The Real Scoop on FDA & eCigarettes!

[Sun Vaporer]

I am wondering if the homeopathic route might be a goodthing? I have heard about that idea being thrown around in the forums. I am sorry i misunderstood your post Ron. I just dont want to see ecigs go down in flames

Brandee--you did not miss the point at all--Ron here posted that the FDA wants "Drug Code for nicotine" and that goes to the cartridges, which in turn goes to Approval of a new Drug--that is the issue. For absent the nicotine, the device could not be a medical device and would be considered a vaporizor. The Homeopathic route may or may not be a viable option--but Nicotine Water only got the go ahead with a very low dose of nicotine in it. Every day brings new and exciting kicks in the head about are vaping and it is getting very frustrating for all of us that quite smoking using it --but we are not allowed to even say that!!--we must say "Smoking Alternative"--AHHHHH--Sun

 

[LaceyUnderall]

I am new to the forum and this is my first post.
I am a direct importer and distributer of E-cigarettes and refill cartridges.
Yesterday Port of LA customs refused entry of a small shipment (sample order of 25) of E-cigars.

They were correctly labled as "Electronic Cigars, trade sample". DHL was the shipping agent.

Thr following quout is supposidly the Email Customs sent to my DHL agent.
"Electronic cigarettes, cigars and pipes are currently an issue with FDA. Although they are not regulated by the ATF they are still subject to FDA scrutiny. They are metal devices that appear similar to a cigarette or cigar and they still deliver the nicotine w/o the carcinogenic properties of burning that leaves and associated additives << Apparently some text is missing here>>
They are commonly sent as electronic cigarettes, e-cigarettes, electronic pipes, electronic cigars or lung guards

The following information will be needed – if the customer cannot provide it then the shipment will ultimately be returned or detained (permanently) by the FDA.
Drug Code for nicotine
FDA registration numbers for both manufacturer and recipient
510K
MDL for the delivery device"

This is just for everyones information.

I wish I could site a reference such as the FTA advisory to US customs but at this time I cannot.

Ron Frank

I promised myself I would stay off of this thread because well... it leads to hysteria...

However...

Ron... Where did you come from? How long have you importing personal vaporizers? According to your web information, your site has been up since Feb 3, 2009. I know we all get our start somewhere, but posting info from a DHL agent in this thread, before stopping in at the Suppliers Private Forum... I have to question you. Sorry.

If you haven't checked in with SmokeyJoe or Cashmere to let them know that you are a supplier, please do so.

 

[itsbetterthansmoking]

Hi Lacey,

Can you tell me how to get on the suppliers forum? I'm not a supplier yet, but I am trying to become one.

Thanks

 

[TropicalBob]

"Electronic cigarettes, cigars and pipes are currently an issue with FDA.

Come on, Lacey, that has got to send chills down even your optimistic spine.

The war has begun, the shipments are being detained. I'm sure before long even you will be directly impacted by the enforcement actions against our unaproved drug delivery products.

 

[LaceyUnderall]

Hi Lacey,

Can you tell me how to get on the suppliers forum? I'm not a supplier yet, but I am trying to become one.

Thanks

Hi IBTS!

Just PM SmokeyJoe... he'll get you all set up... And welcome! We've got some good conversations in the suppliers private forum so come on over and see what's up!

Cheers,

Lacey

 

[LaceyUnderall]

Come on, Lacey, that has got to send chills down even your optimistic spine.

The war has begun, the shipments are being detained. I'm sure before long even you will be directly impacted by the enforcement actions against our unaproved drug delivery products.

I wish I could say it did, but considering I just received a fairly large shipment today with no problems whatsoever... I am not really all that worried. I ship them into two countries across one border... No problem.

 

[TropicalBob]

It will come. This is not an assumption. It has been happening to others. They just haven't been as vocal as this poster - for whatever reason. And I'm not at liberty to name places and confiscations. I wish I could. Really do. I'm sorry the truth is NOT out there.

And if FDA involvement doesn't shake you, nothing will.

Chin up until.

 

[LaceyUnderall]

It will come. This is not an assumption. It has been happening to others. They just haven't been as vocal as this poster - for whatever reason. And I'm not at liberty to name places and confiscations. I wish I could. Really do. I'm sorry the truth is NOT out there.

And if FDA involvement doesn't shake you, nothing will.

Chin up until.

And I still question the posters "newness" to the industry and importing. No offense to IBTS...

But this supplier did just appear in the community out of no-where. We should be able to question newbs especially when they are suppliers who are just starting in their contributions to the community. Right?

 

[RonFrank]

Sorry, I seem to have violated forum protocol.
I have sent my relavent info to Smokey Joe and am awaiting his response.

Excuse my ignorance, I was simply trying to get what I considered relevent and important information disseminated.

I won't post again until I have heard from a MOD and thouroughly read all the forum rules ( if I can find them ).

Again my apology, no offense intended.
Ron

 

[LaceyUnderall]

Sorry, I seem to have violated forum protocol.
I have sent my relavent info to Smokey Joe and am awaiting his response.

Excuse my ignorance, I was simply trying to get what I considered relevent and important information disseminated.

I won't post again until I have heard from a MOD and thouroughly read all the forum rules ( if I can find them ).

Again my apology, no offense intended.
Ron

None taken and I do hope you don't take offense to what I have said either.

New suppliers are always welcome... just have to bust your chops for a bit http://www.e-cigarette-forum.com/fo...ers-forum/1334-suppliers-rules-must-read.html Great thread to get you started!

Cheers and again, welcome!

 

[Kate]

Thanks for posting the information you did Ron, it's good to keep up to date with developments. I don't see the problem with you joining discussions.

 

[Sun Vaporer]

It will come. This is not an assumption. It has been happening to others. They just haven't been as vocal as this poster - for whatever reason. And I'm not at liberty to name places and confiscations. I wish I could. Really do. I'm sorry the truth is NOT out there.

And if FDA involvement doesn't shake you, nothing will.

Chin up until.

Would agree Tropical Bob--and I respect the fact that you are not at liberty to name places or conficiscations. Many of us can read between the lines and "And if FDA involvement doesn't shake you, nothing will" sums it up. Till then, I guess we will just vape away. Glad I did not pitch my last two cartons of cigarettes just in case---Sun

 

[itsbetterthansmoking]

Hi IBTS!

Just PM SmokeyJoe... he'll get you all set up... And welcome! We've got some good conversations in the suppliers private forum so come on over and see what's up!

Cheers,

Lacey

Thanks Lacey,

I PM'd SmokeyJoe when I first joined and again today. Hopefully he will give me supplier rights soon.

 

[itsbetterthansmoking]

For what is it worth, I have a sample order that is supposed to ship from China today. I am waiting on pins and needles now......

 

[karenwest1961]

I think everyone should stock up becuase the battle is about to begin. I find it odd that alot of the suppliers are low or not in stock at all. I agree with terraphon that suppliers need to file an app for a new drug or else we all might be SOL for suppliers and supplies. I just hope i am wrong.

I've been stocked up for a long time. We've been seeing this coming for quite awhile. For those who are new to e-cigs, buy up the ones you like the most and get your juices too. Now's not a time to be ....hin' about the suppliers. They're doing the best they can with what they can get. And soon, we may be lucky just to be able to buy ONE.

 

[winterwoman]

hi everyone,

I'm new here so these might be dumb questions or a topic you've already covered but - why are e-cigs getting treated differently than nicotine inhalers? aren't they similar? aren't they legal? how are e-cigs different in what they do than the patch or the gum? nicotine is a drug. ok. but it's not a new drug. when someone uses an asthma inhaler isn't that a delivery system for some combo of drugs?

I don't understand why e-cigs are being treated like they're in the same class as narcotics or dangerous drugs.

 

[Kate]

Nicotine products are allowed because of historical precident - tobacco or they are medicines. Approved nicotine is medical nicotine that has been tested and researched. Neither our liquid nicotine or devices are tested and approved, they could be made by anyone to any standards and have unknown side effects.

They are classed by the FDA as a new drug and come under medical conditions. That might be arguable, I don't know.

Liquid nicotine has already been banned in Australia because it's a poison.

Some countries have banned it because it's not an approved and tested medical drug.

 

[winterwoman]

Thanks Kate - that helps me understand. Sort of. I'm still confused as to the difference between medicinal nicotine and liquid nicotine. Isn't the medicinal nicotine in an inhaler a liquid? Couldn't we use medicinal nicotine in the juice and circumvent this whole regulatory mess? I've done the gum and the patch before and gotten dizzy/nauseous - especially with the gum when I chewed too much so it's not like medicinal nicotine can't hurt you.

Sorry - I'm trying to find an easy solution and maybe there just isn't one.

 

[Kate]

It might come to finding alternative sources of nicotine. At the moment we are trying to keep using a flavoured nicotine liquid. You can see some of the ingredients on this thread, not many have been tested for long term inhaling - http://www.e-cigarette-forum.com/fo...ion/2202-ingredients-cartridges-e-liquid.html

Some flavourings that are approved for food use can cause lung disease when inhaled so we are in uncharted territory really. We're the guinea pigs with no regulation, standards or security of product.

The question to me seems to be will the FDA overlook the potential health risks ... will they buy the harm reduction argument?

We don't even have a harm reduction argument at the moment anyway really, we have no tests, trials or proof that what we do is better for us than smoking. It's opinion not scientific proof.

 

[winterwoman]

Thank you again - there is such an amazing volume of information here.

Ultimately, I think it will come down to money. If enough money can be made selling these, some corporation will dominate it/control it and get through all the regulatory hurdles.