Tuesday, December 19, 2023

Menthol Cigarettes & Race – FDA Fudges the Facts


After announcing its intention to ban menthol cigarettes two years ago, the FDA has finally submitted its final rule to the Office of Management and Budget for Executive review.  Meanwhile, the Washington Post is reporting that the ban will be delayed until sometime in 2024 due to “political concerns” around Black smokers’ preference for and access to this flavor. 

In 2018, I answered the question, “Who smokes menthol cigarettes?”, using the 2015 National Health Interview Survey (NHIS).  Although federal officials claim that menthol cigarettes pose an existential threat, they only collect information on the topic every few years in the NHIS, their main instrument for tracking smoking.  The numbers were updated in the 2022 survey.

In 2015, the NHIS reported there were 36.5 million U.S. smokers.  By 2022, that number was down to 28.8 million, an impressive decline of 21%.  Table 1 reflects menthol cigarette popularity.


Table 1. Number (millions) of Smokers in the U.S., According to Whether They Usually Smoke Menthol or Not, NHIS 2015 and 2022

Usually Smoke Menthol20152022Percent Change




There is no question that the decline in usual menthol smokers lagged behind that in non-menthol smokers.  The numbers don’t tell us how many started and stopped (or died trying), but they do indicate that the menthol cigarette market was not as fragile as that for non-menthol cigarettes.

When we look at the same data according to race in the next table, we see that the number of White women menthol smokers fell the most, followed by White men and Black women.  Unfortunately, the number for Black men stayed the same, and the number for other races increased from 0.8 to 1.2 million.


Table 2. Number (millions) of Menthol Smokers in the U.S., NHIS 2015 and 2022

Race/Gender20152022Percent Change

White women3.83.2-15.8
White men2.72.5-7.4
Black men1.81.80
Black women1.61.5-6.3



From this table we see that White women and men account for over half of menthol smokers (32% and 25% respectively), while Black men and women together account for only about a third (18% and 15% respectively).

Let’s see how lung cancer mortality rates (LCMR) and deaths from CDC data compare for the periods 2012-2016 and 2018-2021.  The rate is the number of deaths per 100,000 population per year (among persons 45+ years), so it’s the best way to compare different-sized groups.  The number of deaths per year is related to both the rate and the size of the group.

Table 3. Age-adjusted LCMR (per 100,000 persons per year) and number of deaths from lung cancer, 2012-2016 and 2018-2021


Race/GenderLCMRDeathsLCMRDeathsLCMR Percent Change
Black men1849,9161398,687-24
White men15174,22811864,983-22
White women10261,2478455,693-18
Black women937,032746,486-20


While Black men had the highest LCMR in both periods, this group saw the steepest decline.  Keep in mind that Black men don’t have the highest LCMRs because they smoke menthol; it is because they smoke more than White men and women, while the latter groups smoke more than Black women.  In other words, smoking KILLS, but menthol doesn't.

FDA officials consistently portray a menthol ban as a corrective response to the tobacco industry’s targeting of African-Americans, yet far more Whites smoke menthol. 

As for who has been “disproportionately impacted,” Black men have the highest LCMRs of all four groups, but Black women have the lowest, at almost half the rate of the former.  Comparing the two survey periods, LCMRs dropped around 20% for all four groups. Still, over 140,000 Americans die from lung cancer every year. 




Wednesday, December 13, 2023

Ohio State University Gets $20 Million FDA Grant to Trash Nicotine Pouches


Ten Ohio State University faculty members, led by Brittney Keller-Hamilton, published a study in the journal Addiction concluding that two strengths of Zyn nicotine pouches (3 and 6 milligrams) did not relieve “craving symptoms at 5 minutes as strongly as a cigarette.”  They also reported that “using 6-mg pouches was associated with greater plasma nicotine delivery at 30 minutes than 3-mg [pouches] or cigarettes…”

The OSU authors emphasized only one time point for assessing craving relief: five minutes after using the products.  They likely knew that cigarettes would win this contest, as no one expects a nicotine pouch to produce a blood-nicotine spike as quickly as inhaled smoke.  However, they also acknowledged that “no other differences in craving relief were observed through the 90 minutes of follow-up.”

Those familiar with nicotine absorption know that at 30 minutes, users of pouches or other smokeless tobacco products can be equally or more satisfied than those inhaling cigarettes.  The study’s nicotine levels show that in the figure below. 



Further, satisfaction with smokeless products may last longer than with cigarettes, so smokers who normally light up every hour might be able to use fewer nicotine pouches or dips of moist snuff.  That is an observation we made 30 years ago in our pilot study switching smokers from cigarettes to Skoal Bandits.

The OSU results regarding appeal were reasonable.  “Overall, participants reported moderate appeal (e.g. pleasantness, wanting to use, extent of liking and enjoyment) of the study [pouches]…Participants consistently reported both [pouches] as less appealing than their usual brand cigarette.”

OSU handcuffed Zyn with respect to enjoyment.  While the researchers instructed participants to smoke their “usual brand cigarette,” they assigned them only one flavor of Zyn (Wintergreen), even though nine other flavors are marketed (Spearmint, Cool Mint, Menthol, Peppermint, Chill, Smooth, Citrus, Coffee and Cinnamon).  The authors explain this as a typical clinical trial control, but in that case, they should not have judged the product based on subjective participant impressions.

For these reasons, their “less appealing” finding was predestined.  No substitute can perfectly replicate a cigarette’s nicotine/tobacco satisfaction.  However, the results demonstrate that Zyn pouches, while not perfect, were moderately appealing and moderately satisfying.  It’s too bad that the OSU group didn’t include other FDA-approved substitutes, such as nicotine patches, gum and lozenges. 

OSU’s press release grossly misstated the results, with the headline, “pouch products do little to curb addictive nicotine cravings,” causing media outlets to amplify the fabrication (here and here). 

The OSU press release also touts the center’s “newly funded $20 million Tobacco Center for Regulatory Science grant from the Food and Drug Administration and National Institutes of Health. The grant will enable scientists to conduct further research to inform oral nicotine pouch regulations and promote public health.”

Readers of this blog know the sort of research that $20 million will generate (here here, here and here). There is little here for inveterate smokers or tobacco harm reduction proponents to celebrate.



Tuesday, December 5, 2023

A Foundational Call to Action


Now is the time for all good men and women to come to the aid of the Foundation for a Smoke-Free World (FSFW).

The organization was founded in 2017 through a charitable gift from PMI Global Services.  Its mission is simple: “to end smoking in this generation.”  Its founders envision “a world in which combustible tobacco, other toxic forms of tobacco, and smoking-related death and disease are eliminated.”  Contrast that with the U.S. government’s vision of “a world free of tobacco use,” an incorrectly broader behavior blamed by the government for “cancer and suffering.”  

The FSFW not only has a firm grasp on the merits of tobacco harm reduction (THR); it also offers the only substantial funding (currently about $150 million) for legitimate, unbiased THR research. 

The Foundation recently named a new president and CEO, Clifford E. Douglas, whose anti-tobacco credentials are impressive.  He worked to eliminate smoking on airlines and college campuses, and he held high offices in the Coalition on Smoking and Health, the American Lung Association, and the American Cancer Society.  He most recently served as director of the University of Michigan Tobacco Research Network. 

As the FSFW board chair noted, “For decades Cliff Douglas has been a strong and influential voice in the work to eliminate smoking in America and globally.”  What is most remarkable is that Douglas differentiated and focused on the devastating toll of smoking, rather than the broader universe of tobacco use, the term used by prohibitionists to impugn all things tobacco- or nicotine-related.  In short, he came to recognize “emerging efforts around the world related to alternative nicotine products as a complement to traditional tobacco control measures.”

Since its creation, the FSFW has been dogged by claims that it is influenced by its founding sponsor, Philip Morris International.  Mr. Douglas has countered by terminating the receipt of PMI funds, pledging that the Foundation will no longer accept any support from the tobacco or non-medical nicotine industries.  “Any skepticism around our independence can be laid to rest,” he said.

Of course, prohibitionists never rest.  Deborah Arnott, CEO of UK Action on Smoking and Health, said, "Whether it's true or not, [Douglas] will be seen as pursuing PMI's agenda, not that of public health."  Yolonda Richardson, president of the Campaign for Tobacco Free Kids, termed Douglas’s claim “ludicrous”. 

What’s truly ludicrous is that prohibitionists, wearing the sheep’s clothing of “public health”, oppose all funding of THR, no matter its source.  Since 1999, the universities employing me have administered small grants from tobacco companies to conduct THR research.  While this work would not have been possible without such support, attacks from within and outside these institutions have been never-ending.  To quote Carl Sandburg, “If the law and the facts are against you, pound the table and yell like hell” -- about the funding.

I sincerely hope that THR researchers and supporters will stand with Mr. Douglas to make the Foundation a beacon of honesty and accomplishment in the world of public health.


Note: For the past year, I have served as an outside grant reviewer for the FSFW.