Category: Industry insights

The Vape Sectors in Egypt and Israel are Growing

The vaping markets in Egypt and Israel vary, but both are thriving and helping smokers switch.
By Norm Bour
The Middle East has always been full of smokers, and vaping has made an impact, but not to the same degree as other countries. While in Israel, I visited a few vape shops in Tel Aviv and Jerusalem, and there were some immediate similarities between them and the U.S. There were also significant differences.
Mendel Silverman works at the Drop Shop in Jerusalem and has been in the business for several years. When Silverman moved from the U.S. to Israel, he took up hookah—until he realized how unhealthy it was and switched to vaping.
“The industry is very robust, and unfortunately one of the biggest weaknesses is customer service,” he confessed, though that has been the bane of the vape space since the beginning. “We are lucky because we still have enough leeway to offer our own [e-liquid] mixes in a variety of nicotine levels, from 0 to 18 and about a dozen in between. And [nicotine] salt is a big seller, even though the regulators have made it more difficult and taxed the hell out of it.”
Both Israel’s finance and health ministries aimed to tax vaping products at the same rate as cigarettes. Maintaining that vaping is just as dangerous as smoking, the health ministry initially sought an even higher tax. According to Israel Hayom, an Israeli news outlet, Finance Committee chairman Alex Kushnir “reduced the conversion formula by 30 percent compared to what the Ministry of Health wanted.”
That tax comes out to be ILS21 ($5.75) per millimeter, which equals 270 percent of the wholesale cost, plus $4.94 per milliliter of e-liquid, which is the second highest e-liquid tax rate in the world.
E-cigarettes and e-liquids are regulated in Israel under the Tobacco Act, and they are subject to the same restrictions as combustible cigarettes. However, Israel’s health ministry has recently discussed the possibility of banning marketing of electronic cigarettes. The ministry said, “options are being examined due to two difficult cases and the widespread phenomenon,” referring to the increase of youth using e-cigarettes.
Watching Silverman add ingredients to a bottle of base—basic PG and VG—was a throwback to the U.S. pre-restrictions days when vape shops in the U.S. could do the same thing.
“We don’t sell any off-the-shelf flavors,” he shared. “But we can add menthol, flavors and nicotine to match (consumer) needs, and we can sell it cheaper than if we sold a name brand bottle that was complete.”
The owner of Drop Shop started the business selling products from the trunk of his car 10 years ago, a theme that appears to recur worldwide. As demand grew, he opened his first retail shop, which was robust until 2019 when the government banned importation of e-liquids with more than 2 percent nicotine. That devastated the business, so Silverman started creating his own flavors, paid tax on the nicotine and moved into a smaller shop.
Like their counterparts elsewhere, Israeli regulators justified charging higher taxes with the need to curb sales to minors, but such measures are usually equally driven by a desire for money. Even though the market is hurt, sales to all age groups continue, and the taxation affected cigarettes as well but not to the same degree.
Universally, excessive taxation of nicotine has created an underground movement in Israel, with many vapers making their own juices. It also pushed many vapers back to smoking. I shared my surprise at seeing many “religiously dressed” people smoking. “The yeshiva world, which involves the study of the Torah and Rabbinic text, has always been heavily into tobacco because it also includes the social aspect of it,” explained Silverman. Students and practitioners gather in coffee shops and similar places, and they all smoke together. In many cases, they do not have much of a life outside their studies, so tobacco is even more significant.”
According to the Israel Ministry of Health, smoking rates of the 21-plus crowd have been hovering at about 20 percent for several years, including a large percentage of military members. We finished our conversation by talking about the game changer of the past few years: disposable products.
According to Silverman, most Israeli consumers are looking for the simplest way to vape, but they have more interest in the nonrefillable versions even though they are more expensive.
The bottom line for vaping, taxes and smoking in Israel is that most things will probably remain status quo until or unless something seriously rocks the boat.
Over the Border
The vape scene in Egypt is totally different. For many years, vape products were illegal and mostly underground, but that changed in May 2022 when vape products were legalized. Considering that the industry is very much in its infancy, it still has a ways to go.
“The lifting of the ban highlights the Egyptian authorities’ progressive approach to e-cigarettes and sets the stage for the creation of a regulated market rich with business opportunities through serving the demand for easily accessible, quality products by legal age (adult) consumers across the country,” wrote RELX International, a leading player in the segment, in a statement last year.
With its decision to legalize vaping, Egypt joins global and regional markets, such as Kuwait, Saudi Arabia and the United Arab Emirates, which have also legalized and commercialized the consumption of e-cigarettes. As regulators around the world become more accepting of e-cigarettes, the market is expected to continue its steady growth in the coming years.
To complicate the situation, Egypt has a considerable problem with counterfeit products, so it appears that regulated and ethical vape shops have a huge obligation to help smokers quit.
In Cairo, a city of 22 million people, the vape scene is a wide-open opportunity, but finding a vape shop, a true vape shop, proved challenging. Google calls them “vape shops,” but they are more like small kiosks with a limited selection of products.
Many Egyptians are familiar with vaping and the advantages it offers, but true knowledge is rare, and even in a city that large, there were only a handful listed. However, by lifting the ban on e-cigarette products, Egyptian authorities have opened the door to a plethora of business and investment options, according to RELX International.
“Authorized e-cigarette products are traditionally retailed by small-sized and medium-sized businesses, so the move will bolster existing businesses that sell such products and will attract entrepreneurs wishing to set up new retail points across the country. It will likewise draw investment into the country from e-cigarette brands who wish to set up shop in the country and address the market,” the company wrote in its statement.
How much vaping will be embraced by smokers is another story. One in four Egyptians smokes, a ratio that has remained consistent for the past two decades. As high as that number is, Egypt remains near the bottom of the 20 countries with the highest percentages of smokers.
Times are changing, though. In May 2023, the Egypt Vape Expo was held at the Cairo International Convention Center. This event marked the first legal e-cigarette expo in Egypt and attracted many players from B2B channels in North Africa and the Middle East, according to attendees. Many said the show was a success.
The Middle East has long been a black hole for the vaping industry, and it’s only recently that the government has opened the doors for entrepreneurs. However, the success of vaping businesses remains to be seen.
Norm Bour is the founder of VapeMentors and works with vape businesses worldwide. He can be reached at norm@VapeMentors.com.
June 29, 2023
FEELM Wins 7 Times at MENA Vape Awards in Dubai

Credit: FEELM
The closed-system solution provider for the world’s largest atomization company, Smoore, captured seven prestigious awards at the Vapouround Mena Vape Awards 2023 held during World Vape Show Dubai.
FEELM, a subsidiary of Smoore, earned high praise at the vent and was crowned Best Manufacturer and Industry Leader beating out a roster of international competition.
Speaking after the ceremony, Rex Zhang, assistant president of FEELM said it was an honor to be recognized as a main player in the industry.
“This is especially exciting considering FEELM also walked away a winner at the Vapouround Global Awards in the UK earlier this year,” he said. “We pour huge amounts of time, effort and resources into optimizing our brand to be the best it can be and developing new technologies that can level up the vape category as a whole – these awards act as proof that we are very much on the right track.”
As well as celebrating its own successes at the Dubai event, FEELM also saw some of its clients take to the winner’s podium. Vape brands PYRO, Aroma King and DEJA VOO – which use FEELM technology in their products – won Best Newcomer, Industry Leader and Best Disposable respectively.
Adding to the list of accolades for brands using FEELM technology, RELX garnered the Best Brand award and also received recognition for its WAKA device securing the runner-up position for Best Newcomer.
“Congratulations to both of these companies. It’s great to see exceptional brands, who are doing exceptional things, get the recognition they deserve,” said Zhang.
The Vapouround MENA Awards coincides with the World Vape Show (WVS) in Dubai, which is one of the biggest expos in the industry calendar.
FEELM used this year’s WVS event as an opportunity to showcase its latest technological developments such as FEELM Max, Topower and Power Alpha.
June 27, 2023
Olsen: Rethinking the MRTP Approval Process

Photo: Tobacco Reporter archive
Rethinking the modified-risk tobacco products approval process.
By Cheryl K. Olson
It seemed an excellent test case for a new system. After role-playing a U.S. Food and Drug Administration Tobacco Products Scientific Advisory Committee (TPSAC) member, listening to Altria’s presenters rehearse their pitch, that was my impression. I thought that Copenhagen Snuff would likely sail through the modified-risk tobacco product (MRTP) application process.
Sold in some form since the 19th century, the product was well understood. From a regulatory perspective, it was comfortably dull. The reduced-harm claim Altria sought to put on Copenhagen’s label seemed indisputably true: “If you smoke, consider this: Switching completely to this product from cigarettes reduces risk of lung cancer.”
In February 2019, the TPSAC review panel voted 8-0 that the claim was scientifically accurate. Said panel chair Robin Mermelstein, “I am hearing a consensus that this was an understandable statement. It was clear,” and “I think it is a reasonable place to start in messaging.”
Forty-nine months later, the FDA finally authorized Copenhagen Classic Snuff as a MRTP.
“No tobacco product is safe or ‘FDA approved,’ so those who do not use tobacco products shouldn’t start,” said the director of the FDA’s Center for Tobacco Products (CTP), Brian King, in the March 2023 press release. “But tobacco products do exist on a spectrum of risk, with those that are smoked having the greatest risk. In this case, the FDA’s scientific review found that if an adult smoker completely switched from cigarettes to this smokeless product, it would reduce their risk of getting lung cancer.”
How could it take so long to approve the obvious: that complete switching to a (familiar) smokeless product from cigarettes reduces risk of lung cancer? This invites a fresh critical look at the MRTP process: its origin, utility and potential future.
Some MRTP History
The U.S. MRTP application process comes to us courtesy of Section 911 of the 2009 Family Smoking Prevention and Tobacco Control Act. It defines “modified-risk tobacco product” as one “sold or distributed for use to reduce harm or the risk of tobacco-related disease.” In addition to the usual scientific evidence for reduced health risks, complex studies of consumer perceptions and real-world product use are required.
Don’t have an MRTP authorization? Basically, your company can’t say anything on product labeling, advertising or other media “that would be reasonably expected to result in consumers believing that the tobacco product or its smoke may present a lower risk of disease or is less harmful” compared to other products. Or, that product or its smoke has fewer bad things in it. The act also prohibits the use of weasel words like “light,” “mild” or “low.”
In October 2019, Swedish Match USA’s eight General Snus products were the first ever authorized for sale with a modified-risk claim. “Today’s action demonstrates the viability of the pathway for companies to market specific tobacco products as less harmful to consumers,” read the FDA’s press release, “but only following a thorough scientific evaluation by the FDA.”
“It was a priority for CTP to demonstrate that the pathway works,” says Jim Solyst, then vice president for federal government affairs at Swedish Match. But this was four years after the same products received FDA marketing authorization (premarket tobacco product applications (PMTAs)) and took two rounds of TPSAC review.
The MRTP process is gobsmackingly costly in time and resources. In a 2018 regulatory document, the FDA estimated that it would receive three MRTP applications per year “and that it will take the applicant 10,000 hours per response to conduct studies and collect the information needed to support an MRTPA.” After all that, the claim is only good for five years. (A new application might lead to an extension.) Also, postmarket surveillance studies are mandated to show how the authorized claim actually affected consumer perception, behavior and health.
This may be why few companies have even entered the MRTP arena. The last TPSAC meeting to review an application took place in early 2020.
Only four diverse sets of products had emerged successful: snus from Swedish Match, Philip Morris International’s heat-not-burn IQOS systems and their HeatSticks, very-low nicotine cigarettes from 22nd Century Group and Altria’s snuff. (R.J. Reynolds presented on its Camel Snus to the TPSAC but later withdrew the application.)

At one point, it was logical that if you got a PMTA, it made sense to consider a MRTP. Now with the slowness of getting a PMTA, I don’t think companies have the MRTP as a vision of the next step.
Jim Solyst, former vice president government affairs, Swedish Match
Lessons from the Past?
When does it make sense to consider seeking a claim? “At one point, it was logical that if you got a PMTA, it made sense to consider a MRTP,” says Solyst. “Now with the slowness of getting a PMTA, I don’t think companies have the MRTP as a vision of the next step.”
Solyst, who is now principal at JMS Scientific Engagement, points to distinctive factors that gave General Snus products an edge with the FDA. These included product-specific long-term studies from Sweden. “They had an incredible amount of human health data and consumer data,” he says.
The MRTP section of the Tobacco Control Act echoes language from the influential 2001 Institute of Medicine report, Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction. That report mentioned Swedish snus multiple times as an example of a potential reduced-exposure product. This, Solyst notes, “did provide a comfort level [for the FDA] to go ahead with an application.”
Because of these special circumstances, it’s hard to draw firm lessons from Swedish Match’s experience for MRTP wannabes. Nonetheless, Solyst encourages a careful read of the General Snus MRTP decision document: “That indicates what CTP valued in the application.”
As more products are authorized, patterns for success may become easier to spot, encouraging more companies to try.

Willie McKinney
Not So Obvious
The FDA’s goal is to review and act upon each MRTP application within 360 days of receipt if it contains the required information. While the process may streamline with time, it’s unlikely that approvals will ever be rapid.
One factor is the FDA culture. Willie McKinney, who served for three years as the industry representative on TPSAC, points to the example of thalidomide. In the early 1960s, Frances Oldham Kelsey famously prevented untold numbers of severe birth defects by questioning a drug application slated for routine approval. “That’s the ideal FDA reviewer,” McKinney says. “‘I saved lives, stopped a bad thing from happening.’”
McKinney was at times surprised at negative votes on questions posed to TPSAC reviewers about MRTPs. “I came to the conclusion that ‘obvious’ means different things to different people,” he says. In transcripts from past TPSAC meetings, one sees examples of reviewer confusion about how novel products look or work and skepticism about industry-generated data.
One former staff member at the CTP agreed, saying, “Not knowing the unintended consequences is a biggie.” That person did not feel that politics or bias play a role, however.
“I have not had anybody say, ‘Hey, delay the review of this.’ It’s usually something that’s unclear,” they said. The involvement of outside reviewers complicates the process: “There are a lot of moving parts.”
Pluses and Limits
From a public health perspective, a plus of the MRTP system is that it gets thoroughly tested information onto product packages and ads. Ideally, this helps people who do and don’t smoke attempt to meaningfully weigh relative risks.
“The idea of having a health claim is a good one,” says Solyst. “But it needs to be something that is effective, that results in smokers moving to lower risk products.”
One problem is that Section 911 limits messaging to a brief statement about reduced risk of disease or exposure to a substance. As a tool to change what people do with nicotine, an MRTP claim is like one of those L-shaped Allen wrenches. It can work well for a simple, specific task.
But is it adequate for the complex job described in the Copenhagen MRTP press release? By law, the FDA must ensure that the public understands the reduced risk or exposure message used in advertising and labeling. What’s more, they must “understand the significance that information has in the context of total health and in relation to all tobacco-related diseases and health conditions.” That’s a lot to ask from a one-sentence claim.
Consider this: Strong headwinds of misinformation deter the switch from cigarettes to smokeless. It would be surprising to see large changes in perceptions and behavior intentions from one experimental exposure to a single short statement.
As Joe Murillo, then senior vice president of regulatory affairs at Altria Client Services, noted in his 2019 presentation to TPSAC, the FDA’s own survey data found that over 90 percent of adults who smoked thought smokeless products were just as or more harmful than cigarettes. Potential harm to nonusers of tobacco is factored into the FDA’s MRTP decisions. Isn’t harm from inaction—of not correcting high-risk misinformation—just as important to consider?
The Future of MRTPs
Among other recommendations, the recent report from the Reagan-Udall Foundation for the FDA encourages the CTP to develop a “more clear and predictable framework” for PMTA and MRTP submissions and reviews. This includes “simplifying, standardizing, documenting and publicly disseminating review procedures.” It’s noteworthy that the FDA sought comments on its draft guidance for MRTPs in 2018 but has yet to publish final guidance.
An April 2023 letter to FDA Commissioner Robert Califf by a group of distinguished researchers and advocates (including Mermelstein) expands on the Reagan-Udall recommendations. “Introduce a simplified system for evaluating incremental improvements to authorized products so American consumers can benefit sooner from product innovations,” they write. “This should apply to both the PMTA process for authorizations and the MRTP pathway for modified-risk claims. FDA’s processes should encourage pro-health innovation, not obstruct innovation or deny Americans access to the best technologies available worldwide.”
Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors via McKinney Regulatory Science Advisors. She spent 15 years on the faculty of Harvard Medical School.

June 8, 2023
Abboud Shares Insight Into VTA’s Goals for 2023

Credit: f11photo
The Vapor Technology Association continues its mission to promote sensible regulation.
By Timothy S. Donahue
In many countries, such as the U.K., vaping is synonymous with harm reduction. These governments recognize the harm reduction benefits of vaping versus smoking combustible cigarettes. They actively engage their citizens in “swap to stop” efforts backed by sound policy and known science.
In the U.S., however, the Food and Drug Administration is actively pursuing policies that protect, if not elevate, combustible tobacco products’ status in the marketplace and limit consumer access to alternatives that are safer than cigarettes, according to Tony Abboud, the executive director of the Vapor Technology Association (VTA). Abboud and the VTA have been instrumental in advocating for rational science-based regulations for vaping products that will enable a diverse and robust industry to thrive in the U.S.
Vapor Voice sat down with Abboud to discuss the current state of vaping and the future of the VTA. He said that one needs only look at the fact that the FDA is authorizing combustible tobacco products over less harmful vaping products at a rate of 45:1. This is a huge problem for an evolving and innovative industry but with graver public health consequences.
Vapor Voice: What is the current state of the vaping industry in the U.S. in your opinion?
Tony Abboud, director of the Vapor Technology Association. To learn more about the Vapor Technology Association
Abboud: Today, the U.S. industry remains in unnecessary regulatory chaos due to the FDA’s lack of vision in executing its statutory obligations, loss of focus on its harm reduction mission and reactionary decisions made to ameliorate political pressure of special interest groups untethered from science.
[The] FDA’s obstinate inability or refusal to speak truthfully about the importance of less harmful nicotine alternatives, such as vaping and modern oral nicotine products, is imperiling its clearly articulated mission to end smoking. Specifically, [the] FDA’s actions to date have only driven up the public’s irrational fear of nicotine vaping, a fear that can only cement consumers’ bond with cigarettes.
[The] FDA’s unscientific and dramatic policy shifts (cloaked as case-by-case decision-making) have plunged the agency and the industry into costly and unnecessary litigation that will take years to resolve, and, thus, it will be years before a rational regulated marketplace will exist. The net result is that, rather than creating a clear and achievable pathway for innovative companies to introduce new technologies that are 2 [times] to 3 times more effective at helping people quit smoking than the few products, FDA’s actions will continue to drive a wedge between people who smoke cigarettes that kill and the myriad options that will give them dramatic relief.
It is essential that companies in the industry galvanize behind thoughtful efforts to reset the narrative, demand accountability and make common sense changes. It is equally essential that [the] FDA resets its narrative, unapologetically follows the science and uses its power not to rob Americans looking for alternatives to cigarettes but empower them with myriad attractive options that will entice them to switch.
Now that the Covid shutdown and Zoom calls have ended, what has changed for the VTA?
Organizationally, one of the biggest impacts of Covid was the recognition that we had to focus our efforts on the biggest challenges that needed to be addressed rather than taking on every fight. That refocusing has enabled us to architect a thoughtful and impactful strategy to engage with policymakers and decision-makers on the issues most critical to our industry and to public health.
From a practical perspective, the biggest change in the reopening of this country has been the reopening of congressional offices, which only fully occurred this year. That change has made it possible for our team to sit down across the table this year and have meaningful and essential conversations with congressional offices and to bring voices into the fold that have not been heard before. We are on pace this year to far outstrip our prior levels of congressional engagement with a clear and persuasive policy message not only based on science but also supported by leading tobacco control scientists.
What are the VTA’s goals for 2023?
There are 34 million Americans who still smoke. Every two years, a million of them will die from smoking-related diseases. This is an unconscionable and ongoing public health crisis. We can save tens of thousands of lives by not hiding the fact that vaping is far less risky than smoking.
In this year, our priorities are a set of common sense new marketing standards and smart science-based access restrictions for flavored vape products to ensure such flavored products remain available for adult smokers while less accessible to youth. At the same time, we will continue our constructive engagement with [the] FDA to provide insight on the key policy issues and specific regulatory strategies that are necessary to achieve a rationally regulated marketplace.
What will it take to accomplish these goals?
Despite the FDA’s parroting of its mantra that it “follows the science,” the examples of where it has failed to do so have become too numerous to ignore. And despite the FDA’s proclaimed concerns about misinformation, the examples of which it has engaged in are simply too extreme to believe that the agency can easily correct the course it has embarked upon to denigrate, dismiss and deny alternative nicotine products. Hence, public pressure, congressional oversight and accountability in the courts all are necessary to ensure that FDA adheres to the science, follows the law and corrects the record.
In addition, notwithstanding the dramatic decline in youth vaping (now at pre-“epidemic” levels) that has taken place even with the broad availability of flavored products, the industry must continue to demonstrate its commitment to reducing youth access and appeal by supporting long overdue and common sense marketing restrictions that will further reduce underage use. Additionally, just like with 21-plus legislation, for which the industry advocated, new 21-plus policies can further limit youth access to flavored vaping products.
Given the chaos in the marketplace created by [the] FDA’s past and present actions, and its apparent policy to bar every nontobacco-flavored vape product from the marketplace, congressional action can help calm the chaos by adopting leading tobacco control scientists’ recommendations that flavored vape products be sold in adult-only stores, making them less accessible to youth while preserving the availability of adults. All of our goals and strategies are based on both data and science as we continue to amplify the voice and role of science in the decision-making process.
Is there any hope for open systems and/or flavors?
Yes. Facts are stubborn things. There is no scientific or real-world evidence that youth are attracted to or use open systems in any material numbers. At the same time, data from the National Youth Tobacco Survey year after year proves that flavors are now one of the least cited reasons that youth may experiment with vaping.
And each day, more and more peer-reviewed science is published proving the important role that flavored vaping plays in the decision to switch away from deadly combustible cigarettes, particularly when compared to the FDA’s favorite ineffective solutions. There is also hope in the fact that the industry will continue to innovate.
There will be new technologies that capture the market in the future, and we should be open to that—and so should [the] FDA. Flavors are proven to be the preference for adults who are looking to quit, and adults are more likely to succeed when flavors are available to them. Consumers’ demand for flavored nicotine products should be no more paternalistically rejected than consumers’ demand for cannabis products.
Are nontobacco nicotine products going to gain broad acceptance, especially with regulators?
Well, that is entirely up to the FDA now that Congress was convinced by certain industry players that nontobacco nicotine was somehow a problem. True, it was a problem, but primarily for certain businesses which were dependent on tobacco-derived nicotine. But the reality is that nontobacco nicotine is the cleanest and purest form of nicotine available on the market, which is perfectly replicable and traceable to the batch level.
Nontobacco nicotine is precisely the type of innovation in a constantly changing landscape that should be encouraged as the industry advances toward a combustible-free future. Regulators have a huge opportunity to use their authority to regulate nontobacco (synthetic) nicotine products and to encourage their entry into the marketplace. But, given [the] FDA’s current trend toward eliminating virtually all nicotine alternatives from the market, one can only question whether [the] FDA could seize the opportunity to provide consumers access to products that would allow them to break free from the last vestige of tobacco.
Do you see congressional action as the only cure to the current FDA regulatory process?
Congressional action can help, but the challenges are significant. There are three ways that Congress can assist. The first is through its oversight committees, which have jurisdiction to question the FDA’s prior actions that have been inconsistent with the law and inconsistent with, according to CTP’s [Center for Tobacco Products] scientists, the science on vaping.
The second is through its appropriations committees, which must question exactly how FDA is using the hundreds of millions of dollars it receives, why it uses the majority of its resources to remove e-cigarettes from the market while ushering hundreds of new cigarettes to the market and what could possibly justify its request for another $100 million in fees that ultimately will be borne by the vaping consumer (giving them yet another disincentive to switch).
The third is through committees of jurisdiction that can end the absurd discussion of “ban, ban, ban” when it comes to flavors and instead focus on real solutions to real marketing issues of which vaping opponents have complained for years but have never truly sought to address.
Congressional action is not the only cure because [the] FDA currently has placed its thumb on the scale by creating a standard for companies seeking to comply and secure marketing approval without giving them the knowledge or opportunity to do so. For that reason, [the] FDA appears content with letting the courts sort out the mess that it has created.
After all, CTP appears to take delight in declaring that every vaping product on the market is “illegal” and “cannot be lawfully marketed” except for the small handful of tobacco-flavored products [the] FDA has authorized. So, while regulators often complain about industry lawyers, it should come as no surprise that the actions of prior agency leadership, which in a very short period of time demanded a complete reversal of CTP’s priorities, plans and policies as they related to flavored vaping products, would lead to legal challenges.
In the end, any branch of our federal government can have a major impact in fixing the mess created by a disregard for science and the law. The question now is which one(s) will do so.

April 30, 2023
SFATA Safeguards Production, Sales of Vaping Products

Credit: SYCprod
The Smoke-Free Alternatives Trade Association continues to help business owners navigate regulation.
By Timothy S. Donahue
In 2012, the Smoke-Free Alternatives Trade Association (SFATA), a trade association representing small and large vaping businesses, began when the industry was still in its infancy. The trade group has been a staple in the tobacco harm reduction circle for more than a decade fighting for balanced regulations in the United States. It hasn’t been easy. The U.S. Food and Drug Administration has nearly decimated the numerous small business owners who once made up most of the vaping industry.
While the industry has had to evolve, so have the trade industry groups that support it. The SFATA began as an advocacy group for states in its early stages. As federal regulation began to come into reality in 2016, the SFATA altered course and focused on getting balanced regulations on the federal level. In 2021, however, after the FDA either denied or failed to review over 8 million premarket tobacco product applications (PMTAs), it sent the industry scrambling, explains SFATA Board President and CEO April L. Meyers.
“In the winter of that year, it also sent the states scrambling, so we had to shift our focus from federal to state so that we could save as many small businesses as we could,” she says. “There were several battlefronts and issues, most notably, flavor bans.” The organization had success at the state level. The SFATA had stopped several flavor bans. It was around this time that the organization also introduced its Responsible Industry Network (RIN) program.
The RIN program helps retailers combat the problem of youth use. It’s a program that provides a postmarket surveillance pathway through data, training, accountability and corrective measures for vapor manufacturers, distributors and retailers as well as a method for law enforcement and regulatory authorities to ensure that significantly fewer vapor products end up in the hands of youth. The RIN program serves the interest of business owners navigating the complexity of a highly regulated market while also assisting enforcement agencies.
Additionally, authorities can confiscate products that do find their way into the hands of youth and conduct enforcement actions against the parties who are responsible, whether they are manufacturers, distributors, retailers or straw buyers, such as family members or friends. An added value for the industry is that curtailing youth access will lower the biased media attacks that the vapor industry targets children, creating a more stable regulatory environment that allows businesses to grow.
April Meyers, SFATA
“If you’re a small [-sized] to mid-sized manufacturer and you received a marketing order, you’d have to either hire somebody full-time to collect the data for postmarket surveillance or spend a lot of valuable time trying to do it yourself,” said Meyers. “That’s where we came up with a program that streamlines the process. Everybody’s got the same due dates and the same forms. And then the agency is looking at the same form coming in at the same time.”
To receive a marketing order, the FDA states that it “intends to consider how an applicant will target the marketing of its new tobacco product to reach its intended consumers of legal age and to assess the potential effect on nonusers.” The FDA will also consider how the applicant intends to minimize the extent to which youth can access the product and are exposed to its marketing.
“If the PMTA does not address youth access to the product, youth exposure to the product’s labeling, advertising, marketing and promotion, and youth initiation, such as describing how it proposes to restrict the sale or distribution of its product to limit potential youth access to the product, it’s going to be impossible to get a marketing order,” said Meyers. “[The] FDA may be unable to determine that the applicant has made a showing that permitting the marketing of the new tobacco product would be appropriate for the protection of public health. RIN can help provide that data. And that data can be useful in several meaningful ways.”
The RIN program will create a rich database that will expose useful sales and marketing insights for participants, according to Meyers. She said that the data can show aggregate buying and selling behaviors of vapor products, data that can also be useful when faced with federal and state flavor bans and taxation bills.
In order to further help its members, Meyers said the SFATA recently entered a “strategic alignment” with the United States Vaping Association (USVA). She said that teamwork is an important aspect of vapor advocacy and that businesses need to support each other. The partnership creates a more unified voice and prevents wasting valuable industry resources by multiple organizations doing the same work.
“You’d have to be a dual member to realize the full benefits of advocacy. We’re also trying to make it reasonably priced where a store that’s on its feet and planning to move forward can participate,” she explains. “And we wanted to keep it even across the board because we don’t want to tell a big company that you must pay more just because you’re bigger. Nor a small company [that] you have to pay so much, and then they get costed out.”
Currently, the USVA is focused on winning its lawsuit against the FDA. The USVA believes the regulatory agency didn’t consider the economic impact on small businesses that the PMTA process and subsequent denial orders would have. The USVA suit claims that the FDA acted as if vapor applicants would be able to substantially rely on public data or on 70 studies that the FDA itself was conducting at that time. However, the FDA instead wrote an impossibly burdensome PMTA rule that began putting people out of business.
The suit is hoping the courts declare the PMTA final rule in violation of the Regulatory Flexibility Act, an effort by the U.S. federal government to balance the social goals of federal regulations with the needs and capabilities of small businesses and other small entities. The USVA also hopes the judges remand the PMTA final rule to the FDA and enjoin the agency from enforcing the final rule against any members of the USVA. This would also include joint SFATA members.
The suit also criticizes the FDA for prioritizing manufacturers with the greatest market share, companies that were more well funded to tackle the PMTA process. Some of the larger companies were also allowed to make changes to issues with their PMTA submissions whereas smaller companies with the same issues received marketing denial orders for those issues.
Credit: Rafel
“If the courts hand down an emergency injunction for relief, it would mean that every member of the USVA, SFATA joint members and the named plaintiffs on the case go back into review. Where we found synergy between the organizations is if you go back into review, what happens? Are you better off? No. Do you have more time? Yes. Can you make more money in the extra time you’ve been given? Yes. But then what? If you don’t address the broken process, that is the PMTA, you have nothing,” said Meyers. “It affects every state, every business, every vapor product retailer.”
Meyers explained that joining the SFATA helps to safeguard that manufacturers are able to produce products and businesses are able to sell lifesaving vapor devices. The organization is currently laser-focused on the U.S. House of Representatives and is dedicated to trying to do its part to stamp out overzealous and overreaching legislation.
“We focus on the House because that’s where the oversight is of FDA, and that’s where most bills also get introduced. So that’s where we’ve put our focus and where most of our meetings will be concentrated on at the federal level for this year’s session,” she said. “The FDA’s rules are the problem. The members of the House we have spoken to understand that the process is broken. We are presenting science-based solutions and innovation to show that it can be fixed.” While legal action safeguards against the lack of guidance and transparency from the FDA, the SFATA is working with lawmakers to ensure that its “commonsense solutions for American smokers” are understood and communicated to the FDA and Congress, which oversees the agency, according to Meyers.
“The recent report from the Reagan-Udall Foundation found numerous wide-ranging problems at CTP,” she said. “Now Congress is asking the FDA to answer those same questions the Reagan-Udall report asked … SFATA is asking those questions too. What is your strategy? What is your plan? What are you going to do? There’s a lot of pressure on FDA to do something and be clear about it. [The] FDA can’t come up with that plan by themselves. They need industry insight and support. Our goal is to come up with that input. That’s why you would support SFATA. You want to be a part of that conversation and get that information. We are here to help.”
April 29, 2023
Quitting is Easy

Credit: Ivelin Radkov
It seems to be very difficult for many politicians and think-tankers to change their minds.
By George Gay
Ever since they were mentioned in a Guardian newspaper leader in the U.K. in February, I have been fascinated by sea squirts. These tiny creatures start off as eggs and then develop into tadpole-like entities that swim around seeking a suitable rock or piece of coral on which to make their homes for life. But this is the good bit: Once they have attached themselves to their homes-for-life, they no longer need to swim or seek out suitable habitats, so they devour their own brains.
The rest of their lives is spent blissfully drawing in sea water through one orifice, removing the nutrients they need and then squirting out what they do not want through another orifice—all without having to contemplate tricky meaning-of-life questions.
Do these little creatures remind you of anything or anybody? To me, their way of life mirrors that of many politicians and employees of ideologically rigid “think tanks.” I mean, once these people have swum away from home, school or university and attached themselves to their political party or ideology of choice, they no longer need their brains, just a couple of orifices, one of which takes in information that is scanned for the nutrients that will feed their political or ideological prejudices and the other to squirt out the indigestible, inconvenient facts.
You might laugh at this, or you might find it outrageous, but it would explain something that to me is otherwise inexplicable: the fact that it seems to be enormously difficult for many politicians, think-tankers and people in thrall to the aforementioned to change their minds.
It is not unusual to hear a person who has always voted for a particular political party to say, while acknowledging that their party has been in power for years and proved itself to be incompetent, corrupted and lacking ideas, that they will continue to vote for it because “imagine what another party would have done if it had been in power during the same period,” something that, obviously, cannot be known. This is your individual as a sea squirt, operating to her full potential with two orifices while comfortably attached to her easy chair.
In a similar vein, there is no end of people willing to tell you that tobacco smoking is the worst thing that anybody could do, but who will then add that, nevertheless, “can you imagine the awful things that vaping could usher in in the long term.” These two-orifice people look for nothing new, listen to nothing new and say nothing new.
This resistance to doing things in new ways, even putting one foot in front of the other, was highlighted by John D. Barrow in The Book of Nothing when he quoted Francis Cornford. “Every public action, which is not customary, either is wrong, or, if it is right, is a dangerous precedent. It follows that nothing should ever be done for the first time.” Crazy as it might seem, this is where we are with vaping. Traditional tobacco products are customary, so they are OK, but vaping devices could set a dangerous precedent.
It must have been the case that sea squirts or their relatives were in charge at Suring School in Wisconsin, USA, recently. According to a Vaping360 story relayed by Tobacco Reporter, Wisconsin legislators have had to propose a bill that would make certain invasive searches of students illegal.
“The proposed law follows searches of students aged 14 to 17 last year in Suring, Wisconsin, in which the students were made to strip down to underwear in order for the superintendent to search for vapor devices,” the story reported. “The students were not told that they could decline the search, and parents were not informed until after the searches were completed.”
At first, I found this story difficult to believe because it requires your accepting that somebody, or some people, thought that one way of protecting students, who might or might not have been carrying vapes, would be to humiliate them. They apparently thought that theirs was a proportionate response to student vaping.
The students were 14 to 17, at a time of their lives that many find difficult to navigate, when they should be able to rely on the adults running their school to set an example of rational, humane behavior. Instead, they seem to have been confronted by adults obsessed with enforcing petty rules even to the extent of carrying out strip searches, which most people probably associate with prisons.
I would suggest that even if those students vape for 50 years, it will do them less damage than the memory of being strip searched. I salute the legislators who are seeking to stop such incidents occurring again.
An issue that seems to me to arise from the above story and one from Sheridan, Wyoming, USA, is that a lot of adults need to grow up. Their ideas on rules and discipline seem to be aligned with those of your average 13-year-old, which often tend to be inflexible. According to a Sheridan Media story relayed in TR, the city council in Sheridan was due to consider an ordinance pertaining to vaping and tobacco use by minors in the city.
“Under the proposed ordinance, any minor [I assume, anyone under the age of 21] found possessing tobacco or electronic cigarettes (vaping devices) would be subject to a tiered system of fines through municipal court,” the story reported.
Credit: Olly
It’s none of my business, I suppose, because I don’t live in Wyoming, but, nevertheless, perhaps I could respectfully suggest that there should be some consultation on this. Perhaps the authorities might do well to draw on the expertise of people informed about comparative risks and gun laws in Wyoming, where I gather from the internet that just about anybody in the state who is above the age of 18 may carry a gun.
As elsewhere, in clamping down on vaping devices, the authorities in Wyoming seem to be more concerned about things that people can protect themselves from, such as vaping, than about things that it is difficult if not impossible to protect themselves from, like being shot. At the outbreak of the Covid-19 pandemic, the World Health Organization seemed more intent on putting on an anti-tobacco/anti-nicotine conference than protecting us from a deadly virus that, unlike tobacco smoke, could and did sweep unseen across borders.
By the way, the Centers for Disease Control and Prevention (CDC) rank Wyoming as having a firearm mortality rate of 25.9 per 100,000 people, which places it third highest, below Mississippi (28.6) and Louisiana (26.3). And, as another aside, this raises an interesting question about whether the CDC believes that gun ownership is a disease, but that is not for discussion here.
Although, having said that, language does matter, according to Johanna Cohen, Bloomberg professor of disease prevention and director of the John Hopkins School of Public Health’s Institute for Global Tobacco Control. Cohen stars in a video that seems to be an advertisement for language purity by scientists and academics working in the field of opposing new-generation products (NGPs).
It is a rather confusing video to my way of thinking because, while the voice-over makes the point that language evolves, Cohen seems not to be a Darwinist. She seems to lean toward genetically modified language, where such modifications are controlled by people such as her to avoid language developing adjectival diseases helpful to the tobacco industry.
This all becomes rather silly in fact. At one point in the video, according to a piece by Alex Norcia writing in Filter magazine [I quote Norcia because, though I watched the video, I did not transcribe it], Cohen says that “words like ‘novel’ and ‘emerging’ are really misrepresentative by nature as a product is only new for so long.”
I mean, come on, I know that a lot of people who like to go on about tobacco cannot resist dredging up the past, but what is she trying to do here, reignite the 1920s debate between Albert Einstein and Henri-Louis Bergson on the nature of time? As a bit of a diversion, is she seeking the illusive equation that will define for us the “now” moment? Cohen seems to want to set up an Academie Anglais when the object of the NGPs exercise should simply be to make it as easy as possible for those people who want to do so to switch from traditional combustible cigarettes to these less risky products.
As always, if you want to make sense of something, it is best to seek out the experts, and by that, I don’t mean the scientists and academics. I mean the people who smoke and who use NGPs. At the bottom of a TR news report on the Filter piece, a viewer of the video was quoted as saying, “WE use these devices. WE define the terms. You need to stop talking and start listening.” Sixteen words that say it all.
But Cohen is right in one way: Language is important, and those who support tobacco harm reduction (THR) should not be lulled into picking up and repeating whatever ideas the anti-tobacco/anti-nicotine activists put out. And there is a tendency to do this, especially within the tobacco industry, which is forever issuing mea culpas in an effort to curry favor with its enemies. One obvious example of this is the way in which just about everybody applies the word “addiction” to smokers and vapers without bothering to define what exactly is meant by addiction, something that I try to point up in another piece in this magazine.
Another example can be seen in the otherwise useful World Vapers’ Alliance Policy Primer featuring case studies of the most successful countries that have embraced alternative products as a means of combating traditional smoking. It is unfortunate, in my view, that the primer at one point had this to say: “Quitting smoking is one of the hardest things to do, and smokers need all the support they can get instead of being stigmatized.”
I find it hard to believe that anyone whose aim is to get people to switch from smoking to vaping would make this point, which I don’t think is even correct. For one thing, the hardest thing to do would vary from person to person, but it is easy to imagine that, for some people, obtaining a doctorate in quantum physics, playing Hamlet well, knitting a jumper with two arms in the right place, playing Wagner or listening to The Ring Cycle right through … might all come higher up the scale of difficulty than giving up smoking.
I gave up smoking without recourse to any replacement or alternative products, and many of my peers did so, too, and I don’t for a minute believe that we were a particularly strong-willed bunch. Indeed, the figures showed that countless numbers of people did so at the same time.
And even if this were not the case, I would find it difficult to understand under what circumstances any sensible person would try to encourage another person to do something by telling them it was difficult. It is time to take advantage of some corporate speak. For years now, no company worth its salt has faced problems; it has instead faced challenges. Note, the obstacle hasn’t changed, just the way of looking at it.
The worker faced with a problem is entitled to hold her chin and shake her head. The worker faced with a challenge is set up to measure the height of the obstacle and the length of the run-up needed to clear it.
We of the THR persuasion should not perpetuate the myth that quitting tobacco is difficult. We are not sea squirts attached to the anti-tobacco/anti-nicotine rock and being force-fed its solutions. It is not in our interests to perpetuate such myths, though it could be seen as being in the interests of those in the anti-tobacco camp. After all, if smokers came to know that it was not difficult to quit, they might do so and put those employed to be anti-tobacco out of work.

April 24, 2023
Vapitaly and IECIE Join Forces to Boost Opportunity

By Norm Bour
If we look back at vape events and conventions over the past decade, many have come, and most have gone. In 2013, the Electronic Cigarette Convention, known as ECC, was launched in Ontario, California, and for many years was the 800-pound gorilla of e-cigarette trade shows. Others caught wind of the successful event and copied it to the point of where there were dozens of events running year-round throughout the United States.
The ECC held its last event in 2019. However, the international vape market recreated the ECC’s former success with other vaping events. Cities like London, Paris, Moscow and others became powerhouse venues, and then a new entity, IECIE, jumped onto the show scene in the global center of vaping hardware manufacturing: Shenzhen, China. The success of Shenzhen’s show led to the later creation of an additional Shanghai event.
Shenzhen-based companies design and manufacture an estimated 90 percent of the world’s vaping and e-cigarette devices. There are more than 1,000 factories and thousands of support companies that form the supply chain throughout Guangdong Province and the rest of China.
IECIE, a division of mega-event company Informa, launched in January 2016. Over the years, the company has been a major player in international vaping events. Even with the cumbersome visa issues getting into China, the world vape market knew that IECIE brought together the manufacturers that they needed, and the exhibitors showed up in droves. IECIE officials thought that “if they build it, they will come.”
Vapitaly president Mosè Giacomello
Informa puts on 230-plus events annually and brings in 60,000 exhibitors in many industries aside from vaping. Ironically, China put a heavy hammer down on vaping last year by banning flavors, except for tobacco, and is vehemently fighting underage sales of products. Currently, they are still allowed to export products, which is key in the global supply chain.
Those new rules caused many major vaping electronics manufacturing companies’ stocks to drop after the regulations were announced, and most companies have cut back on employees or closed completely. What the Chinese smokers in China will do is unknown since their choices have now been severely curtailed. Numerous experts have predicted that many will return to combustible products.
With all the new regulations in place, event companies like Informa have but one direction to follow, and that is to move the events outside of China. That new path will lead to Verona, Italy, May 27–29, as the IECIE team joins with another longstanding vape player, Vapitaly, in their first joint venture.
The event will be at the Fiere di Verona exhibition center, which houses 8,000 square feet of meeting space, and organizers hope to entice more than 100 exhibitors and 10,000 guests like they did in 2022. Fortunately, Vapitaly has had a successful track record since 2015 in achieving the lofty goal.
In this post-Covid world, it’s also a matter of information sharing and education as well as sales, and the event will bring in speakers and forums to discuss the challenges and possible solutions for the future of vaping. Vapitaly, the only international vaping exhibition in Italy, is already the world’s largest event in the vape space, so this new collaboration should cement its place as leaders in the industry.
Mose Giacomello, Vapitaly president, stated on the company’s website that Vapitaly is “ready to return with all the latest products in the sector, with a focus on internationalization, and [is] proud to have been chosen by the most important vaping show in Asia, which will be in Italy, and Europe, for the first time.
“This major opportunity to meet and do business comes in the wake of the efforts made in recent years to enhance and develop the sector. We are looking forward to seeing operators and professionals from Italy and abroad once more and to seeing vapers browsing the stands of our exhibition.”
An industry player in Italy, who asked to remain anonymous, said that they shared some concerns about what they called “the Chinese vendors,” and fear that they will not follow the stringent rules at the event itself. Laws forbid the sale of products on-site, but IECIE has assured Vapitaly that they understand all the laws as well as the very specific labeling requirements, that IECIE has conveyed the regulations to all their exhibitors and that they will abide by them.
IECIE will have all the current products on display, including disposables, open pod systems and closed pod systems, atomizers, mods, e-liquids and vaping accessories along with new and better products in this ever-changing world of technology.
The challenge that IECIE faces, aside from the regulations about sales of vape products in China, is that those regulations also shut down the Chinese vaping event industry. Without a market in their home country, vaping event planners have no other choice than to form collaborations with other international companies—or hold their own events outside China.
And that is what their next chapter will present as IECIE launches its second IECIE Vape Show Jakarta, Aug. 3–5, with another planned for next winter. This is a partnership with 2firsts.com, a multifaceted supply chain and operations team that works with compliance issues and manufacturing with vape entities worldwide.
This will be the first show that IECIE will sponsor outside China, and they are in conversations with other entities to expand further. They currently have offices in Dubai, New York and Brazil and have a satellite office in Jakarta.
Even though the Southeast Asia market is estimated to reach $766 million in 2023, and grow exponentially, Informa sees that expansion and partnering with the Western world and Middle East as critical. They are also working on an event to be held in Saudi Arabia.
The August show in Jakarta is expected to bring in 300 exhibitors and house them in 12,000 square feet of floor space, a 30 percent increase from 2022.
Norm Bour is the founder of VapeMentors and works with vape businesses worldwide. He can be reached at norm@VapeMentors.com.

2021 IECIE Shenzhen eCig Expo
April 19, 2023
Head in the Clouds

Credit: James Thew
A vaping industry veteran uses some time-tested adages to reflect on his 11 years in the space.
By Chris Howard
In the new year, as I reflect on my past 11 years of experiences in the vapor space, I think it is better late than never to share some thoughts on where we have been and where we should be headed. Because we are never too old to learn, I thought I would strike while the iron is hot (hopefully you can see the theme here).
From 2018 to 2021, the industry suffered incalculable upheaval and uncertainty as we went through a shortened premarket tobacco product application (PMTA) period and a seemingly never-ending series of marketing denial orders (MDOs). While 2022 wasn’t necessarily any better for industry, it sure got a lot worse for the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP).
To recap, we saw multiple challenges to MDOs that shed some inconvenient light on the CTP review processes. We also witnessed significant delays in the CTP’s ability to meet the Maryland Court-imposed deadlines. Congress regularly attacked the CTP (and the greater FDA) for perceived shortcomings. And, finally, we saw the results of the Reagan-Udall Foundation review that, even with the soft touch given to the CTP, did not paint a flattering picture of the workings of our regulator. In all, it was a rough year for a new center director and the staff.
With the above in mind, a few time-tested adages can aptly describe my reflection on the vapor industry—which I offer here for your consideration:
Make a Long Story Short. After nearly seven years since the finalization of the Deeming Rule, the CTP and industry have collectively learned that some of the standards/requirements making up the PMTA process could be streamlined to say the least. By way of example, does the CTP really need for each company to spend thousands of dollars on the same literature review? Are behavioral surveys to show youth aren’t attracted to tobacco-flavored products necessary at this point?
Are there other commonalities across numerous applications that could now be updated or otherwise removed from consideration given consistent findings? As suggested by the Reagan-Udall Foundation, the CTP should consider providing more detailed summaries of applications that have made it through the process—so that industry can place emphasis on areas that the agency deems to be a higher priority and eliminate superfluous activities that ultimately add little value. Doing this and taking steps to simplify the requirements would ultimately enable both the industry and the CTP to employ a more focused approach, resulting in greater efficiency for all involved.
You Get Out What You Put In. Applicants who skimped and filed weak applications without regard to the requirements set forth by the CTP have nearly universally learned a valuable lesson. The PMTA process is expensive, and extremely rigorous science is required to show that your products are appropriate for the protection of public health (APPH). While many sought shortcuts and/or complain that the CTP’s guidance is unclear and/or vague, several companies have demonstrated that vapor products can indeed meet the FDA’s high standards.
Which companies are these? These are the companies who expended significant time and resources to develop robust applications covering each scientific discipline and other requirements set forth in the June 2019 “Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems, Guidance for Industry” and in the November 2021 Final Rule regarding “Premarket Tobacco Applications and Recordkeeping Requirements.”
Don’t Hold Your Breath. It’s hard to believe it now, but there was a time when both applicants and the CTP shared an optimism that reviews of applications could be accomplished in accordance with the prescribed timeline. This “certainty” provided an objective framework enabling industry to develop various business plans for all deemed products in the pipeline.
Unfortunately, the ultimate glut of applications proved to be an insurmountable burden for the FDA—resulting in nearly all timelines falling by the wayside. For anyone with pending PMTAs and for those manufacturers contemplating filing new PMTAs, don’t expect to obtain results quickly. Hopefully, the CTP will adopt some of the recommendations contained in the Reagan-Udall Foundation report to increase its overall efficiency and enable the industry to plan more effectively.
When Life Gives You Lemons, Make Lemonade. For innovators in the vapor space, initially life was very good. They had a great product that was considered profitable and a key to moving harm reduction forward. Unfortunately, things didn’t go exactly as expected, and life gave everyone in the vapor space lemons—and a huge basket of lemons at that. We had youth vaping; e-cigarette or vaping product use-associated lung injury (EVALI); near constant, questionable scientific studies demonizing electronic nicotine-delivery systems (ENDS); state and federal legislation to tax, limit and ban; a regulatory agency that swept the market nearly clean of flavored products—the list goes on.
It’s quite easy to despair, but now is the time to make lemonade. As an industry, we need to innovate within the narrow confines provided. We need to continue to ensure that the FDA makes its decisions based on science while we develop improved nonflavored options and better marketing schemes to prevent youth exposure. Smokers deserve our efforts to offer satisfying, reduced-harm products—I’m confident this innovative and adaptable industry can do just that.
It’s Not Over Until It’s Over. Over the past 11 years, I have seen so many industry advocates walk away from the vapor category due to a variety of circumstances. Unfortunately, with each powerful voice that leaves, the ultimate goal of ensuring that vapor products are an important part of an FDA-sponsored harm reduction platform becomes even more difficult to reach. In my opinion, the story isn’t over. Several vapor products have received market granted orders, and I expect that we will see more in the near future.
Moreover, additional studies continue to show the obvious health benefits of vapor products as compared to combustible cigarettes and that they are a valuable tool for adult smokers seeking to quit. Maybe owning a vape store and selling thousands of flavors isn’t on the horizon, but helping smokers seeking alternatives can still be a meaningful priority. I encourage past and current members of the vapor community to revisit their priorities with a new focus on educating the public—even if the journey hasn’t been as fulfilling as you hoped it might be.
Two Wrongs Don’t Make a Right. In case anyone missed it, several young people decided to experiment with vapor products a few years ago. Fortunately, that trend is unquestionably subsiding thanks to the introduction of T21 and the gradual decrease in the “fad” of vaping. It certainly isn’t right to (and no responsible manufacturer should) sell ENDS products to or in a manner attractive to kids. Unfortunately, the handling of the regulation of ENDS and, more particularly, flavored ENDS by both public health commentators and regulators is also wrong.
In 2016–2017, ENDS were the next best thing. They held the promise and potential to restructure the tobacco use market in the United States from combustible cigarette death and disease to an inhalable nicotine product that reduces risk and disease burden. The “second wrong” in response to Juul, EVALI, the abandonment of harm reduction and an avalanche of inaccurate reporting, propaganda and sensationalism resulted in the gutting of the flavored ENDS space (most of which did not have a youth vaping issue) in the form of refuse-to-file letters and MDOs based on a seemingly arbitrary solution.
These two wrongs, when coupled, don’t make a right—what these two wrongs make is a missed public health opportunity. Unlike the United Kingdom, which has embraced ENDS and driven down smoking rates, the U.S. has moved in the opposite direction—vilifying, banning and restricting. In this case, the two wrongs will result in increased smoking and increased disease.
The Perfect is the Enemy of the Good. As the PMTA review picture gains incremental clarity, we often see policy of pursuit of perfection (e.g., ill-defined demands for long-term cessation trials for flavored products). Whether this pursuit is expedient to remove disfavored products or flavors from the market or we are seeing the level of evidence required to gain a market order rise to a standard only found in the drug center is for you to consider.
However, the net effect is an increasingly complex (and expensive) set of criteria to satisfy the APPH standard. The public health standard, however, should not be a pursuit of perfection—it should be a pursuit of decreasing cigarette smoking mortality and morbidity. While there may be risks associated with some of the reduced-harm products, those risks are dramatically fewer than those posed by cigarettes. Accepting reasonable evidence to support reduction of harm to enact lifesaving and life-extending regulatory policy just makes good sense.
Don’t Miss the Forest for the Trees. Throughout the public health community, harm reduction principles are embraced and promoted to reduce the harms related with drugs, sex and other potentially harmful activities. For some reason, though, with rare exception, nicotine and combustible cigarette smokers don’t seem to merit a harm reduction strategy.
In the face of 460,000 smoker deaths each year, prudent regulatory policy would embrace products down the spectrum of risks—not ban them. European regulators have seen the forest—they promote reduced-harm products while discouraging combustible cigarette smoking. In the U.S., unfortunately, we ran into the first sapling off the trail and haven’t really progressed from there.
While the past 11 years have provided many ups and downs in the vapor space (a lot of downs), I’m hopeful that we can turn a corner in 2023 and beyond. In the past, it seemed like it was the vapor industry versus the world. Today, however, it is possible that we are at the dawn of a new era of tobacco regulation.
My hope is that when I look back on the next 11 years, the CTP has learned from the missteps of the past. I hope the center uses the valuable insights it has been provided, like the findings in the Reagan-Udall Foundation report, to reorient the center on not just prohibiting products but rather crafting policy and standards that assist combustible cigarette smokers in moving away from those harmful products. I hope to look back on tobacco control policy that doesn’t just involve saying “no” to every option but rather embraces harm reduction and doesn’t leave smokers behind. Maybe we can have our cake and eat it too.
Chris Howard is executive vice president of new product compliance and external affairs for Swisher and former senior vice president, general counsel and chief compliance officer for E-Alternative Solutions.

February 28, 2023
German Industry Group Blasts Call for Vaping Ban

Jan Muecke
(Photo: German Association of the Tobacco Industry and Novel Products)
Recent calls to ban e-cigarettes lack a scientific basis, according to the German Association of the Tobacco Industry and Novel Products (BVTE).
In a recent interview with Deutsche Presse-Agentur, Manne Lucha, minister of social affairs, health and integration for Baden-Württemberg, said that e-cigarettes should be treated the same as combustible cigarettes and that flavored vapor products should be banned.
“It is a scientific consensus that the intake of harmful substances when vaping e-cigarettes is much lower than when smoking tobacco. With his ‘post-factual’ statements, the minister is causing consumer uncertainty with counterproductive consequences for health policy,” said BVTE CEO Jan Muecke in a statement.
Muecke cited a 2020 statement by the German Cancer Research Center, which acknowledged that a complete switch from smoking to vaping reduces the consumer’s exposure to harmful substances. He also quoted Public Health England’s finding that e-cigarettes are at least 95 percent less harmful than smoking.
According to the BVTE, e-cigarettes are the most frequently used smoking-cessation tool in Germany, ahead of less effective methods such as medical nicotine replacement products. The wide choice of flavored liquids, meanwhile, is a significant factor for adult smokers to switch to vaping, the organization wrote.
“Instead of fueling fears with false claims and misguided demands for bans, e-cigarettes should finally be promoted in Germany as an opportunity to minimize risks for smokers,” Muecke said.
January 31, 2023
Juul2 Wins UK Retailer’s Product of the Year Award

Taking Retail’s Product of the Year 2023 for the Vaping and Heated Tobacco Products category has been awarded to Juul Labs’ new Juul2 system following an independent nationwide survey of 8,000 adult consumers.
Juul2 was launched in April 2022 following a successful pilot launch on the brand’s website, according to Talking Retail. The rechargeable pod-based system was updated from previous versions with new technologies and features, which the brand said includes the capability to combat potentially harmful and compatible pods.
“We are extremely proud that our commitment to product quality and innovation has been recognized by the voters who awarded Juul2 this accolade,” said Efe Abebe-Heywood, senior director of communications and brand at Juul Labs UK. “Our new Juul2 system has marked a step change in vapor technology, providing adult smokers with a product that more closely resembles the consistency and experience of combustible cigarettes to support them on their switching journey.
“Smoking remains the leading cause of preventable death and disease in the UK, and we remain committed to our mission at Juul Labs to transition even more adult smokers from cigarettes, while combating underage use.”
The award also coincides with the launch of a new Juul2 Blackcurrant Tobacco variant – a classic tobacco flavor with ripe blackcurrant notes, which further extends the Juul2 portfolio in the UK.
The new Blackcurrant Tobacco Juul pods launched on the brand’s website in January and will be rolled out across all major retailers nationally from early February.
In the U.S., Juul2 is under review by the U.S. Food and Drug Administration.
January 27, 2023