November 25th, 2018

More heat than light - new US statistics on youth vaping provide no basis for FDA policy

What’s going on in their lives?

New data on youth vaping. Time to take a closer look at the disclosure of some 2018 U.S. National Youth Tobacco Survey data (see MMWR).  The survey is conducted annually, with field work in February-June.  Usually, the results are published in headline form about a year later (2017 data was published in June 2018) and full datasets some time after that. 2018 is different however.  CDC and FDA (the co-authors) have rushed out data that they argue supports the claim there is an ‘epidemic’ of teenage vaping use (see FDA chief calls youth e-cigarette an ‘epidemic’, Washington Post).

FDA action in response. In response to the alarm that it has done much to create, FDA has now taken a variety of actions, notably to restrict access to e-cigarette flavours that are not tobacco, menthol or mint – as described in a 15 November statement by Scott Gottlieb, FDA Commissioner.

Backing for the action? But does the data support any of this regulator activity? I conclude that the partial release of data does not provide justification for FDA’s policy. This is because the data required to understand underlying changes in the pattern of tobacco use has been withheld. In other words, the data to create alarm has been released, but the data required to understand if the alarm is justified and the policy is sound has not been released.  >> read the full post

November 15th, 2018

Youth vaping and the dangers of over-reaction - a letter to the FDA

 

Letter from Iowa Attorney General Miller and others, including me, to Scott Gottlieb, FDA Commissioner. See PDF at the link below:

Re: Youth tobacco and nicotine use – proportionate and responsible reaction

This is a letter and 7-page briefing to set out issues with youth vaping and to caution against over-reaction. For the fully referenced version, please see the PDF at the link above.  The main text is below.
>> read the full post

October 24th, 2018

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.  >> read the full post

October 1st, 2018

Over 70 experts call on WHO to embrace technology innovation in the fight against diseases caused by smoking

Dear WHO FCTC, do not block the exits for people trying to quit smoking using vaping, smokeless, heated tobacco or novel products. Remember, the enemies of innovation can do more harm than good.

Every two years, the Parties to the WHO Framework Convention on Tobacco Control meet to discuss how to advance the treaty. The 8th meeting of the Conference of the Parties (COP-8) is being held this week, 1-6 October, 2018 in Geneva.

I was one of those agitating for the FCTC back in 1999-2003. Generally, the FCTC doesn’t do what normal international treaties do – address some transboundary issue like climate change, international trade or intellectual property. It tries to establish norms for regulation of tobacco commerce within countries – a kind of solidarity mechanism for national anti-tobacco policy.  The problem is that this idea all goes sour when the WHO, Convention Secretariat and/or Parties agree, in solidarity, to normalise truly terrible policies – for example, to encourage prohibition of e-cigarettes, to treat all smokeless tobacco as though it is the same and just as risky as smoking, or to regulate heated tobacco products as though they are cigarettes.   All really harmful ideas that protect the cigarette trade, perpetuate smoking and cause more disease and death.

Letter to WHO

So, determined to resist this drift into globally harmful policy promotion, a group of 72 of us have put together a letter to register our concern and to suggest there is a better way: to embrace tobacco harm reduction… here it is.  The PDF here: Innovation in tobacco control: developing the FCTC to embrace tobacco harm reduction 

>> read the full post

September 5th, 2018

Letter to WHO's DG against prohibition and for risk-proportionate regulation

Mike Bloomberg and the WHO DG  launching the Bloomberg-funded report on the Global Tobacco Epidemic 2017. An unsurfaced conflict of interest?

We’ve sent a letter to WHO and the FCTC secretariat in advance of FCTC COP-8 (1-6 October, Geneva) – protesting about WHO’s inclination towards prohibition and excessive regulation of alternative nicotine delivery systems (ANDS).  For background, see papers on vaping (FCTC/COP/8/10) and heated tobacco products and others (FCTC/COP/8/8).

The letter by David Abrams, Ray Niaura, David Sweanor and me is available in PDF form with all footnotes here – and the text is reproduced without notes below. >> read the full post