Author: Staff Writer

  • Howard: Will Harm Reduction Prevail?

    Howard: Will Harm Reduction Prevail?

    Photo: Photolia Premium

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

    By Chris Howard

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

    The FDA’s Recent Actions

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 In fact, the FDA made its expectations clear in its 2016 Draft Guidance entitled Premarket Tobacco Product Applications for Electronic Nicotine-Delivery Systems (ENDS).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

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

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

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

    Appropriate for the Protection of Public Health

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

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

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

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

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

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

    Flavors Are Critical for Harm Reduction

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

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

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

    What’s Next?

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

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

     

    Chris Howard is the vice president, general counsel and chief compliance officer of E-Alternative Solutions, an independent, family-owned innovator of consumer-centric brands.
  • Triton May Sell ENDS Pending MDO Review

    Triton May Sell ENDS Pending MDO Review

    Photo: denissimonov

    Wages and White Lion Investments, parent to Triton Distribution, may continue to market its electronic nicotine delivery system (ENDS) devices in the U.S. until its appeal against the Food and Drug Administration’s marketing denial orders (MDO) has been evaluated in court.

    On Oct. 15, the U.S. Court of Appeals for the Fifth Circuit put the MDO on hold pending review. The judges also granted motions to expedite the appeal case and a ruling for emergency relief.

    Triton Distribution filed a motion to stay after the FDA denied the company’s premarket tobacco product application. The company claims that it had been irreparably harmed as a result of the FDA’s actions and faced an imminent shutdown of its business.

    In its motion, Triton contends that the FDA retroactively changed the requirements for PMTAs. “By imposing a new, across-the-board requirement that flavored ENDS products be demonstrably more effective at promoting smoking cessation than otherwise identical tobacco-flavored products, FDA acted contrary to its authority under Section 910 of the Food, Drug and Cosmetic Act (“FDCA), 21 U.S.C. § 387j, and not in accordance with law,” Triton wrote.

    At least six companies have filed lawsuits challenging the agency’s decision to make the companies remove their products from the market. Last week, the FDA rescinded the MDO issued to Turning Point Brands and the company will be allowed to continue marketing its vapor products while the FDA re-reviews the company’s PMTA.

  • Experts Challenge WHO Stance on Safer Nicotine

    Experts Challenge WHO Stance on Safer Nicotine

    Photo: Tom

    The Global State of Tobacco Harm Reduction (GSTHR), a Knowledge-Action-Change (KAC) project, launches a new series of briefing papers ahead of the publication of its latest report, Fighting The Last War: The WHO and International Tobacco Control, on Oct. 27.

    The suite of new GSTHR publications aims to draw attention to, and challenge the direction of travel of, the Framework Convention on Tobacco Control (FCTC) ninth Conference of the Parties (COP9), a major global meeting on tackling smoking. The meeting is being held virtually in early November. According to the GSTHR, the FCTC agenda and briefing papers indicate the FCTC secretariat and leadership are continuing to urge parties against the adoption of tobacco harm reduction approaches that could help save millions of lives.

    The GSTHR briefing papers offer analyses, commentaries or explainers on topics related to tobacco harm reduction and its role in combating the death and disease caused by smoking.

    The first paper provides a brief overview of both the FCTC and the Conference of the Parties biennial meetings, explaining their role in global tobacco and nicotine policy as well as highlighting some of the problematic elements of their current operation. A deeper analysis of these issues will be revealed when Fighting The Last War is published later in the month.

    The second GSTHR briefing paper focuses on the U.K.’s potential leadership role at COP9. According to the GSTHR, the U.K. has successfully implemented important aspects of a domestic tobacco harm reduction policy while retaining a strong tobacco control record. Currently, the FCTC project does not reflect the U.K. approach—yet the U.K. is one of the most consistent and generous financial backers of both the FCTC and the WHO. At COP9, the paper argues, the U.K. must be prepared to take a strong line and advocate for policies it has enacted that are demonstrably increasing the numbers of people successfully quitting smoking.

    These issues and more will be explored in depth in the GSTHR’s forthcoming report, to be published on Oct. 27 at a hybrid launch event, free to attend online. In Fighting The Last War: The WHO and International Tobacco Control, the report’s author, Harry Shapiro, takes a close look at the history, development and often secretive processes of the FCTC COP, its early battles with the tobacco industry—and the range of influences shaping international tobacco control’s response to safer nicotine products in 2021.

    The report launch will be broadcast on Oct. 27 from the Kia Oval in London. Two roundtable sessions will be livestreamed from 11 a.m. British Summer Time, with time allowed for questions from those watching in the room and from afar. Will Godfrey of Filter will host the first session, “The FCTC: Past, Present and Future,” which features Harry Shapiro, KAC report author; Derek Yach, Foundation for a Smoke-Free World, former WHO cabinet director and executive director for noncommunicable diseases and mental health; and Tom Gleeson of the New Nicotine Alliance Ireland.

    The second session will be hosted by Jeannie Cameron of JCIC Consulting and will be centered on the “Challenges to making the FCTC an inclusive international framework convention.” Audience members will hear from Ethan Nadelmann, founder of the Drug Policy Alliance; Nataliia Toropova from Healthy Initiatives and Professor Gerry Stimson, director of KAC.

    Parties to the FCTC must seize the opportunity to consider evidence from countries where tobacco harm reduction is succeeding, including the U.K., New Zealand, Sweden, Norway and Japan.

    Gerry Stimson, director, KAC

    “We’re gravely concerned by the WHO’s continued rejection of tobacco harm reduction,” said Stimson. “It already accepts harm reduction as a valid evidence-based public health intervention for drug use and HIV/AIDS. Harm reduction is explicitly named as one of three tobacco control strategies in the opening lines of the Framework Convention on Tobacco Control. Adoption could hasten the end of the public health crisis caused by smoking.

    “Instead, the WHO rejects and, worse, repeatedly misinforms the public about safer nicotine products, demonstrating a disregard both for the lives of over one billion adult smokers and the eight million deaths each year due to smoking. Parties to the FCTC must seize the opportunity at COP9 to consider evidence from countries where tobacco harm reduction is succeeding, including the U.K., New Zealand, Sweden, Norway and Japan—and ask why the WHO and its influential financial backers are refusing to do the same.” 

  • Biden Eyes Robert Califf as FDA Head

    Biden Eyes Robert Califf as FDA Head

    Robert Califf

    U.S. President Joe Biden is likely to nominate Food and Drug Administration veteran Robert Califf to lead the agency, reports The Washington Post. A cardiologist who teaches at the Duke University School of Medicine, Califf was the FDA’s deputy commissioner for medical products and tobacco before leading it from February 2016 to January 2017.

    The FDA has been without a permanent chief since President Biden took office. Its acting commissioner, Janet Woodcock, is nearing the end of the term that acting officials are allowed to serve.

    While some praised Califf as a strong and experienced candidate, others criticized his ties to the pharmaceutical industry.

    “Rob Califf would be a strong, experienced and effective commissioner,” former FDA Commissioner Mark McClellan was quoted as saying by Politico.

    “The country desperately needs an FDA leader who will reverse the decades-long trend in which the agency’s relationship with the pharmaceutical and medical device industries has grown dangerously cozier—resulting in regulatory capture of the agency by industry,” countered Michael Carome, director of Public Citizen’s Health Research Group. “Califf would not be that leader.”

  • BAT Commits to Net Zero Emissions by 2050

    BAT Commits to Net Zero Emissions by 2050

    Photo: Olivier Le Moal

    BAT has signed up for the U.N.-backed Race to Zero campaign, committing to net zero emissions by 2050.

    Race to Zero is the largest-ever alliance committed to halving global emissions by 2030 and achieving net zero carbon emissions by 2050. The campaign represents more than 4,000 businesses estimated to cover nearly 25 percent of global CO2 emissions and more than 50 percent of GDP. BAT’s commitment comes ahead of important global milestones in the fight to address climate change, including the G20 Summit in October and the COP26 conference in Glasgow on climate change in November.

    “Our purpose of building ‘A Better Tomorrow’ ensures that sustainability is front and center in all we do,” said BAT Chief Marketing Officer Kingsley Wheaton in a statement. “We are proud, therefore, to support the Race to Zero campaign. This is in addition to our New Categories journey—with Vuse, Glo and Velo—and our ambition to have £5 billion of New Category revenue by 2025 and 50 million noncombustible product users by 2030.”

  • Litigation Spikes With Rise of New Products

    Litigation Spikes With Rise of New Products

    Image: inimalGraphic

    Litigation over intellectual property relating to nicotine products has risen more than 10-fold since 2015, reports The Wall Street Journal, citing data from Maxval and Lexis Nexis.

    The increase in patent litigation appears to be related to tobacco companies’ intensified search for smoking alternatives.

    In September, the U.S. International Trade Commission ruled that Philip Morris International and Altria must stop imports of IQOS heated-tobacco sticks due to a patent dispute with R.J. Reynolds Tobacco, which is owned by British American Tobacco. The case is now in review and can be appealed. But in the worst-case scenario, IQOS will be banned from the lucrative American tobacco market.

    PMI and BAT are furthest ahead in their shift to smoke-free technologies with respective targets to derive more than half and one-fifth of net revenue from less harmful products by the middle of the decade. They are also among the most active litigants.

    The two have a patent dispute pending in Japan, another key market for smokeless products. And although September’s U.S. ruling went in BAT’s favor, the British firm recently lost disputes against its rival in the United Kingdom and Poland.

  • Open Mic

    Open Mic

    Photo: Malcom Griffiths

    One of the panelists at the final session of the Global Tobacco and Nicotine Forum (GTNF) 2021, the Open Mic, indicated that he and his colleagues were spending a lot of time trying to validate innovative ways of substantiating tobacco harm reduction. He was responding to a question about whether breaking through to those so far unconvinced about the harm reduction credentials of new-generation tobacco/nicotine products would require more research or whether a different approach was needed. It was obvious that regulators would want to see the results of high-quality studies, he said, but what was not so obvious was what kinds of studies were needed. It was known, however, that if somebody stopped smoking tobacco, they benefited from a whole world of physical improvements that could be measured; the problem was how to measure those changes effectively and in a timely manner.

    The Open Mic session lasted one-and-a-half hours and provided event participants with the opportunity to ask some challenging questions, one of which touched on the fact that in some tobacco markets, up to 35 percent of smokers are occasional or nondaily smokers, most of whom don’t use other nicotine products on days when they don’t smoke. Given this, what was the role of nicotine in moving people away from combustible products?

    One response suggested that the issue of addiction or dependence was oversimplified, as though all smokers were the same and all were addicted, an idea that was not entirely true. There had been overexposure of the problem of addiction and dependence, especially in relation to young people, when, in fact, some people were able overnight and without withdrawal symptoms to quit a smoking habit that had lasted up to 40 years. It was time for the book of addiction and dependence to be rewritten.

    Another panelist took the view that the issue of the spectrum that took in addiction, dependence and pleasure was complex, and focusing on it as if it were the main moral question that had to be grappled with was not helpful. Having such a focus was to miss the target. The target should be to reduce risk and to reduce disease. In fact, the important moral question was do physicians and members of the scientific medical community give smokers an additional option or not? Do they provide them with proper guidance on how to quit but give them the right to choose, or do they condone only the methods of which they approve?

    Broadly speaking, the Open Mic session included three panelists from the world of science and healthcare and three from the world of business, one of whom appeared remotely from China. The session started, however, with a comment from one of its two moderators, who said the 2021 GTNF was the first conference she had been at where the consumer was front and center. But there was a sting in the tail. Some consumers, she added, those who still used traditional tobacco products, were not at the center except in the sense that they were the subject of discussions on how to get them to move to one of the many new-generation products coming onto the market. In a way, the suggestion seemed to be: Where was the “T” in GTNF?

    A corollary to this question came up later when it was asked whether committed traditional tobacco users should be continually bombarded with information by those wanting them to quit or switch to less risky products or whether, at some point, it should be accepted that since they were determined to continue with their habit, they should be left alone to enjoy it. Nobody got to grips with this question, perhaps because it was too raw or because this “hard core” of smokers would make up the 5 percent who would still exist in countries that had “eliminated” smoking. Although one panelist made the point that in a relatively free world, people should be allowed to do what they wanted to do with a legal product, most merely suggested that new-generation products and the messages around them should be improved, presumably until even the hard core of smokers came on board.

    There is clearly a problem with such communications, however. One simple but insightful question asked where a smoker looking to quit should go for advice. This presents a conundrum because the tobacco/nicotine and pharmaceutical industries have financial interests in the outcome, many healthcare professionals are ill-informed and social media is crawling with conspiracy theories. One panelist made the point that it could turn out that your friend who had already benefited from switching from consuming traditional tobacco products to using new-generation products could prove to be the most important medical adviser you would ever consult.

  • Investment Panel

    Investment Panel

    Photo: Malcom Griffiths

    A New Case for Tobacco

    Despite the rough ride for tobacco stocks in recent years, the investment case for tobacco and nicotine remains strong, according to the participants in the Global Tobacco and Nicotine Forum (GTNF) 2021 investors panel. Under the direction of Eric Bloomquist, four prominent tobacco analysts—Jonathan Fell of Ash Park Capital, Rupert Wilson of Strategic Business Consulting, Pieter Vorster of Idwala Research and Gaurav Jain of Barclays—debated the outlook for tobacco in a rapidly changing business environment. Even as the industry suffered from Covid-19-related fallout, its legendary pricing power remained intact and continued to deliver profit growth and cash flow. With supply chain disruptions affecting many sectors, tobacco has even become a safe hiding place again, one panelist ventured.

    That said, some companies have clearly done better than others. Those with greater exposure to noncombustible products are attracting higher valuations than those with a lower portion of their revenues coming from that business, and the panelists debated whether that discrepancy would prompt investors to pressure the underperformers to “get their act together.” Not everybody was convinced. As one participant pointed out, shifting the world’s 1.1 billion smokers to noncombustibles is a very long-term project. “Realistically, there is time for the companies who don’t have the right strategy to eventually get there,” he said. A word of caution was also uttered against compromising the cash flow machines: The transition to less risky nicotine products requires lots of investment, and many of those funds are still generated by sales of traditional cigarettes.

    Speculating on possible mergers and acquisitions, the panelists considered a reunification of Altria Group and Philip Morris International unlikely in the near future. As one participant pointed out, PMI has publicly committed to deriving more than 50 percent of its net revenues from smoke-free products by 2025. Because Altria currently receives a smaller share of its earnings from such offerings than does PMI, it would be harder for the combined entity to meet PMI’s target. What’s more, many PMI investors like the fact that they can currently choose whether or not they want exposure to the uncertain U.S. market—an option that would no longer be available after any merger.

    One panelist suggested Swedish Match as an acquisition target for PMI. After the recently announced separation of its cigar business, Swedish Match would offer PMI attractive complementary smokeless businesses, such as snus and modern oral, the panelist said. Others contemplated the possibility of spinoffs by Imperial Tobacco, which has announced greater focus on its core markets. The problem here, noted one panelist, would be the buyer: With all large tobacco companies keen to reduce their dependence on combustibles, there is no obvious taker for such a business—at least not among the publicly listed firms. This, in turn, led to speculation about the designs of China’s State Tobacco Monopoly, which is not accountable to shareholders—but the panelists quickly agreed it was futile to figure out “what is happening in China.”

    The discussion then turned to the impact of environmental, social and governance (ESG) initiatives on investors. Would tobacco companies’ efforts to transition smokers away from deadly combustibles prompt investors who might otherwise have shunned the sector to take another look? Panelists agreed that the Foundation for a Smoke-free World’s Tobacco Transformation Index, which evaluates tobacco manufacturers on efforts and actions relating to tobacco harm reduction, could prove to be a valuable tool for investors. Companies that are doing the most in this area are already enjoying the best valuations, one panelist pointed out. They also pointed to the entrance into the market of new nicotine companies that offer no combustibles, such as RELX and SMOORE, which have broadened the options. PMI’s recent acquisitions of pharmaceutical companies, such as Vectura, could also generate interest from a new class of investors, the analysts ventured.

    At the same time, the panelists acknowledged the challenges facing tobacco companies in escaping the tobacco “taint.” Many financial websites offer investors a dropdown menu with the option to exclude “tobacco”—a broad label that includes both companies wedded to traditional cigarettes and firms at the forefront of transitioning smokers away from such products.

    One panelist detected a marketing opportunity. Its premise would be simple: Rather than pretending tobacco companies don’t exist, such a fund could offer to invest in their depressed stocks and help them change. “That would be a useful approach for the world and an interesting proposition for investors,” he said. 

  • Joe Murillo and Todd Cecil

    Joe Murillo and Todd Cecil

    Photo: Malcom Griffiths

    The regulator’s view

    When the U.S. Food and Drug Administration began issuing marketing denial orders (MDOs) for vapor products, the industry was understandably shocked. Many companies that had submitted timely premarket tobacco product applications by Sept. 9, 2020, had expected to first receive a deficiency letter and not immediately an order to remove their products from the market. Some MDO recipients complained the agency had “moved the goalposts” by suddenly requiring studies that it had previously said were not required.

    At least three companies have filed lawsuits over their MDOs. All are accusing the agency of making “arbitrary” decisions and not reviewing the submitted data according to the statutes. In a “fireside chat” between Joe Murillo, chief regulatory officer for Juul Labs, and Todd Cecil, deputy director of the Office of Science for the FDA’s Center for Tobacco Products, during the recent GTNF in London, Cecil acknowledged the missing data that caused the flurry of MDOs is not required by the statutes that regulate tobacco products.

    When asked what the “level of expectation” the FDA had in deciding whether to issue a deficiency letter or an MDO after a premarket tobacco product application (PMTA) was moved into scientific review, Cecil said that the agency followed “a randomized approach” to choose the applications the FDA would work on.

    “The randomized approach identified a number of manufacturers’ products that went into this scientific review, and we … evaluated them from top to bottom,” he said. Cecil noted the agency began to see in some applications that “tended to have problems or missing materials that we needed in terms of benefits [of flavors]; that we learned we have to have that benefit piece … that evaluation that we spent several months working on taught us what we had to look for to be able to [conduct] a full scientific review.”

    Cecil said that the agency just figured “if we know going right in that there are pieces missing, why will they go through a deficiency process and with a very short turnaround expecting to get back a full study that wasn’t completed previously?” So, instead of issuing a deficiency letter as required by statute, the FDA just handed out MDOs because the agency knew that it would take a company a significant amount of time and expense to conduct the new required longitudinal and cohort studies. Cecil was then asked why the agency filed the applications in the first place.

    “We had to make a determinant how can we streamline this evaluation and determine those products that have at least the bare minimum for us to do a real and complete evaluation,” Cecil said. “This evaluation is not a standard. It is not a de facto standard or anything else. This is information that we need to see, but it’s not a requirement. An RTF [refuse to file] are those things that are required by the statute. And these studies are not necessarily required by the statute.”

    The FDA has also been facing an unprecedented amount of scrutiny on how its handling of regulation of electronic nicotine-delivery system (ENDS) products and the PMTA process. Numerous health groups, anti-nicotine groups, states attorneys general and even members of Congress have criticized the FDA and demanded action. When asked if the FDA’s actions were influenced by these groups, Cecil said the agency focuses on science.

    “We’re science-based,” he said. “We need look at what is presented to us in the application and in the laboratory. That is what we’re most focused on. If there is new data out there and that new data is brought to our attention through one of these [groups], then that’s fine. We would be happy to get those up and understand the bigger picture, all of the data … We need to evaluate those as scientifically or make a determination based upon that science.”

    Only 100,000–200,000 products remain under FDA review. Of the 6.7 million submitted PMTAs, all others have received either a refuse-to-accept, an RTF or an MDO response. Cecil denied the agency was making a “categorical policy decision as opposed to an application-by-application decision” about flavored products. “We are stating that we understand that there is a significant youth initiation risk that comes from flavored ENDS products,” he said. “We are, in fact, reviewing all of those, and what we have found as we’ve done our reviews is that none of the literature is sufficient to demonstrate that there is not a youth initiation risk for individual flavors.

    “We see that tobacco has a lower initiation risk. We see that menthol has some issues with it, and we are going to be evaluating that as we go forward. However, all of the data points to the flavored products as having significant youth initiation concerns. So what we’re looking for is an adequate indication that there’s a benefit on the other side of the equation. This is not a decision that we aren’t going to accept flavored products. Absolutely opposite. We need to ensure that there is concrete and robust data that demonstrates that there is an existing user benefit for those products.”

    Cecil declined to say when more MDOs would be issued or when the agency would rule on major products, such as Juul, NJOY, blu and Vuse. “We continue to work diligently,” is all he would say. “There are a number of products that are well along. But no, I can’t tell you how many are those ones, but there are some that we’re hoping to move forward in the short term.”

    The FDA’s recent action against flavored e-liquids does not mean that the FDA will never approve a flavored e-liquid, according to Cecil. He said that the rejected applications just lacked the required information that those products met the agency’s “appropriate for the protection of public health” standard. “You are welcome to reapply once you have addressed the issues that we provided to you,” he said. “And we will reevaluate that at a future date.”

  • Amanda Wheeler

    Amanda Wheeler

    Photo: Malcom Griffiths

    Continuing the fight

    Amanda Wheeler got involved in the vapor business after a personal tragedy. Despite a cancer diagnosis, she was unable to quit smoking for years—until she discovered vapor products. Eager to share her success with others, Wheeler and her husband, Jourdan, opened JVapes, an e-liquid manufacturer and retail store in Prescott, Arizona, USA, in 2012.

    The business was successful, quickly expanding to multiple locations across three states. Wheeler was helping her customers quit smoking combustibles and became increasingly involved in advocacy.

    In October of 2020, Wheeler and fellow business owner Char Owen created the American Vapor Manufacturers Association (AVM) to help small businesses navigate the U.S. Food and Drug Administration’s onerous premarket tobacco product application (PMTA) submission process. The organization also engaged in federal lobbying and sought to provide reduced-cost scientific testing and expert regulatory compliance advice to members preparing PMTAs.

    The deadline for submitting PMTAs to the FDA was Sept. 9, 2020. Wheeler submitted timely applications and was allowed to keep her products on the market for up to one year while the FDA reviewed her submissions. But on Sept. 9, 2021, Wheeler received a marketing denial order (MDO). The regulatory agency appeared determined to put the company she and her husband had built, along with the industry she passionately defended, out of business.

    That day, the FDA issued MDOs to more than 130 companies, requiring them to pull an estimated 946,000 products from the market. The bloodbath continued in the following weeks. At press time, the FDA had issued 323 MDOs accounting for more than 1,167,000 flavored electronic nicotine-delivery systems (ENDS). As of Sept. 28, not a single ENDS had been approved.

    “[The] FDA knew that they didn’t have the time or the resources to give our products fair consideration, but instead of asking for help, they let the 9/9 deadline pass and left the more than 500 companies subject to their decision in an unstable and probably untenable position,” Wheeler explained. “The FDA’s arbitrary ruling effectively criminalizes thousands of long-standing businesses in communities all across the country. Those entrepreneurs now have to junk their inventory, fire their employees, stiff their investors, and defer their dreams.”

    Wheeler said she was standing up for the “little guy”—the thousands of small business owners who manufacture, distribute and retail open system products in vape shops all over the United States. She explained that her business and other AVM members made every attempt within their means to comply with the FDA regulations. It was an expensive process. It was also a system designed for small businesses to fail from the very beginning, she said.

    “My company personally submitted several hundred thousand pages of documents to the FDA in an attempt to comply with this one premarket tobacco application standard. The [FDA’s] decision doesn’t just make a mockery of that earnest work. It also makes the more than 10 million Americans who made the switch to vapor products—in our vape shops, with our liquids—into outlaws, too,” said Wheeler. 

    Wheeler said the FDA, in an act of “regulatory arson,” was creating a tobacco-led monopoly over the vaping industry, as only the companies with the deepest pockets stand a chance to survive the agency’s cumbersome PMTA process.

    She also focused on what she perceived to be one of the biggest challenges facing the industry today: misinformation. “There is one other group I want to address with my time here. It’s the activists and the press who—whether because they are misguided or malicious—spread the falsehoods and distortions that directly led to this tragic outcome,” she said.

    The biggest victims of the FDA’s actions, according to Wheeler, are the vapers who will now struggle to acquire the products that have helped them stay off of cigarettes. Wheeler vowed she would continue to fight for her customers and fellow business owners. “Even through their dismay, I am hearing a constant refrain: We are not going to stand for it,” she noted.

    “We will be at the FDA’s doorstep demanding answers or forcing them through Freedom of Information Act laws and the courts. We are not surrendering our business or abandoning vapers to cigarettes,” she said. “As we say in Arizona, this is more than just a fight. It’s going to be a reckoning.”