Except that wasn’t true. By November, the CDC had identified what it called “a very strong culprit” for EVALI’s cause: vitamin E acetate, an adulterant and cutting agent that had been discovered in illicit THC cartridges. The damage, though, was done: Recent studies have shown that misinformation around the misnamed condition has increased cigarette sales, and the public remains generally unaware about the relative risks of safer nicotine products like vapes.

I wish I could say that I recognized, instantly, the extent to which a new moral panic was developing, but that wouldn’t be true.

This happened when I was still a staff writer at VICE, and right as we had been given a directive by management to establish “nicher” beats: Cover subjects and stories that the more mainstream press wasn’t covering. I wish I could say that I recognized, instantly, the extent to which a new moral panic was developing, but that wouldn’t be true. It took me some time—learning about a pretty unfamiliar field, and talking to consumers and other experts and sources—to realize that we were seeing the early stages of another drug war.

That impression has only strengthened since, as—initially at VICE and then for two years on Filter’s staff—I’ve reported and written close to 200 articles on tobacco harm reduction (THR). In that period, we’ve seen ever-increasing controversy and polarization around THR, and growing coverage—rarely fair—from mainstream media.

Today, I’m departing from Filter—and from journalism, though I will remain involved in THR. So I have to say goodbye, in some respects, and many thanks to the readers who have trusted me and stuck along all these years. I hope my love for the topic has always been clear. Before I started covering THR, I had little sense of an insular, passionate world. Since then, I’ve met many inspiring and brilliant individuals who devote their careers and lives to fighting for people’s right to accurate health information and access to safer options. I’m glad I was able to give a platform to voices and issues that weren’t being heard.

It leaves me with a sense of just how fast the news has moved. But it can get, unfortunately, repetitive.

It’s been instructive, at the end of my time with Filter, to have the chance to zoom out. Reflecting on the events I’ve reported for the better part of four years leaves me with a sense of just how fast the news moves.

But it can get, unfortunately, repetitive. In one of the first articles I wrote for Filter, I interviewed nearly a dozen people in New York, New Jersey and Massachusetts who had started operating in illicit markets after their states prohibited the sale of flavored vaping products. As I write today, residents of California are faced with similar choices a few months after the state voted to ban the sale of basically all flavored nicotine products.

Similar examples are not hard to find. In the fall of 2020, before I joined Filter’s staff, I reported how millions of Michael Bloomberg’s dollars had been funneled through so-called public health organizations and helped lead to outright vape prohibition in India. I’m leaving just weeks after Bloomberg Philanthropies announced that it would be pledging another $420 million “to reduce tobacco use globally.” And the World Health Organization (WHO), where Bloomberg has been a global ambassador, has not budged on demonizing vapor products—time and time again.

The stakes of the worldwide THR battle have not budged, either. Close to half a million people still die of smoking-related causes in the US every year. Globally, the total is more than 8 million. Such staggering tolls, the needless individual tragedies behind these numbers, are hard to process. Small wonder that THR advocacy, faced with indifference or worse, implacable opposition to measures and products that we know save lives, frequently spills into anger.

There has been some cause for optimism. But none of that has been without the obvious, gigantic caveats.

There has been some cause for optimism: Smoking in the US has hit record lows, while youth vaping rates—a source of worry, above all, for their role as a pretext for bad policies—are now nowhere near their peak. Some estimates suggest that 82 million adults now vape worldwide. Colorado activists managed to avoid a statewide flavor ban. And the FDA has authorized a handful of e-cigarettes through its premarket tobacco product application (PMTA) process—a completely unprecedented development.

But none of that has been without the obvious, gigantic caveats: The agency has, basically, wiped away the entire independent vapor market, and the PMTAs it has authorized have exclusively favored the companies with the finances and resources to meet the “appropriate for the protection of public health” (APPH) threshold—that is, a product’s likelihood in helping adults transition from cigarettes to the safer alternative instead of introducing a new generation to nicotine. Vape shops have since shuttered, and enforcement has come, albeit inconsistently, with the force of the Department of Justice. Juul, and others, are still in limbo, or have filed lawsuits fighting their marketing denial orders (MDOs).

It might be even more complicated on the international front. Despite the Japanese government’s hostility toward e-cigarettes, its lukewarm acceptance of heat-not-burn products (HTPs) has brought about a 43 percent decline in cigarette sales in half a decade. Meanwhile, in Sweden, snus—a moist oral tobacco product that’s placed inside the upper lip—has largely been responsible for the country nearing “smoke free” status.

I’m indebted, of course, to my sources for the coverage I’ve been able to produce. Thanks to a great tip, Filter managed to publish a feature on synthetic nicotine before it became the new obsession in Congress—and long before it fell under the regulatory purview of the FDA. Through court documents and internal Freedom of Information Act (FOIA) requests, we obtained one of my first scoops on the subject: the revelation that the FDA, likely under a time crunch to review millions of PMTAs, had adopted a checklist-like “Fatal Flaw” standard to evaluate whether applications had certain long-term studies, and summarily deny them if not. In appeals courts throughout the country, countless manufacturers who received MDOs on this basis have argued that the agency never previously made clear that randomized control trials (RCTs) and longitudinal cohort studies were required.

Numerous follow-ups included our reporting on how leadership at the Center for Tobacco Products (CTP) seemingly overruled the recommendation of its own Office of Science to authorize some menthol e-cigarettes.

Now, like everybody else, I’ll be waiting to see. I don’t know the answers to these questions.

I had my own favorite moments as well: I went to Triton, where I watched a company self-regulating as it petitioned the government for a fair shake. I attended the Global Forum on Nicotine in Warsaw. And I watched as leadership changed at the FDA and then at the agency’s CTP, as its longtime director Mitch Zeller retired and was replaced by Brian King, who had come from the CDC with a reputation for having spread misinformation about EVALI. (Soon, Matthew Holman, the center’s top scientist, would resign and take a job in the industry.)

Now, like everybody else, I’ll be waiting to see if the FDA bans menthol combustibles or lowers the nicotine levels in cigarettes or ever authorizes a flavored nicotine vaping product (even menthol). Or whether, on the world stage, more countries will follow pathways like the United Kingdom, Sweden or Japan—or, conversely, prohibition-oriented responses like India, Taiwan and Mexico.

I don’t know the answers to these questions. Like other observers in this rapidly evolving field, I’ve never been able to predict the future. But I’ll still be doing what I can to address the present.

Photograph by Vaping360 via Flickr/Creative Commons

The Influence Foundation, which operates Filter, has received grants from Juul and from Knowledge-Action-Change, which organizes GFN. Filter’s Editorial Independence Policy applies.

The post Tobacco Harm Reduction Reflections, as My Years of Reporting End appeared first on Filter.

News reports and a press call from the White House suggested that he’d make this statement as part of the administration’s Cancer Moonshot initiative, but it was left, it appears, on the cutting room floor. Biden himself did not bring it up.

Pledging to reduce smoking and supporting the best-evidenced ways to do so are two different things.

“We’re committed to continuing to use authorities and programs to keep making progress and especially with a focus on helping individuals avoid smoking in the first place and supporting Americans who want to quit,” Danielle Carnival, the White House’s Cancer Moonshot coordinator, said on a February 7 press call before the SOTU. “So, getting support services out for as many people, reaching as many people as possible so that we can prevent the cancer impact and we know the broader health impact that smoking has.”

But pledging to reduce smoking and supporting the best-evidenced ways to do so are two different things.

Prior to the speech, observers were already beginning to note that it would be a missed opportunity to support tobacco harm reduction (THR)—or, at the very least, clear up some rampant misconceptions among the public. To the extent the issue even has Biden’s attention, he, like the Food and Drug Administration (FDA), appears almost exclusively centered on nicotine cessation and preventing smoking initiation, which has reached record lows in the past few years.

Yet close to half a million Americans continue to die of smoking-related causes each year, a toll higher than that of the overdose crisis—which did make the speech, albeit through troubling plans. The economy, health care generally and sparring with Republicans were the dominant themes of the 73-minute address.

Like some predecessors, the Biden administration has been trying to push forward a long-awaited federal ban on menthol cigarettes—a move that has been applauded by mainstream tobacco control as a way to reduce cancer rates and youth experimentation, and criticized for its racial-justice implications by drug policy and civil rights groups like the American Civil Liberties Union (ACLU).

Despite Biden’s omission, tobacco control policy has started to become even more of a partisan issue—in ways that are uncomfortable to many.

But neither the speech nor the preceding White House messaging remotely hinted to the fact that the FDA has authorized some vaping products through its premarket tobacco product application (PMTA) process, a belabored and much-criticized pathway in which vapor manufacturers have to show that their products are “appropriate for the protection of public health” (APPH)—that is, more likely to help adults transition to a safer alternative than introduce a new generation to nicotine. Biden would not have had to look far, either, for this sort of recent news: For example, the FDA authorized three more heated tobacco products (HTPs) less than two weeks ago.

Despite Biden’s omission, tobacco control policy has started to become even more of a partisan issue—in ways that are uncomfortable, to many, even beyond the basic problem of science and public health interests being overruled. Much of the Democratic establishment continues to obsess over youth vaping rates, while some on the right champion adult use as an issue of individual liberty.

For one thing, Michael Bloomberg, an influential and wealthy Democrat, keeps doubling down on his ill-conceived mission to destroy safer nicotine alternatives: On February 2, Bloomberg Philanthropies announced an additional $420 million “to reduce tobacco use globally,” bringing the organization’s financial commitment—by its own admission—to $1.58 billion since 2005. Around the world, particularly in low- and middle-income countries where 80 percent of the planet’s tobacco users live, THR advocates have accused Michael Bloomberg and the groups he funds, like the Campaign for Tobacco-Free Kids (CTFK), as promoting nothing more than a “quit or die” mentality.

Meanwhile, as Business Insider pointed out, right-wing media pundits like Tucker Carlson—who reportedly chews nicotine gum so much that he stops “only to be filmed or to eat”—have recently argued that encroaching tobacco control policies are, essentially, infringing on individuals’ liberties: At the end of January, he spoke out against the always-forthcoming federal menthol ban, and just a few weeks earlier, had invited Troy ​​Nehls, a congressman from Texas, to discuss lifting an indoor smoking ban in the Capitol.

Neither view, however, touches on the complicated realities of safer nicotine use. With smoking rates highest among marginalized populations, health equity is as unlikely as science to be mentioned.

Image of 2023 State of the Union via the White House

The post Smoking Deaths Sidelined in Biden’s State of the Union Address appeared first on Filter.

The report identifies 52 active consumer groups around the world that advocate for safer nicotine products (SNPs) like vapes, snus, oral nicotine pouches and heated tobacco products (HTPs). It found that 31 of them had not gotten any funding support—and that the combined global funding for these organizations was around $310,000 in the last full year.

It’s a telling revelation, when such organizations are often smeared by opponents as front groups for tobacco or nicotine companies. It also represents a drastic difference from the amount of money spent by billionaire Michael Bloomberg and his funding vehicles to restrict access to THR options worldwide. In 2019, for example, Bloomberg Philanthropies announced that it would spend $160 million over three years to “fight flavored e-cigarettes” and “protect kids” in the United States alone.

“The sustainability of these organizations is one of the main concerns that has come out of the data.”

In light of the consumer organizations’ meager-to-nonexistent funding, it’s little surprise that of the 52 active groups in the paper—with 24 in Europe, 13 in Latin America, eight in Africa, five in the Asia-Pacific region, and two in North America—just seven had any “contracted or paid staff.” Only 13 people, globally, held a paid position at one of these organizations. The rest were all volunteers, most of them people who’d managed to quit smoking through the use of SNPs.

The report goes on to detail some of the groups’ objectives, their often-informal operating structures and their working methods—from grassroots organizing to media outreach and lobbying of officials and lawmakers.

“This survey offered a unique opportunity to map these advocacy organizations for the first time and provide valuable insight into how they are operating all over the world,” lead author Tomasz Jerzyński, of the Robert Zajonc Institute for Social Studies at the University of Warsaw, Poland, and a data scientist for the Global State of Harm Reduction, said in a press statement. “The sustainability of these organizations is one of the main concerns that has come out of the data. All of these groups face challenges due to their small numbers of core workers and their dependence on volunteers.”

The 52 consumer groups are without exception quite young, reflecting, in part, the relatively recent emergence of most key SNPs. Thirty-six of them were founded in 2016 or later; even the oldest dates back only to 2009. Yet they have, at least in their own assessments, been able to advocate quite effectively. “All pointed to important achievements in the public debate about SNP and tobacco harm reduction,” noted the paper.

“This paper starkly demonstrates the major imbalance in resources … unfairly skewing the debate.”

Its authors—also including KAC’s Jessica Harding and Professor Gerry Stimson—concluded that the “immediate challenge” is for these organizations to transition “from a low and fragile start-up phase to become better resourced” and that the “further challenge” rests in gaining “recognition at a national and international levels as legitimate stakeholders in the development of tobacco control policy with respect to safer alternatives to smoking.”

“This paper starkly demonstrates the major imbalance in resources available to consumer organizations advocating for access to safer nicotine products and those opposed to tobacco harm reduction, unfairly skewing the debate,” Stimson, KAC’s director, said in the press statement. “It also highlights why consumer groups must be recognized as legitimate stakeholders in the policy sphere. These organizations have been set up, and are run by, people who have chosen to improve their own health by switching to SNPs—people who have significant expertise to offer, and whose lives are directly affected by policymaking in this area.” 

Image via VaporsCorner National/Youtube, showing vaping advocates protesting in Ontario, Canada, in 2015.

The Influence Foundation, which operates Filter, has received grants and donations from KAC. Both KAC and The Influence Foundation have received grants from the Foundation for a Smoke-Free World. Filter’s Editorial Independence Policy applies.

The post Safer-Nicotine Consumer Groups Have Almost No Funding Worldwide appeared first on Filter.

In 2019, the FDA had authorized IQOS and handful of other Marlboro HeatSticks through its premarket tobacco product application process (PMTA), in which PMI had to demonstrate that these products would be “appropriate for the protection of public health”—meaning, in short, that they’d be more likely to help adults who smoke switch to the safer alternative than to introduce a new generation to nicotine. The agency also granted the company the ability to make some modified risk claims in 2020.

Heated tobacco products (HTPs) heat tobacco sticks without burning them, to produce vapor that is inhaled. Research has suggested that the vapor contains far fewer harmful compounds than cigarette smoke, but probably more than are present in the vapor from e-cigarettes.

It will add to the small availability of FDA-authorized safer nicotine alternatives, but is also a reminder that the PMTA process favors well-financed manufacturers, mainly with ties to the tobacco industry.

HTPs have already taken off in other parts of the world, showing eye-catching potential as a harm reduction option. Most notably, Japan has seen an almost 43 percent decline in cigarette sales over the past decade, right after HTPs were introduced and soared in popularity. And that’s despite the fact that the Japanese government has been, for the most part, rather hostile toward tobacco harm reduction (THR); nicotine vapes, for instance, are effectively outlawed. Critics of mainstream tobacco control—which usually favors prohibition-focused measures—have pointed to Japan as a potential, if limited, model. South Korea has already followed suit, and though Taiwan has just banned even the use of vapes, it has left HTPs alone.

Although the additional IQOS MGOs will add to the small availability of FDA-authorized safer nicotine alternatives in the United States, they are also a reminder that the PMTA process favors well-financed manufacturers, mainly with ties to the tobacco industry.

Still, no flavored vaping products made by anyone have received MGOs. Just days before the IQOS announcement, the FDA rejected two menthol e-cigarettes from Vuse, the R.J. Reynolds-owned vapor company. It left THR advocates and industry observers wondering—again—if the agency will ever authorize any flavored e-cigarettes.

At the moment, IQOS is unavailable in the United States: Altria had begun limited sales of the device in 2019, but a patent dispute with R.J. Reynolds halted any sustained rollout. Then, last October, PMI paid $2.7 billion to regain the US commercialization rights for IQOS from Altria and announced plans to start manufacturing the product in the country.

A new rollout is now set for mid-2024, as the tobacco giant continues to eye the market for safer nicotine alternatives, especially in the US. In November, PMI also took over a majority of Swedish Match—the producer of Zyn, the popular oral nicotine pouch—for $16 billion, inching ever closer toward sole ownership.

Meanwhile, smaller and medium-sized vapor manufacturers—most of which have already had their PMTAs denied—continue to have to fight in court for, perhaps, any hope of an MGO.

Photograph by Vaping360 via Flickr/Creative Commons 2.0

The Influence Foundation, which operates Filter, has received grants from both PMI and Reynolds American, Inc. Filter’s Editorial Independence Policy applies.

The post FDA Authorizes More Heated Tobacco Products, Rejects More Vapes appeared first on Filter.

En banc rehearings, which require a stable of judges to weigh in on a case, are rare; in the Fifth Circuit, fewer than 1 percent of cases are reheard in this way. In the end, 16 judges voted on whether to rehear Triton and Vapetasia’s case—meaning at least nine of them must have voted in favor.

The case is seen as central to tobacco harm reduction advocates’ hope that flavored vapes—which most adults switching from cigarettes find preferable or even critical, but none of which the FDA has authorized—will remain available. Many urge, too, that the market not be restricted to just the handful of large companies that have so far received authorizations for tobacco-flavored products, and that open-system vapes—not at all popular with youth—be judged differently. 

“We look forward to presenting our arguments on the extremely important issues.”

The new hearing will likely occur this spring, according to people familiar with the matter.

“We are pleased that the full court granted the petition for rehearing en banc and look forward to presenting our arguments on the extremely important issues presented by Triton and Vapetasia’s cases,” Eric Heyer, Triton’s lawyer, told Filter.

An FDA spokesperson told Filter that the agency “does not comment on possible, pending, or ongoing litigation.”

Like all vapor companies, Triton and Vapetasia had to file premarket tobacco product applications (PMTAs) to the FDA by September 2020 and demonstrate, ultimately, that their products would be “appropriate for the protection of public health” (APPH)—that is, more likely to be used by adults to switch from smoking than to introduce a new generation to nicotine. In September 2021, the agency denied their applications.

Then, that October, just a month after Triton received its MDO and filed a petition for review with the Fifth Circuit, the court granted the manufacturer a full stay as the case went through the judicial process. The stay order included a scathing 20-page review of the FDA, in which a three-judge panel wrote that the agency “simply ignored Triton’s [marketing] plan” and “pull[ed] a surprise switcheroo” in demanding long-term studies that companies did not anticipate.

By July 2022, following oral arguments, the court—somewhat surprisingly—denied Triton’s petition for review. Of the three judges who heard the original case, Catharina Haynes and Gregg Costa sided with the FDA, while Edith Jones, the former chief judge of the Fifth Circuit who has served since the Reagan administration, dissented.

Triton’s lawyer, Heyer, had put forth two arguments on the company’s behalf: Firstly, that the FDA lacks the authority to require Triton show its flavored vaping products are more effective at promoting smoking cessation than its tobacco-flavored ones; and, secondly, that the FDA acted “arbitrarily” and “capriciously,” failing to make clear that certain scientific studies were necessary and then rejecting the PMTAs on the basis that they were not included and overlooking other material. The latter argument has become common among vape manufacturers appealing agency denials.

With appeals courts essentially in disagreement, these cases “could begin to get some attention  from the Supreme Court.”

Other cases remain active in a number of appeals courts, though most of them have fallen in the FDA’s favor; in August, however, the Eleventh Circuit Court of Appeals ruled that six companies’ PMTAs had to be reconsidered, concluding that the agency had failed to weigh their marketing plans—despite saying that was part of the assessment.

“The Fifth Circuit now breathes life back into the MDO challenges,” Azim Chowdhury, a regulatory and public policy attorney who represents a number of vapor companies, told Filter.

At the heart of these legal battles have been the credible accusations that the FDA has not provided a level playing field—moving deadlines, shifting priorities and adding requirements after PMTAs had already been filed. Growing evidence has pointed to an agency constantly shifting course—as in leadership’s overruling of agency scientists’ recommendation to authorize Logic’s menthol vaping products, which Filter recently reported.

Now, with appeals courts essentially in disagreement, these cases “could begin to get some attention from the Supreme Court,” another industry lawyer, requesting anonymity so as not to affect their company’s PMTAs, told Filter.

Photograph by Blogtrepreneur via Flickr/Creative Commons 2.0

The post Appeals Court Reignites Triton Case Against FDA, Key to Flavored Vapes appeared first on Filter.

“With the introduction and marketing of new nicotine products, it’s not only the marketplace that has diversified,” Cohen says in the video. “The number of terms used to describe these products has expanded significantly as well. Often with word choice that serves tobacco industry interests.”

“Accuracy and consistency,” Cohen continues, “are extremely important because language can shape our thinking, including setting boundaries for discourse and policy options.”

The narrator of the video announces that Cohen and her peers found terms used to describe nicotine products today are too broad, and problematically imply novelty or innovation, or suggest reduced harm. More specifically, Cohen contends that “heat not burn” implies that heated tobacco products are safe (they are safer than cigarettes, though not without any harms), while words like “novel” and “emerging” are really “misrepresentative by nature, as a product is only new for so long.”

What’s regrettable is that there is an important conversation to be had about terminology in the tobacco and nicotine field, but the video misses that opportunity.

She also claims that “alternative”—a synonym for “option”—is actually “problematic,” as it establishes “a choice between two mutually exclusive products” and could bring to mind “something you’d look for in a 1990s record store.” An image of albums including the Smashing Pumpkins’ Siamese Dream helpfully pops up as illustration. The irony that nobody is shopping in a 1990s record store because technology has rendered records obsolete—just as vapes, heated tobacco products and nicotine pouches are doing to combustible cigarettes—does not get mentioned.

Ultimately, Cohen wishes “those communicating about tobacco products, including scientists and public health professionals, to be more careful about the terminology they use and take the time to consider the implications of the words they choose.”

She recommends “using ordinary, precise terms without additional adjectives” to help “establish a common language,” like “e-cigarettes” and “heated tobacco products.”

What’s regrettable is that there is an important conversation to be had about terminology in the tobacco and nicotine field, but the video, from an institution funded by anti-vaping billionaire Michael Bloomberg, misses that opportunity.

In response, Clive Bates, the former director of Action on Smoking and Health (UK), noted that “in the illicit drugs and tobacco fields, language can be weaponized for emotive advocacy purposes by any of the stakeholders and industries involved.” But his suggestions around terminology would differ from Cohen’s. For example, like many in the field, he called for people in tobacco control and public health to consider that “tobacco products”—an umbrella term employed by the narrator in the video—is misleadingly used to refer to products that contain nicotine but not tobacco.

More generally, he said that “loose definitions and language,” like the “youth vaping epidemic” continue to mask “subtleties related to the frequency of use and propensity of tobacco use,” and that “inappropriate conflations” are rampant.

The most obvious example of that last point is probably the labeling of “EVALI” (“E-cigarette, or Vaping Product, Use Associated Lung Injury”), the string of lung diseases that were primarily reported in the summer and fall of 2019. Though the Centers for Disease Control and Prevention (CDC), which named EVALI, identified that the cause was a compound found in some illicit THC cartridges, the agency has still not firmly corrected the record—and it has not, despite numerous pleas from tobacco control experts, changed the name. One study has suggested that legislation borne from misstatements about EVALI and e-cigarettes in Massachusetts ended up increasing cigarette consumption in Boston.

Cohen’s broadest assertion, though, is that many of these terms cause public health experts to do “the tobacco industry’s dirty work for them.” Yet she makes no reference to including consumers in the dialogue. Consumer organizations like INNCO and CASAA, which support rights and access for adults who use safer nicotine to avoid toxic forms of tobacco, have been at the forefront of addressing stigmatizing language, such as avoiding the word “smoker” in favor of person-first terms.

“Using the language of the people using the products, which is typically the terminology most well known, should be their focus.”

“When it comes to language and terminology, it seems to me that people in public health get overly preoccupied with what incumbent tobacco companies are doing, when their actual focus should be on consumers and people who actually use these products,” Danielle Jones, the president of the board of CASAA, told Filter.

“Using the language of the people using the products, which is typically the terminology most well known, should be their focus in order to facilitate clear communication and not confuse people,” she continued. “For instance, not knowing the established terminology when writing survey questions for people who vape can lead to erroneous results if the respondents misunderstand what the researchers are asking.”

“Instead of trying to invent new terms to distance themselves from tobacco companies,” she said, the creators of the video “should focus on learning the language that exists from people who use the products. Tobacco and nicotine research needs to be more user-informed, and terminology is just one example of that.”

Photograph by Vaping360 via Flickr

Both INNCO and The Influence Foundation, which operates Filter, have received grants from the Foundation for a Smoke-Free World.

The post Johns Hopkins Call for Nicotine “Common Language” Falls Flat appeared first on Filter.

In the piece, published in the Journal of the American Medical Association (JAMA), the authors argue for a so-called smoking cessation “care package.” This includes encouraging health systems to provide social and clinical support, offering medication and nicotine replacement therapy (NRT), and moving forward on plans to ban menthol combustibles and lower the nicotine levels in cigarettes.

Though vapes are brought up—“further high-quality research,” they write, is needed on how e-cigarettes “may facilitate smoking cessation among adults”—there is scant mention of tobacco harm reduction (THR). Tobacco use, Califf and King correctly note, is the leading cause of preventable death in the United States, but they fail to make it abundantly clear that the overwhelming majority of these fatalities are a result of smoking.

“They dramatically overweight the risks of youth initiation, seemingly ignoring that it is smoking adults who can benefit from e-cigarettes.”

“In their one paragraph referring to e-cigarettes, the authors state that ‘the potential benefits of these products among adults who smoke must be weighed against the risks of youth initiation,’” Kenneth Warner, the former dean of the University of Michigan’s School of Public Health, told Filter. “This is absolutely correct. Unfortunately, the authors dramatically overweight the risks of youth initiation, seemingly ignoring the fact that it is smoking adults who can benefit from e-cigarettes who are at great and immediate risk of death.”

“The FDA appears to have adopted an absurd precautionary principle that will never recognize e-cigarettes as beneficial to public health until there is an overwhelming body of unequivocal proof of e-cigarettes’ utility for smoking cessation,” he continued. “Note that that body of proof apparently must be far greater than that characterizing the risks of youth initiation. The one body of proof that is clearly unequivocal is that cigarette smoking is killing more Americans than any other consumer product ever invented.”

While Califf and King cite a study by Cochrane, an institute considered the gold standard of research on evidence-based public health interventions, they do not go so far as to explain that this recent review found “high certainty” evidence that e-cigarettes are better at helping adults who smoke quit than FDA-approved NRT. Other studies—like one published in JAMA at the end of 2021—have found that people who did not intend to stop smoking but nonetheless began vaping drastically increased their likelihood of quitting.

The timing of the op-ed is either serendipitous or a purposeful tactic, as it arrives just weeks after an avalanche of criticism closed out the year. As revealed by Filter in mid-December, King had disagreed—and, consequently, intervened—with the CTP’s Office of Science when it recommended that certain menthol-flavored vaping products be authorized through the agency’s premarket tobacco product application (PMTA) process.

The ensuing backlash took something of an “I told you so” form—as THR advocates reasserted that politics had infiltrated the science and that perhaps no non-tobacco flavors, which are preferred by most people who switch from cigarettes, would ever legally make it to market.

The op-ed “seems to be [the FDA’s] attempt at filling the strategy void highlighted by Reagan-Udall.”

Days later, many of those same critiques resurfaced: The Reagan-Udall Foundation, an independent nonprofit tasked by Congress to help modernize the FDA, put out a report commissioned by Califf that found the CTP did not have a “coherent regulatory strategy,” solicit enough stakeholder input or give transparent communication.

Timed as it is, the op-ed “seems to be [the FDA’s] attempt at filling the strategy void highlighted by Reagan-Udall,” Clive Bates, the former director of Action on Smoking and Health (UK), told Filter.

Another op-ed, recently authored by King and published in HPHR, highlighted how the CTP is “bringing health equity to the forefront of tobacco product regulation,” leading some, including Bates, to speculate whether the center was trying to stave off judgment by appearing busy. (At publication time, the FDA had not responded to Filter’s request for comment.)

Kenneth Michael Cummings, a professor in the Department of Psychiatry and Behavioral Sciences at the Medical University of South Carolina who once taught the CTP director, said that the JAMA article looked “very similar” to a commentary that accompanied the 2020 Surgeon General’s Report focused on smoking cessation. (King, then a higher-up at the Centers for Disease Control and Prevention, served as senior associate editor.)

“The message was the same: We can do better in helping smokers quit with evidence-based treatments,” Cummings told Filter. “E-cigarettes don’t have the blessing from the FDA or other health agencies as ‘evidence-based’ cessation treatments.”

“The absence of discussion about e-cigarettes is, of course, disappointing,” he continued. “But steering the FDA battleship back to cigarettes and getting adult smokers off them is refreshing and the right thing to do.”

“It ignores harm reduction, and seems to be a radical reframing of CTP’s mission and focus.”

Others, however, have a more pessimistic outlook, and suggested the article was yet another signal that CTP would not embrace THR anytime soon.

“This JAMA op-ed is a monumentally bad article,” one industry insider, requesting anonymity so as not to affect his company’s PMTAs, told Filter. “It ignores harm reduction, and seems to be a radical reframing of CTP’s mission and focus.”

“It is frightening that those overseeing FDA actions on nicotine fail to show even a basic understanding of the public health challenges and opportunities,” echoed David Sweanor, an independent tobacco industry expert and adjunct professor at the University of Ottawa. “The apparent adherence to an ideological commitment to abstinence and a focus on coercive policy measures misses the extraordinary opportunity to empower people who smoke cigarettes to dramatically reduce their risks.”

Photograph by Matt Trostle via Flickr/Creative Commons 2.0

The post FDA Leaders’ Smoking Cessation “Care Package” Article Draws Fire appeared first on Filter.

The Food and Drug Administration (FDA) announced that it’s moving toward a federal menthol cigarette ban, much to the chagrin of social justice advocates. Congress granted the FDA the power to regulate synthetic nicotine, to which many small- and medium-sized vape manufacturers had switched in the hope of keeping their products on the market.

More and more vape shops shut down as jurisdictions across the country enacted flavor bans. Even the good news was overlooked: US smoking rates—especially among teens—dropped to record lows; youth vaping rates are nowhere near their peak from just couple of years ago.

Below are three areas that Filter will be tracking in 2023.

Industry Moves

These past 12 months have not been awash with positive developments. The FDA authorized just the second tobacco-flavored vaping product, by Japan Tobacco International’s Logic, and then another from NJOY and an outdated product by Reynold’s Vuse.

With documents obtained through public records requests, Filter broke the story of how the FDA’s premarket tobacco product application (PMTA) process requires companies to prove their product meets standards “appropriate for the protection of public health” (APPH). Basically, that their product is more likely to transition an adult who smokes to a safer nicotine alternative, such as an e-cigarette, than it is to introduce a younger generation to nicotine dependence.

Though mainstream attention tends to favor e-cigarettes, oral pouches—such as the Swedish Match-made Zyn—are growing in popularity, and the FDA will at some point have to rule on their PMTA as well. Meanwhile, outstanding decisions on menthol-flavored e-cigarettes and other major vaping products, like others produced by Vuse, have yet to be decided.

Some companies have also entered strategic partnerships to distribute heat-not-burn products that are not yet on the US market, but available abroad.

New FDA Leadership

In July, FDA Commissioner Robert Califf formally requested that the Reagan-Udall Foundation, the independent nonprofit Congress has tasked with modernizing the agency, investigate the food and tobacco divisions. The December report that resulted was a familiar—yet blistering—reminder that the Center for Tobacco Products (CTP) does not have a clear or viable strategy for regulating nicotine. The suggestions amounted to mere abstractions about transparency and better communications. They also alarmed harm reductionists with War on Drugs-esque rhetoric, essentially calling for crackdowns on unauthorized vaping products. The ball is still in the FDA’s court.

In April, CTP director Mitch Zeller retired after almost a decade in the role. He had assumed the position before CTP even had vaping regulation on its radar, and left after a youth vaping frenzy slowed any real chance of putting forth a “continuum of risk strategy”—which is to say, any real chance of educating smokers about how some nicotine products (like vapes and oral pouches) are significantly less harmful than combustible cigarettes.

Meanwhile, CTP was rejecting countless PMTA. It made its most controversial decision in June, when it issued a marketing denial order (MDO) of Juul’s applications—triggering an immediate reversal once Juul filed a lawsuit, then intense public discussion about the agency caving to political pressure. Dozens of other lawsuits accused the FDA of acting “capriciously” and “arbitarily” in issuing many of these MDO.

In July, Brian King stepped into the position Zeller had left. A former higher-up at the Centers for Disease Control and Prevention (CDC), he was known primarily for failing to clarify that “EVALI”—a string of lung illnesses that cropped up in 2019—were caused by illicit THC cartridges and not nicotine vapes.

Around that same time, director of CTP’s Office of Science Matthew Holman also departed. In a somewhat controversial move, he took an executive job at Philip Morris International. Holman, for his part, does seem as though his intention is to help smokers transition to safer nicotine alternatives. All the while, tobacco control lawyers, academics and economists continue to push the CDC to correct the misinformation swirling around EVALI. (No luck so far.)

In December, Filter broke the news that King had disagreed with the Office of Science’s initial recommendation to authorize Logic’s menthol vaping products. These would have been the first flavor other than tobacco to make it past the agency’s APPH threshold.

The day after Filter’s report, a federal court granted Logic a permanent stay. The company’s appeal will work its way through the legal system over the course of 2023.

California and Illicit Markets

We’ll all be watching the outcome of California’s flavored nicotine ban, as the most populous state in the union has some of the most restrictive and confusing legislation. Almost all products are off limits, including menthol cigarettes; the only exceptions are hookah and some premium cigars. 

After a years-long legal battle between the tobacco industry and a Michael Bloomberg-funded coalition of anti-nicotine lobbying groups, voters overwhelmingly chose to enact the law in the November midterms. It does not appear to offer much leeway for consumers, barring the sale of so-called “flavor enhancers”—meaning no purchasing a nicotine-free flavored e-liquid and then adding in flavorless nicotine at home—and shutting out any flavored product the FDA authorizes.

Though other states, like Massachusetts, have flavor bans of their own and witnessed illicit sales increase, California would probably be at a different scale. Similar prohibition in New York, as Filter previously reported, triggered a robust illicit market within months.

Photograph courtesy of Vaping360 via Flickr/Creative Commons 2.0

The Influence Foundation, which operates Filter, has received grants from Juul Labs, Reynolds American and Phillip Morris International. Filter’s Editorial Independence Policy applies.

The post The Biggest Tobacco Harm Reduction Battles to Come in 2023 appeared first on Filter.

Many people who switch from cigarettes to vapes find flavors helpful, or even crucial, in doing so. Previous vape flavor bans, like one enacted in San Francisco, have led to increased smoking in some populations. Some vapers will also still find ways to obtain their preferred products. But in other ways, the landscape that will now emerge across the state is hard to predict.

The legislation behind Prop. 31, SB 793, was technically passed by lawmakers in 2020, but had been delayed following sustained pushback from the nicotine industry and tobacco harm reduction (THR) proponents. Reynolds and other companies had given much of the funding for the campaign against Prop. 31. Billionaire Michael Bloomberg—THR’s leading adversary—almost exclusively bankrolled the committee in support, with much larger sums.

Questions remain about how California will enforce it—and what type of illicit market will emerge to fill the flavor vacuum.

After the November 8 vote, Reynolds and a few other tobacco and vapor manufacturers filed an emergency application for writ of injunction with the Supreme Court, in what many observers saw as a last-ditch, Hail Mary effort to stop the flavor ban. (Reynolds had previously failed to persuade district and circuit courts to stop the law.) The Supreme Court refused to block it.

Now, questions remain about how, exactly, California will manage to enforce a law with technicalities that even seem to be confusing the state government—and what type of illicit market will emerge to fill the flavor vacuum.

Stefan Didak, a California-based THR advocate, said that though he hoped those carrying out enforcement would at least be consistent, he was not optimistic, especially in the short term: He has already heard that the government, specifically the California Department of Tax and Fee Administration (CDTFA), has given conflicting guidance to retailers—some of whom have been told, for instance, that selling online is legal, while others have been informed that it’s not. (Didak believes the legislation does allow for online sales.)

He also cited another example, saying that a few retailers were informed that they could sell “clear” disposables (with no characterizing flavor), but others were advised not to do so, as the law bans anything “other than the taste or aroma of tobacco.”

“In the light of these inconsistencies, it makes me wonder how retailers are supposed to be law-abiding when those in charge of enforcement can’t figure things out,” Didak told Filter. “And if they can’t give clear answers to retailers, how is any of this, if at all, communicated to the local municipalities that are allowed to enforce the new law?”

“Overzealous individuals tasked with enforcement could do more damage to small businesses than the law itself,” he continued, “because overreach of enforcement leaves the retailer without much option other than to seek legal action, and most are not in a position to do so.”

Reynolds, for its part, has now sent “formal warning to approximately twenty retailers in the San Jose, Sacramento and Los Angeles communities that are selling flavored disposable vaping products in violation of applicable local ordinances,” threatening legal action against them. The company sells FDA-authorized tobacco-flavored vaping products, as well as menthol cigarettes that are prohibited under the ban. It stated that “the marketing and sale of [flavored disposables in California] harm those—like [Reynolds] and our customers—that comply with applicable legal requirements and responsible marketing practices.”

“It’s a shame seeing California be a progressive front-runner in other areas of harm reduction, but not for tobacco.”

California’s legislation is unique, too, in the sense that it bars so-called “flavor enhancers”—preventing a person from buying flavored e-liquid with no nicotine and adding it to flavorless nicotine at home—and seems to shut out any flavored product that could one day, perhaps, be authorized by the FDA.

But workarounds, of course, have always existed.

“I’ve been getting my flavored liquids from the black market for actual years now,” Nick “Grimm” Green, who lives in Los Angeles and runs a popular YouTube vaping channel, told Filter. “But I’m a resourceful ex-smoker. The non-hobbyist consumers are going to have a very difficult time and will most likely go for the easier and cheaper option, which in California is tobacco cigarettes. It’s a shame seeing California be a progressive front-runner in other areas of harm reduction, but not for tobacco cigarette smokers.”

Photograph by Diana Robinson via Flickr/Creative Commons 2.0

The Influence Foundation, which operates Filter, has received grants from Reynolds American, Inc. Filter’s Editorial Independence Policy applies.

The post California’s Vape Flavor Ban Begins With Confusion, Enforcement Threats appeared first on Filter.

The almost 40-page report highlighted that Reagan-Udall was “unable to identify a current comprehensive plan that clearly articulates CTP’s priorities, direction for the future, and its near-term and longer-term goals and objectives.” Its sweeping suggestions included improving communications and transparency, perhaps through a potential public meeting; adopting methods to allow more stakeholder input; developing clearer frameworks for “high-quality” marketing applications for nicotine products, and increasing “use of the Tobacco Products Scientific Advisory Committee (TPSAC),” an advisory panel that could help guide the center.

The most specific proposal, however, concerned CTP’s lack of plausible enforcement capabilities in dealing with the unauthorized vaping products flooding the market: Among other points, Reagan-Udall advised that the FDA “seek higher-level Administration involvement to establish an interagency task force to make enforcement of the tobacco laws a government-wide priority”—a move that some harm reductionists have already noted sounds like a future episode in the country’s long-failed “War on Drugs.” The prospect has been lauded by anti-nicotine, prohibition-minded organizations like the Campaign for Tobacco-Free Kids (CTFK).

The CTP’s premarket tobacco products application (PMTA) process has from the start been beset by delays and extreme controversy.

The CTP is charged, ultimately, with protecting “Americans from tobacco-related disease and death,” and has faced constant criticism from vocal sides of the issue. Its premarket tobacco products application (PMTA) process, designed to determine whether vaping products are “appropriate for the protection of public health” (APPH)—a standard read as assessing whether a product is more likely to help adults transition from cigarettes to a safer alternative than introduce a new generation to nicotine—has from the start been beset by delays and extreme controversy.

Any tactical or nuanced perspective has long since appeared to be lost: The “comprehensive approach,” first unveiled by then-FDA commissioner Scott Gottlieb, introduced the idea of the “continuum of risk”—the idea that certain nicotine products, like vapes and oral nicotine pouches, are much safer than others, like combustible cigarettes. But the outcry over soaring youth vaping rates drowned out this approach.

On the one hand, abstinence-oriented organizations and politicians have demanded that the agency swiftly reject all such products—which it largely has, with the exception of a few tobacco-flavored e-cigarettes. On the other, tobacco harm reduction (THR) proponents have demanded much lower barriers to authorization—particularly for the flavored products that many adults find most helpful to switch from cigarettes, which remain on the market without comparable scrutiny. Amid millions of rejections, the FDA has yet to authorize a single vaping product with a flavor other than tobacco.

At times, the two polarized groups have appeared to temporarily unite in condemning the agency for a chaotic, opaque and inconsistent procedure that has left no one satisfied.

At the end of July, Califf asked Reagan-Udall to conduct “a comprehensive evaluation” of the agency’s food and nicotine divisions. THR advocates, nicotine users and vape producers welcomed this tacit acknowledgement of problems, but said it came too late—emphasizing they have long been chastising the CTP for what they view as a confusing, expensive, and draconian regulatory strategy that inevitably favors only well-financed manufacturers, most of which have ties to (or are outright owned by) Big Tobacco. In the months since, Reagan-Udall has met virtually with a variety of stakeholders—ranging from prohibition-minded lobbyists to industry players and consumer advocates—to discuss CTP’s failings in regulation, compliance and enforcement, and public communications.

“At times, a lack of clarity about the distinction between, and the intersection between, policy and science has created controversy within CTP.”

The resulting report also “observed that some issues before CTP are fundamental policy questions that must be informed by science but are not, themselves, scientific issues.”

“Rather, they are policy issues with profound societal impacts,” the report reads. “One such question that scientific analysis alone will not resolve is how to weigh the public health benefits of the percentage of adults who use ENDS that will completely quit smoking combustible tobacco products against the potential public health harms that youth who use ENDS will acquire a lifelong addiction to nicotine or proceed to use combustible tobacco products. At times, a lack of clarity about the distinction between, and the intersection between, policy and science has created controversy within CTP and may lead to a perception that the Center’s scientific integrity is being challenged when, in fact, policy decisions that transcended the science are being made.”

THR proponents and industry observers broadly welcomed elements of the report, which echo what they’ve long been saying.

“The report offers a devastating critique of CTP’s strategic muddle, its lack of clear direction, transparency, and consistency,” Clive Bates, the former director of Action on Smoking and Health (UK), told Filter. “It is clear that the public health test that guides tobacco regulation is so vague and malleable that it allows FDA to do whatever it wants, making it a target for political advocacy that overrides science and public health.”

“Perhaps the most damning aspect of the report is its implication that the FDA has caused many of its own problems.”

“Reagan-Udall’s suggestions are strikingly similar to those made repeatedly by consumers and industry, which the agency has ignored for years,” Michelle Minton, a THR proponent and senior policy analyst at the Reason Foundation, who spoke at a Reagan-Udall session, told Filter. “Perhaps the most damning aspect of the report is its implication that the FDA has caused many of its own problems by its overly broad interpretations of its own powers, it lack of flexibility, and its squishy commitment to science over politics.”

“The report essentially says that, though the FDA is well-intentioned, it has to some degree been fiddling while Rome burns,” Cliff Douglas, the director of the University of Michigan Tobacco Research Network, told Filter. “Thirteen years after the agency received regulatory authority over tobacco products, the smoking epidemic rages on, as does the current rampant sale of unauthorized e-cigarettes. I’m confident the FDA can right this ship if it quickly acts on the reports recommendations to become more proactive and to let science, not outside threats and influences, guide it.”

But one industry insider, who requested anonymity so as not to affect their company’s PMTAs, expressed much more pessimism, telling Filter that the CTP “doesn’t want to modernize,” and instead “wants to use a broken system to break the industry.”

“This report mostly gets to the heart of what has driven dysfunction at the Center for Tobacco Products for the last half decade or more,” Greg Conley, the director of legislative and external affairs, at American Vapor Manufacturers, told Filter. “CTP has actively resisted any attempt to modernize its processes and has made no effort to develop a coherent regulatory strategy or consistently interpret its own standards.”

“We are committed to communicating any changes with clarity and transparency for our many stakeholders.”

The report arrives after a particularly tumultuous year for CTP, which saw the retirement of its longtime director, Mitch Zeller; the departure of its longtime Office of Science (OS) leader, Matthew Holman, to a high-profile role at a major tobacco company; and relentless criticism over its policy decisions—including the recent revelation, first reported by Filter, that newly installed CTP Director Brian King had disagreed with OS, and scientists consequently reversed their opinion on authorizing some menthol e-cigarettes.

And, most notably, CTP has continued to deny countless PMTAs. Its denial—immediately placed on hold—of Juul’s applications triggered even more discussions about an agency often accused of buckling under political pressure. Countless lawsuits have been filed arguing that the FDA acted “capriciously” and “arbitrarily” in issuing many of these marketing denial orders (MDOs).

“While we consider potential improvements to our operations and processes for tobacco product regulation, we are committed to communicating any changes with clarity and transparency for our many stakeholders,” Robert Califf, the FDA commissioner, said in a press statement. “For the FDA to build on this work in the ever-evolving tobacco marketplace, it’s also critical to ensure CTP has what it needs to adequately and efficiently address the recommendations in the report.”

Photograph via Public Domain Pictures

The post Ball in FDA’s Court as Official Review Cites Its Chaos, Opacity Over Vapes appeared first on Filter.