Iowa Attorney General to FDA: Proportionate & Responsible Reaction

Iowa Attorney General to FDA: Proportionate & Responsible Reaction

On Wednesday, November 14th the Iowa Attorney General, Thomas J. Miller, sent a letter to the FDA and it’s commissioner Scott Gottlieb. In this letter Thomas J. Miller outlined the importance of the FDA coming out with appropriate and proportional regulations towards electronic cigarettes.

The Attorney General does a great job throughout the letter to encourage correct regulations rather than criticize possible regulations, at one time stating “we write to urge FDA to take carefully calibrated and proportionate action in response.”

The opening statement reads “We share your widely reported concern about the rise in e-cigarette use among adolescents. At the same time, we remain hopeful that by encouraging smokers who cannot or who choose not to quit to switch to e-cigarettes, we may be able substantially to reduce premature mortality due to smoking, which remains the #1 risk factor in the US and in the world.”

In his letter to the FDA commissioner, Iowa Attorney General listed 7 factors he wishes for the FDA to consider strongly before any regulations are put together. As with many official documents, some of the language can be a bit confusing, so we have paraphrased a little to better convey these factors in layman’s terms.

  • The FDA should consider the frequency of underage use (occasional, regular, & daily use) to better create regulations that target heavy and daily use among teens.
  • Considering adolescent use of e-cig products leads to them being far more likely to use cigarettes, then in return e-cigs would potentially help them quit smoking traditional cigarettes.
  • The risks of using electronic cigarettes cannot be exaggerated and any regulations should reflect those risks. Even though long term health risks cannot be fully evaluated for another couple decades, the studies and research that have been done so far definitively shows that using electronic cigarettes have little harm to adults and adolescents when compared to smoking cigarettes and other risk behaviors.
  • If the FDA wants to avoid teens transitioning from vaping to smoking cigarettes then the banning of the vaping products they already use could in turn lead to unpredictable responses. One potential outcome could be that adolescents move to smoking cigarettes, especially if nicotine dependence has already formed. This would then put the FDA in the position they feared all along.
  • All adolescents grow to become adults and their wellbeing is a product of risks and opportunities available through the life-course. Young people have a stake in the adult society they will grow into. So, if the FDA is to make any ruling, they cannot just set aside the interests of adults in order to regulate the youth.
  • Even if the FDA can fine any correlation between youth vaping and e-liquid flavors or the uptake of youth vaping, there is no way of knowing if FDA intervention will have a negative impact or bring positive benefits.
  • Although the goal of the FDA is to prohibit teens from taking up vaping, the regulations and bans considered may be detrimental to the harm reduction among adults.

 

 

 

 

Thomas J. Miller then ends the letter by saying “We hope that FDA will pause to reflect before taking further action in the vaping market. We would welcome your response to the points raised. We would also welcome the opportunity to discuss this difficult issue with you in person. To that end, we would like to request a meeting at your convenience.

A longer briefing is attached. This provides some background on the points above.”

It seems that Thomas J. Miller does not oppose or support vaping, but instead would just like to see the FDA make a clear and concise ruling. But, in order to do so fairly they must look at a multitude of different views in order to eliminate any tunnel vision that may exist.

The FDA is set to announce some sort of regulations or press release some point today, 11.15.18, or later this week. It is unclear yet if this letter has had any effect on the FDA’s schedule for these announcements.

If you would like to check out the longer briefing portion of Iowa Attorney Thomas J. Miller’s letter to the FDA please click HERE.

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