Article: FDA to Ban Electronic Cigarettes

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Krakkan

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Hit & Run > FDA to Ban Electronic Cigarettes - Reason Magazine


Jacob Sullum | May 1, 2009, 4:46pm
Bill Godshall of Smokefree Pennsylvania reports in a mass email message that the Food and Drug Administration plans to proceed with a ban on electronic cigarettes, devices that deliver nicotine vapor without tobacco or combustion products. Godshall reproduces the following message from Heather Zawalick of the FDA's Office of Legislation, which says the agency will announce enforcement actions against the three largest e-cigarette distributors on Tuesday:
Subject/Headline: FDA Takes Enforcement Action on Electronic Smoking Products
Planned Release Date: May 5
Driving Event: Compliance action
Rollout Plan: Extensive rollout planned including press conference at HHS, press release, fact sheet, video for upload to YouTube, podcast, consumer article, consumer Q &A, key message points, internal media Q & A, Op-Ed, photos of products for posting on Internet.
Other background, hidden factors: Action involves three largest distributors. One of the distributors has just sued FDA seeking a restraining order to prevent us from holding their product at the border.
There is keen interest in this subject. E-cigarette kiosks are all over town, including Montgomery Mall. They're being advertised as a safer alternative to cigarettes. Our concern is that this might introduce nonusers to nicotine use. This is a drug delivery device. The content of the products have not been analyzed by FDA. To be sold, they would have to be approved by the agency.
Our concern is that this might introduce nonusers to nicotine use. And what if it did?Separated from the dangers of smoking, nicotine use is not a big health concern. The FDA itself has approved various nicotine replacement products (gum, patches, even an inhaler), some of them for over-the-counter sale, even though they theoretically might "introduce nonusers to nicotine use." That possibility is an incredibly lame justification for preventing smokers from switching to a product that eliminates virtually all the risks associated with standard cigarettes.
In an open letter to Zawalick, Joel Nitzkin of the American Association of Public Health Physicians says the pending FDA ban seems to be "based entirely on the undocumented assumption that electronic cigarettes may have the potential to attract additional teenagers to nicotine use and addiction." That concern seems to be fanciful: Godshall says "there is no evidence that e-cigarette products have been marketed to youth, nor is there evidence of youth use of e-cigarette products (most of which cost more than $100)." In any case, Nitzkin notes, the government can impose age restrictions without stopping "current adult smokers who are unwilling or unable to quit" from enjoying "the health benefits this product can offer." By Nitzkin's reckoning, based on the available research, smokeless nicotine products "promise a risk of illness and death well under 1% of the risk posed by cigarettes."
In his own letter to Zawalick, Godshall argues that "denying 45 million cigarette smokers access to exponentially less hazardous smokefree nicotine alternatives would result in millions of preventable deaths among smokers, millions of nonsmokers continuing to be exposed to tobacco smoke pollution, and tens of thousands of e-cigarettes users reverting back to smoking cigarettes." He adds that "it is absurd for the FDA to even contemplate protecting the deadliest nicotine products (cigarettes) from market competition by the least hazardous nicotine products."
More on the e-cigarette controversy here and here. E-cigarette testimonials here and here. A report on testing of the Ruyan e-cigarette here (PDF).
 

nycsublimegirl

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From: "Hitch, Mary C", INTERNET:Mary.Hitch@fda.hhs.gov
To: , SMOKEFREE
Date: 5/1/2009 5:05 PM
RE: Email from Heather Zawalick (CBER)

Dear Mr. Godshall:

Your communication was forwarded to me for response as a function of FDA's Office of External Relations. The email to which you refer contains factual errors and does not reflect an official FDA action or policy.

Sincerely,

Mary C. Hitch
Senior Policy Advisor
Office of External Relations
U.S. Food and Drug Administration
 

saintgadreel

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I guess we'll see on Tuesday....

I would find it quite amusing if the FDA took action prior to the Waxman bill actually passing the Senate... Technically, they can't take action on the devices officially unless that bill is approved. They can apparently creatively label the e-cig as a "Drug Delivery Device" which gives them *some* jurisdiction to prevent shipment. At least that is what I have taken out of the FDA's behavior thus far.
 

scintar

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Well, It looks like the PV is going to be officially banned. Planned Release Date: May 5 09 I'll tell ya, people just can not get a break. We all finally find an alternative to tobacco and BAM, just like that it will be gone. I have quit smoking analogs with this method. Now we all will have to sneak arround and finagle ways to keep vaping. May 5th will be a sad day in my lungs. When the going gets tough the tough get going. We will all be criminals in the public eye now.
 

Vicks Vap-oh-Yeah

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We will all be criminals in the public eye now.


No - the ban would encompass importing and selling - it would not be illegal to use and/or possess......Nicotine is not illegal......

Of course, unable to import means the supply will dry up, and we'll be forced to go back to 'sanctioned' methods of handling our addiction - cigs or NRT's.
 

halopunker

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Does it not seem suspicious that a SUPPLIER posted that fake story? I am not making any claims what-so-ever. We all know how easily it is to control others with fear.

It's also funny that another supplier posted a response. I wouldn't look too much into it, we're allowed to post news too =P

And we'll see. The original email could have been a hoax (doubt it) but who knows.
 

scintar

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No - the ban would encompass importing and selling - it would not be illegal to use and/or possess......Nicotine is not illegal......

Of course, unable to import means the supply will dry up, and we'll be forced to go back to 'sanctioned' methods of handling our addiction - cigs or NRT's.
No supply no demand. This things are being swept under the rug as 99% of tobacco users are unaware that this alternative even exists.
 

Vicks Vap-oh-Yeah

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has anyone else taken the time to read the comments that are cropping up on this article???? OMG - this is NOT the way to act. This convinces all the PTB that the vaping community is nothing more than a bunch of ill educated boobs who CAN'T make their own decisions..........can you follow the circle of logic and tell me what comes next??

I see this as strike - counter- strike....

The vaping community has made some mistakes (SE, anyone???) and now the FDA is going to make all of us PAY for those mistakes and snap us back into line......hence the impending ban.

I do not see this as the end - just a setback. I trust that Lacey and the rest of the ECA are working (hell, this is to protect their livelyhood!) on a comprimise. That's what it will come down to.........comprimise. Nobody feels they really won, but nobody really lost either.....
 

Cancer

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wait until the Waxman bill passes, then be afraid, BE VERY AFRAID:evil:
Im spending a small freaking fortune buying from vendors who are (out of stock) hoping that by May 25th or so i will have enough Juice and batteries and atomizers to get me far enough to quit everything. Yet i know everyone here, shares in the dread of dealing with that.
 

Kaston

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What supplier? As far as I know, the first person to post that email here was Bill Godshall, an antismoking crusader who also happens to be one of the few who also supports harm reduction, and ecigs.

The person -who I do not know and am not making any negative claims about- who posted the article has "US Supplier" next to their avatar. AKA they are an e-cig seller.

There is a VERY VERY remote possibility that a supplier would post a news story about the banning of e-cigs to entice with fear customers to buy ...-loads of products before a "ban" goes into effect.

I am NOT saying this is what happened. I am just saying do research and make sure any statements to the effect of banning are checked against other sources.
 

scintar

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Does it not seem suspicious that a SUPPLIER posted that fake story? I am not making any claims what-so-ever. We all know how easily it is to control others with fear.
So you think this is a ploy to quickly dump product? And if true don't you thinks there is a method to this madness? I think we all see the writing between the lines. It is just a matter of time that a ban is coming. Things are moving very quickly in that past month or so. Now with the SE suit is the time for the fdda to react. All the suppliers combined don't have enought to fight it and the fda knows it.
 

Vicks Vap-oh-Yeah

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The person -who I do not know and am not making any negative claims about- who posted the article has "US Supplier" next to their avatar. AKA they are an e-cig seller.

There is a VERY VERY remote possibility that a supplier would post a news story about the banning of e-cigs to entice with fear customers to buy ...-loads of products before a "ban" goes into effect.

I am NOT saying this is what happened. I am just saying do research and make sure any statements to the effect of banning are checked against other sources.


The letter from the FDA came from Bill Godhall a day or 2 ago in a different thread......and the article Krakken's postng just came up today as a leak from Bill. This isn't a ploy for increased sales - but the FDA is running damage control, calling this a "leaked" email and "fabricated" at that....now, I don't believe for one minute that the FDA is speaking true, I think it's damage control.....but it's not a ploy by a supplier for increased sales....the axe is falling..
 
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