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.
Mike Ligon, TMA board chair, and Matt Holman, director of the CTP’s Office of Science, discuss regulatory reaction.
By Timothy S. Donahue
The U.S. Food and Drug Administration has been busy. Before it had the chance to finish the first round of premarket tobacco product application (PMTA) reviews, the agency’s Center for Tobacco Products (CTP) was charged with also regulating all synthetic and other nontobacco-derived nicotine products (see “Unnatural Response,” page 28). Manufacturers must submit PMTAs for the newly regulated products by May 14, 2022.
During the 103rd annual meeting of Vapor Voice’s parent company, TMA, Mike Ligon, TMA board chair, and Matt Holman, director of the FDA CTP’s Office of Science (OS), discussed the regulatory agency’s challenges and lessons learned in regulating electronic nicotine-delivery systems (ENDS) and other novel tobacco products. It was the first time Holman had spoken publicly since Congress granted the FDA the authority to regulate synthetic products, and Ligon emphasized that the audience was eager to hear Holman answer questions.
Holman made clear from the beginning that he heard during the conference that the FDA needs to do a better job with consistency, transparency and predictability. “That’s something I’ve strived to make sure we do as office director, but I’m hearing we’re not doing as good a job as we need to,” said Holman. “That’s something I’m certainly taking back to my colleagues to figure out … I think the point I’ve heard the most along those lines was just the timing and not knowing what the timing would be [for] taking action on applications. We need to do a better job of that.”
Credit: Timothy S. Donahue
After a federal judge ordered the FDA to complete a majority of PMTA reviews by Sept. 9, 2021—one year after the deadline for PMTA submissions—Holman said the review process was still new and that it was a challenge to build the programs necessary to complete reviews on time. He said that staffing the agency, for example, was a giant undertaking.
“Something folks outside the agency don’t think about all that much is staffing levels. When I took over this position, we had something around 325 staff members that were in the office,” Holman explained. “And now, five years later, we have about 575-ish. Any of you who have not been in the federal government and tried to hire—it is a huge-level effort to hire that many people in that period of time; a huge-level effort … half my staff have come on board during the pandemic and have not met colleagues in person.”
Holman said that the big-picture goal for the OS and FDA alike is creating an offramp for smokers to transition to less-harmful products while minimizing any potential on-ramps for youth initiation, adding that youth use has been “decreasing the last couple of years, which is a really positive thing.” He also explained that the agency often hears a lot of criticism, some undeserved, surrounding the misinformation disseminated into the public by “stakeholders” (anti-nicotine organizations, health agencies, tobacco control groups, regulators and industry players).
“We take all the feedback seriously … And we certainly actively encourage all stakeholders to engage with one another. I would hope to be able to sit here and say that I’ve been more successful than I have in that. There’s still a lot of resistance. There’s still a lot of really emotional, heated exchanges and feelings toward stakeholders,” said Holman. “I’m even seeing a shift in some of the stakeholder groups that have been aligned [previously] and now aren’t necessarily aligning.
“I’ve just celebrated 20 years at the FDA in December. That entire 20 years, I’ve spent really actively engaging with all stakeholders, and I think it’s critical as regulators that we hear from and we talk with and we communicate—and we’re trying to be as transparent as possible—with all stakeholders. Unfortunately, I don’t control all the stakeholders. And I keep carrying this message forward. It doesn’t always get heard so well. And so, it’s still very much a work in progress.”
Ultimately, Holman said the FDA is trying its best to base its decisions on the “good” science and not a specific source of data. “I don’t even care who the author is. I mean, the science is science,” he said. “Unfortunately, we have a lot of stakeholders that don’t look [at] it that way, and a lot that think they know what the policies shouldn’t be, and they want to come up with the science to demonstrate that. But we’re very aware of that. We’re very much looking out for that type of thing.”
Being approachable
Holman said he understands the frustration of trying to combat misinformation. On the FDA’s side, he wanted to clarify at least some of the misunderstandings and misperceptions he commonly hears when stakeholders discuss the FDA. For example, he had recently heard a stakeholder saying that the FDA only had one economist on staff. “FDA has more than one economist,” he said. “The CTP has more than one economist. I want to be clear about that … You can agree or disagree with where economists land on their analysis. That’s fine. But just to say that we only have one economist—this concern is just a major misrepresentation of the situation.”
There are also the rumors that the regulatory agency doesn’t read all the docket submissions (everything submitted to the agency, whether a comment on rulemaking or a PMTA). Holman said the quality of the submissions vary greatly, but the agency is required by law to look at every single one. “To suggest that the FDA’s regulators don’t carefully consider the data when we’re weighing options … at the end of the day, we have a public health mission where we’re here to serve,” said Holman. “We’re not here to oppose anyone. I look at data from all sources. I don’t care who it comes from … to suggest anything otherwise, at least for the FDA, honestly, it’s a bit insulting … you can criticize all you want about where we come out on decisions and rulemaking, but at the end of the day, we are very much a science-based organization.”
Credit: Timothy S. Donahue
The agency also tries to consider the unintended consequences of regulatory action, according to Holman.
However, he explained that determining these factors, such as the growth of a black market, is complicated because there’s often not a lot of data.
“It’s very much [speculating] what’s going to happen to the black market or the gray market when we take an action. We don’t often have data on that. So it’s really modeling or predicting,” he said. “We absolutely consider that because, at the end of the day … as I like to say to my staff, we’re trying to tackle this with a scalpel not a machete. Because I think that’s how you sort of leave this fine line that we’re all trying to leave here.”
Ligon asked Holman whether the FDA’s approach to regulating next-generation tobacco products was a workable standard. Ligon wanted to know if the FDA still recognizes that tobacco products exist on a continuum of risk, with combustible cigarettes being the most harmful (the “continuum of risk” is the scientific concept that not all tobacco and nicotine-delivering products are equally harmful). Holman said that while the FDA doesn’t know precisely what the relative risks are of the different products on the spectrum, the agency still believes in the continuum of risk.
“The challenge is having strong, rigorous data that we can stand behind and say, ‘Yes, we know this product is lower in risk than that product.’ That’s one of the biggest challenges still, I think, figuring out how to collect that data, what are the right types of studies, what’s the sort of full body of data that we need to be comfortable saying, ‘Yes, this product is down the continuum from that product,’” he said. “I think the other big challenge in this is … communicating with the consumers because if they don’t understand—and we know there’s a lack of understanding—a lot of misperceptions and misunderstandings [begin to grow].”
Workable solution
Communication is key. Holman said that to better understand the process and the challenges that stakeholders are suffering, the agency needs to better communicate its thought processes and goals. Before the Covid-19 pandemic limited stakeholder interaction, the agency would hold workshops to hear directly from stakeholders about their concerns. Holman wants to bring back that level of communication.
“We need to do workshops. It’s been almost a year since we’ve done the last workshop, and a whole heck of a lot of things have happened in that time period. We’re definitely going to take that back with our staff and talk about how to put some workshops together because the feedback we’ve gotten to date on the workshops we have done [previously] have been very positive,” said Holman. “Folks really appreciate the discussion. Not only to hear what we have to say, but just talks among attendees and some shared ideas and thoughts.”
Matt Holman / FDA
When asked if there were any suggestions from TMA attendees for workshop concepts, several stakeholders offered ideas. One stakeholder wanted to discuss with the FDA how PMTA data is managed and submitted to the FDA. The participant said that his company had received a deficiency letter; however, the additional data requested was already included in the company’s PMTA. Holman said that type of seminar would be a “win-win” for both the agency and the stakeholders.
Another attendee suggested that the agency bring in consumers to allow the FDA to hear from them directly and to understand the consumers’ thoughts, behaviors and attitudes as well as the impact of potential regulations on possible future consumer behavior. “I just feel like there’s a gap,” the attendee said. “I really think that would do a lot in being able to bring all of us together to promote the science.”
Other attendees wanted to have a better understanding of how the FDA comes to its decisions and what some of the common errors were in PMTAs that had received marketing denial letters. “I’m suggesting a little bit [of a] deeper dive by product category into the top 10 reasons you’re finding that something succeeds and [the] top 10 reasons you’re finding that something fails,” the attendee said. “I’m talking more about … here are the reasons why these fail … here’s why this doesn’t work.”
Holman said the fundamental goal of the FDA is moving people down the continuum of risk. He said that the consumer is the most important part of the equation and that all stakeholders need to be better at getting less-harmful tobacco products into the hands of adult combustible smokers. He said that he would hope that five years from now the tobacco product marketplace looks very different. Holman suggested that manufacturers with the ENDS products that exist now, alongside the “products we’re not even talking about that I know are in the pipeline” at various companies, should also consider using the agency’s modified-risk tobacco product (MRTP) pipeline moving forward.
“I would hope that our MRTP program sees a lot more action and that we see a lot more modified-risk statements on products … And again, I think the lack of dialogue amongst stakeholders, and the lack of sort of any level of agreement, really thwarts communication because the information the consumers are receiving, it’s all over the place, right?” Holman suggested. “There’s a lot of misinformation out there that certain stakeholders convey that just doesn’t reflect the science. Just flat out doesn’t … if we could just get stakeholders to agree on some basic key communication points that we would all collectively share with consumers, I think we could really drive this forward. But right now, consumers are just confused.”
Synthetic nicotine could be considered a component of e-cigarettes, which would allow for the product to be regulated by the U.S. Food and Drug Administration. Mitch Zeller, director of the FDA’s Center for Tobacco Products, said the agency was concerned about the use of synthetic nicotine to avoid regulation and enforcement and is considering its options in dealing with its use.
Mitch Zeller, director of the FDA’s Center for Tobacco Products
On Nov. 17, the first day of TMA’s “From Chance to Change” webinar, Zeller said that the agency is charged with regulating tobacco products, which according to the Tobacco Control Act is anything that’s “made or derived from tobacco that is intended for human consumption, including any component, part or accessory of a tobacco product.” Zeller said that components and parts could include everything from coils and batteries to all the ingredients comprised in producing e-liquids (such as flavorings and vegetable glycerin) even if the product does not contain nicotine.
“That’s an assessment that we need to make on a case-by-case basis based upon the totality of all the information that we have,” said Zeller, adding that another challenge is that synthetic nicotine is now of such high quality and complexity that it has become difficult to differentiate it from nicotine derived from natural tobacco. “Historically, that hasn’t been a problem,” he said. “It’s not a problem now, but it could become a challenge for us going forward.”
Zeller explained that nicotine is comprised of 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 (as high as 99.9 percent pure), making it harder to tell synthetic apart from natural nicotine. Tobacco-derived nicotine is also becoming higher in quality.
“Tobacco-derived nicotine is now being made available at a higher quality … pharmaceutical grade from a purity standpoint. And with that, it may be harder for us to see that chemical fingerprint, if you will, whether it’s tobacco DNA or tobacco-specific nitrosamines,” he said. “We could see this as a problem going forward. Coupled with the clear intent of certain companies to do this to evade FDA regulation … We are concerned about what this means for product regulation, for the public health, and a product like Puff Bar proudly proclaiming its use of synthetic nicotine, [and] being the number-one brand used by youth.”
In the short term, Zeller said the FDA is talking internally about how to best address the growing number of products that are using synthetic nicotine to skirt FDA regulation. He said the agency is also responding to questions from Congress about synthetic nicotine and providing technical assistance to members when asked.
“There are a lot of companies out there that pride themselves on playing by the rules. They have every right to expect that the playing field is going to be level. That’s where we come in with our compliance and enforcement authorities,” Zeller said. “We agree that one of the most important things that we can do, using our compliance and enforcement tools, is to level the playing field and to have our actions [in the e-cigarette space], hopefully, serve as a deterrent. There’s nothing that I can say from a compliance enforcement standpoint on synthetic nicotine other than we have ongoing investigations.”
For more on Zeller’s speech at TMA read the next issue of Vapor Voice coming in mid-December.
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 Tobacco Lab Testing Expert Kimberly Hesse.
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 postmarket 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, 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 for 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 retailers’ 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 producst 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.
To register, please click here. Registrants will also have access to previously aired sessions.
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.
Vapor Voice, in partnership with TMA, has created a tool to track PMTA submissions as they make their way through the review process.
By Timothy S. Donahue
The world is waiting. When premarket tobacco product applications (PMTA) were due to the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) on Sept. 9, 2020, the vapor industry wanted to know what companies had submitted the required data and could remain in the U.S. market legally. In response, the CTP stated it would release a list of products that may continue to be sold during the review process.
Nearly five months later, the CTP has yet to produce anything to help the retailers, wholesalers, manufacturers and suppliers. In late January 2021, CTP Director Mitch Zeller said that the FDA would release the information in the “coming weeks.” Zeller has also said that “thousands” of PMTAs were submitted. Meanwhile, the CTP has stated that before making such a list available, the agency needs to ensure that publishing any such information complies with federal disclosure laws.
The CTP did finalize PMTA and substantial equivalence rules (SE) meant to guide how a manufacturer can seek a marketing order for electronic nicotine-delivery systems (ENDS). The text of the final rule was published long after the provisional PMTA submissions were due. Then, nearly a week after its posting, the new Biden administration froze all new and pending rules introduced in the last part of the Trump administration, including the just-finalized PMTA rule. The rule was removed from the Federal Register prior to its effective date.
“While a memo from the White House chief of staff ordered the withdrawal of any rules that did not publish by noon on Jan. 20, 2021, and the PMTA and SE final rules were withdrawn, this does not impact the FDA’s review of PMTAs or SEs that the agency has received,” an FDA spokesperson told Vapor Voice. “The agency continues to process the large number of submissions received and has already begun reviewing many applications. In the coming weeks, the FDA intends to provide a more detailed update on the agency’s progress since the Sept. 9, 2020 deadline.”
The FDA spokesperson says the agency will work closely with the new administration to advance appropriate regulations and policies that were withdrawn and are in line with the agency’s public health mission.
To help stakeholders gain some visibility on this crucial issue, Vapor Voice partnered with data specialists TMA to locate and confirm who has submitted PMTAs and at what stage the application is in in the regulatory process. The PMTA list can be found here.
Because there is no central, publicly available database, the information had to be pieced together from multiple sources, according to TMA research assistant Karen Pace. Several organizations issued press releases as their PMTAs moved through the process. Many others did not. Pace says that Vapepmta.com, an online resource also attempting to collect PMTA information, has been a valuable resource in her research.
“Not all of the press releases are as specific as others,” says Pace. “I tried to research those that had minimal information. Sometimes that worked, sometimes I could not find anything more. Then I found Vapepmta.com. The site was extremely helpful and is where I gathered most of the information. It was still a challenge to gather information on the total number of submissions a company had and the actual products submitted.”
It was also difficult to know what brands and how many flavors or nicotine strengths (or even if a submitted product used a freebase or salt nicotine) a company submitted. Pace says the only way to know for sure about some submissions was to go to the source. “We checked corporate websites and also called or emailed the companies directly to verify submissions,” she says. “It is something we will continue to do moving forward as we update the listing.” In the end, Pace choose to list companies individually and list the brands submitted when possible. “We are going to need help from the industry in keeping the information accurate and up to date,” she says.
The Vapepmta.com team built and operates its platform and has no affiliation with the FDA or any other company. Dan Daniel Racowsky has been in the industry for more than five years and says limited information and confusion around PMTAs led the group to take on the task of building a PMTA listing.
“It wasn’t very challenging to gather data upfront. After launching, we gained some publicity and were flooded with inquiries from brands asking to be included in our database,” Racowsky said. “Somewhat of a challenge has been keeping our data as accurate as possible. We’re in direct contact with the majority of brands listed on our platform, and most are pragmatically keeping us informed on their PMTA’s progress.”
The list is a solid source for interested parties, however, it is impossible for VV/TMA to guarantee its complete accuracy. While many companies have confirmed the accuracy of their listings, in some cases we have not been able to reach the applicant.
“We put in a lot of effort to validate these submissions, but there are still some companies that haven’t returned calls or emails to confirm their listing,” says Taco Tuinstra, editor-in-chief for Vapor Voice. “We note those instances in the list.”
If you note inaccuracies in your listing, please send an email to pmta@vaporvoice.net and we will be pleased to update the information.
Methodology explained
Thousands of manufacturers and importers submitted premarket tobacco product applications (PMTA) to the U.S. Food and Drug Administration (FDA) by the Sept. 9 deadline to keep their products on the U.S. market. But which products exactly are under review and how all those submissions have fared in the process is less clear. A comprehensive list promised by the FDA has yet to materialize.
In the absence of an official database, Vapor Voice decided to create its own tracker. As a news outlet, we already receive many press releases relating to PMTA submissions. In addition, we continuously monitor corporate websites, social media platforms and other industry sources. Individually, the pieces of information gathered during those endeavors make for interesting news announcements; taken together, they provide a coherent dataset to track PMTAs.
Of course, this approach has its limits. The data is self-reported, and at present, we cannot fully verify the veracity of all claims made in the announcements used to compile the list. The quality of the information that reaches us also varies greatly, from exact counts in all list categories to more general statements on a brand or brand family without further elaboration. As per our protocol, these issues are noted in the list. While we cannot present our dataset as a representative sample, we believe that, after capturing information on 180 companies, it paints as coherent a picture as possible.
Our tracker lists company, brand family, brand styles and PMTA stage. We view it as a “living document” that will be updated as new information becomes available. To that end, the tracker also includes a tool for user input. If the status of your application has changed or if you notice inaccuracies, we invite you to share that information with our editors, who will be pleased to make the required updates.
Keeping in mind the limitations of our tracker, we recommend using this tool to gain directional understanding of the volume of submissions for which the FDA’s Center for Tobacco Products is processing and as a starting point in a comprehensive due diligence search regarding products. We also strongly recommend that any retailer gain certification of products in their inventory from the manufacturer and rely upon advice of counsel as to appropriate due diligence and safe harbor.
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.
