This is my response to the operational review of the performance of the FDA’s Center for Tobacco Products by the Reagan-Udall foundation. The heart of the problem is the lack of a coherent regulatory strategy, grounded in real-world understanding
…and now we go live to Silver Spring, Maryland
The Reagan-Udall foundation is conducting an “operational review” of the FDA’s handling of its tobacco and nicotine brief. The review was commissioned by Robert Califf, the FDA’s Commissioner. I have submitted comments through the stakeholder portal. Please consider making your own submission – it’s easy.
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.
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.
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.
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]
