Iowa's Attorney General, Tom Miller, issued the strongest public challenge yet to Mitch Zeller, head of the FDA's Centre for Tobacco Products, to intervene in the way vaping products are regulated.
Speaking at the Food and Drug Law Institute's Tobacco conference luncheon on October 27th, he urged Mitch Zeller to "come to the rescue and use his authority to the fullest extent to not overregulate e-cigarettes and the implementation of the rule."
Tom Miller has served nine consecutive terms as Iowa's AG, was the president of the, and has a deep and long-standing involvement in US Tobacco Control efforts. AG Miller was instrumental in the Master Settlement Agreement of 1998, in which the tobacco companies were forced to pay, in perpetuity, a proportion of profits to each US state to cover smoking-related health care costs. He sits today as the Chair of the Truth Initiative, America's largest anti-tobacco NGO.
His intervention, in which he spoke in his capacity as Attorney General of Iowa, will carry an enormous amount of political weight, especially amongst the community of Attorneys General, of which 40 wrote to the FDA in 2013 urging them to implement regulations urgently. One imagines that those AG's will not be amused if they feel the CDC has misled them.
AG Miller's complaint centres around two principal issues: that the US population has been misled about the safety of vaping products, and that alarm has been created over a "new epidemic of nicotine addiction" in American youth that is not justified by the data.
Miller praised Zeller's contribution to the CTP, stating that he has an enormously difficult challenge from "pressures from all different sides, intense pressures, pressures from people who are true believers of one position or another, pressures of the bureaucracy and being part of the bureaucracy and being part of the political system."
But he maintained that Zeller must face reality head-on and act creatively to ensure that the opportunity is realised to save the "13 to 15 million" smokers lives that are currently at risk from cigarettes.
In an apologetic note, he conceded: "I'm putting way too much responsibility on his [Mitch's] shoulders, but there is not a lot of choice at this point."
FDA's "deeming" of e-cigarettes to be tobacco products
The FDA's "deeming regulation" has been criticized for being excessively burdensome to an industry that mainly comprises of SMEs, which stand no chance of compliance. The fear is that any positive effect currently being seen at the population level is in jeopardy from a regulation that will eradicate most of the industry participants.
Mitch Zeller has stated previously that the "English example" does not apply to the United States due to skyrocketing domestic teen usage. But doubts have surfaced over the methods used to gather this data and the way they were interpreted. Last year, the CDC reported a "tripling of e-cigarette use" amongst youth following it's latest wave of the National Youth Tobacco Study. They stated that as many adolescents were vaping as were smoking, such that there had been no overall decline in tobacco usage.
CDC reported only overall usage which only reflects exposures within the last 30 days. Accordingly, a range of vaping behaviours is collapsed together, including daily usage, single day usage, one-off experimental usage, a puff from a friend's device and so forth. It's impossible, then, to compare like with like. Additionally, the MTF group found last year that around 70% of adolescent vapers were using e-cigarettes without nicotine.
Miller's topology of adolescent vaping usage
Where the CDC claims 13-16% of teens are users of e-cigarettes, Miller states that from this figure:
- Half of teen users only use them when shared by friends (Truth Initiative)
- Only 1 in 140 kids who were not previously smokers become daily or semi-daily vapers (Ken Warner, from MTF data)
- 3.3% of kids are daily smokers, 1% of kids are "trying to get off cigarettes" using vape (source not available)
- Of all kids using vape of any description, only a minority use products which contain nicotine (MTF)
Miller concludes that "this looks like a Gateway to nowhere."
There has never been any acknowledgement from the CDC regarding other interpretations of this data. Tom Miller has now given Mitch Zeller the political room to course correct and look again at the English example, which increasingly seems to be a case with more similarities than differences to the USA situation.
The English example
This year the Royal College of Physicians issued a report stating that vaping is at least 95% safer than cigarette smoking. Further, population level studies conducted in the UK by Professor Robert West (the smoking toolkit) has shown vaping to be more efficacious in aiding cessation than pharmaceutical nicotine products, and that vaping products are now the UK's most popular quit tool, despite their not being marketed as such.
Out of a population of around nine million smokers, UK's main anti-smoking campaigners, ASH, found 1.3 million are now ex-smokers but use vaping products, and that children are not being recruited to smoking through vaping products.
This is not to say that the UK is all rosy as far as vaping is concerned. There remains deep scepticism about the involvement of the tobacco industry in the sector, despite the continued positive impact the products are having. UK smokers, similarly to US smokers, remain confused about the safety of vaping due to relentless media scare stories generated from research conducted by US researchers.
The UK government is obliged to implement the EU's Tobacco Products Directive, but the authority assigned to regulate the products, the MHRA, has chosen to do so in as liberal fashion as they are able.
You can read a transcript of Tom Miller's presentation here courtesy of Clive Bates, or listen below.
Edited November 24th to clarify that Tom Miller was speaking solely in his capacity as Attorney General of Iowa.
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