Category: This Issue

GTNF: Always Evolving

Credit: Mapix
This year’s Global Tobacco and Nicotine Forum (GTNF) focused on innovation and sustainability in the ENDS industry.
By Vapor Voice staff
The Global Tobacco and Nicotine Forum (GTNF) has been one of the most insightful conferences over the past decade, especially in its embracing of electronic nicotine-delivery systems (ENDS) and their potential for harm reduction. During this year’s event, held in London from Sept. 21-23, speakers were challenged to focus their insights on this year’s theme: Continuing Change: Innovation & Sustainability. Below, we have provided session overviews of the many keynote speeches and panel discussions that centered on ENDS products. Next year’s GTNF will be held in Seoul, Korea on Sept. 20-22.
GTNF Fireside Chat with Todd Cecil, FDA
The U.S. FDA insists its banning of all flavored e-liquids other than tobacco is not a de facto ban on the products.
By VV staff
When the U.S. Food and Drug Administration began issuing marketing denial orders (MDOs) for vapor products, the industry was understandably shocked. Many companies that had submitted timely premarket tobacco product applications by Sept. 9, 2020, had expected to first receive a deficiency letter and not immediately an order to remove their products from the market. Some MDO recipients complained the agency had “moved the goalposts” by suddenly requiring studies that it had previously said were not required.
Credit: Malcolm Griffiths
At least four companies have filed lawsuits over their MDOs. All are accusing the agency of making “arbitrary” decisions and not reviewing the submitted data according to the statutes. In a “fireside chat” between Joe Murillo, chief regulatory officer for Juul Labs, and Todd Cecil, deputy director of the Office of Science for the FDA’s Center for Tobacco Products, during the recent GTNF in London, Cecil acknowledged the missing data that caused the flurry of MDOs is not required by the statutes that regulate tobacco products.
When asked what the “level of expectation” the FDA had in deciding whether to issue a deficiency letter or an MDO after a premarket tobacco product application (PMTA) was moved into scientific review, Cecil said that the agency followed “a randomized approach” to choose the applications the FDA would work on.
“The randomized approach identified a number of manufacturers’ products that went into this scientific review, and we … evaluated them from top to bottom,” he said. Cecil noted the agency began to see in some applications that “tended to have problems or missing materials that we needed in terms of benefits [of flavors]; that we learned we have to have that benefit piece … that evaluation that we spent several months working on taught us what we had to look for to be able to [conduct] a full scientific review.”
Cecil said that the agency just figured “if we know going right in that there are pieces missing, why will they go through a deficiency process and with a very short turnaround expecting to get back a full study that wasn’t completed previously?” So, instead of issuing a deficiency letter as required by statute, the FDA just handed out MDOs because the agency knew that it would take a company a significant amount of time and expense to conduct the new required longitudinal and cohort studies. Cecil was then asked why the agency filed the applications in the first place.
“We had to make a determinant how can we streamline this evaluation and determine those products that have at least the bare minimum for us to do a real and complete evaluation,” Cecil said. “This evaluation is not a standard. It is not a de facto standard or anything else. This is information that we need to see, but it’s not a requirement. An RTF [refuse to file] are those things that are required by the statute. And these studies are not necessarily required by the statute.”
The FDA has also been facing an unprecedented amount of scrutiny on its handling of the regulation of electronic nicotine-delivery system (ENDS) products and the PMTA process. Numerous health groups, anti-nicotine groups, states attorneys general and even members of Congress have criticized the FDA and demanded action. When asked if the FDA’s actions were influenced by these groups, Cecil said the agency focuses on science.
“We’re science-based,” he said. “We need look at what is presented to us in the application and in the laboratory. That is what we’re most focused on. If there is new data out there and that new data is brought to our attention through one of these [groups], then that’s fine. We would be happy to get those up and understand the bigger picture, all of the data … We need to evaluate those … scientifically or make a determination based upon that science.”
Only 100,000–200,000 products remain under FDA review. Of the 6.7 million submitted PMTAs, all others have received either a refuse-to-accept, an RTF or an MDO response. Cecil denied the agency was making a “categorical policy decision as opposed to an application-by-application decision” about flavored products. “We are stating that we understand that there is a significant youth initiation risk that comes from flavored ENDS products,” he said. “We are, in fact, reviewing all of those, and what we have found as we’ve done our reviews is that none of the literature is sufficient to demonstrate that there is not a youth initiation risk for individual flavors.
“We see that tobacco has a lower initiation risk. We see that menthol has some issues with it, and we are going to be evaluating that as we go forward. However, all of the data points to the flavored products as having significant youth initiation concerns. So what we’re looking for is an adequate indication that there’s a benefit on the other side of the equation. This is not a decision that we aren’t going to accept flavored products. Absolutely opposite. We need to ensure that there is concrete and robust data that demonstrates that there is an existing user benefit for those products.”
Cecil declined to say when more MDOs would be issued or when the agency would rule on major products, such as Juul, NJOY, blu and Vuse. “We continue to work diligently,” is all he would say. “There are a number of products that are well along. But no, I can’t tell you how many are those ones, but there are some that we’re hoping to move forward in the short term.”
The FDA’s recent action against flavored e-liquids does not mean that the FDA will never approve a flavored e-liquid, according to Cecil. He said that the rejected applications just lacked the required information that those products met the agency’s “appropriate for the protection of public health” standard. “You are welcome to reapply once you have addressed the issues that we provided to you,” he said. “And we will reevaluate that at a future date.”
GTNF Panel: The Fork in the Road: What is Next for Tobacco and Nicotine
Regulators must remember the vaping industry began with hobbyists and enthusiasts who built their own devices.
By VV staff
The vaping industry faces many challenges. The road to a viable future for these products must pass through sensible regulations based on science. In the current environment, unfortunately, this will be challenging, according to speakers on the GTNF plenary panel The Fork in the Road: What is Next for Tobacco and Nicotine. Misperceptions surrounding nicotine and vaping products, the panelists agreed, are furthered by the mass media’s “wonton disregard” for the science behind the tobacco harm reduction potential of electronic nicotine-delivery systems (ENDS).
Credit: Malcolm Griffiths
One speaker noted that in addition to many countries banning or erecting insurmountable barriers to vaping products, well-funded anti-nicotine activists are attacking the people who are bringing reduced-risk products to adult combustible cigarette smokers trying to quit smoking. These groups are opposed to the tobacco harm reduction that science and innovation can bring.
All of these activities together only serve to enhance the vaping industry’s problem: the massive public misperception that vaping is as deadly as smoking cigarettes. The fact that a significant number of physicians mistakenly belief that nicotine, rather than combustion, is responsible for smoking-related illness, bodes ill for the perceptions among the general population. “If physicians believe this, imagine the views of the average smoker in Kenya or Chicago, Illinois, or in Australia,” one speaker said.
While anti-nicotine activists have done their share to misperceptions, the vaping industry too is partly to blame, according to one panelist. The ENDS industry can do a lot more than feel helpless or complain, this speaker noted. Innovation in harm reduction cannot occur without the vaping industry’s support. That means responsible marketing, combating illicit trade, limiting youth access and making sure that the ENDS industry is doing what it can to prevent underage use.
Panelists also expressed concern about the direction of the vapor market in the wake of the U.S. Food and Drug Administration’s marketing denial orders (MDOs), with some describing a “Wild West” scenario. After receiving MDOs, some companies have turned to synthetic nicotine because that product currently is outside of the agency’s jurisdiction. A panelist said that the FDA’s “scorched earth” approach to flavored products is only creating bigger problems in the market, adding that if a market isn’t regulated, there is still going to be an unregulated illicit market that has the potential to be more deadly than that for combustible tobacco.
“Nobody wants kids to take up the products … it’s a very significant responsibility that we in industry be there to be the stewards of that concept in generating science and evidence,” a panelist said. “We should all be proud of the good science that is being generated … that is our responsibility: to generate and publish and participate in the scientific debate and pursue reasonable regulation. What is reasonable? I don’t know. It’s not going to be nothing. We all have to get over it and figure out what is the right way forward so we can go back to helping the consumer and making sure we’re only serving smokers who are looking for alternatives to combustibles.”
GTNF Panel: Consumers: The Key Stakeholders
Harm reduction should empower individuals to make their own choices about what products they consume.
By VV staff
For many people, the threats they face in day-to-day life are far more immediate than their long-term health. The mission of harm reduction should be to empower people to make their own choices about what products they consume and their own health decisions, even if those decisions don’t align with what public health experts would say is optimal. This was the general focus during a plenary panel discussion at the GTNF called Consumers: The Key Stakeholders.
Credit: Malcolm Griffiths
Most of the session centered consumers standing up and advocating for the industry, the global attacks on flavored e-liquids and growing threats from the World Health Organization (WHO), which remains suspicious of tobacco harm reduction. Panelists agreed that while some consumers prefer to remain on the sidelines, many others are willing to get organized and campaign for tobacco harm reduction and the vaping industry. “The consumer voice is very powerful,” a panelist said.
A major concern for the vaping industry is the concerted campaign against flavors. Flavors, according to one panelist, are used to by the industry’s enemies to redirect the conversation toward children. “They’ll say vaping flavors attracts children, and then they get us to play in their playground,” he said. “It’s very different. You [consumers] have got to keep asserting that adults use flavors.”
The WHO is a threat no matter what, the panel agreed. The global health body is now even talking about redefining smoke to include anything that’s heated and emits a vapor. “This means that any customizability of a product will be restricted and have limits on it, which basically means all the vape products will be the same,” explained one panelist. “These [recommendations] have to be resisted. The WHO doesn’t make laws, but it’s very influential, and these things can’t just be waved away.”
The scientific studies the WHO uses to justify its negative view toward next-generation products as tools for harm reduction are “fantasy and cherry-picked” studies, according to another speaker. “The people who are against harm reduction will never sleep. They’re always working, and they’re highly funded,” a panelist said. “[Consumers] have to stay alert, and they have to stay organized because, at the end of the day, there are more consumers than there are activists against harm reduction, and we’ll vote. So, consumers really have a big role to play.”
Consumers are the key stakeholders. However, when talking about consumers, regulators must acknowledge that not every smoker is the same, according to the panel. Many smokers don’t want to quit combustibles. “The important thing is to understand why and respect their choice,” a panelist said.
One speaker said that the industry also needs more responsible vape reviewers on YouTube because the current ones “are absolutely appalling.” The speaker urged consumers to make their voices heard in politics. “You’ve got to have somehow to get ahold of your Parliamentarians or your politicians in your country and get them to campaign on your behalf because there are many, many consumers, but you haven’t got great voice in government, and that’s what you really need to try and get,” he said.
At the end of the session, an audience member asked the panel if it could see a situation where consumers would sue regulators over counterproductive rules, such as flavor bans. “I have mentioned the fact that it would be interesting if someone could do a test case, but I don’t know whether that someone could come from the consumer side and sue [over regulatory action],” the panelist said. “It’s also expensive, and someone will end up having to pay if you lose.”
GTNF Panel: Science Driving Innovation
The nicotine delivery of products and being conscience of the environment are key points in innovation.
By VV staff
Regulators globally are becoming more understanding of what they expect next-generation tobacco products to accomplish. Regulators want manufacturers to demonstrate, on a product-specific basis, whether the vaping products are a benefit to combustible cigarette smokers. More importantly, manufacturers must ensure that vulnerable populations such as youth are not using these products.
Credit: splitov27
During the lunchtime GTNF panel “Science Driving Innovation,” one speaker also mentioned that manufacturers must be more conscious about the environmental impacts of vaping products too. The environment is a big issue in the minds of governments, regulators and society as a whole. The panelists agreed that vaping manufacturers should produce products that are environmentally sustainable.
“Think about all the batteries that go to waste every time an e-cigarette is disposed of. What are we doing as an industry to address the fundamental questions that society and regulators are concerned about?” a panelist asked. “We need to start thinking about what views of science we need to really put our investments in [and start] focusing on going into the future.”
Another major industry concern that should be addressed through innovation is youth initiation. One panelist said this topic should be a primary focus of scientific efforts relating to vaping products. Reduced-risk products must exist for adult smokers, so it’s imperative that the industry proactively addresses the underage use issue. “If we don’t, others will try to do it for us, and then collectively, we will all compromise the potential that [we are focusing on during the conference] today,” one panelist said. “It’s a critical balance. It’s important that we offer adult smokers an alternative, and we can also combat underage use. We can do both, and we must because there’s too much at stake if we don’t.”
Another speaker discussed her company’s global retailer compliance monitoring program. The company sends thousands of “mystery shoppers” into U.S. retail outlets that sell its vaping products and collects data around whether the retailers are abiding by federal age verification laws and/or other local policies.
“What we found is that retailers need help. There’s a lot going on in this world. We help them by providing information on how they’re performing, education and training, and we can also assist in changing their existing point-of-sale technology,” she said. “It can actually prompt the clerks to check ID when they’re selling an interesting new product. And it alleviates the mental burden on their end.”
Another concern for the industry that can be addressed through innovation is improving nicotine delivery and satisfaction. That satisfaction delivered by products today is not enough to sustain the large number of people we want to see switching from cigarettes to electronic nicotine-delivery systems.
“To achieve meaningful harm reduction, we need these products to appeal to and be affordable to most adult cigarette smokers. Which means those consumers would need to like the product and be able to afford the product,” a speaker said. “They need to be able to trust these products, and it requires a significant investment in innovation if you want to do it properly.”
GTNF Plenary Panel: Innovation as the Path to Progress
The more freedom the industry has to innovate, the more likely smokers are to transition away from combustibles.
By VV staff
Innovation is grounded in regulation. Regulators can either embrace innovation as a tool to support harm reduction, or they can regulate them to the point that any innovation is impossible to bring to market. During the GTNF panel Innovation as the Path to Progress, one speaker explained that the U.S. Tobacco Control Act was written with the goal that the state of public health will change over time. The idea is that as smokers quit and product standards are implemented, many may migrate to products lower on the risk continuum. As a result, as the state of public health changes, the products that the U.S. Food and Drug Administration determines to be appropriate for the protection of the public health (APPH) will also change.
Credit: Urupong
“If you think about the significance of the innovation of the e-cigarette, today we have major companies that are in the tobacco space talking about eliminating combustion altogether,” a panelist noted. “We have companies giving up their entire combustible segments, and that would not have happened, in my opinion, had it not been for the innovators.”
Making innovative progress in the vapor industry is measured by transitioning adult smokers to noncombustible products, according to the panel. However, there are many avenues to accomplish this goal as well as numerous obstacles. One speaker offered the audience three focus areas that he described as the pillars of innovation. The first pillar is product innovation. “If the product is not satisfying, people are not going to switch,” the speaker said. “In order to get there, we will need a very disciplined, science-based approach in understanding some of the questions underlying satisfaction. As we think about innovation and product innovation, it’s important for smokers to have a range of products to choose from.”
The second pillar is scientific innovation. There must be a comprehensive assessment of science to demonstrate that a product is APPH, and while all novel products tobacco products must be held to this high standard, it is rigorous and takes time. There are innovations in scientific methodologies that must be made, the speaker explained.
The speaker cited dissolution methods to understand nicotine release profiles and computation of toxicology as examples of tools that can help accelerate this pathway for getting products in the market. “Along with that, I think that regulators have an opportunity to create some innovative processes,” the speaker said. “For example, establishing product standards that will hopefully help these products be reviewed in an expedited manner, and most importantly, get them in the hands of consumers.”
The third pillar is communication. The industry needs to make clear the benefit to smokers by switching to noncombustible products. The industry needs to address the misperceptions surrounding nicotine and the wrong assumption nicotine causes cancer. “This clouds the decision-making process of adult smokers,” the speaker said. “As manufacturers in the U.S., we have to seek FDA authorization before we can communicate a modified-risk or modified-exposure order. That, too, is important but time-consuming and resource intensive. This is a responsibility for everybody to explore innovative communication approaches that can address these misperceptions.”
Another area ripe for innovation in the electronic nicotine-delivery system industry is environmental sustainability. For example, e-cigarette batteries contain heavy metals. The industry must innovate battery technology that will reduce their products’ environmental impact. Responsible disposal of any product is important. Regulation can also impact environmental issues. In the U.K., for example, requiring 10 mL bottles instead of larger bottles creates more waste.
Finally, synthetic nicotine also offers innovative advancements for next-generation products. “I think that when we talk about moving away from combustion, that is one thing, but when we talk about moving away from tobacco—in other words, giving consumers a truly tobacco-free option—that’s where science comes in,” a panelist explained. “The promise that is involved with synthetic nicotine is significant. They need to research it closely and recognize that it does provide certain benefits that perhaps the tobacco-derived nicotine does not.”
GTNF Keynote: Frank Han
The leader of FEELM said that exciting innovations are happening every day in the vaping industry.
By VV staff
During a keynote address for GTNF, Frank Han, senior vice president of Shenzhen SMOORE Technology Co. and CEO of its FEELM business division, said that there are exciting innovations—big and small—happening every day in the vaping industry. Vaping products using FEELM atomization technology have now reached millions of users in more than 50 countries.
Credit: Malcolm Griffiths
“Vaporization technology is still just at the beginning; we could welcome the opportunity for innovation to create a better life together … Basic Science Innovation has been the cornerstone for sustainable growth; it is the science of atomization that we need to build as the foundation supporting the industry,” he said, speaking through an interpreter. “As a firm believer of innovation, SMOORE has integrated disciplines like engineering thermodynamics and biomedical sciences into our atomization research.”
SMOORE has been actively learning to understand and assess the long-term health effects of vaping, according to Han. The company currently has seven research centers between the U.S. and China, “bringing in global talents” from different backgrounds. In addition to in-house R&D resources and efforts, SMOORE is also focused on partnering with leading universities to transform the company’s scientific discoveries into applied technologies. “The way vape products are manufactured is also constantly evolving; more effectively and definitely more environmentally friendly,” said Han.
SMOORE had begun operations using the first fully automated pod production line in the world. Each new manufacturing (single) line can produce 7,200 standard vaporizers per hour, double the previous generation’s output. “We have been working with business partners to improve sustainable practices in all stages of product development, especially manufacturing with the common goal of reducing carbon footprint,” said Han.
SMOORE is currently evaluating the underlying technology of atomization for its potential applications in other fields. “With one direction of our R&D focus on the atomization application in healthcare, I am proud that SMOORE has made progress on the research of atomized medication, along with partners from different sectors,” Han said. “The initial results are all positive. We are hoping in the near future, more and more people might be able to inhale medicines or even vaccines with atomization devices.”
Looking ahead at the vaping industry overall, Han said that policymakers and NGOs must be inclusive. Regulation has been a heated topic recently in both the U.S. and China, and while institutional innovations to promote healthy industry development and more balanced regulations are needed, regulators must also embrace vaping as a strategy to improve public health while safeguarding against youth initiation, he said.
“The global media must also be inclusive. We must value the media that report from an unbiased perspective, involving more people in the public dialogue on vaping, discussing the pros and cons and discovering the truth,” said Han. “I’d like to share an old Chinese saying here: ‘Though the road ahead is dangerous and difficult, we can only achieve our goals with constant efforts.’ We must press ahead with a sense of perseverance to expect a better future.”
Amanda Wheeler: NO SURRENDER
Her dreams and business crushed by a marketing denial order, Amanda Wheeler vows to continue the fight for vaping.
By Timothy S. Donahue
Amanda Wheeler got involved in the vapor business after a personal tragedy. Despite a cancer diagnosis at age 19, she was unable to quit smoking for another 11 years—until she discovered vapor products. Eager to share her success with others, Wheeler and her husband, Jourdan, opened JVapes, an e-liquid manufacturer and retail store in Prescott, Arizona, USA, in 2012.
Credit: Malcolm Griffiths
The business was successful, quickly expanding to multiple locations across three states. Wheeler was helping her customers quit smoking combustibles and became increasingly involved in advocacy. She joined several support organizations, including Arizona Smoke Free Business Alliance, Vaping Advocates of Oklahoma, Rocky Mountain Smoke Free Alliance, Smoke Free Alternatives Trade Association, American E-Liquid Manufacturing Standards Association and Vapor Technology Association.
In October of 2020, Wheeler and fellow business owner Char Owen created the American Vapor Manufacturers Association (AVM) to help small businesses navigate the U.S. Food and Drug Administration’s onerous premarket tobacco product application (PMTA) submission process. The organization also engaged in federal lobbying and sought to provide reduced-cost scientific testing and expert regulatory compliance advice to members preparing PMTAs.
Wheeler and the AVM assisted 230 e-liquid manufacturers that submitted PMTAs for more than 1.7 million products following a plan she developed with Azim Chowdhury, a partner with the law firm Keller and Heckman and a regulatory and public policy attorney with a focus on vapor, nicotine and tobacco product regulation.
The deadline for submitting PMTAs to the FDA was Sept. 9, 2020. Wheeler submitted timely applications and was allowed to keep her products on the market for up to one year while the FDA reviewed her submissions. The agency’s deadline to decide on all the applications was Sept. 9, 2021. When Wheeler’s application was accepted, she felt confident that her business could survive and that the industry had a future.
As the deadline approached, however, Wheeler became anxious. The FDA was slow to release information before the deadline. Then, on Sept. 9, 2021, Wheeler received a marketing denial order (MDO). The regulatory agency appeared determined to put the small company she and her husband had built, along with the industry she passionately defended, out of business.
That day, the FDA issued MDOs to more than 130 companies, requiring them to pull an estimated 946,000 products from the market. The bloodbath continued in the following weeks. At press time, the FDA had issued 323 MDOs accounting for more than 1,167,000 flavored electronic nicotine-delivery systems (ENDS). As of Sept. 28, not a single ENDS had been approved.
That’s how Wheeler found herself on the global stage, sharing her story with some of the largest players in the nicotine industry at the recent GTNF conference in London.
“[The] FDA knew that they didn’t have the time or the resources to give our products fair consideration, but instead of asking for help, they let the 9/9 deadline pass and left the more than 500 companies subject to their decision in an unstable and probably untenable position,” Wheeler explained. “The FDA’s arbitrary ruling effectively criminalizes thousands of long-standing businesses in communities all across the country. Those entrepreneurs now have to junk their inventory, fire their employees, stiff their investors, and defer their dreams.”
Wheeler said she was standing up for the “little guy”—the thousands of small business owners who manufacture, distribute and retail open system products in vape shops all over the United States. She explained that her business and other AVM members made every attempt within their means to comply with the FDA regulations. It was an expensive process. It was also a system designed for small businesses to fail from the very beginning, she said.
“My company personally submitted several hundred thousand pages of documents to the FDA in an attempt to comply with this one premarket tobacco application standard. The [FDA’s] decision doesn’t just make a mockery of that earnest work. It also makes the more than 10 million Americans who made the switch to vapor products—in our vape shops, with our liquids—into outlaws, too,” said Wheeler. “Their freedom as Americans no longer includes the right to use a product with none of the well-established, deadly effects of those other substances, and which has undoubtedly saved the lives of countless former smokers.”
Wheeler said the FDA, in an act of “regulatory arson,” was creating a tobacco-led monopoly over the vaping industry, as only the companies with the deepest pockets stand a chance to survive the agency’s cumbersome PMTA process.
She also focused on what she perceived to be one of the biggest challenges facing the industry today: misinformation. “There is one other group I want to address with my time here. It’s the activists and the press who—whether because they are misguided or malicious—spread the falsehoods and distortions that directly led to this tragic outcome,” she said. “In this malign effort, those activists had enthusiastic help from nearly the whole of the national news media. By focusing on the messaging of Bloomberg dark money NGOs [nongovernmental organizations] and beneficiaries of MSA funds, our media and political class have criminally neglected the harm reduction aspects of vaping under the guise of moral virtue. The years added to their lives by our products are never mentioned.”
The misinformation plaguing the vapor industry has been around since Hon Lik introduced e-cigarettes to a mass market in 2006. The Wall Street Journal, for example, recently ran a gushing story about a Truth Initiative advertising campaign that misleadingly asserts that vaping nicotine “can worsen symptoms of anxiety and depression.” There is no evidence to support the claim. According to Wheeler, the statement is also contradicted by studies on the Truth Initiative’s own website. The Journal article even quoted a Truth Initiative executive admitting that “it is unknown whether a causal link exists” between nicotine and those symptoms.
“Just last month, FDA records gathered by Freedom of Information Act laws revealed that America’s most preeminent news organization, the New York Times, would send its articles in their entirety and before publication, to FDA officials for review and feedback. Neither that reporter, Sabrina Tavernise, nor her editors have summoned the integrity to offer any explanation,” Wheeler said. “Remember, these are publications and outlets that routinely praised and awarded themselves for taking on Big Tobacco. And yet on a decision that has given Big Tobacco exactly what they wanted—a monopoly—they are silent. Marching arm in arm with the very businesses they once excoriated as merchants of death.”
The biggest victims of the FDA’s actions, according to Wheeler, are the vapers who will now struggle to acquire the products that have helped them stay off of cigarettes. Wheeler vowed she would continue to fight for her customers and fellow business owners. “Even through their dismay, I am hearing a constant refrain: We are not going to stand for it,” she noted.
“We will be at the FDA’s doorstep demanding answers or forcing them through Freedom of Information Act laws and the courts. We are not surrendering our business or abandoning vapers to cigarettes,” she said. “As we say in Arizona, this is more than just a fight. It’s going to be a reckoning.”

October 29, 2021
Into the Void

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

October 28, 2021
Gay: Taxing Decisions

Credit: Orlando Bellini
Higher taxes and graphic warnings are not the best ways to encourage smokers to switch to ENDS.
By George Gay
Towards the end of August, the U.S. Food and Drug Administration announced that it had issued marketing denial orders (MDOs) in respect of about 55,000 flavored electronic nicotine-delivery system (ENDS) products. At about the same time, the FDA announced also that the deadline for combustible-cigarette manufacturers to print new health warnings on their products and product advertising had been delayed until October 11, 2022.
I think these two developments will strike you as odd if you subscribe to two almost universally-held ideas: that the consumption of combustible cigarettes kills and that graphic health warnings help to discourage people from such consumption; and if you subscribe to the idea that is less widely held: that ENDS are the most effective products for helping people quit smoking.
Indeed, to say that these two developments seem odd is something of an understatement. They represent a world turned upside down; a world in which the consumption of combustible cigarettes, which are regarded as deadly, is not discouraged, while the consumption of less-risky, cigarette-substitute products is discouraged.
Credit: Timothy S. Donahue
It is important to say, however, that what has happened is not entirely down to the FDA, which, in line with its obligations under the Tobacco Control Act of 2009, initially tried to bring in graphic health warnings on combustible cigarettes about 10 years ago, only to have them challenged in the courts and declared unconstitutional. The latest attempt at bringing in such warnings, the details of which became known in 2020, was similarly subjected to challenges, and to court-imposed delays.
However, it is reasonable, I think, to quarrel with the types of warnings proposed, which seem in large part to follow the same tired pattern of those used in other countries and regions. For instance, the proposed U.S. graphic warning pictures and captions, in line with those introduced elsewhere, do not tell the full story – that is, they don’t tell the whole truth.
Just to take one example; the caption on one picture reads, Warning: Smoking causes cataracts, which can lead to blindness. I don’t smoke, but I have cataracts forming; so obviously there are other causes of cataracts, the biggest of which I would say is probably, as in my case, getting old.
If there is to be an honest attempt at informing smokers, the cataracts warning needs to answer a lot of questions specifically aimed at people living in the U.S., questions that could be answered easily on a pack insert. Are there other causes of cataracts and what are they? At what age do smokers and non-smokers generally start to suffer from cataracts? Are cataracts more common in smokers than in non-smokers? Given that removing cataracts is one of the more common and more successful operations performed, how often do cataracts lead to blindness? Is the incidence of cataract-induced blindness more common among smokers than in the general population?
That the caption doesn’t answer these questions and the others that might rightly be raised by smokers, in my view is down to the paternalistic attitude of the FDA – and agencies in other countries that are in charge of determining the form of such warnings. Largely, I think, because smokers tend to be found in what are termed lower socio-economic groups, it is assumed they have to be told what is good for them without bothering their heads with details; whereas, in fact, some of them are rather smart.
Meanwhile, the FDA, while not being directly responsible for the delay in requiring health warnings on cigarette packs and advertising, is, in my view, more culpable in respect of the muddle over ENDS products. Basically, it has become hoist on its own petard – entrapped by its own propaganda about youth vaping.
In issuing its MDOs in August, the FDA said it had determined that the “applications for about 55,000 flavored ENDS products from three applicants lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products. The products from JD Nova Group LLC, Great American Vapes, and Vapor Salon subject to this action are non-tobacco-flavored ENDS and they include flavors such as Apple Crumble, Dr. Cola and Cinnamon Toast Cereal.”
This whole idea of considering public health, or population-wide health, rather than individual health, has its merits, but it is also flawed; as is the idea of utilitarianism on which it seems to be loosely based. If the idea is to bring about the maximum good for the maximum number of people, the calculations necessary become overwhelming and, in part, require the foretelling of the future.
As the FDA says, the applicant must demonstrate that the product is appropriate for the protection of public health. “This public or population health standard is quite high and requires considering the product’s risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account the increased or decreased likelihood that existing users of tobacco products will stop using such products, and the increased or decreased likelihood that those who do not use tobacco products will start using such products,” it says.
If a doctor you have consulted wants to prescribe for you an inhaler, is it incumbent upon her to take into account the fact that the production of that inhaler, and all the inhalers you will need for the rest of your life, will produce CO2 emissions that will exacerbate the existential climate crisis we have created and, therefore, the health of Joe Blow, who will then need an inhaler so that there are now two such devices being produced on a regular basis along with more CO2…?
To my way of thinking, it makes sense to consider population-wide health effects where there is a population-wide health threat, such as that caused by pollution, which is a far bigger killer than is tobacco smoking but which is largely consigned by those who should be tackling it to the too-hard drawer. But it seems to make little sense where what is in question comprises health threats to individuals and possible solutions for those threats.
Of course, what those who like to consider population-wide health benefits or threats will tell you is that there is no point in allowing the sale of vaping devices so that middle-aged Joe Blow can use such devices to quit smoking if young man John Doe takes up vaping and goes on to become a smoker, at least when this example is extrapolated across the population. I really don’t accept this argument because, to me, Joe and John are individuals, as are all the other people who make up the population and who make their own choices about what they do with their lives.
What has happened here is that, as mentioned above, the FDA has found itself hemmed in by its own propaganda. Take another look at that part of the FDA’s statement above where it tries to justify dumping 55,000 vaping products and where it talks of: ‘the public health threat posed by the well-documented, alarming levels of youth use of such products’.
To me, the use of the word “alarming” is an example of where the FDA’s claim to scientific rigor runs out of road. Compare what the FDA had to say with what was stated recently in a report entitled, Balancing Consideration of the Risks and Benefits of E-Cigarettes, which, I understand, was penned by 15 past presidents of the Society for Research on Nicotine and Tobacco.
Although the authors argue that the overwhelming focus of US policies and media attention on decreasing youth vaping has distracted from the goal of reducing smoking, they concede that: “Still, concerns emanating from substantial increases in youth vaping in 2018 and 2019 are readily understandable and important to address.”
It is also important to take note of something else that I think is significant. A contributor to the Global Forum on Nicotine held in the UK earlier this year explained how U.S. government policies were driven by the fears and wishes of the majority population, made up of the suburban, white, middle-classes. This was why tobacco smoking, a habit mainly of the financially less-well-off, had been largely tolerated [health warnings delayed again], while vaping, the subject of scare stories about an epidemic among the children of the middle class, had launched a moral panic [55,000 products dumped].
The Balancing Consideration report is indeed a model of balance; as can be glimpsed from this passage: ‘Smokers unable to quit smoking with evidence-based cessation methods should be well informed about the relative risks of vaping and smoking and vaping’s potential to help them quit smoking. They should understand that, while the long-term health consequences are unknown, completely substituting vaping for smoking likely reduces health risks, possibly substantially.
Dual use of cigarettes and e-cigarettes will not have a comparable beneficial effect. However, a period of dual use may be necessary for some smokers to transition from smoking. Because vaping itself poses some risk, the best advice is to eventually stop vaping as well.’
I find it impossible to argue with almost anything in this passage or in the objective of the authors, which is to encourage more balanced consideration of vaping within public health and in the media and policy circles. There is certainly a need for such balance. As the authors say in the introduction to the report: “Opponents focus on e-cigarettes’ risks for young people, while supporters emphasize the potential for e-cigarettes to assist smokers in quitting smoking.
Most U.S. health organizations, media coverage, and policymakers have focused primarily on risks to youths. Because of their messaging, much of the public – including most smokers – now consider e-cigarette use as dangerous as or more dangerous than smoking.”
The authors are correct; this is a situation that needs to be rectified.
And yet, I cannot go along with everything in the report, though it talks with empathy about smokers. “Today’s smokers come disproportionately from lower education and income groups, the LGBTQ (lesbian, gay, bisexual, transgender, and queer or questioning) community, and populations suffering from mental health conditions and from other drug addictions,’ it says. ‘Smoking accounts for a significant proportion of the large life expectancy difference between affluent and poorer Americans.”
And the report is right in making the point that a lot of people hardly realise that smokers still exist. “To the more privileged members of society, today’s smokers may be nearly invisible,” it says. “Indeed, many affluent, educated US persons may believe the problem of smoking has been largely ‘solved.” They do not smoke. Their friends and colleagues do not smoke. There is no smoking in their workplaces, nor in the restaurants and bars they frequent. Yet one of every seven U.S. adults remains a smoker today.”
But then, to my mind, the report loses its way. “Tax cigarettes and other combustible tobacco products heavily; impose a more modest tax on e-cigarettes,” it advises. “Taxes should be proportionate to risk. A much higher tax on combustibles will encourage adult smokers to quit smoking or to switch to less expensive e-cigarettes. By raising the price of e-cigarettes, a modest tax will discourage their use by price-sensitive youths.”
There are several problems with this, I would suggest, partly perhaps because, I suspect, the authors don’t smoke and don’t generally rub shoulders with those in the lower socio-economic groups. The authors want to tax smokers heavily having already declared that these people generally come from groups less well-off financially. They say that this is to encourage smokers to stop smoking, but it is nothing of the sort. It is an attempt at bludgeoning them into giving up.
To my way of thinking, if a smoker is given the facts about her habit, partly through the medium of comprehensive, fact-based health warnings, and she chooses to keep smoking, that is her business. Hitting her with levels of taxes that would not be tolerated but for the fact that smokers comprise an unrepresented minority is grossly unfair.
And what will happen to the money raised? Will it be spent on helping these people? The record shows that this will not be the case. The money will be spent on politicians’ vanity projects, while nine million children will still go hungry.
And finally, what about the seemingly worthwhile aim of increasing the life expectancy of these smokers by bludgeoning them into quitting? Given that the last years of these people’s lives are hardly likely to be halcyon; it might be a good idea to ask them if they really want another 10 years of struggling to make ends meet as they become increasingly infirm. Walk – or perhaps hobble – a mile in my shoes.
October 27, 2021
Dubai WVS: Grand Slam

QBM pulls off a remarkably successful vaping exhibition in an uncertain environment.
Story and Photos by Norm Bour
It’s not often that a rookie gets a chance to come up to the plate and hit a Grand Slam home run, but that is exactly what happened when the Dubai World Vape Expo hit the ground at full speed and never let up. Considering that this was Quartz Business Media’s (QBM) first vape expo and the fact that this was the first truly international show in a year and a half—and considering this show was held in a country where up until a year ago vaping was illegal—well, what you have is a trifecta.
OK, enough sports analogies.
The industry has been hungry—starving—for live events, and in this not-quite post-Covid period, this was a risky move in many ways.
Vaping continues to be under attack in the U.S., with the Food and Drug Administration still looking for ways to make life difficult, and even in Europe and the rest of the world, many people still consider vaping to be as dangerous as smoking, regardless of what the Royal College and Public Health England say.
Science be damned, media loves controversy, and vaping can be a lightning rod.
This was my first visit to Dubai, and aside from Singapore, this is probably the cleanest, most polite and grandiose city I have visited. Considering that Dubai strives for many firsts, this first vape show falls in line.
The Burj Khalifa, at 2,722 ft high, 160 floors, is the tallest building in the world, and holds many international records. The Dubai Mall, sitting at the foot of the Burj, is the largest mall in the world at almost six million square ft and could take days to see all the shops. Around the corner, launching the end of October, is Ain Dubai, the soon to be largest Ferris Wheel in the world, at 820 ft, twice the height of the London Eye.
There was a definite British vibe here, and that makes sense since QBM is based in Surrey, U.K. Many of the exhibitors were U.K. companies, and the U.K. Vaping Industry Association (UKVIA), helmed by John Dunne, brought many of the speakers and guidance to the gathering.
I asked Dunne if there was any connection between the Dubai event and the U.K. vaping industry, and he said there was a definite kinship.
“The British vape companies are very keen on international expansion, and the Middle East is a brand new market. Until recently, vaping was illegal in Dubai, UAE and other countries nearby, but the government is now recognizing the benefits of vaping. There were several Chinese and American companies who were unable to attend, so that changed the composition of the attendees.”
The event was intended to be even larger than what it was, which was about 200 exhibitors, and without travel restrictions it would have been even more diverse. Considering this was the first international show in almost two years, those are impressive numbers.
And the eyes of the regulators were on the show floor. I was told that government people were checking the registration process all the way to the show floor and making sure that masks were used, vaping was done in the appropriate areas and no one was abusing the event.
I asked Dunne if he was overall pleased with this show, and he responded, “Absolutely! I’ve seen vape shows develop over the years, and many of the early ones were embarrassing. They were more party and less business, but as the vaping world has matured, so has the event space. We had many conversations with the regulators and had to share with them that vaping is a harm-reduction product and not a smoking product. Since we have had years of experience in the U.K., and since Public Health England has been generally pro vape, we hope that can fast-track the acceptability over here.”
Dunne appreciates that the U.K. keeps things simple from a regulatory perspective, especially compared to the U.S., and he hopes that the Middle East uses more common sense and less bureaucracy.
There were several American companies there, including Charlie’s Chalk Dust, Coastal Clouds, Innevape and The Finest. I asked Jeff Connell, with Innevape, about this show: “This is much bigger than most [events], and we were able to form some strategic partnerships with Middle East distributors, which brings us a whole new market. We’ve seen more activity both in the number of people here, along with their interest in spending money and committing to doing business.”
Salim Lallas with Bawadi Vape, based in Dubai, was ecstatic over the event. His company has been in business since 2016. “Back then our vape community was very small, very intimate, very social,” he recalls. “Now it is becoming more mainstream and less personal, but much larger, and hopefully, more professional. I think the government knew they really couldn’t control it and also that what we were doing was not really dangerous. So rather than fight a losing battle, they concluded that they should learn how to work with us.”
Of the many dozen shows that I have attended worldwide, this one struck a critical balance between business and fun, and based on conversations with many of the attendees, business was definitely getting done!
Alan Caddick helmed the speaking program and worked closely with John Dunne. Their goal was to develop speaking programs that would draw people in.
I asked him if the recent Covid travel restrictions hampered speaker’s commitments. “Yes, absolutely,” he said. “The pandemic has affected our timing, and we had to reschedule twice. Everyone had to jump through hoops to get here, and we appreciated all those that came in person. Being a speaker involves work and preparation, and the extra Covid tests made it even more challenging.”
The pandemic brought some positive changes to the world of events and meetings, and remote sessions have been the norm for the past 18 months. For speakers that were unable to attend, Zoom has filled in that gap.
“No question, technology has made this show much easier than if we did not have it,” Caddick confessed. “We have speakers from Australia, South Africa, the U.S. and England joining us live, so once we account for time zones, it’s just a matter of plugging them in.”
The beauty of the online sessions was the fantastic room-length screen, which afforded great video and accommodated panel sessions.
I spoke with Jake Nixon, event sales manager, and asked, “Why Dubai?” and he replied, “Dubai is a gateway for the whole world. They have an amazing airport, lots of free zones, and we think Dubai will play a big part in the future of vaping. Dubai was always our No. 1 location when we started with this process a long time ago, and we are happy that we were able to pull this off.
“The U.K. hasn’t had an event since before Covid, so that is why we planned our next one in London just a few months from now. We cut our teeth here, and we have learned a lot about the vaping world. This was our first time dealing in that space and found it much more fun than many other industries.”
The organizers plan their next event for Dec. 10–11 in London at the ExCeL Center. They hope that, by that time, more people will be able to, and feel comfortable traveling, but they understand that many speakers will be joining them virtually once more.
Norm Bour is the founder of VapeMentors and works with vape businesses worldwide. He can be reached at norm@VapeMentors.com or +1 949 495 6162.

October 26, 2021
Capitol Crisis

Credit: Bbourdages
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.

October 25, 2021
Responsible Action

Credit: Mex Chriss
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.”
August 25, 2021
The Watchful Eye

Credit: Sergey Nivens
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.

August 25, 2021
Abdicating Responsibility

Credit: Lisa F. Young
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.”

August 24, 2021
An Error in Judgment

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.

August 23, 2021
Market Watch: Philippines
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.”
August 20, 2021