Category: Also in TR

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  • Stepping Up

    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.
  • Flooding the Market

    Flooding the Market

    Photo: Lezinav

    The U.K. vaping industry sounds the alarm over noncompliant products.

    By George Gay

    Earlier this year, the U.K. Vaping Industry Association (UKVIA) called for “tough action against resellers of noncompliant disposable vape products,” which were said to be on sale widely across the U.K. and online. Indeed, a UKVIA investigation was said to have found that “illegal and counterfeit products” were “flooding into the market,” posing “a potential health risk to customers.” Inappropriately branded products were being purposely marketed toward children, the release said.

    The situation is clearly concerning, but care needs to be taken here because it could be lethally counterproductive if reports about the need to combat the problems caused by the arrival of noncompliant disposable vapes were seized upon and used by those opposed generally to the use of vapor products as harm reduction tools proven to help smokers switch from traditional cigarettes to e-cigarettes. It is important to note that there is nothing inherently wrong with the harm reduction credentials of disposable vape products, given that they are registered with the relevant authorities. In fact, such products can act as a handy entry point for those smokers who have yet to make up their minds about the switch to vaping because disposables do not require a significant capital outlay and they are, relative to traditional cigarettes, inexpensive.

    But while this is all well and good when it comes to licit products, things start to fall apart when unregistered products become available, though even here it is not necessarily the case that an illicit product will be more risky or less effective than other products. The problem arises because it is not known under what conditions illicit products have been manufactured and because of the way that such products distort the market. In the eyes of consumers who buy unregistered disposables unwittingly, these products do reputational damage to the legitimate industry and the whole concept of harm reduction if they underperform. And the very existence of unregistered disposables causes reputational damage to the legitimate industry in the eyes of society at large.

    Add to this the fact that under-enforcing regulations on a strictly regulated market, as is currently happening, puts the suppliers of licit products at a disadvantage to the suppliers of illicit products in respect of such matters as costs and speed to market. To place a vape product on the U.K.’s market, a company is required to have that product tested by independent, qualified companies in respect of requirements laid down by the Medicines and Healthcare Products Regulatory Agency (MHRA). It has to submit a registration application complete with the results of the required tests to the MHRA, which then has up to six months to approve the application, request more information or reject the application—a service for which it charges a fee. No product may be placed on the market until it has been approved and that approval has appeared on the MHRA’s website.

    John Dunne

    Facilitating Enforcement

    It is hardly surprising then that, while the industry welcomes robust, appropriate regulation, it can lead to frustration when a parallel, nonregulated market opens up and grows, as has happened and is happening in the U.K. While the UKVIA can and does monitor the market and call out where illicit products are on sale, it cannot enforce the regulations. And this is why John Dunne, the UKVIA’s director general, said in the press note that his organization was “calling upon regulators and the online marketplaces to robustly enforce current regulations and do much more in order to ‘clean up’ the disposable vapes market.”

    At this point, a question arises, and I asked Dunne during a telephone conversation why the regulations were not being enforced robustly. The reality, he said, was that Trading Standards, which is responsible for ensuring businesses are compliant with regulations governing the sale of vape devices and e-liquids, was under-resourced. This is a common problem in austerity in the U.K. and is unlikely to go away given the current government’s policies, so I asked Dunne whether there were ways in which the UKVIA could help ameliorate the situation. “We are trying to work out some creative ways in which, as an industry, we could help,” he said. The industry was considering the provision of funds for further enforcement if resources comprised the issue. And it had offered to provide training to enforcement officers if product knowledge was the issue.

    Dunne added that the UKVIA had recently published a one-page comprehensive guidance on the compliant retailing of disposable vape products in the U.K. And one idea that was in the pipeline was the provision by the UKVIA of one-page documents that include the images and information necessary for Trading Standards officers to easily tell a counterfeit product from a legitimate one, at least in respect of high-profile brands.

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    Unfair Competition

    One problem is that such initiatives take time to implement, especially given that Trading Standards offices operate independently in the various counties and countries that make up the U.K., and, in the interim, those interested in scamming the system have a relatively free hand.

    Another important question that arises concerns the ways in which products appearing on the market are noncompliant: Why haven’t they been registered with the MHRA? There are two basic answers to this question. One is that while the product in question conforms to U.K. regulations, its supplier has not, for whatever reason, put the product through the registration process or because the process has not been completed and the supplier has jumped the gun.

    The other answer as to why a product does not conform with the regulations is obviously more problematic. In some cases, it might be an e-liquid’s nicotine strength that makes its sale on the U.K. market illegal. Dunne said that some of the illicit products that had been identified had nicotine strengths two-and-a-half times the maximum allowed in the U.K. and were clearly marked “For sale in the U.S. only.” In the case of others, it was the tank size that broke U.K. market regulations, something that could be determined from the number of puffs that the device was credited with delivering. Yet other products were noncompliant because of failure to meet packaging requirements, which, as is spelled out in the guidance document issued by the UKVIA, are extensive.

    On the positive side, Dunne said that none of the e-liquids in the illicit disposables the UKVIA had tested contained any substances that raised concerns, and while some e-liquids were of a higher strength than was permitted, those strengths were as indicated on the packaging.

    Nearly all of the noncompliant products originate in China, but then so do nearly all of the compliant products, a geographical monopoly that has at least one advantage. When factories producing counterfeit products are located in China, the authorities act quickly to close them down. There is, after all, no reason to suffer reputational damage as a harborer of counterfeiters when you can sell the genuine product just as easily.

    One of the ways in which consumers can take to protect themselves against illicit products, according to the UKVIA, by consistently buying from a reputable source.
    (Photo: VPZ)

    Know Your Source

    What, for people such as me, is particularly galling about the arrival on the U.K. market by air and by sea of a growing number of illicit vaping products is the fact that this is happening at a time when so many other products are in short supply due, we are told, to Brexit, the Covid-19 pandemic, the Suez snafu and a lack of lorry drivers—when water companies are unable to access all the chemicals they need for treating sewage.

    But while illicit disposables arrive with near-impunity, once in the country, it should be another matter. Dunne said it should be possible to identify how counterfeit products were getting through the distribution system because all the manufacturers were supposed to be able to track their products from manufacture through to the consumer. So if they were doing things correctly, it should be possible to take a picture of a pack code and send it to the apparent factory of manufacture for verification or not. That is the theory. In reality, the system is so far not operating fully, so there is room for improvement.

    In any case, while the information garnered from such systems can be used to good effect in examining the workings of distribution channels and, in retrospect it has to be said, tighten them up, they do little directly for the consumer. For a consumer to discover, post-purchase, that a product is a fake or not registered merely leaves her in the position of having to decide whether she takes the unknown risk of consuming the product or takes the financial hit of throwing it away. It takes only a few seconds’ thought to realize that this situation is not in the interests of consumers or the industry.

    There are, however, some basic precautions that consumers can take to protect themselves. “The advice I always give is that you should buy from a reputable source,” said Dunne. “You buy from your local vape store whose business it is. They know these devices; they know where they come from. And for the most part, they sell only products that are registered correctly or that come from a known supplier.”

    Even so, vapers can be misled, especially, for instance, when they buy online. Dunne said he had contacted a number of platforms, including eBay and Amazon, neither of which, to his way of thinking, controlled the vape products displayed on their websites robustly enough. Amazon claimed it didn’t sell any products that contained nicotine, he said, but during the morning of the day I spoke to him, he had quickly identified 10 different high-capacity vape devices on offer on the platform, all of which contained nicotine. Some of them were displayed under a headline that indicated “No nicotine,” yet nicotine strengths could be seen on the pictures of the products. “So,” he said, “my question to Amazon is: How are you policing the products that are being put on your site? Some of these devices are not sold nicotine-free anywhere in the world.”

    Finally, picking up on a part of the press note in which it was said that disposables had a major role to play in the vape market, I asked whether it wasn’t the case that they also comprised a potential environmental problem. Dunne readily admitted that this was a concern for the industry. “And that is one of the reasons why the association as well as several manufacturers are looking at how these products can be recycled,” he said. “If we can find recyclers here in the U.K. that can deal with volume, there is an appetite within the industry to set up some sort of pick-up and recycle program.”

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    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.
  • Howard: Will Harm Reduction Prevail?

    Howard: Will Harm Reduction Prevail?

    Photo: Photolia Premium

    It could be some time before the U.S. Food and Drug Administration issues marketing orders for flavored vapor products.

    By Chris Howard

    For the past 10 years, we have ridden a rollercoaster together. We have experienced the same highs and lows and shared the hope that harm reduction will prevail in the end. Then, over the course of the past several weeks, the journey ended abruptly with marketing denial orders (MDOs) for so many. Not surprisingly, several question whether the vapor industry can ever recover.

    The FDA’s Recent Actions

    For what it’s worth, the recent actions of the U.S. Food and Drug Administration should not have been a surprise to anyone in the vapor industry. We have known for several years that being part of a highly regulated segment would not be easy. In fact, the FDA made its expectations clear in its 2016 Draft Guidance entitled Premarket Tobacco Product Applications for Electronic Nicotine-Delivery Systems (ENDS). In sum, this document revealed that obtaining a marketing order for vapor products would require scientific expertise, extensive data development and very deep pockets.

    That said, the FDA’s rationale for such broad-based denials has raised questions among many. More specifically, the FDA provided the following rationale in its Aug. 26, 2021, news release:

    In light of the public health threat posed by the well-documented, alarming levels of youth use of flavored ENDS, the agency has reviewed the applications subject to this action to determine whether there is sufficient product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth. Based on existing scientific evidence and the agency’s experience conducting premarket reviews, the evidence of benefits to adult smokers for such products would likely be in the form of a randomized controlled trial or longitudinal cohort study, although the agency does not foreclose the possibility that other types of evidence could be adequate if sufficiently robust and reliable.

    The primary question we are left to ponder is whether this balancing of interests exceeds the FDA’s standard for assessing whether a product is appropriate for the protection of public health. Based on Section 910 of the Tobacco Control Act, which describes the appropriate standard of review, it appears that this balancing is one of many facets of an application that the FDA is required to consider.

    Appropriate for the Protection of Public Health

    Section 910 of the Tobacco Control Act provides the FDA’s standard of review for new tobacco products:

    …whether the marketing of a tobacco product for which an application has been submitted is appropriate for the protection of the public health shall be determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account—

    (A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and

    (B) the increased or decreased likelihood that those who do not use tobacco products will start using such products.

    So clearly, the risk of initiation of flavored ENDS products by youth is relevant as is the likelihood of ceasing use by smokers generally. Without a doubt, the FDA has determined that evidence related to part (A)—cessation—must outweigh part (B), initiation. This risk balancing, in the FDA’s own words, is reflected in data from clinical studies or longitudinal studies demonstrating that adult use of flavored ENDS leads to cessation (or switching) outcomes that exceed the risk of youth initiation of tobacco product use. And yet, despite this seeming clarity, many questions surround this analysis. For example, by how much must adult cessation exceed youth initiation? What if both tobacco varieties and flavored varieties show the same or similar cessation rates? Has the FDA considered the reduction in use by youth resulting from the recent change in the age to purchase tobacco products to 21 when examining the balancing of risks versus benefits?

    These questions are likely to remain unanswered for quite some time. Many committed companies are already beginning efforts to satisfy the FDA’s outstanding requests for clinical studies and/or longitudinal data, but the development of data will take several months. Obviously, this is likely to do significant damage to an already fractured market—and even more potential damage to smokers seeking an alternative to combustible cigarettes.

    Flavors Are Critical for Harm Reduction

    Despite these tumultuous past few weeks, the FDA is arguably the biggest advocate for harm reduction. Given the agency’s desire to provide options to adult smokers to move away from traditional combustible cigarettes, it seems clear that a pathway for flavors to return does indeed exist.

    Along with the rest of the industry and many public health researchers, I believe that 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. And smokers who might have transitioned to ENDS products may now elect not to do so. In the studies conducted at my company, E-Alternative Solutions, we demonstrated that adults prefer flavors and that flavors assist adults in transitioning from combustible cigarettes to potentially less harmful alternatives. Existing literature documenting the research conducted by others also supports this proposition. Moreover, anecdotal reports are easy to find on Twitter and multiple other social media forums.

    While it may not be apparent from the FDA’s recent actions, I do not believe that flavored ENDS are finished in the United States. While the bar appears high, I hope and expect, for the sake of adult smokers in this country, that we will see flavored ENDS on the U.S. market again. That said, it could take time until the agency issues market orders for flavored vapor products.

    What’s Next?

    The FDA’s recent decisions will likely prompt many to appeal and some to resort to litigation [at least two suits are known to have been filed already]. The FDA appears prepared to address these initiatives and is prioritizing enforcement of those failing to comply with MDOs and/or who are selling vapor products that have not undergone premarket review. While these activities are ongoing, many will begin longitudinal studies and the hard work to identify alternative methods to show the FDA that flavors are determinative in adult smokers’ efforts to switch from combustible cigarettes.

    Ultimately, we will have to wait while the remainder of the story unfolds. Hopefully, the FDA will be prepared to work directly with sophisticated manufacturers to ensure that flavored ENDS can continue to play a role for adult smokers seeking alternatives.

     

    Chris Howard is the vice president, general counsel and chief compliance officer of E-Alternative Solutions, an independent, family-owned innovator of consumer-centric brands.
  • ‘Vuse Authorization a Positive for Harm Reduction’

    ‘Vuse Authorization a Positive for Harm Reduction’

    Photo: R.J. Reynolds Vapor Co.

    More governments need to follow the science.

    By Derek Yach

    The evidence is in. For the first time, the U.S. Food and Drug Administration has authorized the marketing of an e-cigarette in the country because it determined the help it offers adult smokers outweighs the attraction such products may hold for youth.

    The decision to allow the sale of British American Tobacco’s Vuse Solo closed electronic nicotine-delivery system, along with three tobacco-flavored cartridges, marks the third time in less than two years that the agency, despite vociferous, emotion-driven opposition from politicians and interest groups, has used peer-reviewed scientific evidence to approve tobacco harm reduction (THR) products.

    With this latest move, the FDA has signaled a distinct turn in the oft-contentious debate surrounding e-cigarettes, in which opponents claim little is known about what toxic chemicals they contain and that the tobacco industry has a terrible track record when it comes to being forthcoming about its products.

    That was not the case here, indicated Mitch Zeller, the director of the agency’s Center for Tobacco Products. “Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust scientific premarket evaluation,” he said in a statement. “The manufacturer’s data demonstrates its tobacco-flavored products could benefit adult smokers who switch to these products—either completely or with a significant reduction in cigarette consumption—by reducing their exposure to harmful chemicals.”

    We have said it before, and we’ll continue to say it again (and again and again) in the face of all this misinformed vitriol and distrust: THR products are effective tools to help smokers lessen their risk of developing diseases such as lung cancer and COPD. So says one study after the next, including a recent measured, sober look at the risks and benefits of e-cigarettes that is signed by no less than 15 former presidents of the Society for Research into Nicotine and Tobacco, a leading international proponent of evidence-based science.

    The key word here is “evidence.” Although e-cigarettes are not risk-free, they have been found to be up to 95 percent less harmful than combustible cigarettes because they contain no tar and significantly fewer chemicals that make up the toxic stew of smoke in combustible cigarettes.

    Evidence, carefully compiled, weighed and debated, is how the FDA reached its earlier decisions to provisionally authorize the sale of Swedish Match’s snus and Philip Morris International’s IQOS heat-not-burn sticks as modified-risk tobacco products (MRTPs), subject to regular review. And “evidence” is how it made its first decision to approve the marketing of Vuse.

    It reached its decision through dispassionate, rigorous diligence—a risk-proportionate, microscopic gauging of the potential harm e-cigarettes pose for young people versus their potential therapeutic uses for adults who smoke combustible cigarettes and would like a less damaging alternative. Indeed, the FDA’s approval process is so thorough, it is accepted as the international gold standard for vaccines, pharmaceuticals and medical devices. As Adam I. Muchmore, a Pennsylvania State University law professor, explained last month [August] in an interview with Newsweek about the wait for Covid-19 vaccine approval, “There are a lot of ‘i’s’ to be dotted and ‘t’s’ to be crossed, and these are not simple bureaucratic requirements. Both producing this data, and reviewing it, requires the work of multiple experts in a wide range of scientific fields.”

    We hope the FDA will continue to use scientific evidence to approve the sale of menthol-flavored e-cigarettes so that combustible menthol cigarette users, among them the majority of African-American smokers, also have the opportunity to reduce their health risk. And we hope it will consider that nicotine-replacement therapy gums and sprays are already marketed in menthol and other flavors, all to help smokers quit.

    One does not need to look far to see the effects of FDA decisions: Following its full approval last August of Pfizer-BioNTech’s Covid-19 vaccine, a “tidal wave” of people were expected to line up for their jabs, spurred by employers and businesses that have been waiting for the green light and at least some doubters who needed more reassurance it is safe.

    And the National Institutes of Health’s Anthony Fauci aptly summed up the FDA’s influence in a comment earlier this year about its approval for Aimmune Therapeutics’ Palforzia, the first drug to treat peanut allergy for children. “Science is showing us the path to a future in which new therapeutic options may provide both solutions as well as peace of mind that individuals with food allergies and their families deserve,” he said.

    Those words could well apply to the field of THR too, although the FDA’s policy of placing the onus solely on individual companies to prove they contribute to public health (to wit, the 2.3 million pages of evidence PMI submitted on behalf of its IQOS application) has already left some smaller, streamlined companies out in the cold.

    That said,  governments in lower and middle income countries (LMICs), where the vast majority of the world’s 1.14 billion smokers live, would do well to study all three of the FDA decisions regarding THR products as they work to strengthen their own national research and regulatory capabilities and to take note of the careful steps the agency continues to take as it examines the applications of other companies that manufacture e-cigarettes, including Juul.

    These governments and their public health authorities need to review the statistics from places such as the United Kingdom, which has supported e-cigarette use as an effective way to lessen health risks and even quit combustible smoking altogether. Or, conversely, they could take two minutes and 42 seconds to watch a graphic Public Health England demonstration of the viscous, oozing, sticky dark brown residue left in the lungs from the smoke from 16 packages of cigarettes over the period of one month compared to the barely discernible trace of vapor left by the equivalent number of e-cigarettes over the same period.

    Right now, a huge gap exists between research output in tobacco control by a few developed countries and LMICs, and when it comes to reduced-risk products, the gap is even greater, a reflection of both the lack of support for homegrown scientific research and a concomitant reliance on advanced industrialized countries for regulatory scientific advice and support. The Foundation is committed to playing its role in closing this gap to allow LMICs to have the scientists able to fully inform their policymakers about the potential benefits of THR.

    There appears to be no interest in tobacco harm reduction as a principle or a tendency to unquestioningly accept the warnings by bodies such as the World Health Organization, which itself is mired in a past overtaken by technological advancements and sounds like the proverbial Greek chorus as it points to the lack of long-term testing and the perils such products pose to youth.

    The most extreme example of this governmental attitude is in India, where, despite 1.3 million people dying each year from tobacco-related diseases, e-cigarettes were banned in haste by the government, which was urged to do so by The Union, a Bloomberg-funded NGO based in Paris that recommends such extreme measures for LMICs on the supposed grounds that youth in these countries are particularly vulnerable. In turn, this has led to a burgeoning black market that prices these products out of reach of many of the disadvantaged communities who could use them most.

    The fact is, the most favored tobacco control measure in India is tax increases, which only serves to exacerbate the difference between the rich and the poor, for the latter group must turn to cheaper, even more dangerous products such as bidis, thin cigarettes composed of unprocessed tobacco that are hand-rolled in leaves and contain higher concentrations of nicotine, tar and carbon monoxide than conventional cigarettes sold in the United States.

    In Indonesia, where more than a quarter of the population smokes, including 19.4 percent of young people between the ages of 13 to 15, the local—and significantly cheaper—cigarette of choice is the unfiltered kretek, made from a blend of tobacco, cloves and other additives. Yet, there is little government oversight, with children even exposed to lengthy tobacco advertisements before blockbuster Hollywood films.

    Still, the WHO refuses to apply the consequences of harm reduction always being part of the definition of tobacco control in the Framework Convention on Tobacco Control. A good start would be for the WHO to consider recent peer-reviewed research by leading scientists that underpins the FDA submission and not reject it simply because it has been funded by the tobacco industry. In its Report on the Global Tobacco Epidemic—2021, it does not waver from its position, stating that new and emerging products simply chart a “new threat to tobacco control.”

    “As they emerge and rapidly evolve, these products can be difficult to characterize and therefore bring with them many regulatory challenges,” it states. “At the same time, the tobacco and related industries behind these newer products pedal misinformation campaigns, marketing them as ‘clean,’ ‘smoke-free’ or ‘safer,’ and claim they are effective cessation aids. By doing so, these industries attempt to appear part of the solution to the tobacco epidemic as opposed to instigators and perpetrators of the epidemic.”

    How disheartening! Yes, the tobacco industry has acted unconscionably in the past, lying about the toxicity of cigarettes and shamelessly professing its primordial dedication to the health and welfare of smokers. But, to paraphrase the old saying, change—real change—starts from within. We are seeing signs of that in the tobacco industry, with the results recognized by the FDA, leading health experts and authorities in countries such as the U.K.  

    It is time for all of us to move on—together.

    To stop treating all nicotine products as the same.

    To acknowledge that we all have a stake in people’s health and well-being and in a healthy future for our children, their children and for generations to come.

    And to start saving up to 4 million lives a year in the interim as the battle—our battle—continues to eradicate combustible tobacco for good.

    Derek Yach is the president of the Foundation for a Smoke-Free World.
  • Shaking off the Shackles

    Shaking off the Shackles

    Photo: prakasit khuansuwan/EyeEm

    The Philippines is rebuffing outside forces seeking to derail its tobacco harm reduction policies.

    By Stefanie Rossel

    The Philippines is about to become the first country in the Asia-Pacific region to introduce risk-proportionate vaping legislation. By doing so, it is defying the World Health Organization, which has been skeptical about tobacco harm reduction (THR). The Philippines is part of a small group of nations that have started scrutinizing the influence of big WHO donors on national tobacco control policies.    

    In December 2020, two Filipino congressmen called for a congressional investigation into the Philippines Food and Drug Administration’s (PFDA) acceptance of funding from the International Union Against Tuberculosis and Lung Disease, which is popularly known as The Union. The Union is a major beneficiary of Bloomberg Philanthropies, a foundation created by U.S. billionaire Michael Bloomberg, that is known for its anti-vaping agenda. By accepting funding from Bloomberg, the representatives argued, the PFDA violated a number of critical regulations in the public sector. These include the Anti-Graft and Corrupt Practices Act, the Code of Conduct and Ethical Standards for Public Officials and Employees, the Tobacco Regulation Act, the Lobbying Act and the Foreign Agents Registration Act. The PFDA’s director general had previously admitted during a public hearing that the agency had received more than $150,000 from The Union, essentially to hire employees to outline the Philippines’s tobacco control policy.

    Since 2006, Bloomberg Philanthropies has invested $1.1 billion to advocate for tobacco control policies worldwide. These policies are largely based on MPOWER, a set of demand-reduction strategies derived from the WHO Framework Convention on Tobacco Control (FCTC). A substantial portion of Bloomberg Philanthropies’ work has advanced tobacco control in many countries. However, support for adult smokers to quit—a component of MPOWER—has been completely ignored by the organization and its partners, according to Derek Yach, founder and president of the Foundation for a Smoke-Free World (FSFW). “These organizations see THR as a ploy of the tobacco transnationals,” he says. “With this perception, they ignore the vast benefits of THR and its potential to end smoking in this generation.”

    Bloomberg Philanthropies and its partners are not investing to develop research and capacity in low-income and middle-income countries (LMICs) on THR and the safety of associated products, notes Yach. “By continuing to ignore the growing evidence, including from the Royal College of Physicians, showing e-cigarettes and other reduced-risk products are much less harmful than combustibles, Bloomberg and others are impeding important progress in the fight to end smoking,” he says.

    Far-Reaching Influence

    Around 80 percent of the more than 5 trillion cigarettes smoked globally each year are consumed in LMICs. By its own reckoning, Bloomberg Philanthropies is present in 110 LMICs through its Bloomberg Initiative to Reduce Tobacco Use. These include India and China, which together account for nearly 40 percent of the world’s smokers. The initiative, Bloomberg Philanthropies claims on its website, “is helping cities and countries implement measures that are proven to reduce [tobacco] use and protect people from harm.”

    Michelle Minton

    The initiative’s influence extends through all levels of society, media and government. According to an analysis by Michelle Minton, senior fellow at the Competitive Enterprise Institute (CEI), it seems to be aimed at imposing its will on the developing world. Minton’s findings are based on a leaked document obtained by CEI, which detailed the 2017 LMIC strategy of the Campaign for Tobacco-Free Kids (CTFK), Bloomberg Philanthropies’ largest beneficiary. The CTFK is part of a complex network of Bloomberg Philanthropies-funded organizations, all of which pursue a zero-tolerance approach to all tobacco use.

    For these organizations, the term “tobacco” includes reduced-risk products (RRPs)—essentially, anything containing nicotine that is not a pharmaceutical nicotine replacement-therapy product. The CTFK has attempted to influence political processes and key players in various countries with the help of partnerships and often financial collaborations with activists, think tanks, professional associations, media, universities and governments. According to Minton, the CTFK and its grantees pay to manipulate news coverage. She calls the CTFK’s strategy “a highly synchronized chorus of interdependent interest, coordinated from afar.”

    Lacking the funds to conduct their own THR research, most LMICs follow the WHO’s guidelines unquestioningly. In recent years, their delegates have continued to confirm the WHO’s anti-THR stance during the FCTC Conference of the Parties (COP) sessions. The next summit, COP9, which was postponed due to Covid-19, will now take place in November 2021 and presents another opportunity for delegates to make a change.

    The influence of Bloomberg and his fellow WHO sponsor, Bill Gates, has also been brought to light by a number of recent articles. A study by Mitsuru Mukaigawara et al., published by Wellcome Open Research, examines the extensive use of media and academic influence by Bloomberg and the Gates Foundation to drive the global tobacco control agenda. “Highlighted by their influence over the World Bank and WHO, the authors show that the two organizations have been able to create a multilayered approach that touches many of the key stakeholders and undermines national sovereignty in tobacco control,” Yach explains. “Their broad and tight grip on various tobacco control activities will be tough to overcome. What may well happen, though, is that the weight of scientific evidence favoring THR will in time break through into the corridors of future WHO COP sessions.”

    Due to the travel restrictions, the ninth Conference of the Parties to the World Health Organization’s Framework Convention on Tobacco Control will be a virtual event. Discussions about tobacco harm reduction have essentially been tabled until COP10 in 2023. (Photo: olrat)

    THR Discussions Postponed

    Yach is less optimistic that such evidence will change minds among participants in the upcoming COP. “Unfortunately, due to the travel restrictions, FCTC-COP9 will be a virtual event with limited technical discussions, essentially tabling THR discussions until COP10 in 2023,” he says. “Even before this announcement, the WHO’s lack of transparency in its reports on novel products reveals a prohibitionist stance on THR.” 

    Over the past decade, Yach observes, media access to the FCTC has been constrained, and documents are published by the secretariat without formal member state input. “In fact, for the upcoming COP9 meeting, documents containing serious implications for THR are presented to be ‘noted’ without being subject to the usual United Nations practice of being thoroughly discussed and revised,” he says. “Many LMICs may well be persuaded by Bloomberg grantees to go ahead with bans and prohibitions of THR products supported or encouraged by WHO documents. These decisions will undermine the long-term health of their smokers.”

    Derek Yach

    In the run-up to the conference, the FSFW has started a campaign to inform COP9 delegates on the potential of THR. “Our goal is simple: Ensure that all involved directly or in advisory roles to member states engaged in COP9 are equipped with the best scientific data and information,” says Yach.

    The FSFW’s new Commission Report: Reignite the Fight Against Smoking, created by an international team of experts, highlights the opportunities to reduce the death and disease caused by smoking through use of THR and, in time, more effective cessation, Yach says. “The report provides member states with up-to-date data and insights about the value of innovation in driving changes in some companies. It spotlights which countries are making the most progress and which are badly lagging.” The report also highlights the need for doctors to take a more supportive role in advancing use of cessation and THR in LMICs, and the need for industry to be more aggressive in addressing youth access and marketing, according to Yach.

    The Commission Report, available at www.fightagainstsmoking.org, is complemented by the Patent Landscape Report, which is available on the FSFW website and presents an overview of current patents for THR technologies. “The FCTC failed to recognize importance of intellectual property and technological innovation,” says Yach. “Both are now driving change in the industry and further exacerbating the advantages developed countries have over LMICS as patenting activities in developing and least-developed countries are not comparable to those in the developed world.”

    Progressive Stance

    The Philippines is not the first country to reject the influence of Bloomberg Philanthropies on its tobacco control policies. In 2017, the government of India prevented two not-for-profit organizations funded by Bloomberg Philanthropies from carrying out tobacco control work in New Delhi after they failed to disclose their financial backers. In March 2021, a Mexican activist revealed that a proposal to prohibit the import, distribution and sale of vaping products had been formulated by CTFK’s legal advisor for Latin America.

    THR proponents hope that the Philippines will become a model for other Asia-Pacific countries where smoking prevalence is high and RRPs are currently either banned or restricted. After years of opposition to RRPs, the Philippine House of Representatives in early 2021 proposed House Bill 9007, which will regulate electronic nicotine-delivery systems (ENDS). If approved, the Philippines Department of Trade and Industry, in consultation with the PFDA, will be assigned oversight of ENDS regulation.

    Among other things, the bill stipulates that only retailers will be allowed to sell electronic nonnicotine delivery products and heated-tobacco products (HTPs). Retailers will be required to check buyers for a valid government-issued ID. Manufacturers, importers and distributors will need to comply with certain packaging and health requirements. Use of RRPs will be allowed only in designated areas, and the sale or distribution of these products will be prohibited within 100 meters of schools, playgrounds and other facilities frequented by minors. (Currently, the minimum age for purchase of ENDS and HTPs in the Philippines is 21.) Bill 9007 passed the House in May with a comfortable majority of votes; the Senate was expected to vote on it this fall.

    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.
  • A Paradigm Shift

    A Paradigm Shift

    Photo: BAT

    Contributed

    For years, smokers weren’t interested in supposedly safer cigarettes. There were some attempts by R.J. Reynolds in the 1990s with a “heated not burned” cigarette in the U.S. (under the brand name Eclipse), Germany (HI.Q), Sweden (Inside) and Japan (Airs). But the time seemingly wasn’t ripe for novel products.

    Instead, the tobacco industry entered an era of consolidation, the majors embarking on a large acquisition spree to expand their sales and distribution reach and to build on the popularity of global brands. The alcohol companies followed a similar strategy. The one exception was Swedish Match, which sold off of its cigarette interests to prioritize less harmful snus. That was before the EU decided to impose a ban on the product.

    The emergence of vaping technology, alongside the continuing focus on the health impact of smoking and an increase in regulatory restrictions saw the arrival of startup companies like Blu, Ploom (now Juul), NJOY, E-Lites and Ruyan. These businesses were at the forefront of starting what Swedish Match originally envisaged—a widespread transition for smokers from tobacco to alternative nicotine-delivery products.

    The tobacco majors stood briefly on the sidelines but quickly began acquiring many of these businesses and renewing their investments in the previously trialed heated-tobacco technologies. Philip Morris International led the way, soon publicly proclaiming its intentions for a “smoke-free future” and committing to transition smokers to less harmful products. Indeed, PMI’s latest acquisitions in the pharmaceutical sector, including those of OtiTopic, Vectura and Fertin Pharma, are intended to transition their business even beyond the nicotine segment.

    But prevailing public perceptions of the tobacco industry are slow to change, and with increasing attention on environmental, social and governance (ESG) issues, many investors have taken a restrictive approach toward tobacco stocks. Whether or not compounded by the disruptive threat of new challenger technologies, tobacco stocks have shed circa $300 billion over the past five years. This is despite the industry’s history of paying generous dividends, which in theory should attract investors. Similarities with “stranded assets” in the oil, gas and coal-mining industries immediately come to mind.

    There is already a noticeable difference in valuations between faster and slower transitioning tobacco companies, skewered in favor of the more active ones. The meteoric rise of Juul (albeit one that has now somewhat deflated) and the explosive valuations afforded to the likes of Smoore and RELX are also indicative of where investors see the future value in nicotine businesses. 

    Increasing public health concerns and huge consumer demand for harm reduction products, set against a complex regulatory landscape, fuel the reduced-risk product (RRP) categories.

    PMI, Altria and BAT are prominent in outlining their significant investment in and commitment to a portfolio of RRPs and their plans to transition smokers away from combustible products. While Japan Tobacco may have appeared to prioritize combustibles, recent developments suggest an intention to increase its presence in the RRP category too. Imperial Brands, while still undergoing a change in the senior management team, is following a similar strategy.

    Tobacco companies are increasingly becoming lifestyle companies with broad product offerings but streamlined brand portfolios.

    Although not widely commented on, this development and the plans that the tobacco majors seemingly have for the RRP category will have significant consequences for a number of industry participants, not least tobacco leaf growers. Prominent tobacco-producing nations, such as Malawi and Zimbabwe, will therefore face significant challenges and will likely need to restructure their entire economies.

    As a result of these developments, tobacco companies are increasingly becoming lifestyle companies with broad product offerings but streamlined brand portfolios. PMI is the most ambitious, trying to converge lifestyle and pharmaceutical categories focusing on inhalation technologies, benefiting from PMI’s expertise in this area. However, the acquisition of U.K.-based Vectura met with protests. On the other hand, PMI’s acquisition of OtiTopic, a U.S. respiratory drug delivery development company did not trigger such a strong public outcry. While Japan Tobacco has long had a pharmaceutical division, no areas of overlap or corresponding synergies with the tobacco business have been made apparent.

    The entrepreneurial small-size and mid-size enterprises, who kickstarted the vaping industry from the grassroots, initiated the transition we’ve seen in the last 10 years. At the outset, public health and tobacco control activists in many countries considered grassroots vaping companies to be a welcome alternative to the large tobacco multinationals. The majority of those early vaping companies were preoccupied with product launch, sales and distribution and overlooked the importance of the public policy and regulatory arena. Many, such as Blu, Ploom, E-Lites, Logic and Juul, then accepted tobacco industry investment, but this led to a negative view toward the category for many in public health and tobacco control.

    Seemingly the stigma associated with the tobacco industry—the “Big Tobacco” factor—quickly attached itself to the vaping industry.

    It seems only a matter of time before history repeats itself in the cannabis industry. Altria, BAT, PMI and Imperial Brands have all made investments in cannabis. Whether a preemptive step or not, it’s certainly a cost-effective manner to understand the sector and thereby be positioned to participate as and when restrictions come to be lifted.

    Only a few years ago, the tobacco industry was considered to be a dinosaur set for extinction. Some industry participants, whether encouraged by early successes of vaping businesses or otherwise, took on the challenge and are reinventing themselves as lifestyle companies, and PMI is daringly entering the pharmaceutical sector. Those that are prepared to transition away from combustible tobacco products have been given a new and exciting line of life.

    The tobacco industry is only at the beginning of its paradigm shift. Special efforts to engage with regulators—which are not only the industry’s biggest partner but will ultimately decide on the success of the “new nicotine” sector—will be required. It seems likely that those industry players who make those efforts and who experiment with new technologies, new products and new business models will be those best placed to thrive in the future.

    This article was contributed by GMTL, a leading risk advisory, due diligence and corporate intelligence firm headquartered in London.

  • The Time is Now

    The Time is Now

    David O’Reilly (Photo: BAT)

    Making tobacco harm reduction a reality has never been more important.

    Never has tobacco harm reduction been more important than in the wake of the Covid-19 pandemic. Public health bodies are now, more than ever, focusing on broader health issues and how they can optimize outcomes while also making the most of their resources. Minimizing the negative public health impact caused by smoking cigarettes continues to be a major challenge that many are trying to tackle, with some countries, such as the U.K., setting themselves ambitious targets to eliminate cigarettes entirely. The real question is, how can they effectively deliver on this goal? 

    We know from experience, such as the U.S. prohibition of alcohol, that simply banning popular consumer products does not work. Based on the evidence, we believe that the most effective way to tackle this issue is through tobacco harm reduction. Policies that are bold, progressive, forward-looking and, most importantly, backed up by robust scientific evidence must be created and embedded into society.

    The reality is that people continue to smoke despite awareness of the adverse health risks associated with doing so. These are smokers who would benefit from greater access to alternative products that can effectively deliver nicotine and provide an enjoyable and, importantly, reduced-risk alternative to smoking.* It is this group of people for whom effective tobacco harm reduction policy matters most.

    BAT is steadfast in its position that the best thing people can do to protect their health is to not start smoking or to quit smoking. We encourage those who would otherwise continue to smoke to switch completely to a scientifically substantiated, reduced-risk alternative. Products that contain nicotine but do not involve combustion (the burning of tobacco at up to 900 degrees Celsius) emit far fewer and lower levels of toxicants compared to conventional cigarettes and have the potential to be significantly less harmful to health.

    The availability of scientifically substantiated, less risky products such as vapor products, tobacco-heating products and modern oral products are crucial to effective tobacco harm reduction. Product regulations should recognize the role these alternatives can play in harm reduction by ensuring that high quality product standards are enforced, that consumers have access to information to make informed choices and, critically, that underage use is prevented.

    Smokers who wish to continue using nicotine via these less risky alternatives should not be punished by regulations and legislation that deprives them of information and denies them access to these products—a system that does not recognize the rigorous scientific process that goes into developing these reduced-risk products.*

    This view is shared by many within the public health community, including Public Health England. However, there are some organizations and public health bodies that disagree with the concept of tobacco harm reduction. Often, this is because the available reduced-risk alternatives are not entirely risk free, which BAT acknowledges. That doesn’t mean that consumers should be denied the choice to make use of alternative products that reduce the risk of harm versus continuing to smoke.

    At BAT, we support regulation that is founded on scientific evidence that can effectively reduce the projected health impact of smoking around the world. Tobacco harm reduction underpins our clear purpose to build “A Better Tomorrow” by reducing the health impact of our business. We have been clear for many years that our business needs to be built on outstanding products, informed consumer choice and a drive toward a reduced-risk portfolio, which is underpinned by world-class science. We are doing this by providing consumers who would otherwise continue to smoke cigarettes with a range of less risky ways of consuming tobacco and nicotine.*

    We recently conducted a long-term randomized, controlled trial of our tobacco-heating product, Glo, which lends credibility to the harm reduction potential of the entire category of high-quality tobacco-heating products. Surely, even our detractors can see the benefit in this landmark new clinical study showing that the health risks of cigarette smoking may be reduced in smokers who completely switch to using tobacco-heating products.

    We advocate for a collaborative, multi-stakeholder approach to advance tobacco harm reduction. We want to see meaningful change in the development of tobacco and nicotine policy. Industry, government, scientists, regulators and governing bodies must put their differences aside and come together in order to create effective tobacco harm reduction policy and provide better alternatives for those who would otherwise continue to smoke. This is not something that can be tackled by one group alone. Engagement, dialogue and communication among all parties is what is required in the development of effective policy. By adopting a more inclusive stakeholder approach to tackling tobacco harm reduction, we can make progress much more quickly.

    We have a goal of 50 million consumers of our reduced-risk noncombustible products by 2030. Every one of these individuals matters. So, to me, this is 50 million reasons why tobacco harm reduction matters and 50 million reasons to believe in “A Better Tomorrow.”

    * Based on the weight of evidence and assuming a complete switch from cigarette smoking. These products are not risk-free and are addictive.

    David O’Reilly is director of scientific research at BAT.
  • Chew on This

    Chew on This

    Photo: Swedish Match

    How sensibly will modern oral nicotine products be regulated in the future?

    By Stefanie Rossel

    Is history repeating itself? The parallels between the development of the vaping sector and that of modern oral nicotine are striking: Quick consumer adoption leads to phenomenal category growth rates. The promising, still-unregulated market lures myriad players and creates an unmanageable number of brands. Leading tobacco manufacturers seek to get their slice of the cake, often by strategic acquisitions. Despite evidence pointing at the reduced harm potential of the product compared to combustible cigarettes, tobacco control activists raise the alarm, urging regulators to crack down. The Wild West, gold-rush atmosphere is then abruptly curbed by the introduction of often-misguided restrictions and even product bans.

    It is at these crossroads where modern oral nicotine currently finds itself. The category, still a niche, has grown impressively in the five years since Swedish Match introduced Zyn, the first product of its kind. Market analysts are outdoing each other in their forecasts. 360Research Reports expects the category to increase to $32.77 billion in 2026 from $2.38 billion in 2020. Five key global players jointly hold a 77 percent share of the world market, according to Precision Reports. With 66 percent, Europe is the largest market, followed by North America and Asia-Pacific with more than 30 percent each, the company states.

    Competition in the market has rapidly heated up. Research and Markets notes the launch of 27 new brands of nicotine pouches in 2020. By now, all major tobacco companies and several smaller players are represented in the category. To cater to the increased demand, many of them had to step up production capacities, among them British American Tobacco, which in September 2020 built a new plant in Hungary that is dedicated to the production of nicotine pouches for export markets.

    The most recent company to enter the segment is Philip Morris International. In an investor presentation in February 2021, then-CEO Andre Calantzopoulos announced the development of a respective product through a “combination of partnerships and internal development.” In May, PMI acquired Danish family business AG Snus, a manufacturer of nicotine pouches. The deal was followed by PMI’s takeover of Danish firm Fertin Pharma on July 1, a company specializing in nicotine-replacement therapy (NRT) type products such as gums, pouches, liquefiable tablets and other solid oral systems for the delivery of active ingredients, including nicotine.

    Less Harmful Than Snus

    Nicotine pouches or “modern oral,” as manufacturers have termed the novel segment, are considered a subcategory of the smokeless tobacco segment. They are an evolution of traditional Swedish snus, a pasteurized oral tobacco that is available as loose products or in pouches and has been consumed in the Nordic country for 200 years. Unlike snus, however, modern oral nicotine contains no tobacco. In some brands, the nicotine used is not even derived from tobacco but produced synthetically. The nicotine pouches are white, pre-portioned little bags comprising nicotine applied to a carrier material, such as food-grade fillers. They come in a variety of flavors and nicotine strengths and even as nicotine-free variants. Like snus, they are discreet and spit-free and can be disposed of in household trash after use.

    For years, Sweden has had the lowest smoking rate in the European Union. According to Statista, the share of daily smokers in the country stood at 7 percent in 2019 (if the rate were to drop below 5 percent, Sweden would be considered “smoke-free” by some definitions). This compares to an average smoking prevalence of 23 percent throughout the EU. Sweden’s low smoking incidence is largely attributed to snus, which is used by 1 million Swedes. Decades of scientific research have confirmed the product’s efficiency as a smoking cessation tool. Snus use is estimated to be about 90 percent to 95 percent safer than smoking combustible cigarettes, which puts the product on par with e-cigarettes on the continuum of risk scale. A 2020 survey conducted by the European Tobacco Harm Reduction Advocates found that 43.3 percent of Swedish ex-smokers had used snus and/or nicotine pouches to quit smoking whereas more than 31 percent of current European smokers would be interested in trying snus if it was legalized.

    However, snus sales have been banned in the EU since 1992 except in Sweden, which negotiated an exemption from the ban when it became part of the trading bloc in 1995. The EU prohibition has survived two lawsuits, and few expect it to be lifted in the foreseeable future. Modern oral products, which offer non-Swedish EU users an alternative to snus, may rank even lower than snus on the risk continuum, according to a recent BAT study published in Drug and Chemical Toxicology. The research found that the company’s nicotine pouches had a toxicant profile comparable to that of NRTs, which are currently considered the least risky of all nicotine products.

    In a Gray Zone

    Given the EU’s attitude toward tobacco harm reduction, such an acknowledgement appears unlikely, however. Because modern oral products don’t contain tobacco, they cannot be regulated under the current EU Tobacco Products Directive (TPD); their status will be reconsidered during in the next TPD revision.

    In Germany, this has recently led to confusion over the legality of nicotine pouches. Several courts at the federal level have ruled that modern oral products are to be classified as foodstuff. As such, they would have to meet the requirements of European food legislation, which does not permit nicotine as food, food ingredient, food additive or flavor. Furthermore, food must not be hazardous to consumers’ health, according to the legislation. However, toxicological studies have shown that the nicotine dose that is taken up even by moderate users of modern oral is linked to health damage, courts argued. The rulings led to local sales bans. Due to this legal uncertainty, BAT in July 2021 suspended sales of its Velo nicotine pouches in Germany. The company called for legislation to set advertising standards for tobacco-free nicotine pouches and to limit nicotine concentration to 20 mg/mL.

    In the absence of EU legislation, several countries have tried to regulate nicotine pouches at the national level. In May, the Czech Republic amended its food and tobacco products act, obliging manufacturers, importers, retailers and distributors of nicotine pouches to ensure that these products meet the requirements for the composition, appearance, quality and characteristics stipulated by the decree of the Ministry of Health under similar conditions as those for e-cigarettes. In addition, they will have to inform the ministry, on a regular basis, on the nicotine pouches that they intend to launch on the EU/European Economic Area market. Manufacturers will also have to collect information on the suspected adverse effects of these products on human health. Tobacco-free nicotine pouches that do not comply with the amendment and that were produced or marketed before May 12, 2021, will have to come off the market in 2022.

    Italy, where nicotine pouches are considered consumer products, will reportedly consider modern oral products when it revises its anti-smoking law by the end of the year. Estonia’s parliament announced in July that it might relax its snus regulations to help reduce smoking.

    The U.K., no longer an EU member and therefore not bound to the common market’s regulation, is expected to follow Sweden’s example. To achieve its goal of a smoke-free society by 2030, the British government is presently shaping a tobacco control plan, which may very well include stronger promotion of cigarette alternatives, such as heated-tobacco products and nicotine pouches.

    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.
  • No Exaggeration

    No Exaggeration

    Photo: asayenka

    The future of tobacco machinery in a rapidly changing market for nicotine products

    By George Gay

    According to the Oxford Dictionary of Humorous Quotations, on June 2, 1890, the New York Journal ran what was to become one of most famous quips by Mark Twain: The report of my death was an exaggeration. The quote is perhaps more often rendered as “Reports of my death have been greatly exaggerated,” and, in this form especially, it could be applied to the tobacco industry. With the word “my” substituted with “the tobacco industry’s,” the quote could have been run in the New York Journal and other U.S. or European newspapers any time during the past 50 years because, while the tobacco industry has suffered a number of well-publicized setbacks, it has always recovered.

    No one can deny, however, that while sales of traditional cigarettes might be increasing slightly in a few markets and holding firm in others, in many, they are falling or even plummeting. Certainly, the long-term, worldwide trend seems to be down, and it is difficult to imagine any future scenarios in which tobacco smoking will be given a boost.

    This, of course, raises questions about where the machinery sector—and here and elsewhere in this piece I’m writing about making and packing machines for traditional cigarettes—is headed. It would seem reasonable to assume that it will decline in line with the market for cigarettes. But things might not be quite as simple as this, partly because there are divisions within this sector.

    Ask around and you will no doubt be told any number of reasons why the tobacco industry has managed to survive in the face of the moral outrage aimed at its existence by the people with the power to put it out of existence, but one of the most important reasons is that it has demonstrated flexibility where necessary, though sometimes reluctantly and, therefore, belatedly.

    There was, about 30 years ago, a sense that machinery suppliers, especially those based in Europe, were working themselves out of a job because, as increases in sales of cigarettes outside China slowed, machinery speeds were being ramped up—at times hugely. And at roughly the same time, technology transfer deals were being made with engineering companies in China.

    In part, though, there was something of a separation between overall cigarette consumption and machine capacities. The very fastest machines became relevant mostly to what were known as long-run brands, the most internationally in-demand products, the sorts that major cigarette manufacturers wanted to focus on and wanted increasing numbers of consumers to focus on while the manufacture of lesser brands was left in the hands of slower—though mostly not slow—machinery.

    On the surface, such a separation was based on the competing claims about machine flexibility. Those supplying slower machinery claimed their equipment was better for manufacturing other than long-run brands because technicians could make the size and other changes needed when switching from the manufacture of one type of cigarette to another more quickly than was the case with faster machinery. And even if changes took the same length of time on the two types of machines, they said, it was more inefficient to have a fast machine sitting idle while lengthy changes were made to it than to have a slower one sitting idle.

    Partly in response to this, perhaps, the suppliers of the fastest machinery made well-publicized efforts to make their equipment more flexible. But this response was more likely to have been caused mostly by competitive issues, supplier to supplier, I think. After all, those that supplied the faster machines offered also slower—though not the slowest—equipment, either directly or, as time went by, through acquired specialized suppliers.

    Of course, there is more to the machinery capacity arguments than cigarette production numbers; it also concerns investment costs. For many years now, we have been used to seeing the major international cigarette manufacturers swallow smaller companies, and, in recent times, seeing those manufacturers consolidate their product portfolios, all of which, I guess, has tipped the scales toward high-capacity machinery.

    New-Generation Products

    But what about the future? I guess it is not beyond the bounds of possibility that, having perhaps taken their eyes off the traditional cigarette ball somewhat, the major cigarette manufacturers have left the door open to startups, at least in those countries where it is possible to start a cigarette manufacturing business from scratch. After all, they have stopped manufacturing some of their shorter run brands and are in the process of converting former cigarette factories to manufacture new-generation products. Clearly, if this door is left ajar, part of the focus might start to switch to smaller manufacturers and, therefore, to lower capacity machinery, including secondhand machinery.

    Such thoughts were brought to the surface again recently when, according to a report in the Guardian newspaper, Philip Morris International’s CEO, Jacek Olczak, called on the U.K. government to ban cigarettes within the next 10 years. Olczak apparently said PMI could “see the world without cigarettes … and actually, the sooner it happens, the better for everyone.” Olczak said, “Give [people] a choice of smoke-free alternatives … with the right regulation and information, it can happen 10 years from now in some countries. You can solve the problem once and forever.”

    I don’t know why Olczak picked on the U.K., but it might have been partly because the country has already seen a fairly dramatic fall in cigarette consumption, because it has taken a generally progressive attitude toward lower risk alternatives to combustible cigarettes and because the country is in a state of transition in respect of tobacco and nicotine as it reviews its tobacco and related products regulations after having left the EU and left behind the necessity to comply with that institution’s Tobacco Products Directive (TPD).

    Looked at like this, the U.K. could become an experiment in tobacco harm reduction (THR), were the government to make such a bold move. And this is not altogether unthinkable even for a semi-detached libertarian regime as is now in power. But the real question is: What would be the conclusion of such an experiment? Would the U.K. become, as those supporting the principles of THR might have it, a tobacco smoke-free heaven in which former smokers were satisfied with the new, less risky nicotine-delivery products, cancer rates plummeted and the economy boomed as improvements in health, productivity and social cohesion provided huge dividends?

    Or would it conclude, as those opposed to THR might have it, with a nation, most of whose youngsters were hooked on nicotine and committing crimes to obtain the money necessary to buy the black market cigarettes onto which they had moved during their summer breaks abroad—a nation with worsening health, productivity and social cohesion?

    Given scenario one, the medium-term to long-term outlook for cigarette machinery suppliers would be bleak because even the best efforts of the World Health Organization and its allies would not be able to hold the tide of countries wanting to take advantage of similar THR dividends. But given scenario two, cigarette machinery suppliers could end up on a roll given that what had appeared to be the only truly viable route out of smoking had been shown to be fatally flawed.

    Of course, it is unlikely, I think, that Olczak believes the U.K. government would ban cigarette smoking within 10 years, but I wouldn’t rule out that he is banking on his plan B being taken seriously: “Give [people] a choice of smoke-free alternatives … with the right regulation and information …”

    This would, of itself, be a valuable experiment, especially if cigarette smokers were also provided with the right, or rather truthful, information and if the information provided to both smokers and vapers included accurate information about the environmental impacts of traditional cigarettes and lower risk products. After all, it is going to be challenging to enjoy a smoke or a vape if your house has been blown away and you are standing up to your neck in water that is being evaporated by the heat dome that has appeared overhead.

    So what is the likely outcome? I think we will see a U.K. scenario that sits somewhere between one and two above. The art of politics is compromise, which, depending on your point of view, means satisfying everybody or nobody. In other words, there will be significant but modest changes in the U.K. that will bring about a welcome boost to the conversion of smokers to less risky products.

    Looking further afield, the U.K. example might have some effect on those countries orbiting at the greatest distance from the WHO, while those in closer orbits will continue to try to rebut the ideas of THR. The result will be that cigarette smoking worldwide will continue to fall for the next 10 years, much as it has in the past, and the requirement for cigarette machinery will fall with it, perhaps with demand tilting toward medium-speed equipment. I think there is simply too much inertia in the market, largely held in place by the opposition to THR inherent in positions taken up by the WHO and its allies, for there to be any sudden, major changes. For one thing, it has to be remembered that while the U.K. might have shaken off the shackles of the TPD, it is still tied to the WHO’s Framework Convention on Tobacco Control and the way that treaty is interpreted by the parties to it.

    One last point: If the U.K. government does decide to ban cigarettes during the next 10 years, it would be consistent and fair for it to also ban alcohol. In fact, it would be hypocrisy not to do so. Alcohol consumption takes a far greater toll on U.K. society than tobacco consumption, and, with the number of smokers falling and the number of drinkers increasing, the damage caused by alcohol is only going to increase relative to that of tobacco.

    Sodim’s Synergies

    Eric Favre

    In communicating earlier this year about a story published in the August issue of Tobacco Reporter, Eric Favre described as synergistic the relationship between the instrument company of which he is managing director, Sodim, and Hauni, the machinery supplier. He made his remark in reply to a question about what advantages had accrued after the acquisition some years ago of Sodim by Hauni.

    Favre made the point, also, that this synergy, this coordination if you like, extended to customers and potential customers. There were, for example, advantages to be had for a customer in acquiring, for instance, a cigarette maker and a quality control (QC) test station as a single package—advantages such as those to do with technology and logistics. And by the same token, Favre added, during an R&D project, a customer could take advantage not only of the machinery expertise and support available from Hauni but also of the quality assurance (QA) and QC oversight of Sodim.

    The idea of such synergies did not make it into the August story but, this, the September issue, provides an opportunity to take the idea further because it is looking at making and packing.

    Tobacco Reporter: Given that Hauni making machinery would, in the normal course of things, be delivered with QA/QC equipment included, what, specifically, can Sodim add to a cigarette manufacturer’s standards armory?

    Eric Favre: Sodim adds the capacity of automatic sampling, a hands-free system that picks a cigarette from the mass flow and delivers it into the hopper of a Sodim test station: a SodiQube or a station from the Sodiline family. The data generated by the test station is then fed back to the maker, which, where necessary, uses it automatically to adjust its settings and thereby keep each cigarette produced very close to the target weight, diameter and dense end position. It is, in fact, a “police camera” that fine tunes the monitoring of the maker.

    What can Sodim offer in the way of additional QA and QC equipment in respect of cigarette packing?

    In the packing area, Sodim can offer a nondestructive pack seal tester that has the advantage of allowing all boxes that are correctly sealed to be returned to the product flow. Currently, this system is manual, and it would be ideal if it were developed so that it sampled automatically. Such automatic sampling would require complex developments, however, and might not be viable economically.

    In respect of making and packing, what can Sodim offer to manufacturers of other tobacco and nicotine products, such as tobacco-heated products (THP) and snus?

    Sodim test stations are suitable for measuring THP weights and diameters, though not dense-end positions. And the nondestructive pack-seal tester is suitable for testing THP and snus packs.

    Are Sodim’s instruments used mainly by major manufacturers, or do smaller manufacturers also use them?

    Sodim equipment is used by any type or size of manufacturer, from small and family-owned businesses to international groups.

    Is it true to say there are certain measurements, such as those that have to do with complying with regulations, that all manufacturers must make, though these will differ from country to country, while others are optional because they provide data for internal use, perhaps for improving efficiencies and reducing waste, etc.?

    This is correct. In the case of traditional cigarettes, Sodim’s very accurate and specialized equipment is needed to meet both the demands of regulations and internal standards of quality control. But for THPs, which do not generate smoke, our equipment is used more for internal QC reasons because there are fewer specific regulations in respect of these products than is the case with traditional cigarettes.

    How does Sodim or a manufacturer running Sodim instruments ensure they are giving the correct readings? Do they need regular servicing and replacement after a given lifetime?

    Sodim instruments will give the correct readings provided that the end users—mainly manufacturers but also laboratories—calibrate these devices regularly. And to allow users to calibrate their instruments, Sodim’s ISO 17025-accredited laboratory regularly delivers calibrated standards to the users. In addition, regular servicing is strongly advised and in most cases is carried out by Sodim at customers’ sites. –G.G.

    A Veteran’s View: Challenging Times Ahead

    Chris Crawley

    In another main story accompanying this sidebar, I question how much longer traditional cigarettes, and therefore the machinery that makes and packs them, will be around. My conclusion is that they will be around for quite some time, even though their demise is perhaps being brought into sharper focus right now.

    That is my stab at predicting the future, but what is happening right now? In an email exchange, I asked Chris Crawley of Axiom Select, who has been observing and working widely in the tobacco industry for many years, whether he believed that demand for traditional cigarette making and packing machinery was currently strong, average or weak. “I believe the market for new secondary (making and packing) machinery—with almost all the multinationals—is soft globally as traditional cigarette markets mature and volumes decline,” Crawley wrote. “If there’s a bright spot, it is probably Asia, but this, too, has its ups and downs.”

    And if Asia is a bright spot, for whom is it a bright spot? Crawley pointed out that the large EU-based machinery producers were finding emerging competition in Asia where labor and materials were often lower. There was an ongoing argument that said the quality of machinery built in Asia was not as good as that built in Europe, but while those putting forward this argument might be correct in some instances, any quality gap was certainly narrowing. And, at the same time, the cost and, therefore, the machinery price gap could be considerable.

    Crawley said he expected these trends to continue as mature cigarette markets slowly contracted, particularly in North America and Europe. But again, there is a bright spot. “Nevertheless, there is a highly competitive market—mostly price driven—for used/refurbished machinery from some of the larger independent cigarette producers,” said Crawley.

    That is all well and good, but isn’t the competitiveness of this market in part down to the fact that supply has been choked off in recent years? “It has been general policy, with the multinational producers, not to resell or trade their surplus machinery,” Crawley acknowledged. “Nevertheless, not all play by the same rules all over the world. Consequently, there is a good amount of used machinery available if one cares to search. This trend, also, is expected to continue.”

    At this point, I couldn’t help asking a question that has often occurred to me in my more fanciful moments. If I decided I wanted to start a modest cigarette manufacturing plant in the EU, what would be my best options in respect of machinery and equipment, assuming that I had a modest budget—whatever that might be—but what I thought was a winning brand name? “A modest startup can still find good used machinery at competitive prices,” said Crawley. “For example, a Molins Mk9 with a Hauni MaxS tipper is a good medium-speed complex with high efficiency/productivity. Spares and expertise are also available. And from this mid-point, you can go up or down in price and type of machinery.

    “For the last 30 years, machinery development has focused on higher speed machinery, and, while there are huge benefits to achieving greater speeds from the same machinery footprint, those speed increases often come with the sacrifice of flexibility. Machinery flexibility lags profoundly and there is little development in this sector. Changing machinery configurations for different lengths, diameters and tipping, etc., remains difficult, time consuming and costly.”

    Finally, Crawley turned his gaze on the future. “Affluent and highly profitable cigarette markets still abound, but they are increasingly finding their volumes shrinking and competition increasing,” he said. “In the longer term, challenging times are ahead for both machinery and cigarette producers.” –G.G.

    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.
  • Uncharted Territory

    Uncharted Territory

    Photo: JHVEPhoto

    The FDA’s review process of PMTA applications won’t be completed by the Sept. 9 deadline.

    By Stefanie Rossel

    Regulation of novel tobacco products can be a tedious and sometimes overwhelming process, as current developments in the United States show. Almost a year after the court-ordered deadline for manufacturers to hand in premarket tobacco product applications (PMTAs) for their products and only a few days before the grace period for unapproved products to stay on the market ends, the U.S. Food and Drug Administration sits on a mountain of more than 2 million applications for “deemed new tobacco products.”

    In 2019, a Maryland district court judge had ordered the FDA’s Center for Tobacco Products (CTP) to set a new and earlier PMTA deadline for electronic nicotine-delivery systems (ENDS), which was finally laid down for Sept. 9, 2020. The court order provided for a one-year period during which time such products might remain on the market pending FDA review. After Sept. 9, 2021, the FDA will be allowed to grant further extensions on a case-by-case basis for “good cause,” but no general extra time.

    If a negative action is taken by the FDA on the application prior to Sept. 9, 2021, the product must be removed from the market or will risk FDA enforcement. If the FDA issues a positive order on a product, it will be listed on the positive marketing orders page and can continue to be marketed, according to the terms specified in the order letter. At the time of writing, however, most applications, each consisting of hundreds or even thousands of pages of scientific data, still needed to be reviewed. In May 2021, the agency published a long-awaited list of vapor companies that had submitted PMTAs by the Sept. 9, 2020, deadline. The publication of the list is believed to signal the start of enforcement.

    Considering the large volumes of PMTAs submitted, though, it is improbable that the FDA will be able to process all submissions before manufacturers are required to withdraw their products from the market. In June, the U.S. Small Businesses Administration (SBA), a federal agency that represents small businesses to the various branches of government, urged the FDA to ask the Maryland district court judge to allow the agency to extend the deadline until September 2022. Most small ENDS manufacturers, the SBA argued, did not have the resources to absorb the losses from having their products pulled from the marketplace for several months or more. It said that once the FDA ordered small ENDS manufacturers’ products removed from the market, those small businesses would close permanently. The SBA also pressed the FDA to end its current practice of processing PMTAs in order of manufacturer market share.

    On August 4, Swisher International filed a motion for an emergency preliminary injunction against the CTP for threatening enforcement against products without PMTAs or substantial equivalence approval authorized. The cigar manufacturer, whose cigars are also in the FDA’s premarket-review process with authorization pending, called the FDA’s process “half baked” and accused the agency of creating chaos.

    Individual instead of standardized

    Jonathan Fell

    Consumer staples specialist Jon Fell, partner at Ash Park Capital, thinks it’s unlikely that the FDA will grant a blanket extra year extension. “The FDA has regularly stressed that it has discretion to defer enforcement action on a case-by-case basis, although it’s very hard to know what that will actually mean for the—presumably quite large number—of products which the FDA still hasn’t had time to review by September. I suspect that they will have to defer enforcement against products whose PMTAs have been accepted for review and aren’t obviously deficient, otherwise they’ll face more legal challenges.”

    The agency has repeatedly issued warning letters to manufacturers and retailers to remove unauthorized products from the market, most recently in late July. “The FDA will continue to prioritize enforcement against companies that market ENDS without the required authorization and that haven’t submitted a premarket application to the agency—especially those products with a likelihood of youth use or initiation,” the agency said on its website.

    In contrast to the EU, which with the Tobacco Products Directive (TPD) created a regulatory framework that sets the legislative standards for nicotine strengths, ingredients, labeling, health warnings and other issues for ENDS, the U.S. opted for an individual approach at product regulation. In its recent application report of the TPD, the European Commission stated that the directive’s restrictions on additives in e-liquids, such as vitamins, likely was the reason why the EU was spared the EVALI (e-cigarette or vaping associated lung injury) that raged through the U.S. in 2019.

    “There are very few pros to the way FDA is regulating e-cigarettes in the U.S.,” says Fell. “About the only one I can think of is that having a product explicitly authorized to be marketed in the U.S. might help build consumer confidence in these products after various health scare stories, including the EVALI crisis. But that is at the cost of an enormously complicated and expensive regulatory process that really adds very little value and is a substantial barrier to innovation. I think it would have been far more effective to define a set of standards that e-cigarettes have to meet and then take enforcement action against any products on the market which don’t meet those standards.”

    IQOS on hold

    But it’s not always the FDA’s long-winded processes that prevent manufacturers from marketing their novel tobacco products. Altria subsidiary Philip Morris USA suspended sales of its IQOS heated-tobacco product (HTP) after the U.S. International Trade Commission (ITC) in late July 2021 had found that PM USA had infringed on two patents owned by British American Tobacco subsidiary Reynolds American Inc. (RAI). RAI, which sued PMI USA last year before the ITC and in federal court in Virginia, claims that IQOS violates its patents over the device’s heating blade and alleges PMI was using a former version of the current technology of its own HTP Glo.

    RAI was seeking to have an import ban into the U.S. imposed on IQOS devices and consumables unless PMI licensed the technology from it. The ITC judge’s findings are subject to review by the full commission, with the investigation scheduled to be completed by Sept. 15. In the Virginia case, Altria responded with its own patent-infringement claims and a separate suit in May. The company also filed petitions with the U.S. Patent and Trademark Office, challenging the legality of several RAI patents, inclusive of three investigated in the ITC court case.

    IQOS had been introduced in U.S. test markets, including Atlanta, Georgia, Richmond, Virginia, and metropolitan areas in North Carolina after the FDA had granted the product PMTA authorization in April 2019. IQOS was the first next-generation inhalable product to be authorized as a modified-risk product in July 2020. Its U.S. expansion is now on hold.

    “I hope that the two-way patent battles between PMI and BAT will be settled in a grown-up way before long,” says Fell. “It’s not a good look for an industry trying to make the case for harm reduction to be squabbling in this way, particularly if it results in consumer choice being restricted, by products being taken off the market or not rolled out as fast as they otherwise might. Robust competition ought to be a potent mechanism for encouraging more innovation and shifts in consumer behavior.”

    Another development with uncertain impact on the cause of tobacco harm reduction is Juul Lab’s recent funding of a scientific publication. According to The New York Times, the vaping company spent almost $60,000 to fund the entire May/June issue of The American Journal of Health Behavior to help establish Juul as a smoking cessation tool. Juul Labs has submitted a PMTA to the FDA for its Juul products.

    In the past, scientific articles on reduced-risk products sponsored by tobacco or ENDS manufacturers repeatedly had difficulties being accepted by renowned scientific journals. “Perhaps optimistically, I think if the tobacco harm reduction concept continues to take a broader hold, then over the medium to longer term, excluding research sponsored by tobacco or nicotine companies from academic journals will not be tenable,” says Fell.

    “It will come to be seen as what it is: an anti-scientific and unjustifiable attempt at censorship, rooted in a view of the industry which is at least a couple of decades out of date. Perhaps this is the other silver lining of FDA regulation: the FDA has to engage with industry science and recognize its integrity, and over time the influence of that might spread. Ultimately, the FDA’s decision on Juul’s PMTA will have to come down to rigorous science and hard data, whatever attempts are made to sway the agency’s hand via the emotive arguments of campaigning organizations.”

    FDA Refuses to File Substantial Share of PMTA Applications

    On Aug. 9, the U.S. Food and Drug Administration issued a “refuse to file” (RTF) letter to JD Nova Group. The letter notified the company that the premarket tobacco product applications (PMTAs) it submitted for approximately 4.5 million of its products do not meet the filing requirements for a new tobacco product seeking a marketing order.

    As a result of this RTF action, JD Nova Group must remove approximately 4.5 million products from the market or risk enforcement action by FDA. The company may resubmit a complete application for these products at any time. However, the products may not be marketed unless they receive a marketing granted order.

    The FDA’s action affects a significant share of PMTAs under review. The agency has received applications for more 6.5 million products from over 500 companies.

    According to the FDA, JD Nova was issued the RTF letter because the company’s applications for these products lacked an adequate environmental assessment. Under FDA’s regulations implementing the National Environmental Policy Act, an environmental assessment must be prepared for each proposed authorization.

    This RTF does not apply to all product applications submitted by JD Nova. The remaining product applications the company submitted by the Sept. 9, 2020, deadline are still moving through the review process, according to the FDA.

    The list of affected products is available at https://bit.ly/3fP6cZj.