More details and analysis of FDA's December 17 hearing

[patkin]

Actually I don't think they'll win. Prohibition of anything never has going all the way back to females and others not being able to vote. When people's backs are against the wall the politicians usually loose. I know fear is making it seem different right now but take look at historical big issues. The pendulum usually swings and right now its way to one side. It will come back to center. BUT it does require passion and the courage to stand by one's convictions as much as the "other" side does.

 

[DC2]

I agree. This is very important as needs all the support it can get. I'll be on that list. Can you post a link please?

The CASAA Call to Awareness not only has the link, but also guidance on what to say...
CASAA: Call to Awareness - FDA Public Hearing on Nicotine Reduction Therapy Products

 

[5cardstud]

The CASAA Call to Awareness not only has the link, but also guidance on what to say...
CASAA: Call to Awareness - FDA Public Hearing on Nicotine Reduction Therapy Products

I found that and that made it possible to find this and submit my comment.Regulations.gov

Actions Related to Nicotine Replacement Therapies and Smoking-Cessation Products: Report to Congress on Innovative Products and Treatments for Tobacco Dependence; Public Hearing

Agency: FDA
Document ID: FDA-2012-N-1148-0001

 

[Drael]

Merry Christmas to everyone!

Very good posts here and thanks to everyone who stood up and testified.

Call me a cynic in some ways then because when it comes to our US Government, I hold NO
faith in them at all because I have seen all too well the "Selfish" reasoning in their law making.

If it involves money in any form, they will do anything in their power to get it.
And if it threatens their money, they will do even more to stop it.

A very good example is the recent incident in Conn.

They are STILL out to attempt further bans and controls on guns when it IS NOT the gun that
is the issue. It is the issue that mentally incapable and criminal minded people will Always be able
to get guns and don't need a "Waiting Period", don't need an ID or even a Birth Certificate.
They can go to their nearest alley (perhaps the same one they get their drugs from) and to the
nearest car trunk and buy any gun they want... including automatics and modified fully auto's.

The "Nut Job" that did that in Conn - from what I have heard - even killed his own relative in order
to get the guns she owned.

The "Gun" is not the issue - if Guns kill people, then Forks "make" you fat, Lighters "make" you smoke,
and Cars "make" you drive drunk!

Fact is - Murder is outlawed but still happens... Theft is banned but still happens. Countries that
outlawed guns still have their share of Crimes involving gun use. So what does banning and control
do?
Absolutely Nothing -- (to the criminals, that is).

More Gun Control and Gun Bans will NOT stop a damn thing... the only thing it will do is make it even
harder for Decent people to protect themselves. All the Gun ANTI's scream "No Guns, No Guns!" but
when they get robbed - the first one they call is -- Someone with a Gun (e.g., Police, Military, etc.)

Anyhow... I hope for everyone's sake that the FDA and US Government finally does the right thing on
this one.

Totally off topic, but here in new zealand, only hunting guns are allowed, and theres a rigorous background check licensing process. We very occasionally have gun related crimes, but its very very rare. Theres no secretly imported or black market guns either.

Nobody gets guns to "protect themselves", because nobody expects guns to be used against them. Criminals do not generally possess guns at all. They are more likely to use a knife, if anything.

Even police dont have guns, just tasers. They dont have bullet proof vests either, they have stab proof ones (for crims with knives).

If someone has a gun, we have a special armed defenders squad for that rare event.

So basically, the idea that gun control doesnt work, from my perspective seems to be inaccurate.

Sad thing is about the US, is you guys all already have guns. Cant exactly put the genie back in the bottle once youve been giving out a gun with every happy meal.

And I would also add that canada has very open gun laws, and gun ownership is very common, but they have nothing like the gun crimes of america.

So, that would suggest that your gun crime problem is one of a culture of violence or some such, rather than nessasarily related to guns. I dont think this has anything to do with "mental stability", but rather a culture that leaves people socially out in the dark and glorifies violence (sorry to say it, but I think that might be true).

Addressing the issue of these things, is a far deeper and more complex issue, than it may appear on the surface. And should, be wont, give your country serious pause for thought. Questioning the cultural, social and moral status quo is not something that comes easy for anyone.

The simplist thing I can suggest, is that more is done to make sure people are not social isolated, and put some restrictions of the media glorification of violence. I mean, one wonders why, a movie with decapitation in it, has a lower rating than one with breasts.

In addition, with such large populations, real efforts should be made to ensure that human to human connection, and empathy persists for all individuals, especially at young ages. Empathy is a learnt characteristic, and if people dont ever receive it, they wont express it. Thats been repeatedly proven in psychological studies that those who are raised with creulty, become criminal in nature, and those who are raised with affection are not. You reap what you sow.

 

[golferx]

Comment submitted

 

[Projectguy]

Bill & Elaine

Good stuff. When will we see some form of feed back based on the panel's hearing?

And Thank you both for your commitment and work

My assessment is that THR and e-cigarette advocates rained all over FDA's planned parade for NRT and the drug industry at Monday's hearing.

THR advocates outnumbered drug industry funded folks 2 to 1, and testimonies by THR advocates were far superior to those of drug industry funded folks.

It was pretty clear to me that 6 of the 8 FDA panelists (i.e. those with the FDA's drug office) had very little knowledge or understanding of THR, e-cigarettes or smokeless tobacco, the comparable health risks of different tobacco/nicotine products, or the many false and misleading claims that have been made by FDA, CDC, US SG, and other DHHS agencies about the risks of smokefree alternatives.

In a nutshell, we gave those FDA staff a sorely needed education about these important issues.

And since the intended purpose of FDA's hearing was NRT and other drug industry smoking cessation products, we basically turned their hearing into an educational session about e-cigarettes, smokeless tobacco products and THR.

We also sent the FDA a message that if/when they propose a deeming regulation to apply Chapter IX of the FSPTCA to e-cigarettes, we'll be back in far greater numbers.

 

[Vocalek]

Bill & Elaine

Good stuff. When will we see some form of feed back based on the panel's hearing?

And Thank you both for your commitment and work

See Response #7 on Page 1 in this thread.

 

[mooreted]

Here is the reply I submitted:

Efficacy of Alternative Harm Reduction Strategies For Tobacco Users



I was a cigarette smoker for approximately 30 years. I decided that I had better stop using cigars and cigarettes when I began having coughing fits. My lungs would hurt when taking a deep breath, and physical exertion became difficult. I tried the patch but it just left me in a constant state of craving. I also tried nicotine gum, but my stomach seems to be sensitive to it. Since these methods did not work, I was soon smoking again.

A little over a year ago, I purchased an electronic cigarette at a local cigarette store. I have now been using electronic cigarettes and have quit smoking. My lungs feel clear, I can exercise again, I have more energy, I feel healthy again.

Since electronic cigarettes do not contain over 4000 toxic chemicals, it stands to reason that they are much less harmful than burning tobacco. With the billions of people addicted to tobacco in the world, allowing smokers a less harmful alternative to smoking could save millions of lives and billions of dollars.

Although abstinence would be the ultimate solution, many people have a very difficult time quitting. For those people we should offer a safer alternative to replace smoking and increase the chance that they will one day quit altogether. The official NRT therapies currently employed by the pharmaceutical companies have proved to be ineffective in most cases. Electronic cigarettes have proven themselves to be effective and safe for millions of people over the last several years.

I believe that electronic cigarettes should be part of a category of harm reduction methods for nicotine consumption. This would allow for the sale of reduced harm products to adults who need a method of consuming nicotine without the associated harm of smoking tobacco. This would reduce medical costs, improve the health of smokers and allow for the education of people who would like a healthier alternative.

 

[mrfixit]

We need to stand up to this type of control freak mentality and make sure we are heard by all these yahoos who think they know what's best for us. What's sad is the amount of money being wasted on this. Guess I should start laying in supplies then because honestly we can petition write our reps but I think that big money will get what it wants in the end. That being whatever regs they want us going underground to continue to be able to vape how we want or wish to. The FDA is a joke it doesn't protect us from anything more than half its funding comes from the companies they are supposed to be regulating. My doctor told flat do not take chantix that it was dangerous for anyone to take. But they gave their seal of approval. Look up what they say about the fireproof bands they approved for cigarettes another chemical added that when burned is more toxic. Our government does not care about us period.

 

[Petrodus]

We need to stand up to this type of control freak mentality and make sure we are heard by all these yahoos who think they know what's best for us. What's sad is the amount of money being wasted on this. Guess I should start laying in supplies then because honestly we can petition write our reps but I think that big money will get what it wants in the end. That being whatever regs they want us going underground to continue to be able to vape how we want or wish to. The FDA is a joke it doesn't protect us from anything more than half its funding comes from the companies they are supposed to be regulating. My doctor told flat do not take chantix that it was dangerous for anyone to take. But they gave their seal of approval. Look up what they say about the fireproof bands they approved for cigarettes another chemical added that when burned is more toxic. Our government does not care about us period.

The owners of this country know the truth
its called the American Dream...
but you have to be asleep to believe it.
George Carlin

 

[Bluesrains]

Thanks Everyone for this Great Info. Im so happy the FDA finally gets some well needed proper info about
ecigs, etc. Ive been so sick and tired of hearing so many misconceptions, exaggerations and down right
crap related to vaping.
Im very proud of the hard work CASAA has been doing along with so many others concerned.

 

[Vocalek]

So far over 200 comments have been submitted, but as of tonight, Regulations.gov has posted only 17. I was reading through some of the comments left and found that I agree with the observations made by RJR that the government should provide truthful information to the public. Regulations.gov

Link to the 17 comments posted so far: Regulations.gov

 

[TennDave]

Elaine, most interesting is the 120 page pdf document that RJR submitted comparing the health risks of smoking compared to smokeless tobacco products.

 

[Vampirecat019]

Is it just me, or do all of the FDA employees' names seem fake? Like they are pseudonyms because they are so corrupt that they need to hide?

 

[Bluesrains]

Heres my post. http://www.e-cigarette-forum.com/forum/legislation-news/361023-more-details-analysis-fdas-december-17-hearing.html


Hello,

I was a tobacco smoker for over 40 years. I felt terrible and coughed all the time. Cigarettes were killing me. I tried many times to quit. I didnt think I could ever do it. I used the patch, pills and cold turkey, but non of these methods worked for me. Then one day I picked up a ecig and within two weeks I had totally quit smoking! Now I vape a 2.4 nicotine juice to keep me off the cigarettes and feel so much better its totally unreal!! I no longer cough, get dizzy and feel like crap. I can now do things without getting tired in a few minutes. The ecig saved my life!!! E-cigs far out perform any and all other methods to help smokers quit cigarettes. I will continue to vape with my ecig to keep me from going back to smoking. This way x-smokers still get their nicotine, but not all the bad chemicals in smoking tobacco.
If you look up nicotine on Wikipedia, youll find nicotine by itself to have no bad effects on the body. All in all, ecigs are way more safe than smoking.
Please dont put restrictions on the manufacture or sale of ecigs. Do not set Nicotine amounts, as some people require higher amounts to quit as I did and still do.
You need to remove your false and outdated info pertaining to ecigs. Call for studies before you make any direct claims.
Please do not propose your regulation because it would ban e-cigarettes and would sharply increase the price and reduce accessibility of the products.
Please approve ecigs as a very useful tool to aid in quitting cigarettes and a more healthy replacement to smoking. Its a better method of getting nicotine. Chantix almost killed a family member of mine!! Please listen to the people who contact you about this matter. We are the voice of people who have kicked smoking with the use of ecig products.
I hope and pray you make the right choice.

 

[orson]

It appears that the comment deadline was on January 2nd?

I submitted mine after that, I was under the distinct impression that it was open until the 16th.

 

[Vocalek]

It appears that the comment deadline was on January 2nd?

I submitted mine after that, I was under the distinct impression that it was open until the 16th.

The original deadline was Jan 2. The FDA failed to notify Regulsations.gov that the deadline had been extended before the time expired and commenting on that document turned off automatically. The FDA had to submit a new document to continue gathering comments. The new document number is the same except for the last 4 digits which were "-0001" on the first one are "-0011" on the new one. If you navigate to the old number document, you cannot submit comments any more. If you were successful in submitting a comment after Jan 2, then you were in the right place.

 

[mssam]

Does anyone know if the video for the FDA's December 17th hearing was made available? If so, would you mind providing a link...I can't seem to locate it just yet...

 

[Vocalek]

Try this: It lists videos recorded by Linc Williams during the meeting.

FDA Public Hearing - December 17, 2012 - YouTube

 

[Vocalek]

It appears that the comment deadline was on January 2nd?

I submitted mine after that, I was under the distinct impression that it was open until the 16th.

Comments were originally due on Jan. 2, but the FDA extended that to Jan 16. Once comments are no longer being accepted, the "Comment Now" button is removed from the docket. So, since you were able to submit a comment, it is there. It just seems to take FDA forever to go through them and display them for public view. Last time I looked they only had 23 out of 5300+ comments showing.