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The vaping flavour ban – Clive bates nail the facts 


1. What is happening about flavoured vaping products in the United States?

On 11 September 2019, the US Federal Government announced it was intending to ‘clear the market of flavoured e-cigarettes‘.

“The Trump Administration is making it clear that we intend to clear the market of flavoured e-cigarettes to reverse the deeply concerning epidemic of youth e-cigarette use that is impacting children, families, schools and communities,” said Health and Human Services Secretary Alex Azar. “We will not stand idly by as these products become an on-ramp to combustible cigarettes or nicotine addiction for a generation of youth.”

FDA argues (with bizarre pedantry) that this is not ‘a flavours ban’ because the products are already technically illegal. This is because all vaping products on the US market have not been subject to pre-market authorisation (a requirement FDA established in 2016 with a hopelessly unrealistic deadline that this should be done by August 2018).  It just that the FDA has chosen not to enforce the law and so any product that was on the market at 8 August 2018 can stay (subject to several other requirements) without expecting enforcement action. This is because the FDA uses ‘compliance policy’ to decide what laws it will enforce and also as a way of making de facto policy. The last update on compliance policy for these products was March 2019: Modifications to Compliance Policy for Certain Deemed Tobacco Products.  FDA, in consultation with the White House, plans to update this sometime soon to implement a new policy.

The revised compliance guidance was submitted to OMB for review on 25 October 2019 – see the notice and scheduled stakeholder meetings. The current political debate centres on whether to allow or to ban menthol and mint flavours.  Apparently, the White House hopes this will soften the likely political backlash from 14m adult vapers as the US approaches an election year.  It is not for me to discuss that.

2. Why is this happening now?

This policy was announced in the context of two aggravating factors:

  1. The cynical and false conflation of regular nicotine vaping with an outbreak of serious lung injuries arising from the use of adulterated black market cannabinoid products (CDC).  This has created an intensified peak to the moral panic surrounding vaping, even though – beyond any reasonable doubt – it has nothing whatever to do with vaping regular nicotine e-liquids. The lung injuries are a result of a contaminated adulterated and illegal supply chain for cannabinoid vapes.  Nevertheless, the confusion has triggered several states into emergency action against vaping products.
  2. An early and (of course) incomplete release of youth vaping data, which showed high school past-30-day vaping rates had risen to 27.5% in 2019 (20.8% in 2018 and 11.7% in 2017). As these numbers have risen.

Any sharp rise like this is bound to cause alarm. But as we will see later, these aggregate numbers betray a more complex underlying picture.

3. The big question: does the FDA have any idea what it is doing?

The question is, and always has been: does FDA have the faintest what it is doing and whether its interventions will do more harm than good?

The answer is, and always has been: no, it has no idea what it is doing and, yes, its interventions will inevitably do more harm than good.

The reason is that FDA does not have a coherent analytical framework for considering the role of vaping on public health, including its interactions with youth and adult smoking,  and no idea how to evaluate the impact of massive prohibitionist interventions like clearing the market of flavoured vaping products.

What does an analytical framework for evaluating vaping policy measures look like?

I last blogged about this in December 2017: Regulating e-liquid flavours – is the U.S. regulator more likely to do harm than good and how would it know? This was based on a letter and briefing to the then-FDA Commissioner, Scott Gottlieb.  The letter is from an informal group of public health advocates led by the Attorney General of Iowa, Tom Miller, and it includes me. The questions raised then remain unanswered now.

The heart of the problem is evaluating and trading possible harms and benefits to adolescents and to adults arising from the likely displacement of smoking by vaping in both adolescents and adult populations. How do you include the adolescents that benefit from vaping in the analysis? How much weight do you give to one additional adolescent who starts vaping compared to one adult who quits smoking using vaping? How do you know what the effect of an intervention like a flavour ban is?  Banning a product used by millions is not the same as the product never existing or becoming somehow uninvented.

In the letter mentioned above, we suggested that 10 questions should be used to interrogate policy on vaping flavours.

  1. Is the flavour used in a combustible or non-combustible product?
  2. Is the cause for concern an actual flavour or the way it is described (or both)?
  3. Are all flavours, whole flavour categories or specific flavours the cause for concern?
  4. How will the subset of flavours that have a particular role in attracting youth be identified?
  5. Does a flavour preference create a change in behaviour to increase e-cigarette use?
  6. What is the behaviour of concern and what is a distraction?
  7. Would youth uptake of e-cigarettes caused by flavours be harmful or beneficial to health?
  8. How are trade-offs between potential harms and potential benefits to youth addressed?
  9. How will beneficial impacts for adults be reconciled with any potential impacts on youth?
  10. What impact would a rulemaking intervention by FDA have?

I do not think FDA has the slightest idea how to address the challenges that such a framework presents. So, to refer back to the title,  I believe that FDA is more likely to do harm than good, and what’s more, it wouldn’t know what effect its intervention was having. The conclusion drawn in that letter remains valid:

If you want the rest to follow the link to clives full article below

Sourced from:

Methodically dismantling the severely flawed arguments from govt and exposing the lies and misinformation pertaining to the banning of e-cigarette flavours is exactly what the public needs to hear.

In Seeking the Truth, you have to get both sides of the story – The Media

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