A proposed tax bill in U.S. Congress would add $40 to the cost of a 120 mL bottle of e-liquid with 6 mg of nicotine.
By VV staff
The proposed U.S. Tobacco Tax Equity (TTE) Act would tax vaping products the same as combustible cigarettes. According to research from the Tax Foundation, an independent tax policy nonprofit, the proposal would double the rates on combustible cigarettes and increase the rates on all other tobacco and nicotine products—including electronic nicotine-delivery systems (ENDS)—to achieve parity with the traditional tobacco tax rate.
The proposed rule aims for the tax per 1,000 cigarettes to be increased to $100.66. Vaping products would be taxed at this same rate, with 1,000 cigarettes being equal to 1,810 mg of nicotine.
“In addition to the one-time increase, the rates would be indexed to inflation, which means they would automatically increase every year,” the report states. “According to Tax Foundation estimates, the tax increases would raise $112 billion over 10 years. The bulk of the revenue, $74.8 billion, is from the doubling of cigarette taxes. The tax on vapor products would raise roughly $15 billion over 10 years.”
According to Alex Norcia of Filter, the proposal would benefit large corporations and traditional tobacco products while unfairly hurting people in lower socioeconomic classes as most smokers do not typically belong to the upper classes. Current cigarette smoking in the United States “is higher among people with low annual household income than those with higher annual household incomes,” according to the U.S. Centers for Disease Control and Prevention.
“This means that a 30 mL bottle of e-liquid containing 3 mg of nicotine per milliliter would be subject a tax rate of $5 for the bottle. A 120 mL bottle of e-liquid that contains 6 mg of nicotine per milliliter would attract a tax rate of $40 for the bottle,” writes Norcia. “In comparison, critics and tax reformists have estimated that a four-pack of Juul pods would be taxed around $9—giving a clear advantage to a giant over the smaller player. More alarmingly, a pack of cigarettes would only be taxed around $2, creating an incentive for nicotine users to pick cigarettes over less risky vapor products.”
In an interview with C-Span on Sept. 15, White House Press Secretary Jen Psaki was asked if the White House believes that the proposed bill on taxing tobacco/vaping products would violate President Biden’s promise to not raise taxes on those making under $400,000 per year. She replied, “No, we don’t,” adding that it was “just one of the ideas out there.”
Vape shops are saying that the proposed tax increase would “completely destroy” their businesses, saying it would be even worse than the U.S. Food and Drug Administration’s failure to approve any ENDS products by the Sept. 9 deadline (see “Authorization Denied,” page?) and the issuing of hundreds of marketing denial orders (MDOs).
“This is going to more than double, and in some cases triple or quadruple, the price of liquids that I sell,” Keith Gossett, the owner of Bucky’s Vape Shop in Columbus, Georgia, told Reason. “I’m going to sit there and try to tell a man with a $6 pack of cigarettes that my [$75] product is better. This tax will close my shop.”
Rather than protecting public health, high excise taxes on lower risk tobacco products jeopardize public health by pushing consumers back to smoking combustible products, according to the Tax Foundation report. “If the policy goal of high taxes on cigarettes is to encourage cessation, taxation of other tobacco and nicotine products must be considered a part of that policy design,” the report states.
The last time the federal excise tax on tobacco was increased was in 2009. While the federal tax has not changed for 12 years, the average tax paid by consumers has increased drastically. Including the last federal increase, the average combined state and federal excise tax rate on tobacco products has jumped more than 80 percent (the average state excise tax rate increased 65 percent between 2009 and 2021), according to the Tax Foundation.
International cannabis attorney Rod Kight discusses minor cannabinoids and the growing cannabis market.
By Timothy S. Donahue
The questions kept coming. When Vapor Voice published an article on Delta-8 THC and other minor THC products in its last issue (see “High Expectations,” Vapor Voice, issue 3, 2021), it seems readers had more questions concerning newly marketed cannabinoids than the story answered. To gain more insight into the state of the current overall global cannabis market, we went to one of the best resources in the business.
In the cannabis industry, there may be no attorney more renowned than Rod Kight. While his firm is based in Asheville, North Carolina, USA, Kight currently spends much of his time in Mexico. His experiences with marijuana started when he used it during chemotherapy treatments in 2011. It had such a positive impact on his recovery that he decided he was going to focus on cannabis law. He wanted others to have the access that offered him such a profound experience.
“It’s kind of funny because I was practicing in North Carolina, which is a prohibition state. I got licensed in Oregon and kind of dove head-in to the laws regarding cannabis. It was right around the time that the 2014 Farm Bill came out that legalized, at the federal level, cannabis for the first time in almost a century,” Kight said. “We started getting calls about CBD. And like any good lawyer, I thought I would do some research and see what the laws and regulations were concerning CBD.”
He did not find much. He said he found nothing on CBD derived from hemp. The only federal restrictions on cannabinoids were centered on the source of the product. If the cannabinoids are derived from marijuana, then they are illegal controlled substances because marijuana is defined as the plant and all its parts. The legal definition is so broad that technically speaking, chlorophyll from a marijuana plant is a controlled substance.
Anything derived from a hemp plant, however, is legal, provided it has less than 0.3 percent Delta-9 THC. “All of the hemp plant’s parts are legal. So, if you get CBD or another cannabinoid from hemp, then it is not a controlled substance. I carved that out and began writing about it,” Kight explained. “We started to get more and more calls, more and more clients … things just went from there. That’s now called the Source Rule, and that was the first thing that kind of put me and the law firm on the map.”
Credit: Rod Kight
When Congress wrote the 2014 Farm Bill, lawmakers specifically stated that hemp is a cannabis plant with no more than 0.3 percent Delta-9 THC. Kight says the law could have easily been written as 0.3 percent of “any” THC. There are 30 known THC isomers. “They singled out that one cannabinoid and had to have some reason for doing so. We don’t know what reason that is. It could be good, bad or otherwise. But it took a special effort to say ‘Delta-9’ and call that out versus just ‘THC,’” says Kight. “The result is that all forms of THC with the exception of Delta-9—no more than 0.3 percent—have been removed from the controlled substances list.”
Another concern is that the U.S. Drug Enforcement Agency (DEA) views Delta-8 as a synthetic form of THC, which is illegal. Kight says the agency is correct in saying synthetic THC is illegal; however, he explained that it is not entirely clear whether Delta-8 produced from CBD qualifies as a “synthetic” form of THC under U.S. law since no generally accepted legal definition of the term “synthetic” exists.
“To be clear, there’s not a special listing for ‘synthetic’ THC. It just says that THC is a controlled substance and that includes synthetic forms of THC … it’s totally accurate. However, the Farm Bill provides an exception. It specifically removed hemp from the controlled substances list, including all of its cannabinoids, extracts, derivatives and isomers. That more specific and recent law trumps the general older law, which is the Controlled Substance Act (CSA).” Legally speaking, this is referred to as the doctrine of “lex specialis,” which means that “the more specific controls over the general. In other words, the Farm Bill exempts hemp-derived Delta-8 THC from the CSA.”
Delta-8 THC and its cousins are not like the synthetic cannabinoids, such as K-12 and Spice, that pushed the DEA to ban synthetic THC, according to Kight. He says that those K-12/Spice synthetics are not anything like the THC molecule. In fact, technically speaking, they are not synthetic forms of THC. Rather, they are best understood as analogs of THC. These fall under the Analogue Act, a section of the CSA passed in 1986. It allowed any chemical “substantially similar” to a controlled substance listed in Schedule I or II to be treated as if it were listed in Schedule I, but only if it is intended for human consumption and has a stimulant, depressant or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the controlled substance.
Delta-8 does not have the same effect on the body as Delta-9 THC. “Synthetics are typically very strong and potent, whereas Delta-8 is up to 10 times less potent than Delta-9 THC,” he said. “That’s a long way of saying that those are compounds that are created in a laboratory. They don’t resemble THC. Delta-8 is a natural compound that the cannabis plant produces and is much less potent than Delta-9 THC.”
Preventing precedent
Another question that arose following our previous article centered on the recent arrests of some Georgia vape shop owners for selling Delta-8 products. The Newnan Times-Herald reports that county authorities were tipped off that a store was illegally selling THC products. An undercover officer bought gummies from the store, and law enforcement tested the product for THC. They tested positive for THC. However, the tests the officers used in the field cannot differentiate between Delta-8, Delta-9 or any other THC, or if the products contained more than 0.3 percent of THC.
While several states have laws, regulations or official agency-level legal positions banning Delta-8 THC, Georgia does not. “Could this case set a precedent for other vape shop owners if they are found guilty?” a reader asked.
Kight says one only needs to look to the state statute for an answer. If the state’s hemp laws mirror the federal law, like (the laws of) many states do, then Delta-8 is a legal product. “If a judge were to be persuaded that it was illegal, however, that could create precedent,” said Kight. “Other states could look to Georgia’s ruling, and that could be very detrimental if the prosecution wins.”
The bigger problem with the Georgia case is the testing protocols, according to Kight. Most state crime labs don’t test to differentiate between different types of THC. To convict someone, you have to prove beyond reasonable doubt that they have committed a crime. The best a crime lab can usually do is identify THC. Depending on the particulars of the case, this may not be sufficient.
“There’s all sorts of forms of THC that are lawful. So, meeting its burden of proof to convict is much more difficult for a prosecutor now that hemp is lawful,” explains Kight. “A related issue is when crime labs test products using heat, which is known as gas chromatography. Since THCA [the acid form of the THC molecule] transforms into Delta-9 THC when heated in a process called decarboxylation, this is problematic. THCA in cannabis begins to decarboxylate at approximately 220 degrees Fahrenheit after around 30 [minutes] to 45 minutes of exposure. That amounts to evidence tampering, namely, converting one piece of evidence into another. … I hope that criminal lawyers will address this issue when it arises.”
Banning cannabinoids is not the way to regulate them, according to Kight. He says lawmakers need to understand that prohibition is a failed concept. Not only does it waste resources, it also drives products that are desired by the public into the underground black market, which results in additional problems, according to Kight. Banning a product means regulators lose the ability to regulate the safety of these products. “They are washing their hands on the ability to regulate them and collect taxes,” Kight says. “Prohibition also incentivizes people who would otherwise operate legitimate legal businesses to participate in an illegal black market.”
Businesses need to understand the laws surrounding cannabis products because they are consistently evolving. There are a lot of U.S. Food and Drug Administration regulations regarding labeling and the manufacturing processes. Importantly, no one should be making medical claims about their products. “You need to understand the laws,” Kight said. “Secondly, you need to be willing to dig in and understand the science so that when you look at a certificate of analysis and an ingredient list, you know what that means so that you’re not pumping out products to the public that may be dangerous.”
Kight said that he expects the FDA to start regulating CBD products in the next 12 months to 18 months. He isn’t sure if those regulations will encompass all cannabinoid products. Currently, several bills dealing with regulating CBD are floating through Congress. For example, the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021 has been in the Subcommittee for Health since early February.
This bill would allow the use of “hemp, cannabidiol (i.e., CBD) derived from hemp, or any other ingredient derived from hemp” in a dietary supplement, provided that the supplement meets other applicable requirements. Currently, the FDA’s position is that CBD products may not be marketed as dietary supplements.
Credit: Jose
Kight said that he also expects the market to consolidate as federal regulators enact rules for the industry. This will be good for some businesses and bad for others. “Companies that are attractive to the bigger companies will either enter into joint ventures or be acquired. Additionally, smaller companies that fill a niche that some of these larger conglomerates cannot fill will fare well,” said Kight. “But for companies that don’t fill a specific niche and also are not going to be appealing as a merger acquisition target, they’re going to struggle once a lot of consolidation occurs.”
Marijuana markets
Marijuana is growing globally. Numerous nations have or are considering legalizing cannabis products. Kight says that global markets are a “moving target” and changes typically do not happen overnight. In December 2020, the United Nations’ drug policymaking body recognized the medicinal and therapeutic potential of marijuana. Following a 2019 World Health Organization recommendation, the U.N. Commission on Narcotic Drugs removed cannabis from the strictest drug tier, Schedule IV, of the 1961 Convention—where it had resided alongside heroin for decades.
The U.S. currently has bills in both the House and the Senate aimed at national legalization for Delta-9 THC products. The Cannabis Administration and Opportunity Act (CAOA) aims to withdraw laws and federal penalties on marijuana. If passed, the legislation would also expunge nonviolent federal cannabis-related criminal records and let states make their own marijuana laws.
The CAOA proposal builds upon the recent Marijuana Opportunity Reinvestment and Expungement (MORE) Act passed by the U.S. House of Representatives. The CAOA expands beyond the MORE Act by proposing a “moon-shot effort to address drugged driving and multi-substance impairment, establishing strong cannabis health and safety standards” under the FDA, and leveraging the expertise of the Alcohol and Tobacco Tax and Trade Bureau within the Department of Treasury to regulate industry practices.
The U.S. cannabis industry grew 32 percent in 2020; and by 2025, it is estimated that the industry could have nearly $45.9 billion in annual sales, according to Grandview Research. Kight says legalization is probably closer at the federal level than many realize, most likely within the first term of the Biden administration.
“Whether that’s 12 [months] or 36 months from now … I think we’re going to see it during that time period,” he said. “We don’t know what form it’ll take, but it’s probably going to either be removing marijuana and THC from the controlled substances list altogether, which is really what should happen, or they’re going to be scheduled in a different way. Most likely, we will continue to have state-by-state regulation within the paradigm of federal legalization; some states will be really liberal, and some states will be really conservative.”
Internationally, Uruguay and Canada were the first countries to legalize marijuana. Several other countries are attempting to follow suit. However, many nations have signed onto treaties that make marijuana and THC illegal. Hemp is also defined differently from country to country, especially in the EU. In Switzerland, it is a 1 percent THC cap, whereas some other countries in the EU have a 0.2 percent cap, according to Kight. Countries have recently been more open to legalizing hemp, and that trend is expected to continue.
“We’re beginning to see producers in certain countries where hemp can be grown inexpensively being shipped to other countries where it can’t be produced inexpensively but where there’s a higher market price and demand. For instance, South America is known for being able to cultivate large tracts of hemp, especially in countries like Uruguay and Colombia, he says. “They want to deliver it to the EU where it’s a lot more expensive, there’s a large demand and people willing to pay more.”
In France, a court case made the decision for the country to legalize CBD products. France’s highest court ruled that CBD—including CBD flower—are legal in the country. The decision referenced last year’s KanaVape judgement in which a European court ruled that the French authorities had acted unlawfully in prosecuting two businessmen who imported CBD flowers from the Czech Republic in 2014, citing that CBD is “not a narcotic.”
The European court said France cannot ban any CBD that’s produced lawfully in the EU. If a product is produced lawfully in one EU country, it must be allowed in all EU countries. “France is changing its laws right now. Spain has got to change,” said Kight. “We are going to see this happen across Europe. These countries are working toward or just coming into compliance.”
One of the biggest stories currently in cannabis reform is Mexico. In late June, Mexico’s Supreme Court declared unconstitutional the prohibition of personal marijuana use in the country, clearing a path to legalization. Mexico’s lower house passed a legalization bill in March, but it is still awaiting legislative approval in a gridlocked Senate.
The Supreme Court of Mexico determined that the laws in Mexico prohibiting the personal use of cannabis is unconstitutional, according to Kight. Mexico has a “really important clause that the U.S. doesn’t have” called The Right to Free Development of Personality. The Mexican constitution protects the individual’s right to be unique and independent.
In several cases, marijuana advocates argued that the state cannot infringe upon that right when the consequences of marijuana consumption—be they positive or negative—only affect the individual who chooses to use the drug. “The Mexican Supreme Court agreed and determined that laws prohibiting cannabis use for personal use violated that constitutional provision,” Kight said.
Under Mexican law, its Supreme Court must rule on an issue five separate times (separate cases) for a decision to have precedence or value. The same process was how same-sex marriage was legalized in Mexico in 2014. The first cannabis case was brought by four members of the Mexican Society for Responsible and Tolerant Consumption in 2015. After the fifth separate marijuana decision was handed down in 2020, the court ordered the Mexican Congress to change the criminal laws prohibiting the use of cannabis.
Mexican lawmakers then failed to meet the Supreme Court’s April 2021 deadline to end marijuana prohibition after spending months going back and forth on a legalization bill that passed both chambers of Congress in differing forms. “There was an expectation that the Senate would again ask the court for an extension, but that did not take place. The Supreme Court of Mexico then entered a ruling that nullified the Mexican laws prohibiting cannabis use, and so we’re kind of in the Wild, Wild West now,” Kight explains. “That’s never happened for any subject under Mexican law, much less cannabis. Now the Congress is under the gun to enact laws and regulations.”
Credit: Stock Photo Pro
Future focus
Overall, cannabis markets are expected to continue to grow globally. According to Market Watch, the global cannabis market size is expected to reach $118.9 billion by 2027 and is valued at approximately $20.6 billion in 2020. It is anticipated to grow with a healthy rate of more than 28.5 percent from 2020 to 2027. Regulation is coming, and many countries will likely regulate cannabis similar to the way tobacco products are regulated.
To help secure the future of the industry, businesses currently selling or manufacturing products using minor cannabinoids need to regulate themselves and produce and/or market only high-quality products using legitimately sourced and tested ingredients, says Kight, adding that one bad product can reverberate through the industry. Business owners should also be actively engaged with regulators.
“There are a lot of cannabis products out there that are not regulated. They might have contaminants in them that harm people, and we don’t want that,” he says. “I think it’s really important that industry players make sure they’re only dealing in high-quality, safe products. And they need to let their representatives in government know how important hemp is to them, including all of its cannabinoids.”
Tobacco companies should be allowed to transition to harm reduction products, but under history’s watchful eye.
By George Gay
I don’t go along with the oft-repeated idea that, if we don’t remember the past, we are condemned to repeat it. This is not to say that particular versions of the past, whether real or invented, are not repeated, just that mostly it is impossible to know whether an event is an original or a repeat. For one thing, memories of the past are mostly not the result of direct experiences and so are not fixed and generally agreed. History, into which the past is roughly sieved, is never objective. It is most often weighted, open to interpretation and subject to disagreements.
I would be happy to consign all versions of history to oblivion, but then, as somebody famously said, there would be no point. In saying that we consign something to oblivion, we suggest that it is simultaneously forgotten and preserved. We are incapable, it seems, of letting go of favorite versions of the past, which get stuck to our shoes like carelessly discarded chewing gum.
Specifically, it concerns me that history, or versions of it, are being allowed to act as a drag on advances that could be being made in reducing the health consequences of cigarette smoking. I recently attended a nicotine conference and, as part of one generally good presentation, a still of a video was shown in which CEOs from U.S. tobacco companies told a Congressional oversight committee sitting a quarter of a century ago that they did not believe nicotine was addictive. I have seen this still, or similar ones, on more occasions than I care to remember, often presented as shorthand for how heinous the tobacco industry was or even is.
But one problem in my view is that what is presented here is a version of history directed by the enemies of the tobacco industry who feel they won the moral war. In other words, a history presented by the victors. It implies that those CEOs were willing to lie about something that everyone knew to be true—that nicotine was and is addictive. There is no time for nuance in a single still. There is no room for other interpretations.
Credit: Sky Next
For instance, were all the CEOs referencing the same, agreed version of addiction? And if, as generally supposed, they were all referencing the same definition of addiction, were they acting in bad faith, or were they, or at least some of them, not informed or badly informed by the scientists working in their companies who did believe that nicotine was addictive? Is it possible the CEOs were right and everybody else was wrong? Was one or more of them delusional and in need of help?
I ask above whether all of the CEOs were referencing the same definition of addiction and, frankly, I have no idea what the answer to that question is. I tend to the view, however, that they were, because I find it difficult to believe their legal teams would have allowed them to give the answers they did without knowing exactly what they were signing up for.
But I have one troublesome doubt in this regard. As far as I am aware, five of the seven CEOs who testified in 1994 said they believed that nicotine was not addictive; one said he believed that neither nicotine nor his company’s products were addictive while another said he believed cigarettes and nicotine clearly did not meet the classic definition of addiction because there was no intoxication.
The reference to “the classical definition” surely suggests that it was admitted there was more than one definition, which possibly means the answers need to be interpreted individually. Additionally, it cannot be ruled out that even if a CEO knew that his company’s scientists believed nicotine to be addictive, his personal view might have been different. We all become fed up with experts at one time or another.
The oversight committee’s hearings later revealed that all sorts of skulduggery had gone on; for instance, at least some of the people within these companies knew or believed that nicotine was addictive and that some had manipulated their products to try to make them more addictive, whatever that means in the context of whatever definition you are using.
But where did this information come from? It came in part from documents voluntarily handed over to the committee at the behest of the CEOs. This seems to suggest that the CEOs were either not aware of what was in those documents or that they were not aware of all that was in them.
But let’s say for the sake of argument that the CEOs, or at least some of them, told the committee they believed nicotine was not addictive, knowing that all this skulduggery had been going on—would they not have been acting in exactly the way they would have been expected to act—perfectly in line with business and societal norms? After all, they were CEOs charged with maximizing company profits at a time when greed was good, so there was some collateral damage. But then, starting only with the “A’s,” look at the alcohol, arms and automobile industries.
I don’t want to defend what the CEOs said during that committee hearing or what the tobacco industry got up to because I don’t know enough about this stuff. But it seems a little odd to me that, at a time when the U.S. was deep in the grip of neoliberal dogma, these men (they were all men) were condemned for following the logic of the market and maximizing profits.
But the committee seemed to want to set itself above all of this tacky business stuff, somewhere on the moral high ground. This is, in part, what the chairman on April 14, 1994, said in opening the hearing: “For decades, the tobacco companies have been exempt from the standards of responsibility and accountability that apply to all other American corporations. … This hearing marks the beginning of a new relationship between Congress and the tobacco companies. The old rules are out; the standards that apply to every other company are in.”
I would imagine that what a lot of people took away from this, whether it was meant or not, is that there goes the wicked tobacco industry again, avoiding its responsibilities for decades. But, if the finger is to be pointed anywhere, it should surely be pointed at Congress, which, as is more or less admitted by the chairman, allowed this situation to exist and to continue. It cannot be expected that businesses will, in the normal course of things, lobby Congress to saddle themselves with additional regulations.
I thought the opening remarks strange in another way also. The chairman at one point says: “Nearly a half million Americans die every year as a result of tobacco. This is an astounding, almost incomprehensible statistic. Imagine our nation’s outrage if two fully loaded jumbo jets crashed each day, killing all aboard. Yet that is the same number of Americans that cigarettes kill every 24 hours.”
As I see it, the chairman is making a comparison as part of what I suppose was meant to be a moral argument, but that comparison does not stand up to even basic scrutiny. As human beings, we take risks every day, balancing those risks, either consciously or unconsciously, against perceived benefits. Smoking and drinking alcohol are two obvious everyday examples of this. And so, too, for a lot of people (though perhaps not recently) is getting on an airplane. As things stand, people get on airplanes because they are overwhelmingly safe to use, so the benefit-to-risk ratio is hugely positive.
But it is inconceivable that if two jumbo jets crashed each day in the U.S. alone, people would still board them. The chairman was ignoring the fact that people make risk assessments so as to conjure up a situation that would never occur. People understand that smoking might cause them to die in 40 years to 50 years, and they understand that falling from 30,000 feet brings on death a lot quicker.
The idea of risk can be manipulated, and often is, as in the story about the therapist with a patient who is still nervous of flying even after being told that the chances of a bomb being on board a plane is a billion to one; the therapist advises her to take her own bomb on board next time she flies because the chances of there being two bombs on board are a trillion to one.
I need to emphasize that I am not trying to defend the past behavior of the tobacco industry or the CEOs in question. What concerns me here is that a single picture is being regularly presented as telling a story that is far simpler than it really is. What has passed into history—what I would imagine most people would “remember” from the picture of the subcommittee hearing—was that all of the CEOs lied in saying that nicotine was not addictive. I doubt that many people would realize that what they said was they believed nicotine was not addictive, let alone the back story to this event.
This is the problem with the versions of history we drag around with us. In the end, what did the hearings bring about? Reputational damage to tobacco companies for sure. But they are still operating in one form or another, and part of their business is largely unchanged. It is said that the number of smokers fell after the hearings, but who knows whether the hearings were a causal factor in this.
It is more interesting to examine what continued: taxes. Local, state and federal agencies continued to benefit from people smoking through the taxes they paid, and later was added the proceeds of the Master Settlement Agreement, very little of which is ever spent on ameliorating the toll of tobacco smoking; so who gets to stand on the moral high ground?
Credit: Gawriloff
Well, the answer to that question might seem strange. I say above that it is not usual for businesses to lobby Congress to try to saddle themselves with additional regulations. But, in fact, odd as it might seem, this is exactly what many nicotine and tobacco companies have been doing in recent times.
I’m not saying they are perfect and that part of this new way of thinking hasn’t to do with competition, but in part it is a genuine attempt to ensure that the new generation products that are being developed and offered to help people transition to safer forms of nicotine consumption are not causing, and can be seen not to be causing, unintended consequences.
And for those people who tend still to be wedded to the idea portrayed by the still of the tobacco CEOs, it is worth noting that, importantly, in the recent past the major tobacco companies have found a way of offering reduced-risk products while roughly maintaining the sorts of business models that were so successful for them in the past. Does this put them on the moral high ground? Of course not, but it has mapped out a route to that ground.
Times are changing, and we desperately need to stop slowing the transition into a new world of nicotine consumption by constantly dragging behind us a little-examined history of what went on 20 years to 30 years ago—a time that few working in the nicotine and tobacco industries could probably remember.
There was a furor just after I started to write this piece about a proposed takeover by Philip Morris International of the pharmaceutical company Vectura, which in news reports was said to be developing inhaled treatments for respiratory diseases. Why the furor? Well, it’s all about history, of course. PMI has in the past sold traditional cigarettes and still does; so, the detractors claimed, we cannot let it near a pharmaceutical company.
There seems to be no way such people can accept that, in order to move ahead with the transition from smoking to other forms of nicotine consumption, we have to look at innovative, even daring ways of doing things.
I have no insights into what PMI is up to beyond what has been reported in the general press, but it doesn’t take a genius to figure out that it might be looking, in part, to benefit from some cross fertilization of ideas in respect of inhalation technologies—ideas that just might allow it to make a breakthrough in respect of reduced-risk, next-generation nicotine products.
At least we should allow companies to try such things—while keeping an eye on them, of course. We should not let history stand in the way.
Divisive WHO report encourages countries to adopt harsh anti-vaping and anti-harm reduction positions.
VV Staff Report
By making demands for prohibitive curbs on the sale and use of electronic nicotine-delivery systems (ENDS), experts say the World Health Organization has declared war on tobacco harm reduction and the vaping industry. In its latest biannual report, WHO Report on the Global Tobacco Epidemic, 2021: Addressing New and Emerging Products, the global health agency’s director-general, Tedros Adhanom Ghebreyesus, stated that countries must remain vigilant to the risks presented by e-cigarettes and heated-tobacco products.
“While framing these products as a contribution to global tobacco control, the tobacco and related industries employ the same old marketing tactics to promote new tools to hook children on nicotine and circumvent tobacco legislation,” he writes. “At the same time, they continue to fight measures and legislation designed to protect people from the many harms of tobacco across the globe.”
In response to the report, Jamie Hartmann-Boyce, senior research fellow in health behaviors at the University of Oxford, said the WHO report’s view that vaping is “harmful” will wrongly concern vapers who have switched over from combustibles and dissuade smokers considering making the switch. He states that, while e-cigarettes are not risk free and people who do not smoke should not start vaping.
“Nicotine is addictive, but it’s not what causes the harm from smoking. Evidence shows e-cigarettes with nicotine can help people quit smoking and that they are considerably less harmful than smoking,” he states. “The latest report from the WHO should not discourage people who smoke from switching to an alternative product—one which evidence shows is less harmful to them and those around them.”
While the report found that more than four times as many people are covered under WHO-recommended tobacco control measures than in 2007, it expressed concern that children who use ENDS products are up to three times more likely to use tobacco products in the future. “Nicotine is highly addictive. Electronic nicotine-delivery systems are harmful and must be better regulated,” Ghebreyesus said.
Writing for InsideSources, Lindsey Stroud, a policy analyst with the Taxpayers Protection Alliance, states that the recently released WHO report is full of both alarmism and misleading information. Just six pages into the report, for example, the WHO asserts that youth who use e-cigarettes can double their risk of smoking combustible cigarettes.
“There is zero evidence to support this. According to data from the Centers for Disease Control and Prevention, in the United States, smoking rates among young adults are at their lowest levels with 11.9 percent of American adult smokers being between 18 to 24 years old in 2019. Conversely, in 2009, 22.5 percent of smokers were young adults,” she writes. “The report also fails to acknowledge harm reduction. In 212 pages, ‘harm reduction’ is mentioned a total of four times, and when mentioned, the WHO paints a picture that tobacco companies are using the concept to promote the use of their products and such marketing is ‘undermining successful tobacco control initiatives.’ If tobacco control measures were effective, smokers would not have developed the modern electronic cigarette.”
This is the first time that this WHO report has included data on ENDS. It states that a total of 111 countries regulate ENDS in some way. The report found that 32 countries (covering 2.4 billion people) have banned the sale of ENDS and an additional 79 have adopted at least one partial measure to prohibit the use of ENDS products in public places, prohibit their advertising, promotion and sponsorship, or require the display of health warnings on packaging. “This still leaves 84 countries where they are not regulated or restricted in any way,” according to the WHO.
In the report, Ghebreyesus states that in places where e-cigarettes are not banned, “governments should adopt appropriate policies to protect their populations from the harms of electronic nicotine-delivery systems and to prevent their uptake by children, adolescents and other vulnerable groups.”
The European Tobacco Harm Reduction Advocates (ETHRA), a group that advises on harm reduction policies, stated that while previous WHO reports were hostile toward ENDS products, the latest report “ramps up the rhetoric” and has transformed into an “all-out attack” on nicotine.
“The report states that progress has been made in the fight against tobacco but adds that there is a need to ‘tackle threats posed by new nicotine and tobacco products,’” the group wrote. “In an attempt to justify their calls for prohibitionist measures such as flavor bans and all out bans, the report makes unfounded claims that safer nicotine products are a gateway to smoking for youth and that their purpose is to ‘hook another generation on nicotine.’ The WHO’s dangerous position on tobacco harm reduction must be resisted in the strongest possible manner.”
Credit: Oleg Kachura
John Britton, emeritus professor of Epidemiology at the University of Nottingham and chair of the group that released the landmark 2016 Public Health England report that found e-cigarettes to be 95 percent safer than combustibles, said that the WHO does not comprehend the fundamental difference between addiction to tobacco smoking, which kills millions of people every year, and addiction to nicotine, which does not.
“The WHO is also evidently still content with the hypocrisy of adopting a position which recommends the use of medicinal nicotine products to treat addiction to smoking but advocates prohibition of consumer nicotine products, which do the same thing, but better,” said Britton. “The WHO is right that nonsmokers, especially children, should be discouraged from using any nicotine product. But for the more than 1 billion tobacco smokers in the world, electronic nicotine-delivery systems are part of the solution, not the problem.”
Rudiger Krech, the WHO’s director of health promotion, said that the challenges associated with ENDS regulation are hugely diverse and are evolving rapidly. Some devices are modifiable by the user, making nicotine concentration and risk levels difficult to regulate. Products have also been found to be marketed as nicotine-free but, when tested, are found to contain nicotine.
“Distinguishing the nicotine-containing products from the non-nicotine, or even from some tobacco-containing products, can be almost impossible,” he stated. “This is just one way the industry subverts and undermines tobacco control measures.”
One of the major controversies surrounding the report is that it was funded by Bloomberg Philanthropies, a foundation created by American billionaire and former New York City mayor Michael Bloomberg. Not coincidentally, Bloomberg was appointed the WHO global ambassador for noncommunicable diseases and injuries, a largely honorary title granted in recognition of the dollars his foundation spends on fighting nicotine policy from small cities to large countries.
“More than 1 billion people around the world still smoke,” Bloomberg stated in a release. “And as cigarette sales have fallen, tobacco companies have been aggressively marketing new products—like e-cigarettes and heated-tobacco products—and lobbied governments to limit their regulation. Their goal is simple: to hook another generation on nicotine. We can’t let that happen.”
Stroud stated that while the report was supported by Bloomberg Philanthropies, the report also strangely states that the report “should not be regarded as reflecting the position” of Bloomberg Philanthropies. “Yet, the report reads like a Christmas in July wish list for a Bloomberg-created anti-tobacco regime, she writes. “[While mayor of New York City] … in late 2019, on top of the $1 billion Bloomberg had already donated to anti-tobacco groups and efforts, the former mayor announced a $160 million campaign to ‘fight flavored e-cigarettes.’”
Knowledge-Action-Change (KAC), a private sector public health agency, condemned the WHO and “its single most significant funder for anti-smoking efforts, U.S. billionaire Michael Bloomberg,” for using the report to distract from “years of failure” in the fight against combustible tobacco.
“Unable to demonstrate that its tobacco control strategy has resulted in meaningful outcomes—the most important of which would be substantial declines in smoking—the WHO focuses instead on how many countries implement its ‘MPOWER’ measures,” according to a press release. “On closer inspection, even progress on the MPOWER measures is underwhelming. The WHO reports that 104 countries have introduced ‘one or more MPOWER measures at the highest level of achievement’ since 2007 but also states that 41 of the 49 countries that have not implemented a single measure are [low- and middle-income countries].”
MPOWER stands for: Monitoring tobacco use and preventive measures; Protecting people from tobacco smoke; Offering help to quit; Warning about the dangers of tobacco; Enforcing bans on advertising, promotion and sponsorship; and Raising taxes on tobacco. More than half of all countries and half the world’s population are now covered by at least two MPOWER measures at the highest level of achievement. This reflects an increase of 14 countries and almost one billion more people since the last report in 2019.
In the U.K., a group of lawmakers expressed concern over the influence exerted by Bloomberg Philanthropies on tobacco regulation policies, especially in low- and middle-income countries (LMICs). In a separate report, the U.K.’s All-Party Parliamentary Group for Vaping Inquiry (APPG) stated that The Union, another group funded by Bloomberg Philanthropies, as well as other anti-vaping nongovernmental organizations (NGOs) should not be permitted as “civil society observers” to the Framework Convention on Tobacco Control Conference of the Parties 9 (FCTC COP 9) meeting, which will dictate tobacco policies in LMICs are “hostile to the concept of tobacco harm reduction and thus the U.K.’s policy approach.”
The report has already begun to impact tobacco policy in LMICs. Shortly after its publication, Ukrainian lawmakers passed a new law after the WHO released its report that prohibits the use of ENDS in public places as well as advertising, sponsorship and promotion of e-cigarettes in the country. The law also bans the sale of flavored e-liquids other than tobacco flavors.
The parliamentarians said that justification for the regulations was based on the WHO’s new report that “suggests e-cigarettes are a gateway to smoking and that they are as harmful as conventional cigarettes,” according to the Independent Women’s Forum. Lawmakers also claimed the flavor ban would reduce underage vaping in Ukraine, while data from the U.S. concerning flavor bans has showed banning flavors actually increases youth use of combustible products.
Nancy Loucas, executive coordinator of the Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA) stated that the WHO’s latest attack on safer nicotine products deserves the global ridicule it has attracted. She says that the organization charged with looking after public health continues to ramp up its efforts to deny smokers access to products that can help them quit.
“Consumer advocates are increasingly angry that the WHO continues to promote its baseless and incredibly destructive view on vaping,” she said. “It comes despite leading scientific evidence confirming vaping is at least 95 percent less harmful than smoking and is the world’s most effective smoking cessation tool.”
A new Yale University study shows that flavor bans cause an increase in underage smoking.
By Maria Verven
A new study by the Yale School of Public Health suggests that San Francisco’s ban on sales of flavored tobacco products may have substantially increased smoking among minors. When San Francisco voters approved a ban on the sale of flavored tobacco products, including menthol cigarettes and flavored e-liquids in 2018, public health groups prematurely celebrated another “win” in their battle to reduce teenage vaping.
Now advocates of the ban must come to terms with the fact that the flavor ban, and most likely similar flavor bans around the world, are inextricably tied to significant increases in teenage smoking rates. According to the study, the odds that high school students would start smoking conventional cigarettes doubled in San Francisco’s school district after the ban was put into effect when compared to districts that didn’t implement a flavor ban, even when adjusting for individual demographics and other tobacco policies.
A Threat to Public Health
Published in JAMA Pediatrics in May 2021, the sole author of the study, Abigail Friedman, associate professor in the Department of Health Policy and Management at the Yale School of Public Health, said the study is the first to assess how complete flavor bans affect youth smoking habits. “These findings suggest a need for caution,” she said. “Even if it is well-intentioned, a law that increases youth smoking poses a threat to public health.”
Before the ban was implemented, smoking rates in school districts in and around San Francisco were on the decline. Using data on over 95,000 youth from the Youth Risk Behavior Surveillance System’s 2011–2019 school district surveys, Friedman compared trends in smoking rates in San Francisco versus other districts. The findings revealed a glaringly large discrepancy after the flavor ban went into effect. In 2019, San Francisco’s smoking rates rose to more than twice the average of school districts without a flavor ban. In those districts, smoking rates among youth continued to fall.
E-cigarettes—and particularly those with flavors—have been the most popular tobacco product among U.S. youth since at least 2014. “Some kids who vape choose e-cigarettes over combustible tobacco products because of the flavors,” Friedman said. “For these individuals, banning flavors may remove their primary motivation for choosing vaping over smoking, pushing some of them back toward conventional cigarettes.”
Michael Siegel, professor in the Department of Community Health Sciences at Boston University School of Public Health, said society is at a critical juncture with regard to youth smoking. “It has plummeted to record lows and on top of that, a culture of vaping has completely replaced the culture of smoking,” he said. “The policies enacted in the next year could likely decide what happens next.”
Huge Policy Implications
Credit: JAMA Pediatrics
The results of the Yale study should have huge implications for other states and even other countries when deciding to ban flavored vapes. According to the National Conference of State Legislatures, five states—California, Massachusetts, New Jersey, New York and Rhode Island—have implemented laws banning flavored electronic nicotine-delivery systems (ENDS), and at least 310 localities have passed restrictions on menthol cigarettes and/or flavored tobacco products (including e-liquids), although these laws vary widely.
The U.S. Food and Drug Administration implemented a partial ban on the sale of flavored closed-system e-cigarette products in January 2020. The FDA ban exempts menthol and tobacco flavor as well as open tank vaping systems, which tend to be sold in vape shops where age restrictions are more often enforced.
Members of Congress have been pressuring acting FDA Commissioner Janet Woodcock to ban all flavored e-cigarettes, maintaining that flavors are attracting youth to ENDS products. Woodcock has not indicated whether the agency has plans to ban or otherwise limit the sale of flavored vapes, but a decision could be made this fall.
When asked to comment on the trend that youth use of cigarettes was declining while their use of ENDS products was on the rise, former FDA Commissioner Scott Gottlieb said the trends are not acceptable, even if they are moving in a more positive direction of reduced overall use of tobacco products. “Even if kids are using ENDS [products] instead of cigarettes—and that migration in part accounts for the decline in youth [combustible] cigarette use—that’s still not an acceptable trade,” he said.
Clive Bates, a tobacco harm reduction expert and former director of Action on Smoking and Health U.K., called this argument outrageous, adding that just because a regulatory agency believes young people should not smoke or vape does not mean that is how it plays out in the real world. “Public health is about dealing with the world as you find it—not giving instructions to people who are not listening, uninterested in your views and unimpressed by your authority,” said Bates. “But that doesn’t mean a regulator is absolved of responsibility for the consequences (good or bad) of its actions.”
Since Gottlieb essentially said that the FDA doesn’t care if vaping is helping to reduce smoking, Bates says the FDA is ignoring a big public health benefit that has been a goal of U.S. policy for decades. “The dangerous corollary is [that] the FDA doesn’t care if their anti-vaping measures increase smoking among adolescents. That’s what is so despicable about this lofty attitude—it’s an indifference to the group most at risk,” Bates said. “Yet the FDA doesn’t care if vaping works as an alternative to smoking for adolescents—and this is deeply unethical.”
Generally, regulators do not allow adolescent experimentation to bend adult society and legitimate choices out of shape, especially if these are beneficial to adults, according to Bates. “It should not be taken as a given that adult products that appeal to adolescents should be banned. For many, it is part of being a teenager to sample the forbidden fruits of adulthood,” Bates explains. “We don’t respond to youth experimentation by banning other potentially harmful adult products like alcohol or cannabis just because adolescents use them,” Bates said. “Though it has risen sharply, vaping is not out of the ordinary compared to the prevalence of other risk behaviors. But crucially, it does not actually pose much risk.”
Decisions That Kill
In June, Health Canada admitted in a regulatory impact statement that its intended flavor ban could lead to an increase in the smoking rate. David Sweanor, an industry expert and chair of the advisory board for the Centre for Health, Law, Policy and Ethics at the University of Ottawa, said that the Health Canada statement is basically saying Canadian regulators know they are going to do something that kills Canadians.
“Countries that simply allow alternatives, even without actively facilitating substitution, are seeing dramatic declines in cigarette sales,” Sweanor said, citing Japan, where cigarette sales over the past five years declined at a very rapid pace—far greater than declines in other countries, including the U.S. “I think the biggest constraint on progress is a lack of understanding of the magnitude of substitution effects. To dramatically reduce the use of lethal cigarettes, we need products that are less hazardous and evidence that consumers will switch to them in sufficient numbers to justify substitution as a policy intervention.”
Sweanor said efforts that show the extent of substitution effects are blocked by the absence of funding for such research, obstruction from the anti-vaping moralists and those pursuing a “tobacco-free world” agenda. He also believes that tobacco companies may be reluctant to release sales and consumer research data that would bolster policies designed to undermine their lucrative cigarette business. “Jurisdictions that allow viable alternatives to cigarettes, where such products are as accessible as cigarettes and consumers aren’t given misleading information on relative risks, will see far more rapid declines in smoking,” Sweanor said.
Friedman said the findings from her study strongly suggest that policymakers should be careful not to inadvertently push minors into using the more harmful product. When asked to suggest an alternative policy, she suggested that states consider restricting all tobacco product sales to adult-only (21-plus) retailers. “This would substantively reduce adolescents’ access to tobacco products at convenience stores and gas stations without increasing incentives to choose more lethal combustible products over noncombustible options like e-cigarettes,” she said.
Sweanor added that good policies are contagious and would be replicated. “I am confident that science and rationality combined with consumer advocacy will ultimately win,” he said. “Unfortunately, those opposing such policies can cause lengthy delays, which can result in a tragic and avoidable loss of life.”
Science, Reason and Humanism
Abigail Friedman, PhD
Seigel says that there is hope that the Yale study impacts future decisions regarding flavor bans; however, the mainstream anti-tobacco groups are not going to publicize the study because it goes against their preordained conclusions. “If flavor bans are widely adopted, I suspect that many youth who are experimenting with vaping will switch over to cigarette smoking and some will use THC vapes off the black market,” he said. “In contrast, with sensible policies that restrict e-cigarette availability to youth while allowing adult smokers to continue to access them, I think we could drive youth smoking pretty much into the ground—perhaps to a level from which it could never recover.”
Bates questioned how regulators and lawmakers alike could continue with confidence in implementing flavor bans after seeing the results of the Yale study. He added that he seriously questions whether legislators will admit that the ban was a bad idea and reverse course.
“It may put the brakes on some of the worst policy mistakes,” he said. “It’s what many of us have been saying should be expected from a flavor ban. But legislators hate to admit they were wrong, so it will probably lead to calls for tougher enforcement and anti-smoking campaigns rather than realizing that the whole idea is wrong.”
In jurisdictions where viable alternatives to combustible cigarettes are made available, data has shown that the rates of combustible cigarette smoking among youth and young adults is plummeting, according to Sweanor. “More importantly, we are seeing longer term cigarette smokers whose lives are truly on the line, substituting low-risk alternatives,” he said. “People’s response to research depends on motivations. There is a very long and frustrating history of reduced-risk alternatives to cigarettes being attacked by those on a moralist quest to rid the world of nicotine.”
Vaping products are attacked based on accusations about formaldehyde, popcorn lung, e-cigarette or vaping use-associated lung injury (EVALI), cognitive impairments and a seemingly endless list of other supposed hazards, Sweanor explained, adding that these arguments are ultimately shown to be meritless, but vaping opponents never admit to being wrong.
“Such behaviors are hallmarks of conspiracy theorists and those seeking to use the power of the state to impose their moral views on the behavior of others. But where lawmakers are open to science, reason and humanism, studies such as this … [Yale study] are very important,” said Sweanor. “Public health breakthroughs are possible when rational lawmakers get past the panics caused by the moralists. We are staring an historically significant public health breakthrough in the face. The sooner lawmakers recognize this, the sooner we can relegate cigarettes to history’s ashtray.”
The original “Vaping Vamp,” Maria Verven owns Verve Communications, a PR and marketing firm specializing in the vapor industry.
The Philippines is set to approve the most progressive and risk-proportionate vaping legislation in Asia-Pacific.
By VV Staff
There are an estimated 17 million smokers in the Philippines. An estimated 117,000 of them die every year from smoking-related diseases, according to Quit for Good, a nonprofit organization that advocates “real, practical and tangible” solutions to smoking cigarettes. However, next-generation tobacco products, like electronic nicotine-delivery systems (ENDS), which studies have shown can be up to 95 percent safer than combustible cigarettes, have had a challenging path to market in the country.
In November 2019, Philippines President Rodrigo Duterte announced a ban on the use and sale of e-cigarettes. It was a sudden and unexpected decision that was made in part due to the rising number of cases of e-cigarette or vaping use-associated lung injury (EVALI) impacting the U.S.. A 16-year-old Filipino girl was also diagnosed with EVALI after using e-cigarettes for six months, prompting the country’s Department of Health to raise concerns.
“I will ban it,” Duterte declared at the time. “The use and importation. You know why? Because it is toxic, and government has the power to issue measures to protect public health and public interest.”
In February of 2020, Duterte signed an executive order that prohibited the use, sale or purchase of cigarettes or other tobacco products by anyone under the age of 18 or ENDS or their components by a person below 21 years old. Then there were proposals to raise the purchase age to 25 for ENDS and ban all vape flavors other than menthol and tobacco.
The U.S. Centers Disease for Disease Control and Prevention (CDC) then finally admitted publicly that EVALI was caused by black market marijuana vaping products rather than nicotine products. As the news spread, the Philippines began to reconsider its position of less-risky alternatives to cigarettes like vapor and heated-tobacco products (HTPs).
Consumer advocates in the Philippines began to promote the regulation of e-cigarettes as a consumer product. They pointed out that the age one can purchase tobacco, alcohol and get married in the Philippines is 18, so the 21-years-of-age requirement to purchase vaping products was nonsensical. At the same time, they argued that adult smokers keen to quit tobacco need reasonable access to safer alternatives, and restricted advertising should be permitted. Product safety standards were also critically important to the consumer advocates.
Earlier this year, the Philippine House of Representatives proposed the Noncombustible Nicotine-Delivery Systems Regulation Act (House Bill 9007). The bill is a massive legislative achievement for tobacco harm reduction advocates in the Philippines, according to Nancy Loucas, executive coordinator of the Coalition of Asia-Pacific Tobacco Harm Reduction Advocates (CAPHRA), a regional alliance of consumer tobacco harm reduction advocacy organizations.
If the measure becomes law, it will authorize the country’s Department of Trade and Industry, in consultation with its Food and Drug Administration, to set rules, regulations and standards on packaging, ingredients and graphic health warnings on ENDS products. The bill also includes the following provisions:
Only retailers can sell ENDS, electronic non-nicotine-delivery systems (ENNDS) or HTPs. Selling to minors is prohibited. Retailers will have to ask buyers for a valid government-issued ID.
Manufacturers, importers and distributors must comply with certain packaging and health warning requirements.
The use of alternative products will be prohibited in all enclosed public places except in designated vaping areas. Indoor use of the products is prohibited in schools, hospitals, government offices and facilities intended for minors.
The sale or distribution of these products within 100 meters from any point of the perimeter of a school, playground or other facility frequented by minors is prohibited.
Manufacturers are prohibited from sponsoring any sport, concert or cultural or art event.
In May, House Bill 9007 passed the House with 192 of its 300 representatives in favor—with only 34 voting against it and four abstaining. The Senate bill is expected to be voted on in September, although as of Aug. 2, it was still in the Philippines’ Senate trade subcommittee, which is deliberating four separate bills seeking the regulation of vaping products.
Several of the country’s health experts and advocates have asked senators to keep the current law with a purchase age of 21 or raise the age to 25 to purchase or use vape, e-cigarettes and vapor products in order “to curb its harmful effects on minors.”
In a press release, Philippine College of Physicians Executive Director Encarnita Blanco-Limpin stated that under the Republic Act No 11467 (a bill based on Duterte’s executive order), the age of purchase for vaporized nicotine products and heated-tobacco products is 21 years old and that should not change. She added that lowering the access of e-cigarettes from those 21 years old to those 18 years old is a retrospective act.
Clarisse Virgino and Peter Dator – Credit: CAPHRA
“Scientific studies have shown the age of maturation actually occurs at the age of 25 years. Now, if we are thinking of changing the minimum age of purchase, maybe what we should do is even increase it to 25 years,” she said. “To be consistent, since all of these [are] addictive substances, maybe it is wise to consider that we put the minimum age of purchase for all the vaporized products, heated-tobacco products, all the regular tobacco products and even alcohol at the age of 21, or even perhaps at the age of 25, so that we will be able to prevent our young from taking up [this] addiction at an earlier age.”
Peter Dator, president of consumer group Vapers PH and a CAPHRA member, hopes the Senate will pass the legislation, and he is confident a clear majority of senators realize just how much is at stake.
“This needs to get passed to ensure millions of Filipino smokers continue to have access to safer nicotine products. At the same time, existing vapers must maintain access to their product of choice to keep them from going back to cigarettes,” he says. “We would like to thank our congressmen for looking at scientific evidence in coming up with a bill that would provide Filipino adult smokers a choice to switch to less harmful alternatives to combustible cigarettes.”
The Philippine representative of CAPHRA, Clarisse Virgino, is also hopeful the Senate will give its approval, which is required to enact the legislation. She says the legislation will legitimize the fact that tobacco harm reduction is “a real thing backed by science,” adding that international evidence continues to put vaping at 95 percent less harmful than smoking.
“It’s vital this legislation gets Senate approval. It will give consumers better protection, enabling them to choose genuine THR products at a reasonable price. Fair regulation will also eradicate any black markets or any sellers who are not authorized to sell THR products, prioritizing the safety of consumers,” she says. “I am confident that like our House representatives, our senators have listened. Without doubt, vaping has proved to be [the] world’s most effective smoking cessation tool. Legitimizing it will go a long way to helping many more Filipino smokers quit cigarettes and protect the rights of consumers to access safer alternatives.”
Loucas says the Philippines’ goal of adopting best practice tobacco harm reduction policies will hopefully be emulated by other Asia-Pacific governments. She says that many of the region’s territories suffer from desperately high smoking rates, and in some countries, such as Thailand, vaping remains illegal.
“This move will only strengthen the Philippines’ independence as it shakes off any remaining vestiges of foreign influence on its public health policies. In recent years, we’ve seen American billionaires and their so-called philanthropic foundations fueling anti-vaping sentiment around the world. It’s well established that the Philippines has been a target,” she said. “As this landmark legislation nears its final hurdle, outside pressure will again pile on, but senators can be confident their positive action will undoubtedly save thousands of Filipino lives.”
According to 6W Research, vaping products are growing in popularity in the Philippines and are “anticipated to witness profound market growth” throughout the forecast period of 2020–2026. The group is predicting a compound annual growth rate of 26 percent.
In April of this year, YOOZ, a major Chinese e-cigarette brand, opened its first store in the Philippines. There are now 31 YOOZ stores nationwide. Willy Lim, a YOOZ franchise owner in Manila, said YOOZ stores in the Philippines have seen a surge in sales, according to a press release. “I am very happy to have made the right decision to join YOOZ,” Lim said. “With such a trustworthy partner, I am very confident in the future of this industry.”
The PMTA process has had some errors and challenges as the FDA’s decision deadline looms.
By Timothy S. Donahue
The U.S. Food and Drug Administration’s process for premarket tobacco product applications (PMTAs) has not been perfect. The regulatory agency has less than three weeks to complete its review of the more than 2 million PMTA submissions that remain of the more than 6 million received (the FDA refused to file more than 4 million submissions from the JD Nova Group). Given the unprecedented number of applications and other factors, the likelihood of the FDA reviewing all the applications by Sept. 9, 2021, is low.
“We will continue to allocate our resources with the goal of working as quickly as possible to transition the current marketplace for deemed products to one in which all products available for sale have undergone a careful, science-based review by [the] FDA,” an FDA spokesperson told Vapor Voice. “With that being said, as with all unauthorized products generally, if products are not authorized by Sept. 9, 2021, and do not come off the market at that time, they risk FDA enforcement.”
A court ruling requires the FDA to complete review of all submitted PMTAs by Sept. 9, 2021. Only a positive order issued by the FDA would allow a company to continue to be marketed according to the terms specified in the order letter.
“At a recent House hearing, acting FDA Commissioner Janet Woodcock pledged the FDA would make every effort to conclude review of the PMTAs from the top five vaping companies by the fall deadline,” said Gregory Conley, president of the American Vaping Association. “The FDA does not exactly have the best track record on keeping to their pledges, but it seems likely that decisions will be made on, at minimum, the tobacco and menthol varieties of Juul, Vuse, NJOY, etc., by September.”
Unfair warning
Complicating matters further, the regulatory agency has also recently been accused of issuing unwarranted warning letters, of leaving companies off its list of accepted PMTAs and of having technical issues with its PMTA filing software. As of July 26, the FDA had issued 135 warning letters for the marketing of illegal vaping products. The majority of those letters centered on e-liquids produced and sold online by small-sized vape shops. As the FDA continues its blitz, however, some companies who submitted PMTAs by the Sept. 9, 2020, deadline have allegedly received warning letters in error.
According to Facebook posts from the American Vaping Manufacturers Association (AVM), at least two companies have received warning letters for products for which they had submitted timely PMTAs. Posts acknowledged that the FDA corrected its mistake in a follow-up letter after receiving complaints from the companies. While the number may be small, it does suggest that the regulatory agency is overwhelmed by the number of submissions it is reviewing.
Credit: Chris Titze Imaging
According to the FDA spokesperson, there has been only one instance where the regulatory agency removed a warning letter from its website after it was discovered that the company had submitted a timely PMTA. The agency did not mention the company by name and said the error had been corrected.
The FDA said the list may change as some companies may not have responded to requests or have not had their PMTA accepted yet. It should be noted that in its guidance document released in January 2020 that identified its enforcement priorities for electronic nicotine-delivery system (ENDS) products, the FDA stated that it “may prioritize enforcement of certain new deemed tobacco products that are marketed without market authorization, including as warranted based on changed circumstances, new information or to better address minors’ use of those products.”
The FDA also recently started listing closeout letters for companies that had responded to warning letters on its website. When the FDA completes an evaluation of corrective actions via a follow-up inspection, it may issue a closeout letter if the agency’s evaluation shows that the issues noted in the warning letter have been addressed.
Recently, however, the agency removed those letters from its website. The FDA offered no explanation for the removal of the closeout letters. Companies such as Dr. Crimmy’s V-Liquid, Bulldog Vapor and CC Apothacary had closeout letters posted, but then it seemed they were removed.
The FDA spokesperson said that the letters are still on the website; however, accessing them changed slightly. Users must now use the search functions to access response and closeout letters. “Any closeout letters issued to firms since Sept. 9, 2020, including Dr. Crimmy’s V-Liquid, Bulldog Vapor [and] CC Apothecary, are still posted on [the] FDA’s website,” the spokesperson said. “On [the] FDA’s ‘Warning Letters’ page, you can find the closeout letters by listing ‘Center for Tobacco Products’ under ‘Issuing Office’ and filtering for ‘Closeout Letter’ under ‘Letters with Response or Closeout.’”
The FDA often lists only a few illegal products in a warning letter. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products. The agency states that it is the responsibility of the company to only sell products with a submitted PMTA.
Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale and/or distribution of the products. The response must also detail the company’s plan for maintaining compliance with the Food, Drug and Cosmetic (FD&C) Act in the future.
Warning letters are expected to continue to be issued for illegal vapor products as the deadline for FDA action moves closer, and their volume is likely to pick up after the Sept. 9 deadline. The FDA has not said if it intends to ask for an extension on the deadline; however, the U.S. Small Business Administration recently sent a letter to the FDA asking the regulatory agency to request an extension.
Making the list
There are other issues with the FDA PMTA process as well. Recently, the FDA released a list of products that are legal for sale in the U.S. As of Aug. 9, 372 companies had submitted PMTAs for more than 6 million products. Of those products, 99.9 percent are standalone e-liquid products—and of those, 80 percent of the e-liquid submissions were from a single company, according to ECigIntelligence, a vapor industry data and research firm.
At least five companies that filed PMTAs were allegedly erroneously left off the list, according to social media posts by an AVM representative. In its own investigation, Vapor Voice found that Humble Juice Co. had submitted a timely PMTA, received an acceptance letter and was subsequently left off the FDA’s list of approved products. The FDA has corrected the error for Humble. The AVM did not name what companies were left off the list or had falsely received warning letters.
The FDA stressed it has not independently verified the information provided by applicants about the marketing status of their products. In addition, the list excludes entries of products from companies that did not provide information on the current marketing status of their products to the FDA so that the agency could determine whether the existence of the application could be disclosed. It is possible companies were left off the list because they did not respond to the FDA before publication of the list.
As stated on the FDA’s website, the lists are not comprehensive or intended to cover all currently marketed deemed tobacco products that a company generally might manufacture, distribute or sell without risking FDA enforcement. The FDA stated that it was making the list available to the public to be transparent and increase stakeholder knowledge of these products. However, the list is only one source of information, and retailers should discuss with their suppliers the current status of any particular tobacco product’s application and marketing authorization, according to the FDA.
“Due to the large volume of information that needed to be processed to generate the list, it is likely that some information may have been inadvertently excluded during the development of the list. After initial posting of the list, FDA has received inquiries from companies about certain products they believe should have been included on the public list,” the spokesperson said. “We are reviewing these requests, and will update the list, if appropriate, to ensure accuracy. In general, due to the large amount of data in the files, FDA has also stated minor edits and corrections may be made to the list files to ensure accuracy, and the files will also be updated to reflect actions taken on the applications for the products.”
Shaky submissions
The PMTA submission process has also suffered from technical problems. Several companies have complained that the FDA’s software that manufacturers must download to submit PMTA data has randomly left out some files that the companies are uploading. At least two companies that have helped prepare more than 500 PMTAs have acknowledged the issue and have presented the problem to the FDA.
“We did 15 PMTAs for various clients and just all of a sudden had somebody come up and they got a deficiency letter asking for information that was included in their submission. We started looking through it, and it’s missing. We then spent a bunch of time going through every single one and found several others that were missing one or two files,” one of the companies that discovered errors told Vapor Voice. “We reached out to the FDA, got a basic response … ‘we’re aware of this; we’ll get back to you’ type of thing. We believe it’s a bug in the agency’s eSubmitter program.”
The FDA spokesperson said that the agency’s Center for Tobacco Products (CTP) submitters have three options for electronic submissions:
1. FDA hosts the Electronic Submission Gateway (ESG) used by all FDA centers for the past 20-plus years. It requires registration and maintaining a security certificate, which has an associated fee. CTP receives electronic submissions directly through the ESG from a small number of companies.
2. CTP provides a simpler zero-cost alternative to using the ESG directly with the FDA eSubmitter software and the CTP Portal. Using the CTP Portal requires obtaining a free account and using the FDA eSubmitter tool to create a valid package of files, which the CTP Portal will upload. Submitters must download the FDA’s eSubmitter software if they intend to use the free CTP Portal. Instructions for use are on the FDA webpage, and detailed technical specifications for creating valid eSubmitter packages can be found under Electronic Submission File Format and Technical Specifications.
3. Electronic files can be mailed to CTP Document Control Center (DCC) on physical media such as CD, DVD or flash drive.
Credit: Yuri Hoyda
The eSubmitter errors that some companies have found may be user error, according to the FDA. The inclusion of invalid file types in the upload package may make it appear as if certain files were left off. A common invalid file type users attempt to include are zero-sized files, according to the FDA.
“A user may unintentionally include *.tmp files, which are temporary files of zero size that the user’s computer creates when it is moving files from one location to another. If a user moves files they are uploading during the loading process, the .tmp file their computer created will become part of the package manifest and appear in the eSubmitter file count,” the spokesperson said. “A user may think they are sending 500 application files, but if one is a .tmp file, they are only sending 499 files related to the application.”
The CTP eSubmissions help desk recommends submitters create a file list and review the file types to be used in the submission against the list of invalid file types. After uploading to the CTP Portal, they can compare the list of valid files against the CTP Portal upload manifest to ensure all files were included. If files were found to not be included, they could be submitted separately, according to the FDA.
“In general, FDA intends to send only one deficiency letter (if appropriate),” the spokesperson said. “It is the applicant’s responsibility to ensure all information has been submitted to FDA and to review all files that were uploaded to the software prior to submission to FDA.”
Because of these issues, some companies are offering free PMTA deficiency reviews for companies that submitted them to the FDA. Delphinus Consulting and Blackbriar Regulatory Services have said they have programs to help companies find faults in their PMTA submissions.
After the deadline
How the vaping industry changes on Sept. 9 remains to be seen. Large companies may soon dominate the U.S. vapor market while e-cigarettes produced by smaller companies may disappear, according to new research by ECigIntelligence. The data firm carried out an assessment of the FDA’s “accepted” list in order to understand how the U.S. market may change in a post-PMTA regulated market.
Analysis of PMTAs shows that more applications for simpler disposables and cigalike devices were submitted than applications for open systems. According to the research, the simpler products usually come from large companies while the open systems usually come from smaller businesses. Only about 30 open system brands have filed PMTAs, implying that 85 percent of open system brands will be removed from the market, even if all 30 filed PMTAs are approved.
“This may indicate the discouragement nontobacco companies face when applying for PMTA approval,” said ECigIntelligence’s managing director, Tim Phillips. “The PMTA process can be a grueling one for nontobacco companies without sufficient financial means or knowhow. And if smaller brands are to become less prevalent in this category, consumers may soon only have the option of a few models provided by a handful of big companies.”
While the industry awaits decisions from the FDA, vape sales are rising. IRI data for U.S. convenience stores shows that dollar and unit sales for electronic smoking devices each climbed approximately 14 percent for the four weeks ending June 13. A 12-week review revealed a gain of 16.3 percent in dollar sales and 18.6 percent in unit sales.
Whether these trends will continue after Sept. 9 is anyone’s guess.
While the legality of Delta-8 THC products is questionable, retailers say consumer demand is booming.
By Timothy S. Donahue
Delta-8 THC is currently one of the hottest cannabis products on the market. During the Tobacco Plus Expo (TPE) in May, an estimated 75–80 exhibitors out of 350 were offering a Delta-8 product. Many companies were introducing new Delta-8 products at the event; for example, Beard Vape Co., Charlie’s Chalk Dust, JustCBD and TD Distribution Co. all launched their own brands.
Recent estimates predict CBD sales in the U.S. could reach $1.8 billion by 2022. Trevor Yahn-Grode of cannabis industry analytics company New Frontier Data recently told MedPageToday.com that Delta-8 THC had retail sales of at least $10 million in 2020. That number is estimated to double in 2021. Based on the number of Delta-8 vendors at TPE (see “Finally Face to Face,” page 20), sales could triple. It was probably the most heavily hawked cannabis product at the event.
The Beard Vape Co. launched its HRVST Delta-8 brand after numerous distributors started asking about the new cannabinoid hitting the mass market, according to Zachary Kestenbaum, vice president of sales. He said his main objective at TPE was to talk with other distribution companies about where the Delta-8 market is headed. Kestenbaum said consumers like the product because it’s not as overwhelming as the traditional Delta-9 THC, the psychoactive component of marijuana commonly referred to as only THC.
“In the ’70s, ’80s, ’90s, people were smoking marijuana with THC levels at 12 [percent] to 15 percent. Now they’re breeding strains that are 24 [percent] to 26 percent THC (Delta-9 THC). It really can give that head anxiety to people,” he said. “That’s why people like Delta-8 THC because you’re getting a little bit of the psychoactive effect but not at that 25 percent level like you get with the Delta-9 THC. People are preferring the Delta-8. They like it better.”
First discovered in 1941, Delta-8 THC is only slightly different from its cousin compound Delta-9 THC. The two chemicals are only one chemical bond apart, according to Josh Church, a scientist and managing director of Roots Holdings. Research has shown that Delta-8 is a powerful anti-seizure drug. “The issue is it just doesn’t naturally occur at significant levels, so it’s really easy to ban,” said Church, adding that Delta-8 also promotes relaxation, clear-headedness and increased positivity.
Research has also shown that Delta-8 significantly helps reduce stress, stimulate an appetite and lessen nausea. Delta-8 is a less “head high” and more of a body high without the nervousness and paranoia often associated with Delta-9 THC. Delta-8 THC, users should be warned, will also turn up on a drug test as “THC,” according to Church.
Looking at legality
While its popularity is spiking across the U.S., Delta-8 is not without controversy. While hemp itself is federally legal (at or less than 0.3 percent THC), each state has different laws and restrictions regarding byproducts derived from hemp, including Delta-8. No products containing Delta-8 have been tested by the U.S. Food and Drug Administration or are FDA-approved.
Twelve states have completely banned Delta-8 sales. Those states include Alaska, Arkansas, Arizona, Colorado, Delaware, Kentucky, Idaho, Iowa, Mississippi, Montana, Rhode Island and Utah. New York has a proposed rule to ban Delta-8 products, which is under a comment period until July 19. California, Oregon, Vermont and Washington are in the process of enacting regulations for Delta-8 products. Several other states are also considering bans.
The federal legality of Delta-8 products is disputed. The misinformation and ambiguity surrounding its legality is why some manufacturers in the CBD industry took time to develop and market their own Delta-8 products. Jakob Gutierrez, product specialist for JustCBD, which launched its JustDELTA-8 brand at TPE, said it took the company time to launch its Delta-8 product because it wanted to be sure it was working within the law. JustCBD only sells its products to retail shops and distributors; it does not sell directly to consumers.
“We wanted to make sure we were covering ourselves and making sure we were doing it right, complying with the right laws. Now, we were missing out a little bit because of that, but we’re back on track,” Gutierrez said. “We got on the train, and orders are exponential for the Delta-8. People are coming in, just ordering various product, and walking out. It’s insane how fast this stuff is flying out.”
Ask eight people if Delta-8 is legal federally and you’ll get eight different answers. Some believe that the vagueness of the 2018 Farm Bill, which legalized hemp and hemp-derived products, means that Delta-8 is currently legal under federal law. “Because Delta-8 is such a new product, many state laws don’t address it at all, which puts it in a gray area of de facto legality,” according to Leafly, a cannabis information source. The reason states have banned Delta-8 products is an uncertainty about what it is and what it does, according to many Delta-8 manufacturers.
On Aug. 21, 2020, the U.S. Drug Enforcement Administration (DEA) issued an Interim Final Ruling (IFR) that stated hemp-derived Delta-8 is federally prohibited and is to be considered the same for enforcement purposes as Delta-9 THC and that “all synthetically derived tetrahydrocannabinols (THC) remain Schedule I controlled substances.” The memo states that these products cannot be shipped to customers from retailers through the U.S. Postal Service or any other shipping method, and it is illegal to use and possess these products in states where cannabis is not legal.
The U.S. Department of Agriculture’s position on Delta-8 THC is that the Farm Bill mandates only a Delta-9 THC limit and doesn’t regulate Delta-8 at all, so Delta-8 is not part of the agency’s hemp mandate, according to previous statements. Since the amount of Delta-8 THC found naturally in hemp is almost 1,000 times lower than the amount of Delta-9, the agency saw no reason to address it at all, including as part of its “total THC” testing requirement.
A hemp trade association and a hemp company have filed a petition in the U.S. Court of Appeals for the District of Columbia challenging the DEA’s IFR. That case is still being reviewed. The D.C. Circuit petition challenges the IFR on the basis that: 1) the DEA did not follow the appropriate notice and comment procedures, 2) the DEA does not have authority under the Farm Bill to issue the IFR, and 3) the DEA’s acting administrator lacks authority to issue the IFR.
Not all states are anti-Delta-8. For example, Florida’s statute states that “any hemp product intended for human or animal ingestion or inhalation which is sold in Florida must comply with all Florida statutes and rules. Any hemp or hemp extract products offered for sale or sold in Florida must comply with all labeling rules and have a certificate of analysis that shows a total THC (THCA x .8777 + THC Delta-9 = total THC) content of 0.3 percent or less.” Florida is the only U.S. state to have enacted legislation to provide a framework for the legal sale of Delta-8.
Florida’s statement on Delta-8 clarifies that Delta-8 does not run afoul of any Florida law and, in fact, certifies that the manufacture and distribution of Delta-8 is allowed in Florida, according to ACS Laboratory, a Tampa, Florida-based CBD testing facility. “Despite Florida’s conservative legislative trends, the state’s public policy toward Delta-8 is progressive and ultimately beneficial,” ACS’ website states. “By establishing a structured and comprehensive regulatory framework for manufacturers and distributors to follow, Florida is enabling a burgeoning industry to continue to grow and evolve while simultaneously ensuring the safety of buyers by mandating certificates of analysis for all [Delta-8] items sold.”
Chemistry lesson
The proposed updates to those New York rules that ban Delta-8 included a provision declaring that all cannabinoid and cannabinol products made through a chemical process called isomerization can no longer be sold in New York. The new rules specified the compounds Delta-8 and Delta-10.
Isomerization is, in its most basic explanation, adding a chemical bond to a molecule, according to Church. “Basically, anything you can make out of the THC molecule is banned because all isomers of said molecule are banned—technically,” explains Church. “If you remember Spice or K2, they were synthetic THC. The issue was the DEA; the FDA would ban the new molecule—say tetrahydrocannabinol (THC) 9753—and then within the next week, they would come up with THC 9756. And it was this cat-and-mouse game where the DEA, the FDA, and the Chinese authorities couldn’t stop them fast enough until they finally just banned all isomers.”
Many industry players say that the federal government will soon legalize marijuana, and the ambiguity around products like Delta-8 and Delta-10 THC will disappear. President Biden has publicly said that he supports the decriminalization of cannabis and removing it from the Schedule I list while Vice President Kamala Harris has gone further, stating that she supports full legalization. But like all the states that have legalized Delta-9 THC and have specifically banned Delta-8, it would not be surprising to see the federal government make some of those same decisions, according to Church.
“Regulation of these cannabinoids … it’s going to take an act of Congress. Then it’s really hard to try and predict what Congress is going to lay forth in the legislation. I mean, look at the nicotine space with synthetic nicotine still not being closed as a loophole around regulation,” explains Church. “Because so many states are banning it right now (Delta-8), I think the federal government will come in with some sort of hefty regulation on all the isomers or conversion molecules.”
Tony Riva, CEO of TD Distribution Co., parent to the Hi Drip e-liquid brand, also launched a Delta-8 brand at TPE. Riva said he didn’t have the concerns many of the other manufacturers had. He says the vapor industry has been dealing with a harsh regulatory environment for nearly a decade. He doesn’t see why the cannabinoid industry is going to be any different, especially as more and more cannabinoids come to market.
“If I lived in fear all the time in this industry, I’d never get anything done. We are just trying to provide a legal product and hope that the government doesn’t tell us that we can’t. It’s a constant battle with their … tyrannical overreach that they’ve thrown down on the vaping industry,” he says, adding that he expects the cannabis industry to be federally regulated in some form within the next few years. “People like Delta-8; people like Delta-10 or CBD. They feel that it helps them. We are just trying to provide high-quality, legal products to our clients. At the end of the day, it’s just going to be another hula hoop to jump through.”
Church says that he recommends any retailer or manufacturer contemplating entering the Delta-8 market to consider having a firm process of chain-of-custody documentation, adding that the cannabinoid industry should look toward the legal marijuana industry as a guideline. Church emphasized that one bad player could destroy the market by doing something wrong and causing the potential for another situation like the e-cigarette or vaping product use-associated lung injury (EVALI) issues that occurred because a few bad players used vitamin E acetate in black market THC vape pens without doing any research on the chemical.
“Those dirty conversions are out there; there is a lot of risk to a finished good. The last thing you want to see is a dirty lab pumping out a bunch of garbage. Then it gets distributed nationally, and we have another EVALI situation. This isn’t because of the Delta-8, which is largely safe, but because it’s a bad product. I would strongly encourage anyone looking to move into the Delta-8 or Delta-10 space to meet those high standards that are required for any type of legal consumer product,” says Church. “The reality is, though, that the sky’s the limit on these types of products. I think we’re just now seeing it with Delta-8 and Delta-10 … but it’s going to evolve into a crazy world of these new designer cannabinoids. And regulation is coming along for the ride.”
A large study conducted by the TPA shows e-cigarettes control youth smoking.
By Maria Verven
An extensive, state-by-state analysis conducted by the Taxpayers Protection Alliance (TPA) proves e-cigarettes are more effective in controlling youth smoking than tobacco control programs started after the Master Settlement Agreement (MSA).
“Tobacco & Vaping 101: 50 State Analysis,” authored by Lindsey Stroud, uses data from the Centers for Disease Control and Prevention (CDC) to argue the benefits of vaping, especially when it comes to teen usage. Ironically, this same data had been used to create public hysteria over vaping rates, especially among youth.
“As lawmakers across the country seek to reduce youth tobacco and vapor product use, many have introduced and passed legislation that regulates, taxes and in some cases prohibits the sale of products that actually help reduce tobacco use,” Stroud said.
Stroud said she’s been using the findings in state legislative testimony this year. “I’ve received positive feedback from pro-vaping and tobacco groups but have not heard much back from the anti-groups,” she said. “They may be surprised to see that I used the same data they do to argue the benefits of vaping,” she said, adding that she’s determined to make this information publicly available and accessible.
Stroud said she hopes other researchers and industry followers will use the report’s state-by-state information on adult and youth use of tobacco and vapor products in future articles and reports.
Of particular interest is the effectiveness—or lack thereof—of tobacco settlement payments, taxes and vapor products on reducing combustible cigarette use.
While all 50 states and Washington, D.C. saw a decrease in the percent of smokers, some states actually saw an increase in the number of smokers, due to an overall increase in the state’s population. Stroud’s analysis took into account both the percent difference and population change in examining adult and youth vapor and tobacco rates.
The analysis of cigarette tax revenues between 2000 and 2019 found that while cigarette tax hikes helped increase revenues in the short-term, these increases didn’t contribute to the decline in smoking rates.
It also shows that most states drastically underfunded programs for tobacco cessation services, education and prevention after collecting cigarette tax revenue and tobacco settlement monies over the past 19 years.
Vapor products tied to decrease in youth smoking
Of greatest importance is the analysis on the reduction in youth use of combustible cigarettes—which is at an all-time low. The report also examines youth vapor rates, specifying whether they ever tried an e-cigarette or are truly current or daily users.
Here’s where the data got really interesting. Stroud compared the smoking rates among 18-year-olds to 24-year-olds in the 10 years after the MSA with the smoking rates in the 10 years after e-cigarettes appeared on the market.
Credit: Vaksmanv
Lo and behold, there were greater decreases in smoking rates in the 10 years after the emergence of e-cigarettes when compared to the 10 years after tobacco settlement lawsuits.
And in the four states where smoking rates actually increased after e-cigarettes came on the market, policymakers had increased scrutiny and restrictions on e-cigarettes due to the perceived youth vaping “epidemic.” Coincidence? Stroud doesn’t think so.
“Addressing youth use of any age-restricted product is laudable, but it should not come at the expense of adult users of such products,” Stroud wrote in Politics, adding that bans, arduous regulations and/or unfair taxation threaten adult access to e-cigarettes and other tobacco harm reduction products.
“Completely disregarding that youth smoking rates are at all-time lows, officials often propose ‘solutions’ that fail to address the real reason why youth use e-cigarettes,” Stroud said.
States with higher rates of youth smoking have higher rates of youth vaping. Stroud said that the data clearly indicate that youth use e-cigarettes because friends and family members use them.
When asked about the “primary reason” for using e-cigarette products (among current users, only 10 percent of respondents from many states answered it was due to “flavors” while 17 percent cited “friends and family” and 51 percent cited “other.”
Vapor Voice caught up with Lindsey Stroud to learn more about this groundbreaking report and how this plethora of tobacco and vaping data can be used to inform future policymaking.
Vapor Voice: How was all this data collected? How long did it take?
Stroud: The idea was to provide policymakers with a plethora of tobacco-related data in a simplified manner.
We compiled the data manually by inputting data from the Centers for Disease Control and Prevention’s Behavior Risk Factor Surveillance System (BRFSS) between 1995 and 2019.
While state-specific BRFSS data included detailed demographic information such as age, gender, race, education level, income and smoking status, it wasn’t easy finding that data for the U.S. as a whole. So I started going through individual state data and putting together state-specific spreadsheets on cigarette use.
In addition, I examined annual state cigarette tax receipts, annual state tobacco control funding, cigarette tax increases and youth tobacco and vapor product use, which came from the CDC’s Youth Risk Behavior Survey.
It’s important to note that the Campaign for Tobacco-Free Kids also uses this same BRFSS data. However, while Tobacco-Free Kids only shows smoking rates and the cost of smoking in each state, we pulled various data items to tell a more complete, insightful picture.
What surprised you the most about this project?
I was amazed that my hypothesis—that e-cigarettes were more effective than the MSA in reducing smoking rates among young adults—actually held true. It was really eye-opening.
It’s still pretty amazing that 45 states and D.C. saw greater decreases in smoking rates among 18[-year-old] to 24-year-old adults in the 10 years after e-cigarettes emerged on the market than in the 10 years after the tobacco companies started shelling out millions that states were supposed to use on smoking cessation programs.
In the outlier states, smoking rates were at their lowest levels ever until 2018—the same year the surgeon general declared a “youth vaping epidemic.” Tragically, that’s when smoking rates began to increase.
Why did you feel this data was needed?
I really wanted to show policymakers data that compared youth vaping to youth smoking rates, which were way higher in the 1990s, especially compared to today’s youth vaping rates.
In all states, cigarette tax increases led to immediate increases in revenue in the short term, but these have all fallen as less adults smoke cigarettes.
I also wanted to call attention to the lack of state funding for tobacco control programs, despite the fact that states receive millions if not billions of dollars annually from tobacco monies such as excise taxes and tobacco settlement payments.
As far as I know, this is one if not the first analysis of the BRFSS data to include graphs—which clearly show the reduction in smoking rates among young adults as well as how little funding is spent on tobacco control.
Finally, I wanted to prove my hypothesis that vaping can take much of the credit for the reduction in both adult and youth smoking rates.
Vaping products don’t create costs; they make some of the costs of tobacco use disappear.
By George Gay
According to a Vapor Voice news story quoting a CStoreDecisions piece by Isabelle Gustafson, lawmakers have introduced into the U.S. Senate a bill that would establish a federal tax on vaping products and increase the traditional tobacco tax rate for the first time in a decade.
I quote below three of the five-paragraph news story in full because I believe that some of the points made by those supporting the bill need to be challenged, though I acknowledge that such challenge will not affect the final outcome:
The Tobacco Tax Equity Act of 2021 aims to “close tax code loopholes for tobacco products by increasing the federal tax rate on cigarettes, pegging it to inflation to ensure it remains an effective public health tool and setting the federal tax rate for all other tobacco products at this same level.”
“Tobacco-related disease accounts for one out of every five deaths in America, and I know that story firsthand,” Senate Majority Whip Dick Durbin was quoted as saying. “Data shows that the most effective strategy to prevent children from starting this deadly habit is to price it out of their range. This bill would help reduce tobacco and e-cigarette use by ending loopholes that the industry has exploited to target our children. If America can kick its nicotine addiction, it would go a long way to improving our public health for generations to come.”
“Loopholes in our tax code continue to favor big tobacco while the American public, especially our youth, pays the price,” said Representative Raja Krishnamoorthi. “The Tobacco Tax Equity Act increases taxes on cigarettes and finally imposes taxes on the e-cigarettes hooking our children on nicotine, which would generate billions of dollars in federal revenue. As a father of a high schooler and middle schooler, I’m determined to make sure we end the youth nicotine and vaping epidemic.”
I would like firstly to question the term “loopholes,” which is used three times, once in the introduction and once each by the two politicians quoted. The word loophole is used normally to convey the idea that some scam is in operation that allows a disreputable individual, corporation or organization to gain an advantage over others by obeying the letter of a law or rule but not the spirit of that law or rule. And that implied criticism is aimed at one of the usual suspects—big tobacco.
But is this what has been going on here? Has big tobacco been using loopholes in the tax system to target young people? Not from the evidence presented. The politicians quoted seem to be complaining that big tobacco hasn’t been falling in line with tax rules not yet in place, which seems a tad unfair. In other words, the complaints, if any, should be aimed at the politicians for not having brought in these new rules earlier, given that they seem to believe they are so important.
But it is not the way of politicians to blame themselves or even to admit that they have been neglectful of their duties, so the politicians try to clamber onto the word loopholes as if it somehow represents the moral high ground.
And on that somewhat unstable ground, they teeter. Durbin is quoted as implying that one or more people from within his circle of family and/or friends died from a tobacco-related disease. I’m sure that most people would sympathize with Durbin at this point, but the problem here is that he is trying to convince people of the correctness of his position by arguing from the particular to the general.
And the concern must be that despite the fragility of such arguments, other politicians will be won over. It makes you wonder what would happen if a politician called for extra taxes on automobiles because somebody from within her circle had been killed in an automobile wreck.
What I don’t like, also, about Durbin’s position is that it smacks of collective punishment. Tobacco consumption led to the death of somebody from within his circle, so all tobacco users should be punished through the taxation system, even though what they are doing is legal and even though they had no interaction or involvement with the dead person. Such actions are banned even in war.
Then, from the dizzying moral heights of language loopholes and particularities, the announcement moves on to the favorite ploy of all: emotional blackmail. We are told that the new taxes will protect “our children”—or, rather, children (three mentions), youth (two mentions) and schoolers (two mentions).
I wonder how? Perhaps, in the light of not enough attention being paid by politicians to some of the other needs of children, the additional money raised through the new taxes could be used to feed the 18 million children who are projected to face hunger in the U.S. this year. But don’t hold your breath.
Credit: Auremar
Krishnamoorthi is quoted as saying that the Tobacco Tax Equity Act “increases taxes on cigarettes and finally imposes taxes on the e-cigarettes hooking our children on nicotine.” Note the use of “finally” here, which I guess is meant to imply that it has taken a long time to bring the bill forward because of the heroic efforts that politicians have had to put in to overcome the huge barriers standing in the way of tax reform, when, presumably, the reason is that they have not been bothered up to this point.
I would also like to take issue with the idea that Krishnamoorthi trots out about “e-cigarettes hooking our children on nicotine.” Does he know this to be the case, I wonder? Has he proof? It is true that if you look on the website of the National Institute of Drug Abuse, you will see a piece that says, “Consuming nicotine—through regular cigarettes or vaping—leads to the release of the chemical dopamine in the human brain. As with many drugs, dopamine prompts or ‘teaches’ the brain to repeat the same behavior (such as using tobacco) over and over.”
But according to a review by Rivka Galchen (London Review of Books, April 22) of The idea of the Brain, the author, Matthew Cobb, casts doubt on such an idea. “The connection of dopamine to addictive behavior—Cobb cites a Facebook founder saying the site was meant to be addictive, to ‘give you a little dopamine hit’—is ‘nonsense’ and ‘neurobollocks,’” Galchen quotes Cobb as saying. I am not saying that Cobb is correct. I am not in a position to be able to judge such things, but what he has to say must surely give people, even politicians, pause for thought, for he is not alone in thinking this way.
One problem in assessing the rights and wrongs of taxing vaping products in the U.S. arises from the fact that politicians have fallen for the Food and Drug Administration’s descent from science to alchemy in “deeming” these products to be tobacco products. Imagine a U.S. in which bread has not been invented and a significant proportion of the population lives on cake as a staple, with the consequence that these people are wobbly fat.
In trying to improve the situation, the authorities have turned to imposing high taxes on cake, but the sugar content proves to be too appealing, and the people keep buying cake, whether tax-paid or illicit. The authorities then declare war on the cake manufacturers who, after a while, admit that too many wobblies are dying, and come up with bread, with which they claim they can wean at least some of the people off cake.
What do the authorities do? Do they welcome this development? Not if we are talking about the FDA. They say that bread, like cake, contains flour, and, since there are still small amounts of sugar in bread to make it palatable, bread must be deemed to be cake. At which point, the politicians, desperate for funds, realize that bread can be taxed. Alice has gone headfirst through the looking glass.
Credit: Highway Starz
A couple of other points come out of the announcement of the bill. It is clear that part of the aim of the bill is to force the U.S. “to kick its nicotine habit.” But nicotine and tobacco use are both legal in the U.S., so people have the right to consume tobacco and nicotine products. There is a danger here that politicians are going to muddle up issues of ethics with those of rights.
Just because you object to something on ethical grounds doesn’t bestow on you the right to make it unobtainable for those who don’t go along with your ethical views. In the U.K., we seem to get stuck in the same morass when discussing the issue of assisted dying, and all too few politicians are willing to make the stand that though they might be ethically opposed to assisted dying, they recognize the rights of others to avail themselves of it. As I believe Michel de Montaigne pointed out in the 16th century, “Life is slavery if freedom to die is wanting.”
At the same time, it seems to me that we enter the tobacco and nicotine tax debate too far along the line. We enter it on the assumption that tobacco and nicotine products should be taxed. But why is this so? Well, one idea has it that products should be taxed according to the harm that they cause. This point was made by a couple of speakers who addressed the Western Economic Association International (WEAI) virtual conference during March.
According to a news report, one of them, Woo-Hyung Hong, professor in the Hansung University Department of Economics (South Korea), said that tobacco taxes should be based on a product’s external economic costs. Such a system should consider medical costs, loss-of-labor capital costs, costs from cigarette-related fires and avoidance costs, among others.
There is a certain logic associated with this idea, but if you accept that logic, then surely you have to apply it to everything. Automobiles, for instance. Look at the medical costs that arise from people driving automobiles. There are, of course, the deaths and injuries caused by car wrecks, the deaths and injuries caused by the pollution most automobiles contribute to, pollution that has now been acknowledged to be a bigger killer worldwide than tobacco consumption. And then there is the issue of people becoming wobbly fat because they use their cars rather than walk.
This, in part, is what the U.S. Centers for Disease Control and Prevention has to say on this subject: “Obesity is serious because it is associated with poorer mental health outcomes and reduced quality of life. Obesity is also associated with the leading causes of death in the United States and worldwide, including diabetes, heart disease, stroke and some types of cancer.”
And what about the loss-of-labor costs? Well, for a start, all of the medical problems outlined above are likely to lead to such loss of labor, and just imagine the loss caused by people snarled up in highly polluting traffic jams.
And while most automobiles still run on fossil fuels, there is the billion-dollar cost of subsidizing the oil companies for pumping these fuels out of the ground—fuels, the use of which is causing eye-watering costs associated with climate change and environmental breakdown, costs from which we might never recover.
None of this is to say that tobacco should not be taxed. We are too far down the road to go back now. But all of the revenue from such taxes should be used to relieve some of the causes that encourage people to take up smoking; one of which is clearly poverty since poverty is a good predictor of the likelihood of a person being a smoker. I believe in the idea of redistributive taxes, but the way that tobacco taxation works at the moment is that it is redistributive “upward,” which is obscene.
And finally, there is no reason to tax vaping devices. They don’t create costs; they make some of the costs of tobacco use disappear. They are a solution, not a problem.
