The FDA forces Juul to pull the most successful anti-smoking product ever

The U.S. Food and Drug Administration is to force the popular Juul vaping products off the US market for spurious and unjustifiable reasons

The U.S. Food and Drug Administration, the regulator of consumer tobacco and nicotine products in the United States has today denied applications from Juul Labs Inc. for its vaping products. FDA will require the company to pull its products from the market. This is an absolutely terrible decision with no basis in ethics, public health, or good regulatory practice.

The key extracts from FDA’s announcement and my statement in response follow below.

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Twenty reasons to be sceptical about rules lowering nicotine levels in cigarettes – and what to do instead

Using regulation to remove nearly all the nicotine from cigarettes is similar in effect to a prohibition – with all that entails. That will trigger a wide range of responses by consumers and suppliers. These have barely been studied or understood.

What matters is how users respond to a rule, not what the rule and rule-makers intend. The graphic illustrates various response pathways to a reduced nicotine rule. These may be combined or evolve over time as producer and consumer behaviour adapts. These pathways are in competition with each other.

Updated: December 2021: I am revisiting this post with a new graphic (above). July 2022: reflecting the return of this rule to FDA’s regulatory agenda, updates on (4) public perception; (8) youth. August 2022: added a pro-VLN commentary.

What would be the biggest possible tobacco control measure? That would be a proposed rule lowering nicotine levels in cigarettes with a view to making “Very Low Nicotine Cigarettes” (VLNC) sub-addictive – thereby persuading adults to quit and adolescents to never start.  The trouble is that consumers, markets, producers, and criminal networks have a way of thwarting such bold ambitions.

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Will FDA harm health, destroy businesses, and protect the cigarette industry through regulatory overkill? A preview.

This blog gives my take on how to think about the FDA’s decisions (some taken, some forthcoming) on approving or denying thousands of “pre-market tobacco applications” (PMTAs) to allow vaping products to remain on the US market.  FDA must make decisions no later than 9th September 2021, following legal action brought against the agency. FDA’s Director of the Center for Tobacco Products, Mitchel Zeller, provides the background in a February 2021 blog.

There’s a lot to be written on this, but I will settle for 16 observations and questions that will shape my take on FDA’s announcements.

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US vaping lung injury outbreak was a public health fiasco or worse – comment to FDA

Public health actors are now routinely more manipulative than Big Tobacco ever was

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.

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Bizarre FDA vaping retail restrictions more likely to do harm than good

Caught in its auto-induced moral panic about the teen vaping epidemic, the FDA has decided that it would be better if certain vaping products were harder to get hold of than cigarettes, and the ones that were easiest to get hold of should be the ones most like cigarettes – tobacco and menthol flavour. This seems entirely mad to me and riddled with the potential for unintended consequences that would increase smoking in both adults and adolescents.

Needless to say, FDA has not acknowledged or assessed possible unintended consequences – yet these are likely to overwhelm any possible benefits.

So I decided to put in a comment on the measures on that theme. First, some background then my comment.
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The great American youth vaping epidemic. Really?

When senior officials claim that the is an epidemic of teenage vaping or nicotine addiction, what do they actually mean and does the claim makes sense? Most vaping is infrequent, and regular use is concentrated among smokers, where is may be benficial.

But is it really?

Updated: 15 February 2019 to add section 17

Update 19 July 2019: Note that Scott Gottlieb, who features in this post, left the FDA on 5 April 2019 and joined the board of Pfizer on 27 June 2019: Ex-FDA boss joins Pfizer 83 days after leaving US drug regulator, Financial Times. 

I have been following FDA Commissioner Scott Gottlieb on Twitter and was alarmed at the threat he issued to vapers and the vaping industry in response to recent trends in US adolescent vaping.

I disagree with the FDA’s analysis of what is happening with adolescent vaping and also what should be done about it. So I need to put some flesh on the tweet above and examine some of FDA’s claims in more depth. Please dip to these talking points… it’s a long blog but I hope at least some of it will be illuminating.

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Rethinking nicotine: FDA asks six questions about the future of nicotine regulation

Will no-one rid me of this turbulent molecule? (after Henry II on Sir Thomas Beckett)

Mitch Zeller, the Director of the Center for Tobacco Products at the U.S. Food and Drug Administration, recently published an article with six questions about the future of nicotine regulation.

See: Zeller M. The Future of Nicotine Regulation: Key Questions and Challenges.  Nicotine & Tobacco Research. 2018 Oct 12. [link]

As he has taken the time to put some questions and expressed interest in the answers, here are mine. I have spent most effort on his sixth question, the one about youth.  Mitch Zeller’s six questions are in bold below and my responses follow each. I also address a further three questions posed by Ken Warner in the same series.  Continue reading “Rethinking nicotine: FDA asks six questions about the future of nicotine regulation”

The urge to ban: 10 questions to ask first

The US media is losing its mind over vaping and Juul – the questions a credible journalist should ask

Losing perspective?

Update 30 April 2018 JUUL: hold the moral panic

Introducing a modern moral panic

Over the weekend in an aside in my long blog about the sophistry of anti-vaping activists,  I mentioned the unfolding moral panic about vaping and, especially, Juul e-cigarettes among teens (see the quote from the blog below for background). I want to add to this with some views on appropriate journalistic inquiry and suggest a line of sceptical questioning a credible journalist could use.   Continue reading “The US media is losing its mind over vaping and Juul – the questions a credible journalist should ask”

FDA wants to reduce nicotine in cigarettes – what could possibly go wrong (and right)?

Some things don’t have to be used to be useful

On 28th July, FDA announced that it wants to hold a “public dialogue” about regulating to reduce nicotine levels in cigarettes to “non-addictive levels”. I’ve previously written about this idea in my critique of ‘tobacco endgame’ ideas, and I was pleased to present on the subject at SRNT 2017 conference.  Generally, I’ve taken the view that the idea is crazy, unworkable, unethical and will never happen, and I have a hefty bet against it.

But now that FDA has announced it, everyone should ask: might any good come of it?  That has prompted me to reconsider my previously entirely hostile approach. So here are some updated views in a report done in collaboration with Dr Carrie Wade, Director of Harm Reduction Policy at the R Street Institute, Washington DC.

The three minute version…

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