FDA to Ban Electronic Cigarettes

[Krakkan]

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).

[Krakkan]

http://reason.com/blog/show/133265.html

[PoppaC]

I can see a huge number of lawsuits against the FEDS if only one previous smoker that has swithched to e-cigs dies. I for one was told by my personal cardiologist that if I didn't quit analog cigs that I'm about finished in a short period of time..... Considering what he said, and finding e-cigs this was a perfect solution for me.... Believe me, I'll jump on the bandwagon of law suits....

[Krakkan]

I can see a huge number of lawsuits against the FEDS if only one previous smoker that has swithched to e-cigs dies. I for one was told by my personal cardiologist that if I didn't quit analog cigs that I'm about finished in a short period of time..... Considering what he said, and finding e-cigs this was a perfect solution for me.... Believe me, I'll jump on the bandwagon of law suits....

From my friend Toni @ Bloog she is on the mailing list too:

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

[PoppaC]

Amen !!

[Royce]

Amen !!

I'll second that

[PoppaC]

From my friend Toni @ Bloog she is on the mailing list too:

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

I was wondering if that is not their official policy then is it possible to obtain what their official policy is at the moment.. without shaking the cart too much?

[Vacker1229]

anyone know what became of Cinco de Mayo FDA Ban????

I have searched and found nothing in the press or on the FDA site.

Was this a hoax, urban legend...?...?

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).

[Krakkan]

anyone know what became of Cinco de Mayo FDA Ban????

I have searched and found nothing in the press or on the FDA site.

Was this a hoax, urban legend...?...?

I dunno but we can breathe easy for another day I aint bitching about it

[Christopher]

You know what I think? I'm getting tired of hearing about the FDA bans only for nothing to happen, I'm not saying I'm not grateful for still being able to smoke my electronic cigarette, but I think unless the FDA actually signs up for a damn account here on Vapor Talk I don't want to hear about it any longer

[Vacker1229]

I'm with you, I believe alot of alarmists are jumping in on this ban. I do understand that goods are being held up by customs but also some are not. I do think SE opened a can of worms, but the FDA has bigger worms to fry.

[Christopher]

Very true.

But when you really think about it what's the FDA going to say to SE? "They are unsafe so we're pulling them"

"oh really? Where is your testing? BEATCH"

It's sort of a catch 22

[Vacker1229]

It's sort of a catch 22

Absolutely!! So let's just enjoy while we have them.

[Royce]

Absolutely!! So let's just enjoy while we have them.

I second that one

[StringDancer]

Well, some e-cig imports are clearly being detained (if not rejected), but many are making it through Customs. Just today I received a package I ordered from China, took about 10 days. From the tracking details, it was only in NY Customs a day or so before it went on for delivery. Many of the suppliers here in the states who a week ago were all sold out are getting restocked.

It could also well be that the SE suit, which to date has not been ruled upon, nonetheless made the pinheads at the FDA reconsider a ban at this time. And with the launch of the Electronic Cigarette Association and the excellent congregate of intelligent, unbiased info there, I think if the FDA doesn't move very soon, it will be too late to put a ban into effect, and if enacted will certainly come under considerable scrutiny immediately.

While retailers have to be careful about touting e-cigs as being "healthier" or a "cessation device" so as not to attract immediate sanction by the FDA, the rest of us do not. In fact, the more we blog, vlog, post and promulgate our own experiences with e-cigs, the more evidence (anecdotal though it may be) is accumulating to refute the FDA's stance on the issue. Myself, I'm posting in my website about e-cigs, and have written Obama, Biden, my Senators and my local Congressman, relating my own story of how e-cigs got me painlessly and completely off tobacco in just a couple weeks, linking them to the ECA, and encouraging them all to help stop any proposed ban on the devices. I also wrote Rachel Maddow at MSNBC, encouraging her to cover the story (she loves to kick the government's *** and point out political hypocrisy, with which this issue is drenched).

It's certainly not time to celebrate victory, but there's a head of steam building (or is it vapor) in a positive way for e-cig technology. I quite expect politicians and agencies in bed with Big Tobacco and Big Pharma to prattle on with their propaganda, but Americans have more common sense than that, I think. It may well not be the government that restricts imports, but tobacco abolitionists and extremist, intolerant health-nazis that whine so much that local ordinances lumping e-cigs together with analog cigs gain a little traction in the less-educated sectors of our country.

My two-bits... in spite of the fact that Chris is sick of hearing about it.

[Christopher]

Well said, I'm not sick of hearing about the FDA so much as I'm sick about hearing ******** claims. Unless the FDA posts an offcial press release about the Ban I don't want to read anymore BS "leaked emails"

And I can't agree more with your post, ecig are starting to be seen in a postive light, the only thing we can do is educated and get the word out.

I also think if the FDA is going to grab anything it's going to be the big orders. We have already seen this happen.

But the orders for our store are coming through fine at the moment. (yea I said store )

[monster]

But the orders for our store are coming through fine at the moment. (yea I said store )

I hate to derail a thread.............but do you have a timeline on the opening? I'm sure many here will be interested in this.

[Christopher]

I don't have an opening date at the moment no. I'm releasing a very limited amount of info as we're still getting everything put together. We're trying to keep everything as legit as possible (which makes things hard)

[Royce]

 (which makes things hard)

That's what she said  (sorry couldn't help myself)

[Vacker1229]

That's what she said (sorry couldn't help myself)

... hard difficult...

[Christopher]

Sorry I was looking at Vacker's avatar when I was typing

[Vacker1229]

eeek, I can see I am going to have to change my avatar if it affects you that hard eeerr I mean that much!!

[PoppaC]

Ahh! When the Old Cat's away, the mice start to play, I see.... Naughty girls and boys!