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

[priorities]

Thank you for posting this for us all............so so important.............*

 

[DC2]

DC2 I am most often in accord with your views, but I think your DIY statement is divisive and we need all the troops out front now.

A person who has everything they think they need and shows no concern for anyone else has already divided themselves from us.
Thankfully such people seem to be a minority but they really piss me off, not that I think they care about that either.

 

[zippersnapper]

Personally, I attend CASAA meetings, I also promote and post throught the ECF Forums, in order to get the word out.
Like many of us, I am no attorney, and dont understand most of the terminology used. I am smart enough to know however, this may
very well be catastrophic for all of us.

I would love to know, what simply, can our government do to us or is trying to do to us vapors?
1. Ban all sales of e-cig related products and or related hardware?
2. Ban internet sales of e-cigs and or related hardware?
3. Ban the importation of e-cigs and or related hardware?
4. Ban the sale of e-liquid containing nicotine?
5. Is the FDA's intention to regulate e-liquid ONLY, and leave the hardware alone?
6. Ban e-cig brick and mortor stores/shut them down?
7. If you were to give a percentage how likely will the FDA succeed in prohibiting the sale of e-liquid and or hardware, what would it be?

I beg any esteemed member of ECF or the CASAA to answer my questions.

If question #7 is not looking very promising, then I know what I must do in the next two months. This, of course, does not indicate by any means, I will not stop fighting.

 

[Darksyde]

I don't mean this in a bad way but I think the whole issue is being blown out of all proportion. There are really just two key points here that I see. Number one is our government cannot or will not let anything that even seems like a "cig" go unregulated. The yuppie moms and dads would have a hissy fit. It WILL happen and we can't stop it. Number two, and most important in my way of thinking, is that this same government cannot crack down on a safer alternative to smoking while leaving the harmful original in place and free to ramble. The public backlash would be huge. There will undoubtedly be testing of our liquids and delivery systems but unless they are deemed more harmful than analogs we are good to go. After all we have the patch and gum as well as medically approved inhalation therapies of various sorts that have gotten the thumbs up. No elected official is going to be the guy who proposed or voted in favor of killing ecigs over fear of being labeled a friend to big tobacco. I'm not saying to not be proactive, just that I think that the talk of a ban is unsubstantiated at this point.

 

[DC2]

The public backlash would be huge.

If that were the case, I would tend to agree with most of what you said.
But there isn't going to be any huge public backlash, or even any public backlash at all.

Whatever backlash there is going to be is going to have to come from us.
And those that love us.

 

[Vocalek]

Personally, I attend CASAA meetings, I also promote and post throught the ECF Forums, in order to get the word out.
Like many of us, I am no attorney, and dont understand most of the terminology used. I am smart enough to know however, this may
very well be catastrophic for all of us.

I would love to know, what simply, can our government do to us or is trying to do to us vapors?
1. Ban all sales of e-cig related products and or related hardware?
2. Ban internet sales of e-cigs and or related hardware?
3. Ban the importation of e-cigs and or related hardware?
4. Ban the sale of E-liquid containing nicotine?
5. Is the FDA's intention to regulate e-liquid ONLY, and leave the hardware alone?
6. Ban e-cig brick and mortor stores/shut them down?
7. If you were to give a percentage how likely will the FDA succeed in prohibiting the sale of e-liquid and or hardware, what would it be?

I beg any esteemed member of ECF or the CASAA to answer my questions.

If question #7 is not looking very promising, then I know what I must do in the next two months. This, of course, does not indicate by any means, I will not stop fighting.

I'd love to be able to give you definitive answers to all your questions, but some of what you ask simply isn't known.

The Agency demonstrated its prejudice against e-cigarettes (and its lack of concern for the health and well-being of consumers who use them) by greatly exaggerating and sensationalizing the significance of findings in lab tests of 18 samples of two brands of e-cigarettes in 2009. In fact the Agency’s cleverly-worded press release gave the impression that e-cigarettes were more likely to trigger cancer or poison users than continued smoking. FDA and Public Health Experts Warn About Electronic Cigarettes

They continued the myth that e-cigarettes are hazardous on the page “E-Cigarettes: Questions and Answers”, claiming that e-cigarettes lead children to use of real tobacco products, again without a scintilla of evidence. E-Cigarettes: Questions and Answers

That page also demonstrates that FDA has no idea about the make-up of e-cigarette consumers and what experiences they have been through. The last Q&A on the page advises smokers to use FDA-approved products “to reduce their dependence on nicotine.” The FDA appears to be unaware that many e-cigarette consumers don’t care about reducing their dependence on nicotine. They just want to escape the harmful effects of inhaling smoke. They also have tried those products dozens of times without success and I, for one, consider that suggestion an insult to my intelligence. (Sarcastic tone: Duh! Why didn't I think of that!)

Everyone should carefully read the FDA deeming announcement issued last spring: Regulation of E-Cigarettes and Other Tobacco Products

Section 201(rr)(4), for example, prohibits the marketing of a “tobacco product” in combination with any other article or product regulated under the FD&C Act (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement).

This is disturbing, as it indicates that the FDA may continue its efforts to ban e-cigarettes by using the argument that e-cigarette liquid is being delivered in combination with a battery and atomizer.

The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”

Registration, product listing, ingredient listing, and good manufacturing requirements are reasonable controls. However, most e-cigarette companies are small businesses that cannot afford the level of user fees levied on huge corporations (tobacco companies). The mention of premarket review requirements for “new tobacco products” sends up a red flag.

“Tobacco products” marketed as of February 15, 2007, which have not been modified since then are considered “grandfathered” and are not subject to premarket review as “new tobacco products.” A “tobacco product” that is not “grandfathered” is considered a “new” tobacco product, and it is adulterated and misbranded under the FD&C Act, and therefore, subject to enforcement action, unless it has received premarket authorization or been found substantially equivalent. FDA has already developed draft guidance explaining how manufacturers can request a determination from FDA that a “tobacco product” is “grandfathered.”

The above provision was written for the purpose of preventing the proliferation of combusted cigarettes. Applying it literally to to both hardware and liquid will have the effect of removing all models that were not being sold before February 15, 2007. If there are any such models still being made, they are the early ones that had leaky cartridges, batteries that died too quickly, and other quality control issues.

Nothing within the deeming announcement even hints at the idea that Center for Tobacco Products will be tailoring regulations to fit our innovative products. Applying all exactly as written would decimate the e-cigarette industry. The effect on consumers would be devastating, creating a public health crisis instead of helping to solve one.

I wish we had more definite information to share.

 

[Vocalek]

Addendum:

FDA employees have also had articles about e-cigarettes published in scientific journals. Again, nothing they publish is very friendly. See: http://www.e-cigarette-forum.com/fo...eading-report-adverse-events.html#post6896219

 

[Fiamma]

It's just really hard to guess what FDA has in mind, but it will suit the tobacco companies and big pharma to a Tee, you can bet on that.

They are ignoring every study that conflicts with what they want to believe and just forging ahead with their agenda. I keep trying to be optimistic but I am preparing for the worst case anyway. If it doesn't happen, I'm ahead with supplies. And I will not shut up and go quietly away. There is too much at stake and too many lives to be saved.

 

[zippersnapper]

Vocalek, MUCH appreciated. This of course, is unnerving to say the least.

I know I'm not alone in saying if the FDA restricts Nicotine e-liquid, I'm in a world of hurt.

 

[Petrodus]

It's just really hard to guess what FDA has in mind, but it will suit the tobacco companies and big pharma to a Tee, you can bet on that.

They are ignoring every study that conflicts with what they want to believe and just forging ahead with their agenda. I keep trying to be optimistic but I am preparing for the worst case anyway. If it doesn't happen, I'm ahead with supplies. And I will not shut up and go quietly away. There is too much at stake and too many lives to be saved.

Reminds me of the long running thread on Law and the E-Cigarette forum
originally posted on Jan 21, 2009 and is still active (for good reasons)
If they banned ecigs, would you stockpile?

 

[Petrodus]

What is not being discussed is the FDA's "real" long term agenda.
By that I mean ... Even if the FDA doesn't INITIALLY come down
hard with heavy handed regulations ... They WILL do so later.

There is No Such Thing as LIMITED Regulations in America.
Once an agency starts regulating ... They go NUTS and keep
adding more and more restrictive regulations.

The FDA couldn't care less about e-cigarettes save lives ...
However, they do care about protecting BP's profits (period)

 

[DC2]

The FDA couldn't care less about e-cigarettes save lives ...
However, they do care about protecting BP's profits (period)

Obviously Big Pharma is aware of the many new and exciting potentials they see for nicotine as a drug.
It is being shown every day that it can possibly treat numerous maladies.

Now in such a world, what do you suppose the end goal of Big Pharma would be?
And how do you suppose they would get there?

That path, whatever it may be, is the most likely direction the FDA will go.
And it would look an awful lot like the newly proposed EU Tobacco Control Directive does.

Big Pharma wants nicotine, and they mean to have it.

 

[Petrodus]

One thing is for sure ...
We all will know soon what the FDA's INITIAL regulations will be.

 

[Huntsvappin]

Here's a question; Is it possible that multiple lawsuits against the FDA from business could slow or prevent these regulations?

 

[DC2]

Bill Godshall has indicated in the past that if the FDA issues "deeming" regulations, there are people prepared to file lawsuits...
http://www.e-cigarette-forum.com/fo...acco-products-released-today.html#post4790722
http://www.e-cigarette-forum.com/fo...ata-misrepresenting-evidence.html#post6982918
http://www.e-cigarette-forum.com/fo...-approves-deeming-regulation.html#post5785843
http://www.e-cigarette-forum.com/fo...kes-new-report-press-release.html#post6857867

No further details have been made available, but if you have concerns you might consider contacting him for further information.

 

[Hulamoon]

Bump, this is important.

 

[pmos69]

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

 

[WoundedIcon]

I don't know what the tobacco companies are planning, but just the fact that Lorillard is in on the e-cig market should give us some hope. I don't think BT will take this lying down. They'll probably start a sue-pocalypse. But then again, BT might then turn around and rip our small vendors a new one.

 

[WoundedIcon]

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.

 

[Fiamma]

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

You know in the dark of the night tonight I was thinking the same thing. Everything is hitting all at once, suddenly.