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UTC to Manufacture PM Products for Egypt

Photo: akolosov.art

Philip Morris is set to start manufacturing its products for the Egyptian market at its United Tobacco Co. (UTC) subsidiary, reports Daily News Egypt.
The current licensee, Eastern Co., will continue to manufacture Philip Morris’ cigarette products until its production stock has been depleted.
Philip Morris stated that it is proud of the strategic partnership with the state tobacco company, which lasted for nearly half a century, and is looking forward to sustaining this partnership through Eastern’s shareholding in UTC. In May, Egypt’s General Assembly approved Eastern Co.’s plan to buy a 25 percent share in UTC for EGP100 million ($5.2 million), according to the Enterprise Press.
Eastern Co. Managing Director Hani Aman said at the time that his firm would be represented by two members on UTC’s board of directors.
The acquisition was part of the Philip Morris subsidiary’s agreement with Eastern Co. to locally manufacture cigarettes. UTC was the only company to bid in last year’s tender after other companies complained that the conditions of the tender would establish a monopoly over the local market.
Philip Morris confirmed its full commitment to all existing contractual relationships with traders and suppliers to guarantee the availability of its products across Egypt’s governorates. The company said it will continue to provide all of its products at the same prices as recently officially set with no change to the packaging.
Aman said that the Eastern Co. is trying to absorb the rise in production costs internally, resulting from the recent rise in the cost of raw materials.
He pointed out that the disruption of supply chains had a direct impact on the rise of some production inputs, in addition to the impact of the rise in the price of the U.S. dollar on other products.
Eastern Co.’s tobacco business reported revenues of EGP12.78 billion for the first nine months of fiscal year 2021-2022, up 5 percent over those of the comparable period in the previous year.

September 1, 2022
FTC Reports Surge in Flavored Disposables

Photo: Paul Brady

Sales of flavored disposable e-cigarettes and menthol e-cigarette cartridges surged dramatically in 2020, according to the U.S. Federal Trade Commission’s (FTC) second report on e-cigarette sales and advertising nationwide.
This increase coincides with a federal ban on the flavored cartridges popular with young vapers, suggesting that youth e-cigarette use shifted to substitute products rather than declined.
The FTC has been reporting on tobacco sales annually since 1967 and smokeless tobacco sales since 1987. Last year, the agency expanded its studies of industry and published its first-ever report on e-cigarettes.
This year’s e-cigarette report covers sales and advertising data from 2019 and 2020, a period in which the Food and Drug Administration published an enforcement policy banning the sale of flavored e-cigarette cartridges other than menthol.
Overall, the report found that total e-cigarette sales, which had increased from $304.2 million in 2015 to $2.05 billion in 2018, grew to $2.7 billion in 2019 but then declined to $2.24 billion in 2020.
The sale of disposable e-cigarettes—which are exempt from the FDA’s 2020 policy—increased substantially, with “other” flavored disposable products making up 77.6 percent of all disposables sold in December 2020. The FTC’s data did not show an increase in disposable sales. The FTC report notes that the 2020 decline may not represent the market given major industry shifts.
Similarly, the report found that the sale of the remaining non-FDA-banned flavored cartridge, menthol, increased significantly, to 63.5 percent of all cartridges sold in 2020.
The report also noted record-high e-cigarette discounting and a doubling of nearly free e-cigarette samples.
“This report shows that youth are still at risk from flavored or deeply discounted e-cigarettes,” said Samuel Levine, director of the FTC’s Bureau of Consumer Protection, in a statement.
“Marketers of e-cigarettes have proven skillful at evading FDA regulation and hooking youth on addictive products,”

September 1, 2022
SindiTabaco’s President Recognized

Photo: SindiTabaco

The Brazilian media conglomerate Grupo RBS has recognized Iro Schunke, president of the Interstate Tobacco Industry Union (SindiTabaco), for his contributions to the development of Rio Grande do Sul, one of Brazil’s leading tobacco producing states.
During an Aug. 30 ceremony in the municipality of Esteio, Schunke accepted the Guri trophy, which honors the accomplishment of citizens in areas such as agribusiness, music and technology.
A graduate from the Federal University of Santa Maria, Schunke has worked as an agronomist, manager, director and production superintendent. In addition to leading SindiTabaco, he is the director of the Federation of Industries of Rio Grande do Sul. In 2015, he also became director-president of the Instituto Crescer Legal, an entity that promotes professional education for rural young people.
“I thank Grupo RBS for this honor,” said Schunke in an article published on SindiTabaco’s website. “Rest assured that I will continue to work on behalf of the state, the tobacco sector and the Crescer Legal Institute.”

September 1, 2022
Belgium: One in Five Cigarettes Untaxed

Photo: paolo

More than one in five cigarettes smoked in Belgium are untaxed, reports The Brussels Times, citing new research carried out by Cimabel, the Belgium-Luxembourg federation of cigarette manufacturers.
A study of discarded packets and cigarette butts collected between April 18 and May 9 found that 21.8 percent of cigarettes consumed had escaped Belgian tax authorities, accounting for around €700 million ($699.69) in lost tax revenue.
Of the untaxed cigarettes, 1.9 percent were counterfeit. The remaining 19.9 percent were legally brought into Belgium from countries with a lower tax burden. Of the cigarettes purchased outside of Belgium, more than half (51.8 percent) came from Bulgaria. Other countries of origin included Poland (7.8 percent of supply), Turkey (6.88 percent) and Romania (3.67 percent).
During Cimabel’s previous semi-annual survey, which took place in October 2021, the share of untaxed cigarettes was 13.8 percent. The organization attributes the increase in tax-evading tobacco products to drastic tax hikes introduced on April 1, 2022, which have encouraged smokers to find cheaper ways of purchasing cigarettes.
Cimabel urged the Belgian government to refrain from further tobacco tax hikes.
“As long as the federal government continues to drastically increase excise duties on tobacco products each year, the demand for cheap cigarettes will continue to grow, and criminal organizations will continue their illegal practices on Belgian territory,” the federation warned.

September 1, 2022
On a Mission

Photos: EUBAM

The EUBAM supports Moldova and Ukraine in their fight against illicit cigarette trade.
By Stefanie Rossel
In June, Ukraine and Moldova became candidates for accession to the European Union. Driven primarily by the huge difference in price between a pack of cigarettes in these countries on the one hand and the EU member states immediately to their west on the other, both Moldova and Ukraine are among the leading origin and transit countries for illicit cigarettes trafficked into the EU market. According to the European Commission, EU member states miss an estimated €10 billion ($10.57 billion) in tax revenues every year due to the smuggling of both genuine and counterfeit cigarettes. This is equivalent to approximately 10 percent of the community budget.
To harmonize border control, customs and trade standards of the two countries with those of the EU member states, the European Union Border Assistance Mission to Moldova and Ukraine (EUBAM) was set up in 2005. Its aims are to ensure full implementation of integrated border management practices at the Moldova-Ukraine border, assist Moldovan and Ukrainian authorities to combat cross-border crime and contribute to the peaceful settlement of the Transnistrian conflict by supporting the development of Transnistria-related confidence-building measures and approximation of legislation and procedures in customs, trade, transport and trans-boundary management. Transnistria is a breakaway state that is internationally recognized as part of Moldova.
Cigarette smuggling, which includes both duty-nonpaid illicit whites and counterfeit products, is a major threat in the EUBAM’s area of operations, particularly at the central, Transnistrian segment of the 1,222 km border between the two countries. There are 67 border crossing points along the Moldovan-Ukrainian border, including 25 at the central part. Cigarette trafficking in the region comes in various forms, ranging from cross-border small-scale smuggling of packs hidden in vehicles to large-scale shipments being secretly transported at night. Other smugglers exploit legal loopholes.

Slawomir Pichor

Platform Against Contraband
To combat illicit cigarette trade more efficiently, the EUBAM in 2010 set up the Task Force Tobacco (TFT). The mission assists both Moldova and Ukraine in developing comprehensive anti-illicit strategies. At the practical level, the EUBAM helps its partner services to establish direct contact with their EU counterparts. It supports the law enforcement agencies of Ukraine and Moldova in their cigarette smuggling investigations, analysis and enforcement activities. This includes joint border control operations. Since the TFT started, the partner services have gradually developed the knowledge and expertise to conduct these operations through their own initiatives and in close cooperation with EU member states.
In addition, the EUBAM supports partners from the two countries in combatting tobacco smuggling by assisting them with the coordination of risk management decisions, targeting risky shipments of cigarettes as well as joint investigations and border operations. A recent success of the TFT was joint border control operation “Scorpion II,” during which Ukrainian, Moldovan and Romanian law enforcement agencies in cooperation with the EUBAM and OLAF, the European anti-fraud office, seized 8.5 million cigarettes between August and October 2021.
General Slawomir Pichor, head of the EUBAM and chairman of the TFT, says the platform has become a highly effective tool. “Most importantly, the Task Force Tobacco has been initiating and suggesting collaboration on certain proposals for tightening the legislative framework. Law enforcement action is not enough to effectively combat illicit trade; you also have to make interventions to close the legal loopholes to set signs. The platform has been kind of an early warning system. It is also elaborating substantial proposals for making legislative changes, which has been very effective in the long term as the mission is working to strengthen cooperation between Moldova and Ukraine law enforcement agencies and neighboring European member states, which we brought to this forum. It’s actually those countries that are affected by smuggling from this region, so it was important they could share experience and exchange information with Moldova and Ukraine.”

Moldova Joins the WHO Protocol
Internationally recognized as part of Moldova, Transnistria is a special case in the fight against illicit tobacco. The breakaway republic controls most of the narrow strip of land between the Dniester River and the Moldovan-Ukrainian border as well as some land on the other side of the river’s bank. Although unrecognized as independent, the region has its own government, parliament, military, police, postal system, currency and vehicle registration system. Over the years, the Transnistrian region has become a gray economic and security area 190 km from the EU’s external borders that attracts all sorts of cross-border crime. The illicit tobacco trade is no exception. According to the EUBAM’s observations, between 2012 and 2014, the delivery of tobacco products to the Transnistrian region vastly exceeded the potential demand on the local market, which meant that those products were destined for the much larger EU market.
“There is no presence and no control by the Moldovan enforcement authorities in the Transnistrian region, which means a lack of transparency and essential information, which is very important in effectively fighting illicit tobacco trade,” explains Pichor. “The mission was helping Ukraine and Moldova to monitor this tobacco trade very closely. In May 2015, Ukraine closed all border crossing points at the central Transnistrian segment of the border for excisable goods, including tobacco and cigarettes. Even though tobacco supply was cut off from the Ukrainian side, smugglers in the Transnistrian region misused other mechanisms, such as duty-free shops. In 2020 alone, 1.7 billion cigarettes were imported to the region with roughly 480,000 residents. EUBAM was raising this issue at different levels, including TFT, and in December 2020, the Moldovan side took proper actions at the policy level by intervention to the regulatory framework.”
In March 2022, the Moldovan Parliament decided to accede to the World Health Orgnization Framework Convention on Tobacco Control’s Protocol to Eliminate Illicit Trade in Tobacco Products. “This protocol is introducing elements which will cover the existing gaps in Moldovan legislation, so this is a very good step,” comments Pichor. “This protocol provides a very good toolbox for the effective fight against the clandestine factories. It also adds more surveillance and monitoring of cigarette production, from growing tobacco till the final finished product. It will also require amendments in the Moldovan legislation to introduce this tool set as well to effectively use it, and our mission has been advocating for its adoption. Overall, it will contribute to the effective fight against illicit tobacco trade.”

New Smugglers’ Routes
The Covid pandemic markedly impacted the nature of cigarette trafficking in the region, according to Pichor. “Covid-19 influenced the modus operandi for cigarette smuggling significantly. With borders closed and regular flights and shuttles canceled, small-scale smuggling significantly decreased. Although, large-scale trafficking wasn’t influenced because cargo transportation is used in this case. In general, during this period, there have been fewer seizures, and a growing number of illegal cigarette factories was set up on EU territory.”
The next change came with Russia’s war against Ukraine. Not only is Ukraine a source of illicit cigarette production, but it is also a transit hub for cigarette smuggling. Three important seaport cities, among them Odesa and Chornomorsk, until recently Ukraine’s largest maritime gateways for imports and exports, have been blocked by the Russians. “This was the route for smuggling the cigarettes from Asia and the Middle East,” says Pichor. “Belarusian cigarettes, also a significant part of illicit tobacco trade, went via Ukraine too. Now that this route is closed, we can expect other channels to replace it. At the same time, there will now be more pressure from illicit production inside EU member states. With no internal borders in the community, the risk of detection is much lower.”
Even though the EUBAM had to shift its priorities following Russia’s invasion of Ukraine, the fight against illicit tobacco trade continues, according to Pichor. “Currently, there is immense pressure on Ukrainian authorities to get agricultural commodities out of the country, and our role is now to facilitate this,” he says. “As for the fight against illicit tobacco, we cooperate with the Bureau of Economic Security of Ukraine, which is very active in this sphere. Established in 2021 as an umbrella body to investigate all kinds of economic crimes, the bureau serves as a platform for constructive dialog between the state and the business community. As you see, we have not abandoned combatting cigarette trafficking and will continue our efforts, which we are strengthening even more with the help of recently recruited profile experts.”
At the beginning of the war, the EUBAM relocated its Odesa headquarters to Chisinau and deployed some of its staff to assist in managing the influx of refugees into Moldova. To support the mission in this task, the EU made €15 million available for additional staff, equipment and training.

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.

September 1, 2022
The Perfect Match?

Photo: Swedish Match

A takeover of Swedish Match would give Philip Morris International a comprehensive portfolio of reduced-risk products.
By Stefanie Rossel
Philip Morris International may take a giant step this year toward its goal of becoming a smoke-free company. In May, the multinational offered $16 billion to acquire Swedish Match, a Stockholm-based maker of oral nicotine products known for brands such as Zyn, General, Oliver Twist and Longhorn. If accepted by shareholders, PMI CEO Jacek Olczak said in a webcast on May 11, the deal would greatly accelerate the fulfilment of PMI’s smoke-free ambitions and position it to lead that transformation in the industry. PMI aims to reach more than 50 percent smoke-free net revenues by 2025 as compared to 30 percent in the first quarter of 2022 and essentially zero in 2015, when the company launched its IQOS heated-tobacco product.
The takeover has the potential to greatly benefit both companies. Swedish Match’s large portfolio of pouch and snus brands is largely complementary to that of PMI, and company cultures and organizations of both businesses are a fit, Olczak emphasized. The Swedish manufacturer shares PMI’s vision of working toward a smoke-free future without cigarettes; more than two-thirds of its revenues and around three-quarters of operating profits are from smoke-free products.
Around one quarter of sales are generated by Swedish Match’s cigar business, which the company in 2021 planned to separate via a spin-off to shareholders and a subsequent listing on a U.S. securities exchange. However, in mid-March this year, Swedish Match’s board of directors decided to suspend the preparations for the contemplated spinoff until further notice.
If Swedish Match’s shareholders approve the takeover, it would give PMI a comprehensive global reduced-risk products portfolio with leading positions in heated tobacco and nicotine pouches, the fastest-growing category of oral nicotine, with potential for accelerated international expansion, Olczak explained. Together with PMI’s emerging presence in the vape segment through its Veev product, the combined companies would have a strong position with brands across all three major smoke-free platforms, Olczak pointed out. The merger would add more than 3 million adult users of smoke-free products to PMI’s roughly 18 million IQOS users.
Strong in the U.S. Smoke-Free Market
The Swedish company is also well established in geographies where PMI would like to expand its smoke-free products. Of Swedish Match’s sales, more than 64 percent come from the U.S. and 29 percent come from Scandinavia.
An important aspect of the deal is Swedish Match’s strong position in the lucrative U.S. market. Excluding China, the U.S. nicotine industry is the world’s largest by value, with retail value accounting for around 30 percent of the international market. Around 34 million Americans smoke.
In smoke-free products, the U.S. alone generates more than half the retail value of all other countries bar China combined. In 2021, the U.S. smoke-free market accounted for about 23 percent of the country’s total nicotine volume, and its retail value continues to grow strongly at a compound annual growth rate (CAGR) of around 13 percent since 2018, according to Olczak. The purchase of Swedish Match would increase PMI’s directly addressable market for smoke-free products in the U.S. by approximately 60 percent.
Of the U.S. $1 billion nicotine pouches category, Swedish Match holds a 64 percent volume share with its fast-growing Zyn brand. The product’s extraordinary performance catalyzed the category in the U.S. in 2021, leading to an expansion of volumes by approximately 80 percent last year alone, Olczak said. With more than 500 salespeople, access to over 150,000 points of sale and manufacturing and support functions, Swedish Match has a substantial platform in the U.S. In 2019, eight products sold under Swedish Match’s General snus brand received the first modified-risk tobacco product (MRTP) orders from the Food and Drug Administration.
To date, PMI has made only limited progress in the U.S.’ growing smoke-free market. In the U.S. and elsewhere, the company has zero or negligible presence in the nicotine pouch category, according to Olczak. And while IQOS, too, has received MRTP orders, PMI had to halt the product’s U.S. rollout in November 2021, when the International Trade Commission (ITC) ruled that the heat-not-burn device infringed on two BAT patents.
PMI had intended to commercialize IQOS under an exclusive licensing agreement with Altria Group’s PMI USA subsidiary. Following the ruling, PMI USA was forced to remove the product from the market.
In February, during the company’s full-year 2021 earnings call, Altria CEO Billy Gifford said that while he didn’t expect to have access to IQOS devices or Marlboro Heat Sticks in 2022, his company remained focused on returning IQOS to the U.S. market as soon as possible. According to the ITC ruling, PMI can either change IQOS’ design, which would require it go through the cumbersome FDA authorization process again, or manufacture the product domestically. The company has opted for the latter, Olczak revealed in an interview, but he didn’t disclose where in the U.S. production will take place. However, the company said it plans to start selling IQOS again in the first half of 2023.
Leading in Modern Oral Nicotine
The global nicotine pouch market is valued at around $2 billion, having grown by approximately 65 percent in 2021. Here, too, Swedish Match leads the category with a volume share of about 40 percent. PMI anticipates the modern oral nicotine category’s retail value to grow by a CAGR of 30 percent to 40 percent over the next five years, with the rest of Europe overtaking fast-growing Scandinavia in the next three years. PMI views low-income and middle-income countries as attractive targets for nicotine pouches, given the products’ simplicity, affordability and ease of use.
This is where the advantages for Swedish Match from a potential deal would come in: In addition to benefiting from access to the resources of a much larger corporation, IQOS’ extensive international commercial infrastructure and PMI’s complimentary development capabilities would provide Swedish Match with a significant international opportunity for Zyn. PMI is committed to invest in the nicotine pouch category, according to Olczak. Leveraging the strengths of the companies’ respective nicotine offerings could translate into great potential for PMI’s position in Scandinavia.
Whether the deal will be completed remains to be seen. Swedish Match’s board of directors accepted PMI’s offer and recommended to do the same to its shareholders. Under Swedish law, some 90 percent of shareholders need to agree to the deal for it to proceed. Several investors have objected to the takeover, claiming it was unclear whether the offer price sufficiently reflected the long-term value of Swedish Match. Swedish Match is a fast-growing and profitable company, experiencing a CAGR of more than 17 percent, excluding currency fluctuations between 2018 and 2021, and increasing its cash from operating activities at a CAGR of 20 percent during the same period, from $426 million in 2018 to $738 million in 2021.
In July, U.S. activist investor Elliott was rumored to be building a stake in Swedish Match to stop the deal, according to Bloomberg. Opposing shareholders can have a significant impact: In 2021, pharma company Astra Zeneca blocked a $7.6 billion takeover of Swedish player Orphan Biovitrum by withholding its 8 percent stake in the company from a buyout offer.
In the case of Swedish Match, things may turn out differently. Mads Rosendal, an analyst at Danske Bank, wrote in a research note that it was unlikely that Elliot will succeed in building a large enough stake in Swedish Match to thwart the deal on its own.
Of course, the deal will take effect only after the last signature has been placed. Swedish Match shareholders have until Oct. 21, 2022, to accept the offer.

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.

September 1, 2022
How to Save 100 Million Lives
Photo: Smoore
Innovation and creative destruction in the evolving tobacco market will render cigarettes obsolete and end the burden of smoking-related disease—if we let it.
By Clive Bates
Let’s play strategy consultants. Imagine an international public health agency has hired us. We are tasked to advise on reducing the global burden of noncommunicable disease associated with tobacco and nicotine use and how to do it as deeply and rapidly as possible. Our assignment is to propose a clear-eyed, unemotional and results-driven approach to addressing this problem. What would we do?
First, we define, limit and quantify the problem. According to the Global Burden of Disease study published in The Lancet, in 2019, around 1.1 billion people smoked 7.4 trillion cigarettes. Worldwide, 7.7 million died from smoking-related disease and 200 million disability-adjusted life-years were lost. On top of the burden of mortality, there are additional economic and welfare harms from smoking. Then there are further harms caused by the policy response, such as regressive taxes, stigmatizing campaigns and restrictions on smoking. These policies might be justified to reduce disease and protect nonsmokers, but they add to the welfare burden for people who continue to smoke. The problem is overwhelmingly caused by smoking tobacco—inhaling products of tobacco combustion—and not directly by the use of the drug nicotine.
Second, we determine why this problem persists. If it causes so much harm, surely it is just a matter of informing people? This seemed like the obvious answer to the anti-smoking pioneers of the 1960s onward. Doctors would educate people on the risks, and people who smoke would reassess their interests and would stop smoking or never start. Some analysts suggest that this could be the only anti-smoking strategy that has ever worked, but it has been painfully slow. Our working theory is that the underlying demand for nicotine is robust and potentially dependence forming. We determine that for some people, nicotine use may be rational or appealing for its mood control, cognitive advantages and pleasurable sensations. We note the long delay between the positive reinforcing experience of smoking and the most severe health effects and how people tend to devalue or discount negative impacts far in the future compared to gratification today. But if we can separate the experience of using nicotine from the harms of using it by smoking, maybe there is a way around this.
Third, we ask what is wrong with what we are already doing. Maybe it is a matter of letting evidence-based tobacco policy work through multiple countries and generations. Yet, despite 50 years of concerted action, we still have about one in seven adults smoking in the United Kingdom and the United States and about one in four in the European Union. Now that 80 percent of the world’s smokers are in low-income and middle-income countries, we ask if the intense and sustained regulatory, fiscal and campaign focus necessary to drive down smoking and nicotine use are viable and sustainable. Or would the process be slow and incremental as it has been in Europe and North America? We look for signs that the World Health Organization Framework Convention on Tobacco Control (FCTC) has been working but find surprisingly little credible evaluation. The available analysis, published in the BMJ, found no evidence “to indicate that global progress in reducing cigarette consumption has been accelerated by the FCTC treaty mechanism.”
Fourth, can we go further with the established measures? The problem with pulling harder on the existing levers is that we may start to run up against barriers of public consent and political acceptability (politicians are only willing to be tough on voters up to a point), or we start to see escalating unintended secondary consequences. For example, high tobacco taxes are regressive and likely to trigger black markets or adverse behavioral responses. The public might see smoking bans in workplaces as acceptable to protect workers, but would they feel the same way about banning smoking outdoors? We might push harder with enforcement, but the danger is that the measures start to look illiberal, excessive or unfair. What about escalating and just banning cigarettes or forcing manufacturers to remove the nicotine? After all, if that is the problem, why not take the most direct way to address it? Again, we run into difficulties of public consent, political appetite and perverse consequences that are all too foreseeable given the experience with drug and alcohol prohibitions.
Fifth, what innovative options are available to expedite progress? Here, there really is a potential game-changer. If the underlying demand is for the experience of using nicotine and the harm is caused by the use of nicotine by smoking and inhaling products of combustion, then there is an obvious path forward. Our key strategy advice is to do everything possible to refocus the nicotine market from the dangerous smoking products to the much safer smoke-free products, for which estimates suggest there are already more than 100 million users. There are two reasons to adopt this strategy. First, it provides a relatively simple way for existing smokers to switch to products that eliminate nearly all the additional risks of continued smoking. When someone who smokes switches, they do not have to give up the nicotine, a sensory experience, or much of the behavioral ritual. Second, these products provide low-risk alternatives available to people who wish to use nicotine in the future. This second function is essential because we do not believe it will be possible to stop future nicotine use any more than we could wind down the use of caffeine, alcohol or cannabis. To the extent we have managed to reduce demand for nicotine, it is mainly on the back of messaging and measures to address the harm caused by smoking. But it is precisely that harm we are trying to eliminate. We need to rethink our relationship with nicotine.
Sixth, how could we expedite progress? Here, we may rely on what the economist Joseph Schumpeter termed a “gale of creative destruction” or the “process of industrial mutation that continuously revolutionizes the economic structure from within, incessantly destroying the old one, incessantly creating a new one.” So, should we just wait for this process to run its course? Of course not! Four critical contextual pressures will drive the inevitable creative destruction of the cigarette market. The right strategy for government, civil society and the tobacco industry is to shape them to expedite the obsolescence of smoking to create a viable nicotine market with acceptable risks:
The information environment – what do people believe about smoking and the alternatives? What do trusted professionals and organizations say and advise? What do newspapers report, and how reliably do scientists communicate their findings in scientific papers and press releases? A significant tobacco control effort has been made to engineer misperceptions about relative risk and to dissuade smokers who would switch from making that move. The information environment is highly contaminated with harmful misinformation.
The regulatory environment – regulations can encourage consumers to move from high-risk to low-risk products—an approach we know as “risk-proportionate regulation.” However, the regulatory landscape for cigarette alternatives is filling up with anti-proportionate regulation: prohibitions and stealth prohibitions, including outright bans, bans on flavors, limits on nicotine levels, advertising bans and so on. Again, the current trends protect the cigarette trade.
The fiscal environment – the tax system can create incentives for consumers, retailers and manufacturers to favor low-risk smoke-free alternatives over high-risk cigarettes. But we now see persistent calls to raise taxes on vaping and heated-tobacco products to equivalent levels to cigarettes. Again, the direction is anti-proportionate when it comes to taxation.
The innovation environment – how favorable are the market conditions to the emergence of improved products and new entrant firms? Is the market competitive, or does oligopoly form a barrier to innovation? Does it require massive regulatory costs and delays to bring a product to market (e.g., the U.S. Food and Drug Administration) or notification or compliance with standards (e.g., the European Union)? Can innovators communicate with consumers and explain their innovation, or are advertising and other commercial communications banned? Does innovation go into improving customer experience relative to cigarettes, or is it primarily directed to regulatory compliance that does little for product users?
These pressures will fundamentally change the tobacco market, perhaps ruining some companies but making revitalized giants out of others. A determined goal-driven strategist would shape these four environments to harness market dynamics for public health. That will mean challenging those purporting to represent public health interests while doing all they can to delay the market-based obsolescence of the cigarette. They may slow a necessary and inevitable transformation and cost thousands of lives. But ultimately, innovation and creative destruction will prevail. Every stakeholder involved should grasp the implications of that and act accordingly.
“Accessing Innovation” is the theme for this year’s GTNF, to be held in Washington, D.C., Sept. 27–29, 2022.
Clive Bates is the director of Counterfactual Consulting and the former director of Action on Smoking and Health (U.K.).
September 1, 2022
Smart Connection

Illustration courtesy of Maschinenbau

Koehl’s new communication platform connects field-level tobacco machinery with the Cloud.
By Stefanie Rossel
Communication is key—not only in everyday life but also on the factory floor. On the road to Industry 4.0, the Industrial Internet of Things (IIoT) is an important milestone. The digital mapping of production plants and their connection to systems for collecting and evaluating production data is the basis for smart analysis methods to optimize production processes. To keep up with the fast-paced development of new ideas and concepts that the fourth industrial revolution brings about, manufacturing companies are confronted with the difficult task of driving their digital transformation.
Modern tobacco manufacturing equipment comes with built-in features that allow it to communicate data on performance, settings, history and so on. However, the secondary machinery communication landscape in most tobacco factories is highly fragmented, both for machine-to-machine and machine-to-higher-systems data streams. Over the years, many production lines have formed a heterogenous machine landscape. The individual plant components often comprise controllers from different suppliers and generations. Over time, physical media, protocols and data formats, sometimes proprietary, have accumulated, leading to unnecessarily complex integration efforts. Fragmentation also limits the opportunity to extract manufacturing insights from the machine data.
To solve this problem, the world’s four leading cigarette manufacturers—Philip Morris International, BAT, Japan Tobacco International and Imperial Brands—and the OPC Foundation created a working group about five years ago to describe general requirements for manufacturers for primary and secondary machinery. “OPC” stands for Open Platform Communications. The OPC Foundation is responsible for the development and maintenance of OPC UA, the interoperability standard for the secure and reliable exchange of data in the industrial information space and in other industries. It is a platform-independent, open and license-free communication platform and ensures the seamless flow of information among devices from multiple vendors.
The jointly developed companion specification for the tobacco industry, named Tobacco Machine Communication (TMC), is based on the OPC UA information model and aims at harmonizing data exchange and interoperability requirements for the common benefits of both cigarette manufacturers and original equipment manufacturers (OEMs). It seeks to create interoperability between the various OEMs. The main objective of the companion specification is to provide information-modeling concepts and object libraries that can be applied to model a complete production work center. It covers machine configurations, product flows, setup, service, live status and historical information and can be applied to conventional tobacco products as well as products in the heated-tobacco environment. The OPC UA server of the work center can expose information in a harmonized way to upper-level systems or to other compliant work centers. While the working group started out by focusing on secondary machinery, the new standard 2.0, which was introduced in May, also covers primary equipment.
The TMC standard can be downloaded from the OPC website. All new tobacco machinery delivered today needs to be compliant with the standard.
Enhancing Efficiency
Arno Fries
However, cigarette-making equipment is known for its longevity, which means there are many shop floors with equipment that was developed before the standard was introduced. For such factories, Koehl Maschinenbau, a Luxemburg-based supplier of processing and logistics equipment for the tobacco industry, has designed a machine-to-cloud solution, the IIoT Server. Based on the TMC companion specification as a platform, the application server enables vertical data transmission to a business intelligence system (BIS) without, in the best case, changing the components’ programming. This way all data accumulated on the shop floor can be semantically processed in the same way to collect and analyze it centrally. The server collects and handles data at the shop floor level and forwards it to a Cloud or Fog environment where the data is stored, analyzed and archived.
“For the customer, this leads to an increase in efficiency and a reduction of costs,” explains Arno Fries, technical director of logistics and information systems at Koehl. He heads the company’s manufacturing IT department, which implements solutions and products for intralogistics and production logics. The IIoT Server is a proprietary development commissioned by one of Koehl’s tobacco clients. “It’s an easy, flexible, cost-effective and future-proof way to integrate and digitalize established machines into the customer’s preferred Industry 4.0 ecosystem,” says Fries. “An intelligent production optimizes workflows, maintenance, energy consumption and service management.”
The ability to interact with various programmable logic controllers (PLCs) in a heterogenous production environment is key to standardized data processing in the IIoT, says Fries. “The PLC connection module of Koehl’s TMC server is based on a highly flexible and exchangeable driver technology that is used for communication with different PLCs and different protocols. Drivers are available for the most common PLCs, such as Siemens Step-(300, 1200, 1500) or Beckhoff or for protocols, for example OPC UA.”
Easy Installation
The IIoT Server allows for collection of data from all machinery, whether new or old, is OEM independent and provides tailor-made solutions for equipment that is not standard. Transformation and normalization of data take place just in time. There are no programming changes of existing PLCs required. The web-based configuration enables central configurations for all instances. The server consists of a small data processor that fits into a control cabinet, which is required to have two Ethernet ports.
Depending on the customer’s requirements, the IIoT Server can be installed in a decentralized or centralized architecture. In a decentralized installation, each PLC is connected to a separate server unit, with data being transferred from the production network to the cloud in a secure way. In a centralized environment, all PLCs of a production line or an entire plant are connected to a central IIoT Server unit, which according to the company can be easily integrated into existing server or virtualization architectures. Either way, hardware requirements are minimal.
Implementation is uncomplicated, according to Fries. “The data to be transferred and their respective addresses are set once for each PLC through a configuration tool. The storage of the data retrieved by the various controllers and their depiction in the TMC information model is the main characteristic of Koehl’s server application. In addition, it allows for storage of data, which the PLC can neither provide nor store. After configuration, the TMC server runs in the background and provides the configured data as TMC objects to each OPC client for further processing. The operator is not involved unless he wants to add a further configuration.”
Koehl’s server can either be used if existing production lines are to be connected or if an OEM needs a bridge between a machine and the IT level that is compatible with the TMC standard and that he can’t or won’t realize himself.
Successful Pilot Project
The pilot project was installed at an Other Tobacco Products (OTP) manufacturer’s site. Three pilot lines out of nine OTP lines were selected for connection to the cloud-based customer BIS via the TMC standard. For each system, an industrial inter-process communication was placed in the respective control cabinet. “With these having a second network adapter, it was not necessary to take the PLCs out of the production network. The PLCs are therefore accessed via a different network than the data collected here,” relates Fries. “In order to be able to compensate failures of the higher level system, the IIoT Server also allows for the archiving of data movements and changes over a longer period of time.”
Across machines, data about machine running time, downtime and root cause analysis is now collected and can be accessed by the BIS via the TMC standard. Information about material rejects, production defects, material turnover and machine efficiency as well as predictive maintenance and machine configuration changes are also provided.
“The greatest challenge was the collection of data from existing production lines with different controllers without program changes in the PLC,” says Fries. “After we had collected the data, it was validated by the machinery operators, and since then, system has been running smoothly.”
Following the successful pilot, Koehl has been ordered to roll out the system to the customer’s remaining OTP lines. Fries observes increasing interest for his company’s solution in the industry. “If a tobacco manufacturer has several locations and lines and a fully automated production, the IIoT Server is ideal because it not only allows to comply with the TMC standard but also to control and evaluate processes.”

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.

September 1, 2022
Leaving No Trace

Photo: McAirlaid’s Vliesstoffe

McAirlaid’s Genia cigarette filters decompose in a matter of weeks rather than years.
By George Gay
Some time ago, Rachel Roddy, a food writer specializing in Italian cuisine, wrote in The Guardian newspaper’s Feast magazine that 80 percent of recipes could be improved by omitting the tomatoes usually included. Being a renowned tomato-phobe, I was delighted with this story and set out on a campaign to have the message more widely disseminated and acted upon—a campaign that was met with little success, I’m sorry to say, and that fell by the wayside.
But I was reminded of Roddy’s piece recently when reading the McAirlaid’s Vliesstoffe’s website, which, at one point, poses an intriguing question: Is it possible to achieve more by omitting something? Of course, I was a convert and knew the answer immediately. Yes. Leave out the tomatoes!
While answering yes to its own question, McAirlaid’s would not be too happy with my response, I think, because part of its business is focused on food packaging, and tomatoes probably figure in the makeup of that business. But I’m getting ahead of myself. This piece mainly concerns another aspect of the company’s business: cigarette filters—specifically, cigarette filters that offer tobacco-smoke taste similar to that provided by cellulose acetate filters but that are manufactured using only pure cellulose, free from bonding agents, and that, therefore, decompose in a matter of weeks rather than years as is the case with cellulose acetate products.
A Patented Process
Katja Selle
McAirlaid’s specializes in manufacturing nonwoven absorption fleeces from pure, nonchlorine-bleached cellulose fibers using only a patented “airlaid” thermo-mechanical process to bond the fibers. In other words, the company omits from its SuperCore fleece the nonabsorbing bonding agents typically used to make fleeces, allowing SuperCore to achieve greater absorption and fluid distribution than is achieved using traditionally bonded fleeces.
The company, which sells its SuperCore fleece either as a raw material or as finished products, has four production sites in Germany and one in the U.S. Associate Sales Director Katja Selle told me during an email exchange that the company even had its own engineering department with machine design and building capabilities, which allowed it to develop “innovative and unique technologies.” Currently, it operates with five airlaid machines to produce its SuperCore fleece and more than 100 processing machines to service the particular requirements of the various markets with which it is involved and which it designates as food packaging, hygiene, medical, cigarette filters and home and garden.
And while McAirlaid’s products may rightly be described as environmentally friendly, so, too, can its processes. The company’s cellulose production, which is certified by the Program for the Endorsement of Forest Certification, operates with low carbon dioxide emissions and without the use of freshwater—and therefore without creating wastewater. Production buildings are climate controlled by means of efficient heat recovery systems.
McAirlaid’s, which now has more than 500 employees and customers in more than 70 countries, was founded in 1997 in Steinfurt, North Rhine-Westphalia, Germany, with production at its Heilbad Heiligenstadt factory starting the following year. It opened its third factory in Virginia, USA, operating as subsidiary, McAirlaid’s Inc., in 2006 and set up a new marketing organization offering Genia cigarette filters in 2017. 2020 saw the start of its first face mask machine.
The material that makes up Genia cigarette filters was developed by McAirlaid’s and is made from 100 percent EN-13432-certified cellulose produced using the same airlaid technology that is used for producing the company’s other products, though modified to meet the specific needs of the tobacco industry (EN-13432 is an industrial compostability standard). It is offered bleached or unbleached and is said to be available in just about any filter rod specification, including those suitable for heat-not-burn products. Genia filters are already part of tobacco cigarettes, filtered cigarillos and hemp cigarettes that are available in Europe, and, currently, tests and developments are being carried out in conjunction with many small and large manufacturers in the cigarette, cigarillo and roll-your-own segments.

McAirlaid’s biggest factory, at Berlingerode, Germany

Ahead of its Time
Development of these cigarette filters has been a long time coming. The founder of McAirlaid’s, Alexander Maksimow, recognized the littering problem associated with cigarette butts in the 1990s, at a time when, according to Selle, the market wasn’t ready to accept a change to more sustainable products. Once started, development took several years but was accelerated with the arrival of McAirlaid’s own rod-making machine, which allows it to manufacture efficiently at one of its German factories sample rods for testing by prospective adopters of Genia filters. This is important because Genia filters are always custom made for individual cigarette manufacturers after a joint development process aimed at identifying the most appropriate product to replace a cellulose acetate filter.
And things are likely to move much quicker in the future. The major filter producers are said now to have similar machines that run equally well as the one developed by McAirlaid’s, and the company has worked with filter-rod-machine builders to optimize the use of airlaid materials through their machines. Additionally, Selle said, McAirlaid’s airlaid material was being manufactured into filter rods and sold by global filter producers.
Selling Genia filter rods could be seen as pushing at an open door. These filters are price competitive and closely mimic the cellulose acetate products they are replacing, in respect of both their smoke-modifying and taste retention characteristics. But perhaps the major selling point is the fact that while carelessly discarded traditional cellulose acetate cigarette filters take up to 15 years to break down, Genia cigarette filters are biodegradable and compostable and break down within a few weeks of being discarded. Of course, McAirlaid’s emphasizes that the best option would be for smokers not to carelessly discard cigarette butts, but we are where we are, and a note on the company’s website indicates that, annually, carelessly discarded butts would fill up to 253,000 cargo containers. The number of containers that would be needed to house the butts carelessly discarded over the years that cellulose acetate filters have been widely used does not bear thinking about.
The construction of the Genia material is important from the point of view that it does not contribute to the ever-growing problem caused by micro-plastics being released into the environment. And it is important from the point of view that cigarette manufacturers need to comply with plastics reduction regulations in certain jurisdictions—regulations that are bound to become more widespread. At the same time, the material’s ability to break down quickly is important because it reduces the risk of butts being swallowed by water-dwelling or land-dwelling creatures. And it is important from the point of view of aesthetics, given that cigarette butts have long been an eyesore for many people, though one that seems to be reducing with the reduction in smoking in at least many Western cities.

Opportunities Ahead
With these advantages in mind, I asked Selle whether she thought there would be good opportunities for McAirlaid’s to grow its cigarette filters business in the future even though cigarette consumption overall might go down. She started by saying that her company was currently experiencing, especially in Europe, increased demand for sustainable alternatives to cellulose acetate, something that was being driven by various factors, one of which stemmed from a new European Commission regulation, the Single-Use Plastic Directive, which was put in place in July last year. Under the provisions of this directive, there was a package-marking requirement for products that included filters containing plastic of any kind, a designation that encompassed cellulose acetate filters but not Genia airlaid filters. In addition, there was the Extended Producer Responsibility policy, which levied a littering tax on, among any number of products, cigarette filters containing plastic. Again, Genia was exempt from the requirements of this policy. At the same time, McAirlaid’s was seeing an increased demand by consumers for sustainable products, so it was likely that demand would keep increasing.
In the U.S., the situation was different, Selle added. There, the Food and Drug Administration regulated the tobacco products sector, so moves toward the use of sustainable cigarette filters would first require the FDA to accept their use. This would come either through changes to their rules or through tobacco manufacturers agreeing to submit new cigarettes with sustainable filters through the premarket tobacco product application route. Consequently, McAirlaid’s was encouraging any U.S. tobacco company wishing to develop new products to consider a trial using Genia filters. For one thing, emerging initiatives, such as California’s proposed single-use plastic regulations, were likely to increase the momentum toward more sustainable materials.

George Gay is Tobacco Reporter’s European editor, but his territory spans the globe. Based in London, George has covered the tobacco industry since 1982, initially for a U.K.-based publication and since 2004 for Tobacco Reporter. George’s understanding of industry issues, combined with his keen sense of observation and dry wit, have earned him a loyal following among Tobacco Reporter’s readers.

September 1, 2022
A Curious Case

Photo: steheap

The U.S. Food and Drug Administration’s marketing denial order for Juul may have been a political decision.
By Stefanie Rossel
In June, long-simmering criticism of the way the U.S. Food and Drug Administration is handling premarket tobacco product applications (PMTAs) culminated in a public uproar. “The whole regulatory process is becoming surreal now,” wrote Clive Bates, an independent public health and sustainability advocate, on his blog The Counterfactual. Bates was referring to the agency’s June 23 marketing denial orders (MDO) for all currently marketed Juul Labs products in the United States and compared them to the FDA’s previous marketing authorization of 22nd Century’s low-nicotine combustible cigarette. “No one could make a vape product even remotely as toxic as a cigarette,” Bates stated, “but guess which one got the green light.”
In its press release, the FDA said that Juul’s applications lacked “sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.” In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data, the agency claimed. The problems of genotoxity and potentially harmful chemicals leaching from Juul’s propriety e-liquid pods had not been adequately addressed in the applications, according to the FDA, thus precluding the agency from completing a full toxicological risk assessment of the products.
However, the agency admitted that to date it had not received clinical information to suggest an immediate hazard associated with the use of the Juul device or Juul pods. A further reason for the MDO, the FDA wrote in a statement, was that there was “no way to know the potential harms from using other authorized or unauthorized third-party e-liquid pods with the Juul device or using Juul pods with a non-Juul device.”
Michel Mital, acting director of the FDA’s Center for Tobacco Products, said that the agency was tasked with ensuring that tobacco products sold in the U.S. met the standard set by the law but that responsibility to demonstrate that a product meets those standards was with the manufacturer. “As with all manufacturers, Juul had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards,” she said. “However, the company did not provide that evidence and instead left us with significant questions.”
The FDA’s Volte-Face
One day later, Juul Labs requested and was granted an emergency stay of the FDA order by the U.S. Court of Appeals for the D.C. Circuit to give the judges time to evaluate the merits of Juul’s appeal. In its court filing challenging the FDA ruling, the company called the FDA’s order “extraordinary,” “discriminatory” and “unlawful” and said that it would suffer significant irreparable harm without a stay.
The agency, Juul Labs claimed, had overlooked more than 6,000 pages of data in the applications on the aerosols that users inhale. The company, which argued that it has helped 2 million adult smokers quit traditional cigarettes, also suggested that the FDA’s decision was influenced by political pressure—through letters and at hearings, the company said in its filing, members of Congress pressed FDA officials to commit that Juul products would not be authorized. Furthermore, the manufacturer questioned the agency’s handling of the MDO announcement, which had been leaked to the media before it was officially announced.
On July 5, the FDA backed down and temporarily halted its ban on Juul Labs products while the manufacturer appeals the agency’s decision. The agency said it had determined that there were scientific issues unique to the Juul application that warranted additional review. The FDA stressed that its suspension did not mean rescission of the MDO. While the stay technically doesn’t allow Juul to continue selling its products, the FDA later explicitly stated, for the first time, that it did not intend to take enforcement action against the Juul products subject to the MDO.
Different Treatment
The removal of Juul products from the U.S. market would have far-reaching implications. The company had experienced a fairy-tale rise from a small business to U.S. market leader of the vape category. It was said to have revived the stagnating U.S. vape market and became so popular that the term “Juuling” became almost synonymous with “vaping.” Coming in a sleek design and with a nicotine salt-based pod system, Juul products were easy to use and able to satisfy the nicotine cravings that smokers previously satisfied with cigarettes. At the height of its success, Juul Labs accounted for more than 80 percent of U.S. nicotine vape sales. In 2018, it sold a 35 percent stake to Altria. If its products were to exit the market, smokers seeking to switch as well as vapers would be left with a mere handful of FDA-approved, but decidedly less popular, vape products.
In a letter to investors, the financial services company Morgan Stanley wrote that a Juul MDO would create opportunities for other reduced-risk products that have already received PMTA approval, most notably BAT, which recently overtook Juul as the leading U.S. vape manufacturer through its Vuse brands with a market share of more than 33 percent. In recent months, the FDA has authorized several vape products for marketing in the U.S. market, among them Njoy and Logic variants.
While tobacco control activists welcomed the FDA’s decision, vaping advocates were shocked, and the events following the MDO sparked much speculation. The agency treated Juul’s application very different from those submitted by competing vaping companies, according to critics. Following its normal process, the FDA should have sought answers to its “significant questions” about Juul’s application through a deficiency letter. Instead, the FDA simply banned Juul’s products. Also, the agency did not rescind its MDO for Juul as it had done for other companies after admitting potential errors. In addition, the FDA in its MDO held Juul responsible for third-party or counterfeit Juul products—a task that belongs to the regulator.
Punishing Past Mistakes
“It looks like the FDA searched for a pretext for denying Juul’s products, and this is the best they could come up with,” wrote Bates. The MDO seems to be designed to punish Juul for past mistakes. When the company entered the U.S. market in 2015, its early ad campaigns were heavily criticized for targeting youth.
Critics held the company single-handedly responsible for triggering a youth vaping “epidemic.” By the time Altria purchased a stake in Juul, the e-cigarette manufacturer was facing a sea of lawsuits. Around 2,000 cases have been filed against the company, by cities, counties, school districts and states, claiming that Juul purposefully addicted teenagers to its products with high-level nicotine pods.
Although youth vaping, which was never high on a daily basis among youth who have never smoked, has been declining since 2019 and vaping adolescents have turned to other, mostly disposable products such as Puff Bar, Juul Labs continues to bear the blame for youth vaping in the popular imagination.
Over the past years, the company has gone out of its way to please anti-vaping advocates—perhaps mistakenly, according to critics. Instead of challenging the misinformation spread by its opponents, Juul removed its flavored pods from the market before the law required this.
FDA Processes Questioned
While the MDO decision surprised many, the FDA’s subsequent administrative stay later made the story only more curious. Almost immediately querying a decision that the FDA had taken two years to reach appeared odd at best. Experts assumed the FDA realized that its arguments were weak and wouldn’t stand up to a legal challenge. The withdrawal leaves the agency with two options: issuing a new, amended MDO or admitting that it has erred, releasing a full rescission and putting Juul back in scientific review.
In an interview with Filter, Bates said the PMTA process was “wide open to abuse” as the agency can set arbitrary standards for what it considers acceptable.
In mid-July, the American Vapor Manufacturers Association (AVMA) asked the U.S. Department of Health and Human Services inspector general to investigate whether the FDA’s MDOs were driven by political pressure. “Manufacturers are routinely meeting the PMTA requirements to scientifically demonstrate how their products are appropriate for the protection of public health,” wrote AVMA President Amanda Wheeler. “Despite compliance, the agency isn’t approving the vape products sought by adults who want to quit smoking. The Office of Inspector General should open the door and hold the FDA accountable to its standards.”
In recent months, the FDA has faced increasing public and congressional scrutiny not only over its regulation of novel nicotine products but also for its role in a shortage of infant formula. On July 19, FDA Commissioner Robert Califf announced an external review of the agency’s offices on food safety and tobacco regulation.
The agency has tasked the Reagan-Udall Foundation with an assessment of the resources, procedures and organization of the offices on food and tobacco as well as parts of the Office of Regulatory Affairs, the division that conducts inspections. Whether the measure will improve Juul’s odds remains to be seen. The initial evaluation of the reviewing process was scheduled to be completed within 60 days.

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.

September 1, 2022