a lot of people hardly realise that smokers still exist. “To the more privileged members of society, today’s smokers may be nearly invisible,” it says. “Indeed, many affluent, educated US persons may believe the problem of smoking has been largely ‘solved.” They do not smoke. Their friends and colleagues do not smoke. There is no smoking in their workplaces, nor in the restaurants and bars they frequent. Yet one of every seven U.S. adults remains a smoker today.”
But then, to my mind, the report loses its way. “Tax cigarettes and other combustible tobacco products heavily; impose a more modest tax on e-cigarettes,” it advises. “Taxes should be proportionate to risk. A much higher tax on combustibles will encourage adult smokers to quit smoking or to switch to less expensive e-cigarettes. By raising the price of e-cigarettes, a modest tax will discourage their use by price-sensitive youths.”
There are several problems with this, I would suggest, partly perhaps because, I suspect, the authors don’t smoke and don’t generally rub shoulders with those in the lower socio-economic groups. The authors want to tax smokers heavily having already declared that these people generally come from groups less well-off financially. They say that this is to encourage smokers to stop smoking, but it is nothing of the sort. It is an attempt at bludgeoning them into giving up.
To my way of thinking, if a smoker is given the facts about her habit, partly through the medium of comprehensive, fact-based health warnings, and she chooses to keep smoking, that is her business. Hitting her with levels of taxes that would not be tolerated but for the fact that smokers comprise an unrepresented minority is grossly unfair.
And what will happen to the money raised? Will it be spent on helping these people? The record shows that this will not be the case. The money will be spent on politicians’ vanity projects, while nine million children will still go hungry.
And finally, what about the seemingly worthwhile aim of increasing the life expectancy of these smokers by bludgeoning them into quitting? Given that the last years of these people’s lives are hardly likely to be halcyon; it might be a good idea to ask them if they really want another 10 years of struggling to make ends meet as they become increasingly infirm. Walk – or perhaps hobble – a mile in my shoes.
October 27, 2021
Bangor, Maine Bans Flavored Vaping Products
The city of Bangor, Maine has banned flavored vaping products, including e-cigarettes. The Bangor City Council voted 7-1 in favor of the ban, which will not go into effect until after the Maine Legislature reconvenes next year. The ordinance bans the sale and marketing of all flavored tobacco products in the city — including menthol cigarettes and e-cigarette flavors that have a taste or smell besides tobacco — beginning on June 1, 2022.
Credit: Ianm35
While the amended ordinance falls short of the pre-session ban that advocates hoped would spur the Legislature to action on a statewide prohibition on the sale of flavored tobacco, it is a strong gesture for a council with many members who believe the flavored tobacco issue was better solved at the state level, according to Maine Public Radio.
Opponents and supporters saw the Bangor vote as an important step in the fight to ban the sale of flavored tobacco at the state level. That bill, LD 1550, was reported out of committee earlier this year but had not come to a vote before the end of this year’s legislative session.
Many opponents brought up the contents of messages the National Association of Tobacco Outlets requested under Maine’s Freedom of Access Act that they said showed an effort by Bangor councilors, especially Councilor Sarah Nichols, to not include the voices of merchants in the process of crafting and debating the ordinance. Many of the exchanges are text messages between Nichols and Matt Moonen, who had brought the proposal to ban flavored tobacco to her. Moonen is the executive director of Equality Maine.
Earlier Monday, the New England Convenience Store and Energy Marketers Association had called for the council to suspend decisions on the tobacco ban and evaluate how councilors had acted. Sprague, one of several councilors to turn back those arguments, said such allegations had ultimately hurt the opponents’ case.
“The comments about the process and how the city has not supported open dialogue are insulting, if not repulsive,” Sprague said. City Council Chair Dan Tremble was the only councilor to vote against the ordinance. Nichols did not directly respond to statements about her during the meeting, though she referenced them in her remarks on why she supported the ordinance.
Retailers who continued to sell or market flavored tobacco products after the ordinance took effect would first face a warning, and then a $50 to $100 fine for their next offense within a two-year period after the warning. A fine of $300 to $1,000 would then be levied for each additional offense within that two-year period.
October 27, 2021
WHO Urged to Embrace Tobacco Harm Reduction
The ninth Conference of the Parties (COP9) to the World Health Organization Framework Convention on Tobacco Control (FCTC) will operate under conditions of secrecy comparable to those of the U.N. Security Council, according to a new report by the Global State of Tobacco Harm Reduction (GSTHR) titled, Fighting the Last War: The WHO and International Tobacco Control.
The public and media are banned from attending all but one largely ceremonial opening plenary, yet millions will be affected by the decisions taken at COP9, which is scheduled to take place virtually Nov. 8–13.
The report contends that current implementation of the FCTC is a global public health failure. In force since 2005, when there were 1.1 billion smokers around the world, the FCTC set out the principles of global tobacco control—to reduce the death and disease caused by smoking. In 2021, however, there are still 1.1 billion smokers worldwide and 8 million smoking-related deaths each year. What’s more, the number of smokers is predicted to rise, and the number of smoking-related deaths is set to top 1 billion this century.
Change is urgently needed, and harm reduction for tobacco offers the opportunity for that change, according to the GSTHR.

Fighting the Last War notes that while tobacco control policy has remained frozen in time, innovative noncombustible nicotine technology and supporting evidence have moved forward. Vaping devices, snus, nicotine pouches and heated-tobacco products are significantly safer than cigarettes as they deliver nicotine without combustion, according to the report’s authors. This, they argue, enables people who cannot or do not want to stop using nicotine to quit deadly smoking and switch to less risky products.
“Just as delegates at COP26 will be discussing the world’s urgent need to stop fossil fuel combustion, the technology is now in place to ensure the end of the age of combustion for tobacco as well,” the GSTHR wrote in a press note. “A number of Parties to the FCTC, such as the United Kingdom and New Zealand, have successfully introduced tobacco harm reduction policies alongside their tobacco control regimes and have seen marked decreases in smoking rates.”
When given accurate information about comparative risk, many smokers switch, the organization notes. Worldwide, the GSTHR estimated in 2020 that 98 million people worldwide were using safer nicotine products.
The authors also point out that the concept of harm reduction is embedded in the WHO response to drug use and HIV/AIDS. It is explicitly named as the third pillar of tobacco control alongside demand and supply reduction in the FCTC. Yet the WHO has remained implacably opposed to harm reduction for tobacco and is increasingly viewed as having overseen a “mission creep,” which now sees international tobacco control setting its sights on prohibition for nicotine in all its forms.
“There are concerning signs in published agenda and briefing papers that the FCTC secretariat and leadership continue to urge Parties against increasing access to, or even to prohibit, safer nicotine products,” the GSTHR wrote.
Fighting the Last War considers the motivations—ideological, financial and historical—that have led to many global tobacco control practitioners becoming so hostile to what others see as the greatest potential public health advance in decades.
The report argues that Parties to the FCTC need to seize back control of the COP meetings from the FCTC secretariat, which it says has become overly influential with little oversight. FCTC Parties should press for more evidence-based discussions, calling upon the widest breadth of scientific, clinical and epidemiological expertise on safer nicotine products and tobacco harm reduction, according to the authors. “This should include evidence from Parties that have implemented harm reduction policies, those involved in manufacturing safer nicotine products and the lived experience of consumers,” they wrote. “The establishment of a working group on tobacco harm reduction would offer a pragmatic route to move the FCTC toward a tobacco control regime fit for purpose in the 21st century.”

“As global leaders prepare to make important pledges on climate change under the glare of the media spotlight at COP26, we urge them to demand more from their delegations inside the closed and unscrutinized rooms of COP9,” says Gerry Stimson, director of Knowledge-Action-Change and emeritus professor at Imperial College London. “Every day, more than one billion smokers are being failed by the international tobacco control regime. The age of combustion—for tobacco as for fossil fuels—must end.
“Tobacco harm reduction offers new routes out for adult smokers. GSTHR estimates suggest that 98 million of them have already switched. At COP9, government delegations must seize back control and prevent the slide into outright nicotine prohibition that would see many return to smoking and many millions more never succeed in quitting.”
“The fight to reduce eight million smoking-related deaths a year is now being actively undermined by the WHO and the international tobacco control establishment,” said report author Harry Shapiro. “Together, they are fighting the last war against the tobacco industry—to direct attention away from the evidence that safer nicotine products can make a significant contribution to reducing that death toll.”
“If those who dominate the global tobacco control discourse were truly committed to public health imperatives, harm reduction principles and policies would be front and center,” said Ethan Nadelmann, founder of the Drug Policy Alliance. “This valuable report exposes the ways in which international institutions have turned their backs on scientific evidence and the human and political rights of hundreds of millions of people whose lives might be saved by safer nicotine products.”
“Fighting the Last War provides an insight into the dark arts of the WHO that many would find breathtaking and incomprehensible,” said Jeannie Cameron from JCIC Consulting. “It shows a concerning difference between the world’s preparations for COP26 on climate change and COP9 on tobacco. Governments need to stand up at COP9 to support tobacco harm reduction against the outdated views of the WHO.”

The fight to reduce eight million smoking-related deaths a year is now being actively undermined by the WHO and the international tobacco control establishment. Together, they are fighting the last war against the tobacco industry—to direct attention away from the evidence that safer nicotine products can make a significant contribution to reducing that death toll.”
Harry Shapiro, author, ‘Fighting the Last War’
“The challenge for lower and middle-income countries while fighting the last war and promoting real tobacco control is about two major issues,” said Nataliia Toropova from Healthy Initiatives. “Firstly, the current provisions of the WHO FCTC have not been properly implemented due to stretched government resources. Thus, smoking cessation programs are nonexistent, and adult smokers feel hopelessly stuck while making their numerous unsuccessful attempts to quit with no medical help or guidance provided. Secondly, the lack of a comprehensive harm reduction strategy is aggravated by a massive misinformation campaign about harm reduction products and a declared war on nicotine. Unless these two issues get tackled, unless the powerful voice of doctors becomes loud and gets heard, unless education and awareness building campaigns take place, no changes will occur, and this last war will be lost.”
October 27, 2021
Turning Point Brands Posts Third-Quarter Results
Turning Point Brands reported net sales of $109.9 million in the third quarter of fiscal 2021, up 5.5 percent over that of the previous year’s third quarter. Gross profit increased 12.3 percent to $54.3 million and net income increased 49.3 percent to $13.4 million.
“Our third quarter performance fell within our expectations with sales growth of 11 percent in our core business despite facing the headwind of Covid-related consumption and other benefits we experienced in the prior year period,” said TPB President and CEO Larry Wexler in a statement.
“Zig-Zag had another robust quarter driven by our strategic initiatives and growth within our Canadian business. Stoker’s saw double-digit growth in our Moist Snuff Tobacco (MST) business which drove growth in the overall segment. Regarding capital deployment, we continued to repurchase our shares during the quarter and today announced an increased share repurchase authorization. We also maintain a strong balance sheet to pursue a healthy pipeline of investment opportunities. Overall, we remain optimistic about the growth prospects in our core business.”
NewGen Products gross profit increased 22.4 percent to $13.5 million for the quarter. The segment gross margin expanded 760 basis points to 36.2 percent with the improvement partially driven by industry pricing pressure ahead of the PMTA submission deadline in the previous year comparable period.
Wexler said he was encouraged by the U.S. Food and Drug Administrations recent decision to reconsider and place back into review the premarket tobacco product application for TPB’s proprietary vapor products, which the agency had earlier rejected.
“I am confident that we submitted a robust application and look forward to engaging with the FDA in its review,” he said. “We continue to believe that robust regulatory oversight is a positive for the industry and we believe we are favorably positioned to leverage our strong regulatory and logistics capabilities to capitalize on an attractive long-term opportunity.”
October 27, 2021
Youth THC Vaping More Than Doubles Since 2013
While nicotine vaping by youth takes the headlines, teen vaping of marijuana more than doubled between 2013 and 2020, according to a new study. Youth use of nicotine vaping products, however, dropped the past two years. The results may indicate that young people may be swapping out joints, pipes or bongs for vape pens, according to a new study.
Credit: H Ko
Researchers also found that adolescents who say they vaped cannabis within the last 30 days increased 7-fold — from 1.6% to 8.4% — during the same period. The report was published in JAMA Pediatrics on Monday by researchers who analyzed 17 studies involving nearly 200,000 adolescents in the U.S. and Canada.
Overall, they say, the cumulative data points to what may be a shift in preference from dried herb to cannabis oil products, which is how marijuana is ingested via vaping, according to NPR. This may be due to the more intense high that can be achieved by cannabis oils, which contain higher levels of THC, the psychoactive ingredient in marijuana, and the “misconception” that vaping devices are safer than smoking.
“Regular use of high THC products could increase the risk of dependence, other substance use and many other health, social and behavioral problems later in life,” study author Carmen Lim, a doctoral candidate in health and behavioral sciences at the University of Queensland in Australia, told NPR.
The Monitoring the Future survey — a large U.S. survey on drug and alcohol use related attitudes in adolescents — is one of the 17 studies included in the new meta-analysis. Although it showed that marijuana use has remained relatively stable among 12th graders in the last few years, hovering around the 35 percent mark, the growing popularity of electronic pot vaping devices is alarming, Lim said.
October 26, 2021
Texas Vape Shops Sue Over State’s Delta-8 THC Ban
Texas recently released an updated guideline making Delta-8 THC products illegal in the state. Delta-8 THC products now are listed as a Schedule I controlled substances, and state health officials noted that the products have been banned for months now.
Credit: Promesaartstudio
The move prompted several Texas CBD and vape shops owners to file for temporary restraining orders regarding the announcement. Those who filed the temporary restraining orders prayed it to be granted against the state. According to The Dallas Morning News, Ashley Flood, the owner of a CBD American Shaman franchise, said that she and other owners and consumers were not informed of the move to update the state’s website regarding the use and selling of marijuana-related products.
The Dallas Morning News quoted Flood saying, “We didn’t find out from the state, we didn’t find out from law enforcement, we didn’t find out via letter, email — nothing. We found out from one of our suppliers.” Flood added that she purchased $20,000 word of Delta-8 products for her store, accounting for 50 to 60 percent of her profit. If they are illegal, her business will be badly hit.
What is interesting about the DSHS’ statement regarding Delta-8 is that it follows a popular trend among states regarding Delta-8: state agency prohibition against certain cannabinoids that appear damning, despite the fact they might not carry the force of law, according to renowned cannabis attorney Rod Kight.
“Other states across the country, including Iowa, Kentucky, Massachusetts, North Carolina, South Carolina, and Vermont, to name a few, have, through various agencies, enacted similar prohibitions. However, while other states across the country are attempting to chill the fervor of Delta-8 via agency or administrative actions, what makes Texas’ prohibition unique is that it appears to be the result of deliberate action taken over a period of time to amend Texas’ list of controlled substances to be different than the federal list of controlled substances,” Kight said. “Importantly, this agency amendment followed the Texas legislature’s inability to pass a bill that would have banned Delta-8 THC during its most recent legislative session.”
The Dallas Morning News said that the 2018 Farm Bill might be the one confusing sellers and consumers regarding Delta-8 products. The bill legalized Delta-8 products at the federal level, but it allows individual states to develop more stringent laws regarding the selling and consumption of such.
Further, many believe the Delta-8 products remain legal because, under the law that Gov. Greg Abbott signed in 2019, hemp products with less than 0.3 percent tetrahydrocannabinol are legal.
October 26, 2021
FDA Rescinds Another Marketing Denial Order
Credit: AliFuat
The U.S. Food and Drug Administration has rescinded another marketing denial order (MDO), placing Fumizer’s flavored vapor products back under review, reports Filter. Fumizer received its MDO in September.
This rescission comes just weeks after the agency withdrew an MDO issued to Turning Point Brands (TPB).
In a letter to Fumizer’s, the FDA stated that “upon further review of the administrative record, FDA found relevant information that was not adequately assessed previously.”
“Specifically,” the letter states, Fumizer’s “application did contain randomized controlled trials comparing tobacco flavored ENDS [electronic nicotine-delivery systems] to flavored ENDS as well as several cross-sectional surveys evaluating patterns of use, likelihood of use and perceptions in current smokers, current ENDS users, former tobacco users and never users, which require further review.”
The FDA has indicated that it “does not intend to initiate an enforcement action” on Fumizer’s flavored vapor products returning to the market during the new review.
Many MDO recipients have complained that the FDA has been “shifting its goal posts,” during the review process, demanding certain studies that it did not appear to require before the PMTAs were filed.
According to industry insiders, the most recent MDO recission demonstrates that TPB’s successful petition for review and motion for a stay wasn’t a one-off, resulting from the legal jurisdiction it was filed in.
“A rescission in California for Fumizer is evidence of the systemic failure of the agency to ‘adequately assess’ the science and data of a wide range of small- and mid-sized applicants while giving all of their time and attention to the large companies like Juul and Reynolds,” a source told Filter
Multiple companies have challenges their MDOs. Triton, Bidi and Gripum recently received some temporary form of stay, and My Vape Order has demanded a recission due to the fact its PMTA includes some of the same data and studies that also appears in TPB’s applications.
October 26, 2021