Category: Cheryl Olson

  • Cheryl Olson

    Cheryl Olson

    Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors via McKinney Regulatory Science Advisors. She spent 15 years on the faculty of Harvard Medical School. In this section we feature a selection of Olson’s contributions to Tobacco Reporter

    Cheryl Olson

    Read a selection of work from Tobacco Reporter’s special contributor Cheryl Olson.

    Unlikely Bedfellows

    How free-flowing data streams can help advance public health goals for nicotine products.

    The Credibility Gap

    What industry scientists wish they could say to public health researchers about their work.

    Gold Nuggets

    Willie McKinney and Cheryl Olson share their insights into the FDA’s final PMTA rule

  • Why Don’t They Just Stop?

    Why Don’t They Just Stop?

    Photo: Wosunan

    Utopian visions and unintended consequences

    By Cheryl K. Olson

    “The decline in smoking prevalence has slowed to a trickle.” That’s how Kenneth Warner of the University of Michigan’s School of Public Health phrased it in a 2013 editorial on the tobacco endgame. With progress stalled, tobacco control advocates searched for dramatic measures to kick-start it. A Google Scholar search for “tobacco endgame” brings up over 7,000 results for the past decade.

    One popular idea is to simply declare game over. A 2018 editorial in Tobacco Control pointed to clever ads placed in U.K. newspapers by Philip Morris International saying, “We’re trying to give up cigarettes.” Rephrasing that slogan as “Stop me before I kill again,” the editorial stated, “There is no reason why a plan to phase out cigarette sales cannot be developed and pursued now.”

    The disruptions and isolation of the Covid-19 pandemic brought fresh calls in major medical and public health journals to stop marketing smokes. “In this context, now is an opportune time to move toward removing cigarettes from general retail sale,” said a BMJ editorial.

    If the tobacco industry is sincere about reducing harm, why don’t they just stop selling cigarettes? “That’s a very common talking point. It’s a nice utopian vision,” says Dave Dobbins, an independent consultant currently working with Altria and former chief operating officer of the Legacy Foundation/Truth Initiative.

    What would actually happen if Big Tobacco shut down cigarette sales tomorrow? And more realistically, what actions might speed the day when the last Marlboro or Salem is packaged and trucked? Experts in public health, economics and law enforcement have some thoughts.

    ‘In the Hands of Criminals’

    Cigarette sales could stop, but the desire to buy them wouldn’t. “All industries are a product of supply and demand,” says Dobbins. “And eliminating supply does not eliminate demand.” He pictured equipment idled by Big Tobacco being bought up and put to use by less-scrupulous entities.

    “If the tobacco companies stopped selling cigarettes, you would find an explosion in the black market and the counterfeit market,” says Richard Marianos, retired assistant director at the U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives and faculty member at Georgetown University. “They would be smuggled into the United States and supplant that demand that has been voided by the tobacco companies.”

    Halting sales of cigarettes would have unintended consequences. Currently, tobacco companies are regulated and taxed, and their products are distributed in legal commerce.

    “By taking them out of commerce, you put the market in the hands of criminals who will sell on the street and create additional crime,” says Marianos.

    We see an analogous situation unfolding with the regulation of vaping. After the U.S. Food and Drug Administration prioritized enforcement against mint and fruit-flavored prefilled cartridges in January 2020, youth sales of disposable flavored brands soared. On June 22, the FDA announced a “nationwide retailer inspection blitz” that led to warning letters cracking down on the disposable brands Elf Bar and Esco Bars.

    “There’s vaping out there that is designed for a tobacco harm reduction strategy, which is good, to get people off combustibles,” Marianos says. “But these disposable vapes with flavors like bubblegum and gummy bear, marketed to kids, made by unregulated factories in China, need to be put away.”

    Marianos also points to an additional public health risk from counterfeit or contraband overseas products: “A lot of them are made in facilities that contain rat feces and dirty machines.”

    A report in the June 23 issue of the CDC’s Morbidity and Mortality Weekly Report noted an increase in e-cigarette associated cases reported to U.S. poison centers. Sixty percent involved Elf Bar, and more than 90 percent of those were among children younger than five.

    Prohibition Lessons

    “It’s just not clear that there are methods that are both plausible and coercive enough to enforce a prohibition if people really want drugs,” says Dobbins. “The drug wars in every other field have been an utter failure. I don’t think there’s a lot of hope that there’d be a different result if you declared a drug war on nicotine.”

    The U.S. experience with alcohol Prohibition in the early 20th century is enlightening. Entertaining examples of law evasion can be found on the website for the Ken Burns public television documentary about this failed experiment. Grape juice concentrate was sold with sly warnings not to leave it sitting too long, lest it ferment into wine. Home distilling equipment could be bought at hardware stores, and instructions on making booze could be found at the library. In short, “The law that was meant to stop Americans from drinking was instead turning many of them into experts on how to make it.” And the problem of alcohol abuse, far from being solved by Prohibition, was made worse.

    “It’s hard for me to imagine the kind of coercive measures a state would have to employ to curtail supply, much less demand,” Dobbins says. “In countries that essentially eliminated marketing and imposed plain labeling or graphic depictions of the death and disease that can occur from cigarette use, those efforts have only very mildly curtailed demand.”

    During the Covid-19 pandemic, South Africa enacted a temporary ban for the public good. Research showed that people who smoked were at higher risk for severe illness; this could buckle the healthcare system. Unfortunately, the usual happened: Less than 10 percent of smokers quit. The existing black market ramped up production. Prices increased over 240 percent. When the ban ended, the illicit sellers had a larger share than before. (For other examples, see “Prohibitionists at Work” on Clive Bates’s The Counterfactual website.)

    Harm Maintenance?

    In 2013, Warner noted the lack of consensus on what the “end of the endgame” might look like for tobacco control. The end of smoking? Of all forms of tobacco use? A nicotine-free population? Or “a more modest tobacco harm minimization objective”?

    In that 2018 Tobacco Control editorial,  Ruth Malone wrote, “So we should all be clear about one thing: ‘Giving up cigarettes’ for PMI does not mean the company wants people to quit using its addiction sticks. It means they want to get people hooked on a different type of addiction stick.”

    Harm minimization looked like a profit-maintenance ploy to skeptics in public health. They felt burned by “light” cigarettes and saw poor adoption of the available nicotine replacement options. As John P. Pierce wrote in Nicotine & Tobacco Research in 2002, “Without more research on whether these products can be substituted effectively for smoking, endorsing harm reduction as a goal could lead to another 25 years of harm maintenance.”

    How different things look 21 years later! Novel nicotine alternatives abound. We have data that many people who smoke, including those from vulnerable groups, are indeed willing to substitute these products. Anti-smoking eminences such as Warner now advocate for “nicotine e-cigarettes as a tool for smoking cessation.”

    For public health people, it’s hard to let go of the desire to punish Big Tobacco for real and serious past harms. But we can’t wish away the accumulating data. Evidence suggests that helping multinational cigarette makers transform into diversified sellers of noncombustible nicotine products will save more lives with fewer unintended effects. Ditto for helping people who can’t or don’t want to quit smoking switch to satisfying lower risk options.

    ‘Novelty Items’

    Michael Pesko, an associate professor at Georgia State University who studies nicotine policy, gave me the economist perspective. “How do we intervene in a marketplace determined by supply and demand to reduce purchases of combustible tobacco products? No intervention will fully stamp out combustibles, but it may be possible to reduce their use to novelty items,” he says.

    He recommends a combination of education and risk-based regulation. “Raising public health awareness about the dangers of combustibles and the harm reduction benefits of reduced-risk tobacco products such as e-cigarettes is a way to reduce demand for combustible tobacco products,” he says. “Heavy regulation of combustibles, such as taxing them, can be used to reduce supply.”

    A new article by eight prominent academics and lawyers titled Do Tobacco Companies Have an Incentive to Promote “Harm Reduction” Products? says, yes, they do—provided there is competition from noncigarette companies and appropriate government regulation.

    The authors mention multiple ways that tobacco control researchers can add sunshine to speed this transition. This ranges from analyzing the effects of government regulations on competition and the market position of noncombustibles versus cigarettes to monitoring and exposing smoking promoting or alternative discouraging activities by tobacco companies.

  • Staking a Claim?

    Staking a Claim?

    Photo: Tobacco Reporter archive

    Rethinking the modified-risk tobacco products approval process.

    By Cheryl K. Olson

    It seemed an excellent test case for a new system. After role-playing a U.S. Food and Drug Administration Tobacco Products Scientific Advisory Committee (TPSAC) member, listening to Altria’s presenters rehearse their pitch, that was my impression. I thought that Copenhagen Snuff would likely sail through the modified-risk tobacco product (MRTP) application process.  

    Sold in some form since the 19th century, the product was well understood. From a regulatory perspective, it was comfortably dull. The reduced-harm claim Altria sought to put on Copenhagen’s label seemed indisputably true: “If you smoke, consider this: Switching completely to this product from cigarettes reduces risk of lung cancer.” 

    In February 2019, the TPSAC review panel voted 8-0 that the claim was scientifically accurate. Said panel chair Robin Mermelstein, “I am hearing a consensus that this was an understandable statement. It was clear,” and “I think it is a reasonable place to start in messaging.”   

    Forty-nine months later, the FDA finally authorized Copenhagen Classic Snuff as a MRTP.

    “No tobacco product is safe or ‘FDA approved,’ so those who do not use tobacco products shouldn’t start,” said the director of the FDA’s Center for Tobacco Products (CTP), Brian King, in the March 2023 press release. “But tobacco products do exist on a spectrum of risk, with those that are smoked having the greatest risk. In this case, the FDA’s scientific review found that if an adult smoker completely switched from cigarettes to this smokeless product, it would reduce their risk of getting lung cancer.” 

    How could it take so long to approve the obvious: that complete switching to a (familiar) smokeless product from cigarettes reduces risk of lung cancer? This invites a fresh critical look at the MRTP process: its origin, utility and potential future.

    Some MRTP History

    The U.S. MRTP application process comes to us courtesy of Section 911 of the 2009 Family Smoking Prevention and Tobacco Control Act. It defines “modified-risk tobacco product” as one “sold or distributed for use to reduce harm or the risk of tobacco-related disease.” In addition to the usual scientific evidence for reduced health risks, complex studies of consumer perceptions and real-world product use are required. 

    Don’t have an MRTP authorization? Basically, your company can’t say anything on product labeling, advertising or other media “that would be reasonably expected to result in consumers believing that the tobacco product or its smoke may present a lower risk of disease or is less harmful” compared to other products. Or, that product or its smoke has fewer bad things in it. The act also prohibits the use of weasel words like “light,” “mild” or “low.”

    In October 2019, Swedish Match USA’s eight General Snus products were the first ever authorized for sale with a modified-risk claim. “Today’s action demonstrates the viability of the pathway for companies to market specific tobacco products as less harmful to consumers,” read the FDA’s press release, “but only following a thorough scientific evaluation by the FDA.”

    “It was a priority for CTP to demonstrate that the pathway works,” says Jim Solyst, then vice president for federal government affairs at Swedish Match. But this was four years after the same products received FDA marketing authorization (premarket tobacco product applications (PMTAs)) and took two rounds of TPSAC review.

    The MRTP process is gobsmackingly costly in time and resources. In a 2018 regulatory document, the FDA estimated that it would receive three MRTP applications per year “and that it will take the applicant 10,000 hours per response to conduct studies and collect the information needed to support an MRTPA.” After all that, the claim is only good for five years. (A new application might lead to an extension.) Also, postmarket surveillance studies are mandated to show how the authorized claim actually affected consumer perception, behavior and health.

    This may be why few companies have even entered the MRTP arena. The last TPSAC meeting to review an application took place in early 2020.

    Only four diverse sets of products had emerged successful: snus from Swedish Match, Philip Morris International’s heat-not-burn IQOS systems and their HeatSticks, very-low nicotine cigarettes from 22nd Century Group and Altria’s snuff. (R.J. Reynolds presented on its Camel Snus to the TPSAC but later withdrew the application.)

    At one point, it was logical that if you got a PMTA, it made sense to consider a MRTP. Now with the slowness of getting a PMTA, I don’t think companies have the MRTP as a vision of the next step.

    Lessons from the Past?

    When does it make sense to consider seeking a claim? “At one point, it was logical that if you got a PMTA, it made sense to consider a MRTP,” says Solyst. “Now with the slowness of getting a PMTA, I don’t think companies have the MRTP as a vision of the next step.”

    Solyst, who is now principal at JMS Scientific Engagement, points to distinctive factors that gave General Snus products an edge with the FDA. These included product-specific long-term studies from Sweden. “They had an incredible amount of human health data and consumer data,” he says.

    The MRTP section of the Tobacco Control Act echoes language from the influential 2001 Institute of Medicine report, Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction. That report mentioned Swedish snus multiple times as an example of a potential reduced-exposure product. This, Solyst notes, “did provide a comfort level [for the FDA] to go ahead with an application.”

    Because of these special circumstances, it’s hard to draw firm lessons from Swedish Match’s experience for MRTP wannabes. Nonetheless, Solyst encourages a careful read of the General Snus MRTP decision document: “That indicates what CTP valued in the application.”

    As more products are authorized, patterns for success may become easier to spot, encouraging more companies to try.

    Willie McKinney

    Not So Obvious

    The FDA’s goal is to review and act upon each MRTP application within 360 days of receipt if it contains the required information. While the process may streamline with time, it’s unlikely that approvals will ever be rapid.

    One factor is the FDA culture. Willie McKinney, who served for three years as the industry representative on TPSAC, points to the example of thalidomide. In the early 1960s, Frances Oldham Kelsey famously prevented untold numbers of severe birth defects by questioning a drug application slated for routine approval. “That’s the ideal FDA reviewer,” McKinney says. “‘I saved lives, stopped a bad thing from happening.’”

    McKinney was at times surprised at negative votes on questions posed to TPSAC reviewers about MRTPs. “I came to the conclusion that ‘obvious’ means different things to different people,” he says. In transcripts from past TPSAC meetings, one sees examples of reviewer confusion about how novel products look or work and skepticism about industry-generated data.

    One former staff member at the CTP agreed, saying, “Not knowing the unintended consequences is a biggie.” That person did not feel that politics or bias play a role, however.

    “I have not had anybody say, ‘Hey, delay the review of this.’ It’s usually something that’s unclear,” they said. The involvement of outside reviewers complicates the process: “There are a lot of moving parts.”

    Pluses and Limits  

    From a public health perspective, a plus of the MRTP system is that it gets thoroughly tested information onto product packages and ads. Ideally, this helps people who do and don’t smoke attempt to meaningfully weigh relative risks. 

    “The idea of having a health claim is a good one,” says Solyst. “But it needs to be something that is effective, that results in smokers moving to lower risk products.”

    One problem is that Section 911 limits messaging to a brief statement about reduced risk of disease or exposure to a substance. As a tool to change what people do with nicotine, an MRTP claim is like one of those L-shaped Allen wrenches. It can work well for a simple, specific task.

    But is it adequate for the complex job described in the Copenhagen MRTP press release? By law, the FDA must ensure that the public understands the reduced risk or exposure message used in advertising and labeling. What’s more, they must “understand the significance that information has in the context of total health and in relation to all tobacco-related diseases and health conditions.” That’s a lot to ask from a one-sentence claim.

    Consider this: Strong headwinds of misinformation deter the switch from cigarettes to smokeless. It would be surprising to see large changes in perceptions and behavior intentions from one experimental exposure to a single short statement.

    As Joe Murillo, then senior vice president of regulatory affairs at Altria Client Services, noted in his 2019 presentation to TPSAC, the FDA’s own survey data found that over 90 percent of adults who smoked thought smokeless products were just as or more harmful than cigarettes. Potential harm to nonusers of tobacco is factored into the FDA’s MRTP decisions. Isn’t harm from inaction—of not correcting high-risk misinformation—just as important to consider?

    The Future of MRTPs

    Among other recommendations, the recent report from the Reagan-Udall Foundation for the FDA encourages the CTP to develop a “more clear and predictable framework” for PMTA and MRTP submissions and reviews. This includes “simplifying, standardizing, documenting and publicly disseminating review procedures.” It’s noteworthy that the FDA sought comments on its draft guidance for MRTPs in 2018 but has yet to publish final guidance. 

    An April 2023 letter to FDA Commissioner Robert Califf by a group of distinguished researchers and advocates (including Mermelstein) expands on the Reagan-Udall recommendations. “Introduce a simplified system for evaluating incremental improvements to authorized products so American consumers can benefit sooner from product innovations,” they write. “This should apply to both the PMTA process for authorizations and the MRTP pathway for modified-risk claims. FDA’s processes should encourage pro-health innovation, not obstruct innovation or deny Americans access to the best technologies available worldwide.”

  • Fighting the Dip Mentality

    Fighting the Dip Mentality

    Photo: Andrey Popov

    What will it take for women who smoke to consider smokeless?

    By Cheryl K. Olson

    When Brittney Niquette first tried smokeless tobacco two years ago, it was from a sense of obligation. She runs customer support for Lucy Goods, a maker of nicotine pouches, gums and lozenges.

    “I like to know what our products taste like, so that I have a genuine opinion and feedback to give customers,” she explains. “They’re just not marketed to women. So I honestly didn’t know what a nicotine pouch was. I was thinking tobacco, like, brown in a pouch.”

    Niquette started smoking at 15, repeatedly quitting and restarting. She now uses tobacco-free pouches every day. “My favorite is the berry citrus. And I like espresso flavor with coffee in the morning.”

    In Scandinavian countries, widespread use of smokeless tobacco products has driven smoking rates to astonishing lows. In his recent article “Can alternative nicotine put the final nail in the smoking coffin?,” Karl Fagerstrom writes, “The availability and use of snus has contributed to Sweden’s record-low prevalence of smoking and the lowest level of tobacco-related mortality among men in Europe. This phenomenon is sometimes referred to as the ‘Swedish experience.’”

    Public health modeling that factors in that experience and the low-harm chemical constituents of modern products suggest that a huge number of deaths could be averted if more people switched, as Niquette did, from cigarettes to smokeless. But so far, most of those switching, even to the newest smokeless alternatives, have been men.

    “Of all adult smokers, about 45 percent are women, and 55 percent are men,” says Allison Bolyard, vice president for innovative nicotine products strategy at Altria. “But if you look at lifetime smokers who have successfully switched, only about one-third are women. We see a big opportunity in providing alternatives for women that they can enjoy and can be successful in switching, because they’re falling behind.”

    In recent behavioral studies on smokeless products that I’ve conducted for industry, women described negative stereotypes about smokeless users. One said, “You kinda have to fight the dip mentality. Marketing needs to be classy and discreet. Not a country boy dip and spit.”

    What innovations and approaches might get women who don’t want to quit nicotine to consider a smokeless alternative? To better understand this, I talked with people in industry working to provide appealing options for women. I also collaborated with the Consumer Advocates for Smoke-Free Alternatives Association (CASAA) on a survey of its female members about their smokeless tobacco perceptions and experiences.

    Deadly Misperceptions

    Surveys consistently find that smokeless products are wrongly seen as more risky than e-cigarettes and often as more risky than smoking. A recent analysis of the nationally representative Population Assessment of Tobacco and Health Study found that a higher percentage of Americans believe smokeless tobacco products are more harmful than cigarettes than believe the (actual) reverse to be true. What’s more, “the study demonstrates that harm perceptions not only predict future product uptake in nonproduct users but also predict continued product use among existing users.” 

    Unfortunately, these misperceptions are even more widespread among women. Previous research found that among people in the U.S. and Canada who smoke, women were significantly less likely than men to agree with a statement that some types of smokeless tobacco are less harmful than cigarettes.

    Daunting Barriers

    Along with exaggerated fears of health risks, there are psychological and practical barriers to female interest in smokeless products. (More on these below.) One is outdated perceptions of smokeless products. Discreet modern products, such as tobacco-free nicotine pouches, do not involve what one CASAA member labeled “the nasty habit of spitting out the juice.” As Niquette’s story above implies, these small, white pouches bear little resemblance to the stereotype of a wet, brown wad of chew.

    Another barrier is the unfamiliar mode of delivery. Bolyard previously oversaw Altria’s On! tobacco-free nicotine pouch line. She notes that users of traditional moist smokeless tobacco (MST) are about 95 percent male: “As opposed to men, women who smoke cigarettes aren’t used to putting, and parking, a product in their mouth.”

    A third barrier is fear of being associated with negative stereotypes of smokeless tobacco users. In my previous research, smokeless users were perceived as being mostly men, “biker guys and baseball players.” There were mentions of “gross people” with brown or black teeth.

    Based on this, women were reluctant to be observed using smokeless. One said, “Folks were noticing it [the round pouch tin] in my pocket and expecting me to spit somewhere.”

    Unfamiliar, uncomfortable mouth sensations are a fourth barrier that may turn off women. In the CASAA survey, a number of women referred to “burn” or irritation as a reason for stopping smokeless use or avoiding certain brands.

    “The familiar stinging/burning sensation on the gum when trying either snus or nicotine pouches is a huge deterrent to switch to smokeless oral products, especially for women,” says Bengt Wiberg, a Swedish economist turned snus advocate and innovator. His startup company, Sting Free, markets nicotine pouches with a patented shield technology that provides flavor and nicotine sans discomfort. “I think the U.S. expression ‘You only have one chance to make a first impression’ applies very much to this issue,” he says.

    Wiberg also notes that today’s smaller, slimmer pouch products fit more comfortably in women’s mouths. Niquette seconded this, saying, “I could be talking to somebody, and you won’t know I have one in.”

    Bolyard noted that Altria’s On! product was designed to minimize some of these barriers. The can is a square shape instead of an MST-like circle and includes 20 small pouches to match the typical cigarette pack size.  

    Unexpected Benefits

    As women get better acquainted with smokeless products, they may discover unexpected benefits over other nicotine-delivery methods. Niquette appreciates the hands-free convenience of smokeless tobacco. “Women do so much stuff: We’re busy people—we cook, clean, raise kids. Sometimes your hands are full,” she points out. “So vaping or smoking is not an option.”

    “I have three computer screens; I’m typing all day,” she adds. “And I don’t have to break. I can just grab a pouch out of the can, put [it] in my mouth and keep going.”

    To ease the transition, Niquette suggests that women start with a smokeless alternative that comes in flavors they enjoy in other products, such as fruity or minty gum.

    “Not Messy or Gross Like I Thought They Would Be”

    Here is a selection of comments from 260 female members of the Consumer Advocates for Smoke-Free Alternatives Association on what makes women who smoke decide to try or reject smokeless tobacco products.

    We defined “smokeless tobacco” as including nicotine pouches, snus, dip and chew. However, we learned that unfamiliarity with these products extends to the terminology. One wrote, “I’m confused; I thought vaping was smokeless tobacco?”

    What would make women consider a smokeless product? The most common response was “nothing.” This included variations such as “threat of death,” “a million dollars,” or less hyperbolically, “a vaping ban.” However, a few respondents were open-minded: “I have no idea what it is, but this email was enough to have me interested. I currently vape.”

    Factors listed that might make smokeless products appealing included: not having to spit, smaller size, “a bigger spectrum of flavors,” “cleaner,” “nonstaining” and “not noticeable to others.”

    Few who had tried traditional moist smokeless tobacco found it appealing. One said, “It was convenient, and there was no annoying smoke, but it irritated my mouth a bit, and I worried about my teeth or developing cancer.” “The smell and the taste [were] overpowering, the ‘juice’ burned my mouth, spitting was gross, but swallowing was even worse,” said another.

    But tobacco-free pouches, and to a lesser extent snus, found some favor. A user of both said they are “not messy or gross like I thought they would be and are advertised in the media.” Reasons for trying these products among those who use(d) them include not being able to smoke or vape at work or while traveling; wanting to quit vaping (“to give my lungs a break”), ease of access (“Vaping products became less available online … pouches were available at our convenience store”), ease of use, and curiosity.

    Other positive comments included “Liked that it was discreet and just nicotine”; “It works just as well as the smoking of something, and it’s easy to just spit it out when you have enough”; “Use to get through the day at work without having to take a break. I liked how they curb cravings; the flavors and the size of the pouch makes it easy to be discreet”; and “Can do them anywhere. Try these pouches!! No smoke, but satisfaction given.”

    Women who tried and stopped using pouches gave a variety of reasons. Some missed the “hand-to-mouth action—still wanted to smoke.” Others complained of hiccups, nausea or irritation: “I’m not a big fan of pouches because they burn the inside of my cheeks.” A few mentioned other sources of discomfort, such as “uncomfortable material that hurts my gums/mouth” or too much bulk. There was also just difficulty getting used to this type of product: “Flavors were good, but it was weird having something in my mouth that I wasn’t supposed to be chewing.” Some disliked the taste.

    Because “smokeless” received various interpretations, many women left comments on other nicotine products, including gums, lozenges, tablets or sprays. These received a similar range of positive comments and complaints. This supports the idea that women seeking alternatives to cigarettes may have to try a variety of products and brands to find their fit. As one wrote, “Try it if it will benefit your health and you’re OK with it. To each their own.”

    In short, it’s clear that many women hold strong, perhaps outdated stereotypes of smokeless tobacco. Many will never try it. However, there appears to be an untapped demand for the benefits some women report from modern oral nicotine products: a discreet product to use where no smoke or vapor is allowed or a hands-free product that gives nicotine and flavor without effort. –C.K.O

  • Where’s the Parade?

    Where’s the Parade?

    Photo: TRITOOTH

    Record-low youth smoking rates get no respect.

    By Cheryl K. Olson

    Back in 2009, when planning its 10-year public health objectives, the U.S. Department of Health and Human Services (DHHS) set an ambitious goal for reducing youth smoking. At the time, said government data, one in five teens (19.5 percent) had lit up in the past month. The Healthy People 2020 target was 16 percent.

    These targets aren’t meant to be slam-dunks. In 2020, a third of the 985 trackable Healthy People objectives were met; the rest improved some, stayed the same or got worse. So what happened with high school smoking?

    It plummeted. After passing the goal in 2013 (15.7 percent), teen cigarette use kept on falling. At the ten-year mark, in 2019, it hit 6 percent.

    The Healthy People 2030 youth smoking target is 3.4 percent. The newest national figures suggest we’ve already left that number in the dust. The 2022 National Youth Tobacco Survey (NYTS) pegged high school cigarette use at an astonishingly low 2.0 percent. That’s even just a puff in the past 30 days, not daily use.

    “We’re crushing it, right? It’s great news,” says Dave Dobbins, former chief operating officer at the Truth Initiative who is now a consultant for Altria. “For many years, I never thought we’d get youth smoking under 5 percent; I thought the job would be done around seven or eight. And we’re beating the heck out of that.”

    Did I miss the champagne cork-pop celebration? Why aren’t we talking about this? 

    There’s a clue in the title of this 2016 DHHS press release: “Cigarette smoking among U.S. high school students at an all-time low, but e-cigarette use a concern.”

    In the 2022 NYTS, past-month e-cigarette use was 14.1 percent. The answer may be that we’d have to give e-cigarettes some credit for choking off youth smoking. And we have decidedly mixed feelings about that.

    In the Rearview Mirror

    The article in the New York Times Magazine was provocatively titled “If It’s Good for Philip Morris, Can It Also Be Good for Public Health?” It included an interview with Matthew L. Myers, president of the Campaign for Tobacco-Free Kids.

    “The challenge to me is not to eliminate smoking but the death and disease from smoking,” Myers said in 2006. “That should be the end goal. If you had a product that addicted 45 million people and killed none of them, I would take that deal. Then you’d have coffee! I have to believe that if the marketplace incentives were such that over time someone could devise a product that would give the same satisfaction as tobacco but didn’t kill them, people would flock to it.”

    In that first decade of our century, the future of youth smoking looked gloomy. This 2010 DHHS press release title summed up the mood: “Little Progress Being Made in Reducing Smoking Among High School Students.” It noted that cigarettes’ rate of decline had slowed.

    Kathleen Sebelius, then secretary of health and human services, wrote an introduction to the 2012 Surgeon General’s report Preventing Tobacco Use Among Youth and Young Adults. “Despite the well-known health risks, youth and adult smoking rates that had been dropping for many years have stalled,” she stated.

    The surprise decline in teen smoking that followed isn’t fully explained by tobacco control policies or changing demographics, experts say. Michael Pesko, an associate professor of economics at Georgia State University, has published over 20 papers on e-cigarette policies and their effects.

    “Something unexpected clearly happened between 2012 through 2019 that caused this exceeding of the smoking reduction goal by 400 percent,” he says.

    “Tobacco 21 happened, and research suggests this had an impact in the later part of the decade. But the other big thing that happened was wider availability of e-cigarettes.”

    The Pivot to E-Cigarettes

    Rather than celebrating minuscule smoking rates, anti-tobacco organizations pivoted to e-cigarettes and nicotine addiction. Consider a recent Campaign for Tobacco-Free Kids press release on the 2022 Monitoring the Future survey findings. In his statement, Myers relegated smoking’s decline—“a remarkable public health success story that will save lives for generations to come”—to the third paragraph. He led with youth e-cigarette use and a call for the Food and Drug Administration to eliminate “the flavored products driving this youth addiction crisis.”

    The Healthy People website today describes tobacco use in teens as “getting worse.” Reducing past-month tobacco use is a 2030 target. The new focus is on “cigarettes, e-cigarettes, cigars, smokeless tobacco, hookah, pipe tobacco and/or bidis.”

    “I understand the reasoning of people who are skeptical of reduced-risk products,” says Dobbins. “There’s a fear that people who otherwise would not have used nicotine will use them and then be more likely to transition to cigarettes if they continue to exist in the market.”

    “However, this has yet to be reflected in population data,” he continues. “Instead, the data suggest a transition to less harmful products. I think we have done a better job at educating people of all ages about the dangers of smoking than I gave credit.”

    Is Vaping Displacing Smoking?

    Pesko and colleagues have been analyzing the natural experiments created by variations in state policies regarding sales of e-cigarettes. He points out the remarkable consistency across a large body of research, none of it industry funded. In short, when governments regulate e-cigarettes—including taxes, minimum legal sales ages and advertising restrictions—it reduces e-cigarette sales to and use by both youth and adults.

    “And it also increases combustible cigarette use, again across all populations,” Pesko says.

    “The laws operate as intended in terms of reducing e-cigarette use but with the large unintended effect of increasing combustible use.”

    Vaping appears to be displacing smoking. Set aside the moral panic over vaping and legitimate fears of this new unknown; what’s left looks like a public health success story.

    “That’s what I believe is happening: a remarkable public health achievement,” says Pesko. He applauds advocates for passing Tobacco 21 but says nicotine companies also deserve credit. “Sometimes there is overlap between profit incentive and public health. The adoption of e-cigarettes may have been one of those things.”

    Nicotine Gut Check

    How should we feel about nicotine once it’s separated from combustible cigarettes? If, as Myers speculated about in 2006, we have appealing but addictive products with health risks similar to coffee … is that OK? This is a massive cultural adjustment that may take years to process.

    Social scientists Kirsten Bell and Helen Keane described our confused emotions in an article critiquing the gateway theory. “The nicotine in NRT [nicotine-replacement therapy] products is ‘good’ because it weans smokers off the ‘bad’ nicotine in cigarettes and ideally nicotine itself,” they wrote. “The nicotine in e-cigarettes is ‘bad’ because it facilitates addiction to nicotine, which, in turn, drives the user to seek it in ‘harder’ or more dangerous forms.”

    “My belief is that there will be an ongoing persistent demand for nicotine,” says Dobbins. “And if I’m right, it’s important that that demand be met with products that don’t subject the user to disease and death.”

    Another new objective for Healthy People 2030 is “Eliminate cigarette smoking initiation in adolescents and youth adults.” In 2018, four percent of youth aged 12 to 25 first picked up a cigarette. The 2030 target: zero percent. Does this trajectory suggest that zero youth use of nicotine should be the next goal?

    Pesko is not a fan of that approach. He uses the analogy of the Environmental Protection Agency’s regulation of water. They generally don’t use a zero standard for even nasty things like lead.

    “It’s so expensive to go from that trace level to zero, and the benefit is so small,” he notes. “It’s a reasonable goal to try to get use very low and with as safe a nicotine product as possible. But to go to zero nicotine use by kids, I can’t imagine the types of aggressive regulation and extra policing we’d need to do that. And even then, we wouldn’t achieve the goal, as we’ve seen with the war on drugs.”

    More Productive Policies

    Given limited resources, where might policymakers and regulators most productively put their attention to reduce tobacco product risks to youth?

    First, if we accept that the demand for nicotine exists, steer it toward reduced harm. “In terms of policy, having lower regulation of e-cigarettes than cigarettes makes a lot of sense,” says Pesko. “We want to incentivize people to use safer products. We should be taxing proportional to risk.”

    He would also like to see lower regulatory hurdles for products like e-cigarettes and nicotine pouches and incorporation of studies like his into appropriate for the protection of public health calculations: “Natural experiments are a strong, consistent body of evidence that could be used to approve more PMTA [premarket tobacco product application] applications. I’d like the FDA to use this body of work more.”

    Another suggestion is to turn up the heat on those nicotine companies known to sell to youth. Journalists have reported on the FDA failing to police vape products with candy flavors and toy-like packaging. Reynolds American even submitted a citizen petition a to the FDA requesting ramped-up enforcement of disposable e-cigarettes like Puff Bar and Elf Bar.

    Dobbins understands the discomfort of many anti-tobacco advocates with this evolution in thinking.

    “The reduced-harm products option allows companies that make money off selling cigarettes to continue doing business, albeit with much less harmful products,” he says. “But I think the most likely alternative of restrictive policies will be a move to a gray market that won’t be accountable to regulatory systems or the law, the way large companies must operate in the present.”

    Recalling industry chiefs’ past staunch denials of tobacco harms, Dobbins adds, “We must acknowledge that we are nearly 30 years from 1994.”

  • A Teaching Moment

    A Teaching Moment

    Photo: Darren415

    Nicotine’s lessons for cannabis regulation

    By Cheryl K. Olson and Willie McKinney

    From the industry perspective, regulation of tobacco products by the U.S. Food and Drug Administration went from impatient foot-tapping to a lurching roller-coaster ride. The recently released “operational evaluation” of the FDA’s tobacco program, requested by Commissioner Robert Califf, lays out in sedate but clear terms some causes of industry’s frustrated exhaustion: years of delay in establishing requirements. Sudden major shifts in policy. Cycles of litigation and reprieve.

    Based on feedback from FDA employees, and people from industry and public health, the independent Reagan-Udall Foundation for the FDA made recommendations to start repairing the regulatory mess. After “observ[ing] that CTP [Center for Tobacco Products] has been forced to operate primarily in a reactive mode, moving from one challenge to the next,” the first recommendation to the agency is to get proactive. The Reagan-Udall panel encouraged the CTP to make time now to “think strategically about where it is today and where it needs to go in the next several years.”

    This advice might apply equally to whatever future the FDA faces with regulation of cannabis products. The FDA has authority over cannabis and its dozens of biologically active chemical compounds, including CBD and THC. Although marijuana falls under the federal Controlled Substances Act, the 2018 Farm Bill removed hemp (a low-THC cannabis plant and its derivatives) from that definition.

    Principal Deputy Commissioner Janet Woodcock recently announced in a press release that existing regulatory frameworks for food and supplements are not appropriate for CBD. “The agency is prepared to work with Congress” on a new pathway, she stated.

    What might we take from the U.S. tobacco experience to ease headaches for future cannabis regulation? Below are some points to ponder in three areas: regulatory structure, medical versus recreational use, and the effects of misinformation on regulation.

    What Should a New Structure Look Like?

    First, what regulatory structure makes sense: Should the FDA create an all new one for cannabis products, or should it employ some existing channels? Consider the tobacco parallel.

    “Safe and effective” is the FDA’s traditional standard for evaluating drugs and medical products. In the 1990s, then Commissioner David Kessler tried to assert the FDA’s authority to regulate nicotine as a drug—intended by industry to affect the body’s structure or function—and cigarettes as delivery devices. A 2000 Supreme Court ruling found that the “s and e” standard left no room for regulation of tobacco.

    In 2009, when Congress chose to place tobacco under FDA jurisdiction, a novel department was created. But this promising, fresh science-based regulatory approach for tobacco faced headwinds. This Center for Tobacco Products was largely staffed by people rotated from elsewhere in the FDA. The “appropriate for the protection of public health” (APPH) tobacco standard was a difficult departure from their accustomed ways and views. The combination of suspicion from past industry misbehavior and the political uproar over youth vaping fostered an “us versus them” mindset. The founding legislation’s focus on cigarettes, the most deadly of tobacco products, affected attitudes toward emerging alternative nicotine products with the potential to greatly reduce disease risks for people who smoke.

    Perhaps there is light at the end of the tunnel. The FDA appears to recognize that shoehorning cannabis into existing structures has its own problems. Each type of intended use must find a fit in an existing department, such as human food, veterinary products, cosmetics or drugs. Under the Federal Food, Drug and Cosmetic Act, a drug is any product (including marijuana or hemp) intended to affect the structure or function of the body or intended to diagnose, cure, mitigate, treat or prevent disease.

    What factors will influence staff mindset about cannabis in these various departments? How will that affect regulation?

    Medical vs. Recreational Pathways

    Another issue: How best to regulate cannabis for medical versus recreational use? Like tobacco, cannabis has been used historically for medical purposes, such as treating pain. Both nicotine and cannabis are reportedly used to self-medicate for mental health disorders. Use of marijuana to manage mood disorders is reportedly higher in states with medical marijuana laws. But there currently is no such thing as “medical” marijuana. (This is not unlike the confusion over what constitutes “natural” food.) The FDA drug pathway would create medical cannabis. A standardized product would be evaluated for quality, safety and efficacy for a particular medical indication.

    We lack randomized, controlled clinical trial data on whether cannabis effectively treats disorders such as depression. However, such studies could be done by industry and submitted to the FDA’s Center for Drug Evaluation and Research. Several specialty products containing THC or CBD (e.g., for chemotherapy-related nausea or severe forms of epilepsy) have emerged from this path.

    But what regulatory pathway might recreational cannabis take? And what complications arise from product format and route of administration: smoked, vaped, applied to skin or eaten? Where would combusted flower fit?

    Nicotine is regulated by the FDA as a drug and as a recreational product. Two paths for cannabis also make sense. Although there is overlap (to get technical: Gum bases that contain nicotine are regulated as both pharmaceuticals and recreational tobacco products), combusted tobacco products that contain nicotine are only regulated by the Center for Tobacco Products.

    We propose that Congress modify the 2009 Tobacco Control Act to give the CTP authority over combusted and vaped cannabis. Such products are very unlikely to pass the “safe and effective” drug standard, but the APPH standard may be applicable to recreational cannabis. And the CTP has built up expertise in combusted and vaped products.

    Keep Moral Panic Out of Regulation

    A third issue deserving of thought is how to prevent moral panic and misinformation from derailing the potential benefits of cannabis. One lesson from nicotine is how these can fog the ability of regulators, politicians and the public to see data clearly.

    Research shows that youth use of nicotine and cannabis (as well as alcohol and other substances) overlap. A 2022 analysis of Population Assessment of Tobacco and Health study data found that more than half of e-cigarette users aged 15 to 24 had vaped cannabis. At the population level, teen cannabis youth has been fairly stable for the last quarter century. However, there will be concerns that the spread of state laws legalizing cannabis for adults could ease access for youth.

    Once it takes hold, misinformation is hard to uproot. Witness stubborn rates of misbelief that the outbreak of vaping-related lung injuries (e-cigarette or vaping product use-associated lung injury, or EVALI) were caused by e-cigarettes instead of THC vapes adulterated with vitamin E acetate.

    We see signs of a potential moral panic over cannabis. When the Centers for Disease Control and Prevention noted that marijuana vaping was most often linked to EVALI, the Wall Street Journal editorial board decried the “risky social experiment [of] legalizing and especially destigmatizing cannabis”—a drug that “could be damaging young brains for a lifetime.” News reports tout studies suggesting higher potency cannabis could mean higher risks of addiction and health harms.

    Research to clarify the specific nature of cannabis risks to youth is needed. We also need research on the current state of cannabis misinformation, including overly rosy views of risk that could create a backlash when problems are publicized. Using the results of this research for outreach ASAP, before the pot panic gets rolling, could soften the impact.

    Scrutinize and Enforce

    To avoid repeating mistakes of the past, we also need rigorous oversight. The FDA has been criticized for reluctance to use its powers to remove illegal nicotine vapes from the market. Some companies continue to sell despite warning letters. We need to study what cannabis products drive youth use and proactively target those makers and distributors.

    Products likely to attract underage users deserve particular scrutiny. Although no deaths were reported, a study in the journal Pediatrics2 documented a worrisome increase in child poisonings from edible cannabis products. To protect both adult access and child well-being, it’s common sense to require that edibles come in clearly marked, child-resistant packaging with no resemblance to candy.

    We have tools to unmask the bad actors. Youth will tell us in surveys what products they buy. The FDA’s own National Youth Tobacco Survey identified products not legally on the market, such as Puff Bar and Hyde, as favorite brands (Hyde was identified through write-in responses).

    With nicotine, regulatory delays and gray areas (such as regulation of synthetic nicotine) were abused by companies willing to skirt the law for quick profit. We see analogous situations with cannabis. One example is hemp-derived delta-8 THC products, said to produce a milder high similar to that from marijuana-derived delta-9 THC. Sales are rising fast. So are concerns. There are safety risks from impurities created during delta-8 manufacturing. And public confusion over delta-8’s legal status could complicate marijuana legalization efforts.

    The Reagan-Udall Foundation review of the CTP highlighted the need for “truthful and accurate information to help adult consumers make informed decisions about the role of nicotine” and product-specific risks. This applies equally to cannabis.

  • Science-based Regulation?

    Science-based Regulation?

    Photo: Li Ding

    Politics and data in tobacco harm reduction

    By Cheryl K. Olson

    In the last couple of years, I’ve written several articles for Tobacco Reporter on how the U.S. Food and Drug Administration thinks about science. Trying to get a novel nicotine product authorized by the Center for Tobacco Products (CTP)? Tell a story about why your particular vape, pouch or gum, is appropriate for the protection of public health, illustrated by data.

    That’s how the system is supposed to work. FDA staff make decisions based on what the science says about the relative health risks and benefits of a novel nicotine product. The CTP’s website states: “Our ability to enact science-based regulation has the true potential to reduce the death and disease toll from tobacco products.”

    But evidence suggests that stronger forces have shoved science out of the driver’s seat. Recently released memos from the CTP’s Office of Science show that subjective factors drove the decision to deny a marketing authorization for a flavored vaping product. JTI’s Logic brand was teed up as the first menthol-flavored electronic nicotine-delivery system (ENDS) likely to complete the premarket tobacco product application review process. After CTP leadership changed last summer, the emphasis shifted from how menthol vapes might help adults quit smoking, to the purported risks that any flavored ENDS product (including menthol) posed to youth. Prominent politicians have openly pressured the CTP to eliminate flavored vaping products. 

    In 2019, a CTP toxicologist filed a complaint that the organization had changed its review process from a “fully quantitative review to a more qualitative one,” according to a report on the Government Executive website. CTP researchers were found to have been retaliated against for raising concerns and disagreeing with interpretations of science.

    Disagreements about research findings ought to be dispassionate and evidence based. But in tobacco harm reduction, debates about “the science” are often mere veneers over deeper disputes. Trying to make sense of divergent perspectives on e-cigarettes, researchers from the University of Toronto and the University of Cambridge recently interviewed 21 experts on tobacco and harm reduction. They concluded, “The majority of meanings attached to tobacco harm reduction were rooted in values, ideology, politics and opinions rather than straightforward disagreements about the scientific evidence.”

    Some industry commenters found the Reagan-Udall Foundation’s much-anticipated operational evaluation of the CTP to be a damp firecracker. Their report does correctly note 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.”

    Before we can talk about the science, we need to acknowledge the values-laden differences in meaning that make logical, civil discourse about nicotine products so difficult. It would take a book to cover it all, but here are a few of the stumbling blocks.

    The Legacy of “Light”

    In 2009, Mitch Zeller (future director of the CTP), Dorothy Hatsukami and colleagues laid out a vision and blueprint to guide tobacco control efforts. It focused on harm reduction, defined as “strategies that would reduce morbidity and mortality … from continued use of tobacco or other nicotine-containing products.” It noted the now-famous continuum of risk—with smoking far more hazardous than noncombustible nicotine sources—and cautiously acknowledged a role for “potential reduced exposure products,” between cigarettes and nicotine-replacement therapies.

    But the article also made clear that all novel reduced-harm products are burdened with the legacy of past industry deception: “The major concern held by some public health experts is that these new products may be nothing more than a more scientifically sophisticated version of the ‘light’ cigarette.” As tested by smoking machines, such products appeared lower risk; as used by humans, they were not. In the authors’ view, naive public health officials were duped by industry into promoting light cigarettes to health-conscious smokers.

    Fear of repeating the experience of “light” cigarettes, where claimed reduced exposure to toxins did not lead to reduced disease or death, shaped the Tobacco Control Act of 2009. A well-intended effort to prevent future deceptive advertising now blocks another stated goal of Zeller and colleagues: to “educate the public accurately on the precise risks of different [nicotine] products.”

    Unclear Definitions

    Before moving full-time into harm reduction, I studied the potential effects of violent video game content on youth. I learned how important shared, clear definitions are to research. In that case, the biggest problem was defining “aggression.” To some researchers in the field, arguing or play-fighting were equivalent to attacks with intent to harm. A study about time spent virtually running amok has very different implications if the consequences are teasing versus criminal assault.

    Nicotine research has similar problems with definitions, often also involving youth. For example, anti-tobacco organizations, such as the Campaign for Tobacco-Free Kids, have long worried that “kid-friendly flavors” might attract teens to experiment with vaping.

    What constitutes a “kid-friendly flavor”? As Clive Bates has pointed out, as of 2017, this label was attached to candy store or ice cream shop ENDS flavors, or silly ones like “Unicorn Puke.” Removing them from the market would still leave many options for adults who smoked. But today, by definition, all ENDS flavors—other than “tobacco,” and including menthol—attract kids. This is a classic case of moving the goalposts to achieve a win. (The use of “kids” to represent adolescents is a separate debate.)

    Unquestioned Assumptions

    In a recent interview, author Malcolm Gladwell defined bad science as “science committed by people who think they know the answer before they start.”

    Assumptions about vaping’s harm to youth have an increasingly tenuous relationship to science. Objections used to be automatically couched, as in this 2020 article, as a concern that these new nicotine users “may become addicted to vaping, which may lead to smoking.”

    Has the availability of vaping coincided with a youth smoking increase? Look at the newly released results from Monitoring the Future, an ongoing national study of U.S. youth substance use. Among 12th grade students, who are typically aged 17–18, any reported nicotine use other than vaping showed a “quite dramatic” decrease, from 21 percent in 2017 to 8 percent in 2022. (Vaping and marijuana use have also dropped, and stayed down.)

    By contrast, past-year alcohol use by 12th graders is up, at 52 percent. Documented youth appeal of “alcopop” flavors receives little attention. Interestingly, a Google Scholar search for recent papers on “flavored alcohol youth” brings up more articles on e-cigarette flavors than on alcohol products.

    Data suggesting that the gateway from vaping to smoking may be imaginary does not make it less real in the minds of believers. The Campaign for Tobacco Free Kids’ website still describes a vaping epidemic and “serious health risks to the health of young people.” Their list of risks consists of the possibility that nicotine “can harm … parts of the brain responsible for attention, memory and learning,” the risk of nicotine addiction and the increased risk of smoking or “future addiction to other drugs.”

    On one hand, we see declining nicotine use and limited real-world evidence of specific health harms to youth. On the other, we see hundreds of thousands of dead adult smokers every year. It’s hard to understand how U.S. regulators consistently weight the former more heavily than the latter. The Reagan-Udall report singled out this balance (on page 15) as one that “scientific analysis alone will not resolve.”

    A Shared Goal

    Finally, we come to the ultimate policy controversy that research can inform but not solve: Is the goal to end all nicotine use (and addiction)? Or, is the goal to reduce tobacco-linked death and disease? Whether the latter goal is your endgame, or just step one of two, all sides ought to be able to work toward it together.

    Dismissing data that doesn’t fit a desired narrative has consequences for public health. As eight respected U.K. experts wrote in response to repudiations of tobacco harm reduction: “The pursuit of arguments that vaping cannot help people to quit smoking, in the face of clear evidence that it does, risks undermining public trust in science.” 

    It’s time to rethink our assumptions and take a fresh look at patterns of evidence. One pattern we observe, exemplified by Karl Fagerstrom’s new country-by-country analysis, is that more use of reduced-risk noncombustible tobacco is linked to less smoking. Let’s start a discussion about how to rapidly put attractive, lower risk nicotine products in the hands of people who smoke.

  • Reality Check

    Reality Check

    Photo: Grispb

    To what extent do flavor bans achieve their stated objectives?

    By Cheryl K. Olson

    As a California resident, I set aside an evening before every state election to educate myself about that year’s crop of “propositions”—proposed policies that have gathered enough signatures from registered voters to place on the ballot. This year’s motley assortment addressed kidney dialysis centers, arts and music education, online gambling … and flavored tobacco products. The brief text on my ballot stated that a “yes” vote would approve a stalled 2020 law prohibiting retail sale of certain flavored tobacco products. And this would decrease state tobacco tax revenues as much as $100 million per year.

    The California ban includes all flavored tobacco products (aside from premium cigars, loose leaf tobacco and certain hookah tobacco) as well as flavor enhancers designed to be added to tobacco products. Bans of flavored vaping products are now in effect in states such as Massachusetts, New Jersey and Rhode Island. New York bans both flavors and online sales (five states ban online sales but not flavors). Various cities and counties, including Chicago and Boulder, Colorado, also forbid flavors.

    This led me to wonder about the purpose of laws prohibiting flavors in various types of nicotine products. Are flavor bans a useful way to achieve tobacco policy goals? And what unintended consequences might result?

    Why the Focus on Flavors?

    Despite questionable evidence, it’s now dogma that flavored tobacco products addict youth and are a slippery slope to smoking. “The ban on flavored nicotine vapor products will protect our children, who, thanks to the tobacco industry’s marketing efforts, have been using vaping products at alarming rates,” said New York state’s commissioner of health in May 2020. “We will no longer permit Big Tobacco to target young New Yorkers for a lifetime of nicotine addiction.”

    “Flavors are complicated. They are initiation products for new users, no question,” says Dave Dobbins, former chief operating officer of the Truth Initiative. “We see this play out in alcohol as well. Kids start with flavored seltzers. We tolerate this because adults like flavored alcohol also.”

    “That said, nicotine can be dependence inducing, and youth initiation is a serious issue,” he adds. “But, if we expect adults to switch, measures that reduce combustible appeal (no flavored cigars or cigarettes) and increase the appeal of safer products (flavored nicotine pouches) will be important.”

    A nicotine researcher who has worked in academia and industry (and asked for anonymity) notes, “Just because most youth use flavors doesn’t mean they need flavors to experiment. They didn’t need flavors to experiment with cigarettes 20 years ago.”

    Unintended Consequences of Flavor Bans

    What do we know so far about the effects of flavored product sales restrictions? There are hints in a recent scoping review by Todd Rogers and colleagues at RTI International and the Truth Initiative Schroeder Institute. They looked at studies of local U.S. policies, most passed in 2015–2019. Research designs and measures were generally weak, and there were many gaps. None of the studies gave evidence on whether flavor bans reduced youth access to or susceptibility to use tobacco products, for example.

    The authors did find post-policy short-term reductions in flavored product sales but little assurance that these would be sustained. Most of the studies looked at unintended effects. There was evidence of cross-border sales and substituting other products rather than quitting. There were also creative workarounds as when large numbers of New York City retailers began selling “noncigarette products with concept flavor descriptors” such as “purple” instead of “grape.”

    Three included studies that measured policy success via scanner sales data found “significant, sustained levels of sales of restricted products in policy-affected areas.” The review’s authors piled on the pessimism by noting that retail scanner data leave out online sales, sales from specialty vape and tobacco stores, out-of-town purchases and “illicit sources.”

    The upshot? Rather than express skepticism of flavor bans, the review authors doubled down. They encouraged larger scale (state or national) bans because “these governments typically have more resources … to defend and enforce policies and measure outcomes.”

    A new survey and interview-based study looked at how young adult e-cigarette users in six major cities responded to the combined effects of 2020 federal restrictions on flavored cartridge-based vapes and state/local flavor bans. Very few (one in 12) reduced e-cigarette use. They went to alternative providers (including online) or used menthol/tobacco flavors. Faced with further restrictions, some intended to switch to cigarettes.

    Recent studies of flavor bans have found preliminary evidence linking bans to increased cigarette use among young adults and high school students. Any reversal in the longstanding downward trend away from smoking is cause for concern.

    In short, there’s little evidence thus far that bans achieve their stated goals. And unintended effects are potentially serious. One cynical but supportable conclusion: Tax Foundation researcher Ulrik Boesen called the Massachusetts ban on flavored e-liquids and menthol cigarettes “a public health measure that merely sends tax revenue to its neighboring states without improving public health.”

    Alternatives to Flavor Bans

    Atakan Erik Befrits, chief operating officer of the International Network of Nicotine Consumer Organizations, notes growing international interest in flavor bans as a means to protect children. He fears that the European Union and World Health Organization may have “painted themselves into a corner” with their current negative stances and find it difficult to change course. This would leave nicotine users, including those in low-income and middle-income countries, “with only the most dangerous delivery devices and the worst possible (if any) harm reduction alternatives to cigarettes for the 15–25 extra years that it will take for the natural experiment to run its course and become self-evident.”

    Are there policies that meaningfully target youth tobacco use without torpedoing reduced-harm options for adults who smoke? Dobbins favors policies, such as the recent raise in the age of sale, and using technology and volume purchase limits to reduce youth access. He also supports prohibitions on “lifestyle” marketing, such as desktop DJ parties.

    “After all, nobody will ever try an unflavored nicotine pouch, and few will switch if tobacco is the only option,” he says. “In the end, a balanced approach is the most sensible. I hope we get there.”

    Adapting to Tobacco Flavor Bans

    What do people who quit smoking with reduced-risk products do when flavors are banned? Members of the Consumer Advocates for Smoke-Free Alternatives Association (CASAA) were asked, “If you live in a state where flavors are banned, how has that affected your ability to stay smoke-free?” Examples below are representative of dozens of emailed responses.

    When flavor bans shuttered trusted local vape shops, many former smokers felt adrift. “There was a store with a very knowledgeable owner who answered all of my questions. Unfortunately, because of the ban in New York, he was forced to close,” said Melanie. “The options were scary at best because you never knew if what you were getting was safe. I am still vaping and have found reputable places to get my products.”

    To those former smokers used to buying products online, local flavor bans can be irrelevant. “I learned most of my information about vaping on various YouTube channels,” said Dave. “I think flavors are banned in my state/county, but I mix my own liquids, so the bans do not affect me.”

    Many who responded get their products across borders, in person or via family. “The New Yorkers that refused to go back to smoking either started to DIY [do it yourself], went out of state, found an online store that still ships to N.Y., or go to a Native American reservation for their flavored e-liquid,” said Dale.

    “I’m close enough to Connecticut to be able to get flavors there,” noted Rolf. “Without that, I think I would’ve returned to smoking.”

    “My fiance has a daughter who lives in North Carolina, so I usually make a big juice order and have it delivered to her” for drop-off when she visits New York, reported Roger. “I do not know what I would do if I did not have the ability to get the juice. My favs are black licorice, almond and bubble gum.”

    The extra effort required raises the costs of vaping, reducing its appeal versus smoking. “I can no longer afford to buy my favorite juice anymore. What was once a relatively cheap hobby has become too high priced,” said Zack from California. “I’m not going to lie; I’ve slipped up a few times since the flavor laws and nicotine taxes went into effect and found myself having a cigarette when socializing with friends.”

    Calling flavor bans “nonsensical,” Rob in California blamed “our government [that] can’t enforce the age barrier to buy these products” and block “teenagers looking for kicks.” He has written repeatedly to his representatives in Congress and the California state legislature to educate them about vaping and “let them know that if vaping is ever banned or flavors we need are banned, I will have to seriously consider going back to cigarettes.”

    “The flavor ban has been devastating. It feels like some states want the people to go back to cigarettes to recover some of that lost [Master Settlement Agreement] money,” said a former smoker who requested anonymity. “With that said, I’m still able to get flavored liquid. It just has to be done in a different way that I’m not going to outline here for obvious reasons.”

    “The flavor ban has not affected me much; I want my vape to taste like an authentic tobacco vape,” said Marc. However, “the ban has hindered what was an alleged battle against the dangers of cigarettes. All the vape ban did was pull Big Tobacco up off the canvas after a KO a few years ago.”

  • Choosing Wisely

    Choosing Wisely

    Photo: manovankohr

    Are choices key to successful switching?

    By Cheryl K. Olson and Willie McKinney

    Like many people who smoke, Doug Halterman wanted to quit. “I tried other ways, even prescription drugs, and nothing worked.” When he decided to try vaping, “At first, it was a research and development stage. I had to figure out what ones best acted like a cigarette,” he recalled. “I started with menthol tobacco. I then liked the fruit flavors because it helped stay clear of cigarettes. After vaping fruity flavors, cigs tasted absolutely disgusting.”

    Halterman’s story of switching is one of several dozen generously shared via emails from members of the Consumer Advocates for Smoke-free Alternatives Association (CASAA). This exploration of what drives change was triggered by anecdotes and research suggesting that encountering and trialing a range of alternative nicotine products, or rotating among an engaging mix of options, can be key to ditching smoking. The typical successful quitting journey seems less like a thruway and more like a meandering river. The U.S. Food and Drug Administration’s Center for Tobacco Products’ approach to researching switching, described in its Final Rule guidance, assumes simple choices and straight lines.

    The Wrong Framework?

    Premarket tobacco product application (PMTA) behavior studies are supposed to describe likely changes (and related health risks) created by the marketing of a single novel tobacco product of a particular flavor and nicotine strength. This is not unlike studies the FDA’s Center for Drug Evaluation and Research (CDER) reviews, comparing effects of a new drug to a placebo on particular symptoms or endpoints.

    In a September 2021 PMTA Technical Review Summary available online, the FDA laid out a new standard that flavored electronic nicotine-delivery system (ENDS) products must meet. Balancing concerns about youth uptake demands “acceptably strong evidence that the flavored products have an added benefit relative to that of tobacco-flavored ENDS in facilitating smokers completely switching away from or significantly reducing their smoking.” What kind of evidence? “Most likely product specific evidence from a randomized controlled trial (RCT) or longitudinal cohort study.”

    Again, it’s like testing whether a medicine to treat gout or acne is superior to the current standard therapy, except it casts tobacco flavoring (the taste of cigarettes) as the standard and mango or vanilla as the unproven alternative. 

    Does an approach that may work for “safe and effective” prescribed drug authorizations make as much sense for a balance-of-risks consumer product standard? Does the CDER mindset serve well the end goal of moving people off combustibles? This pharma-influenced standard may be the wrong tool to address tobacco product effects.

    Comments from people’s real-world switching experiences (see sidebar) suggest that a test-in-isolation model fails to capture a lot of key information that could accelerate the move away from smoking and its unacceptably high risks of disease and death.

    Unlike pharmaceuticals and devices approved by other FDA centers, nicotine consumer products are not prescribed as a course of treatment. Tobacco users looking to switch aren’t making comparisons among two (or three) options. They meander through shops and gas stations, picking up nicotine products at will and whim. Many use multiple products to suit situations or prevent boredom. They learn through trial and error: How does this product work? What does it do for me? How does it fit into my life? And they choose again.

    Another problem: As Neil McKeganey of the Center for Substance Use Research pointed out recently, it’s not clear by how much the FDA values youth vaping prevention over adult smoking cessation. How obviously better would a flavored product need to be at helping smokers switch, compared to a tobacco flavor, to offset concerns about youth appeal? The recent longitudinal study of Juul, where over half of participants switched completely from cigarettes at one year, found that what flavor smokers chose did not significantly affect success.   

    Missing Variables

    Most studies aren’t designed to address the power of choices. Even large surveys that support the importance of flavors in switching tend to collapse flavors into categories (like “sweet” for fruit and candy) and ask about main flavor used, obscuring the paths taken by individual quitters. But there are tantalizing hints. For example, a six-week switching study of tobacco-free pouches found a link between trying more flavors and fewer daily cigarettes smoked. A 2018 study of MarkTen found that smokers who switched completely used more flavors.

    Based on her experience researching oral and vapor product behaviors (including MarkTen), “Most smokers don’t successfully switch and sustain their switching through one product category,” said Jessica Zdinak, chief research officer at Applied Research and Analysis Consulting. She notes that academic studies of smoker transitions often leave out important variables, such as previous quitting experiences or stressful changes in life circumstances.

    Adding Real-World Evidence

    FDA Commissioner Robert Califf has been quoted repeatedly as supporting greater reliance on real-world evidence to support drug regulation decisions. During his first stint as FDA head, Califf said at the 2016 Food and Drug Law Institute conference that “In the past, so-called ‘regulatory trials’ tended to focus on high-quality studies with detailed study procedures, restrictive inclusion and exclusion criteria and have been conducted in special study sites.” By contrast, he noted that “pragmatic clinical trials,” studies that look at treatments and outcomes in actual medical practice settings, “may be the most important source of knowledge in the future.”

    Another difference from pharmaceutical products: Many alternative nicotine products have been on the market for several years. Why not consider real-life evidence, as in natural choice situations over time, for tobacco product switching behavior? Don’t throw away tried-and-tested tools but see how they fit in a new context.

    Zdinak would like to see long-term randomized trials that incorporate this approach, showing the effect of having or lacking a range of options. To demonstrate the effects of flavors on switching, “What does the world look like if I’m a smoker of 30 years who enters a vape shop, and I have tobacco-flavored vapes as my sole option? Or what happens if I see citrus, mango, cinnamon, coffee and caramel?” She is currently in the design and review phase for one such realistic study.

    To quote prominent researchers Dorothy Hatsukami and Dana Carroll, “Most in the tobacco control community would agree that an immediate main goal is to rapidly eliminate tobacco-related death and disease.” If regulators agree, let’s look at what obstacles are preventing smokers from switching more rapidly. That includes tailoring methods and assumptions borrowed from pharma research to suit appropriate for the protection of public health (APPH) standards and goals.

    The Power of Choices: Stories from CASAA

    Founded in 2009, the Consumer Advocates for Smoke-free Alternatives Association (CASAA) is a 501(c)(4) consumer nonprofit organization that aims to “ensure the availability of a variety of effective, affordable reduced-harm alternatives to smoking.”

    In response to an emailed request from CEO Alex Clark, a number of former smokers took time to share their experiences of switching to vaping or other smoke-free products. One question posed by Clark was whether the variety of products was helpful in staying engaged with smoke-free options and reducing the temptation to return to smoking.

    Clark himself recently switched from vaping to using pouched snus. Along with a concern that overconsumption of stimulants, such as coffee and rapid-delivery nicotine products, were triggering heart palpitations, he said, “The hands-free nature of snus fits more with my needs. And I can still get all of the different flavors when I order from Sweden.”

    Here are excerpts from CASAA member comments, edited for length and clarity. No doubt, people who smoke have a range of goals and preferences that evolve in sometimes surprising ways through product exploration.

    Nancy S.: “I started vaping because I was unable to stop smoking tobacco cigarettes because I am so addicted to nicotine. And I don’t want to die from lung cancer like my father did. The products I tried were exactly what I was looking for. I wanted something that tasted like a real cigarette. No funny flavors.”  

    Roger M.: “I love the variety of products—both hardware and e-juices. My favs are black licorice, almond and bubble gum. They say only the kids like these flavors, but I have loved them since I started vaping 12 years ago. I am now 61.”

    Sara C.: I liked trying new flavors in the beginning then found my favorite [strawberries and cream] that I’ve stuck with for years.”

    Marc C.: I’ve tried the patch, the gum, hypnosis, as seen on TV products, medications and counseling. Nothing worked or works for me except vaping. I want my vape to taste like an authentic tobacco vape. But I’m okay with some flavor of tobacco, like coffee, vanilla, apple or maple. Almost like a pipe tobacco assortment.”

    Sean O.: “The first product I tried wasn’t all that good. Eventually, I found that using what’s called a ‘box mod,’ which takes two high-powered batteries … gave the great sensation in your throat of inhaling the same way a cigarette did. The large clouds of vapor that you can produce using these mods and tanks is incredible. [And] the variety of flavors is exactly what has kept me away from cigarettes.”

    Joni L.: “The device was key for me. I chose a Vaporesso Swag because of the size. It felt close enough to a pack of cigarettes for me, and a lot of my habit was actually reaching for my smokes. My first e-juice was a house-made vanilla custard tobacco; I was afraid to go too far away from tobacco flavors because I actually believe I liked the flavor of a cigarette. After three or four days, I went back to the vape shop and bought some mixed berry-flavored juice. That was it. It didn’t take long for my cigarette cravings to go away.”

    Kelly P.: “I did try a different device but went back to Juul. I liked the mint and found it better than the menthol cigarettes I had smoked. Also, Juul wasn’t one of those devices that you would blow out a cloud of smoke.”

    Glenn N.: “I believe that the first ‘e-cigarette’ I bought was the first Blu. I vaped that for a couple months, but it was missing something, and I thought I would go back to cigarettes. So I started looking online. With that ProVari, I knew that I would never smoke again. I found what I needed. I started with 36 mg liquid and went down to 12 mg in about a year.”

    Steve T.: “I will be 68 this year and feel I made a great decision with vaping. Access to flavors is a critical component necessary to transition away from cigarettes. I have reduced the nicotine levels from 18 mg to 3 [mg], and my Kona e-juice was replaced with dessert and blueberry flavors.”

    Jessie C.: “NRT [nicotine-replacement therapy] options like snus and nicotine gum/lozenges never worked for me as more than a way to avoid smoking at an event or during a long work shift. I’m very much a tech-oriented person, so the idea of having many options was stimulating for me. At the time, CE4 atomizer [tanks] and little pens were the most accessible items on the market [and did not meet expectations]. When the Kangertech Subox Mini hit the market, I was satisfied and stuck with that.”

    Cindi K.: I started vaping in 2014 not because I was looking to quit smoking but because I was avoiding convenience stores; I had just entered AA [Alcoholics Anonymous] and that is where I’d bought alcohol. Two doors down was a vapor store. I bought an eGo Tank and some tobacco-flavored e-liquid in 24 mg. I made friends in AA that were also vaping and noticed their liquids smelled much better than what I was using. I continued to be what I labeled a dual user for a few more months and decided to use flavored e-liquid and willpower to quit smoking. I also learned how to make my own flavors. I had about 12 I used in rotation and loved.”

    Tanya L.: “The first product I tried was in 2013: a vanilla-flavored vape liquid, Kanger T3S tank and coils, which I still use. I like vanilla. I just had to find the best vanilla.”

  • ‘Forgotten’ Smokers

    ‘Forgotten’ Smokers

    Photo: Chris Ferenzi

    Rather than being “forgotten,” as the session’s title suggested, people who smoke are an unexplored, stigmatized and often misunderstood species, according to the participants in a GTNF discussion about consumers. While consumer centricity has become a buzzword in the reduced-risk product industry, companies still have a lot to learn about their target group.

    Altria, whose vision is to responsibly lead the transition to a smoke-free future, examined the plight of consumers on their journey to less hazardous products. “We had done a comprehensive research program about the interest in vape products, but what was really missing was to bring the voice of the consumer directly to the organization,” said Brent Taylor, managing director of consumer and marketplace insights at Altria.

    Last year, the company initiated “Project 21,” a study of 21 consumers of combustible tobacco who were interested in switching to less harmful nicotine products (see “Listening to Nicotine Users,Tobacco Reporter, September 2022). Over 21 days, Altria’s researchers catalogued the study participants’ behavior via videos and weekly surveys. The participants were asked to “do their best” but didn’t get any guidance, as Altria wanted to learn how they tackled the challenge on their own. Their progress was checked after three weeks, three months and six months.

    After six months, 15 participants were still smoke-free. The people who were most successful were those who really wanted to switch and held themselves accountable. The project also showed that many factors unrelated to the product category, such as a bad day at work, impacted the success of participants in transitioning. Each of the journeys was unique and entailed its own set of complications. For all participants, it was a highly emotional experience, according to Altria.

    Kim “Skip” Murray, a person who vapes and a tobacco harm reduction (THR) advocate who until last year ran a vape shop in Minnesota, related experiences from her customers that illustrate how external factors, such as misinformation and economic strain, can impact attempts at switching. One of her customers, a Vietnam veteran with chronic obstructive pulmonary disease, returned to smoking for some months after press reports and health authorities mistakenly attributed the e-cigarette or vaping product use-associated lung injury (EVALI) outbreak to nicotine vapes.

    Some clients reverted to more harmful but less expensive cigarettes when their budgets were tight. Discouragingly, the Food and Drug Administration’s marketing denial orders forced products off the market that had helped Murray’s customers quit cigarettes while leaving combustible products widely available. Murray said she was unable to dispel the myths about EVALI and many of the other false narratives about vaping. The number of people who came into her shop wanting to quit dropped substantially, eventually forcing her out of business.

    Alex Clark, CEO of the Consumer Advocacy for Smoke-free Alternatives Association, stressed the importance of language in the smoking and health debate. “Smoker,” he said, has become a pejorative term. “We’re now focusing on people who have a history of being underprivileged, undeserved and oppressed—people who we don’t see in offices or at conferences; people who have been pushed to the margin of society.” Having smoked heavily in his youth, Clark recalled being told that his habit was a character flaw. The stigma of having no control over his decisions and essentially being a drug addict, Clark said, stuck with him even after he had switched to vaping.

    Most of the 30 million Americans who smoke today belong to vulnerable groups, suffering, for instance, from mental illness or unemployment, according to health behavior consultant Cheryl K. Olson. Among people in custody, the percentage of people who smoke is four times higher across the world. Together with other researchers, Olson explored the potential of vape products for use in a prison environment and found that the acceptance was 95 percent. “For vulnerable groups, harm reduction is a realistic goal if nicotine abstinence is not,” she said. “Our findings about these groups have the potential to rebalance the conversation about appropriateness for the protection of public health.”

    Will Godfrey, editor-in-chief of Filter and executive director of the Influence Foundation, bemoaned the lack of synergy between harm reduction for illegal drugs and harm reduction for tobacco.

    Many illegal drug users smoke, and it would make sense to apply harm reduction strategies to both habits. In reality, those running drug-related programs are often unwilling to apply harm reduction to tobacco use. Bizarrely, some needle exchange programs for intravenous drug users are accompanied by anti-vaping policies, noted Godfrey.

    He blamed the “deep suspicion” of the nicotine industry within the left-wing harm reduction movement as well as the growing influence of Bloomberg Philanthropies, a big funder of anti-smoking programs that is notoriously hostile to vapor products.

    Godfrey urged the administrators of drug harm reduction programs to extend the harm reduction principle to smoking. “It is vital that THR, including the industry, builds momentum in this direction,” he said. “The hostility to the industry won’t go away but is surmountable, as the role of pharma in drug harm reduction has shown.”