Attorney General

Posted 13th July 2018 by Dave Cross
Iowa Attorney General Thomas Miller has written to the Food and Drug Administration (FDA), demanding a more reasoned and evidence-driven approach to tobacco regulation and the treatment of vape products. The harm reduction advocate has included a number of experts as co-signatories to his letter.

Miller has been banging the harm-reduction drum for a while now. He spoke about the benefits of vaping in 2016, in a speech described by Clive Bates as: “Quite simply the best speech I have ever heard on tobacco and nicotine policy, science and ethics. From Tom Miller one of the architects or the United States Master Settlement Agreement and Chair of the Truth Initiative. A model of decency, humility and rigorous scientific reflection, in my opinion.”

Then, in 2017, he sent a letter to FDA Commissioner Scott Gottlieb, where he said that said that research demonstrated only a small number of young adults (2%) were regular users – challenging Gottlieb’s figure of 16%. He insisted the FDA should “take action to avoid unnecessary damage to the market for innovative and disruptive technology.”

In his latest contribution to influencing the future of vaping, his letter states that his cosignatories might disagree on reducing nicotine in cigarettes, but all fall behind supporting vape technology because vaping works for current smokers.

“The availability of alternative nicotine delivery systems is integral … by providing beneficial migration pathways for continuing nicotine users” – Iowa Attorney General

“The availability of alternative nicotine delivery systems is integral to a strategy of reducing nicotine levels in cigarettes by providing beneficial migration pathways for continuing nicotine users; necessary to maintain a credible threat to introduce such a rule; and required as an alternative strategy which renders a reduced nicotine rule for cigarettes unnecessary because the alternatives themselves will drive the appropriate rate of switching and exit from smoking.”

Miller quotes a section from a study by Abrams et al: “[Vape devices] have the potential to disrupt the 120-year dominance of the cigarette and challenge the field on how the tobacco pandemic could be reversed if nicotine is decoupled from lethal inhaled smoke. [Vape devices] may provide a means to compete with, and even replace, combusted cigarette use, saving more lives more rapidly than previously possible.”

The letter makes a number of recommendations:

  • The FDA should systematically apply the principles of good regulatory practice The product registration process (PMTA) should be redesigned to make its costs and burdens more proportionate to risk while recognising the significant benefits that alternative nicotine delivery systems can provide when used as an alternative to smoking.
  • The PMTA process should be clear and transparent.
  • The FDA should focus standards on the safety of the devices, liquids and aerosol.
  • The FDA should rely on post-market surveillance and not modelling studies.
  • The FDA, CDC and the US Surgeon General should make clear, consumer-friendly, statements about vaping, emphasising it isn’t harmless but offers greatly reduced harm.
  • People should stop talking about there being “no safe” or “harmless” tobacco product.
  • The FDA should use its influence and credibility to promote risk-proportionate policies that discourage smoking and encourage switching.
 Dave Cross
Article by Dave Cross
Freelance writer, physicist, karateka, dog walker