FDA issues notice of intent to propose "deeming" regulation by April of 2013 for e-cigarettes and other tobacco products

[Janet H]

i hope what I submitted was OK -
I am 64 years old and have been smoking at least a pack a day since I was 14 years old. Many attempts to quit smoking were unsuccessful until I found eCigarettes. Assuming that I was never going to quit I got the eCigarette to help me cut down, but to my surprise, found that I no longer needed or wanted cigarettes. I've now been vaping for 17 months. My wheezing stopped, I feel better, no longer have coughing fits and am no longer contributing to 2nd hand smoke. I no longer have panic attacks and am happier, alert and more relaxed, which was not the case the times I was briefly able to stop smoking. During my physical yesterday my doctor was very happy with my check up. I also have several friends who have successfully switched to vaping exclusively or drastically reduced their cigarette use.

The key to my success in quitting smoking is that I was able to control the strength and duration of my vaping.

I am concerned that the FDA will regulate the eCig industry in a way that will interfere with how people manage their vaping. We are all different and our need to vape is different. While I would like to know that the products I use are pure, I need to control what and how I use the products to my health advantage.

It is well documented that smoking has thousands of additives that are extremely harmful. There is also much documentation proving that vaping is no where near as harmful. Smoking is still legal and harmful. I would think that if the FDA was truly interested in protecting the public they would encourage vaping.

I am very concerned that the tobacco and drug companies will want to control the vaping industry for their profit and only see them making it more difficult for people to be able to help themselves. I would hate to see the FDA help them succeed.

Respectfully.

 

[Plumes.91]

US bans haven't really stopped chinese imports of many things, including drug analogues and weapons. An amphetamine analogue becomes bath salt, a shipment of brass knuckles become belt buckles. The FDA may ban devices that are not reminiscent of cigarettes, but our precious tanks and rebuildables have a good chance of becoming aroma therapy and tobacco vaporizing devices. This isn't going to be a pretty transition and we need to do our best to avoid this because as some of you may know, even the loopholes get banned eventually. We cannot sit back and allow this to happen to our lifestyle. This is who we are. We need to fight to preserve that.

 

[nerofiend]

I have a feeling that all of our testimonials about how we were able to stop smoking by using an E-Cig and how it saved our lives is going to be the very reason they make sure that they get them banned.

We all know they dont care about anyones health, only money. And E-Cigs take a lot of that money away from them. They will seek either TOTAL control of E-Cigs, or a TOTAL ban on them. They will accept no middle ground.

 

[Vocalek]

I completely agree with what you have stated here.

I did write to the link provided by CASAA , my point . is that even after following the link (which I received in an e-mail) is it wasn't real clear where to write ( there were several links and when followed were a bit confusing) I saw many people simply "replied" which I don't think got to the right place.. . I wish there was a central pro-vaping org. that broke it down and made i easier to get involved. I almost gave up.. (pathetic , I know ..but it's honest and I doubt I'm alone)

CASAA is the most central pro-vaping organization. We are the people who have been following what the government is up to, sending out newsletters, and posting Calls to Action on our web site. We are the people who show up in person at FDA public hearings and testify.

If there is another pro-vaping organization doing all this, they are doing a good job of hiding, because I haven't seen them showing up consistently to testify at the FDA.

Some of the confusion about where to go to comment was caused by the FDA. Originally, their deadline for commenting was January 2, 2012, a mere 3-1/2 weeks after the public hearing (for which we had only a week and a half notice). Somebody must have complained, because on the day of the hearing, the FDA announced that it was extending the deadline for comments to January 16.

How comments are collected by the government is that the Agency proposing a regulation posts a document on the web site Regulations.gov. In this case, the FDA posted Docket ID FDA-2012-N-1148-0001. So the web site Regulations.gov put a Comment Now button on that Docket page. Unfortunately, the FDA forgot to notify Regulations.gov that the deadline for comments and been changed, and the Comment Now button on that docket expired. This occurred AFTER the email was sent out by CASAA. Those who followed the link in that email BEFORE January 2 were able to leave their comment via the original document. Those who attempted to follow the link in that email AFTER January 2 found that there was no Comment Now button.

The FDA had to file a new document to continue collecting comments. It is the same "root" number, except that the last 4 digits are "0011" instead of "0001". CASAA updated the link on our Call to Action page the next day. All anyone needs to do is go to our CTA page, and click the link provided. The page explains what the action is about and even provides a list of things to say.

If you "replied" at the bottom of the CTA page, your comment did not go to the government. It was merely stored on CASAA's web site. If that's what you did, please go back to the CTA page and follow the directions there.
CASAA: Call to Action! Submit Written Comments – Sec. 918 of Tobacco Act

This is a quote from the CTA page.

How to Submit Written Comments:

To submit a comment electronically: On the page http://www.regulations.gov/#!documentDetail;D=FDA-2012-N-1148-0011 (Link updated 1/3/13), click the “Comment Now” button.

 

[DC2]

I have a feeling that all of our testimonials about how we were able to stop smoking by using an E-Cig and how it saved our lives is going to be the very reason they make sure that they get them banned.

This used to be a concern of mine, until I realized that they already know most everything there is to know about us.
The only thing they don't know yet is how much of a ruckus we will make if they screw us.

And to be honest, that is the one thing I don't know yet either.
But I have a LOT of hope, because this is our lives at stake, and that SHOULD make for quite an uprising.

And that is the one reason I feel okay about our flood of comments.
It shows we are being vigilant, and it might just make them think about things a bit.

 

[markdm4805]

This almost seems like a coordinated attack.
EU vapers are busy at this time with petitions and other actions against proposed EU legislation that effectively puts e-cigarettes in the pharmaceutical field.

Sent from my GT-I9000 using Tapatalk 2

Bingo exactly how I have felt. Mistakenly I thought for a nanosecond that some good might come of the public hearing until I read the text of the deeming regulation. If you read the proposed regulations it puts BT and BP in position to get everything they want including controlling share of the E Cig market and deep sixes all of the mom and pop companies. I have seen many threads on here and talked to many vapers who rejoice that big tobacco is in this fight with us. I caution everyone that they are not here to help us or to make sure that our mods are protected. This is very evident when you read the deeming regulations that the FDA can give BT what they want while still sacrificing us. Also as a reminder I looked at the comments page and saw a total of 17 comments. I really hope and pray out of 250 million vapers that is not all of the comments. We as vapers are the only allies in this fight. Dont trust BT or BP or the FDA if you have not commented yet then head on over.

 

[budynbuick]

I know I've tried absolutely every idea I could come up with, and none have really worked.

Just because folks have not posted in this thread does not mean they have not responded in the petition. Also, pretty much all have acknowledged the fda is crooked. With that said, why would we think they would even read our micro minority petition, much less respond to it? Petitions only count when a majority sign it. A democracy does not listen to the individual, but rather the majority. Majority trumps individual rights in a mobocracy. Majority/mob rule. Build a majority & you can make up down, & down up.
Keith

 

[Vocalek]

Bingo exactly how I have felt. Mistakenly I thought for a nanosecond that some good might come of the public hearing until I read the text of the deeming regulation. If you read the proposed regulations it puts BT and BP in position to get everything they want including controlling share of the E Cig market and deep sixes all of the mom and pop companies. I have seen many threads on here and talked to many vapers who rejoice that big tobacco is in this fight with us. I caution everyone that they are not here to help us or to make sure that our mods are protected. This is very evident when you read the deeming regulations that the FDA can give BT what they want while still sacrificing us. Also as a reminder I looked at the comments page and saw a total of 17 comments. I really hope and pray out of 250 million vapers that is not all of the comments. We as vapers are the only allies in this fight. Dont trust BT or BP or the FDA if you have not commented yet then head on over.

Actually, as of this moment 1,218 people have left comments. This number is displayed in a box at the right-hand column on this page: Regulations.gov

When you scroll down, you see that there are links to only 17. This is typical of the application. The agency that asked for comments gets to "approve" them for public display. So far, we have not seen any of our comments on past postings censored. They show up eventually, but it can take weeks.

You might want to take a look at some of the 17 that are now available for viewing. (Click on the blue "View All" link next to the red headline "Comments".) Notice that the most recent posting date was January 4. Those are probably the comments that were submitted under the old Docket ID document number (ending in "-0001").

In fact, I highly recommend reading the PDF attachment that Jim Solyst submitted with his comment. To see the file, click the little button labeled "PDF" on this page: Regulations.gov

Here is a quote from that attachment:

In the meantime, on its website the FDA cautions against the use of e-cigarettes and in no way characterizes the product as a harm reduction product. To the contrary, the website message is that e-cigarettes “may contain ingredients that are known to be toxic to humans, and may contain other ingredients that may not be safe. Additionally, these products may be attractive to young people and may lead kids to try other tobacco products, including conventional cigarettes, which are known to cause disease and lead to premature death.”27

The message in the FDA website is essentially that unlike potential MRTPs, there is no current science-based process for determining the health impact of e-cigarettes

His conclusion:

It is understandable that FDA has chosen not to be proactive and formulate an all products nicotine policy. FDA already has it plate full implementing the modified risk provisions of the Tobacco Control Act and that will remain the priority, certainly in the short-term. But eventually there may be pressure to connect NRTs, modified risk tobacco products, and e-cigarettes and establish a FDA wide policy. It would be wise for FDA to start that process now by asking the Institute of Medicine to build on previous efforts and examine the need for a national nicotine delivery product policy; recommend elements of such a policy, and assess if and how it could benefit public health.

His was one of the earliest comments posted (on 12/07/2012. ) Each time a new "document" is added to the Docket Folder, the number at the very end of the Document ID number is incremented. The FDA's original document ended in "-0001". Ten comments were posted between the time the docket opened and when the FDA posted their second document (ending in "-0011") on Jan 2. We have no way of knowing exactly how many comments were submitted under the original FDA document before the comment period closed on Jan 2. But quite obviously, those were added to the queue of comments waiting approval.

 

[jeapa]

I just submitted my comment. Thank you for posting the link. I will do my best to get all of my family and friends to comment also. This issue is so important. I did not realize until reading this thread just how important it was.

 

[markdm4805]

Actually, as of this moment 1,218 people have left comments. This number is displayed in a box at the right-hand column on this page: Regulations.gov

When you scroll down, you see that there are links to only 17. This is typical of the application. The agency that asked for comments gets to "approve" them for public display. So far, we have not seen any of our comments on past postings censored. They show up eventually, but it can take weeks. Vocalek thanks for the clarification and for posting the link. I tried to open Jim Solyst's attachment but

You might want to take a look at some of the 17 that are now available for viewing. (Click on the blue "View All" link next to the red headline "Comments".) Notice that the most recent posting date was January 4. Those are probably the comments that were submitted under the old Docket ID document number (ending in "-0001").

In fact, I highly recommend reading the PDF attachment that Jim Solyst submitted with his comment. To see the file, click the little button labeled "PDF" on this page: Regulations.gov

Here is a quote from that attachment:


His conclusion:



His was one of the earliest comments posted (on 12/07/2012. ) Each time a new "document" is added to the Docket Folder, the number at the very end of the Document ID number is incremented. The FDA's original document ended in "-0001". Ten comments were posted between the time the docket opened and when the FDA posted their second document (ending in "-0011") on Jan 2. We have no way of knowing exactly how many comments were submitted under the original FDA document before the comment period closed on Jan 2. But quite obviously, those were added to the queue of comments waiting approval.

I was on my tablet and I couldn't get it to download so I'm gonna try again. My main point though is that I really can't say enough that we need to be careful of trusting BT as an ally in this fight. I mean they could end up being very innovative competitors in this industry but when I saw the text of the deeming regulations it really looks like it's poised to help them attain a near monopoly on E Cigs. This is one time where I would be thrilled beyond belief to be wrong. I do have to say with blu cigs using Johnson Creek smoke juice as their supplier does tell me somewhat that maybe BT is trying to turn over a new leaf and maybe they will work with the Vaping community. Just be guarded in this.

 

[Petrodus]

I was on my tablet and I couldn't get it to download so I'm gonna try again. My main point though is that I really can't say enough that we need to be careful of trusting BT as an ally in this fight. I mean they could end up being very innovative competitors in this industry but when I saw the text of the deeming regulations it really looks like it's poised to help them attain a near monopoly on E Cigs. This is one time where I would be thrilled beyond belief to be wrong. I do have to say with blu cigs using Johnson Creek smoke juice as their supplier does tell me somewhat that maybe BT is trying to turn over a new leaf and maybe they will work with the Vaping community. Just be guarded in this.

Quoting Kristin ...
Big Pharma and its paid shills like the ALA, ACS and CFTFK lobbying,
are the enemy ... NOT "Big Tobacco".

 

[ethebull]

Just ordered 1000ml of 100mg nic as a hedge on this ugly debacle.

 

[sonicdsl]

My letter has been submitted!

I read a few of the comments (will read more later). I thought the Lorillard letter was especially interesting (obviously they want to protect their investment, but I liked that overall it was on par with our message in general), particularly the part about the FDA misleading consumers about the dangers/efficacy of ecigs.

I look forward to reading more, and seeing more... site states over 1400 comments submitted, but still only 17 viewable. They need to get caught up quickly!

 

[markdm4805]

Quoting Kristin ...
Big Pharma and its paid shills like the ALA, ACS and CFTFK lobbying,
are the enemy ... NOT "Big Tobacco".

Well I will say I do highly trust Kristin and CASAA. It would make a lot of sense for BT to come into this industry and run a good clean operation as I said earlier that is what I think lorilard is doing with Blu Cigs. If you compare their current models from ones made about 3 years ago its a vast improvement. Still needs some work but the effort is shown. As well dont get me wrong I totally agree Big Pharma is the main enemy.

 

[rockymtnrobin]

And by the way, I'm a new vaper and I'm quite concerned about this. I don't know if I can do anything though, because testamonial-wise I don't have much to say. I've been using this stuff for much too short a time to say much of anything about my experience.

your new. you can post in the new members forum. I bet you have a reason for this journey your on. Join CASAA.

 

[rockymtnrobin]

If you are thinking of hoarding, I recommend you think about advanced devices rather than hoarding juice making supplies. Propylene Glycol, Vegetable Glycerine, and flavors will always be available. No one is banning those. Premixed nicotine solutions are under fire, however nicotine is easily extracted from tobacco leaf. If you truly plan to be an underground vaper should an apocolypse happen, it is the advanced devices that you need to start hoarding, and fast. Things like rebuildable atomizers, rebuildable atomizer tanks, etc... because if this bill were to pass, (it will not if we stand up together) we may end up stuck with pre-2007 atomizers, or, no atomizers at all. In order of priority I would list 510 battery to heads connections, rebuildable atomizer systems, variable voltage chips and pre-made nicotine solution. But we will stand together and fight this bill and hoarding will not be necessary my friend. We are going to win this battle. The war is further off but we are going to win this battle if our morale stays strong. I am confident that if the fda were to ban e-cigarettes this forum and forums like it would revert to their roots, modding forums. This is what we want to avoid. We want e-cigs to be accessible to ALL and we will not win this fight if we lay back and believe that we will survive with our DIY and garage mods. It is going to take every 1 of us, from the 808s to eGo user to the altoids cans, to the silver bullets, to the zens.

I agree with you for sure.

 

[zippersnapper]

Just ordered 1000ml of 100mg nic as a hedge on this ugly debacle.

Well done.

 

[JUDGMENT AFFIRMED]

Thanks everyone.
Just got my lazy self going and gave my comments to our FDA.

 

[DJ RyckRak]

I do not want MY GOVERMENT involved in any way in the regulation of Personal Vaporazation Devices (PVD), componets, ingredents or industry. I do not believe that it is nessessary, nor is it the best use of limited FDA resources.
I started using a PV nine days ago, after smoking cigarettes some 45 years.
I stopped smoking cigerettes nine days ago after many, many repeated attempts without success, because of all ingredents added to cigerettes to keep me addicted.
I am now and forever will be free of the foul cigerette addiction because of the electronic PVD- and I thank God for that.
I do not want MY GOVERMENT to be involved with the PV industry at all.

This is my commet on the FDA site- Hope it helps.

 

[ethebull]

This is my comment on the FDA site- Hope it helps.

This is Great! I encourage everyone to post on the FDA input site, and to share it here for much needed inspiration.

Here's my post to the FDA site:

-------------------------------------------------

I would like to share my experience using e-cigarettes for the last few months.

I have been a smoker since age 19. I turned 53 in September. I would smoke between one half to a full pack a day. I tried to quit many times, cold turkey, using nic gum, substituting Snus, and always had a difficult time. Twice I successfully quit and got off the substitute, staying cig and nic free for about a year each time. I found I missed nicotine constantly, and the urge to smoke again was very difficult to resist. Eventually I would fall off the wagon. My mood and sense of well being takes a downward curve when I can't satisfy my craving for nicotine.

In late October 2012, I received my first e-cigarette starter kit. I unpacked it, charged the batteries, and gave it a try that afternoon. I have not had a cigarette since and I have not experienced the same difficulty and strong urge to fall off the wagon. Nic gum and Snus were far less effective in satisfying my cravings. With an e-cig, I get the pleasure of "vaping" with flavor and satisfaction.

I have always been physically active and in decent fitness throughout my 50+ years. Still, I have noticed a marked improvement in my cardio strength and overall sense of health since "switching" to e-cigarettes.

I would be crushed if this product were to suddenly be taken away from me. I have read much material about their potential for short or long term health issues and I am very comfortable having made the substitution. Cigarettes are a far far worse choice, and if e-cigs are banned, I would be back to smoking.

Thank you for listening,

Erik (comment # 1jx-82x1-9012 )