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.

 

 

For Smokers Only: The E-Book With Bonus E-Cig Chapter

In 1994, I published the first professional medical articles documenting that smokeless tobacco contained satisfying doses of nicotine (in the Journal of the American Dental Association, here) and was vastly safer than smoking (in Nature, here), and I proposed “that smokeless tobacco be recommended as a cigarette substitute by persons who cannot stop smoking.” (in the American Journal of the Medical Sciences, here).

My scientific articles drew massive opposition.  The National Cancer Institute investigated my university, claiming that my strategy was unethical (documented in Jacob Sullum’s excellent book, For Your Own Good, available here) as other medical groups launched vicious attacks.  

One fact was beyond contradiction: Smokeless tobacco use was at least 98% safer than smoking.  While scientific evidence for tobacco harm reduction was overwhelming, smokers were completely uninformed about the lifesaving option of switching to a smoke-free delivery system.  This led me, in 1995, to address smokers directly with a book, “For Smokers Only: How Smokeless Tobacco Can Save Your Life.”

Recognizing the continuing relevance of this groundbreaking work, publisher Rick Newcombe of Sumner Books has just released it as an e-book, updated with a bonus chapter on e-cigarettes.  From exaggerated health scares to bogus gateway claims, opponents of e-cigarettes are using the same tactics they’ve used against other smokeless tobacco products for decades.   

Dr. Dean Edell, physician and host of an award-winning health radio program for 31 years (here), described For Smokers Only as “credible, logical and eminently do-able.”

The FDA Tobacco Product website offers as an example of “Health Fraud” (here) the suggestion “that a tobacco product is safer, less harmful, contains a reduced level or is free of a harmful substance, or presents a lower risk of tobacco-related disease compared to other tobacco products…To date, no tobacco products have met the requirements that would permit them (sic) to make claims of reduced risk or harm to users and nonusers of their regulated tobacco products.”

Applying that absurd definition, I have been conducting health fraud for 20 years.

Smokers, smokeless and e-cig users, get the help you deserve.  Download For Smokers Only from Amazon (here), Barnes and Noble (here) or ITunes (here).