TMA is collaborating with EAS Consulting Group to host a one-day workshop on tobacco product manufacturing practices (TPMPs) on Tuesday, June 13, 2023, from 9 a.m. to 3:30 p.m. at the Hyatt Regency Crystal City at Reagan National Airport.
The workshop will include expert speakers from manufacturers, suppliers and law firms to give a balanced and comprehensive analysis of the proposed regulation, its impact on business and the ability to hear shared experiences.
The event is open to all industry stakeholders interested in attending, though space is limited.
Participants hear from CTP Office of Science Director Matt Holman, among others.
The second day of TMA’s “From Chance to Change” online seminar included a presentation by U.S. Food and Drug Administration Center for Tobacco Products (CTP) Office of Science Director Matt Holman along with panel discussions titled “Early and Often: Navigating Your Path to Market” and “Connecting U.S. and Global Trends.”
Matt Holman
Holman discussed the FDA’s recent actions on premarket tobacco product applications (PMTAs), key considerations in the agency’s “appropriate for the protection of public health” determinations and the final rules for PMTAs and substantial equivalence reports.
Holman touched on the agency’s marketing granted orders (MGOs) to four Verve oral tobacco products—all of which were discontinued by Altria Group in 2019—and R.J. Reynolds Vapor Co.’s Vuse Solo vapor cigarette. In both cases, he said, the applicant had demonstrated that the products have lower toxicity levels and abuse liability risks than cigarettes along with minimal youth appeal.
In the PMTA final rule, Holman highlighted the ability for recipients of a marketing denial order (MDO) to rectify the shortcoming in their original application with a supplemental PMTA that cross-referenced the original application, thus streamlining the process for both applicant and reviewer.
Jennifer Smith
Holman then participated in a “Path to Market” panel discussion, moderated by Altria Client Services Director of Regulatory Advocacy Jennifer Smith, that also included Gerry Roerty, vice president, general counsel and secretary of Swedish Match North America; Tara Couch, senior director of dietary supplement and tobacco services at EAS Consulting Group; Elaine Round, vice president of scientific and regulatory affairs at RAI Services Co.; and Kimberly Hesse, tobacco lab testing expert.
One of the takeaways from this session was the importance of starting “with the end in mind.” Getting things right from the beginning will save applicants time and money because even minor product changes involve new, time-consuming applications under the FDA’s pathways.
According to one panelist, the first question in the journey to market should be: Can we make this product, and can we make it consistently? Applicants should think about samples and suppliers and conduct environmental assessments. With the FDA seeking greater consumer insights, applicants should look for professional assistance in obtaining such information. And it pays to involve product testers early in the process. Lab workers may be unfamiliar with the product and require explanations on its operations. And then there are safety considerations. Hesse recalled instances of products that sparked and ignited when connected to laboratory machinery.
Round said one lesson she learned from Reynolds’ successful Vuse Solo marketing application was that “bridging”—the referencing of existing studies—works, provided that the applicant explained it well. She also advised applicants to generate a volume of information that is “exactly enough and not too much.”
Several panelists mentioned the challenge of obtaining consumer insights in PMTAs. They suggested that the FDA should consider allowing more of that information to be gathered as part of post-market surveillance, which would have the added benefit of generating more realistic data.
Jeannie Cameron
The final session of the TMA webinar explored the differences and similarities between the U.S. and the rest of the world in terms of nicotine product regulation. Moderated by Jeannie Cameron, CEO and managing director of JCIC International, this panel included Abrie du Plessis, regulatory affairs counsel at the South African Trade Law Centre; Patricia Kovacevic, general counsel and head of external affairs and regulation strategy at Cryomass Technologies; Rob Koreneef, public affairs advisor; and Flora Okereke, head of global regulatory insights and foresights at BAT.
The discussion focused on the recently concluded ninth Conference of the Parties to the World Health Organization Framework Convention on Tobacco Control (FCTC), which was developed before the emergence of reduced-risk products and which the panelists agreed was “frozen in time.”
Du Plessis described the positions of the various health bodies in relation to reduced-risk products. The Conference of the Parties, he said, is divided on the issue, providing no guidance on new and emerging products. The WHO has slight ideological opposition to novel products whereas the FCTC secretariat—which has gradually evolved from an administrative body to an implementation agency—appears to have no use for reduced-risk products. The secretariat, said du Plessis, is focused on getting countries to implement the FCTC’s standard measures.
Okereke examined the diversity in regulatory regimes for novel tobacco products around the world. She distinguished three themes: how harm reduction is treated, the premarket approval process and product categorization. Tobacco harm reduction, she said, is acknowledged by regulators in the U.S., the U.K., Canada, Germany, Ireland and New Zealand. Everywhere else, it remains an elusive concept. The U.S. is the only country with a robust premarket requirement, and when it comes to categorization, the world is divided. Some countries put vapor products under existing tobacco regulations (EU); others regulate them as pharmaceuticals (Australia); and yet others ban the products altogether (Brazil, Mexico, Turkey and Japan).
Kovacevic highlighted the discrepancy between the United States, where the CTP, which is funded by industry user fees, is required to interact with the tobacco industry, and the rest of the world, where regulators keep the industry at arms’ length. She also pointed out the irony that even though the U.S. is not a party to the FCTC, it generates much of the science that the treaty’s signatories rely on—including industry science generated through the various marketing application processes.
During the question-and-answer session following the panel discussion, one participant asked why U.S. tobacco companies should care about the international environment. Kovacevic responded by describing the high barriers to entry in the U.S. If access to the U.S. market closes through MDOs, she pointed out, the only remaining market is abroad. And there is also a moral motive: Most of the smokers who stand to benefit from reduced-risk products live outside of the U.S., often in low-income and middle-income countries. If companies are committed to harm reduction, they have a civic duty to serve them, said Kovacevic.
Read our summary of the first conference day here.
Participants heard from scientists, retailers, legal experts and CTP Director Mitch Zeller.
Scientists, data analysts and legal experts shared their insights into the rapidly changing U.S. nicotine business on Nov. 17, the first day of TMA’s “From Chance to Change” webinar. Participants also heard from retailers and the industry regulator.
Mitch Zeller
Mitch Zeller, director of the Food and Drug Administration’s Center for Tobacco Products (CTP), reviewed the latest data on youth e-cigarette consumption, which he said continues to be concerning. However, Zeller was quick to point out that because the 2021 study was the first to be conducted completely during the Covid-19 pandemic, the data could not be compared to that of the previous year.
Zeller also provided an unprecedented behind-the-scenes peek into the center as it processed millions of premarket tobacco product applications. The agency received applications covering more than 6.5 million deemed products, and most of them were submitted close to the Sept. 9, 2021, deadline—a date that, Zeller reminded his audience, had been brought forward by a full year following litigation by public health groups.
Because companies were not required to submit their applications in a particular way, the agency had to be ready to process a wide variety of formats. “We had to prepare operationally, technically and logistically to ‘ingest’ all those applications,” said Zeller, adding that the agency was thrilled its submission system did not collapse under the volume of last-minute applications.
The FDA has by now acted on the vast majority of applications, sending refuse-to-file letters, issuing marketing denial orders (MDOs) or, in a handful of cases, granting marketing orders. “We are down to 80,000 products—most of them in the final stages of review,” said Zeller. Those still-pending applications, he acknowledged, include ones submitted by the companies with the largest market shares because they tend to be the largest and most complex applications.
Zeller also commented on the rising popularity of synthetic nicotine, which some MDO recipients, including market-leading Puff Bar, have embraced as a tool to keep their products on the market because they believe it is outside of the regulator’s remit. The FDA defines a “tobacco product” as anything “made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product.”
Synthetic nicotine, said Zeller, presents a new challenge for the regulator, in part because it is increasingly difficult to distinguish the compound from its naturally derived counterpart. Nicotine, he explained, comprises two isomers: R and S. Tobacco-derived nicotine is 99 percent S, and early synthetic nicotine had a 50-50 split between R isomers and S isomers. However, newer versions of synthetic nicotine have much higher proportions of S isomers, making it harder to tell them apart from natural nicotine.
Jim Solyst
The first panel discussion of TMA’s online seminar, moderated by Jim Solyst, principal of JMS Scientific Engagement, debated the status quo from an applicant’s perspective. The panelists included Brittani Cushman, senior vice president, general counsel and secretary at Turning Point Brands; Beth Oliva, partner at Fox Rothschild; Brian Erkkila, director of regulatory science at Swedish Match; and John Pritchard, vice president of regulatory science at 22nd Century Group.
While all participants expressed appreciation for the FDA’s daunting workload, some voiced disappointment with the fact that many applications appear to have received only a perfunctory “fatal flaw” review—a review in which the agency, rather than reviewing a submission on its merits, simply looks for the presence or absence of certain studies. The panelists lamented that the pathway to market is more cumbersome for reduced-risk products than it is for deadly combustible products.
Participants worried also about how the public would interpret the lack of determinations on major applications, citing persistent misunderstanding of reduced-risk products and the continuum of risk by legislators, journalists and even physicians.
Asked to look forward, one panelist suggested the industry should consider what it would do when the next e-cigarette or vaping use-associated lung injury (EVALI) happens, referring to a mysterious outbreak of lung injuries in 2019 that was caused by illicit THC products but tainted the entire industry. Another participant stressed the importance of enforcement after all marketing applications have been decided. If any “yahoo” can sell products without authorization, she said, it would render the investments by the good actors worthless.
Mary Szarmach
The second panel of the TMA webinar, moderated by Mary Szarmach, senior vice president of governmental and external affairs at Smoker Friendly, reviewed the market from a retailer’s perspective. The panelists included Don Burke, senior vice president of Management Science Associates; Tom Briant, executive director and legal counsel at the National Association of Tobacco Outlets; and Amanda Wheeler, president of the American Vapor Manufacturers Association.
Burke sketched the latest trends in the nicotine market. The pandemic, he said, makes comparisons with 2020 difficult. With many people working from home last year, sales of cigarettes and large cigars experienced unusual growth, but as people returned to the office in 2021, those trends are starting to level off or are even reversing. Burke expects cigarettes to resume more normal consumption patterns next year. Modern oral continues its remarkable growth, albeit at a lower pace than last year because most convenience stores are by now carrying the product. And volume sales of vapor cartridges are up by more than 18 percent as the EVALI crisis fades from memory.
Briant provided a regulatory update, touching on the proposed nicotine tax hike in the Biden administration’s Build Back Better legislation, the FDA’s proposal to ban menthol in cigarettes and flavors in cigars and the status of graphic health warnings, which are currently being challenged in court. Litigation has pushed the implementation date to January 2023, and this could be further extended. Briant noted that there have been no hearings yet on the merits of graphic health warnings.
Asked to analyze vapor retailers’ current predicament, Wheeler drew an analogy with the Hindenburg disaster, after which shattered public confidence marked the abrupt end of the airship era. She cited the avalanche of MDOs, the U.S. Postal Service ban on shipping vapor products and the proposed federal excise tax on vapor products, which would make vapor products more expensive than some cigarettes.
Wheeler said these developments were driving vapers back to cigarettes, illicit products and synthetics—many of them made abroad and falsely labeled. She described a “misguided crusade,” funded by deep-pocketed donors and cheered on by the irresponsible media. “When smoking was plummeting, they took action to make it increase; when American entrepreneurs innovated a news sector, they strangled it,” she said.
Asked what kept them up at night, the panelists named employee safety, flavor bans and lack of enforcement.
Szarmach related how a tax increase in Colorado had instantly resulted in more break-ins and robberies at her stores—an unwelcome development at a time when workers were already in short supply. Briant said that local flavor bans drove customers away without affecting total consumption—consumers would simply buy their products elsewhere. Wheeler said Arizona was not enforcing Tobacco-21 legislations, enabling bad actors to do good business.
The TMA online seminar continues today at 10:30 a.m. Eastern Time with a keynote from CTP Office of Science Director Matt Holman and panel discussions on “Your Path to Market” and global trends.
Read our summary of day two of the TMA conference here.
TMA will hold a virtual annual conference on Nov. 16-17, TMA 2021: From Chance to Change. As the industry has been challenged in many ways this year, TMA believes it is important to share insights among all stakeholders to equip its audience and members with the understanding and information necessary to successfully navigate the changes that lie ahead. TMA 2021 will feature two half-day interactive virtual sessions with keynotes from regulatory leaders and panel discussions from industry and stakeholder thought leaders that covers everything from Food and Drug Administration policy, marketing denial orders, product authorization pathways (PMTA, SE, MRTP, exemptions) and global trends that may surface in the U.S. and vice-versa.
“For this year’s TMA Annual Conference, we felt it was important to capitalize on the breadth and depth of speakers and expertise that only TMA can bring and condense that into the most important topics for our attendees who have also spent the last 24 months living virtually. We are very proud of our lineup for TMA 2021 and the information that it brings to the people doing the work on the front lines. You simply cannot get this anywhere else but from TMA,” said TMA President and CEO Chris Greer.
The program includes live keynote presentations with Q&As by FDA CTP Director Mitch Zeller and CTP Office of Science Director Matt Holman followed by these panel discussions:
An Applicant’s Perspective: Reflections on Where We Stand – Moderated by Jim Solyst, industry consultant
The Marketplace Perspective: Adjusting to Change – Moderated by Mary Szarmach, Smoker Friendly
Early and Often: Navigating Your Path to Market – Moderated by Jennifer Smith, Altria Client Services
Connecting U.S. and Global Trends – Moderated by Jeannie Cameron, JCIC International Consultants
“2021 was another challenging year for in-person events; following feedback from our members and guests, TMA elected to hold our annual conference virtually and will host our annual meeting and conference in 2022 as an in-person and virtual event,” said Greer.
For this year’s TMA Annual Conference, we felt it was important to capitalize on the breadth and depth of speakers and expertise that only TMA can bring and condense that into the most important topics for our attendees who have also spent the last 24 months living virtually.
TMA 2020 | Digital was TMA’s first virtual only event and featured an expansive program of hour-long discussions and keynotes spread over several months. TMA 2021 takes the best of that format along with a super-charged program aimed directly at those most active in the industry and stakeholder community.
Registration will open on or about Nov. 1 and run up through the conference commencement. Registered attendees will have the ability to view content for 30 days following the end of TMA 2021 and TMA members will have access for longer still. Registration is $299 for non-members and $199 for TMA members.
For more information, please see tma.org or send inquiries to tma@tma.org.
The U.K.’s new anti-tobacco measures may not achieve their stated objectives.
By Giles Roca
Giles Roca is the director general of the U.K. Tobacco Manufacturers’ Association.
May 20 saw a series of major changes to the U.K. tobacco market, the most noticeable being the full introduction of standardized or plain packaging. This was accompanied by a suite of other measures, including a ban on all small packs (which previously made up around 75 percent of the U.K. market); a ban on flavored tobacco; new pictorial health warnings; and various restrictions on e-cigarette size, tank size, nicotine liquid strength, etc. On the same day, the government introduced a minimum excise tax.
All of these measures were introduced directly or, in the case of plain packaging, indirectly under the revised EU Tobacco Products Directive (TPD2) that was transposed into U.K. law by David Cameron’s government in May 2016. While TPD2 does not mandate plain packaging, it allows member states to adopt it as a tobacco control measure.
To understand the impact of these measures, the Tobacco Manufacturers’ Association (TMA) undertook three waves of consumer polling of 1,000 smokers. The results should worry all of those involved in law enforcement, those in the U.K. treasury who depend on the annual £12.5 billion ($16.22 billion) in tobacco taxation and of course those legitimate independent retailers for whom tobacco often makes up 30 percent of sales.
Deprived of the ability to purchase smaller and therefore more affordable packs of tobacco, smokers are not, as those in the health lobby claim, simply quitting, but they are moving into buying from the black market or from abroad, thereby avoiding U.K. duty and benefitting the criminal gangs involved in tobacco smuggling. Over the past six months there was a 15 percent increase in smokers buying packs of 20 cigarettes from illicit sources and abroad. Smokers buying larger packs of hand-rolling tobacco from such sources and abroad almost doubled with a 91.7 percent increase. There was a 32 percent increase in smokers buying online from social media and websites advertising cheap illegal tobacco, and there was a 22 percent increase in smokers buying any tobacco product from abroad, thereby avoiding U.K. duty.
Despite how some like to portray it, the tobacco industry does not believe its products should go unregulated. It is clear about the risks involved, and that is why the industry is at the forefront of developing reduced-risk alternatives. However, it is opposed to measures that are proved to not work, where there is no evidence of their effectiveness or where they are more about totem interventions championed by largely taxpayer-funded health lobbyists.
Indeed, on some of these recently introduced measures, the health lobby itself cannot agree on their merits. “People buy smaller pack sizes, such as 10s, when they are attempting to reduce their tobacco consumption and quit,” said Martin Dockrell, then head of policy at the U.K. anti-tobacco lobby group Action on Smoking and Health, in 2008. “If you wanted people to lose weight, you wouldn’t take away fun-sized chocolate bars and only sell jumbos. I’m with the retailers on this one.” Dockrell is now head of tobacco control at Public Health England, the lead agency tasked with promoting good health.
Plain packaging will simply make it easier to produce counterfeit packaging, while there is no evidence that it has been effective in reducing youth access to cigarettes either in Australia, where it was introduced in 2012, or in France, which introduced it at the start of this year and has seen overall sales actually increase.
Meanwhile, the restrictions on e-cigarettes will have the perverse effect of deterring those who wish to move off combustible tobacco by reducing the experience available in electronic form. It is notable that the recent U.K. smoking prevalence figures, published in June, show a steeper decline since 2013 thanks to emergence of harm reduction technology such as e-cigarettes. This stands in direct contrast to the tranche of tobacco control measures implemented in the U.K. by successive governments over the past decade, which have had minimal effect on smoking rates and negative consequences such as making the problem of black market tobacco even worse.
The TMA will continue to closely monitor the impact of these measures and is currently conducting a survey of 12,000 smokers across the U.K. that will give unprecedented insight into the impact that they are having. It will make its data fully available for all interested parties to see.
So what lessons can we draw from this? Clearly, don’t believe the hype that some of those in the health lobby both generate and want you to believe. Measures are advocated with scant evidence while their adoption into law has more to do with keeping such groups quiet—a damaging way to make public policy.
We also know that what happens in tobacco will happen sooner or later in other sectors, regardless of any evidence on the effectiveness of the measures—just look at the growing calls for plain packaged food and alcohol both in the U.K. and around the world. We also know what happens in the U.K. will happen sooner or later in other places, particularly following the decision of the U.K. government to provide £15 million to the World Health Organization’s Framework Convention on Tobacco Control to push forward with implementing a U.K. model of tobacco control in other countries.
Given that many of these measures originated in Europe, we will be calling on the government to look again at them as the U.K. leaves the European Union so that we have an approach based not on legislative totems but on hard facts, evidence and education.
Giles Roca is the director general of the U.K. Tobacco Manufacturers’ Association.
The TMA has appointed Christopher B. Greer as its new president and CEO.
Greer comes to TMA from Japan Tobacco International’s U.S. division, where he served first as regulatory affairs manager and then as director and department head of corporate affairs & communications.
Greer’s work at JTI focused on FDA, government relations, corporate communications, corporate and regulatory compliance, Master Settlement Agreement management and anti-illicit trade. In addition, he served as the JTI representative to the TMA board of directors.
Greer brings a fresh perspective to the organization as both an end-user of TMA products and services and as an executive whose experience lies at the heart of many issues facing the industry.
He is taking over at a time highlighted by industry changes and opportunities driven by regulation, sustainability and new product innovations.
The Tobacco Merchants Association will be hosting its 98th annual meeting and conference May 15–17, 2013, at the Kingsmill Resort and Spa in Williamsburg, Virginia, USA.
The conference will include opening remarks by Mitchell Zeller, the newly appointed director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP). Other speakers include David Ashley, director of the CTP Office of Science, and Michael Siegel, of the Boston University School of Public Health.
This year also features a pre-conference workshop dedicated to laboratory testing and clinical research. Riccardo Polosa, of the University of Catania, in Italy, and Konstantinos Farsalinos of Athens University, in Greece, will cover e-cigarette research and clinical trials.
Top securities analysts will discuss the state of the industry, with detailed analysis of all of the product sectors.
