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.
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.
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.
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.
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.
If this is his analysis, @SGottliebFDA hasn’t tried hard enough to understand what is – and is not – a material risk in these youth vaping numbers. Yet he appears willing to put millions of adult lives at risk by imposing regulatory overkill on a life-saving product for smokers. https://t.co/HB64pgtjRJ
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.
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.
It came as a surprise, but today’s announcement from FDA on tobacco policy is huge. The video of Dr Gottlieb’s speech and background is available here and speech text here.
The new Commissioner, Scott Gottlieb calls for FDA to develop a ‘new comprehensive plan for tobacco and nicotine regulation’ and announced ‘bold and far-reaching measures’ based on ‘ a firm foundation of rules and standards for newly-regulated products’. FDA announced it would “begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards“.