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Appropriate for the Protection of Health?

Photo: 22nd Century Group

The FDA’s focus on nicotine is coming at the expense of true harm reduction.
Cheryl K. Olson
I was gobsmacked last December when the U.S. Food and Drug Administration issued modified-risk tobacco product (MRTP) authorizations for two reduced-nicotine combustible cigarettes, 22nd Century Group’s VLN King and VLN Menthol King. Both contain non-GMO tobacco that’s very low in nicotine (VLN). If 22nd Century Group can reduce the disastrous health effects of smoking by offering low-nicotine combustible cigarettes, that’s great. What took me aback was the implicit message from the FDA on its priorities.
VLN products such as these were supposed to be part of a smoking harm reduction landscape—one that includes approaches proven to reduce the risks of illness and death among cigarette smokers, such as vaping, heat-not-burn and smokeless tobacco. But this ideal, data-driven society in which addicted smokers bob gently down the famous continuum of risk via the path they prefer (perhaps starting with VLN cigarettes, perhaps with another product and ultimately landing at their low-risk nicotine maintenance or tobacco-free destiny) isn’t where we’re living.
Such a Candide-like world would feature a rainbow of reduced-risk products that match the needs of individual smokers and smokers and people who influence them (such as doctors) fully aware of these products and of how and why they’re lower risk. They’d also know that traditional approaches to quitting (hello, “cold turkey” and nicotine-replacement therapy) have proved depressingly ineffective, especially among heavily addicted, low-income, longtime smokers: the folks who need our help the most.
The FDA claimed to envision such an environment when Scott Gottlieb, then the agency’s commissioner, stated in 2017 that “Nicotine lives at the core of both the problem and, ultimately, the solution to the question of addiction and the harm caused by combustible forms of tobacco. … So, how can we take a new and comprehensive approach to nicotine?”
Gottlieb continued, “Armed with the recognition of the risk continuum, and the reality that all roads lead back to cigarettes as the primary cause of the current problem, we need to envision a world where cigarettes lose their addictive potential through reduced nicotine levels. And a world where less harmful alternative forms, efficiently delivering satisfying levels of nicotine, are available for those adults who need or want them.”
Instead, the FDA prioritized very low-nicotine cigarettes and dropped the ball on that last, essential part: the “less harmful alternative forms.” Those products, despite considerable and growing scientific evidence of their real-world effectiveness, have been left in limbo.

A Passing Grade on the Wrong Test
What exactly happened? An MRTP is simply a request to the FDA that a tobacco-related company be allowed to make some specified changes in how it describes a product or set of products to the general public through its packaging, marketing, advertising and other forms of promotion and communication.
In this case, 22nd Century Group wanted to state that each of its products contains “95 percent less nicotine,” “helps reduce your nicotine consumption” and “VLN smells, burns and tastes like a conventional cigarette but greatly reduces your nicotine consumption.” They provided the scientific evidence to back up those claims.
Among the hurdles for a successful MRTP authorization is that the manufacturer demonstrates that the product is “appropriate for the protection of the public health,” or APPH. In other words, that the requested modifications do or have the potential to do more good than harm if approved. That’s a core question that needs to be addressed in any tobacco-related application or authorization request to the FDA.
The Tobacco Control Act of 2009 begins with the words, “To protect the public health ….” That shows the clear focus and intent of the legislation. While the phrase “appropriate for the protection of the public health” appears several times in the act, it’s frustratingly vague and subject to interpretation.
What’s clear, however, is that the FDA should prioritize those aspects of smoking that are the most harmful to individual and public health. While reducing nicotine intake is appropriate for the protection of the public health, it should be nowhere near the top of the list.

It’s Not the Nicotine That Kills
Morbidity and mortality among smokers, including cancers and heart disease, are caused by the “tars” and other byproducts of combustion—what researchers often call harmful and potentially harmful constituents (HPHC). Because it’s addictive, nicotine is also considered an HPHC. As Michael Russell famously put it, “People smoke for the nicotine, but they die from the tar.”¹
In its February 2020 presentation on its products to an FDA Tobacco Products Scientific Advisory Committee panel, 22nd Century Group clearly states, “VLN cigarettes yield essentially the same HPHCs as conventional cigarettes. The benefits of VLN accrue from reduced cigarettes per day and reduced abuse liability.” That’s consistent with their authorization request since they’re only claiming a reduction in the amount of nicotine.
Think about that for a moment. The premise that reduced nicotine in combustible cigarettes will reduce harm is based on an assumption that the number of cigarettes smoked will decrease. That’s because the other HPHCs—the substances that lead to illness and death—are the same in the very low-nicotine and the regular cigarettes. Will they?

Compensatory Smoking
Maybe. Maybe not. It’s an empirical question that requires research with these specific products. Researchers studying smokers who switched to earlier generations of low tar and low nicotine cigarettes, known as low-yield cigarettes, found that many engaged in what’s known as compensatory smoking.
According to the Centers for Disease Control, “Most people who smoke are addicted to nicotine. They may compensate when smoking low-yield cigarettes in order to take in more nicotine.”⁵
A historical review of tobacco industry approaches to marketing low-yield cigarettes concluded, “Unfortunately for the industry, smokers did not care much for the taste of reduced tar cigarettes and, as expected, the lower nicotine levels became a problem as well. Smokers were not receiving the same nicotine ‘satisfaction’ and therefore began to compensate for the reduction in nicotine by smoking more cigarettes, thus increasing their health risk.”²
These earlier studies were conducted on combustible cigarettes with significantly higher levels of nicotine than the VLN products. Some well-respected smoking harm reduction experts such as Clive Bates theorize that the nicotine levels in this generation of cigarettes is so low that compensatory smoking will not be a problem. But how, then, is this different from the low success cold turkey approach? Also, what about dual use? There is nothing to prevent a smoker from using both types of products.

What’s the Real Harm?
But this distracts from the fundamental problem. The FDA’s focus is on the wrong chemical: nicotine. It’s often the first or only chemical most people can name when describing tobacco. That’s one of the reasons why the addictive quality of nicotine is so often conflated with combustible tobacco’s relationship with heart disease and cancer.
Several studies of physicians’ knowledge about the clinical effects of nicotine find misperceptions are frustratingly common. Roughly four out of five doctors surveyed incorrectly linked nicotine to cardiovascular disease (83.2 percent), chronic obstructive pulmonary disease (80.9 percent) and cancer (80.5 percent).⁹ They should know better.
This distortion of the role of nicotine among smokers, and some of the people who counsel them when they try to quit or at least reduce their medical risk, can interfere with their motivation to use some of the proven pathways away from combusted tobacco.
This focus on nicotine reduction and the misunderstanding of its risks may be precluding addicted smokers from switching to products that significantly reduce harm. According to Public Health England, “One assessment of the published data on emissions from cigarettes and e-cigarettes calculated the lifetime cancer risks. It concluded that the cancer potencies of e-cigarettes were largely under 0.5 percent of the risk of smoking. Comparative risks of cardiovascular disease and lung disease have not been quantified but are likely to be also substantially below the risks of smoking. Among e-cigarette users, two studies of biomarker data for acrolein, a potent respiratory irritant, found levels consistent with nonsmoking levels.”
My frustration is that the FDA, through its priorities and recent actions, is inadvertently reinforcing misinformation that interferes with the goal of protecting the public health by focusing on nicotine reduction at the expense of true harm reduction.
Last year, I interviewed former industry scientist Justine Shaw Jackson for another Tobacco Reporter column; she spoke of the need to give people nicotine “without all the nasties in the smoke.” That phrase stuck in my head, creating a mashup of her words and Russell’s insight: “It’s not the nicotine that kills—it’s the nasties in the smoke.” Let’s embroider that phrase on pillows and send one to every doctor and nurse in the world.

Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors. She spent 15 years on the faculty of Harvard Medical School.

February 1, 2022
State of Euphoria

Photos courtesy of Demecan and the German Cannabis Association

Germany’s new government plans to legalize cannabis.
By Stefanie Rossel
With Germany’s new government, a coalition of the center-left Social Democrats, the Green party and the liberal Free Democrats, taking office on Dec. 6, 2021, a long-awaited change moved closer to becoming reality. The country, the parties announced in their coalition agreement, will legalize the sale of cannabis to adults—that is, consumers from the age of 18—for recreational purposes. Although no details were mentioned and no timetable was set, the announcement sent cannabis stocks to new heights.
The Financial Times described the announcement as “game-changing precedent for the global business of growing and selling marijuana” that would be closely watched by other countries. With its proposal, Germany would join a movement of cannabis reform around the world. Canada, Uruguay as well as 19 U.S. states and the District of Columbia have already legalized recreational cannabis. In the European Union, Malta in mid-December became the first country to permit the use and growth of weed for recreational purposes. Sales, however, will remain prohibited.
After legalization, Germany will be the biggest EU cannabis market by far. For the time being, the recreational consumption of marijuana in the country is not explicitly illegal, but sales, imports and cultivation are prohibited. Germany legalized medicinal cannabis in 2017.
With further legalization, the government aims to dry out the illegal market, lower criminal justice expenditures and protect public health. According to the German Cannabis Association, illegal marijuana is often contaminated with sand, sugar, glass or spices. Increasingly, synthetic cannabinoids, up to 100 times stronger than natural psychoactive cannabinoids, are used to dilute the weed.
The proposal also includes preventive measures, such as the creation of facilities where consumers can check cannabis from the black market for harmful additives. Marijuana advertising will be strictly regulated. The coalition has agreed to keep the ban on private cannabis cultivation. Whether foreign nationals will be allowed to buy cannabis in Germany, too, remains unclear. According to the coalition agreement, the measure will be evaluated after four years, especially in terms of youth protection.

Georg Wurth

Details Unknown
What cannabis regulation in Germany will look like exactly remains unclear. The coalition is expected to introduce a cannabis tax; a recent study by Heinrich Heine University Duesseldorf estimates that such a tax could contribute €1.8 billion ($1.14 billion) annually to the state treasury. Legalization would bring in an estimated €4.7 billion per year due to additional revenues from corporate tax, trade tax and value-added tax as well as from savings in prosecution and the judicial system. It could also create 27,000 new jobs, the study found.
Apart from pharmacies, the licensed dispensaries mentioned in the coalition agreement reportedly might include tobacconist shops and perhaps even dedicated coffee shops as in the Netherlands, which tolerates recreational cannabis for personal consumption. The new government is expected to define thresholds for the content of tetrahydrocannabinol (THC), the psychoactive ingredient in cannabis, in the products to be sold. The government might also review Germany’s traffic laws, which currently allow 1 nanogram of THC per milliliter of blood serum.
The legalization proposal, long opposed by previous Christian Democrat party-led governments, has triggered a heated debate in Germany. Physicians specializing in addiction treatment warn that it would boost consumption and encourage related issues, such as dependence, depressive and anxiety disorders, psychoses and developmental delays in young people. Meanwhile, law enforcement officials are skeptical that legalization will erase the black market. A tax, they claim, would make legal cannabis significantly more expensive, thus leading to competition between legal and illegal sources.
Georg Wurth, managing director of the German Cannabis Association, does not share law enforcement’s concerns. “The black market will at least be pushed back,” he says. “Every single euro of revenue that will be generated on the legal market will be retracted from the illicit market, and every percent that moves from the black to the legal market is a progress. I’d rather have a legal and a black market than a 100 percent illegal market. If you take cigarettes as an example, there is also a black market, but there are no plans to prohibit cigarettes in order to rein that in.”
The right pricing will be decisive for deflating the illegal market, Wurth adds. “All three coalition partners are aware that they shouldn’t overplay their hand if they really want to force back the illegal market. I am confident that they will succeed if they find the right approach at pricing. In Canada, it took about two and a half years until half of the cannabis revenues came from the legal market.”
Illicit cannabis currently retails at €10 per gram in Germany. Interestingly, this is also the sales price for medicinal cannabis in pharmacies. “Cannabis already is relatively inexpensive in Germany,” says Adrian Fischer, co-founder and managing director of Demecan, which supplies medicinal cannabis. “We presume that consumers will be willing to pay a higher price for legal cannabis for recreational purposes that has a better quality than illegal weed, but the price shouldn’t be much higher than €10. In addition, it has to be guaranteed that there are a sufficient number of points of sale for marijuana. If a consumer must drive 50 kilometers to the next legal dispensary, he is more likely to stick with his dealer round the corner.” If legal cannabis is priced competitively, Fischer forecasts that the German marijuana market will be worth €5 billion in five years.
While the German Cannabis Organization opposes a limit on the THC content, Fischer suggests linking it to certain age limits, as with alcohol. In Germany, drinks with a low alcohol content, such as beer or wine, can be legally purchased from the age of 16 while liquor drinkers have to wait until they turn 18. “Similarly, cannabis with a lower THC content could be made available for 18-year-olds and with a higher THC content for 21-year-olds,” says Wurth.

Adrian Fischer

Important Considerations
The German Cannabis Organization believes the coalition should consider four aspects in shaping regulation. For starters, it should permit private cultivation for personal consumption. “In other countries that have legalized marijuana, such as Uruguay and some U.S. states, this is part of the law,” says Wurth.
Traffic laws are another issue. “Presently, limiting values and criminal proceedings are extremely strict. Cannabis users may lose their driver’s license even though they did not drive stoned, only because they have remainders of cannabis in their blood from consumption days ago that don’t have any effect on their driving behavior anymore,” says Wurth.
He also insists on an amnesty for the cannabis users who are currently listed as criminal offenders. “Their entries have to be deleted,” says Wurth. “In the U.S. states where marijuana is legal, this is regularly being done.”
Lastly, the sale of legal cannabis should remain restricted to specialist shops, according to the German Cannabis Organization. This would also guarantee better youth protection.
However, neither the legalization of cannabis for adults nor prohibition can prevent marijuana consumption among youths, cautions Wurth. “Legalization would nevertheless have a positive impact on youths, even though it cannot principally prevent youth consumption,” he says. “Youths are more susceptible to prevention measures, hence the latter should be stepped up significantly and reformed.
“Currently, police give preventive lessons in schools. They tend to get the message across that youths shouldn’t touch cannabis or else they would end up in the gutter, lose their driver’s licenses, etc. I hope that with the legalization there will also be more investment in better education and credible prevention measures so that youths seek drug counselling help earlier.”
If youths do consume cannabis, Wurth adds, it is safer if their older friends or siblings bring them legal weed from a licensed dispensary rather than potentially contaminated marijuana from a street dealer as is the case now.

Companies currently supplying medical cannabis say they will be able to scale up production rapidly when Germany legalizes recreational cannabis.

Gold Rush
The German illegal marijuana market is estimated at about 400 tons, most of which is imported from Morocco. Since Germany is a signatory to the 1961 United Nations Single Convention On Narcotic Drugs, the country will not be allowed to import or export cannabis for recreational purposes once the substance has been legalized. This means the coalition will either have to negotiate new conditions or stipulate that all cultivation has to take place in Germany.
Presently, only medicinal cannabis is grown in Germany. That business is controlled by three companies: Tilray, Aurora and Demecan. Under supervision of the state-owned cannabis agency, they jointly cultivate 2.6 tons of medicinal cannabis annually to cater to a market that is estimated at 12 tons to 15 tons per year, with demand increasing, according to Fischer. Due to the strict rules and standards, the companies grow the plants in hermetically sealed buildings, with product stored in high-security vaults. The first domestic crop reached pharmacies only last summer; a large amount of medicinal cannabis is still imported.
After legalization of recreational cannabis, manufacturers say they will be able to quickly expand production. Demecan has opened a center for medicinal cannabis in Ebersbach and recently finalized construction of Europe’s largest indoor marijuana production site. It presently has the capacity to produce 1 ton of medicinal cannabis but can supply 50 percent more at short notice, according to Fischer. “Within a year, we could step up capacity to 4 tons and in the mid-term to 10 tons per year. We are prepared to cater to growing demand. Our aim is to cultivate life quality and to ensure patient care, hence it is important to us that legalization of recreational cannabis doesn’t happen at the expense of patients. Therefore, we have built large production capacities to cater to both markets.”
The three providers of medicinal cannabis alone will nevertheless not be able to meet the demand for recreational cannabis, he admits. “To reach this target, legislature must tender licenses for the cultivation of marijuana in Germany relatively quickly and right on time before the actual legalization.”
With medicinal cannabis being a medicine, all aspects of production are subject to the narcotics act and must be compliant with good manufacturing practices and good agricultural and collection practices guidelines. A relaxation of production regulations for the cultivation of recreational weed, Fischer says, could contribute to less costly production.

Medicinal cannabis has been legal in Germany since 2017

Role Models
Wurth expects it to take another one or two years until the law takes effect—and even longer until the first licenses will be allocated, cultivation gets started and the first shops open. “The quickest part of such a law would be the decriminalization of consumers. The U.S. have shown that this can happen immediately.”
In shaping the law, he says, Germany has several role models it could draw upon. “The Netherlands are no example of a legalized market as the coffee shops are only tolerated, and supply is not regulated, so that criminal structures have emerged like everywhere else. But the coffee shops are a good example of allowing consumption on-site, which is not the case in most other countries that have legalized marijuana. As for points of sale, Germany should look to Canada and the U.S.—licensed specialist shops in a limited number; no access for youths; exact declaration of the products, their origins and their CBD and THC contents. Uruguay allows cultivation for personal use; people can even join grower communities to cultivate their weed or have it cultivated.”
In the end, the legalization of cannabis in Germany might go more smoothly, critics fear. In February 2021, the Cato Institute published a study on the legalization of marijuana by some U.S. states. It found that both proponents and opponents overstated their cases. Except for tax revenues, which exceeded some expectations, the report says state legalizations have mainly had minor effects.

Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.

February 1, 2022
Eye of the Tiger

Photo: byrdyak

Turning Point Brands is embracing next-generation tobacco and alternative products by taking calculated risks.
By Timothy S. Donahue
It’s hard to argue the success of Turning Point Brands (TPB). In business since 1988, during the past decade, the company has been turning the typical tobacco business model on its head. It is involved in almost all aspects of the industry, generating nearly $450 million in sales every year. From its iconic brands like Zig-Zag to its more recent investments in the growing legal cannabis industry, TPB is turning heads.
Headquartered in Louisville, Kentucky, USA, TPB’s business includes three operating segments. Its main line of revenue comes from its “smoking” segment, which includes the rights to the Zig-Zag brand in the U.S. and Canada, according to Scott R. Grossman, TPB’s vice president of corporate development. Zig-Zag is one of the oldest, most recognized “other tobacco products” (OTP) and cannabis accessory brands. “Founded over 150 years ago, Zig-Zag holds the No. 1 share of both rolling papers and wraps in North America, and its products can be found in more than 200,000 retail outlets,” says Grossman. “Given that Zig-Zag generates roughly 40 percent of TPB’s revenue and a majority of our operating income, the brand and its growth initiatives are a major focus for us.”
TPB’s second segment is “smokeless,” which is predominantly the Stoker’s brand, a leading player in the moist snuff tobacco and chewing tobacco markets. The company also owns the Beech-Nut brand and a diverse collection of other chewing tobacco products. Another compelling segment of the TPB operation is its new generation of products (NewGen), which covers the company’s electronic nicotine-delivery system (ENDS) and cannabis brands.
NewGen includes an assortment of brands serving multiple industry segments, such as TPB’s business-to-business (Vapor Beast) and business-to-consumer (International Vapor Group) distribution platforms and its new product engine, Nu-X Ventures. The company has online platforms under brand names such as VaporFi, South Beach Smoke and DirectVapor. TPB also owns the e-liquid brand Solace and within its NewGen segment includes recent minority investments in the emerging cannabinoid space, including brands such as Old Pal, Dosist, Docklight and Wild Hemp.
TPB was one of the first traditional tobacco companies to publicly announce its foray into the legal cannabis market. That decision came under the leadership of TPB’s former president and CEO, Larry Wexler, who retired from the company and was succeeded by Yavor Efremov on Jan. 11. “Larry took the company public in 2016 as an OTP business, and over the next five years, he successfully drove significant initiatives to drive value, including the investment in new talent to drive TPB forward,” says Grossman. “We’ve been strategically focused on introducing new products to serve both B2B and B2C customers across on-premise retail and online channels.”

Yavor Efremov

Bump in the Road
Being a business with major assets in ENDS comes with challenges. TPB was one of the first major companies to receive a marketing denial order (MDO) from the U.S. Food and Drug Administration after the agency’s Sept. 9, 2021, deadline to decide on premarket tobacco product applications (PMTAs). Convinced that the FDA’s decision was unjustified, TPB immediately filed a legal challenge. Before the lawsuit made its way through the courts, the FDA rescinded the MDO it issued to TPB. The term “Fatal Flaw” was used by the FDA for PMTA submissions that lacked certain studies. The term has been at the center of nearly all lawsuits filed against the FDA for its handling of the PMTA process.
“The Fatal Flaw standard is obviously one that departs from the pre-September 2020 guidance. In fact, it’s in direct conflict with that guidance. It’s helpful that [our MDO] was rescinded and that the agency admitted it had not reviewed certain [TPB] studies,” explains Paul Blair, TPB’s vice president of government affairs, adding that TPB made the decision to file suit because there was information that the regulatory agency overlooked in its review process. TPB wasn’t unique in that respect; however, the agency didn’t look at specific study data for several businesses.
“[The rescission] is an important recognition that our denial was not related to nitpicking over data. The science we submitted about transitioning combustible cigarette consumers to our products in particular … It was an oversight. And that’s helpful not only as we try to navigate the process moving forward but also because it doesn’t seem it was an attack on the body of our application generally,” explains Blair. “We maintain that we provided data that is sufficient for the agency to authorize the marketing of our PMTAs. It’s fair to say, though, there’s not a publicly announced standard for the approval process, whether it’s for open system products, closed system products, flavors and, honestly, even tobacco and traditional flavored products.”
That’s what Blair believes the FDA is doing now; the agency is probably reviewing its communications plan on how to reassess the PMTA process and come to some conclusions on deciding on a standard for authorizing products. Traditionally, the FDA would engage in good faith conversations with businesses trying to get products approved and offer some clarity on what information the agency needs. According to critics, the FDA’s Fatal Flaw analysis for ENDS products proved this isn’t the case anymore.

Paul Blair

Embracing Change
Unlike most traditional tobacco companies, TPB isn’t shy about its cannabis investments. The company’s management team and its board have embraced legalization, according to Grossman. Currently, 37 U.S. states have legalized medical cannabis and 18 have approved it for recreational use. During the past few years, the company has invested in several cannabis operations. In 2021, TPB completed an $8 million strategic investment in Old Pal Holding Co., a cannabis lifestyle brand, and an $8.7 million strategic investment in Docklight Brands, a consumer products company led by its anchor brands Marley Natural and Marley CBD. In 2020, TPB entered into a long-term distribution and profit-sharing arrangement with Wild Hempettes, the Texas-based manufacturer of Wild Hemp Hempettes brand smokable CBD, and made a $15 million strategic investment in the global cannabinoid company Dosist.
Grossman says that while every investment needs to be able to stand on its own, TPB’s strategy is focused on finding highly synergistic companies that strengthen the current TPB platform. Old Pal is a good example of how its strategy is being deployed—Old Pal sells roll-your-own (RYO) cannabis products with rolling papers inside the packaging. “Zig-Zag has historically been mainly focused on the convenience store channel, so this investment enables TPB to further accelerate growth in under-indexed stores such as dispensaries and head shops while supporting the growth of Old Pal,” says Grossman.
In August, TPB made its first move into the international market by increasing its stake in ReCreation Marketing, a Canadian distribution company with ties to Canada’s recreational cannabis culture. In December, ReCreation Marketing rebranded as Turning Point Brands Canada. “TPB Canada has a number of proprietary branded products in its portfolio, and we are exploring strategies to leverage that proven model and its portfolio to increase distribution within the U.S.,” says Grossman. “We are one of a select group of established companies—especially public companies—that are actively looking to deploy capital in the cannabinoid space. Historically, we’ve been predominately focused on brands given our expertise, but we’re exploring many verticals within the cannabinoid sector. Our pipeline is very healthy, but at the same time, we have to remain highly disciplined with how we spend our time and capital.”
It’s not just vaping and cannabis products in TPB’s future. In July, the company acquired certain cigar assets of Unitabac. The acquisition was for a portfolio of cigarillo products and all related intellectual property, including cigarillo non-tip, homogenized tobacco leaf, rolled leaf and natural leaf cigarillo products. “The cigar business is a $2.5 billion wholesale business in the United States. We’ve historically participated in that market, but we didn’t have the scale necessary to be really competitive. The Unitabac acquisition allows us to further extend into the cigar market,” says Grossman. “You’ll see a number of initiatives with that asset rolling out natural leaf products and other cigar assets, both under the Unitabac portfolio of brands as well as extending it to Zig-Zag.”

Scott Grossman

Facing Uncertainty
The FDA will soon have a new leader (Biden’s appointee, Robert Califf, had yet to be confirmed at press time). The FDA’s Center for Tobacco Products (CTP) will also have a new leader; its current director, Mitch Zeller, plans to retire in April. Blair says that the individuals in those positions will have a significant role to play in determining how the agency and CTP will work with stakeholders and communicate policies about how those regulations will go into effect. The FDA, he says, doesn’t have any previous experience regulating vaping products, so there is going to be a lot of action, reaction and learning along the way.
“It’s not as if Congress explicitly wrote how the approval or denial process might look. In fact, they didn’t write the details,” says Blair. “At least [the FDA is] thinking about the process, and they’re thinking about the consequences. But there is this opportunity beyond vapor product PMTAs in 2022 for a future generation of products to have some certainty because at the end of this, whether it’s because of litigation, because it’s further issued guidance, because it’s approvals or denials, there will be a pathway for companies and a better understanding of how the process works.”
Blair says that overcoming the challenges of getting a PMTA approved will be stepping stones toward determining how the company approaches the future regulation of other products, such as cannabis. He says there is a real opportunity for TPB to play a critical role in the future of cannabis regulation and policy. “I think our action is going to be guided by our business’ experience as a regulated tobacco business. There are other tobacco businesses that have cannabis interests or investments, but there aren’t many that are willing to publicly engage in the way that ours is as an advocate for legalization, as an advocate for appropriate regulations. There needs to be a balance of consumer protection with entrepreneurship and opportunities in the investment space.”
Grossman says the future of TPB is to align itself with the growth of the cannabinoid industry and possibly make more direct cannabis investments outside its current portfolio. “We are concentrated on trying to learn and execute on a variety of cannabinoid initiatives,” he says. “Although we’ve historically focused on brands, we are deeply embedded in the sector and are actively studying many verticals across value-added products and services, brands and distribution. We believe the U.S. cannabis market will exceed $50 billion over the next five to 10 years, which we clearly think will benefit TPB over the long term.”

Timothy Donahue is the assistant editor of Tobacco Reporter. Since joining our team in January 2013, he has become not only an expert on the traditional tobacco business but also a well-respected voice in the rapidly developing vapor industry. Tim spends much of his time on the road, attending conferences and interviewing industry representatives. His networking skills, work ethic and quick mind are valuable assets to our diverse audience.

February 1, 2022
The Ties That Bind

Photos: HB Fuller and Baumer hhs

Despite challenging times, optimism prevails among manufacturers of adhesives and adhesive application equipment.
By Stefanie Rossel
Tobacco industry suppliers have gotten used to annual statistics revealing declining cigarette consumption. News about additional restrictions is unlikely to shock them. Covid-19, however, took challenges to a new level, including for suppliers to tobacco adhesives.
“A prolonged period of high demand and tight supply is resulting in the highest inflation of raw material costs this industry has seen in living memory,” says Selda Akbasli, global business manager for rolled paper and tips at H.B. Fuller in the U.S. “Most forecasts indicate that costs will continue to increase through at least the end of the second quarter of 2022.”
Selda Akbasli
Logistics also remain an issue, with global demand for containers remaining high and rates likely to further increase in 2022. “The logistics industry continues to be disrupted by Covid-19 and capacity shortages. Container availability and air capacity remain tight; waiting times for vessels outside of ports remain lengthy, and warehousing capacity continues to be a bottleneck,” says Akbasli. “Congestion at both ocean and rail terminals and container freight stations, namely in the U.S., persists. In Greater China, power outages and blackouts are impacting manufacturing outputs; however, demand for shipping container space is still high in the region. Our goal is to keep our customers informed as we monitor this dynamic and essential situation for our business.”
According to Akbasli, 2021 was a year like no other for manufacturers, with the supply chain crisis delaying goods and creating raw material shortages. “What it really highlighted is the importance of a robust and secure supply chain,” she says. “At H.B. Fuller, we are proud of how our teams in sourcing, manufacturing and logistics worked together with our global and regional supplier partners to ensure minimal disruption for our customers. Our range of adhesives with global formulations really proved their worth in providing manufacturing and sourcing flexibility.”
For 2022, the company will focus on people’s safety, sustainable product innovation and security of supply. To this end, H.B. Fuller is working with responsible global vendors who have strong partnerships within their supply chains networks, according to Akbasli.

Baumer has increased the performance of its products and solutions to ensure maximum reliability.

Fit for the Future
Judging from market forecasts, Akbasli is confident that the value of the global tobacco business will continue to increase in the next years. “This industry is constantly evolving, and our customers are always open for opportunities to improve their product performance and overall manufacturing efficiencies,” she says. “We believe the changes we made over the past years, including our organization realignment and our approach to doing business differently during the pandemic, will serve as a competitive advantage in the years ahead.”
Tobacco remains an important segment for H.B. Fuller. The company, which had a fiscal net revenue of $2.8 billion in 2020, develops adhesive products for many markets across the world, from packaging to solar panel assembly, electronics to automotive, disposable hygiene to woodworking.
Floriano Erario
Floriano Erario is business development manager of tobacco packaging at Baumer hhs, a manufacturer of glue application and quality control systems. The company is headquartered in Germany and present in more than 90 countries through an international network. Erario is equally optimistic. “Although the decline in cigarette users worldwide is a fairly consolidated fact, our activity of designing and manufacturing glue systems for various types of projects is in continuous development, and we continue to assist our customers day after day constantly,” he says.
Baumer remains focused on innovation for the tobacco sector. By creating a tobacco competence center, which was opened in October 2018, Baumer brought its expertise for the cigarette market to Milan, Italy. “The Italian team, assisted by the headquarters in Germany, has a very broad portfolio of solutions for the traditional—or commonly called high-risk—cigarette business,” he says. “These solutions are by now consolidated and range from systems for filter makers, combiners or tubes. We are strongly active in the packer machine to finish with the production of cases for cigarette packets and the end-of-line case packer. We also design and customize dedicated systems and dedicated solutions for our customers every day.”
H.B. Fuller’s focus, meanwhile, is to create a global portfolio of innovative adhesives and systems that significantly reduce costs, improve efficiency and make products more sustainable. Recently, the company introduced Swifttherm 6200, a hot melt for all filter types. According to H.B. Fuller, Swifttherm 6200 delivers a superior bond strength, both during production and storage, increasing productivity while reducing the share of rejects. With a long “open time” and short setting time, it can be used for conventional and new-generation products, reducing complexity. According to H.B. Fuller, customers can reduce the number of filter hot melts to just one adhesive.
The company has also launched a solution for bonding untreated filmic carton board, such as Transmet, laminated and metallized boards. Ipacoll 2948 is a water-based adhesive.
With the Ipacoll 2600 series, the company has developed a range of high-performance tipping adhesives that allow customers to simplify their adhesive needs across their entire manufacturing network, Akbasli says.

Catering to a Highly Regulated Market
Regulatory compliance remains among the most important requirements. “The tobacco industry is one of the more highly regulated markets in which H.B. Fuller operates,” says Akbasli. “We have specialized industry expertise and know-how to keep products compliant with manufacturing requisites and regulation that, as you can imagine, are completely different in each market and each region,” she says.
“To navigate the complex world of regulatory matters, we have dedicated regional regulatory teams within our regulatory global function that work directly with industry associations, governmental agencies and our own technical and sales units to make sure we are engineering the right products for today and the future. The specific adhesive performance requirements can vary from customer to customer, but in general they require a consistent adhesive performance that enables their production to run seamlessly without any adhesive-related downtime. That consistent performance includes clean application through the adhesive equipment and profile-optimized adhesive setting for the range of machine speeds and substrates, secure adhesion both during production and in the hands of the consumer.”
Sustainability has become another driver in the tobacco industry. “We have seen a rise in demand for greener products as regulations around the handling of chemicals have become tighter, especially in Europe,” she says. “Around the world, natural-based articles are in high demand, and it’s a trend set to continue apace. The global tobacco market changed dramatically over the last ten years, and we expect this pace of change to continue. Adhesives are a key enabler for our customers to produce more sustainable products, whether they are natural/bio-based, compostable or recyclable.”
H.B. Fuller has multiple projects involving top scientists designing and engineering technologies that contribute to the circular economy and help customers meet their own sustainability goals. Projects range from formulating adhesives using bio-sourced raw materials to developing new, natural and responsible sourced adhesive raw materials. “We already have an advanced solution that enables our tobacco customers to significantly reduce the carbon footprint of their production facilities,” says Akbasli. “It requires them to work in a slightly different way, but the customers partnering with H.B. Fuller are excited to see what they can achieve in 2022 and beyond.”

H.B. Fuller aims to create a global portfolio of adhesives and systems that reduce costs, improve efficiency and make products more sustainable.

Dedicated Solutions for NGPs
Next-generation products (NGPs), too, are high on the agenda of adhesives and adhesive application manufacturers. “Baumer hhs has been active in the New Generation Project (low-risk cigarette) market since its inception,” explains Erario. The company has also been exploring opportunities beyond tobacco. “We also have ready-made solutions for the new—even if it’s not really ‘new’—cannabis market or even pre-roll hemp. Our knowledge in terms of contact and noncontact glue application, the knowledge of world players will help our consolidated customers and new ones in this new business.”
For the new generations of cigarettes and the packages that contain them, Baumer is drawing on its know-how of the traditional cigarette market. “We have developed dedicated solutions and at the same time increased the performance of our products and solutions to ensure maximum reliability for our customers’ machines,” says Erario. “Today, this is recognized by having systems on the market that guarantee flexibility, sturdiness and ease of use, our customers say.”
H.B. Fuller says it has a market-proven range to produce consumables for all NGPs, regardless of brand. The key differences in the production of heat sticks for heated-tobacco devices involve the design of the stick, the filter, the materials used to manufacture the stick and the mode of operation, explains Akbasli.
“The filters are designed differently using new materials, and they have a more complex construction,” she says. “With this comes new and additional issues related to adhesive performance requirements. Higher grammage papers used are stiffer in nature, the nonwrap acetate filter material is harder to bond and the smaller length used presents process challenges. All this combined requires the use of an adhesive with higher wet tack and a stronger setting bond.
“Overall, the heat stick and filter consist of more parts versus a conventional cigarette. Many of these parts have a reduced level of elasticity when compared to conventional cigarettes, and this means they are harder to form into the desired shape for the stick during production. This has been a challenge for suppliers and NGP producers to overcome through extensive collaboration that required the design of new machines, materials and adhesives. And lastly, the mode of operation for these products is different. They are only heated and not burned, posing different challenges for the adhesive to remain functional whilst the cigarette stick is being used.”

Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.

February 1, 2022
Budding Business

Photo: Canadian Greenfield Technologies

The market for processing equipment is flourishing as more authorities legalize cannabis.
By Stefanie Rossel
If you think tobacco is a complex plant to handle, try processing cannabis. The plant consists of more than 100 cannabinoids, with each of them having a different effect on the body. In addition, it contains terpenes, naturally occurring chemical compounds that make certain strains taste or smell different than others.
The herb comes in two different varieties of the Cannabis sativa species: hemp and marijuana. Hemp is usually grown outdoors or in a greenhouse whereas marijuana is cultivated indoors or in a greenhouse.
The major difference between the two, however, is tetrahydrocannabinol (THC), a psychoactive constituent that produces the “high” people feel when they smoke marijuana or eat foods containing it. Hemp contains less than 0.3 percent THC whereas marijuana can have between 5 percent and 30 percent of the compound.
By contrast, the concentration of the nonpsychoactive component, cannabidiol (CBD), which is thought to have various therapeutic benefits, is high in hemp and low in marijuana. The latter species is grown for the highest concentrations of THC and CBD possible, with derivatives ranging from leafy material to THC and CBD extract and products such as candy or drinks. Hemp, on the other hand, is cultivated for CBD and other cannabinoids. It is the basis for CBD extracts, health foods and cosmetics. The stalks of hemp are used to create building materials, plastics, industrial oils, paper and textiles, among other products.
The global cannabis market was valued at $28.266 billion in 2021. With legalization gaining momentum, analysts predict unprecedented growth. Fortune Business Insights expects the global cannabis market to increase to $197.74 billion in 2028, reflecting a compound annual growth rate (CAGR) of 32.04 percent. In the U.S., the world’s leading market, where recreational cannabis is legal in nineteen states and the District of Columbia, the cannabis market was worth $13.5 billion in 2021, according to Grand View Research. Valued at $2.8 billion in 2020, the CBD segment is expected to expand to $13.4 billion in 2028, which corresponds to a CAGR of 21.2 percent. Grand View Research expects sales of hemp-derived CBD to grow even faster, at a CAGR of 23.4 percent post-pandemic due to increasing demand from the pharmaceutical sector and rising health awareness among consumers.

Separating the Green Fraction
Since recreational cannabis was legalized in Colorado a decade ago, a whole sector of dedicated, specialized processing equipment suppliers has emerged throughout the U.S. and Canada. Getting the desired compounds out of a marijuana or hemp plant is a complex, multi-step separation process.
In the case of hemp, it starts with the decortication of the tough woody interior or “hurd” material from the softer, fibrous exterior of the stalk. Depending on the size of their crop, farmers can outsource this procedure to third-party processors or do it themselves with specialized machinery. They can choose from equipment of various sizes, ranging from small mobile machines to industry-scale decorticators, such as the HempTrain, an advanced processing system developed by Canadian Greenfield Technologies Corp of Calgary. Conventional decorticator systems, which are based on a hammermill process, cause damage to the bast fiber and attrition to the hurd and are unable to separate the clean green fraction rich with CBD. The Hemp Train, by contrast, employs high-speed kinematic action, according to its manufacturer.
“The HempTrain is indeed a mini factory,” explains Stephen Christensen, vice president of Canadian Greenfield Technologies Corp. “HempTrains use our patented advanced processing technologies in two different modes: a) to separate dry feedstock into long, structural bast fiber, clean, size-specific hurd, and a nutrient-rich microfiber, and b) to separate fresh/green feedstock into a high-CBD fraction containing bud leaves and a lower CBD fraction containing all other material. Bearing this in mind, the typical target groups would be general hemp processors, or product specific producers—including CBD from industrial hemp or other hemp streams. This is not available from any other technologies.”
The company, which sells its equipment in the U.S. and Canada, is in the process of licensing its technology to an African company to manufacture and distribute its decortication technology and equipment in eight African countries, the U.K. and the Caribbean. Christensen says that currently the U.S., Eastern Europe, Southern Africa and Australia account for the most international interest as these countries have been the most successful in educating their people and governments about the benefits of whole-plant utilization.

Multi-Step Procedure
In the next step, the biomass undergoes an extraction process, during which it is placed inside an extraction vessel with a solvent to remove soluble components.
“There are three primary methods of extracting hemp and cannabis: CO2, ethanol and light hydrocarbons, propane and butane,” explains Fritz Chess, founder Eden Labs, a supplier of cannabis extraction equipment based in Seattle. “All of these methods have their pros and cons. CO2 has the advantage of being a nonflammable, solventless method that also has great marketing cachet. Once the equipment is paid for, it is also the lowest cost method, which means in the long run, CO2 will likely rule the industry. Initial costs for CO2 are much higher than the other two methods—up to 10 times as much.”
Ethanol has the lowest cost of entry, he adds, but involves a multi-step process using large volumes of a flammable liquid.
In many ways, hydrocarbons are the most efficient method, Chess says. “It’s a very fast extraction and requires less post-processing than other methods. Equipment costs are less than the other two methods. The problem is the extreme flammability of these gases adds an enormous burden of safety requirements and regulations, which can negate the cost advantage of the equipment purchase.”
With all three methods, the desired constituents cannabinoids and terpenes, which have value for medicinal and recreational use, can be extracted simultaneously. “Flowers and leaves are the part of the plant that is extracted, with flowers being the most desirable,” Chess points out.
His company has been on the market longer than most other players in the field. It was established in 1994 as a manufacturer of plant botanical extraction but began to include cannabis extraction early on. Meanwhile, the latter generates the majority of his company’s turnover, Chess says. “When proposition 215 passed in California [permitting cannabis] for medical use, cannabis became about 20 percent of Eden Labs’ business. When recreational [use] passed in Washington and Denver, it went to about 80 percent, and the company doubled sales for three consecutive years.”
Eden Labs supplies extraction equipment using CO2 and ethanol but occasionally builds custom hydrocarbon extractors, says Chess. A recent solution by the company combines the advantages of the two solvents CO2 and hydrocarbon, catering to both marijuana and hemp companies. The machines are making use of the higher output achieved by hydrocarbon extraction while at the same time reducing the danger of flammability by diluting the hydrocarbon with CO2. “We have a method combining CO2 and a small percentage of propane, which has the advantages of making a very high-quality extract quickly in a process that is nonflammable. We are currently marketing this design to select customers.”

Refining Exercise
After extraction, the liquid obtained from extraction, which contains cannabinoids, THC and/or CBD, waxes, fats, lipids and terpenes, must be winterized. During this procedure, proof alcohol is added to the oil to thin it and causes the fats, waxes and lipids to coagulate. The consecutive filtration separates them from the oil.
After that, the liquid undergoes solvent recovery, during which the majority of solvent in the crude cannabis extract is removed and the cannabinoids are separated from the solvent. High-speed evaporators help accelerate the process.
The liquid is then filled into a reactor, chiller, condenser or vacuum pump for decarboxylation, a chemical process that converts THCA and CBDA, the biosynthetic precursors of THC and CBD, into THC and CBD via heating and drying. This procedure can take up to ten hours.
Finally, distillation will further refine the cannabis extract. Through vacuum-assisted evaporation, the cannabinoids are separated from impurities, such as terpenes and plant material. The extract is heated and each of the undesired components separated due to their different boiling points.
As ever more countries legalize cannabis for medicinal and recreational use, Chess has a clear vision of how the market will develop. “As cannabis legalizes globally and an import/export market forms, we expect the same market forces to come into play that used to rule the black market. Tropical regions will once again dominate the market because of the longer growing season and superior product that comes from that part of the world. The expensive indoor grows that currently dominate the market will be priced out of existence.”

Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.

February 1, 2022
Halo Exempted From Vape Mail Ban

Photo: will milne

The U.S. Postal Service (USPS) has granted Pure Labs permission to ship its Halo brand of vaping products to compliant businesses through the brand’s Master Distributors, Syndicate Global Distribution and Halo Wholesale Direct.
The approval constitutes a regulatory exception to the mailing restrictions described in the Prevent All Cigarette Trafficking (PACT) Act.
The original PACT Act was amended by Congress on Dec. 27, 2020, to incorporate e-cigarettes and vaping products.
“This is a huge win for Halo and for all of our retail partners,” said Kevin Dietz, director of Halo brand sales, in a statement. “Halo’s tobacco and menthol vape products are in demand by adult consumers throughout the country, and we are excited to have USPS solidify the supply chain. Halo has been here from the start and has numerous ENDS products in the final stage required for FDA authorization, furthering Halo’s commitment to remain America’s No. 1 tobacco-flavored e-liquid brand.”
In December, Turning Point Brands received a USPS exemption to ship vapor products to age-restricted vape shops across the United States through VaporBeast and other websites.

January 31, 2022
Publishing Ban for Industry-Owned Firms

Photo: PixieMe

A group of international respiratory societies has banned researchers associated with tobacco companies from publishing papers in their journals following Philip Morris International’s acquisition of the U.K.-based pharmaceutical firm Vectura, reports Nature. The measure comes on top of the groups’ decade-long publishing ban on researchers directly funded by tobacco companies.
In a joint statement, the groups describe PMI’s purchase of Vectura as “highly unethical and inappropriate.”
Scientists at Vectura produce drugs that treat asthma and chronic obstructive pulmonary disease, including some smoking-related respiratory illnesses. “That is the ultimate conflict of interest,” said Gregory Downey, a pulmonologist at the University of Colorado Denver and president-elect of the American Thoracic Society, which co-signed the statement.
“The issue is that ‘Big Tobacco’ could use, and will use, this technology not only to potentially enhance delivery of tobacco-containing substances and nicotine devices but to addict more people.”
Moira Gilchrist, vice president of strategic and scientific communications at PMI in Lausanne, Switzerland, says the idea that the company would use Vectura’s technology in this way is “false and without basis.”
“We openly welcome and encourage legitimate critique and debate about our business transformation, but when this morphs into actively ostracizing scientists and attempting to prevent the prescribing of proven medicines for patients, we should pause and think of the implications,” Gilchrist adds.
Signatories of the statement include The European Respiratory Society, International Union Against Tuberculosis and Lung Diseases, Asian Pacific Society of Respirology, Asociacion Latino Americana De Torax, and the Global Initiative for Asthma.

January 31, 2022
Korea: E-Cigs Gain as Combustibles Stagnate

Photo: Dzmitry

Sales of cigarettes in South Korea were flat from 2020 to 2021 but demand for electronic cigarettes rose amid the protracted pandemic, reports the Yonhap News Agency, citing data from the finance ministry.
South Korean smokers purchased 3.59 billion 20-cigarette packs in 2021, similar to the number logged the previous year, according to the Ministry of Economy and Finance.
Sales of traditional cigarettes fell 2 percent on-year to 3.15 billion packs last year while those of heat-not-burn tobacco products rose 17.1 percent to 440 million packs.
Compared with 2014, however, cigarette sales declined 17.7 percent last year—a development the government attributed to rising prices and anti-smoking campaigns.
In January 2015, South Korea increased cigarette prices by 80 percent to KRW4,500 ($3.72). The next year, the government required tobacco companies to print graphic images depicting the harmful effects of smoking on the upper part of cigarette packs.
As of 2020, the smoking rate among Korean men aged 19 or older dropped to a record low of 34 percent, down 1.7 percentage points from a year earlier, according to the health ministry.

January 31, 2022
FDA Menthol Cigs and Flavored Cigars Plans on Track

Photo: Yulia Usikava

The U.S. Food and Drug Administration is on track to propose rules prohibiting menthol as a characterizing flavor in cigarettes and prohibiting all characterizing flavors (including menthol) in cigars by spring.
The FDA’s actions “are an important opportunity to achieve significant, meaningful public health gains and advance health equity,” said FDA Center for Tobacco Products Director Mitch Zeller in a statement. “For far too long, specific populations have been targeted and disproportionately impacted by tobacco use, especially when it comes to characterizing flavors that entice them to start and keep smoking.”
In April 2021, the FDA announced its commitment to advancing these two tobacco product standards. Then in November, attorneys for the FDA appeared in court as anti-tobacco groups accused the agency of failing to implement a ban on menthol cigarettes.
The National Association of Convenience Stores (NACS) cautioned that banning menthol in cigarettes and all characterizing flavors in cigars would boost black market sales.
“Menthol makes up more than 37 percent of the tobacco market,” Lyle Beckwith, NACS senior vice president of government relations, said in an article published on the association’s website. “That demand will not go away due to a ban. NACS is on record opposing menthol bans as we believe illicit vendors will quickly source and begin selling foreign and counterfeit menthol cigarettes. Illicit vendors do not verify age, do not collect and remit taxes, and they sell other illegal products beyond just menthol cigarettes.”
In the convenience retailing channel, cigarettes contributed 27.79 percent of in-store sales in 2020, according to the NACS State of the Industry Report of 2020 Data. Other tobacco products, a category which includes cigars, accounted for 6.9 percent of in-store sales in 2020.
After reviewing and considering comments to its proposed rules, the FDA could then proceed to issue final product standards, which would become enforceable once in effect.

January 31, 2022
Philippine Vaping Bill Heads to President’s Desk

Photo: Oleksii

The Philippine House of Representatives and Senate have ratified a vaping bill that critics describe as too industry-friendly. The legislation will now be forwarded to President Rodrigo Duterte for his signature.
Among other provisions, the bill transfers regulatory powers from the Food and Drug Administration to the Department of Trade and Industry (DTI) and lowers the legal purchase and consumption age for vapor products from 21 to 18. The DTI is also in charge of setting technical standards for the safety, consistency and quality of these smoking alternatives.
Philippine College of Physicians (COP) President Maricar Blanco-Limpin said he was particularly concerned about the lower vaping age. “We have been telling all the legislators that making these more available at a younger age is making these e-cigarettes and heated-tobacco products more available to all, including the nonsmokers,” she told CNN Philippines.
Blanco-Limpin said vape products could lead to health concerns and the “mandate to protect the health of the country falls under the FDA, not the DTI.”
If the president signs the measure, Blanco-Limpin said the COP would consider all actions, including bringing the issue to the Supreme Court.

January 31, 2022