Author: Staff Writer

William Gifford

Photo: Malcolm Griffiths
Speaking through a video link at the 2021 Global Tobacco & Nicotine Forum in London, Altria Group CEO William Gifford explained why he believes it is possible to make more progress in tobacco harm reduction in the next 10 years than has been achieved over the past 50 years.
Gifford said he was optimistic about the outlook for tobacco harm reduction in the U.S. He was encouraged not only by the U.S. Food and Drug Administration’s commitment to science but also by the growing support of tobacco harm reduction among public health advocates.
As an example, he pointed to a recent landmark article offering a rare balanced look at vaping in the U.S. Writing in the August issue of the American Journal of Public Health, 15 former presidents of the Society for Research on Nicotine and Tobacco (SRNT) recognized the benefits of vapor products.
Meanwhile, data from the National Youth Tobacco Survey suggest that underage vaping, while still high, shows signs of decline. Underage use of traditional tobacco products remains at historical lows. The minimum age to purchase tobacco products has been raised to 21, and many states are considering and implementing lower rates of taxation for FDA-authorized reduced-risk products. Risk-proportionate taxation is important, according to Gifford. “We must not impede consumer switching,” he said.
Despite his optimism, Gifford also detected headwinds. He identified four areas where progress was still needed: correcting misperceptions about nicotine, ensuring that harm reduction is equitable, allowing for real and meaningful scientific engagement between industry and public health, and ensuring that harm reduction is an off-ramp for adult smokers and not an on-ramp for underage tobacco use.
Nicotine, Gifford reminded his audience, is not the primary cause of disease and death from smoking; rather, it’s the combustion of the tobacco—so it makes sense to transition adult smokers who can’t or won’t quit from the most harmful form of nicotine consumption to a less risky alternative.
While the risk continuum is today widely embraced by public health, the scientific community and the regulator, many smokers—the people who most stand to benefit—don’t understand the concept. Seventy-three percent of people either incorrectly believe nicotine is the main substance in cigarettes that cause cancer or are unsure. Eighty percent of surveyed physicians in a recent study strongly agreed that nicotine directly contributes to the development of cardiovascular disease, COPD and cancer. Left unaddressed, said Gifford, these widespread nicotine misperceptions could discourage adult smokers from switching to smoke-free tobacco products.
Industry has an important role to play, he noted. “It’s on us to conduct the science and seek MRTP [modified-risk tobacco product] authorization claims to persuade adult smokers about the benefits of switching to smoke-free products,” said Gifford. “But industry alone cannot correct nicotine misperceptions,” he added. “FDA has said, ‘we need a national debate on nicotine.’ We agree; we think FDA is best positioned to lead it. That’s why we recently asked the agency to launch a targeted public education campaign geared toward adult smokers about nicotine misperceptions.”
Access to tobacco harm reduction must also be more equitable, according to Gifford. A recent study among Black, Asian, Hispanic and LBGTQ+ communities revealed that a greater proportion of those groups mistakenly identified nicotine as the chemical that causes cancer. What’s more, Altria’s own data shows that Black, Hispanic and female adult smokers lag behind white male adult smokers in transitioning to smoke-free products.
A comprehensive approach to harm reduction means that all smokers, regardless of background, demographics or financial means, have equitable opportunities to reduce the harms of smoking, according to Gifford. While not claiming to have all the answers, he insisted that Altria was committed to engaging and listening.
“We face an unprecedented opportunity for America to lead the way in shifting millions of smokers away from cigarettes if we follow the science, support innovation and clearly communicate scientifically accurate information,” he said.
Getting the best possible science and data to guide policy decisions, he said, requires more than well-designed studies or lab work; it requires peer-to-peer engagement, review and open-minded inquiry. However, many organizations are seeking to exclude industry from scientific forums and research. For example, the National Institute on Drug Abuse discourages industry participation in harm reduction research. The SRNT recently decided to ban industry employees from attending and sharing their science at its annual conference.
“In this situation, nobody wins—not science, not good policy and certainly not adult smokers,” said Gifford. “We stand by our science and make it a point to welcome good faith scrutiny. If there is one lesson we all learned during the pandemic, it is the importance of science-driven communications.”
Gifford related how he’s often asked when the last cigarette will be smoked in the U.S. “The honest answer: It depends,” he said. As variables, he cited industry innovation, regulatory legislative policy, whether adult smokers can get the smoke-free products they like and whether adult smokers get accurate information on smoke-free products.
“But I am confident we can make real progress if we engage, listen and act,” he concluded.
November 2, 2021
PMI Invests in Growth Stage Companies

Photo: William W. Potter
Philip Morris International plans to dedicate a further $200 million to minority investments in early and growth-stage companies through PM Equity Partner (PMEP), PMI’s corporate venture capital arm. This allocation follows a 2016 commitment of $150 million that PMEP has since fully invested and is intended to support PMI’s smoke-free and beyond nicotine ambitions.
With this latest round of funding, PMI will leverage its strengths to help investee companies translate innovation into commercial success. Developed through PMI’s journey to replace cigarettes with smoke-free alternatives, the company’s best-in-class capabilities include advanced life science expertise, preclinical and clinical research, and aerosolization.
PMEP is focusing its investment activities on four distinct technology segments: life science innovations, such as inhaled therapeutics and computational research methodologies; industrial technologies like industrial robotics and automation, the internet of things and technology-based process optimization; product technologies, particularly those that relate to inhalation and aerosolization, chemical formulation and bio-authentication; and consumer engagement technologies, such as user identification and age authentication, innovative customer care and experience management.
“PMI’s scientific and technological leadership has enabled us to reinvent our company in our pursuit to ‘unsmoke’ the world,” said PMI Chief Financial Officer Emmanuel Babeau in a statement. “We are dedicating further funds to our venture capital arm at a moment when we are in an even stronger position to leverage our expertise to support the development and commercialization of cutting-edge technologies to the benefit of both PMI and investee companies.”
“PMEP is looking to invest in companies that can help PMI accelerate and further sophisticate our transformation while we support them through our industry-leading expertise to mature their technologies and businesses,” said Alexander Stoeckel, head of PMEP. “We see this exchange as a win-win for PMI, the companies we invest in and society.”
November 2, 2021
Doctors Reluctant to Prescribe E-Cigarettes

Photo: omphoto
Not all doctors and nurses are enthusiastic about England’s intention to let physicians prescribe e-cigarettes to smokers, reports Daily Mail.
A yet-to-be-published study, involving the University of Oxford, which interviewed 11 medical staff, found most struggled to advise long-term use of e-cigarettes because of concerns about unknown long-term effects.
A survey commissioned by Cancer Research UK two years ago indicates that two in five English nurses and doctors would feel uncomfortable recommending e-cigarettes to smokers and one in six would never do so.
General practitioners “find it difficult handing patients something which may cause them harm, even where e-cigarettes are far safer than cigarettes… They struggle to give people devices which may not be entirely safe or may perpetuate addiction to nicotine,” said Paul Aveyard, professor of behavioral medicine at the University of Oxford, who was involved in both pieces of research.
Martin Marshall of the Royal College of general practitioners urged more investment in community smoking cessation centers. “’Vaping should only be seen as a way to give up smoking, with the intention to then give up vaping,” he said.
Simon Capewell, professor of clinical epidemiology at Liverpool University, called the Department of Health plan for prescription e-cigarettes deeply worrying.
“England is out on a dangerous limb,” he said. “Officials here have fallen for the exaggerated claims of the pro-vaping lobby, and are ignoring the health risks. The main claim, that e-cigarettes are a major aid to quitting, is wrong. If that were true, why would the multinational tobacco corporations be pushing vaping so hard?”
November 2, 2021
Christoph Tepr Joins Poda Holdings

Photo: Andryei Yalanskiy
Tobacco industry veteran Christoph Tepr has joined Poda Holdings as vice president of European sales & international expansion effective Jan. 17, 2022. In the interim, Tepr has joined the company’s global advisory board.
Tepr has more than 15 years of commercial experience with some of the biggest tobacco and e-cigarette companies in the world, including Philip Morris International, British American Tobacco, and Juul Labs. His broad management experience spans sales operations, commercial deployment, brand management and professional services—targeting customers in mature and emerging product/service segments. He has helped drive the growth of iconic brands such as L&M, IQOS, and Juul.
At PMI, Tepr held several key sales and management positions and was instrumental in deploying the IQOS product into the Swiss marketplace. At Juul, Tepr was hired to build the Swiss commercial organization from the ground up and, together with his team, took the company to category leadership within 12 months of launch. Subsequently, he successfully restructured the German commercial organization for Juul. Prior to this he held a commercial leadership position with British American Tobacco, focusing on commercializing and growing their Heat-not-Burn and conventional product portfolio.
Tepr holds a MSc in International Business from Maastricht University as well as an executive certificate in Driving Strategic Innovation from IMD Lausanne / MIT Sloan.
“Poda is an agile challenger in the fast-growing heat-not-burn space,” said Tepr in a statement. “With their proprietary technology platform, Poda represents a rare opportunity that has the potential to capture significant market share and ultimately transform and expand application areas within the category—while simultaneously improving the lives of the world’s 1.3 billion adult smokers by offering them a potentially less harmful alternative to conventional cigarettes. Having worked in multinational tobacco companies as well as for the fastest-growing e-cigarette start up in U.S. history, I look forward to using that experience to establish Poda’s European operations, set up a world-class team and make commercial headway into key European markets.”
“I am thrilled that Mr. Tepr has agreed to join the Poda team, both as a member of our global advisory board and, in January 2022, as the vice president of European sales & international expansion for Poda,” said Poda Holding CEO Ryan Selby. “Our goal is to build Poda into a truly global company that can challenge big tobacco head on, and we believe our superior heat-not-burn technology will allow us to do just that.”
November 2, 2021
Malaysia Plans Excise for Vapor Products

Photo: chachanit
The government of Malaysia plans to introduce excise duties on all vapor products containing nicotine, reports Malay Mail.
Without revealing the height of the intended taxes, Finance Minister Tengku Zafrul Abdul Aziz said the move was to promote a healthier lifestyle among Malaysians.
British American Tobacco managing director Nedal Salem commended the plan, saying it was a right move towards tobacco harm reduction in Malaysia.
“Regulation will not only allow vape users access to reduced-risk alternatives to smoking, but also ensure the products used are compliant to quality and safety standards,” Salem wrote in a statement.
However, he warned the government that any new tax framework must be carefully crafted to ensure it does not drive consumers toward cheaper, less-regulated alternatives.
“If not, the mistakes of high tobacco excise rates will be repeated where currently the government loses MYR5 billion (1.2 billion) annually,” Salem wrote.
November 1, 2021
Tobacco Tax Dropped from U.S. Legislation

Photo: RomanR
Previously proposed tobacco tax increases have been removed from the U.S. Build Back Better Act, a massive piece of legislation conceived to fund Covid-19 relief, boost economic recovery and invest in new infrastructure. The most recent version of the proposed bill, H.R. 5376, makes no mention of the measures.
The dropped proposal would have effectively doubled the federal excise tax on small cigars and cigarettes, and it would have increased the tax on chewing tobacco from a little over $0.50 to $10.70—more than 21 times its current level. It also called for a new tax on vapor products.
The proposed tobacco tax hikes attracted fierce criticism from retailers and tobacco harm reduction advocates, among others.
On Sept. 24., the National Association of Convenience Stores sent a letter warning lawmakers against unintended consequences, such as illegal trade and underage sales.
“When the price of a product rises too much too fast, illicit purveyors will seize the opportunity to exploit and take advantage of current users and entice new users without discriminating based on age,” the letter read. “This undermines the responsible measures our retailers have taken and creates a problem for society as a whole.”
Earlier, the Tax Foundation cautioned that the proposal would make cigarettes—the most harmful tool to consume nicotine—cheaper than other, less-risky tobacco products in many states.
While every U.S. state taxes cigarettes by quantity, a majority tax other tobacco products by price. When states tax tobacco products by price, the tax on the product will “pyramid” since the federal tax is levied at the manufacturer level and the state tax is levied at the distribution level, according to the Tax Foundation.
“In effect, the state tax base includes the federal tax and becomes a tax on a tax,” wrote Ulrik Boesen, senior policy analyst in excise taxes of the Tax Foundation.
While the most recent version of the H.R. 5376 omits tobacco tax hikes, there is no guarantee the measure will not reappear in future renderings of the proposed legislation.
November 1, 2021
Brazil: Tobacco Harvest ‘Inaugurated’

SindiTabaco President Iro Schunke honors tobacco growers during a ceremony in Rio Grande do Sul celebrating the sector’s contributions. (Photo: SindiTabaco)
Brazil leaf tobacco sector “inaugurated” the tobacco harvest on Oct. 28 in the Faxinal de Dentro district of Rio Grande do Sul. Promoted by the Secretariat of Agriculture, Livestock and Rural Development, the festivity is an official event of the state government and relies on support from the Interstate Tobacco Industry Union (SindiTabaco), Tobacco Growers’ Association of Brazil (Afubra) and the municipal administration of Vale do Sol.
Speaking during the ceremony, SindiTabaco President Iro Schunke said the inauguration of the harvest, held on Tobacco Growers’ Day, is an excellent opportunity to acknowledge tobacco farmers’ social and economic contributions.
“Approximately 10 percent of all Rio Grande do Sul exports last year consisted of tobacco shipments,” he said in a statement. “Several mayors report that, after the arrival of tobacco in their municipalities, things changed for the better, seeing that there was an increase in tax collection for the benefit of all citizens.”
November 1, 2021
Puff Bar CEOs Profiled

Photo: Puff Bar
The Wall Street Journal recently profiled Patrick Beltran and Nick Minas, co-CEOs of Puff Bar, a top-selling disposable e-cigarette brand in the United States.
Puff Bar entered the U.S. market in 2019. At the time, it was owned by Cool Clouds Distribution of California. Cool Clouds sold the Puff Bar to the brand’s Chinese manufacturer, DS Technology Licensing, in early 2020.
In February 2020, to curb youth vaping, the Food and Drug Administration implemented new restrictions excluding sweet and fruit flavors in reusable e-cigarettes such as those offered by Juul Labs. The restrictions did not apply to disposable devices such as Puff Bars.
In the summer of 2020, however, the FDA ordered Puff Bar products off the market. Critics said the brand was replacing Juul as the vape of choice among young people as Juul discontinued certain flavored products. In February 2021 Puff Bar resumed sales with redesigned product containing synthetic nicotine, which remains outside the FDA’s purview.
Minas and Beltran became executives of Puff Bar as CEO and CFO respectively in the spring of 2020, when the brand was taken over by two men and DS Technology as per company filings. The entrepreneurs owned and operated an online e-cigarette retailer called Eliquidstop.
In the Wall Street Journal article, Beltran described the Puff Bar ingredient change as “a forced innovation,” saying that the FDA gave the company no choice.
Puff Bar sales in retail stores tracked by Nielsen totaled $156 million for the year ended Sept. 25, according to Goldman Sachs, although it is unclear how many of those sales are counterfeit products. In a federal survey released in Sept., 26 percent of high-school vaporizers said they used Puff Bars. Among middle-school e-cigarette users, 30 percent reported that their generic brand was Puff Bars.
November 1, 2021
Clouded in Confusion

Photo: Prostock Studio
Confusion persists even as the U.S. Food and Drug Administration approves an ENDS product for marketing.
By Timothy S. Donahue
The U.S. Food and Drug Administration has created quite the mess. The regulatory agency’s handling of premarket tobacco product applications (PMTAs) has left many in the nicotine industry bewildered. It started with numerous refuse to accept and refuse to file letters. Then the agency began sending out marketing denial orders (MDOs). After publicly rescinding one of the MDOs—and with rumors circulating about additional rescissions—the agency is now being sued by at least 28 companies for making “arbitrary” decisions in reviewing PMTAs. The MDOs of least four companies have been granted a temporary stay through the courts or by the FDA itself.
As of this writing, the FDA has granted the Vuse Solo device and two tobacco-flavored pods produced by the R.J. Reynolds Vapor Co. (RJRVC) the first-ever marketing orders for a vapor product. The decision shocked many because the Vuse Solo is an unpopular and outdated device, according to some observers. RJRVC’s main e-cigarette product, Vuse Alto, which accounts for the vast majority of the company’s market share, has yet to receive a marketing order. The Alto PMTA was submitted an estimated two years after the Solo PMTA, according to media reports.
Sam Salaymah, president of AMV Holdings, parent to Kure CBD and Vape, called the FDA action a historic win for adult smokers that confirms e-cigarettes have been scientifically proven “appropriate for the protection of public health.” “[This] verifies that adult users are exposed to significantly fewer toxic aerosols and less harmful or potentially harmful constitutes than found in combustible cigarettes,” he says. “The science has spoken, and this is a great public health win for countless adult smokers looking to transition from deadly cigarettes.”

Vuse Solo received the first-ever marketing orders for an ENDS product.
(Photo: RJRVC)
But while approving Vuse Solo tobacco-flavored pods, the FDA rejected five of RJRVC’s flavored products. The agency is expected to only approve tobacco flavored pod systems; however, the outlook for open systems (alongside bottles of flavored e-liquids) is anyone’s guess. James Xu, president and founder of Avail Vapor, says that eventually he expects the FDA to approve an open system and some bottled tobacco-flavored e-liquids. He says that studies have shown that very few youths use an open system to vape, and the FDA is likely considering that factor. “I think it is just a matter of time,” he says. “In light of the many lawsuits and confusion in the vaping industry, the FDA is now likely taking more time to review the PMTAs before making any more decisions either for or against a product. I think we will have an open system with a marketing order at some point.”
Chris Howard
As of Oct. 19, the agency had announced 323 MDOs, accounting for more than 1,167,000 flavored vaping products (there may be more unannounced). Many vaping industry representatives and public health researchers believe the removal of all flavored products would negatively impact harm reduction efforts in the United States. “Some vapers will undoubtedly return to smoking combustible cigarettes,” says Chris Howard, vice president, general counsel and chief compliance officer of E-Alternative Solutions. “And smokers who might have transitioned to ENDS [electronic nicotine-delivery system] products may now elect not to do so.” The current state of the ENDS industry is what many industry observers predicted as far back as 2016, according to Howard. Given the entry of ENDS products into an already highly regulated space, manufacturers would need to be “significantly capitalized and possess material expertise to navigate the requirements” to survive FDA regulation, he says.
“Unfortunately, despite a near universal view that flavored ENDS products present a tremendous harm reduction opportunity to smokers seeking to quit or reduce their combustible cigarette intake, cost-saving shortcuts during the premarket approval process are very unlikely to meet FDA’s threshold regarding the quality, quantity and type of data required to obtain market orders,” says Howard. “In the short term, this will have a significant impact on consumers as they will now have significantly fewer choices of both devices and flavors available. That said, I remain confident that given time, the industry will obtain more clarity, and a path for the return of flavored vapor options will materialize. FDA is the biggest proponent of harm reduction when it comes to tobacco and recognizes that providing adult smokers with options is important.”

Jamex Xu
In the meantime, MDO recipients are fighting back. Pursuant to Section 912 of the Tobacco Control Act, companies who receive PMTA denials have 30 days to petition for a judicial review of the decision. Days after it received its MDO, Turning Point Brands (TPB) filed a petition for review with the United States Court of Appeals for the 6th Circuit, followed shortly thereafter with a motion to stay the MDO. Just days later, the FDA rescinded Turning Point’s MDO. The FDA admitted that after “further review of the administrative record,” it made an error in TPB’s PMTA review, and TPB did in fact submit studies that the agency decided during the PMTA process were needed, after saying for years the studies were not required. “We are encouraged by the FDA’s decision to reconsider our product applications and look forward to engaging the agency as our PMTAs are reviewed,” said Larry Wexler, TPB’s president and CEO, in a statement following the rescission. “It is important that the PMTA process is transparent, purposeful and evidence-based. Our organization dedicated significant time and resources in filing our applications in accordance with agency guidance.”
Azim Chowdhury
The FDA has set an extremely high bar when it comes to authorizing e-liquid flavors, explains Azim Chowdhury, a partner at the law firm Keller and Heckman who specializes in vapor, nicotine and tobacco product regulation. According to Chowdhury, the MDOs essentially created a new standard for flavors: Applicants must demonstrate an “added benefit” of a nontobacco flavor that outweighs the known risk to youth use through the use of either a randomized controlled trial (RCT) or a longitudinal cohort study (LCS).
“[The] FDA clearly jumped the gun with at least some of these companies in the way that they issued the MDO without giving the PMTAs a full scientific review as required by the statute. That being said, even if some of these lawsuits are ultimately successful, the outlook for flavored ENDS, to me, looks pretty grim,” says Chowdhury. “Even if we’re successful in these lawsuits and the MDOs get vacated and the PMTAs go back into review—which is good—the FDA is ultimately going to have the final say in what science is required and what is going to be enough for them to believe a flavored product is appropriate for the protection of public health.”
Whatever data Vuse submitted for its flavored PMTAs hasn’t been disclosed publicly. Chowdhury says that it was likely robust and exceeding anything that most small manufacturers submitted for their flavors. “Right now, no one can tell you what it takes scientifically to get a flavor through,” he says. “Even in the best-case scenario, if we get the courts to say that FDA did this wrong, they should have done a hard look at the PMTAs, that they should have given companies fair notice about this requirement for RCTs and LCSs, they should have perhaps even gone through a notice and comment rulemaking period … even if one of those arguments win in court, it’s still only going to result in the PMTAs going back into scientific review.”

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TPB’s stay motion (which the company dropped after the FDA rescinded its MDO) stated that the agency had moved the goalposts for data needed to receive a marketing order based on what the agency “learned” from the “review [of] PMTAs for flavored ENDS so far.” Nearly every MDO/PMTA lawsuit filed has followed TPB’s blueprint and is asking the courts to review the FDA order “on the grounds that it is arbitrary and capricious.” The FDA has already had MDOs for Triton Distribution, My Vape Order and Gripum LLC placed on hold by the courts, and the agency has told at least two other companies that received MDOs that it would rescind the orders or “not enforce” them, according to sources.
Chowdhury said that technical project lead reports concerning PMTA reviews obtained through Freedom of Information Act requests revealed that the FDA performed a “box checking” exercise to see if an application contained an RCT or LCS instead of an actual scientific review of the application. “The first thing they have in these decision memos is, literally, a table where it says, ‘Do you have an RCT?’ No. ‘Do you have an LCS?’ No … then that’s it. If you said ‘no’ to both of those responses, they didn’t look at the rest of the application. This is mind-boggling because the statute, guidance and final PMTA rule, etc., all make clear that the APPH standard is a complex, multifactor standard. It requires all sorts of evidence and data, and it doesn’t require any one particular type of study. FDA avoided considering any of the other information contained in the PMTAs, including marketing restrictions and youth access prevention measures.”

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Chris Allen
The FDA’s rationale for banning flavored products is its desire to address what the agency has long described as an “epidemic” of youth vaping. However, recent evidence seems to show that the overall youth use of e-cigarettes in the U.S. is declining. According to the 2021 National Youth Tobacco Survey (NYTS), the FDA and the Centers for Disease Control and Prevention (CDC) found that youth use of e-cigarettes fell sharply in 2021. It’s the second consecutive year of major declines.
Many in the industry say the FDA’s negligence in the PMTA review process and its single-minded focus in preventing youth uptake is going to create additional issues, further clouding the vapor industry’s outlook. Chris Allen, chief scientific officer at Broughton, a contract research organization (CRO) delivering analytical, scientific and regulatory services for the ENDS industry, says that the FDA might well be using the NYTS to justify the “flurry of MDOs” issued for flavored e-liquids. He also said the majority of the companies that have fallen foul of the recent MDOs are responsible manufacturers supporting tobacco harm reduction.
“I completely accept that youth use is unacceptable; however, the issue doesn’t appear to lie primarily in open systems but a product that is currently outside the jurisdiction of FDA: a disposable containing synthetic nicotine,” says Allen. “Regardless of the product, or the source of nicotine, there’s no place for irresponsible marketing and distribution practices that keep adding fuel to this fire. I fear that the latest action is simply going to lead to a seismic shift into the black market and unregulated (synthetic nicotine) products, which will be near on impossible for the U.S. government to control. From my personal perspective, this doesn’t seem an appropriate way to support THR [tobacco harm reduction].”
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.

November 1, 2021
Stepping Up

Tim Liddicoat
(Photo: Hall Analytical)
Hall Analytical is investing in reduced-risk product analysis to meet growing demand driven by innovations and regulatory requirements.
By George Gay
Hall Analytical’s sponsorship of the recent GTNF in London represented the company’s first participation in this annual conference, and Tobacco Reporter was keen to discover why it had decided to take part this year. Did its participation represent, for instance, a vote of confidence in the future of the nicotine industry?
Given the chance of an email exchange with managing director Tim Liddicoat, Tobacco Reporter started off by asking whether he believed Hall Analytical’s nicotine industry business would increase or decrease in the future.
Tim Liddicoat: We are convinced that our nicotine industry business will significantly increase in the next five years. With our investment in reduced-risk product analysis at Hall Analytical, we believe that client requirements for our analytical expertise will substantially increase in the next several years. The recent report in Research and Markets predicts the global ENDS [electronic nicotine-delivery systems] market to reach $84.43 billion in 2025, and we have the infrastructure and expertise to service this market with high-quality scientific data.
Tobacco Reporter: Why this optimism? Do you believe the nicotine industry regulatory environment will become more demanding in the future?
As the burden of proof required to prove APPH [appropriate for the protection of public health] increases incrementally in the U.S. and as European legislation develops, along with the need to support new innovations in the space, we see the analytical testing requirements becoming more demanding. This drives us to develop even more sensitive, precise, accurate and robust analytical methods.
In addition, as regulatory frameworks continue to be strengthened in established markets around the world and client demand for high-quality product characterization, emission analysis, stability and E&L [extractable and leachable] studies will only increase. The recent publication of the U.S. FDA’s final rule for the PMTA [premarket tobacco product application] pathway has established the minimum data requirements for a deemed tobacco product to enter substantive review. This certainty has been welcomed by the RRP [reduced-risk product] sector, enabling product regulatory compliance strategies to be reviewed and re-engaged. The published final rule, and limited market authorizations of tobacco-flavored ENDS to date, strongly suggest the agency’s burden of proof to demonstrate APPH is substantial. The European TPD [Tobacco Products Directive] regulatory review is imminent, and there’s every indication that a tightening of regulation around flavored ENDS products is favored by the majority of member states. This will potentially increase the requirements for analytical services from our European TPD clients.
Client requirement for our services will not only be fueled by regulatory compliance but rapid innovation in product technology with safety and user experience at the heart of new product development.
ENDS clients are also looking to emerging markets for growth, with national regulators examining established markets for guidance on appropriate regulatory frameworks. Tobacco companies traditionally focused on combustible cigarettes are rapidly diversifying their product portfolios toward reduced-risk alternatives for a sustainable business future. Growth in global markets for the next generation of nicotine-containing products will progress rapidly, and our ability to respond to clients’ needs will enable Hall Analytical to attract new business servicing the RRP sector.

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Who owns Hall Analytical?
Hall Analytical is owned by Element Material Technology, a leading global provider of testing, inspection and certification services on a wide range of products, materials, processes and services for a diverse set of end markets, where failure in service is simply not an option.
Headquartered in London, U.K., Element’s scientists, engineers and technologists, working in its global network of over 200 laboratories, support customers from early R&D, through complex regulatory approvals and into production ensuring that their products, materials, processes and services are safe, compliant and fit for purpose.
Is ownership about to change?
Hall Analytical was acquired (along with VR Analytical, Crawford Scientific, Anatune and APEX Scientific) in July 2021, and ownership is not about to change again.
What, in layman’s terms, are the main methods you use and the main pieces of equipment you use, especially in respect of testing e-cigarette and heat-not-burn products and vapors?
When testing ENDS products, we focus on the analysis (testing) of the e-liquid and resultant vapor emissions, which are inhaled by the user. E-liquid testing can be more straightforward than analyzing ENDS vapor. The e-liquid samples received from clients are prepared in the laboratory and tested using analytical instruments, which employ either liquid chromatography (LC) or gas chromatography (GC) to separate the complex mixture of chemicals. The LC or GC is connected to a detector, such as a mass spectrometer, which can detect, identify and accurately quantify trace levels of chemical compounds. To unequivocally quantify trace chemicals in complex e-liquids and vapor emissions, we use tandem mass spectrometry for extremely sensitive and specific chemical detection. Trace metal quantities in e-liquid and vapor emissions are determined using a technique called inductively coupled plasma mass spectrometry.
For vapor emission analysis of both ENDS and heated-tobacco products (HTPs), we employ the same analytical instruments but need to generate vapor emissions from the test devices in a standardized procedure. To do this, we use an automated e-cigarette/HTP vaping machine specifically designed to be compliant with international testing standards. The test device emissions are generated by the machine, collected, prepared in the laboratory and then analyzed by the techniques previously discussed.
You mention above quantifying “trace chemicals in complex e-liquids.” How would you explain to a layman what complex trace analytical chemistry is?
Many chemicals can be found in complex mixtures at very low “trace” concentrations in different matrices, such as pharmaceutical products, environmental samples, physiological samples (blood, urine, etc.) and e-liquids used in e-cigarettes. Most of these trace chemicals were not detectable for many years due to limitations in analytical instruments and methods. With modern advances in instrumentation and techniques, laboratories can detect and precisely determine the amount of trace chemical present in a complex test sample.
What are the main services you offer, apart from those already mentioned?
Hall Analytical delivers industry-leading scientific expertise that supports our customers’ ability to ensure product safety. We do this in support of a number of industries: tobacco (to support both product development and regulatory submission for reduced-risk products) and pharmaceutical and medical device supply chain and manufacturers. Our main services are in support of chemical analysis of RRPs and E&L testing for all aforementioned industries.
Do you offer any services in respect of traditional tobacco products?
We have recently moved into analytical testing of HTPs but currently do not analyze traditional tobacco products.
Where is your company based?
Hall Analytical is based at a 25,000-square-foot facility in Wythenshawe, Manchester, [U.K.]. This is the only Hall site, but the wider Element organization has a global network of over 200 laboratories, some of which support reduced-risk product testing similar to that carried out at Hall Analytical.
How many people work for Hall Analytical?
Hall Analytical currently has 50 staff. There are about 200 people in the wider Element Life Sciences EMEAA [Europe, Middle East and Africa] organization split over five companies (Hall Analytical, VR Analytical, Crawford Scientific, Anatune and APEX Scientific), with the Element Material Technology business working in a global network of over 200 laboratories.
Are they mainly chemists and technicians?
Hall Analytical employees are split between the operational team, quality, science (study direction, R&D and subject matter experts, E&L specialists), commercial and supporting functions (project management, HR, HSE [health and safety], admin and IT) with the majority directly supporting our customers by delivering industry-leading scientific expertise that supports our customers’ ability to ensure product safety.
In which countries are your main customers based?
Our customer base is primarily European and North America[n], but we have customers based worldwide. Many customers are large multinational organizations, and we have supported them from Australia to South America and beyond.

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Which industries provide the bulk of your business?
Tobacco companies, pharmaceutical companies, medical device organizations and their supply chain partners make up the bulk of our business.
You expressed confidence earlier, so would it be fair to say that your business is growing?
We have a strong business that is well placed for future support of all of our customers. We fully expect the business to sustainably grow in the coming years and to further expand its services and offerings in tobacco RRPs, pharmaceutical E&L and medical device E&L. We see fantastic opportunities with our acquisition by Element and will continue to work in partnership with our customers to meet their needs as their businesses develop.
Does this mean you invest significantly in the business?
In recent years, we have been well supported with significant investment in infrastructure (£2 million), instrumentation and data systems (£1 million), business leadership and our quality management system to reflect changing customer needs and maintain our commitment to state-of-the-art, high-quality analytical services.
Has your business been affected by Brexit and, if so, how?
The only impact we have had from Brexit has been with supply of chemicals from the EU. With changing REACH [Registration, Evaluation, Authorization and Restriction of Chemicals] regulations, it has become more difficult to predict which reagents and standards will be available, but we have mitigated well with increased stock of hard-to-get chemicals.
Has your business been affected by the Covid-19 pandemic and, if so, how?
Covid has impacted our business in ways that we would not have predicted. On the one hand, we saw a slowdown in the responsiveness of the FMCG [fast-moving consumer goods] markets we serve due to the restrictions of working on-site for many of our customers, but, in contrast, supporting vaccine development, ventilator production and a general acceleration of pharmaceutical and medical device projects accelerated.
Operationally, we flexed well to a hybrid work model where some activities could be done remotely, and there was little impact. We also moved facility at this time, and this was delayed a little.
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.

November 1, 2021