Thursday, September 22, 2022

My Commentary on FDA Regulation That the American Journal of Public Health Invited, Rejected, and Then Maligned Me For


Earlier this year, the American Journal of Public Health’s editor-in-chief Alfredo Morabia invited me to comment on FDA tobacco regulation.  A month later, he rejected my commentary, then in July he published an editorial effectively, and falsely, labeling me a tobacco industry shill.  I reported the details of that experience in a Retraction Watch article.  Following is my rejected but still relevant article.

Commissioned Commentary: It’s Time for Federal Officials to Save Smokers’ Lives: Switch from Prohibition to Pragmatism

Inhaling the smoke of burning tobacco kills 480,000 Americans every year.  The United States government response – regardless of the political party in power – has been the obstinate pursuit for a quarter century of an idealistic and unattainable “world free of tobacco use” (  This mindset is now embodied in punitive FDA regulation of smoke-free nicotine and tobacco products, thereby ignoring the continuum of risk in the agency’s own comprehensive tobacco regulation plan ( ).

For all e-cigarette/vapor products, Congress requires manufacturers to submit pre-market tobacco applications (PMTAs) demonstrating that they are “appropriate for the protection of public health” (APPH).  The FDA has applied the APPH standard injudiciously.  It blamed vapor manufacturers exclusively for a so-called “teen vaping epidemic” and laser-targeted non-tobacco-flavor offerings, even though teen smoking plummeted during a 2017-19 vaping increase and during the sharp vaping decline two years later. (

Federal officials base their “epidemic” claim on the high usage numbers in the National Youth Tobacco Survey, but they ignore lower estimates from other credible federal sources ( ).  Regulators also ignore NYTS findings that a large majority of high school vapers, regardless of frequency, have vaped marijuana (   

Their data cherry-picking morphed into deliberate deception when e-cigarettes were wrongly implicated by the CDC in a 2019-20 lung injury outbreak that stemmed from contaminated marijuana vaping products, resulting in 2,800 hospitalizations and 68 deaths (1).On September 7, 2021, the FDA revealed how it applies the APPH standard: “…only the strongest types of evidence will be sufficiently reliable and robust —most likely product specific evidence from a randomized controlled trial (RCT) or longitudinal cohort study.” (2)  These studies take years and millions of dollars to perform, but the FDA disclosure came one year after the PMTA deadline for manufacturers.

When the FDA authorized a second group of tobacco-flavored vapor products on March 24, 2022 ( ), Commissioner Robert Califf commented: “As a cardiologist, I’ve personally seen the devastating health effects of tobacco use, so I’m highly motivated for the FDA to help reduce death and disability caused by these products.  We know that there is a demand among adult smokers to use e-cigarette products to try to switch from more harmful combusted cigarettes, but millions of youth are using these products and getting addicted to nicotine.”

Dr. Califf was mistaken.  The devastation, death and disability he saw was not from tobacco use, but from smoking.  Substituting the former for the latter is not accidental; it is intentional, unscientific and imprecise.  Califf acknowledged adult demand for vapor, but smokers don’t just “try to switch.”  A federal survey documented that 4 million adult vapers are former smokers ( ).  Also, millions of high schoolers aren’t “getting addicted.”  Only 467,000 – 3% of high school students – vaped 20+ days in 2021 (, putting them at risk for addiction.  While that number is unacceptable, it does not constitute an epidemic.

Federal officials’ obsession with the small percentage of youth who try or use smoke-free tobacco is out of proportion to far more serious high school behaviors, including using alcohol (30%) or marijuana (20%), binge drinking (14%), driving while texting/emailing (39%), carrying a weapon (16%), and considering suicide (17%) ( ).

The obsession is also inconsistent with the government’s official health objectives for the U.S. population (3).  Adolescent smoking and vaping rates (1.5% and 7.6%) are already lower than the 2030 targets (3.4% and 10.5%), while adult smoking (12.4%) is still far higher (5%), killing 480,000 Americans yearly.

The federal government should abandon its pursuit of nicotine/tobacco prohibition, and focus on FDA regulation of tobacco products proportionate to their risk.

Disclosure: Dr. Rodu’s research is supported by unrestricted grants from tobacco manufacturers to the University of Louisville and by the Kentucky Research Challenge Trust Fund.


1. Bates C. (2021). The outbreak of lung injuries often known as “EVALI” was nothing to do with nicotine vaping. Qeios

2. U.S. Food and Drug Administration. Sample Decision Summary: Technical Project Lead (TPL) Review of PMTAs. September 7, 2021.  (

3. U.S. Department of Health and Human Services, Office of Disease Prevention and Health Promotion.  Healthy People 2030.  Available at: .


Friday, September 16, 2022

Nicotine and the Iron Law of Prohibition


I just read an interesting piece in Filter about the Iron Law of Prohibition, a theory described by Richard Cowan in a 1986 National Review article.  Referring to banned substances, he wrote: “the more intense the law enforcement, the more potent the drugs will become.”  Cowan’s Law may very well apply to nicotine vaping products.

With millions of users around the world, e-cigarettes and vaping are here to stay.  The nicotine solutions in these products are satisfying in single puffs, and the vaping cartridges provide the equivalent of up to a few packs of cigarettes, depending on size.  They are not highly toxic when used as intended, but the liquid is dangerous if swallowed.  A tsunami of misinformation about vaping has prompted considerable discussion about the lethal dose of nicotine if swallowed.  The most common claims are based on old references and distorted facts.  For a review, please read the excellent summary by Bernd Mayer in Archives of Toxicology. 

The bulk of the chart at left, from the Filter article, shows the effects of prohibition on illegal drugs.  I’ve added nicotine to the chart, because legislation, regulation and litigation are pushing that addictive but otherwise mostly harmless drug towards prohibition.

It is possible that chemists might develop more potent nicotine analogues, but for now, the more likely path is more concentrated nicotine to make transport easier.  As restrictions tighten, pure liquid nicotine may fill the gap.

My research group used pure liquid nicotine as a control in 1994, when we were the first to publish nicotine levels in brand-name American smokeless tobacco products.  Pure nicotine is quite toxic, and at the time, there were strong warnings about inhalation, ingestion or skin contact.  One manufacturer’s material safety data sheet for 95% nicotine sends a clear warning: “Wear self-contained breathing apparatus, rubber boots, and heavy rubber gloves” for any spill.  “Use only in a chemical fume hood.”

Many readers might dismiss my cautionary words as not relevant for a drug that is now widely available in a fairly safe form, but look at the chart.  Prohibition creates illicit suppliers who must transport and deliver their products in more efficient ways.  If banned, nicotine may well invite the same unintended consequences seen with other banned drugs, including chaotic doses and contamination by dangerous fillers/additives, both of which can be toxic and/or fatal. 

Prohibition could morph today’s largely benign nicotine products into Frankenstein variants peddled by criminal elements. Consider what is happening with fentanyl, per the Cleveland Plain Dealer: “fentanyl…is 100 times stronger than morphine, and carfentanyl…is 100 times stronger than fentanyl. In addition, users have begun adding stimulants like cocaine and methamphetamines to the mix.”

This may be our nicotine future. Beware of unintended consequences.