Update: I subsequently published a detailed rebuttal of the claim that nicotine vaping is implicated in these lung injuries: The outbreak of lung injuries often known as “EVALI” was nothing to do with nicotine vaping, Qeios, July 2021.
The Food and Drug Administration of the United States has requested information on “Vaping Products Associated With Lung Injuries” – see Regulation.gov and Docket FDA-2020-N-0597 to make a submission or read the views of others.
In my view, the sly attribution of this problem to e-cigarettes and nicotine e-liquids by activists, academics and supposed public health agencies has been as bad as the worst ‘merchants of doubt’ operations of Big Tobacco in the 1970s. I have labelled it a mere “fiasco” only out of politeness because the word implies that only incompetence and negligence lay behind it. But I think it was much more deliberate than that – and we know that because virtually nothing has been done to correct misperceptions that were created and spread across the US and worldwide from July to December 2019.
I don’t wish to indulge this propaganda operation by providing straight-up evidence to the FDA on this. Pretty well everything that needs to be known is already known about the cause and consequences. What is missing is a truthful account of the response. So instead, I would like to take the opportunity to speak truthfully and directly about what was done here. So here is my brief response to FDA’s call for information.
I would like to contribute four observations to this request for information.
1. The problem under investigation arises from THC products outside the FDA’s jurisdiction
The lung injury problem has nothing to do with nicotine-based e-cigarettes or vaping products. It arose from the adulteration of THC vaping products with a thickener – Vitamin E acetate – added to illicit THC oil-based products by negligent and unregulated criminal operators. It is not possible to add this substance to nicotine e-liquids and there is no reason to add a thickener or unconventional diluent to nicotine e-liquids. Because it is impossible and serves no purpose, it has never been done and the problem does not exist in the nicotine e-liquid market. This also explains why the problem is almost unknown outside the United States and has not been seen in the 10 years of the routine operation of the worldwide nicotine e-liquid market. Congress has granted FDA jurisdiction over tobacco products, which it defines to include nicotine liquids. The problem products are not tobacco products. Congress has not, however, legalized cannabis-derived products and therefore FDA does not have a role.
2. Residual doubt and focus on the supply chain
Anti-vaping activists, academics and agencies have been trying, with ever more desperate arguments and tenuous evidence, to maintain doubt about the attribution of the lung injury problem to conventional nicotine vaping. FDA’s investigation inappropriately aids those efforts. A basic focus on the supply chain that manufactured and supplied these adulterated products should have ended all doubt in the latter part of 2019. To the extent there was residual doubt it came from two sources: (1) misattribution of exposure – some people are understandably reluctant to acknowledge their use of THC vapes because of criminal, employment, educational, or parental consequences and claim to be using nicotine only; (2) the actual lung condition is vaguely defined and may be misdiagnosed or attributable to something else (and should be handled in the normal way adverse events are reported).
3. Consequences of agency actions
Overall, the “EVALI” episode has been a fiasco for US public health agencies including both FDA and CDC and many of their equivalents at the state level and internationally, The cause was implicitly and explicitly misattributed by various US authorities to nicotine vaping products when, by August 2019, the cause was clearly attributable to adulterated THC products. The procedures that would normally be used in an outbreak of an illness (e.g. a food-poisoning episode) were not adopted in this case. These procedures would focus on identifying causes within a supply chain. It was clear in August 2019 that the problem was specific to the illicit THC supply chain. That being the case there was a vanishingly small chance that a similar problem with similar risks would emerge at exactly the same time and in the same geography in the nicotine supply chain. This was clear in August 2019, but both FDA and, especially CDC, persisted with labelling “EVALI” as a nicotine liquid problem long after it was clear it was not connected with the legal, regulated nicotine market. This had two deleterious effects: (1) to frighten people about vaping (potentially causing harm by reducing switching from smoking to vaping and potentially causing vapers to relapse, based on unfounded fears); (2) a failure to give a clear warning about the clear and present danger of illicit THC vapes on sale in 2019 (potentially causing more people to use dangerous THC vaping products). To many observers, including me, the panic generated around EVALI (itself a term with a built-in deception) has the appearance of an information ‘black ops’ exercise in the federal government’s war against vaping and tobacco harm reduction, drawing on whatever expedient arguments they could get away with, no matter how dishonest.
4. Review of agency actions
Instead of seeking information on vaping products associated with lung injuries, which are now well understood, the FDA should be re-examining the conduct of the federal government from July 2019 to January 2020 and how well it served the public in the United States and beyond. For example:
- Has it finally and definitively identified the cause and did this take too long? Or is it continuing to sustain doubt?
- Did the agencies involved approach the problem efficiently and correctly or did they nurture doubt instead of eliminating it?
- Was its advice unduly vague and ambiguous given what was known or could have been?
- Were officials trying to use lung injuries to advance an anti-vaping anti-nicotine agenda?
- Were operations or research funds wasted and misapplied due to mischaracterization of the problem as a nicotine vaping issue?
- What harms were caused by misattributing the problem to nicotine and who is accountable?
Regulation.gov tracking number and link: 1k4-9g3u-a4e7
This episode was a public health disgrace. However the anti-vaping activists are repeating the same misinformation campaign with vaping and COVID-19.
It is now part of the ruthlessly deceitful playbook of tobacco control. The symmetry with 1970s Big Tobacco is striking.
Understating the harms of smoking to encourage people to keep smoking has the same ethics and consequences as overstating the harms of low-risk alternatives to smoking to discourage vaping.
US is repeating now for vaping nicotine what happened repeatedly during War on Drugs. Then and now doubt is being deliberately sown by authorities regarding effective harm reduction strategies. Vaping is potentially an extraordinary opportunity for major public health advances. But by exaggerating risks and ignoring huge potential benefits, US is missing out on opportunity to reduce 450,000 smoking related deaths per year in US. The 2019 epidemic of lung injury in US did not affect dozens of other countries other countries where vaping nicotine had been increasing for up to a decade and was most severe in US states where cannabis prohibition was enforced.
Submission provided as a consumer. Thanks for leading the way Clive.
The “EVALI” episode went further beyond the USA. In Latin America health authorities at all government levels and NGO’s repeated a risk communication that can be summarized as “smoking will kill you in 20 years and vaping in 2 months”. The CDC deliberate miscommunication has provided the “technical” justification. On February 25 importation of all vaping (and HnB) gear and parts was banned by a presidential decree in Mexico. Similar bans and harsh measures took place in the whole region in the second half of 2019 and early 2020. The fact that all these very similar actions took place in roughly simultaneous timing, in so many countries, points out to a well funded and professionally coordinated effort sanctioned at the highest level of the WHO and paid by Bloomberg Philanthropies.
The way the CDC handled the “EVALI” episode is really a text book example of severe malpractice of public health (bordering on criminality), originating in the USA but with global resonance. Millions of smokers have been mislead into believing that vaping would kill them fast, and thus will continue smoking. Hopefully, one day it will be possible those responsible for this criminal fiasco to justice.
This was already a talking point in the European Parliament and of course has formed part of both versions of WHO’s completely misleading vaping Q&A.
And once the damage is done, it is impossible to undo. Another great analysis, Clive, thank you
I think the point is that the activists and agencies involved don’t want to undo the damage of misinformation about the lung injuries episode.
The damage is the point.
I don’t think I have heard a single word from CDC or FDA attempting to put risk perceptions back on track with reality. No media have returned to re-evaluate their earlier coverage. No academic has retracted, corrected or clarified a single paper. No legislator has withdrawn draconian measures introduced with “EVALI” as a pretext. No activist has popped up to say that their Bloomberg funded propaganda was inappropriate – because it wasn’t: it served its paid-for purpose.
This is how we know they are insincere and why the EVALI scare was deliberately and cynically used against nicotine vaping. If it had been an innocent error, much more would have been done (by which I mean more than nothing) to reset public understanding.
Research last year by the Wellcome Trust found that only 59% of Americans trusted government health advice a ‘lot’ – or even ‘some’! Perhaps the FDA and CDC should be looking at the causes of that catastrophic decline in trust (a mirror should help) and how repeatedly crying wolf on such things as nicotine issues has impacted the ability to save lives from COVID-19.
The CDC still hasn’t publicly announced what they did. I think they are inept! So, what about this pandemic? How much disinformation is coming out about it? What are they really doing to stop the spread, get everyone tested? Are they playing solitaire when they should be looking for a solution? I was so upset with the CDC when all that was happening! Upset is a very mild word for how I felt. I think they ahould all be replaced with real professionals who want to help people, not kill them with lies by omission!
The FDA is certainly not without fault concerning EVALI, or the freakin’ Surgeon General!
Thank you for your assessment of this issue. I have been researching for the past several months the reports which were released by the CDC and FDA about EVALI. (Both organizations fall under the purview of US Health and Human Services, headed by Alex Azar).
I, too, have serious concerns about the scientific reasoning demonstrated by the CDC regarding the outbreaks of severe respiratory illness. In particular, I am alarmed that it seems the CDC accepted without further evaluation the premise that the mysterious illnesses were caused by vaping. That conclusion, that vaping caused the illnesses, was based on the observation of doctors in Wisconsin of 5 cases of the respiratory illness in previously healthy teens. All cases from that point on had a requirement a patient history of vaping. By collecting data in this way, they would have excluded any evidence that the illness could be from a source besides vaping.
I have not found evidence that a novel virus was ever considered by the CDC as a cause of the EVALI cases. Furthermore, having learned that SARS-cov-2 was originally a less contagious virus prior to the emergence of a G-variant strain, I am suspicious that the EVALI cases- which were responsible for at least 200 hospitalizations a day in the US last September- may in fact have been early signals of the novel coronavirus.
It would be incredibly helpful to me to have more input on this question.
I am still seeing Canadian medical organizations claiming that nicotine vaping can cause sudden severe lung injury. The scale of the damage done is enormous. The CDC was either stupid, ignorant, or corrupted, perhaps by funding from Bloomberg.
John… my critique of these ridiculous EVALI claims may be worth sharing.
For the full discussion: The outbreak of lung injuries often known as “EVALI” was nothing to do with nicotine vaping, Qeios, July 2021. The abstract is below.
The CDC and FDA should set things straight with the United States citizens as well as the rest of the world. What they did was wrong in so many levels. They should be held accountable for misleading the world. It makes one wonder what else they are lying about. What is the truth about COVID, really?