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 (http://bit.ly/2IWTSWj ) 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.”