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.