Category: Cheryl Olson

Crossing the Divide

Photo: es0lex
When scientists work for a tobacco company
By Cheryl K. Olson
Carlista Moore Conde never expected to work for Big Tobacco. A chemical engineer by training and a former NASA scholar, her career had focused on R&D for multibillion-dollar brands of household name consumer goods at Procter & Gamble.
“I spent 20 years working on products that improved people’s lives,” she told me soon after we’d met at the 2021 Global Tobacco and Nicotine Forum in London. “Now I’m working on products that can save lives.”
Carlista Moore Conde
As group head of new sciences at BAT, Conde is part of a trend among tobacco companies to hire from outside the fold—industries that often have nothing to do with nicotine, as well as academia and government—to work on reduced-harm products that lower the health risks to people who are already addicted to combustible cigarettes.
“I have family members, dear aunts and uncles, who spent a lifetime smoking and suffered the [health] consequences,” she continued. “So I never even considered working for a tobacco company, honestly. I misperceived the harm of alternative nicotine products as being the same as traditional smoking.”
Mohamadi Sarkar took a different path to working in the industry. He’d been a professor of clinical pharmacology at the Medical College of Virginia at Virginia Commonwealth University where he’d done research on smoking-related diseases. He was approached by scientists from Altria about joining them after he’d presented at a conference run by the Society for Research on Nicotine and Tobacco.
“And my first reaction was ‘Heck no!’” he said. “I was a tenured professor. Never in my wildest dreams had I thought I’d work for corporate America, let alone work for a tobacco company!” He’s now a fellow in scientific strategy at Altria Client Services. Sarkar has been at the company and its predecessors for 19 years. He maintains a faculty appointment at VCU and teaches three courses there per year.
Brian Erkkila was a neuroscientist at the National Institutes of Health before joining the then-new FDA Center for Tobacco Products in 2011. He was a lead toxicologist there for more than six years. After a three-year stint at the Foundation for a Smoke-Free World, he moved to Swedish Match in 2021, where he is director of regulatory science.
“It was certainly comforting to see how ‘all-in’ everyone I work with at Swedish Match is about tobacco harm reduction,” he said. “Looking out from inside the industry, there is a magnified sense of uncertainty concerning the regulatory environment. It’s very difficult to know what the nicotine marketplace will look like even one or two years from now.”

Looking past the cliches: While the tobacco industry engaged in questionable and even spurious research a generation or two ago, its recent approach has been quite different.
(Photo: Seventyfour)
New Scientists, Old Beliefs
Mohamadi Sarkar
A generation ago, the tobacco industry was largely an old boys’ network. Tobacco was “in your blood.” As the health effects of combustible cigarettes became apparent, many scientists from outside that industry saw joining it as a career killer.
But Big Tobacco has moved on. In response to public health findings, combined with social, regulatory, and economic pressures, it’s shifting away from combustible tobacco and focusing on alternative, less harmful nicotine-delivery systems. Still, scientists who are recruited from outside the industry often respond with healthy skepticism about whether this new focus is sincere. Conde shared that skepticism until she spoke with BAT employees who had come from outside tobacco and took a close look at the company’s operations.
“You hear stories about big bad tobacco from the past,” she added. “But what I found is that the science done here is done in a very transparent and rigorous way and is shared, even with our competitors.”
Erkkila added, “Sadly, I feel that some former colleagues will simply write me off for joining [the] industry. However, they need to understand that this is not the same industry from decades ago. FDA regulation of tobacco products has ensured that the research being done by companies is vetted and carried out in a robust manner.”
Sarkar admits that he struggled a bit with the reactions of some people at his university when he started at what was then Philip Morris USA. “Folks I knew from my past experience in academia who were my friends and colleagues started distancing themselves,” he recalled. “They were not happy with my decision to work for a tobacco company. But we do good science with the right rigor. I take great pride in the work we do.”
For Sarkar, as well as other scientists who’ve worked previously as professors, one of the strong advantages of corporate research is the consistency of funding. Another is the speed with which a novel idea can be pursued. Research grants to university laboratories often require months of detailed paperwork. The success rate of scientific research grant applications to the federal government—the largest funder of such research—is notoriously low. (In 2020, the National Cancer Institute rejected six grant applications for every grant that it funded.)
“At PMUSA, I was just amazed at the resources available to do the research, and the commitment not only to conduct the research but to publish and share it with the scientific community,” Sarkar continued. “Unfortunately while we are keen on publishing and sharing our research, some journals don’t accept industry funded research for peer-review consideration. In this situation, nobody wins—not science, not good policy, and certainly not adult smokers.”

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A Caste System for Researchers?
Brian Erkkila
There’s a paradox to the resurgence of suspicion and even outright rejection of industry-conducted science on tobacco harm reduction and alternative nicotine products. While the tobacco industry engaged in questionable and even spurious research a generation or two ago, its recent approach has been quite different.
“In this age of rampant misinformation, certain groups ignoring quality science because they don’t like the source strikes me as a hindrance to public health,” said Erkkila.
Recently, the editorial board of Nicotine & Tobacco Research, the journal published by the Society for Research on Nicotine and Tobacco, announced that “In order to continue the journal’s policy of alignment with the SRNT, which owns the Journal, N&TR will no longer allow tobacco industry (TI) employees to submit work to the journal in any format. TI employees include those individuals who work for companies owned in part or in whole by manufacturers of commercial tobacco products.”
This concern flies in the face of one of the fundamental tenets of scientific research: that it should be judged solely on its rigor not on the provenance of the researchers. That is the purpose of anonymous peer review. Preemptively excluding all research from the industry (or academia or government or pharmaceutical companies) is naive at best and will likely do harm to the public health.
All researchers who publish should cite both their affiliations and their sources of funding as well as other potential conflicts of interest. This encourages readers to employ a gimlet eye when considering conclusions and recommendations. It’s a pretty safe bet what the National Pork Producers’ Council will recommend for dinner. But does that mean I should automatically reject its nutritional analyses or its studies of African Swine Fever risk and prevention?
The new policy draws some bizarre distinctions. I’m a former academic researcher. During my career, I’ve worked on tobacco harm reduction and youth smoking prevention projects that were funded by government, nonprofits and industry. Am I a “good guy” or a “bad guy?” Is there a formula by which a certain amount of government-funded research cancels the stigma of industry-funded research, the academic equivalent of buying carbon offsets? (I’m only being slightly facetious.)
Note that the SRNT definition of “tobacco industry” does not include e-cigarette makers, except those linked to traditional tobacco product companies. (It also does not exclude consultants to tobacco companies from its conferences or journal, only industry employees.)
We run the risk that some of the “bad actors”—companies that have shown scant interest in harm reduction and youth use prevention—will have access to communications channels being denied to “good actors” that currently or have previously manufactured tobacco products. Under these rules, researchers for companies side-stepping Food and Drug Administration regulation by using synthetic nicotine could have their work considered for publication while scientists who crossed from government and academic posts to Juul (which is partially owned by Altria) would have their work summarily dismissed.
Simplistic approaches such as this may feel righteous, but they elevate form over function. We lose sight of the ultimate goal—a goal more likely to be achieved by sharing data and resources. Many scientists who have entered the industry believe that they can do more to block the dangers of combustible tobacco from the inside than from the outside.
“My moves from regulator to the Foundation and ultimately to Swedish Match have all been about reducing the public’s harms from tobacco,” said Erkkila. “Others’ view of me may have changed, but these moves have allowed me to appreciate the issue from many sides.”

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Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors. She spent 15 years on the faculty of Harvard Medical School.

November 1, 2021
Taming the Moral Panic

Photo: romankosolapov
A recent landmark article offers a rare balanced look at vaping in the U.S.
By Cheryl K. Olson
In the 1930s, there was considerable handwringing among politicians and academics about how gangster films would turn an entire generation of teenagers into thugs and thieves. After a few years, film scholars recognized that it was a moral panic—a widespread and irrational fear supported by emotions rather than by scientific data. They moved on.
In the 1950s, sociologists feared that crime and horror comic books would destroy the morals of that era’s youth. There were U.S. Senate hearings on whether they should be published as well as mass comic book burnings around the country. After a few years, sociologists recognized that it was a moral panic. They moved on.
In the early 21st century, a popular London-based tabloid claimed that video games are as addictive as heroin and that “Britain is in the grip of a gaming addiction, which poses as big a health risk as alcohol and drug abuse.” On the other side of the Atlantic, then-Senator Hillary Clinton claimed that “violent video games increase aggressive behavior as much as lead exposure decreases children’s IQ scores.” It was, psychologists have largely concluded, another moral panic with echoes that remain in today’s public policy.
We may have just seen the turning point on the moral panic surrounding vaping. Writing in the August issue of the American Journal of Public Health (AJPH), 15 former presidents of the Society for Research on Nicotine and Tobacco (SRNT), the world’s leading scientific organization for the study of smoking, concluded that concerns about youth vaping are overblown and may be undermining attempts to get current combustible tobacco users to quit. The much-touted fears are simply not supported by the data.
Rebalancing the Conversation on Vaping
As the title—“Balancing Consideration of the Risks and Benefits of E-Cigarettes”—suggests, the authors were particularly concerned about the public’s misunderstanding of the products’ relative risks.
“Of respondents to a 2019 national survey, nearly half considered vaping nicotine just as harmful as or more harmful than cigarette smoking,” they wrote. “Only one in eight considered vaping less harmful. (The rest responded, ‘I don’t know.’) By contrast, the U.S. National Academies of Sciences, Engineering and Medicine and the British Royal College of Physicians have concluded that vaping is likely far less hazardous than smoking cigarettes.”
In the U.S., youth vaping prevention programs have done their work too well. In recent years, the tone of coverage of vaping, in academic journals and news media, has gone from a mix of curious, skeptical and optimistic to a presumption of acute danger. A 2018 content analysis of 2015 news coverage of e-cigarettes, published in Nicotine & Tobacco Research (the SRNT’s journal), noted that “quoted physicians, researchers and government representatives were more likely to refer to e-cigarette risks than benefits” in the run-up to U.S. Food and Drug Administration regulation.
They presciently cited concerns about harm from this increasingly negative media coverage: “While the news media is an important vehicle for informing the public about the potential risks of these new products, it has also been argued that news stories that focus only on risks without contextualizing their risks relative to cigarettes or discussing their harm reduction benefits may contribute to misperceptions about the risks of these products.”
“Contextualizing the risks”—in other words, framing the issue affects the terms of the debate. For example, we’ve seen the framing of flavored vapes shift as public opinion on vaping soured. The initial focus on eliminating child-attracting names, imagery and packaging (sugary breakfast cereals, cartoons, baby bottle shapes) morphed into suspicion of fruit flavors in general and then to all nontobacco flavors. This gradual shift masks the absurdity of mandating that nicotine stay linked to the taste of cigarettes, when the goal is to wean people off them.
While no one who looks at the data would claim that vaping is safe or that nonsmokers should start, the 15 AJPH authors put our concerns into perspective. The melodramatic public service announcements implying that vaping will disfigure your face and send eel-like creatures to invade your brain or that it “can escalate teen mood swings” are as irrelevant as the much-mocked Partnership for a Drug-Free America’s series of “This is your brain on drugs” public service announcements from the 1980s featuring sizzling fried eggs.
Smokers Are Still Here
Smoking remains a massive and challenging public health problem. In the United States alone, nearly a half-million people will die this year from smoking-related illness. The headlines and health campaigns about smoking may be gone, but smoking is not.
In the AJPH authors’ eloquent phrasing, “To the more privileged members of society, today’s smokers may be nearly invisible. Indeed, many affluent, educated U.S. persons may believe the problem of smoking has been largely ‘solved.’ They do not smoke. Their friends and colleagues do not smoke. There is no smoking in their workplaces nor in the restaurants and bars they frequent. Yet one of every seven U.S. adults remains a smoker today.”
The stalled decline in adult smoking rates gets little attention in academic journals. One 2017 study (Zhu S et al. – “Smoking prevalence in Medicaid has been declining at a negligible rate.”) found that about a third of people on Medicaid (who must have incomes below a certain threshold and often deal with chronic physical or mental illnesses) are smokers; their quit rates were basically flat from 1997 to 2013.
As part of restoring balance between vaping’s youth risks and adult smoker benefits, the 15 AJPH authors bring up smoking as a social justice concern. For example, “African Americans suffer disproportionately from smoking-related deaths, a disparity that, a new clinical trial shows, vaping could reduce.”
Further, “Smoking accounts for a significant proportion of the large life expectancy difference between affluent and poorer Americans. For smokers with serious psychological distress, two-thirds of their 15-year loss of life expectancy compared with nonsmokers without serious psychological distress may be attributable to their smoking. Vaping might assist more of these smokers to quit.”
I shared the AJPH article and related material with someone whose business is specially designed e-cigarettes for incarcerated persons, replacing various types of dangerous contraband combustible tobacco. Watching the short video that accompanies the article, produced by the University of Michigan School of Public Health and featuring study co-author Kenneth Warner, made her staff literally stand up and cheer.
The 15 researchers’ conclusions bode well for helping those who are addicted to combustible tobacco and who will not or cannot yet quit. Vaping provides a reduced harm pathway for providing the nicotine that smokers’ brains crave without most of the extremely dangerous combusted byproducts of tobacco. The contents and existence of this landmark article are a reason to celebrate—not for us but for the smokers whose lives may be saved.
Why is it important that these authors are past presidents of the Society for Research on Nicotine and Tobacco? Because this is not an organization known for friendly relations with the nicotine product industry. But they looked at the data and are moving on.
The New Merchants of Doubt
An interesting commentary accompanied that American Journal of Public Health consensus statement by 15 respected experts. In it, Martin Dockrell and John N. Newton worry that the drumbeat of concern about vaping’s risk “leads to cognitive bias” that makes us discount evidence of benefits. For this mindset, they use an interesting and potentially stinging turn of phrase: “Public health risks stealing the [tobacco] industry’s clothes, becoming the new merchants of doubt.” This references the famous 2010 book Merchants of Doubt: How a Handful of Scientists Obscured the Truth on Issues from Tobacco Smoke to Global Warming.^*
Dockrell and Newton are not the first to label e-cigarette critics as merchants of doubt (just as I’m far from the only person to call moral panic on youth vaping). But it’s quite another thing to sling that history-laden insult in the editorial pages of the venerable American Journal of Public Health.
Merchants of Doubt tells the story of how the tobacco industry pioneered the creation of controversy and uncertainty in the face of general scientific consensus. “How could the industry possibly defend itself when the vast majority of independent experts agreed that tobacco was harmful and their own documents showed that they knew this?” asked authors Naomi Oreskes and Erik M. Conway. “The answer was to continue to market doubt.”
This approach of creating controversy and marketing doubt was copied by other industries, including to deny global warming. They describe the industry’s “key insight: that you could use normal scientific uncertainty to undermine the status of actual scientific knowledge. As in jujitsu, you could use science against itself.”
For example, longitudinal studies may well uncover yet-unknown health risks of vaping for certain types of products or use patterns or people with certain genetic makeups. Because vaping is new and the technologies are still evolving, it will take decades to collect the kinds of evidence we have now about smoking. The new merchants of doubt take advantage of that to play up the inevitable uncertainty about risks, blowing smoke to obscure the fact that today, the “vast majority of independent experts” agree that vaping is a far less dangerous alternative.
For decades, the hero’s narrative was public health against Big Tobacco, charging ahead, the good guys beating back lies from the bad guys promoting disease and death. Now, 15 Society for Research on Nicotine and Tobacco past presidents invite us to look up from the haze of that long battle and consider how positions have altered. Some public health advocates may now be engaged in the wrong fight. Or worse, we may be fighting on the wrong side. —C.K.O.
*Oreskes N, Conway EM. Merchants of Doubt: How a Handful of Scientists Obscured the Truth on Issues from Tobacco Smoke to Global Warming, Bloomsbury Press, 2010.
Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors. She spent 15 years on the faculty of Harvard Medical School.

October 1, 2021
The Credibility Gap

Photo: ia_64
What tobacco industry scientists wish they could say to physicians and public health researchers about their work
Cheryl K. Olson
“I was an ardent antismoker who believed that the tobacco industry was a bunch of evil scientists just working out how they could addict children,” said Justine Shaw Jackson, who is also known as Justine Williamson. Her grandfather, a smoker, died of COPD; her father’s smoking was likely linked to his heart attack and cancer.
She simply didn’t believe anything that tobacco industry scientists said. “I thought they wanted to make their products even more harmful,” she added.
So, how did she end up working for Big Tobacco?
Scientists employed by most industries face predictable concerns about the independence and credibility of their work and even whether they’re “real” scientists. After all, we have a pretty good idea what the Egg Board will be recommending we eat for breakfast. This problem is particularly acute for scientists who work in the tobacco industry.
Despite their detailed and sophisticated knowledge about harm reduction for smokers, they’re sometimes excluded from professional interactions with nonindustry researchers in which that expertise would be of benefit. The history of Big Tobacco from decades ago has stripped them of their credibility.
Current employees of tobacco companies are constrained by a combination of government regulations and corporate nondisclosure rules. I spoke with several scientists who had recently left positions at tobacco companies about what they wished they could say to physicians and public health researchers about the work they’d been doing. Some agreed to speak on the record; others agreed to provide background information.
Twenty years ago, Jackson was finishing her doctorate in genetic technology at Swansea University. British American Tobacco was funding a project in a professor’s laboratory. She met some of their scientists. “These guys were working incredibly hard on understanding what in smoke was causing problems and on reducing the harm of tobacco products,” she added.
Across the pond in the U.S., Willie McKinney, a toxicologist, had a similar start to his career at Philip Morris USA. He had finished his doctorate in toxicology at the University of North Carolina, met with industry scientists and was impressed with their honest assessment of tobacco’s health effects.
“They told me that they were out of alignment with society and that their products cause harm,” he said. “That alignment with society means modifying products to be less harmful or selling products that do not cause harm. They can’t make money if they’re shut down. So for 20 years, that was my focus: testing and evaluating potentially reduced-risk products.”
They both became experts in harm reduction for smokers. Yet because of their association with Big Tobacco, they were frustrated that public health practitioners, medical professionals and government policymakers left researchers like them out of the conversation when it came to helping smokers stay healthier or quit smoking.
Both recently left industry positions. Jackson is now an executive coach; McKinney formed his own consulting company. (Full disclosure: I’ve worked and written articles with McKinney.)
One of the concerns I heard from them and others was being unable to respond to the rampant misinformation on the relative risks of nicotine products, especially when that misinformation comes from well-intended government sources or nonprofit organizations. Like epidemiologists facing anti-vax propaganda, industry scientists watch in frustration as facts lose ground to uninformed beliefs and outright lies—information that could interfere with smokers quitting combustible cigarettes.
I asked them to imagine a long plane flight. Their seatmate, whom they had never met before, is a public health researcher. Upon discovering that they work in the tobacco industry, the public health person starts peppering them with questions. If they could have spoken freely, how would they have responded?
Why can’t you just stop selling cigarettes? That would solve the problem!
Unfortunately, it wouldn’t. In an ideal world, there would be no cigarettes. There would be no nicotine. But the world we inhabit includes 1.14 billion smokers.
This number may startle the seatmate, who probably doesn’t know many current smokers. Smoking is not evenly distributed among the population nowadays. In North America, it’s relatively rare among the highly educated and well-to-do, for example. It’s banned in most workplaces. Anti-smoking ad campaigns have waned. But the deaths continue—nearly 8 million a year. Yet many smokers cannot or will not quit, even with all the available information on how smoking kills. That’s an incredible challenge that won’t respond to simplistic solutions.
“We know from past experience with prohibition of alcohol and opioids that simply banning something doesn’t work,” noted Jackson.
In fact, one of the predictable consequences of prohibiting the sale of combustible cigarettes at the commissaries of state and federal prisons has been the growth of a resilient black market. That’s a reflection of how powerful the addiction to nicotine is.
But combustible cigarettes, the most dangerous of nicotine products, are not the only option for people who are addicted. There’s growing evidence that e-cigarettes work better than nicotine gums or patches at helping people quit smoking.
But isn’t vaping just as bad?
Public service campaigns in the U.S. that are meant to keep youth from vaping have stoked fears. National surveys show that more and more people incorrectly view vaping as equal in harm to smoking. Reports of potential benefits get scant attention.
It’s another example of a moral panic—a widespread and irrational feeling of fear that’s not supported by scientific data. (A moral panic in the 1920s was that motion pictures about gangsters would turn millions of innocent teenagers into hoodlums. We now refer to those films as “classics.”)
By contrast, health authorities in Europe, such as Public Health England, the Royal College of Physicians and Cancer Research U.K. are taking a different approach than their North American counterparts. They’re educating adult smokers about the relative risks of smoking versus vaping and encouraging them to switch, ideally as a first step toward quitting nicotine altogether. Their experts say that e-cigarettes are about 95 percent less harmful than combustible cigarettes and doubt that vaping leads youth to take up smoking.
But what about the flavors?
Some e-cigarette flavors, unfortunately, are attractive to teens. That’s a legitimate concern. We need to have a combination of effective youth vaping prevention programs, buyer age verification protocols, responsible marketing and nicotine addiction treatment programs for those who get hooked.
But this concern about flavors seems inappropriately focused on vaping. My local grocery store sells stacks of mango-flavored and watermelon-flavored White Claw fizzy alcohol drinks with no visible protest. Yet these types of “alcopops” are highly attractive to underage drinkers and have been linked to dangerously high blood alcohol concentrations.
Also, banning flavored vapes may do more harm than good when it comes to public health. Grown-ups prefer flavors too. “Evidence shows that flavors are incredibly important for adult smokers to use e-cigarettes to switch with,” Jackson added. “So how do you responsibly market those flavors with age-appropriate adult names? In the U.K. and in Europe, we worry whether the levels of nicotine in these products are high enough for smokers to be able to switch satisfactorily.”
In other words, adequate nicotine levels may be a critical variable in getting addicted smokers to switch to reduced-harm vaping.
Can’t we just get rid of the nicotine?
Not only does the proverbial “man on the street” wrongly point to nicotine as the health danger in smoking; new studies show that most physicians “strongly agree” (also incorrectly) that nicotine directly contributes to cancer and heart disease.
“Yes, nicotine does have addictive properties; that’s beyond question,” said Jackson. “But it’s all the other stuff. There are 10,000 components in cigarette smoke, and a chunk of them contain the carcinogens and toxicants that do the damage.”
That’s where harm reduction comes in. If nicotine is not the health danger, how can you improve the health of addicted smokers who don’t (or don’t yet) want to quit? We now have a variety of delivery systems, such as e-cigarettes, heat-not-burn products, pouches and snus that can give smokers the nicotine their brains crave “without all the nasties in the smoke,” as Jackson put it. Ideally, they’ll use those reduced-harm products as a bridge to quitting tobacco and then nicotine completely.
How can you work for Big Tobacco?
“I was hired to focus on harm reduction because the people at the company knew that their product caused harm,” said McKinney.
Today’s industry scientists work under different assumptions than past generations and toward different goals. We know and can openly say that smoking is addictive, dangerous and deadly. From inside, we can work to save lives without being dependent on the vagaries of grant support.
The flight is coming to an end. The seatbelt light is on. Your seatmate has one final question.
What can we agree on?
The development of Covid-19 vaccines has shown what can happen when industry, academia and government work together on solving a critical public health problem. The ongoing threat and lives lost from smoking is similar to that of the pandemic. Imagine what could be achieved with that same level of cooperation and transparency.
Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors. She spent 15 years on the faculty of Harvard Medical School.

September 1, 2021
Filling the Gaps
Photo: fizkes
The FDA gifted you a PMTA deficiency letter … what’s your strategy?
By Willie McKinney and Cheryl K. Olson
“I read it. And I thought it was over.”
Anne* held the letter she’d just pulled from the brown and white UPS Express envelope marked U.S. Food and Drug Administration. She recalled last September’s frantic scramble to submit a premarket tobacco product application (PMTA) to keep her specialty vape product on the market. Her little team did the best they could to meet the deadline; she knew there were gaps.
Now the FDA’s review of her product had reached a new milestone, marked by the small all-caps header at the top of the letter: DEFICIENCY. “Additional information is needed for FDA to make a determination,” it said.
She stared, speechless, at the 25 pages of highly technical questions—what was HPHC? Puff topography? Abuse liability?—that she had 90 days to answer.
Hundreds of companies, big and small, submitted PMTAs to comply with a court-ordered Sept. 9, 2020, deadline and to keep their novel tobacco products on the market. At a June 11 virtual meeting with the FDA’s Center for Tobacco Products (CTP) Office of Science, we learned that PMTAs for 6.5 million products from over 500 companies have been processed, with more awaiting attention. Given this crush, there are many people waiting and worrying, with the future of their businesses at stake.
This article will help you get your bearings in this confusing review process. We’ll explain how to read and interpret a deficiency letter and how to develop a response strategy. Also, you don’t have to wait for that letter; there are things you could do now to prepare.

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So what is a deficiency letter?
Let’s step back and review what happens after you submit your PMTA. First comes an acceptance review, typically a low administrative bar to clear. Does the product fall under the CTP jurisdiction? Is your application in English? Does it contain an Environmental Assessment? If it’s all yes, you’ll get an acceptance letter.
Then comes filing. This involves a preliminary scientific review that ensures the application contains all the items under section 910(b)1 of the Family Smoking Prevention Tobacco Control Act. If it does, you’ll get a filing letter. Your application will move into phase three: substantive review. A team of specialists evaluates the scientific information and data in your application. If there are gaps or questions, the FDA can ask for more information to help them make a marketing authorization decision. That request comes in the form of a deficiency letter.
Not everyone gets one. But at the June 11 meeting, Office of Science director Matt Holman said the FDA has issued “many” deficiency letters.

Should I feel happy or panicked?
If you, like Anne, have a deficiency letter in hand, the answer is both. You should feel excited because you’re well on your way; the FDA has given your application a pretty through review. You should feel nervous because you have 90 days to respond. You’ve got to get cracking!
How you feel will also depend on what they’re asking you. If, whether by strategy or necessity, your application was light on data, you may get 25 or 30 technical questions. FDA staff need all of that information to finish their evaluation of your application. If you don’t supply it, their decision is easy.
Many companies were brand new to this regulatory process and invested just enough in their PMTAs to pass the first two phases of review. If that was your strategy, it may not have been a bad one.
Some people in the tobacco products industry felt the FDA did not want any of these products on the market. They believed the PMTA process was designed for failure. If that’s your fear, and you have a lump sum you’ve made sitting in the bank … do you spend it on expensive tests and studies for an unknown process with an agency that may not like you? Or do you just dip a toe in and see what the response is?
One client we know said, “I’m not in this for the money. I was a smoker.” The vape product he developed changed his life and the lives of friends and neighbors in his town. So he concluded the PMTA was worth the investment on principle despite the uncertain return.
But as Anne found, when you get that deficiency letter, there’s no way you can respond on your own. This is a communication from a team of FDA experts, saying what they need from a scientific perspective. You have to decide whether to invest in your own team of experts to address these questions or to say, “I had a good run,” pack up and be done.
The key point is that you will have 90 days to respond. The FDA has made it clear that during this crunch time, they will send only one deficiency letter. Ninety days is not a lot of time, especially if the letter is requesting additional data—that means new studies and tests.
Can you get an extension? Maybe. It’s at the FDA’s discretion whether to grant one. It is likely that your odds get better if you can give a rationale for the extension by explaining in detail the work you’re doing to fill those gaps.

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What’s the best way to answer questions raised in my deficiency letter?
Both what you say and how you say it are important. First, your narrative. A PMTA is an opportunity to explain to the FDA why having your product on the market is appropriate for the protection of public health (APPH); it’s essentially storytelling supported by data.
Don’t just contact a lab, get pages of numbers and toss them at the FDA, saying, “We include the data you requested.” You need to understand what data you need, what it shows and how it supports your APPH story. For example, highly variable product data could suggest that you don’t have control of your manufacturing process.
Second, set the right tone. As the CEO at a company one of us worked for told the FDA, “We may disagree. However, we will not be disagreeable.” That helped build rapport.
FDA staff deserve respect for their expertise and dedication. But they are human too. They may make a statement about your product that is wrong (especially given the plethora of PMTAs received). Respectfully making them aware of their error is perfectly acceptable.
Do I have to wait for my letter, or can I respond proactively?
Prepare in advance and avoid a panicked sprint against that 90-day clock. You may already have a pretty good idea of where your PMTA was lacking. You can check FDA guidance documents for more clues (see “Perception and Intention Studies,” Tobacco Reporter, February 2021, and “Gold Nuggets,” Tobacco Reporter, March 2021). Make sure you’ve done enough to address sensitive issues, such as flavors, youth access, acceptability of ingredients and the ability to switch smokers to your product. Get expert feedback to identify gaps; give priority to filling the ones that take time to address. Then, when your letter comes, the workload will be manageable. And you can get some sleep.
However, there are no guarantees. This is not a check-the-box exercise. The FDA has made it clear that getting authorized depends on both the information in your original PMTA and your response to questions. If you’ve made a solid data-based case that your product is APPH, the agency will probably come to that conclusion too. If you don’t give them what they need to evaluate, they can’t.
As of this writing, everyone is still somewhere in the process; FDA had not issued any marketing authorizations for PMTAs submitted in September 2020. But if you haven’t heard about acceptance of your application soon after you read this (by mid-July to late July), reach out to the CTP for an update.
*A pseudonym
Common PMTA Gaps Raised in Deficiency Letters
As consultants, we’re seeing some patterns in the letters our clients receive. Here’s what your PMTA may be missing:
Behavioral science: Perception and intention studies and actual use studies. Confused about what the FDA wanted, many companies submitted marketing research data, information on their product category (e.g., consumer perceptions of vaping instead of views on their vape) or just skipped these parts.
HPHC (analytical chemistry): A common oversight was testing liquids for toxicants but not testing the aerosol.
Limited toxicology review: Either not enough tests or not good enough explanations to show that it’s OK to inhale the ingredients (e.g., there are no carcinogens, or they’re at very low levels).
Proof of action: Many PMTAs we’ve read talk about great stuff people do to make their product and to keep it out of the hands of youth. But it’s all talk. They provide no certificates of analysis or data to support what they say. You need details and “teeth.” For example, how and when will you monitor youth purchase attempts? And what are the penalties for failure?
Willie McKinney is the founder of McKinney Regulatory Science Advisors. He’s held senior regulatory roles at major tobacco product companies and served for three years as the industry representative on the FDA’s Tobacco Products Scientific Advisory Committee.

Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors. She spent 15 years on the faculty of Harvard Medical School.
July 1, 2021
“Grandfathered” Attitudes

Their legacy endures…
New to the tobacco product industry? There are some things you need to know about past industry behavior that affect how U.S. regulators treat you.
By Cheryl K. Olson
I was finishing my doctoral studies at the Harvard School of Public Health when this headline hit the newsstands: “Tobacco Chiefs Say Cigarettes Aren’t Addictive.” It was April 15, 1994.
The New York Times opened its coverage with, “The top executives of the seven largest American tobacco companies testified in Congress today that they did not believe that cigarettes were addictive but that they would rather their own children did not smoke.” My professors shared studies showing that children could recognize Joe Camel (a then-ubiquitous cartoon cigarette spokesperson) as easily as Mickey Mouse.
I shared this memory with a colleague of mine, who joined Big Tobacco as a newly minted Ph.D. in 1998, hoping to make a difference with modified-risk products. That year, the Master Settlement Agreement was upending decades of freewheeling industry practices.
“Companies had been saying things like, ‘No one knows the mechanism for how cigarettes cause disease,’” he recalled. “And we still don’t know the mechanism. But that’s not the point. The point is cigarettes cause disease. With a relative risk of 15, they are the cause!” He described the tension created by his company “transitioning to, and being honest and open with, that truth.”
If you’ve dealt with the Food and Drug Administration’s Center for Tobacco Products, you’ve seen the term “grandfathered.” Tobacco products marketed as of Feb. 15, 2007, are “grandfathered,” or not affected by new rules, and don’t need authorization to stay on store shelves.
My colleagues in public health, medicine and science who are middle-aged or older might be said to have “grandfathered attitudes” about companies that sell nicotine products. These attitudes were shaped by years of exposure to industry bad behavior, recalled from advertising, news coverage and academic articles. Whether you’re coming to the tobacco industry fresh from university, transferring in from another field or starting a company meant to disrupt and transform how people consume nicotine … congratulations. To the eyes of public health, you wear the modern face of that old villain, Big Tobacco. The history of industry misbehavior is now your history too. When people hear you speak or see your products, marketing materials or research, they’ll assess everything in the context of that history.
Based on two decades working with evolving tobacco technologies and regulations, toxicologist Willie McKinney shared this advice: “If you’re going to disrupt tobacco, because of all the baggage, you’ve got to know the history. Because it’s still nicotine. And still addictive.”
Here are some examples of how yesterday’s misbehavior affects you today.

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Misuse of research and statistics
Past misuse of the trappings of science colors how industry research is perceived today.
The 1954 advertisement “A Frank Statement to Cigarette Smokers,” signed by the heads of 14 companies and associations, is a landmark of the industry’s disingenuous promises and misuse of science. Claims include “Distinguished authorities point out that medical research of recent years indicates many possible causes of lung cancer” and “We believe the products we make are not injurious to health. We always have and always will cooperate closely with those whose task it is to safeguard the public health.”
In his 2020 TEDx Mid-Atlantic talk, “The Past, Present and Future of Nicotine Addiction,” Center for Tobacco Products Director Mitch Zeller includes the famous 1930s advertisement showing a physician with a white coat and whiter teeth smiling at a pack of Lucky Strikes. The ad reads: “20,679* Physicians say ‘Luckies are less irritating’” and “Your Throat Protection against irritation against cough.” The asterisk points to a statement assuring that “the figures quoted have been checked and certified to” by an auditing firm.
This misuse of the trappings of science colors how industry research is perceived today. McKinney served for three years as the industry representative on the FDA’s Tobacco Products Scientific Advisory Committee (TPSAC). He recalled with frustration that when FDA staff presented data to the TPSAC, “They would have a little asterisk by any references or papers that were published by the tobacco industry. That’s why I gave a talk once called ‘Life Without the Asterisk.’ Because FDA always seemed to have to call out, ‘this is a paper published by them.’”

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‘Safer’ cigarettes that weren’t
Be sensitive to the history of products touted by the industry as technical advances in safety or pathways to quitting. Zeller’s talk mentioned two such safety snafus. In the 1950s, the innovative Kent Micronite filter turned out to be lined with asbestos. In the 1960s and 1970s, the “light” cigarette was a bust.
In the transcript of the January 2018 IQOS TPSAC meeting, member Gary Giovino shared his personal experience with this: “I’m 35 years past cigarettes … but I relapsed a couple of times because I thought light cigarettes were safer, and we know now that that’s not true.”
As it turned out, tar and nicotine levels were indeed lower when a machine “smoked” the cigarette but not when a human blocked the ventilation holes with his lips and fingers. From the industry’s perspective, the machine numbers were meant for comparative analyses, but their use in advertising was perceived as deliberately deceptive.
As the Center for Tobacco Product’s website states, “FDA’s traditional ‘safe and effective’ standard for evaluating medical products does not apply to tobacco …. There is no known safe tobacco product.”
Denial or trivializing of addiction
Oh, that indelible front-page image of tobacco company executives, right hands in the air, being sworn in before Congress: seemingly swearing that cigarettes aren’t addictive! Industry testimony in the 1980s and 1990s tried to muddy the waters by mentioning addictions to coffee, television, tanning and (my weakness) chocolate. In 2005, some major companies’ websites were still waffling, saying smoking is addictive “as commonly understood today” but not “in the same sense as heroin [or] cocaine.”
Denial of marketing to youth
A tobacco industry youth smoking prevention campaign two decades ago
In the 1960s, U.S. companies adopted voluntary codes to keep cigarettes away from minors nearly identical to some used today: No models who look younger than 25. No celebrity testimonials with youth appeal. No samples to persons under 21.
Purported anti-smoking ad campaigns (Lorillard’s “Tobacco is whacko if you’re a teen!”) were colorful, creative and attractive. Researchers poring over millions of pages of industry documents made available through litigation (see tobaccoarchives.com) found ample evidence of industry targeting the historical age of starting smoking. For example, one 1989 internal market research report stressed the strategic importance of young replacement smokers, noting that only one in three smokers started after age 18.
Menthol/marketing to minorities
Industry documents showed that menthol cigarettes were perceived (and marketed) as healthier. They appealed especially to Black Americans and inexperienced young smokers. This helps explain the sensitivity to claims about flavors.
The Responsive Chord
Picture a public health researcher at an FDA meeting. He’s listening to an industry scientist present data on the addictive potential of her company’s product. But to him, what she’s communicating goes beyond her words or the images on her slides. When her message strikes his existing mental storehouse of tobacco industry science and lore, it creates in his mind what media theorist and advertising guru Tony Schwartz¹ called a “responsive chord”—sensory impressions that provoke a predictable emotional response. The meaning of the communication is not found in what the speaker conveys; rather, the meaning is created when her listener combines her message with his existing emotions and knowledge.
To avoid triggering negative stereotypes and suspicions, be mindful of the history above when presenting to regulators. Stick with the science and the data. Don’t refer to products as “safe” or “safer.” Avoid phrases like “we believe that …” which echo those deceptive “frank statements.” Rather than pledging to market responsibly to adult consumers, provide details of how you will verify age of purchasers and monitor and respond to any underage sales.
Be especially mindful of reactions by reviewers from outside the FDA, such as TPSAC members. Center for Tobacco Products staff often rotate in from jobs as chemists, project managers or lawyers at other centers at the FDA and (as one put it to me) “don’t really have a horse in the race.” Rather, their loyalty is to their profession. Outside reviewers are more likely to have spent their careers in tobacco control and to have more “responsive chords” when it comes to tobacco science.

1 Schwartz T. The Responsive Chord. How Media Manipulate You: What You Buy, Who You Vote For, And How You Think (2nd Ed.) Coral Gables, FL: Mango Publishing, 2017. (First edition published by Anchor Press/Doubleday, 1973.)
Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors. She spent 15 years on the faculty of Harvard Medical School.

May 1, 2021
Gold Nuggets

Photo: Stokkete | Dreamstime.com
Gaining insights from the FDA’s final PMTA rule
By Willie McKinney and Cheryl K. Olson
On Jan. 19, the U.S. Food and Drug Administration finalized a “foundational rule” about the “minimum requirements for the content, format and review of premarket tobacco product applications (PMTAs).” Within days, before many of us had a chance to download the 516-page document, let alone read it, the rule disappeared. The link says, “page not found.”
Don’t worry. This is part of a normal review by the incoming Biden administration of recent rules from the old regime. Given that little FDA staff turnover is expected, their thinking, and the rule, will probably stay the same. The document will be back, nicely formatted.
What to do while we wait for the final-final rule to appear on the FDA’s site? Well, the bulk of the document addresses “about 1,000 comments” (!) the FDA received on the proposed rule issued in 2019, including many questions from industry folks confused about PMTAs.
Understanding the subtleties and subtext of the FDA’s responses to comments can dramatically increase your chances of getting a marketing granted order. Ignoring them can lead to a significant waste of time and money.
Let’s wade into the FDA’s responses and see what gold nuggets of insight we can pan. What fuzzy areas affecting your strategy are now clear? What costly studies or paperwork might be trimmed or skipped?

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A PMTA is not a box-ticking exercise
We can begin with how the FDA thinks and what that means for PMTA strategy. Remember, interacting with tobacco product makers and sellers is still relatively new for the FDA’s staff and consultants. As they read comments, held conversations and began reviewing the recent flood of PMTAs, they realized that companies couldn’t figure out what the FDA was asking for. We know this because the PMTA rule lays out, much more clearly than in previous documents, what the FDA needs from companies. There are details on required content and format. The rule contains dozens of “musts”—must list, must include, must state and so on.
The FDA also says what can happen if you don’t meet minimal requirements: Do this, and we won’t accept or file. Or: This will slow the review process. Think of it as a series of red lights (“FDA will refuse to accept a PMTA … where it lacks constituent testing information required by § 1114.7(i)(1)(v)”) and yellow lights (“FDA may refuse to accept or file an incomplete application for review”). All of this is welcome clarity.
That doesn’t mean, as we’ve heard it described, that having a PMTA accepted and filed is a check-the-box exercise. Parts of a PMTA are like that, but the substantive review of data definitely is not.
Many of the comments to the FDA hint at frustration. “Why can’t they just tell me what studies to do so I can market my product?” The short answer is that a PMTA is partly a checklist of required information, but it’s also a narrative. You’re telling a story about why your product is appropriate for the protection of public health (APPH), illustrated by data. An effective PMTA is driven by story—explaining why your product on balance is likely to benefit public health—and merely organized by the PMTA format.
If you try to follow the rule document like a cookbook recipe—add a cup of pharmacokinetics (PK) studies and a tablespoon of label comprehension, and it’s baked—you will likely fail. That’s because the rule is descriptive but not prescriptive; it doesn’t tell you how to deliver. Why? First, because each product is different, with its own particular characteristics and target customers and therefore a distinctive set of potential public health benefits and risks that need to be demonstrated or mitigated. Second, a how-to list would tie the FDA’s hands as they make and rethink decisions about what is APPH. In Response 105, the agency notes that “Due to the nature of the Federal rulemaking process … FDA may not be able to update such standards in a timely manner.”

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Expect APPH to evolve
APPH is about relative health risks; it’s about “net benefit to the health of the population as a whole.” A definition like that, based on comparing ever-evolving tobacco products, will create a moving target. See FDA’s Response 123: “Because market conditions will change over time, what might be APPH at one point in time may no longer be APPH in the future.”
A static approach for granting marketing orders means the FDA couldn’t keep riskier products off the market, “thus undermining its core statutory mandate to reduce the harm caused by tobacco product use.” Basically, if you can show that your novel tobacco product is less risky than today’s cigarettes, that’s great. But as more tobacco users move to reduced-risk products, both the comparators and the risk equation will change. And if your tobacco product has, say, slightly more of a potentially harmful chemical than others in its category, adding your product to (or keeping it among) consumers’ options is not reducing harm.
Save with bridging, bundling and master files
Another reason the FDA “declines to require that an applicant conduct a list of new studies as part of every application” (Response 59) is that shortcuts are allowed. Applicants can also “provide scientific data to inform FDA’s review” through bridging. Rather than generating all new data on your product, you can sometimes leverage the research literature to show your product is APPH. Just a little new data connects you to more.
Suppose you show from chemistry that your product releases nicotine in the same way and has the same nicotine concentration as another product already tested in published literature. That may let you bridge to their PK and abuse liability studies, saving you hundreds of thousands or even millions of dollars. In Response 62, the FDA “declines to define” bridging but instead gives useful examples of how to do it.
Another cost-saving and time-saving shortcut is bundling or combining applications. Let’s say that you have four flavors or two nicotine strengths. The FDA sees them as separate products. But the FDA allows you to submit one PMTA for all of them. A bundled PMTA includes “a single, combined cover letter and table of contents across all products” (Response 19).
You still need to provide unique information about each product, but you can collect and present it more efficiently. For example, you might conduct and present one bundled perception and intention survey that asks noncustomers about perceptions of the labeling of each of your four flavors in turn. But be aware that the FDA will break up your bundle for review, so list in tables which parts of the PMTA apply to which products.
Bundling isn’t always best. Are your harm reduction story and target audiences the same across products? A high nicotine vape may appeal to a heavily addicted smoker, but it has different health implications than a lower nicotine sister product. Combining the two into one PMTA might muddy your case for APPH status.
A third PMTA shortcut to know about is called a tobacco product master file (TPMF). A master file contains information you can reference again and again for multiple applications. In Response 17, the FDA defines a TPMF as “contain[ing] trade secret and/or confidential commercial information about a tobacco product or component that the owner [e.g., manufacturer, ingredient supplier] does not want to share with other persons” but is willing to share with the FDA. That’s useful if your new tobacco product uses an e-liquid made by a manufacturer who doesn’t want to share their formulation but who will give you a letter of authorization to cite their master file in your PMTA.
There are other TPMF options. “When companies want to rely on the same pool of data, FDA encourages the use of shared resources, such as tobacco product master files, where appropriate” (Response 18). This might be the fruits of a thorough literature review on a particular topic. Rather than cite and submit 150 articles over and over, you can reference the master file.
More information is not always better
PMTA applicants now need to provide “only high-level marketing plan information” (Response 30) rather than detailed consumer research. The FDA’s main concern is youth exposure. It emphasizes descriptions of intended audiences and how they’ll be targeted. Note, however, that if you have already done consumer research, “the results of such research will be required” to go to the FDA.
As Comment 14 notes, “the tobacco industry has a history of marketing its products to … vulnerable populations,” which may include low-income communities, racial/ethnic minority group members, rural residents and youth, among others. Your PMTA story should include how your product might improve (or not worsen) the well-being of some of these vulnerable populations. Harm and benefit to subgroups that are more likely to start, less likely to stop and/or more likely to get sick from using tobacco products “are an important part” of the FDA’s APPH calculations. Groups of interest “will vary depending on type of tobacco product and may change over time.”
However, the FDA does not clearly state that conducting research with some of these subgroups is unethical or unsafe. This includes people under the age of 21 and women “who are pregnant or trying to become pregnant.” (The document mentions the need for special attention to vulnerable populations, including children and incarcerated persons, when discussing FDA plans to issue future regulations concerning use of Institutional Review Boards for tobacco product clinical studies.)
In Response 79, the FDA allows for “studies using individuals under the minimum age of sale” with extra protections and parental consent but “does not require it [or] anticipate that it will be necessary.” Don’t go there. Instead, over-sample young adults in your studies as a proxy for youth. Report, for example, whether intentions to use your product were different for people under age 25 compared to the rest.

Cheryl K. Olson is a California-based public health researcher and consultant who specializes in behavioral health issues. She spent 15 years on the faculty of Harvard Medical School.

Willie McKinney is the founder of McKinney Regulatory Science Advisors. He’s held senior regulatory roles at major tobacco product companies and served for three years as the industry representative on the FDA’s Tobacco Products Scientific Advisory Committee.

March 1, 2021
Perception and Intention Studies
Photo: Darya Petrenko | Dreamstime.com
The most confusing part of an FDA application explained
By Cheryl K. Olson
In October 2020, the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products issued draft guidance sharing “current thinking” about “principles for designing and conducting tobacco product perception and intention studies.” As a researcher, I raise a glass in celebration. Unlike toxicology, behavioral science is fuzzy and subject to interpretation. We need signposts to follow.
The guidance applies to premarket tobacco product applications (PMTA), modified-risk tobacco product (MRTP) applications and substantial equivalence reports. If you understand why and how to do tobacco product perception and intention (TPPI) research, your application is more likely to be approved. Let’s stroll through the guidance, highlighting key points and noting ways to put the FDA’s suggestions into action.
Why TPPI?
Behavioral research is one type of evidence the FDA uses to decide if a new tobacco product is “appropriate for the protection of public health.” As the guidance notes, perceptions refers to “beliefs, attitudes, judgments and expectancies” about a tobacco product. In other words, how do you—a tobacco user or nonuser—understand what the label says, what the risks are or who this product is meant for?
Why do we ask about intentions? As the guidance says, “intentions to use tobacco products may help predict future tobacco use behavior,” especially near-future actions. The FDA wants to know whether smokers will switch to your smokeless, electronic nicotine-delivery system (ENDS) or heat-not-burn product (a good thing) and whether nonsmokers or former smokers will take it up (a bad thing). But it’s seldom practical or affordable to follow people around to watch what they do or to survey them repeatedly.
So, we fall back on measuring behavioral intentions as the next best thing. We compare smokers intending to quit—now or within the next six months—to smokers with no plans to quit. We measure whether smokers’ quit intentions change after reading about your product and seeing pictures of your packaging or advertising.

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TPPI study aims: your essential roadmap
“[The] FDA recommends that you develop TPPI study aims (the overall goals of the study) prior to conducting the study.” This step is not a nice-to-have; it’s essential. Defining the aims of your study and turning them into answerable research questions creates a roadmap for everything you do. Just as important, study aims tell you what not to pay attention to. If you skip this step, you’ll end up wading through confusing piles of data, perhaps shoveling it all into your application and hoping the FDA can make sense of it.
As you write your survey questions, figure out your sample quotas and review your data tables, you will periodically get lost in the details and need a touchpoint. Referring to your study aims will reorient you and keep you moving in the right direction.
Here’s another way to look at study aims. What product story do you want to tell the FDA? There are some research questions all PMTAs need to address, such as perceptions of risk (more on that later). Others will be specific to your product and your story.
Perhaps your smokeless product appeals more to a particular group, such as female or lower income smokers, than competing products do; your story includes addressing the needs of that underserved group of smokers. Or your high-nicotine vape product is “appropriate for the protection of public health” in part because it attracts heavily nicotine-dependent smokers who, to use FDA-speak, perceive it as an acceptable substitute for cigarettes. If your less-toxic tobacco product appeals to smokers not intending to quit—who are discouraged or unmotivated—that’s a further public health win. If your product and its various flavors do not appeal disproportionately to youth or you have a solid method of restricting youth access, say so.
From market research or conversations with customers, you might have a good idea of your story. But to tell that story to the FDA, you must design research questions and collect data to support it.

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Study types (qualitative or quantitative) and methods
Are you telling your story with words or numbers? When you don’t know a lot about perceptions and intentions (say, a new product or target population), start with focus groups or individual interviews. But qualitative doesn’t equal free-form; a structured set of questions, an unbiased interviewer and an analysis plan are a must if the FDA is going to take you seriously.
Some research questions might be answered with experimental studies. For example, you could test effects of new labeling by seeing how subjects randomly assigned to view that labeling answer questions about product perceptions differently than a control group. Another option is an observational study: for example, watching a subject follow directions to operate or charge a new vaping device without prompting from researchers.
Often, your behavioral research aims can be met entirely through cross-sectional quantitative studies: one-time surveys of people who’ve used your product and people who haven’t.
You can get some of the benefits of a qualitative study by adding open-ended questions to your multiple-choice survey. Let’s say you’re surveying users of Vape A. You ask, “Why did you choose to try Vape A? (Select all that apply).” You then invite those who clicked on “To help me quit smoking cigarettes” to “Please tell us more about your experience using Vape A to cut down or quit.” This offers two benefits: It helps you better understand how people use Vape A. And, when paired with solid numbers, user quotes help make your case to FDA reviewers that Vape A deserves a spot on that continuum of risk.
Study measures
Your best bet is to adapt questions from research published in academic journals, especially studies by authors who work for the FDA or other government health agencies. Next best are validated measures from the industry—for example, Philip Morris International has tested questions on addiction and health risk perceptions. Note that your questions need to “be written or adapted in a manner that specifically refers to the product (by name) that is the subject of the study.”
Perception questions should include risks to health and risk of addiction asked in several ways: the absolute risk of using your product; the relative risk as compared to other products in the category as well as cigarettes, nicotine-replacement therapies and no tobacco use; and the effects of dual use (health risks of sticking with smoking, partly substituting your product or switching completely). A good question will be direct, specific and unambiguous: Ask about perceived personal risk of specific types of serious illnesses or earlier death from using Vape A not generically about harm to health.
Behavior intention questions include intent to buy, try, use or stop use of your product. Detailed questions, such as intent to partially or completely replace cigarettes with Vape A, are best left to surveys of Vape A users; it’s too much guesswork for people new to the product. (The guidance doesn’t cover “actual use” studies, but don’t forget to ask your customers about monthly and daily use, reasons for use and use situations.)

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Participant sampling and recruitment
Now that you know what to ask … who do you ask, and where do you find them?
For the who part, you need a sampling plan and eligibility criteria. You want to show that Vape A appeals to intended users (smokers or users of other tobacco products) and not to unintended users (nontobacco users and former users, especially youth). Your sampling plan might call for equal numbers of smokers intending to quit, smokers not intending to quit, never-smokers and former smokers—making sure to include a disproportionate number of young adults and a minimum number of people with vaping experience.
Eligibility criteria can be tricky; check the published research. For example, a “never-smoker” is often defined as someone who has smoked fewer than 100 cigarettes in their lifetime!
As to the where … the FDA is open to a variety of modes of data collection (e.g., online, phone, in person) and subject recruitment methods (such as online panels and random-digit dialing). All methods will introduce some bias; online panels may have fewer low-literacy participants, for example. Have a scientific justification for the approach you choose. And phrase your screening questions carefully, so online panel members who just want the dollars can’t guess the “right” answers to join.
Common TPPI mistakes

Not documenting your research methods (e.g., survey response rates, how you recruited)
Biased recruiting; for example, if you offer product coupons as an incentive to fill out your survey, people who don’t like your product won’t respond, and your study sample won’t be representative of the larger population. Use neutral incentives (like a choice of retailer gift cards).
Not enough people in your study—this might be a too-small total sample size or not enough members of important subgroups to detect between-group differences (e.g., women versus men).
Unclear questions or incomplete response options: Prevent confusion by pre-testing your survey with individuals from your target groups (including less-educated folks).
Generic questions—the FDA doesn’t want general perceptions of vapes or snus. They need to draw conclusions about your product, including any flavor or strength options.
Not protecting privacy of research subjects—document your “adequate procedures for human subjects protection;” that is, their “rights, safety and welfare.”
Treating TPPI studies like market research—the FDA asks that companies “select appropriate study personnel for TPPI studies … who have sufficient formal education, training and experience in conducting social or behavioral science research to ensure the study is designed or conducted appropriately.” Translation: We want to hear from academics like us who speak our lingo.
Cheryl K. Olson is a California-based public health researcher and consultant who specializes in behavioral health issues. She spent 15 years on the faculty of Harvard Medical School.
February 1, 2021