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Brick by Brick: Questions for the Lay Comment

Some questions that lay comments can answer in writing to FDA about their deeming proposal.

This post focuses on the questions the FDA asks in its deeming proposal that best fit for layperson comment. Some questions may be best answered by experts or by vendors and manufacturers, but a variety of questions are suitable for comment by vapers themselves.

Foremost, in submitting this type of comment, you should lightly pepper it with phrases like, “further study is needed.” The FDA wants existing studies, existing science. But in many important areas there have been no studies, and the FDA will be undertaking studies based on areas of comment that show scientific ignorance.

By submitting particular comments about these areas, saying you believe there is a relationship between aspects of vaping, but do not have a study to show them, it will establish the need to undertake that type of study. In many ways, this comment period is as much about influencing the regulation as it is about influencing the direction of FDA dollars to study the real issues that can help vaping.


The flavor issue is not directly regulated in the proposal, which has been described as foundational. The FDA could include flavor regulations in its final proposal, but it is more likely to address flavors in subsequent proposals.

That said, product users can and should address the flavor issue head-on in their comments to FDA. Particular areas of interest to FDA will be:

  • What flavors do you, as an adult, use? Not just in ecigs, but do you really like some particular Halloween candy (that you steal from your children who worked so hard trick-or-treating to get it)? Do you really like a certain flavor of ice cream? Of soda?
  • What flavors have you tried that may be “adult-oriented” that you found unsatisfying in vaping? Did you start on a tobacco flavor that did nothing for you?
  • What other adult-oriented products have a variety of flavors that might be seen as appealing to children?
  • What effect did flavors have on your potential to dual-use ecigs with cigarettes? Did you find cigarettes disgusting after trying to smoke a cigarette following prolonged use of vapor products?

In general, the FDA would prefer some magical study that showed definitively how flavors affect human behavior, but we do not have that magic study yet. So they should be interested to know the reality of the flavor situation, if only to inform them of future areas of research they should pursue.

Product Variability

The FDA wants comments on how to regulate ecigs. While you may not want them to, or you might want to limit regulation to a few key areas, you can still give them information that will help strike the right regulatory balance.

Did you “progress” in the types of vapor products you use? How did that progression go for you:

  • Was it easy to move to more advanced products?
  • Did you find the less advanced products less satisfying (both at the time they were your primary products and once you had moved on)?
  • If you started as a dual-user, how did the advanced products help you switch exclusively to ecigs?
  • If you lowered your nicotine levels over time, what about the products made that possible? What could have made it easier?
  • How many flavors did you try that you did not like? How many did you try before you found an “all-day vape” or a favorite?

You should distinguish what the advance was for you. Was it longer battery life? Better vapor production? Better flavor production? Easier to use? More consistent?

Studies on cigarettes show that the first cigarette of the day is the hardest to give up for a subset of smokers. The FDA should hear if you struggled with that, or if you found that once you used ecigs it was not a problem. Particularly, did you find it easier once you began using more advanced products?

Other types of variability will interest them.

  • What is the most frustrating part about using vapor products? They are often more complicated to use than cigarettes. Was there any point during your use (especially early use) when something frustrated you enough to have or almost have a cigarette?
  • Does the fact that some flavors of liquids need to “steep” cause frustration? Do you have trouble waiting, or do you forget to order liquids soon enough so that they have time to “steep?”
  • How consistent are products? A new coil versus old coil? A new bottle of liquid versus an old bottle?

Online Sales

Finally, you could discuss the amount of products you have bought online versus in person. While the FDA has not made any express moves against online sale of vapor products, they may do so in the future. You may also point to some of the benefits that online commerce presents over traditional commerce including (especially if you have participated in or used them):

  • Co-op buys
  • Auctions/used equipment sales
  • Comparison shopping (including price, quality, reviews, etc.)
  • Increased competition driving improved product quality

The FDA does not want to ban online sales, but may be sympathetic to the issue of youth access. You can tell them if you believe that technological systems to prevent youth access are a viable option (comparing viability to other access controls, such as for online banking).

We should let the FDA know that consumers support a more robust and comprehensive system for handling nuances in online commerce (including, e.g., prescription verification, which is right in their wheelhouse). It will benefit not only ecig commerce, but the growth of online commerce in general.

Wrapping Up

The FDA would love if they could do valid scientific studies on everything. They can’t, and in many cases they either don’t know what to study or science lacks the ability to measure what they want to study.

I believe average vapers that include feedback on these issues will at least give them direction on what they should study to inform future regulations. It may also help them to improve potential product manufacturing standards in ways that result in better equipment, especially for newer vapers that have not progressed to advanced products.

The flavoring issue is particularly important. The FDA has no science to back claims that they should ban particular flavors. But they need to understand that flavors are also one of the biggest draws switching to ecigs. By sending them comments that raise your particular experiences with flavors, you will help convince FDA to undertake flavor-specific studies that will show that flavors are an important component of the success ecigs offer to help smokers switch. They will find that flavors also help vapers drop their nicotine levels. And so on.

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