US E-Cigarette Policy is Not Harm Reduction, it is Harm Transfer

By Kirsten Axelsen and Benson Hsu

Harm reduction is an intervention that reduces the chance of
death or poor health associated with adverse behavior when it is difficult to
stop that behavior entirely—for example, providing clean needles to people who
inject drugs or access to naloxone to reverse opioid overdose. While getting
people to stop would be ideal, addiction is hard to treat, so harm reduction makes
an incremental improvement in health.

As smoking is addictive and deadly, harm reduction through access to non-combustible tobacco (e.g. e-cigarettes) has been considered. But, smokeless nicotine still has risks. Furthermore, it is popular among younger people who aren’t smokers. The proportion of young people using tobacco has returned to nearly the same level it was 20 years ago, supported by retail and online marketing. Policy that allows broad access to e-cigarettes justified as harm reduction may benefit smokers, although e-cigarettes are not proven effective as smoking cessation aids.[1] But such policy increases the risk of harm to younger non-smokers—that is harm transfer, not harm reduction. There are enough health policies that disfavor youth; smokeless tobacco should not be another.

A sales clerk exhales vapor while smoking with a vaporizer during a wait for customers at the e-cigarette shop Henley Vaporium in New York, U.S. June 23, 2015. REUTERS/Lucas Jackson

Non-combustible nicotine delivery likely releases fewer chemicals, although there is broad variability in devices. Many who try to quit smoking with e-cigarettes return to cigarettes or use both.[2] Quitting smoking is hard, and many people who try to quit fail. E-cigarettes, if they really did help people quit and remain off cigarettes, could be harm reduction if smokers exclusively were targeted. But that is not the case: Promotions are seen by nearly everyone including young people.

The US Food and Drug Administration (FDA) authorizes
marketing of an e-cigarette considering the risk and benefit to public health. This
means the FDA evaluates the benefits for smokers from possibly switching
away from cigarettes relative to the potential harm to (mostly younger) non-smokers
who may start using. In essence, the FDA is asked to determine if the US is
better off on average from allowing broad access to a product with
risks. There is tremendous evidence about the harm from smoking and limited
information about the long-term risks of e-cigarettes. So, this calculus will
almost certainly favor the e-cigarette putting youth at risk.

It is a huge contradiction that the FDA also reminds consumers that e-cigarettes are not approved for smoking cessation. Furthermore, there are FDA-approved stop-smoking medicines that have been evaluated in several thousand-person, multi-country clinical trials.[3] Consider if the policy for marketing authorization were different, where an e-cigarette could only be marketed if the FDA determined that it provided a benefit to smokers and made non-smokers no worse off. That may include more careful dispensing. Sudafed is behind the counter with quantity limits; why wouldn’t there be more care in dispensing with millions of youth at risk?

The authorization of e-cigarettes comes on top of a legacy of other policies. In the COVID-19 pandemic, young people, less vulnerable to the infection, also bore the burden of the isolation to protect more at-risk people. We are seeing the fallout in mental health along with high use of tobacco products among youth and particularly those in mental distress.[4] While a pandemic is an extraordinary circumstance, other decision-making does not need to transfer harm to the young.

Imagine if prescription drug decisions were made like this. What if we stopped with just the evidence from the adult trials for the COVID vaccine? Moving forward with broad inoculation based on adult evidence would have created a lower viral load in the country, making the US better off on average . . . But that real-world experiment on youth would not be tolerated, and it shouldn’t be. Now with e-cigarettes, wouldn’t it make more sense to invest in other proven ways to help smokers quit rather than conducting this national experiment in harm reduction where children and young people are the ones most likely harmed?

Kirsten Axelsen is a consultant to biopharmaceutical and other life sciences companies including those developing and or marketing medicines for smoking cessation. She is also a visiting Scholar with the American Enterprise Institute.


[1] Wang RJ, Bhadriraju S, Glantz SA.
E-Cigarette Use and Adult Cigarette Smoking Cessation: A Meta-Analysis. Am J
Public Health. 2021 Feb;111(2):230-246. doi: 10.2105/AJPH.2020.305999. Epub
2020 Dec 22. PMID: 33351653; PMCID: PMC7811087.

[2] Pierce JP, Chen R, Kealey S, et al.
Incidence of Cigarette Smoking Relapse Among Individuals Who Switched to
e-Cigarettes or Other Tobacco Products. JAMA Netw Open. 2021;4(10):e2128810.
doi:10.1001/jamanetworkopen.2021.28810

[3] Anthenelli RM, Benowitz NL, West R, St
Aubin L, McRae T, Lawrence D, Ascher J, Russ C, Krishen A, Evins AE.
Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine
patch in smokers with and without psychiatric disorders (EAGLES): a
double-blind, randomised, placebo-controlled clinical trial. Lancet. 2016 Jun
18;387(10037):2507-20. doi: 10.1016/S0140-6736(16)30272-0. Epub 2016 Apr 22.
PMID: 27116918.

[4] Riehm
KE, Young AS, Feder KA, et al. Mental Health Problems and Initiation of
E-cigarette and Combustible Cigarette Use. Pediatrics. 2019;144(1):e20182935

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