FDA Takes Enforcement Action on Electronic Smoking Products

[ccure]

I think this worth a new thread here:

http://www.e-cigarette-forum.com/for...pdated-28.html

The following e-mail was inadvertantly sent to at least several members of Congress. Looks like the FDA has been planning this for awhile, and next Tuesday could bring very bad news to e-cigarette marketers and users in the US. But the US Senate can still trump the FDA by amending the Waxman/Kennedy legislation to allow e-cigarettes on the market.


From: Zawalick, Heather (CBER) [mailto:Heather.Zawalick@fda.hhs.gov]
Sent: Wednesday, April 29, 2009 4:08 PM
To: Zawalick, Heather (CBER)
Subject: [LIKELY_SPAM]FDA Outreach: FDA Takes Enforcement Action on Electronic Smoking Products, Entering Clearance

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.

Spokespersons: Janet Woodcock and Deborah Autor

Heather Zawalick
FDA/OC/Office of Legislation
301-827-0090
Heather.Zawalick@fda.hhs.gov

[eplanet]

this is very soon...

[ccure]

Very soon indeed!!!

[Tugger]

njoy, smoking everywhere, and...who?


so much for my njoy 1 year warranty, btw.

[ccure]

njoy, smoking everywhere, and...who?

Don´t know. We'll see very soon!

[Sun Vaporer]

njoy, smoking everywhere, and...who?


so much for my njoy 1 year warranty, btw.

Tugger--my take---Smoke 51 would be the 3rd if this e-mail is correct--Sun

[Vicks Vap-oh-Yeah]

Ruyan has a presence in the US - but they don't actively sell here - so I'm thinking they're out....

My guess for 3rd would be either Janty or Smoke51.


We'll know on the 5th. Smoke 'em if you got 'em has never been so apt.

Our concern is that this might introduce nonusers to nicotine use.

I take this as the most telling statement - this is the beginning of nicotine prohibition.

[Rexa]

What I am really interested in knowing is, is this going to affect just people RESELLING the products or also the people who are simply buying them for their own personal uses.

The FDA cannot stop people from buying items in China or wherever else for their personal use. It's more of a ban on people trying to aquire mass quantity to resell.

I hate to say this but as a consumer I don't personally feel all that affected by it. I don't need to order a huge box of a lifetime supply of parts and liquids if I can still just order small quantities as needed.

Judging by everything I am reading it does not sound like they are making it illegal to vape. They are just making it illegal for people to sell these products.

[TropicalBob]

I believe the import notice is FDA 66-41. Near the top of that list of confiscated items, you will read that personal delivery of a banned product is illegal. It says there is great misunderstanding about this point, but you in fact cannot order one from China or anywhere else if e-cigs are banned. The restriction is not just for large orders, but for all orders of any size.

[Rexa]

I believe the import notice is FDA 66-41. Near the top of that list of confiscated items, you will read that personal delivery of a banned product is illegal. It says there is great misunderstanding about this point, but you in fact cannot order one from China or anywhere else if e-cigs are banned. The restriction is not just for large orders, but for all orders of any size.

Thanks for clarifying that for me.