FDA My FDA-submitted comment on dual-use

[Gato del Jugo]

Not posting all my FDA-submitted comments here at ECF, but I am with this one because I really haven't read much about dual-use..

Just wanted to throw this topic/angle out there.. Perhaps others could do a better job and/or put a different spin to it in their submitted comments...


Anyway, hope it didn't sound too threatening towards to the end, there..



Greetings, FDA!

I'm writing to you concerning your proposed regulations re: e-cigarettes.

Allow me to introduce myself: I'm a former cigarette-smoker, and also a proud member of CASAA. I have been vaping for about 2 years now. And I know the pharmaceutical companies don't want to hear this, but e-cigarettes have truly been a life-saver for me.


Tonight I'd like to discuss "dual-users," i.e., cigarette-smokers who also use e-cigarettes. I understand Mitch Zeller is publicly concerned about this sub-group of people, so allow me to set the record straight.


When I first started vaping, it was for a couple of reasons. One, I wanted to improve my overall health, as years of inhaling burning tobacco was slowly killing me. And two, it was so I could have a bit of nicotine indoors when it was cold or raining outside, without stinking up my home and creating an unhealthy environment for loved ones.

Well, something happened: I discovered I enjoyed vaping with e-cigarettes much better than smoking those nasty unhealthy combustible cigarettes that apparently Mitch hates so much. Imagine that! So, I started vaping more, while smoking fewer cigarettes. After several months of part-time vaping and part-time smoking, or what would be defined as dual-use, I found myself no longer smoking combustible tobacco! Isn't that awesome news?


I suppose it had to do with gradually learning more about these e-cigarette products, and buying better ones during that time. The bottom line is, there's a learning curve with these things. There's quite a bit of variety out there, and it takes some time for smokers to discover what works for them, personally, whether in terms of flavors, e-liquid ingredients, battery life, battery charging, form factor, price, etc., as everybody is a little different.

As they figure out what they like in particular about vaping equipment and e-liquid, and how it fits into their individual lifestyle and personal preferences, many of these dual-users gradually quit smoking and go onto full-time vaping. If that takes a few weeks, or a few months, or a year or more, yes, they will probably be a dual-user for a while. This is reality. But this is not a bad thing, as many smokers eventually make the switch, especially when they have access to choices in the marketplace. They simply need a transition period, which is quite understandable and acceptable.


E-cigarettes do not cause smokers to want to delay quitting combustible tobacco, as Mitch is apparently so publicly concerned about. In fact, it's the opposite! They learn that they can still get their nicotine, but without all the smelly, disgusting and unhealthy aspects of combustible tobacco. Why smoke really bad-tasting cigarettes, for example, when you can enjoy something that tastes better? If anything, they now want to quit smoking as quickly as possible as their taste-buds start working again!

I assure you, this is not at all uncommon. Many who now vape full-time were once dual-users. I speak from personal experience, and I speak from reading and hearing countless stories from others. This is how it happens. These are real-world end-users of the products you are unfairly trying to regulate. We know exactly what we've gone through, and why, and how, where and when. Can those at the FDA and other non-vapers who are submitting comments against e-cigarettes personally say the same? No, I didn't think so. You simply have no real-life experience with these products as an end-user. You are not qualified, to put it bluntly, to understand even a small portion of all this.


These e-cigarettes are life-savers. And for you to implement undue regulations on these products will be criminal, as you will not only kill off a huge chunk of the current e-cigarette industry, but also assist in subsequently killing off a huge chunk of current cigarette-smokers who otherwise would have had a good chance at a much better nicotine alternative.

Are you willing to live with this in the eyes of God, in the eyes of the court of law, and in the eyes of a very angry and upset populace of millions of cheated smokers, e-cigarette users and all their loved ones?


Thank you for your time and very careful consideration.

 

[DrMA]

Very nice!

 

[Augmented Dog]

Well done!
They most likely are willing unless enough of us make noise and news about the subject. How often do you hear anything at all on the subject except on forums like these? The topic needs (WE need) mainstream coverage to build the knowledge base, understanding and support of non-vapers if we expect to be able stop unreasonable regulation of vaping and e-cigs.
Just my two cents added to yours.

 

[bigdancehawk]

Well done and very much deserving of broader readership than a single FDA pencil pusher. The "duel use" thing is a make weight argument devoid of logic, evidence or common sense. Duel use is a good thing and the only purpose their "concerns" serve is to illustrate how feeble the reasoning is behind the proposed regulations.

 

[Kent C]

"Dual use" is a construction that was 'reverse engineered' to justify the deeming in the face of so many smokers going to ecigarettes. Zeller said it best, but Glantz is the junk scientist that likely floated the idea - that he (Zeller) thinks it is good that the hard core smokers (who would never quit) have moved to ecigarettes, but his 'concern' is for the 'greater number' of smokers who want to quit and may quit completely, but are attracted to ecigarettes in the manner that Homer's Odysseus is lured by the Sirens singing And as Zeller thinks, those dual users would also be killed by their continued addiction to nicotine and that it would be a pathway back to smoking.

Aikanae1 points out in another post - "IMO if ecigarettes were a gateway to smoking, wouldn't the smoking rates be rising instead of dropping? I think that's concrete proof since ecigarettes have been around long enough to appear in trends."

I've pointed out that those dual users who are 'concerned about their health' go to ecigs because of that. Zeller attempts to make the argument that they are 'concerned enough to perhaps attempt to quit', but then throws that 'concern' out, when he says that via ecigs, they'll go back to cigs. So the 'reverse engineering' doesn't really make sense, except to guys like Harkin, Durbin, Rockefeller, et al.

But that and with the dropping sales of cigs and the boom in ecigs, Zeller et al. remain unfazed. They MUST have a greater number of people affected so as to justify carrying out their plan under the guise of the 'greatest number' or in their jargon - 'for public health'.

 

[aikanae1]

"Greetings" (let's have a beer and chat about this) LOL! I definatley like your style.
Question: Did you loose formatting when you submitted your comments? I did and that made it hard to read.
I have a hard time keeping any comments down to under 5,000 words. Ugh.

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As a 45 year + smoker, I am a primary stakeholder in FDA's deeming regulation. I've tried patches, gum, acupuncture, hypnosis, and except for chantix (just once), more times than I can count. My 2 non-smoking ex-husbands probably have a better count. Nothing made much difference. Finally, quitting became so demoralizing and demeaning that I gave up on quitting.

I bought an electronic cigarette out of curiosity at a gas station. It was better than other products but didn't help much. Almost a year later I walked into a local vape shop and the staff helped me find an electronic cigarette customized to help me quit. The level of nicotine I needed was less than the daily dose in NRT's. I was missing the vapor. Maybe it's inhaling deeply. There's a lot to learn beyond nicotine addiction.

I remembered from "Quit Smoking" literature to change familiar flavors when quitting so I intentionally did not choose tobacco flavors. My taste buds were numb so all I could taste were strong, sweet flavors like gummy bears. No joke.

I firmly believe cigarette smoking should be discouraged and vaping is one more way to do that. What I see as the biggest health benefit is having parents and grandparents around to council kids against smoking without puffing on a cigarette while I'm doing it. I can smell if my teen has smoked now and before I couldn't. That is an immediate benefit - not something 20 years from now. Vapers can become militant non-smokers just as fast as ex-smokers do.

Vapers are also compelled to give other smokers the opportunity to quit like ex-alcoholics do with AA. That is how the electronic cigarette industry has grown so fast without advertising. Devices were designed to help smokers make a quit attempt which a corporation can't do as easily because quitting is a "limited growth market" (WSJ, Herzog, Wells Fargo Investments) which was a reason tobacco companies didn't buy into the market until after 2012. In fact, tobacco companies have contributed nothing towards developing products that help smokers quit - just as ineffective as pharmaceutical companies have been for all these years. Chantix is an example of a cure worse than the disease with thousands of deaths.

Just as cigars can be divided into 2 markets, so can electronic cigarettes. There is the phony tobacco company device that has changed little, standardized, sold everywhere for less than $30, most likely to promote dual use and most accessible to youth. If the FDA were worried about "renormalizing smoking" that is the device to target.

Instead the FDA is targeting 99% of unique products, some are manufactured in the USA including chipsets. These devices cost more than $100 and are designed to help smokers quit, avoiding dual use, customizable, sold in stand alone shops where screening is more effective and support thousands of small independent business'. One online retailer claimed to offer 10,000 unique products not including eliquids. These devices require more knowledge to operate so they are less available to youth exploration.

The OMD Economic Impact didn't even bother to collect figures on the electronic cigarette market and instead used a percentage of cigar sales - what do cigar sales have to do with ecigs? They also predicted the market would be reduced to 25 products and state that consumer choice would be limited but not necessarily the volume of sales. On what planet does that advice apply to?

The FDA has no idea what they are regulating nor does it seem like they care. I'd swear the bulk of the deeming regulations were written by industry lawyers and accountants since only the pharmaceutical and tobacco companies could see the value in the regulations, as "exciting" and it appears that TVECA (tobacco companies) had advance knowledge before regulations were published.

I understand the FDA is largely supported by application and filling fees which also make it appear to be an employee of the industries paying them and there's little reason to disagree when most of the regulations concern competition and marketplace control and little to do with valid (not imaginary) threats to public health.

If electronic cigarettes posed a risk for non-smokers wouldn't that be spotted as a trend over the last five years? Instead both youth and adult smoking rates have declined proving that is not a risk and ecigs are a benefit to public health.

The FDA risks undermining their credibility and loosing public trust by supporting deeming as it is written. When I read about how Sweden came to have the lowest smoking rates and realized I could have reduced my harm ten years ago, I wondered where I could send my medical bills for reimbursement for the damage done to my health from being mislead by the FDA and CDC. I can never fully trust these agencies again.

I know the FDA understands the continuum of risk for nicotine products and it's past time to tell the public the truth. I hope the FDA will do the right thing.

Note: I don't believe the FDA or Congress would consider a ban on cigalikes since they pay too much of their paychecks and that's why I pick on them. I think eliminating competition (small business) and a specific sector of the market has regulations against it (SBA and other comments). Zeller is clearly afraid of some type of court action, which IMO is leverage. And I'm often wrong.