Washington Post Attack on E-Cigarettes Deserves Emergency Room Treatment

 

Dr. Leana Wen, an emergency physician and Washington Post columnist, attacked tobacco harm reduction in a Post column last week, “The New Nicotine Product Replacing e‑Cigarettes to Addict Teens” (paywalled).  It dealt mainly with Zyn nicotine pouches, but it touched on the gamut of safer cigarette substitutes. 

Matt Holman, Ph.D., Chief Scientific and Regulatory Strategy Officer at U.S. Philip Morris International, has responded (here) with an accurate point-by-point rebuttal of Dr. Wen’s numerous misstatements. 

I’d like to focus on one especially egregious statement in Wen’s article: “Mitch Zeller, former director of the FDA’s Center for Tobacco Products, explained that as much as 70 percent of people who vape continue to smoke. He showed me industry data from two years ago that showed 84 percent of adult pouch users kept up cigarette use.”

I was astonished that Zeller would cite 70 percent, when he can readily access updated information from the gold standard CDC National Health Interview Survey (NHIS). In this chart of the smoking status of 17.8 million vapers estimated from the 2024 NHIS, the highest percentage were former smokers, while only 26 percent were current smokers.

While dual use is a transition period for many smokers, dual use has another, more ominous driver: misinformation from federal agencies and major medical organizations.  For example, Matt Holman noted: “under the helm of Mr. Zeller, [the FDA Center for Tobacco Products] authorized more than 2,800 cigarette products to be marketed while only authorizing 30 novel smoke-free products (heated tobacco products, Swedish snus, and vapes). These actions resulting in 100 times more authorizations for combusted tobacco than novel smoke-free products are in direct opposition of CTP’s stated mission ‘To protect the public health of the U.S. population from tobacco-related death and disease...’”

Additionally, in 2018, CTP director Zeller launched the FDA Real Cost E-Cigarette Campaign, which is a misinformation circus.  It ostensibly targets kids, but I calculated – using the FDA’s formula – that this campaign also dissuaded hundreds of thousands of smokers from switching to safer vape products (here).

The Washington Post should run a major correction for Dr. Wen’s article.

There Never Was a Tobacco/Nicotine Addiction “Secret”

 

Mitch Zeller, former director of the FDA Center for Tobacco Products, provided valuable insights on the war against tobacco harm reduction in a May 19 presentation at the Johns Hopkins University Bloomberg School of Public Health.  His slide presentation is available here.

Zeller justifies tobacco regulation primarily on perceived industry misdeeds, which he illustrates with quotes from the 1960s, 70s and 80s from industry documents: “Tobacco products uniquely contain and deliver nicotine, a potent drug with a variety of physiological effects,” “Nicotine is addictive,” “Think of a puff of smoke as the vehicle of nicotine.”

Zeller implied that corporate executives knew but covered up critical nicotine facts, like nicotine was the active, addictive ingredient in tobacco.

Everybody knew about the nicotine addiction “secret.” 

Nicotine is one of the most thoroughly studied drugs in the history of medicine. A mere 80 years after Columbus discovered tobacco and the New World in 1492, crude nicotine was isolated and identified.  It was chemically purified in 1828, and its molecular formula was determined in 1843.  British scientists described the effects of nicotine on the nervous system as early as 1889.  From the 1930s to the 1950s, many medical authorities already considered tobacco use to be habit-forming or addictive. In 1936, tobacco use was described as “a form of drug addiction, even though a pleasant one, not affecting criminal statistics.”

In 1942, L. M. Johnston conducted some remarkable experiments where nicotine was successfully injected into smokers to satisfy their cigarette cravings.  Johnston reported these findings in the renowned British medical journal The Lancet, where he also discussed nicotine tolerance, craving and withdrawal symptoms, concluding: “Clearly the essence of tobacco smoking is the tobacco and not the smoking. Satisfaction can be obtained from chewing it, from snuff-taking, and from the administration of nicotine.”

By the 1950s, the topic of nicotine addiction had moved beyond medical journals to books for the general public.  The Habit of Tobacco Smoking (by W. Koskowski, Staples Press Ltd.) appeared in 1955, followed in 1959 by A. King's The Cigarette Habit: A Scientific Cure (Doubleday and Co.).

During the 1960s and 1970s, when, according to anti-tobacco zealots, suppression of tobacco industry research on nicotine peaked, nicotine was the subject of thousands of independent research articles. Medline, the National Library of Medicine's computerized data base, lists 1,000 such studies between 1966 and 1976. The number increased to 1,500 in the period from 1976 to 1984, and to nearly 4,000 during the next decade. Many of the 1970s and 1980s research reports provided scientific validation of what smokers had been saying for nearly a century:

It's hard to quit smoking.

 

 

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.”