Keller and Heckman will has announced the agenda for its sixth Annual E-Vapor and Tobacco Law Symposium.
The two-day virtual seminar will focus on legal and regulatory issues critical to the vapor, tobacco and CBD industries in the aftermath of the U.S. Food and Drug Administration’s decisions on millions of premarket tobacco product applications (PMTA).
Among other topics, the seminar will cover PMTA marketing denial order challenges, new requirements for PMTAs and substantial equivalence reports and the outlook for synthetic nicotine products.
In addition to Keller and Heckman’s regulatory attorneys and scientists, this year’s program features numerous expert guest speakers, including from Tobacco Vapor Cannabis Group, the American Vaping Association, McKinney Regulatory Science Advisors and the Tax Foundation.
The symposium will take place Feb 2-3 from 10:30 am to 6:30 pm Eastern Time.
After a year of making do with virtual gatherings, industry representatives were delighted to meet each other face to face again during the World Tobacco Middle East exhibition in October. Thousands of tobacco professionals gathered in Dubai to reconnect with one another and learn about the latest product and services. Above are some impressions from the exhibition floor.
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.
Coresta will hold two virtual conferences this fall. Attendance is free of charge. The deadline to register for both events is Sept. 25.
The Agronomy & Leaf Integrity and Phytopathology & Genetics Study Groups conference will take place Oct. 4–14. The meeting will cover topics such as genetic tools, crop production and sustainability. Each presentation is prerecorded, with a live question and answer session where participants can interact with the presenter.
The Coresta Smoke Science and Product Technology conference will be held from Oct. 18–28. The program includes topics such as perception and behavior, nicotine science and statistical modeling. The conference will comprise daily sessions with prerecorded 12-minute oral presentations followed by a live Q&A with the presenters.
Umberto Roccatti, president of the National Association of Electronic Smoke Manufacturers (ANAFE) in Italy and vice president of the Independent European Vape Alliance (IEVA), is biking 700 km to protest a planned vapor tax hike in Italy.
Italian vapor taxes are set to increase from Jan. 1, 2022. “The gradual increase, every year for three years, of the taxation on electronic cigarettes is pure absurdity that risks bringing to its knees a sector already severely affected by the pandemic and which today counts about 45,000 employees,” said Rocatti in a statement.
The new tax regime, he added, will not only cripple a supply chain comprising small and medium enterprises but also encourage black market sales. According to Rocatti, the tax hikes would make some vapor products more expensive than some cigarette brands, encouraging vapers to return to smoking.
Rocatti’s “Ride4Vape” left Bolzano Sept. 20 and will pass through Abano Terme, Santarcangelo di Romagna and Sangemini before finishing in Rome. Along the way, Roccatti will explain on Facebook the disastrous effects of the fiscal policy call on lawmakers to reverse their plan.
“What the whole sector hopes for is a revision of the current tax burden—which turns out to be particularly excessive,” says Roccatti. “Moreover, it should be noted that the revenue—referred to the first months when the tax came into force before it was suspended by the new government—was not what was expected but quite the opposite, thus confirming the fact that raising taxes, especially in the midst of a pandemic, does not contribute positively to state revenues. We therefore ask for stability and fiscal balance on a sector which already underwent four tax increases in the last six years.”
The 2021 International Cigar Expo, which was scheduled to take place Nov. 8–10 in Chengdu, China, has been postponed because of the persisting Covid-19 pandemic.
The decision aims to protect the safety and health of exhibitors, visitors and staff.
Although by the end of July over 95 percent of booths had been booked, it is still difficult for exhibitors and visitors from overseas to attend the expo amid the current pandemic, according to the organizers.
Lee Sang-hak (right), head of KT&G’s sustainable management division, during the award ceremony (Photo: KT&G)
KT&G has been awarded a presidential commendation at the government award ceremony for the 2021 Social and Economic Merits organized by the Ministry of Strategy and Finance on July 2.
The award ceremony was held to discover successful business models in the field of social economy and to reward institutions and individuals who contributed to the realization of social values. KT&G won the presidential commendation in the social value realization category in recognition of its young startup support projects and assistance for the socially disadvantaged.
KT&G has been running the Sangsang Startup Camp since 2017 to discover and foster socially minded entrepreneurs who would like to make contributions in promoting environmental causes and providing jobs to the underprivileged. Up to this year, 97 startup teams have been produced through the fifth operation, of which 36 have been selected by the government for its entrepreneurship development projects. So far, the camp has recorded 745 employments and cumulative sales of about 19.8 billion won.
“With this award, our contribution to the revitalization of youth startups and efforts to realize social values have been recognized,” said Lee Sang-hak, vice president of KT&G and head of the sustainable management division, in a statement. “We will continue to support social and economic causes.”
The U.K. Institute of Economic Affairs (IEA) will host a discussion today on the impact of the World Health Organization’s ninth Conference of the Parties (COP9) to the Framework Convention on Tobacco Control (FCTC), which is scheduled to take place on Nov. 21 in the Netherlands.
The COP is the supreme decision-making body of the FCTC, where all parties to the FCTC meet biennially to review the implementation of the convention and adopt the new guidance. For the first time since leaving the European Union, in November 2021, the U.K. will send a delegation to the COP.
According to the IEA, COP9 poses a significant threat to the U.K.’s approach to harm reduction policy. “The WHO is increasingly, and against the clear evidence, positioning itself as an enemy of vaping,” the think tank states on its website. “The U.K. is a world leader in tobacco harm reduction, and a significant reason for this is our comparatively liberal approach to vaping products and e-cigarettes.”
Participants in the IEA forum will discuss who represents the U.K. at COP, how decisions are reached, the impact of these decisions on the U.K.’s harm reduction progress and the country’s 2030 smoke-free target, among other topics.
Speakers includes IEA Director General Mark Littlewood (chair), Matt Ridley (vice-chair of the All-Party Parliamentary Group on Vaping), Christopher Snowdon (IEA head of lifestyle economics) and Louis Houlbrooke (NZ Taxpayers Union).
The discussion can be followed live on the screen or here.
Keller and Heckman will has announced the agenda for its sixth Annual E-Vapor and Tobacco Law Symposium.
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.
