FDA CASAA Call to Prepare re FDA Regulations Comments

[Jman8]

A key part of my comments to FDA (which I'm still drafting) will be that science ought to drive politics, wrt to how might eCigs impact public health.

In my preparation, I was going to gather all relevant scientific studies that address actual questions being asked by FDA that are requesting scientific data.

And after a bit of analysis, I am finding that there isn't actually much scientific data being requested. In fact, I found just 2 areas requesting actual scientific research, even while the word "research" appears more than 100 times in the proposal. I believe other people would differ in this estimation. My intent up until today was to present lots of science, and yet CASAA has essentially suggested we not respond with scientific studies, or as noted on the Second Call To Prepare:

However, reciting sciencey claims that are incomplete or inaccurate might tend to diminish the effectiveness of what you know best: your own story and what this will do to you.

I now concur with this, and yet, am still going to make the larger claim that science must drive policy wrt a regulatory framework dealing with public health.

I say all this cause I think it might help with other comments and cause I am having a little bit of a tough time coming to terms with the fact that our side may not be providing lots of scientific studies. Yet, FDA isn't exactly asking for much, and with what they are asking for, the scientific studies are rather sparse. There is exception to this, I feel, in that FDA does essentially ask in about 80 different ways, "do we know if eCigs are safer than other products?" I think all CASAA people know the answer to that, plus we know that the FDA (for sure) knows the answer to this. And to the degree that they may pretend to not know, would result in regulatory policy that would make them look utterly foolish to .... I think, everyone.

 

[DavidOck]

Done and done... Here's my comment...

RE: FDA, Docket No FDA-2104-N-0189, Regulatory Information Number (RIN) 0910-AG38

I'm a 66 year old human – not a corporate person – and smoked cigarettes for almost 45 years, averaging about 25 to 30 per day for the last few years I smoked. For nearly two years, I have been a non-smoker. My last one was on Oct. 11, 2012, after about a week of “vaping” and adjusting the hardware needed to my satisfaction. I joined CASAA to find a resource that could provide accurate information on current research into vaping.

Prior to that, I'd tried many different “approved” methods of quitting. I went through the entire regimen of the “patch.” Twice. Nicotine gum irritated my gums. Cold turkey was an abject failure. Of course, my attempts were before you approved the new “mist” – which has more added chemicals than the available e-cigarette liquids, so where's the benefit in that?

Now, after almost two years of vaping, my dental hygienist says my gums are getting better. My physician says my lungs are clear, my wife says my skin looks healthier, and I have more energy than before.

So for me, vaping has proven to be an effective method of harm reduction where the “approved” methods were absolutely useless to me for the same harm reduction.

I use the larger, refillable devices, as the small ones – commonly called “cigalikes” due to their form – are totally unsatisfactory. They do not provide, to me, the experience that the larger ones do, and moving from them to larger devices is what finally got me “over the hump” to becoming a non-smoker. And the idea of disposable devices, when we're already filling the land and oceans with trash, is repugnant to me when there are reusable – and better – options. Should those options be made illegal, I'm not sure at this point if I'll become a criminal or start smoking again, since the products left will be totally un-satisfying to me. Just as other substances have been made illegal, there will be a “black” market, so for me it might depend on how much faith I have in that.

I “vape” a variety of different flavors. I like a variety of flavors. Don't you? Or do you ONLY eat the same food at every meal? Since one of the typical results of smoking cessation is over-eating, I find different flavors an effective way to combat those urges. Rather than eat, I can satisfy my “sweet tooth” cravings with something that has zero calories.

Nicotine, without the combustion products and by-products, and in low amounts, is being used to treat cognitive disorders, ADHD and many other disorders:

“There's a cheap, common, and mostly safe drug, in daily use for centuries by hundreds of millions of people, that only lately has been investigated for its therapeutic potential for a long list of common ills. The list includes Alzheimer disease, Parkinson disease, depression and anxiety, schizophrenia, attention deficit hyperactivity disorder (ADHD), and even pain and obesity. Why has interest in this potential cure-all been slow to develop? One reason: in its current forms the drug offers pharmaceutical companies no possibility of substantial profit. Another, perhaps more important: the drug is reviled as the world's most addictive. The drug, of course, is nicotine.” Nicotine as Therapy (Bolding is mine.)

This is from a Nov. 2004 NIH publication. Numerous other studies of nicotine without carcinogens show similar findings.

So to me, it seems clear that efforts to restrict vaping to the products offered by “big tobacco” and “big pharma” are not at all directed at the health of citizens other than corporate “people.” I have yet to hear of Phillip Morris getting treated for lung cancer or emphysema.

Your website – What We Do – states:

“FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health. FDA also has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.”

The restrictions imposed by your deeming regulation will stifle innovation, not speed it; make vaping less effective and less affordable, not more effective and affordable; and are clearly NOT based on current science-based research.

They seem to be based on mis-information and a desire to protect the profits of the tobacco and pharmaceutical companies.

(Submitted July 25, 2014. Tracking number 1jy-8df4-va80)

 

[Ken_A]

Wow. A lot of these are much less nice than I was.
They are all good, but I tried to stick to facts and general information.
I placed links to about 12 studies and polls just before my last paragraph.
In my last paragraph, I tried to very nicely word it and still managed to tell them that if they pass the regulation, they are pandering to big tobacco.
And I sent my comment number to CASAA.

 

[DC2]

I am always comforted when I find that my posts are being read and liked, it makes me post more

I "spend" a lot of my "likes" on posts from people who clearly have interesting things to say but don't post often enough.
I hope to encourage them to post more, and I'm glad to see that approach may indeed work sometimes.

 

[DC2]

Done and done... Here's my comment...

Outstanding comment.

But then it seems a lot like mine in many ways so of course I think it is outstanding.


And although I don't usually post my comments here, for reasons I have mentioned before, I'll do it this time just for the heck of it...

I started smoking at age 16, and smoked for 27 years. Although I smoked for 27 years I was never a heavy smoker, and averaged around 7 cigarettes per day. Of course I would smoke much more than that when I was drinking, but there were also many days where it was much less than that. I loved smoking, and never wanted to nor officially tried to quit, although my wife hated the odor that I carried around with me when I returned from smoking a cigarette.

Smoking for me was not so much about the nicotine. It was more about taking a break from the world in small 10 or 15 minute increments. It was a chance to get away and be alone with my thoughts. To sort things out, to prepare for something, to solve a problem, or just to escape an uncomfortable situation. Because of the odor (and wishing to make my wife a little happier) I did in fact try to replace my smoking habit with other habits. I tried drinking tea, playing the harmonica, and trying my hand at Rubik’s Cube. Nothing worked, nor even came close to working. I needed something to keep my hands occupied, but it also had to be something completely mindless. Smoking afforded me both of those things, as well as rhythmic breathing, and the mentally soothing opportunity to watch swirling smoke dance above me.

One day, over five years ago now, my sister showed me her new electronic cigarette, and urged me to give it a try. On that very first puff I knew that this is what would allow me to put down the real cigarettes for good, and it turned out I was right. Since that time my health has improved in surprising ways, as I was never even really aware that my health had been affected. For example, shortly after I switched to the electronic cigarette I could only hold my breath for about 30 seconds. After 12 months I could hold my breath for 90 seconds, and after 30 months I could hold my breath for 110 seconds, which is how things stand to this day. I hope someday soon to start exercising again, so that I can take advantage of this improved ability to breathe.

If the proposed deeming regulations were to restrict the market to small cigarette-like devices with only prefilled cartridges available in only certain flavors, I would go back to smoking. Luckily, I have for years now been afraid of just such an occurrence, so I have stocked up on of the products that I like to use such that they will last me for at least a decade. Honestly, I will never let ANYONE drive me back to smoking again. If I run out of my stockpile, I will turn to the black market without hesitation. As an otherwise productive member of society and law-abiding citizen, the thought of being forced into such a position outrages me, and everyone who knows me. We are watching, and we are waiting.

But in reality, this isn’t about me. This is about making sure that the millions of people who are still killing themselves daily by inhaling burning plant matter are afforded the same opportunity that I had. It is critical that advanced products that actually work remain freely available. It is critical that a wide variety of flavors remain freely available. Switching from smoking to using electronic cigarettes can be hard, but it can become very easy when a person finds the right equipment that works for them, and the right flavors that make them never want to smoke again. And that saves lives. We are watching, and we are waiting.

As you can see, my story is not very "inspiring" but then again, maybe it is?

 

[bigdancehawk]

It sure inspired the heck out of me! It even inspired me to see how long I can hold my breath. When I was smoking I could barely hold it for 15 seconds. I just did 105 seconds. Could have gone a bit longer but I started craving my Banana Nut Muffin vape. I may take up free diving.

EDIT: Seriously, it would not be difficult to do before and after lung function tests. The "before" data is already there. It would just be a matter of finding vapers who had their lung function tested before they quit smoking and then re-testing them. A couple of hundred ex-smokers should do the trick. Maybe we should start a thread to solicit volunteers? I'm 100% confident that the results would be impressive.

 

[dragonpuff]

I just made 5 new comment submissions to the FDA docket. Each one contains a pdf of an e-cig study and says "please review the study in the attached file." The studies I sent them cover smoking reduction and cessation using e-cigs, harm reduction in general, and a meta-analysis of chemicals found in e-liquid and vapor.

And I'm not done yet!

 

[DC2]

EDIT: Seriously, it would not be difficult to do before and after lung function tests. The "before" data is already there. It would just be a matter of finding vapers who had their lung function tested before they quit smoking and then re-testing them. A couple of hundred ex-smokers should do the trick. Maybe we should start a thread to solicit volunteers? I'm 100% confident that the results would be impressive.

I've posted this before, but although I don't have a "before" test result I do have an "after" test result...

That was done "after" 17 months of vaping.

The important part is the FEV1/FEC ratio, which shows 103% of normal.
That means my lungs were, at that time, healthier than the average person.

 

[bigdancehawk]

I seem to recall that somebody somewhere compiled a list of the questions posed in the deeming regulations. Do you or does anybody know where to find that?

 

[bigdancehawk]

I've posted this before, but although I don't have a "before" test result I do have an "after" test result...

That was done "after" 17 months of vaping.

The important part is the FEV1/FEC ratio, which shows 103% of normal.
That means my lungs were, at that time, healthier than the average person.

That is so cool! Darnit, I wish you and I had a "before" test. I'm going to insist on an "after" test on my next visit to the doc.

 

[DavidOck]

I seem to recall that somebody somewhere compiled a list of the questions posed in the deeming regulations. Do you or does anybody know where to find that?

I thinkk that was in the third call to action? On the CASAA site?

 

[Kent C]

I seem to recall that somebody somewhere compiled a list of the questions posed in the deeming regulations. Do you or does anybody know where to find that?

http://www.e-cigarette-forum.com/forum/fda-regulations/573178-comments-listing.html

first 5 posts.... ;-)

 

[bigdancehawk]

That's it! Took a lot of work on your part. Many thanks. Quite a few of the questions are impossible to answer now, and maybe not ever. Surely they must know that. And many more would require long term and very expensive studies which can't possibly be completed within the allowed time period. Surely they know that also. They're pretending to ask for information, but in reality I seriously doubt it. Either they are playing games or they're idiots.

Maybe the best approach would be to say: "Here's how we think you should regulate e-cigarettes," followed by some concrete suggestions of what they should do and what they shouldn't do. I suggested that they should establish objective standards for e-juice content and manufacturing methods, along the lines of AEMSA. I told them that any attempt to regulate mods would be pointless and counterproductive. I don't care what they do with cigalikes. The more ineffective they are, the more people will turn to 2nd and 3rd generation products.

 

[Kent C]

That's it! Took a lot of work on your part. Many thanks. Quite a few of the questions are impossible to answer now, and maybe not ever. Surely they must know that. And many more would require long term and very expensive studies which can't possibly be completed within the allowed time period. Surely they know that also. They're pretending to ask for information, but in reality I seriously doubt it. Either they are playing games or they're idiots.

Maybe the best approach would be to say: "Here's how we think you should regulate e-cigarettes," followed by some concrete suggestions of what they should do and what they shouldn't do. I suggested that they should establish objective standards for e-juice content and manufacturing methods, along the lines of AEMSA. I told them that any attempt to regulate mods would be pointless and counterproductive. I don't care what they do with cigalikes. The more ineffective they are, the more people will turn to 2nd and 3rd generation products.

Within that thread was another link:

Brick by Brick: the Questions | diehealthy.org

Also good....