Friday, April 22, 2022

A Critique of Mitch Zeller’s Tenure at the FDA Center for Tobacco Products


Mitch Zeller, director of the FDA Center for Tobacco Products for the past nine years, is scheduled to retire this month.  The agency released an interview with Zeller on April 20, in which he “reflects on the time he spent helping to make tobacco-related disease and death part of America’s past…”

One focus of the interview was Zeller’s account of the center’s accomplishments under his direction.  He said, “I stand by having a long list of efforts and accomplishments,” noting the following:

  • “It starts with continuing to stand up the Center.  When I started as Director of CTP, it had its doors open for a little over three years, and we were 426 people. We’re now over 1,110.” 
  • “incredible ongoing work from a compliance enforcement standpoint through our state contracts.” 
  • “our remarkable public education efforts and accomplishments in the Office of Health Communication and Education.” 
  • “I saw us as a Center work hard for many, many years on the nicotine reduction product standard.” 
  • “we are using the product standard authority to prohibit menthol in cigarettes, and all characterizing flavors, including menthol, in cigars.” 
  • “We’ve done an incredible job in the face of receiving applications for 6.7 million products under that court ordered deadline…We’ve taken action on just over 99 percent of those applications but of the approximately fifty thousand that remain, there are important decisions that still need to be made…the challenge will be in getting through those remaining applications as quickly as possible.”

I don’t doubt the increase in CTP staff or the agency’s compliance enforcement efforts, however, its public education efforts were far short of “remarkable.”  They were, in fact, abysmal, as reflected in the fact that numerous studies demonstrate that Americans are horribly misinformed about nicotine health risks.  For example, a 2018 study, using federal survey data, reported that over half of American adults incorrectly believed that nicotine causes cancer.  The study was conducted by Pinney Associates, which provides consulting services on tobacco harm reduction to tobacco manufacturers.  (Prior to joining the FDA in 2013, Zeller was employed by Pinney, which at that time had no tobacco clients.) 

In 2020, I noted in the American Journal of Public Health, “The [second] largest FDA Center for Tobacco Products budget item ($159.5 million, or 22%) supports public education campaigns and communications to ‘reduce tobacco use’ and tell ‘target audiences’ about the ‘harms of tobacco product use.’ (here)  In this category, ‘The Real Cost’ Youth E-Cigarette Prevention Campaign ( ) shows e-cigarettes invading adolescent bodies as worms and a magician converting e-cigarettes into combustible cigarettes. The FDA has acknowledged, apparently without concern, that the campaign convinces adult smokers that e-cigarettes are equally or more harmful than cigarettes, thus suppressing quitting.”  In 2018, I called American smokers’ misperception of e-cigarettes’ relative harm a nation disgrace (here).

During Zeller’s tenure, the FDA misinformation campaign consistently targeted smokeless tobacco, without substantiation, as I discussed previously (here, here and here). Zeller boasts of implementing a standard reducing nicotine in cigarettes to near zero, a flawed smoking cessation prescription that I first criticized 28 years ago (here and here).  He also touts the agency’s menthol and flavor bans (here), which are destined to fail (here).    

Zeller is effusive in his praise for his “incredible” CTP colleagues and their “dedication” and “commitment to the mission,” which is an apparent reference to “a world free of tobacco use” (here).  Zeller twice characterizes CTP staff as having “a never-say-die attitude,” which is ironic, given that during Zeller’s nine-year tenure, four million Americans died from smoking-caused illnesses.  The annual death toll in 2013 was 443,000; today it is 480,000. 

As Clive Bates recently noted: “It remains hard to identify a single thing FDA's Center for Tobacco Products has done that has a demonstrable public health benefit. The priority should be to reform this failing and bloated institution.”

Bates continued, “FDA needs to find a better way to embrace harm reduction and make that work for public health.  At present, FDA regulates nearly 3,000 cigarette brands that are pervasively available and uniquely harmful. But it is hard at work squeezing the life out of the vaping industry with ridiculously disproportionate regulatory burdens.  The problem is a lack of vision and a failure to grasp fundamentals about youth risk behaviours, flavors, and the way most of what it does has the effect, if not the intention, of protecting the incumbent cigarette trade from competition.”



Thursday, April 14, 2022

Prevalence Estimates of Sexual Orientation & Gender Identity From the 2021 National Youth Tobacco Survey

While analyzing the 2021 National Youth Tobacco Survey results, I discovered fascinating participant data that are not specific to tobacco use.  In particular, the survey poses these two questions on sexual orientation and gender identity:

Question 155: Which of the following best describes you?

  • Heterosexual (straight);
  • Gay or Lesbian;
  • Bisexual;
  • Not Sure.

Question 156: Some people describe themselves as transgender when their sex at birth does not match the way they think or feel about their gender. Are you transgender?

  • No, I am not transgender;
  • Yes, I am transgender;
  • I am not sure if I am transgender;
  • I do not know what this question is asking.

The 2021 NYTS may have been the first federal survey to simultaneously pose both of these questions to this population.  The responses enable researchers to estimate the national prevalence of gender identity according to sexual orientation, which to my knowledge hasn’t been accomplished before.   

There are some caveats to consider in reviewing the results.  First, 20,400 students age 9 to 19+ years old participated in the 2021 NYTS.  For all surveys like this, the CDC has developed a complex weighting system in order to generate estimates for the nation’s 28.7 million youth. I employ that weighting system here.

While 23 of 38 survey participants who were 9 or 10 years old were asked the above questions, those numbers were so small that I chose not to include their responses in my analysis.  Furthermore, because 11- and12-year-olds were almost twice as likely to respond that they did not know what the transgender question was asking, I evaluated only results for teens 13 years and older.  The final participant number for my analysis was 13,800, which represents 19.3 million nationally.

Prevalence (%)* of Sexual Orientation and Gender Identity of Participants 13+ Years in the 2021 National Youth Tobacco Survey
Gender Identity


NoYesUnsureDon’t KnowAll
Heterosexual (straight)74.9%0.3%0.3%1.9%77.4%
Gay or Lesbian2.
Not Sure5.


*Percentages may not add up due to rounding.

Extrapolating as noted above, of the 19.3 million teens, 3.4% (648,500) reported being gay or lesbian, and 11.4% (2.2 million) being bisexual. The combined total is slightly higher than that reported in an analysis of the 2019 Youth Risk Behavior Survey (here).  An additional 7.8% (1.5 million) of teens were unsure about their sexual orientation.  About 1.9% (368,000) of teens described themselves as transgender, a figure which is consistent with a CDC analysis of the 2017 YRBS (here).  The majority of teens identifying as transgender in the NYTS were gay/lesbian or bisexual.  Almost a half-million teens said they were unsure about their gender identity, and over 600,000 did not know what the question was asking.

It is my hope that this survey analysis will inform the discussion around teen sexual orientation and gender identity.




Wednesday, April 6, 2022

Why Do High Schoolers Vape? National Youth Tobacco Surveys Suggest Answers




Federal officials blame vape manufacturers and retailers for teen vaping, focusing in particular on the industry’s use of flavoring, but government surveys indicate the truth is more nuanced.

The government’s National Youth Tobacco Surveys (NYTS) routinely collect information on teenage e-cigarette use.  I examined survey data for the years when vaping accelerated (2018 and 2019), and when it declined (2020 and 2021).  In the first three years, the survey asked, “What are the reasons that you have used e-cigarettes?”  In 2021, the question changed to, “Why do you currently use e-cigarettes?”  Other survey modifications occurred, as noted in the Table footnotes.


High School Vapers: Percentage Reporting Why They Have Used [Currently Use*] E-cigarettes, NYTS 2018-2021


Used by friend30%*21%*37%27%
Used by family member

To quit other tobacco11984
Costs less than other tobacco6634
Easier to get than other tobacco6655
Used by people on TV, online, movies1432
Less harmful than other tobacco25181410
Use unnoticed8181714
Other reason30182519
Peer pressure---8------
Used to do tricks---232419
Use when anxious, stressed, depressed---------42
Nicotine buzz---------44
*Friend and family member combined
--  Reason not asked
Participants could choose multiple reasons


Let’s look at some of the bigger trends.  First, among reasons measured in all four years, “friends’ use” is consistently the most important, which jibes with the common observation that most teens obtain e-cigarettes from friends rather than retail stores.  “Other” reasons ranks second, followed by “flavors”, “less harmful”, and “use unnoticed at home or school”.  Note that the percentage of respondents mentioning flavors fell from 36% in 2018, to 13% in 2021, undercutting activist arguments to ban them.  The percentage mentioning less harmful also declined, from 25% to 10%, likely reflecting the success of the FDA’s grossly misleading “Real Cost” campaign that asserts that e-cigarettes are equally or more harmful than cigarettes.

Additional reasons for vaping, offered in NYTS after 2018, were also selected at high rates; these included “performing tricks” and “curiosity”.  In 2021, 42% of vapers said they vaped because they were anxious, stressed or depressed, and 44% were trying to get a nicotine buzz.

Also of note: “Quitting other products”, “costing less”, “easier to get”, and “celebrities” were not frequently cited as important reasons to vape. 

Why, one might ask, was there so much variation across the four years?  The answer may well lie with the inherent variability of self-reporting by teenage respondents.