Tag Archive: “ecigs”

Ideas for Useful Vapor Studies

Posted in science by Adam

31 January 2015

Some ideas of studies that could actually be useful in vaping, rather than simply looking at formaldehyde repeatedly and incorrectly.

We’ve seen some useless studies come down, but what are some useful studies that scientists could do to inform the public better about vaping?

Fine details on nicotine absorption

This will likely take a series of studies to gather enough data over various levels of vaping, but the gist is how do various vape parameters alter nicotine absorption rates?

Examples of the parameters involved include wattage/vapor density, technique of inhale/exhale (e.g., steal vaping versus cloud chasing versus “regular” vaping), and length of puffing session.

Unknown parameters might include modifications by ambient temperature, food, drink, circadian rhythm/oral mucus membrane’s biocycle, etc.

Also, how much does the same vaping regimen vary nicotine absorption between individuals? Are some subjects naturally more efficient at vapor-nicotine absorption than others?

Just-noticable Difference (JND) of nicotine levels

If a vaper uses a 12mg concentration, can they tell if they try an 11mg or 13mg? Does the JND vary with vapor density or other parameters above (it likely does with some)?

Understanding the JND may help with vapers that wish to lower or discontinue their vapor use. If they can step down at the right rate, it may improve their success.

It may also help manufacturers decide how to optimize their products. E.g., if an atomizer has a “hot start” feature that can increase vapor density for the first vapes of the day, it may help smokers that are reliant on that first cigarette but otherwise vape. If they can tell a smoker something like, “studies have shown that this increase in vapor density is equal to increasing the nicotine solution by x%,” it could help the vaper make a more informed choice about how to use the product to overcome their “first cigarette” issue.

It could also be used to innovate a dual-tank design where one tank is nicotine-free. If the user receives nicotine vapor for the first several puffs of a session, and the device then switches to the virgin liquid, is the session still satisfying?

Innovations in detecting nicotine absorption levels

Is there an easy-to-use proxy measure for measuring blood serum levels of nicotine? For example, can heart rate or blood pressure measures be sufficiently correlated to get a robust measure without blood draw? Such a finding could significantly improve the variety of studies done, as they would be simpler to design and conduct.

Investigations of dehydration

How much of an issue is dehydration? Can it be alleviated through using higher-density vapor with higher nicotine levels? Lower-density with higher levels? At this time the issues of dehydration appear to be anecdotal with no formal investigations. Are some individuals more vulnerable to the effect? Is it even a real effect (i.e., does vaping actually lower body hydration)?

These issues may not seem as profound as detecting formaldehyde, but each of them could positively help both public health and the vaping marketplace improve. For example, the FDA might require dehydration warnings on vaping products if the concern is great enough. But lacking evidence, the FDA apparently ignores that potential hazard entirely in their proposed rules.

Proper hydration is a real issue not just in daily health, but long-term avoidance of organ stone formation among other problems. It deserves to be given at least a cursory study if vaping is to be regulated.

Scientific Misunderstanding in Vaping Science

Posted in society by Adam

24 January 2015

Another scientific analysis of vaping showed that scientific analyses of vaping continue to be insufficiently informed on the subject matter. What gives?

A letter published in the New England Journal of Medicine, “Hidden Formaldehyde in E-Cigarette Aerosols”, discusses an analysis on the production of formaldehyde from heating ecig liquids. And once again we have a scientific analysis that is based on a misunderstanding of the investigated system.

Their analysis showed high levels of formaldehyde production, but that finding directly resulted from overheating a tank system that was not designed for the test conditions. The authors were unaware of the constraints of the tested device, and they marched on believing that real people would use the device according to their test protocol.

These are likely very intelligent people, so how can they get it so wrong? They know a bit about chemistry and measurement and so on. But they failed to study the knowledge base they were working in. Not for a lack of its availability, what with the widespread information in the vaping community. For a lack of recognition that there is information they lacked.

They see a very simple system: fill with liquid, push a button, inhale. So we can measure what is inhaled. Oh, it has a dial that changes the voltage. We can see what they inhale at different voltages. Just as you can mismatch a light fixture with bulbs that fit but are not rated for the use, you can misuse ecigs.

There are other scientists doing meaningful work in this area. At the very least, these scientists could have consulted with those, agreed on protocols, and we could be on our way to having replicated results much sooner. Instead we have another dud of an investigation into formaldehyde in vaping, and we await the real results.

Formaldehyde is a known risk of vaping (one of the few), but an entirely avoidable risk as well. But we need the fine details of how much is produced under which conditions to know just how much effort is needed to eliminate the risk, and we do not have that data yet. And scientific misunderstanding, not knowing what they don’t know, muddies the water for safer products.

The other side of this debacle is that as these errors get repeated it hopefully raises scientific awareness of them. Future studies will focus more correctly on the real questions around vaping, and we will get our answers. It may take more time and money than necessary, but science tends to work like that. Indeed, I would not be surprised to see another half-dozen of these sorts of broken studies performed before the community-at-large clues in that this isn’t valuable information for science.

For a vaper it is a valuable lesson when they learn it themselves, in that they will tend to recreate the failed experiment and find it unpleasant and lower their power. The basis of a good vape is just enough heat and wicking to deliver a high-density vapor. Too much heat, an unvapable puff of formaldehyde. Too little heat, nothing to vape. Too much wicking, a gurgling, leaking pain-in-the-ass vape. Too little wicking, an unvapable puff of formaldehyde.

Vapers will naturally avoid all those conditions (or give up). The question for science is how big the margins are. How much formaldehyde can coincide with a good vape? And how do we eliminate it?

Brick by Brick: The Final Stretch

Posted in society by Adam

2 August 2014

Post about the last week before FDA comments are due on deeming regulations.

We’re closing in on comments-due on 8 August 2014. If you haven’t commented, I urge you to do so by then. I will be submitting my own comment as well.

The process from 9 August 2014 is for the FDA to read all the comments they have not yet read, process them, and then formulate their new view of the matters at stake. Then they will amend the proposed regulation and it goes through the OMB loop again, letting them push back a bit. And then it eventually gets finalized.

Once finalized, the fun really starts. Lawyers of various stakeholders will begin helping them formulate their compliance behaviors for the new rules (larger and more established companies probably already have regulatory compliance work ongoing, but it will have to be modified and extended to fit the new rules). Lawyers will also begin considering how challenges to various provisions of the rules on various grounds might play out.

The provisions will all have effective dates, compliance periods, and so on. The companies will have to decide whether they want to force the issue on certain provisions by failing to comply entirely or let the FDA come after them for partial compliance, etc. Posturing will go on. The media will do whatever it is that they do. Throw darts at the proposal and print the words they land on?

But right now we still have time to finish our comments. For a little under a week, anyway. And then we get to wait for the final rule. Or maybe another comment period. If the FDA believes enough has changed once they reformulate, they could offer us another chance to comment, on an updated proposal. I actually think this may be the case.

We asked the FDA to extend the comment period, which they did. But they didn’t extend it very much. A very strange move, that. My guess is that either they don’t think the comments matter very much, or they feel that enough will change that spending too much time on first-round comments will be somewhat wasted. Given the comments do tend to matter, I lean toward the latter.

Keeping it short today, as I want to spend more time on my comment. Good luck!