CASAA Call to Action! Submit Written Comments – Sec. 918 of Tobacco Act

[kristin]

History:

The FDA held a public hearing on Section 918 on Monday, December 17, 2012. Many THR advocates testified. See: http://www.e-cigarette-forum.com/fo...etails-analysis-fdas-december-17-hearing.html

For the hearing, we issued a Call to Awareness. This is now a related (as noted below) but separate Call to Action. The FDA will use the testimony that was given at the December 17 hearing, plus the written comments submitted by January 16, 2013 as input for the report to Congress required by the tobacco Act.

How to Submit Written Comments:
To submit a comment electronically: On the pageRegulations.gov, click the “Comment Now” button. Comments that you type into the comment field are limited to 2,000 characters. If your comment is longer, you can upload a file that contains your comment and just type “See attachment” into the Comment field.

To submit a comment by U.S. Mail: Send to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number [Docket No. FDA-2012-N-1148].

Electronic or written comments will be accepted until January 16, 2013.

What to Say:

1. Describe your history as a smoker: When did you start? How long did you smoke? How much did you smoke....

[READ FULL CTA]

 

[cocoabellaRSD]

What are we supposed to put in the field "Organization Name"?
that is a mandatory field when you submit your letter electronically.

History:

The FDA held a public hearing on Section 918 on Monday, December 17, 2012. Many THR advocates testified. See: http://www.e-cigarette-forum.com/fo...etails-analysis-fdas-december-17-hearing.html

For the hearing, we issued a Call to Awareness. This is now a related (as noted below) but separate Call to Action. The FDA will use the testimony that was given at the December 17 hearing, plus the written comments submitted by January 16, 2013 as input for the report to Congress required by the Tobacco Act.

How to Submit Written Comments:
To submit a comment electronically: On the pageRegulations.gov, click the “Comment Now” button. Comments that you type into the comment field are limited to 2,000 characters. If your comment is longer, you can upload a file that contains your comment and just type “See attachment” into the Comment field.

To submit a comment by U.S. Mail: Send to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number [Docket No. FDA-2012-N-1148].

Electronic or written comments will be accepted until January 16, 2013.

What to Say:

1. Describe your history as a smoker: When did you start? How long did you smoke? How much did you smoke....

[READ FULL CTA]

 

[Placebo Effect]

You can say "None" or "Individual"

 

[RoseB]

Thank you for posting this I almost forgot. BTW can I do both? Fill it out online and mail in a letter? As long as it's the same thing with all of my info?

 

[zapped]

Done and thanks for posting this!

 

[redg8r]

Will do my part

 

[TennDave]

Just submitted- had to keep cutting my comments short as I went over and over my limit.
I would have submitted a text file as an attachment, but I was thinking more in line with too much and they wouldn't read them. I'll leave attachments to CASAA and those who have charts, graphs. etc. This is what I submitted:

I am very pleased to see that there is consideration being given for innovative products and a re-look at current NRTs. In my opinion, there should be no action to restrict them- only that quality, safety and effectiveness be TRUTHFULLY conveyed.

I was a smoker for 32 years- went up to 2 packs a day and had trouble breathing and would cough in the morning. My dentist always complained about the staining and tarter on my teeth when I went for a cleaning. I tried numerous times on my own to quit but without success. I also tried patches, gums and lozenges, but I found that they did not give me enough nicotine in order to stop smoking. On many occasions with one patch on each arm, my cravings got so bad, that I still went out for a cigarette. I finally got discouraged and just resigned myself to being a smoker until I died. Then I saw a young man puffing on an e-cigarette at a bar so I asked him about it. This was in December 2010 and within a week of using an e-cig I had no desire to smoke again- I was amazed as were my friends! The funny thing is, that although I started off with a large amount of nicotine, within a few months, it was as if my body was telling me I did not need so much, so I cut my nicotine in half. I find now that if I cut it any further, I have cravings and am not as functional. I have used e-cigarettes for the last 2 years and my dentist is happy with me and my doctor is ecstatic that I quit smoking! I breathe easier and I do not have a cough in the mornings. I truly believe that e-cigs saved my life! E-cigs work for me because they satisfy the cravings and the behavioral aspect of smoking.

Why aren't NRT's more effective? From my own experience, it's the amount of nicotine. Flexibility is needed with these products so people don't have cravings. The time limits are ridiculous too- everyone is different and require a different time period to quit- or maybe some need a maintenance level.

Please allow flexibility with variety!

 

[Vocalek]

Thank you for posting this I almost forgot. BTW can I do both? Fill it out online and mail in a letter? As long as it's the same thing with all of my info?

Yes, you can do both, but it isn't required. You can even submit different things in each manner. CASAA is planning to supplement its in-person testimony with additional information via the online comments.

 

[Docliv]

I just sent the following 1964 character comment in:

I am 63. After smoking 2 packs of tobacco cigarettes a day for over 45 years I discovered that I had Type 2 diabetes. I then had congestive heart failure and had to have open-heart surgery and a pacemaker implanted. Of course (left with 1/3 of my heart), I quit smoking. Despite patches, nicotine gum and lozenges, I never seemed to make up for the loss of my very favorite (albeit unhealthy) habit. After years of frustration with the likes of nicotine patches, gum and finally lozenges (I was up to 8-9 - 4mg lozenges - 32-36mg per day) and still unsatisfied and unhappy... I heard about e-cigarettes.

Within 24 hours of receiving my 1st e-cigarette, I was “vaping” not smoking. I could “smoke” as much as I wanted without the damaging chemicals present in tobacco cigarettes. In less than a week my coughing was gone and 25 months later (and not 1 tobacco cigarette smoked) my doctor says I am in perfect health. I breathe normally, have much more energy and have no desire to smoke tobacco at all.

I have used 11mg. nicotine in my e-liquid from the beginning and 0 nic. in the evenings (so I can sleep easily) have no desire to change the dosage. With all the flavors available and the cool, smoothness of vaping, I truly enjoy vaping more than I ever did tobacco smoking. I am certain that e-cig technology is a godsend for any tobacco smoker. The transition is nearly instant and I feel this will save millions from an early, painful death.

I urge the FDA to not propose the "deeming" regulation because it would ban e-cigarettes, and would sharply increase the price and reduce accessibility of the products even if FDA exempted e-cigarettes from Chapter IX. Also, please remove the inaccurate and/or misleading text from your FDA web site. For example, the amount of carcinogens you detected in e-liquid is no higher than in pharmaceutical nicotine products such as the patch and gum, and the only toxin detected was at a level that does not endanger health.

 

[cocoabellaRSD]

You can say "None" or "Individual"

okay, thanks for the reply. will submit my letter today.

 

[cocoabellaRSD]

submitted my letters(s) today to the FDA, both electronically and via snail mail. I hope everyone on ECF will take the time to write a letter to the FDA. Thanks to CASAA for fighting for the rights of vapers and for keeping us informed on legislative matters.

 

[Sadluckdame]

I submitted.
Thank you for posting this for us.

 

[Dee74]

Done, this needs to be sticky on the front page of forum!

 

[Vocalek]

Good idea, Dee. I just asked Smokey Joe to publicize this thread.

 

[Trick]

Submitted. For the sake of a bump, here's what I've sent both electronically and via post:

To whom it may concern,

I began smoking at the age of 14. Since then until now, at the age of 46, I have tried countless times to quit. I've tried patches, gum, lozenges, hypnosis, food substitution, and even juggling, among other methods, and none of them worked for me. Even after a heart attack earlier this year, I was unable to so much as cut down on my smoking. Every time I tried was a miserable experience where I experienced bad dreams, irritability, and a host of other discomforts, and every time ended in failure when I would inevitably go back to smoking, lighting up two packs a day until quite recently.

In December of this 2012, I decided to try e-cigarettes, using a juice with 36mg of nicotine per ml. Within a day or two, I knew this time would be different. Except for some very mild cravings for a cigarette occasionally, none of the other symptoms of tobacco addiction appeared. I was not anxious or irritable. Other people smoking nearby didn't make me want one. Now, a month after my last cigarette, I am confident I'll never need one again. My craving for them is completely gone. I can breathe more freely, my sense of taste is returning, and I'm feeling better than I have in decades.

In the last month, I have slowly cut the nicotine content of my e-cigarettes to 6mg/ml, with the intent to wean myself off nicotine completely, and I have every reason to believe I will succeed. Why? I believe it is because I've been able to regulate my nicotine throughout the day at a rate which works for me. None of the other cessation products I've tried gave me this degree of control over how I quit.

I am very concerned with the idea of nicotine levels being strictly regulated. Obviously, different people are going to need different levels of nicotine, for varying lengths of time, in order to quit cigarettes comfortably. I would urge the FDA not to restrict nicotine dosage to low levels that might encourage quitters to use multiple products just to stave off withdrawal symptoms.

I would also strongly urge against any rulings that would prevent or restrict flavorings. One of the things that made my quitting attempt successful was that I enjoyed the taste of the e-cigarette. That, coupled with the nicotine delivery, helped ensure I did not put down the e-cigarette and pick up a real one. Being able to choose a flavor that I enjoyed was absolutely critical to my success in quitting.

I sincerely hope the FDA does not propose the "deeming" regulation, and it would limit access to e-cigarettes for the many people for whom they have been an extremely effective tool for harm minimization. These are devices that have not been shown to have any real cancer risk (regardless of the arguably misleading information which currently appears on the FDA's site), and are certainly far less of a health risk than conventional cigarettes, if they are a health risk at all.

Please do not propose regulation that would limit access to e-cigarettes and associated products to people like me; people who have finally been able to quit after decades of smoking, because they were finally able to find something that worked.

Respectfully,


Patrick R. Morris

 

[nomoMarlboro]

The link for the new comment did not work for me. Is it working for anyone else?

 

[BigLungs]

I just tried to submit my testimony and it is saying the document no longer exists. I thought they were supposed to be accepting until January 16th!!

 

[mwa102464]

I just tried to submit a comment also and it would not accept it,,,, did the Feds cut us off from any further comments ? where we blowing up there comments section to much or what ? Rotten Feds

 

[Vocalek]

Here is what happened. The FDA could have contacted the Help Desk at Regulations.gov to ask them to change the cut-off date from January 2 to January 16.

Instead, they entered a new Docket ID

CASAA will be changing the link on the CTA to the following:

http://www.regulations.gov/#!searchResults;rpp=25;po=0;s=FDA-2012-N-1148;fp=true;ns=true

"http://www.regulations.gov/#!searchResults;rpp=25;po=0;s=FDA-2012-N-1148;fp=true;ns=true"

There is a Comment Now button on that page, and it works.

 

[idahohermit]

@IMTrick

Absolutely LOVE your comment. Pretty much covers my story too. Thank you for mentioning the flavors as well.