FDA and e-cigarettes: Your action needed now.

Status
Not open for further replies.

glassmelter

Full Member
Verified Member
Dec 21, 2011
34
27
Louisiana
Got mine in. Thanks for the reminder.

Comment tracking No. 1jx-833z-hku3

I was a 2-pack per day smoker for 36 years. I tried all manner of methods to quit, including nicotine patches and gum, but always returned to smoking in spite of the damage I knew I was doing to my health and the growing expense of cigarettes.

In late 2011 I purchased a Blu brand e-cig at Walgreens out of curiosity. To my surprise, within a day after I began using the e-cig, I found I no longer wanted the "real" cigarettes. The vapor from the e-cig tasted better, did not have a nasty, lingering odor, and delivered the nicotine I needed and the sensation of smoking without the carcinogenic effect of burning tobacco and without other harmful chemicals that are added to tobacco cigarettes by manufacturers.

2 days after purchasing my first 3-cig, I threw away half a carton of Camels and began using the e-cig exclusively. I have not smoked a tobacco cigarette since. Since I've been using e-cigs, my cardiopulmonary health has improved. I'm no longer out of breath after the slightest exertion. My chest no longer aches. My smoker's cough is gone. Electronic cigarettes made it simple and painless for me to switch from a product which is a known killer to one that is no more harmful to me than the caffeine in my morning cup of coffee. This is a miracle product and I strongly believe that all tobacco smokers should have access to it.

I respectfully ask that the FDA not regulate electronic cigarettes in any way that makes them less available, less effective, or less affordable. I urge the FDA not to propose "deeming" regulation, as this would effectively ban e-cigarettes, and sharply increase the price and reduce accessibility of the products.

Finally, I ask that the FDA remove from its web site inaccurate information about electronic cigarettes which serves to mislead and scare consumers who might benefit from these products. For the FDA to perpetuate such misinformation is unethical and deleterious to the public health.

Thank you
 

FantWriter

Super Member
ECF Veteran
Dec 11, 2010
601
5,429
Kentucky
I kept mine short (589 characters) because big blocks of text rarely get read.

Sadly, I felt it in my best interest to delete my favorite line: "Please do not make me choose between going back to smoking or becoming a criminal because regulations will make my only alternative illegal." (Alerting the powers-that-be that you're going to be a rebel is never a good idea.)
 

DC2

Tootie Puffer
ECF Veteran
Verified Member
Jun 21, 2009
24,161
40,974
San Diego
I kept mine short (589 characters) because big blocks of text rarely get read.

Sadly, I felt it in my best interest to delete my favorite line: "Please do not make me choose between going back to smoking or becoming a criminal because regulations will make my only alternative illegal." (Alerting the powers-that-be that you're going to be a rebel is never a good idea.)
I would have done it...
Or would I have?

It's not like they are keeping a list...
Or are they?
;)

I am really impressed with the comments I am seeing.
We've got some smart cookies around here.
:)
 

Winemiller1

Senior Member
ECF Veteran
Dec 17, 2012
83
36
46
Iowa
Submitted tonight!


Skip Navigation


Home Help Resources Feedback and Questions
Advanced Search
Start of Main Content
Your comment was submitted successfully!
Thank you for submitting a comment on the following Proposed Rule:

Food and Drug Administration Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products; Report to Congress on Innovative Products and Treatments for Tobacco Dependence; Public Hearing; Extension of Comment Period

Agency: FDA
Document ID: FDA-2012-N-1148-0011
Your Comment Tracking Number: 1jx-8340-wuf1
Note this tracking number to find your comment at a later date.

When will my comment appear online?
After submitting your comment, you will not be able to view your comment until the appropriate agency reviews and publishes it on Regulations.gov. Given certain regulations may have thousands of comments, processing may take several weeks before it is viewed online. To obtain further information, please follow-up with the agency contact listed in the document soliciting your input. To view this document click the link above.
How do I find my comment in the future?
The best way to find your comment in the future is to enter your Comment Tracking Number in the search field on the homepage. You can also search by keyword or submitter name.
Home

Search
Advanced Search
Browse By Category
Browse By Topics
Learn
About Us

eRulemaking Program
Newsroom
Agencies
Awards & Recognition
Enhancements & Fixes
Resources

Site Data
Regulatory Agenda
Agency Reports Required by Statute
Executive Order 12866
Executive Order 13563
Developers Beta
Help

How to use Regulations.gov
FAQs
Glossary
Connect With





Feedback and Questions
Privacy Notice
User Notice
Accessibility Statement
Partner Sites
ExchangeFederal RegisterReginfoThomasUSA.govE-GovOpengovParticipate Today!
 

elfstone

Ultra Member
ECF Veteran
Verified Member
Jan 15, 2012
2,601
3,018
OH
Regarding your earlier post that being a "tobacco product" was a quick fix shortcut and we should have fought harder for a different designation, that was not possible. This was determined via a lawsuit and a judge's opinion. The FDA was arguing that e-cigarettes were drug treatments and must be banned until they could be proven "safe and effective" as a way to nicotine abstinence, the same as approved NRT products are required. At the time of this case, the FDA regulated nicotine in only 2 ways - as drug treatments or tobacco products. The e-cig companies only had those two choices to choose from and of the two, e-cigarettes which allow for the recreational use of tobacco-sourced nicotine are much more like smoke-free tobacco for "intended use" than NRT. There is no category for "used like tobacco leaf product but contains no tobacco leaves" and at the time of this trial, no company had the time, money or influence to get Congress to create such a category before the judge made his ruling. Now that the FSPTCA has passed, there is the possibility of products being categorized as "modified risk," which most e-cigs would be able to apply if the FDA hadn't made it impossible to qualify.

Hope that clears some things up for people! :)

This needs to be made known better to every vaper. This is the situation, but it doesn't necessarily make sense. The way law works is certainly not what most people would arrive at rationally.

The crux of the matter, though, is why the FDA makes it impossible for e-cigarettes (or anything newer and better that might come up in the future) to qualify as modified risk products? That is what a sane mind can't comprehend.

As far as I can see, the FDA, same as the EU authorities, still do not believe in harm reduction. They feel that smokers should not have any other choice than quitting smoking and nicotine altogether. Even more perverse and absurd, based on the requests made at this particular hearing by pharmaceutical manufacturers, smokers could continue a nicotine habit only if that is indefinite use of approved NRTs. In this scenario, there is no chance in hell that the FDA would reconsider its position about e-cigarettes.

Edited to add: Bear in mind that there are smoke-free tobacco products which are just as safe as e-cigarettes are believed to be. In fact, it's the plethora of studies showing the safety of Swedish snus that help support the likely safety of e-cigarettes. Given this fact, it's irrational to be defensive over classification as a "tobacco product."

Well, e-cigarettes are not believed to be safe, not outside our little bubble. As for the smokeless tobacco products, the only thing that they bring up out there is that kid with a missing jaw, and they end the discussion. Reason has no place.

EU almost risked its own fracture in trying to ban snus again in Sweden. They BAN snus. There are two large cohort studies that showed essentially no increased cardiovascular or cancer risk in snus users as opposed to non-users. Population data shows Sweden as having an abnormally low number of smokers. In depth analysis showed no trend of non-users becoming snus users and then becoming cigarette smokers thus disproving the 'gateway drug' hypothesis. Still, EU authorities brush it all off as something "culturally specific to Sweden" that "might" not be applicable to the rest of member countries. Does it get more absurd than this?

So no, it's not rational to shy away from a "harm reduced tobacco product" classification, but it's not an advantage either since "they" are not rational.
 
Last edited:

rotku

Super Member
Supporting Member
ECF Veteran
Sep 4, 2012
458
333
64
columbus, oh
Got my heads up e-mail. Although not "text-book" I submitted the following:


Hello,
I am commenting to support continued access to electronic personal vaporizers (e-cigs). I smoked for 35 years with little success at quiting. A pack a day habit was both expensive and unhealthy. The personal vaporizer has filled the void of a behavioral addiction I could not beat for a long time. My wife, a non-smoker, is a huge advocate of the switch, The foul smell of cigarettes as well as the proven health dangers are happily replaced with vaping. We both recognize there could be health issues with personal vaporizers but the goal would eventually be nicotine free. I have converted at least a half a dozen co-workers to switch away from cigarettes. This would not have been possible without the huge success of personal vaporizers. Please consider this when determining any actions related to "e-cigarettes".


Hope others were able to submit as well. Good luck.
 
E-cigs are supposed to be a healthier alternative to cigarettes, nothing else. Not an introduction to nicotine for minors because of the fruity flavors, the flavors are made specifically for adults to Vape all day. The health benefits of quitting smoking to vaping are infinite. The fda says that people should not Vape because they don't know what's in it, it's simply five ingredients. Propilyne glycol, vegetable glycol, organic or in-organic flavoring. Possibly some coloring depending on what company created it. That's all, that's in it. I really hope they are not suggesting that people would be better to keep smoking just because they know all the 4, 000 chemicals in cigarette smoke. Personally my cardiovascular health increased ten fold after only vaping for six months. I smoked cigarettes for 14 years so I could specifically measure the increase in my stamina while exercising, or doing anything to increase my heart rate like simply walking and not being out of breath. In my opinion the gvt. and the FDA could care less about the publics health in this matter with their witch hunt on e-cigarettes because of their total disregard for over 15yrs of research in Europe. None of the data has any negative health effects compared to cigarettes and second hand smoke. And countless testimonials of their constituents who have been only positive in their support for e-cigarettes. Which leads me to question their motives for wanting to rewrite the tobacco tax to include e-cigarettes. A tax with a 120% increase on a product that is saving lives of countless addicted cigarette smokers. Once again the primary objective of electronic cigarettes is to provide current cigarette addicts a healthier alternative to cigarette smoking, nothing else. No other alternative schemes or misleading research or marketing towards teens or any person not already addicted to nicotine.
 

natchez

Senior Member
ECF Veteran
Verified Member
Aug 4, 2012
76
52
Nevada
I sent the following to the FDA, my two US Senators and my Congressman:

To the FDA:
As a 40-year former smoker who was only able to stop utilizing electronic cigarettes I urge you to not try and further regulate or ban these products. They have been a godsend for both my wife and I. I tried all of your previously approved therapies without success and with some awful side effects from the patches.
I have been gradually weaning the amount of nicotine in my electronic cigarettes down. My doctor is also very supportive of this process and my lung capacity tests have improved after switching to electronic cigarettes. Within 90 days I was able to breathe about 20% better. I have also been able to resume many activities that I had had to forego while being a heavy cigarette smoker.
Electronic cigarettes may not be good for folks, but in my experience they are world’s better for me than regular cigarettes. The text on your website regarding electronic cigarettes is dated and until a true long-term test is performed on today’s high quality electronic cigarette products it is really too soon to draw any significant scientific conclusions. Accordingly, proposing the "deeming" regulation could effectively ban e-cigarettes, and would sharply increase the price and reduce accessibility of the products even if you exempted e-cigarettes from the most onerous provisions in Chapter IX.
I urge you to consult with the American Association of Public Health Physicians who has taken a serious view towards a tobacco harm reduction policy. Electronic cigarettes provide this option to many, including this former cigarette smoker. The electronic cigarette is not a panacea, but a very useful tool in reducing cigarette smoking.
See also this Boston University study indicating that the electronic cigarette may be a helpful tool: News Archive
Thank you,
Dr. Richard Mason
Reno, Nevada
 
Status
Not open for further replies.

Users who are viewing this thread