Taiwan authorities are concerned about the growing popularity of “zombie vapes,” e-cigarettes containing etomidate, reports The Taipei Times.
According to health experts, etomidate is a type of central nervous system depressant that can induce anesthesia. Abusing etomidate could lead to irritability, disorganized behavior, tremors, twitching or even death, explained Lin Yi-ching, a pediatrician at Kaohsiung Medical University Chung-Ho Memorial Hospital.
From July to October, authorities seized 14,128 zombie vape cartridges, along with e-liquid and powders that could be made into more than 1.83 million cartridges worth about NTD4.6 billion ($143.33 million).
While etomidate is listed as a Category 3 narcotic, a review committee will consider whether to upgrade the drug to Category 2, Ministry of Justice Department of Prosecutorial Affairs Director-General Kuo Yung-fa said.
Overall e-cigarette use among junior high school students in Taiwan increased from 1.9 percent in 2017 to 3.9 percent in 2021, a HPA survey reported by Taiwan News showed. Among senior high school students, the rate rose from 3.4 percent to 8.8 percent during the same period.
Taiwan outlawed vapes in 2023, with violators risking fines of up to NTD10,000.
The rate of “battery thermal Runaway incidents”—instances of lithium-ion batteries overheating on passenger planes—hit a five-year peak last year, with e-cigarettes being the biggest culprit, according to a report from UL Standards & Engagement (ULSE), a nonprofit organization focused on safety standards.
The data comes from ULSE’s Thermal Runaway Incident Program (TRIP), a voluntary lithium-ion battery incident reporting system. TRIP comprises 35 passenger and cargo airline participants. The program was designed with the aviation industry to better understand the extent of thermal runaway incidents caused by lithium-ion batteries onboard aircraft and how to prepare for, or ideally prevent, future incidents.
“Passengers are often unaware that many devices they bring on board are powered by lithium-ion batteries, let alone the risks they carry, and it’s much harder to solve a problem that they do not know exists,” said David Wroth, director of technology and systems at ULSE and the leader of TRIP, in a statement. “Thermal runaway incidents on board aircraft are largely preventable but admittedly more difficult to contend with at 40,000 feet. TRIP provides a unique opportunity for the aviation industry to come together to find strategies to mitigate the risk of these incidents.”
As technology evolves and more products rely on rechargeable power, lithium-ion batteries are getting more powerful and in some cases larger, further complicating the thermal runaway threat. Damaged, substandard, or counterfeit batteries run the greatest risk of going into thermal runway, presenting serious consequences in flight.
Key takeaways from the report include:
Incidents are at the highest point in five years of data collection, rising 28 percent from 2019-2023. There are an average of two thermal runaway incidents reported in the TRIP database each week. While on the rise, with approximately 180,000 flights in U.S. airspace per week, it is still highly unlikely to experience a thermal runaway incident.
The average passenger brings four rechargeable devices on board. Most common items include smartphones (82 percent), laptops (41 percent), wireless headphones (39 percent), and tablets (36 percent). E-cigarettes were responsible for the most incidents in 2023, with 35 percent of reported incidents attributed to vaping devices on passenger flights, followed by power banks, representing another 16 percent of incidents.
Most incidents happen on the aircraft with devices that are stored near the passenger’s seat. Almost nine out of 10 (87 percent) incidents are reported on the aircraft, with the remaining 13 percent occurring when baggage and personal items are on the move. On the aircraft, thermal runaway incidents occur in or around the passenger’s seat nearly 60 percent of the time.
The vast majority of incidents are addressed before reaching the fire or explosion stage of thermal runaway. Most (85 percent) incidents in 2023 were addressed when batteries showed warning signs such as overheating and smoking prior to entering full thermal runaway. While only 15 percent of incidents resulted in fire or explosion, the speed in which thermal runaway can develop means that the events in the majority could have been more serious had the issue not been addressed quickly.
Rechargeable devices are being packed in checked luggage. The devices that were most cited in thermal runaway incidents in 2023 were also the two most frequently put in checked luggage, according to passengers surveyed. More than a quarter (27 percent) of travelers reported checking portable chargers, and another 27 percent said they checked e-cigarettes. Devices that enter thermal runaway in checked baggage cannot be accessed by crew while in flight, and fires may not be detected as quickly in the cargo hold as they would be in the cabin.
“Our research highlights several trouble spots that need to be addressed, from passengers missing warnings about lithium-ion batteries to packing rechargeable devices out of reach,” said Lesley Rohrbaugh, head of insights and policy analysis for ULSE. “But we also see clear opportunities to reduce the risk and that’s where we’re focused.”
Through additional passenger and cabin crew focus groups and interviews conducted by ULSE and data from TRIP, strategies to reduce these risks include passenger education, cabin crew training, and standards for aircraft baggage handling.
Exposure to secondhand vapor from vaping at home could be considered a violation of Thailand’s child protection laws, according to child health and rights experts who are calling for more awareness of the dangers of vaping around children, reports The Pattaya Mail.
Under national laws, vaping around children could be considered “domestic violence,” according to Thai authorities. They are calling for stricter enforcement.
The Royal College of Pediatricians of Thailand wants stronger government measures to restrict the import and sale of e-cigarettes and increase educational campaigns about the risks of nicotine.
John Dunne, director general of the U.K. Vaping Industry Association (UKVIA), traveled to China to educate vape companies on Britain’s changing regulatory landscape.
The U.K. will ban disposable e-cigarettes from April next year, and the Tobacco and Vapes Bill, which is currently working its way through Parliament, seeks to give ministers unprecedented powers to ban flavors and decide how vapes are packaged and sold.
Speaking at the headquarters of the Electronic Cigarette Industry Committee of the China Electronics Chamber of Commerce (ECCC), Dunne shared his expert knowledge to conduct on-site compliance training to some of the world’s leading vape companies, including Elf Bar, SKE, ELUX, HQD, Hangsen, Greensound, Aspire, ICCPP, RELX, ALD, Uwell and Zinwi.
Describing the U.K. regulatory landscape as “complex and changeable,” Dunne said issues such as the protection of minors, battery recycling and environmental protection were high on the agenda of politicians, regulators and the general public.
“It is absolutely vital that all companies operating in the U.K. are fully compliant with all local laws and work at all times to show the industry in the best possible light,” he said in a statement.
Dunne said the UKVIA would continue to work with the ECCC to help members comply with current requirements, prepare for future regulatory change and to foster global cooperation to promote the development and prosperity of the global vaping industry.
The board of directors for the Brazilian Health Surveillance Agency (Anvisa) voted unanimously on April 19 to maintain a ban on the sale of e-cigarettes and other vaping products.
Manufacturing, selling, importing, and advertising vapes has been banned in the country since 2009, but e-cigarettes are easily found in small shops and online stores across Brazil. And consumption, especially among young people, is on the rise.
According to a survey by the Brazilian Institute of Geography and Statistics (IBGE), a federal government agency that gathers population data, 16.8 percent of students aged 13 to 17 said they had tried vaping at least once, according to media reports.
Also, data from Covitel, which carries out surveys related to health matters, reveal that 4 million people have already used electronic cigarettes in Brazil, even though sales have not been authorized for 15 years.
In 2022, Anvisa approved a technical report that indicated the need to maintain the ban and adopt additional measures to curb irregular e-cigarette sales, including more inspections and educational campaigns about the harms of vaping.
The agency discussed the case again last week after a public consultation to hear contributions from experts, vape manufacturers, and consumers. Once more, Anvisa took a stance against the sale of vapes and based the decision on four main points.
The CTP’s inability to apply its enforcement priorities often leaves state regulators and businesses baffled.
By Rich Hill
The recent onslaught of vapor registry bills in the United States is creating a lot of anxiety. Proposed registries have brought tension to public hearings and drama on social media. Unfortunately, like most current domestic issues, neither side appears to appreciate the perspective of the other. While only a handful of states have enacted product registries, many legislatures have considered and/or are considering such legislation. Understanding what these registries do, why they are promoted and their consequences is essential for all sides of this debate.
Rationale for Developing Vapor Product Registries
At present, the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has granted marketing authorization for only a handful of tobacco-flavored vapor products and insists that all other vapor products are illegal. That said, the CTP has communicated its enforcement priorities related to deemed products numerous times. More specifically, the CTP has indicated its intention to prioritize enforcement efforts concerning certain deemed tobacco products (1) not covered by timely filed premarket tobacco product applications (PMTAs), (2) that have been the subject of marketing denial orders or those covered by PMTAs subject to negative determinations, including those rejected on procedural grounds (i.e., refuse-to-accept or refuse-to-file letters), and (3) that raise youth-use concerns.
Unfortunately, the CTP’s inability to apply these enforcement priorities consistently to the ever-changing and large number of unscrupulous manufacturers often leaves state regulators and businesses baffled about which products are at increased risk of enforcement action.
In short, this circumstance, with thousands of products remaining the subject of pending PMTAs that fall outside of the scope of the CTP’s enforcement priorities being sold alongside thousands of noncompliant flavored disposable vapor products, many of which fall within the scope of the FDA’s enforcement priorities, creates confusion in the marketplace and for state product regulators. Given the shortfalls in enforcement against vapor products that are not the subject of still-pending PMTAs, state tobacco regulators need a mechanism by which to determine which products should and should not be sold in their states—hence the value of vapor product registries.
Rich Hill
How Do Vapor Product Registry Bills Work?
Vapor product registry bills establish registries requiring companies to submit evidence demonstrating that products that have FDA marketing granted orders are the subject of pending PMTAs filed by specified dates related to PMTA deadlines or are the subject of administrative or judicial reviews. For example, registration in Louisiana requires manufacturers to attest to the marketing granted or still-pending PMTA status of each product and pay a registration fee. Then these products will be placed on a public-facing registry.
Positive Aspects of Product Registry Bills
Regardless of one’s position on registry bills, the legislation at least has the potential to create positive change. By way of example, registry bills can:
Provide objective criteria. Vapor product registries can theoretically provide objective criteria upon which wholesalers and retailers can rely in making purchasing decisions. While there will be fewer products available, these products may be purchased without the threat of state regulatory enforcement.
Supplement CTP enforcement resources. The CTP has limited enforcement resources. While flavored disposable vapor products have been a high enforcement priority for the center, these products still proliferate the retail space. Vapor registries could aid in making up for the CTP’s enforcement limitations.
Target youth-friendly products. The 2023 National Youth Tobacco Survey reported that certain flavored disposable vapor products make up the majority of products used by youth. Registries may help in clearing the market of these products that lack pending PMTAs and are the most popular among youth.
Generate Revenue. Of course, registries also provide another revenue stream for state governments. With registration fees for each product, the amounts are not insignificant.
Consequences of Vapor Product Registries
All legislation and policy decisions invariably come with costs. Vapor product registries are no different. Some examples include:
Inhibit harm reduction efforts. Vapor products are harm reduction tools that benefit adult cigarette smokers seeking to quit or reduce their combustible cigarette use. Prohibiting access to such products prohibits access to the tools necessary to reduce combustible cigarette-related mortality and morbidity.
May not slow bad actors. Bad actors will continue to be bad actors. If a company violates the rules now, there is little reason to believe that a vapor product registry will prevent such actions.
Burden state resources. States are continuing to be required to do more without increased resources. In many instances, state tobacco regulatory enforcement agencies may simply lack the resources to effectively enforce registry requirements.
Innovation outpaces regulation. As the industry has observed before, evolution in the space moves more quickly than the regulatory arms can keep up. Innovative products falling outside of the scope of existing regulatory structures undoubtedly will winnow the effectiveness of product registries in the future. Indeed, most recently, innovations such as nicotine analog products are not covered by most registry bills.
Prohibitive scope can be too broad. In several instances, products not within the scope of the problem are swept into the “solution.” In a number of cases, modern oral nicotine products—products that sit at the lowest levels of the continuum of risk—are included in these product registry bills, which continues to undercut harm reduction efforts.
Final Thoughts
The problems that created the need for product registry legislation will continue. Until federal regulators embrace a harm reduction agenda and provide adult smokers, who will not or cannot quit, the products that have been demonstrated to assist their transition away from combustible cigarettes, the marketplace, whether legitimate or not, will respond by making them available. Vapor product registries, in and of themselves, will not solve the problems in isolation. The policies driving the need for such registries, ineffectual prohibitionist policies, need attention as well. Until the collective vapor product space, including manufacturers, retailers and consumers, aggressively advocates for policy change, new laws and regulations further limiting the ability to serve adult consumers are likely to evolve.
Richard Hill is senior director of E-Alternative Solutions.
The U.K. has been held up as providing the “gold standard” in proportionate vape regulation.
By John Dunne
It is astonishing how much ground the vaping industry has covered since Vapor Voice launched in 2014. Back then, the nascent vape industry offered a tantalizing alternative for smokers looking to quit smoking. Cig-a-like devices were the order of the day, but they often leaked, had a limited range of flavors and were rather underpowered. The main thing is that they were not cigarettes and provided a smoking alternative that really worked. It was unclear how e-cigarettes would evolve, but while many dismissed this as a passing fad, budding vaping entrepreneurs were already working on business plans.
What was clear from the beginning was that a passionate fanbase of devotees emerged, and they spread the word about this new smoking alternative far and wide with evangelical passion. The relatively unsatisfying flavors from these earliest devices turned out to be a massive boon for the fledgling industry as fans made their own e-liquid with readily available ingredients, resulting in an explosion of new flavors being tested on friends and family members.
These humble beginnings led to the industry that exists today. Many international brands started with someone experimenting with different flavor combinations created in their kitchens or garden sheds, only to discover that they had stumbled upon a product with enormous commercial potential. Technological advances led to more powerful batteries, larger tanks and more efficient heating systems, which excited the growing army of fans.
The Vaper Expo U.K.—now one of Europe’s most essential vape events—came to the U.K. in May 2015 and saw thousands of vape fans queueing for hours to be among the first into the arena. The interest in vaping was astonishing, and things began to move very quickly. Former smokers morphed into passionate advocates for this new technology. Expos featured spinoff cloud-chasing contests and performances from talented individuals who found they could make a living by producing intricate patterns from exhaled vapor clouds.
Specialist vape shops sprung up to meet the demand of former smokers and hobbyist vapers while flavor names from these early days were often exotic and fantastical. Names like “Beach Bum,” “Eye of the Tiger,” “Flaming Hot Tamale,” “Dragon’s Crown,” “Vamp Toes” and “German Chocolate Beefcake” dominated.
E-liquid came in glass bottles of various colors with pipette droppers, and branding often featured the most complex and colorful designs, which would not have looked out of place in a modern art graduate’s portfolio. Many early adopters abandoned their careers to invest their life savings in producing their own e-liquids. As vaping became more popular and moved from niche to mainstream, politicians took notice, and regulation changed everything.
The European Union updated its 2001 Tobacco Products Directive to include e-cigarettes in 2014 and, after a two-year grace period, the U.K. began enforcing regulations covering product safety, vapor emissions testing and new limits on tank and bottle sizes and nicotine strength. This saw the demise of many hobbyist e-liquid creators who had supplemented their incomes with home-grown e-liquids they sold locally or online, but it also paved the way for the serious players to grow and flourish.
The U.K. Vaping Industry Association (UKVIA) was formed in 2016 to “support, develop and promote” the vape industry and promote the public health benefits of this reduced-risk alternative to smoking. It was immediately clear that there was a lot of opposition to overcome.
Just like we have seen in the U.S., the mainstream media in the U.K. found it could generate huge numbers of clicks and views by stirring up a new moral panic around vaping. Scare stories misrepresented already dubious scientific research, and baseless articles linking vaping with cancer, lung disease and heart disease flourished. The press demonized a product that was allowing smokers to quit and quietly ignored the enormous death toll caused by cigarettes.
I have never been in more demand from national TV, radio and newspapers to speak about vaping. Media interviews can range from productive to utterly frustrating. Some presenters want me on their shows just to shout at me, and others have their minds made up and refuse to listen to reason, but some want a balanced discussion about vaping and its role in harm reduction.
Emotive subjects, such as environmental concerns and youth access, are staple interview topics, and I am happy to get up at the crack of dawn for the first segment of the morning TV breakfast show or appear live in the studio for a late-night current affairs debate to promote the benefits of the vaping industry.
The U.K. has been held up as providing the “gold standard” in proportionate vape regulation for the rest of the world to follow. Although not perfect, our regulations have generally offered the right level of public protection while allowing the industry to flourish by offering adult smokers a far less harmful alternative to cigarettes.
In recent years, that has started to change, with the U.K. poised to ban disposable devices next year on the grounds of environmental and youth access concerns. These concerns are important, but there are better ways to tackle youth vaping. For four years, we have been calling for the government to introduce a vape retail licensing scheme, similar to the way alcohol is licensed, with fines of up to £10,000 ($12,453) per instance for those who sell illegal products or sell to anyone underage. This scheme would fund a national enforcement campaign backed by regular inspections and test purchasing to ensure retailers comply with the law or face losing their license and their ability to trade.
Vape Club, one of our UKVIA members, has already drafted the framework for such a scheme, yet the government insists it has no plans to introduce such a system. Back in 2016, I could hardly have imagined a future where the vape industry would be proposing more robust and more effective legislation to a government that seems unable or unwilling to do so, yet that is exactly how things turned out.
We currently have proposed legislation making its way through Parliament that would give the government unprecedented new powers to restrict flavors, point-of-sale displays and packaging. The government accepts that bringing in new restrictions could cause current vapers to resume smoking but, astonishingly, has not conducted a risk assessment to determine the health harms this may bring.
The evolution of the vape industry in the past decade has brought many challenges and has been far from smooth. The industry started with disposable devices, moved to refillable tank systems, witnessed a recent renaissance in disposables and is moving back to refillable tank systems once again. E-liquid flavors, absolutely vital to help adult smokers quit, will continue to evolve to meet changing consumer demand, but I can’t see a return to the days of “Flaming Hot Tamale,” “Dragon’s Crown” and “Vamp Toes” flavors—and that is not a bad thing.
We have achieved so much in a decade, and I am convinced we can eventually win over a skeptical media. Until that happens, I will patiently explain why vaping does not cause popcorn lung and how nicotine does not cause cancer.
I am also heartened to see just how far the vaping industry has come in one decade, and I am intrigued to see what incredible advances will occur between now and 2034.
John Dunne is the director general of the U.K. Vaping Industry Association.
At the current rate, tobacco harm reduction is likely to remain a fantasy in South Africa.
By Asanda Gcoyi
Like other countries around the world, South Africans have taken to vaping in great numbers over the past 10 years. What started as a small community of smokers seeking out less harmful alternatives to cigarettes has now morphed into a massive industry that is growing in leaps and bounds.
Since 2013, vaping devices in South Africa have become a ubiquitous sight, with many a smoker giving up their deadly habit in favor of vaping. For the past decade, vaping has remained outside the regulatory net while tobacco has been regulated through the Tobacco Products Control Act, 83, 1993. While hailed in its initial days, the act has failed to reduce South Africa’s smoking rates successfully.
This is reflected in recent statistics, which show that South Africa’s smoking rate has increased from about 18 percent in 2018 to over 25 percent in 2022. This is a result of lax law enforcement and the proliferation of cheap illicit tobacco products that are reported to account for over 60 percent of the South African smoked tobacco market.
For a time, harm reduction advocates were hopeful that vaping would make a significant contribution toward reducing smoking in the country. There was even a faint hope that regulators would embrace the vaping industry in the spirit of reducing the harm that smokers are exposed to and hopefully also reduce the external costs of smoking, which are borne mainly by the poorly performing public health system.
Not so. Over the past two years, the South African government has succumbed to pressure from the anti-smoking lobby, which relies on misinformation and disinformation to discredit tobacco harm reduction. In part, the antipathy toward vaping has arisen out of fears that young people were taking up vaping in droves.
Except, there is minimal evidence for this contention. The research that has been done is limited in scope and reach, and its conclusions cannot be generalized to the rest of the South African youth. No doubt, young people are curious and are trying out vaping. However, there is no evidence that large numbers are regular vapers or that they are progressing to smoking cigarettes, as has been claimed by those in favor of strict regulations of vaping.
Asanda Gcoyi
What is beyond any doubt is that a significant number of young people are smokers due to the accessibility and low prices of illicit tobacco. In its rush to be seen to be doing something about the manufactured crisis of youth vaping, the government has embarked on two processes: the introduction of a vaping tax and the amendment of the country’s tobacco control laws to include vaping.
After a two-year public consultation charade, the government started levying an excise duty on vaping liquids on June 1, 2023. This immediately made refillable vapes unaffordable for your average vaper, as the price of a 100 mL bottle more than doubled overnight. At ZAR2.90 ($0.16) per milliliter, South Africa’s rate is on the steep side and has made smoking more attractive from a price point of view.
Perversely, the excise duty has made disposable vapes much cheaper than refillable vapes. Up to the introduction of the tax, refillable vapes had been the preferred choice for smokers who were using vaping as a harm-reduced alternative to smoking. Common wisdom has it that disposable vapes are the most preferred option for young adults and teenagers.
In introducing the steep rate, the government has failed to deter the people who should not vape from doing so while forcing many former smokers and dual users to vape higher nicotine disposables and revert to smoking due to price.
Parallel to the tax’s introduction, Parliament has been processing the Tobacco Products and Electronic Delivery Systems Control Bill, which was introduced in December 2022. This anti-harm reduction draft law dismisses the possibility that vaping is less harmful than smoking and that there should be a differentiation in law between how the two are treated.
It conflates vaping and smoking and extends draconian regulations to vaping, some of which will virtually wipe out any communication about vaping as a harm-reduced alternative to smoking. In the process, it will confirm smoking’s importance as the only viable form of nicotine delivery for the millions of nicotine addicts who do not know enough about vaping or believe the disinformation that vaping is as harmful, if not more so, than smoking.
Supported by Bloomberg Foundation-funded organizations, the bill is a clear demonstration of the deep-seated disdain that the South African government has for the smoking public. In countless public hearings, the ruling party and its fellow travelers in the anti-tobacco campaign loudly proclaimed their contrived belief that harm reduction is a ruse.
They have used every opportunity to talk up the dangers of youth vaping while completely ignoring the plight of the more than 10 million smokers in South Africa. In their telling, smokers should just quit because vaping is as bad, if not worse, than smoking. In one hearing, they were even proud to display a poster showing the diseased body of a vaper, science notwithstanding.
While there is always a chance that the new government to be elected on May 29 will revisit the draft Bill submitted to Parliament, there is little hope among tobacco harm reduction experts of any change in direction. It has become clear that the South African government has lost its ability to make public health policy guided by its unique circumstances. It is content to defer to the ideological prescripts of the World Health Organization and the Framework Convention on Tobacco Control, even when it clearly goes against its own interests as a country.
This is a disheartening and anti-democratic exercise in policy capture, which, left unchecked, will prejudice South African smokers by foreclosing the possibility of switching to less harmful alternatives. At the current rate, tobacco harm reduction is likely to remain a pipe dream rather than a reality.
Asanda Gcoyi is CEO of the Vapour Products Association of South Africa.
The vaping industry continues to overcome regulatory challenges and false narratives.
By Greg Conley
Over the past decade, Vapor Voice has closely tracked the vaping industry’s turbulent evolution from niche interest to a subject of global attention. These years have been marked by significant shifts due to technological advancements, evolving regulatory landscapes and changing public health views. As a longtime advocate for safer nicotine alternatives, I’ve observed the industry’s struggle for legitimacy and its ongoing battle against misinformation.
In the early days of the vapor industry, doubts and skepticism were rampant. I had a memorable encounter in 2011 at a conference filled with tobacco industry executives. There, an executive remarked to me, “Enjoy this while it lasts. You’ve got about a year left before the U.S. Food and Drug Administration crushes you.” There was no malice or ill will in his voice but rather a resigned acknowledgement of the regulatory hurdles that lay ahead, courtesy of the FDA’s Center for Tobacco Products (CTP) and the 2009 Family Smoking Prevention and Tobacco Control Act. This insight foretold the imminent regulatory challenges we were about to face.
Greg Conley
Initially, certain industry players were confident in their ability to satisfy CTP requirements. Despite the plain text of the Tobacco Control Act, some manufacturers still believed that the CTP would not outright reject flavored products. A stark reality check was dealt when the CTP’s original deeming proposal was leaked online in 2015. Had the Office of Management and Budget at former President Barack Obama’s White House not intervened to object to a provision that would have immediately pulled flavored products from the market, the industry could be radically different today.
The appointment of Scott Gottlieb as FDA commissioner during former President Donald Trump’s administration was initially met with cheers. This ignited industry hopes for a science-based approach to the impending deadlines for submitting premarket tobacco product applications (PMTAs). Yet, Juul’s skyrocketing popularity and the associated increase in youth vaping quickly became a major point of contention, halting any progress toward streamlining the PMTA process.
A profound nadir of the last decade was undoubtedly the summer 2019 e-cigarette or vaping product use-associated lung injury (EVALI) crisis. Even as the evidence grew linking the illnesses and deaths to illicit THC products, the legal nicotine vaping industry was unjustly blamed and the subject of sensationalist media coverage. Worse still, several of the nation’s top health officials spearheaded efforts to cloud the true cause of EVALI.
Notably, one health official who played a central role in the U.S. Centers for Disease Control and Prevention’s mishandling of the EVALI situation now holds a significant role in shaping the future of vaping—Brian King, who heads the CTP. It is deeply ironic that King, who helped add fuel to the fire that caused a remarkable decline in public perception of nicotine vaping, now oversees the CTP’s purported efforts to rectify misconceptions about smoke-free nicotine products.
As the industry emerged from the doldrums of the EVALI crisis, it faced the longstanding regulatory challenges that advocates had been cautioning about for years. Following numerous delays, the submission deadline for PMTAs for tobacco-derived nicotine vaping products finally arrived in September 2020. Amid the global focus on Covid-19 and the impending presidential election, the media was uninterested in stories about small business concerns with the CTP’s flawed system.
September 2020 was not an easy month for CTP employees. When it proposed the deeming regulation, the CTP predicted that it would receive fewer than 3,000 PMTAs. However, the vapor industry firmly stood its ground. Through an effort spearheaded by the founding members of the American Vapor Manufacturers Association, over 200 manufacturers inundated the CTP with several million PMTAs.
As anticipated, chaos ensued. The FDA’s system was completely overwhelmed. The agency was at a loss on how to proceed with the PMTAs. The indecision ended after an April 2021 legislative hearing, during which FDA Acting Commissioner Janet Woodcock was harangued by House Democrats who wanted to see all PMTAs for flavored vaping products immediately denied. She returned to the FDA and mandated that the CTP create a new system to expedite the denial of the backlog of vapor product PMTAs.
The FDA’s infamous “fatal flaw” memo resulted in the banning of millions of nicotine vaping products. These bans were not based on any direct public health risk posed by the products. Rather, they were implemented because, well, after the PMTA submission deadline had passed, the FDA decided it would not review PMTAs for flavored vaping products without a specific clinical trial or longitudinal study. As a result of ongoing litigation, which could potentially reach the Supreme Court in the next year, many of the PMTAs submitted in 2020 are still pending resolution.
As a testament to the industry’s dynamic nature, the products caught up in court fights have fallen out of favor with adult consumers. Since 2020, the explosion in popularity of flavored disposable vapes, fueled by ambiguous regulations and enforcement regarding synthetic nicotine, has significantly reshaped the industry. This shift has happened amid steep declines in youth usage and steady increases in adult usage.
The ongoing legislative and legal battles surrounding disposable vaping products signal the onset of a struggle that will likely shape the next decade of vaping. Approximately 10 million adults in the U.S. use flavored disposables, with a significant portion turning to these products as a complete replacement for combustible tobacco products. In our interconnected society and in a country growing more skeptical about government interference with the private choices of adults, preventing adults from accessing flavored vaping products will prove to be no simple feat.
Looking back at the evolution of the vaping industry over the last decade, the road has been both rocky and rewarding. From regulatory challenges to breakthroughs in harm reduction, the narrative is rich with lessons learned and battles fought. Amid these uncertainties, one thing is clear: Our journey is far from over.
Greg Conley is the director of legislative and external affairs for the American Vapor Manufacturers Association.
U.S. Senate Majority Whip Dick Durbin has again decried the Food and Drug Administration on its unacceptable failure to “protect children from the dangers of vaping” as the agency continues to miss and delay critical deadlines.
In a press release, Durbin stated that he has repeatedly criticized theFDA for its long-overdue review of premarket tobacco product applications (PMTAs) from e-cigarette manufacturers, which originally had a federal court deadline of September 9, 2021.
FDA has missed that court-ordered deadline by 28 months as unauthorized e-cigarettes flood the market.
During his speech, Durbin also called on the Biden Administration to swiftly implement a proposed public health rule to prohibit the production and retail sale of menthol cigarettes and flavored cigars.
“I know this President cares deeply about the toll of cancer. It has touched his family personally, as it has mine,” the Senator said. “If we want to make a difference in the health of Americans—and set a legacy for future generations—then the Administration must finalize this public health measure to end Big Tobacco’s predatory promotion of menthol cigarettes. Lives hang in the balance.”
The FDA stated in prior status reports for PMTAs that the agency would complete a review of 100 percent of the applications by the end of 2023. The agency is now estimating that completion of the reviews may be delayed as the FDA considers the D.C. Circuit’s opinion in Fontem US v. FDA, affirming in part and vacating and remanding in part marketing denial orders for certain vaping products.
