FDA Briefs U.S. Supreme Court on the Nicotine Brain Fallacy

Responding to a petition from the FDA, the Supreme Court agreed to review the Fifth Circuit Court of Appeals decision in the Triton case (formally known as Wages & White Lion Investments, LLC).  The Circuit Court, sitting en banc, had found that the FDA failed to follow proper administrative procedures in considering Triton’s vaping pre-market tobacco application (PMTA), and the agency’s denial order was vacated.

Appealing that decision, the FDA filed a brief to the Supreme Court, available here.  I will not comment on the myriad legal and regulatory implications of the case, but in their “scientific” discussion, lawyers for the FDA made numerous false statements about nicotine and e-cigarettes, such as:

“Nicotine is a highly addictive drug that can harm the developing adolescent brain.  Studies have found that e-cigarette use may be associated with diseases such as asthma, chronic bronchitis, emphysema, and chronic obstructive pulmonary disease.  And e-cigarette users may progress to conventional tobacco products, which can endanger human health even more.” (emphasis added, legal references removed)

I have repeatedly warned the tobacco harm reduction (THR) community that the NIH-funded bad-science tsunami would result in federal and state regulations aimed at stifling safer cigarette substitutes (here, here and here).  Now we have a concrete example.

Over the years, I have exposed distorted and false research findings concerning e-cigarette use and respiratory conditions (here, here and here), so today I will focus on the nicotine brain fallacy, which I first discussed four years ago (here):

“Let me be crystal clear.  The harm in brain development federal officials talk non-stop about only happens in laboratory torture of mice.  Mouse studies are well known to be of questionable value in predicting human effects.  There is absolutely no scientific evidence to support the claim that nicotine causes harm to human brain development, so it is astounding that federal officials traffic in this false narrative.  This nonsense is an affront to 34 million adult current smokers and 55 million former smokers in the U.S., virtually all of whom started when they were teenagers.  There is no evidence that their brain development was harmed.”

The facts remain the same today, and still the unfounded attacks on THR continue. For example, the Journal of the American Medical Association (JAMA) recently published a viewpoint authored by tobacco prohibitionists Robert Jackler and Pamela Ling (here).  Criticizing Medscape for creating continuing medical education courses on THR, they also attacked my design of the course content, complaining that my “expert opinion” conflicts with the CDC’s claim that “nicotine can harm brain development…until about age 25.”  They cited a review that purportedly contains “a sizable body of human data,” but that treatise actually offers no evidence of harm to brain development in human smokers.  The fact is that no study has ever demonstrated that human brain development is harmed by nicotine. 

It is a travesty that bad science and fraudulent claims against THR have persisted for so long. No court, including the Supreme Court, is likely to end the onslaught of misinformation that remains the hallmark of the powerful, government-funded tobacco prohibition movement.

 

 

Lessons to be Learned About Menthol from Lung Cancer Mortality Rates

 

For years we have seen a battle over the banning of menthol cigarettes.  On one side are prohibitionists, who believe that society’s ills can be cured by proscribing specific behaviors and products.  Opposing a ban are libertarians and those civil rights advocates who fear that prohibition would promote illegal sales and consumption, particularly in the African-American community. 

I have commented several times on who smokes menthols (here, here, here and here); this column was precipitated by a March 22 New York Times article by Sheila Kaplan, “Menthol Cigarettes Kill Many Black People.”

The best way to look at smoking-related deaths is to examine lung cancer mortality rates (LCMRs), expressed as deaths per 100,000 people per year.  The CDC Wonder website provides tools for investigating deaths for the period 1968-2022, including age-standardized rates, so that researchers can compare all of these years, which had different population distributions.

The chart shows LCMRs for Black and White men and women in the U.S.  Keep in mind that these mortality rates are latent with respect to smoking, stemming from smoking rates 20 years earlier.  For example, when LCMRs peaked for both Black and White men around 1990, that reflected high smoking rates from around 1970.

The most striking finding here is that while the LCMR for Black men was similar to that of White men in 1968, the rate for the former skyrocketed, peaking in 1989-90 at 367.  However, after that, the rate plummeted every year except one.  If menthol was the cause of smoking among Black men, then it didn’t persist.  By 2022, the LCMR among Black men was still higher than that among White men, but the gap was much narrower. 

It’s hard to specify menthol as a major factor, as the LCMR decline was just as impressive as the LCMR increase.  If, as prohibitionists claim, menthol is easier to start and harder to quit, we wouldn’t see this impressive reversal.

LCMRs were very similar among Black and White women until around 2000, after which rates among White women were somewhat higher.  

Also, note that LCMRs did not peak among women until over a decade after they peaked among men, and women experience much more of a plateau, from around 2000 to 2003.  And we still haven’t seen a sharp decline among women yet.

In 2012, FDA Center for Tobacco Products scientist Brian Rostron published a study finding “evidence of lower lung cancer mortality risk among menthol smokers compared with nonmenthol smokers at ages 50 and over in the U.S. population.” (here).  These results were in agreement with two previous studies (here and here).

FDA officials consistently portray a menthol ban as a corrective response to the tobacco industry’s presumptive targeting of African-Americans.  But, as I wrote previously, 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.