VapeAtron

According to a statement from an FDA official, the FDA will "officially" add e-cigarettes to the list of items outlawed, most likely citing their status' as "new drugs" and the devices being "drug delivery devices". Therefore of course, needing FDA review and approval before being able to be sold in the USA.

Of note, one of the larger importers of e-cigarette products just sued the FDA to prevent seizure of product at customs.

The statement from Heather Zawalick of the FDA's Office of Legislation is as follows:

This comes from Bill Godshall of tobaccofree.org via email announce lists and other means.

FDA crackdowns on these products began a while ago, and US distributors selling E-cigarettes began getting their incoming shipments from China held at customs randomly. With this public announcement and stance on the issue, it could be concluded that this will continue and increase in the incoming months.

How this affects e-liquid producers based in the US (not many) or those attempting to produce personal vaporizing devices completely within the USA, bypassing customs, is not known.

Bottom line, e-cigarette usage is going to get harder in the USA starting - Tuesday.

Stay tuned to Vapeatron and other sites like ECF for the latest info over the coming days.

Credit: Opposing Views and ECF.

UPDATE: As of late Wednesday, no official statement, video or announcement of any kind was made by the FDA regarding e-cigarettes. For now, their status remains "legal but in limbo".

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Primus

I would imagine it was Smoking Everywhere or Ruyan that sued them. Who knows though.

VapeAtron

Yeah, Njoy too. All of those have vested interests here on levels above normal small time suppliers.

Very interested on how this applies to personal possession and use. Haven't seen anything concrete yet.

SmokeShop

I ordered a minimal shipment of 250 bottles of e-liquid for resale on April 10th, 2009. It was due to be delivered on April 13th.
Well, last I checked it was still with the FDA in PA, being either destroyed or sent back to the supplier!
No reason given, no story, no nothing!
So I am afraid we have come to an empass. What happens next who knows!?
I do know it is time for change.
HealthySmokeShop.com is closing its website after Sunday. I am having a big sale, and all my loyal customers are welcome! If everything works out next week, I will be launching
HealthyFlavorings.com, which is now online but not stocked. This site will ONLY offer e-liquid with NO NICOTINE. There will be no mention of e-cigs, parts, etc.
Only Healthy Flavorings which contain only the best quality ingredients, and ALL FDA approved!
What you do with them is up to you! Just know they are all approved by the FDA.

So thank you all, and Thank You Vapeatron! You have helped me to make this a grand adventure indeed! And God willing, we can all continue to benefit from sites like these, and the people who run them.
I don't think everyone stops to think about how hard it is to run a company where the FDA Wolf is always at your door...The Chinese are constantly sending you parts that don't work like they should, and trying to make your customers happy!

That is nothing compared to the effort that goes into running an informative and great site like Vapeatron! Kudos Vapeatron, for your hard work in helping us stay informed and giving us all the latest in the field of e-cigs!

Here's to you!

God Bless,
Patrick
HealthySmokeShop.com

Primus

So, looks like it was Smoking Everywhere that sued them. Hopefully SE gets justice.

sinner

im still baffled that smokers have finally found something that can not only make us happy, but keep non smokers from bitching so much and STILL they want to ban it.

what happened to this being the land of the free? now its turning into the land of the cry babies and douche bags that think everyone should be exactly the same.

sorry, i usually dont flame threads like this, but this is really irritating. i better put in a juice order today and get a stockpile.

SmokeShop

Thank You All for a Great Adventure!
Yes, the site is officially closed! I do have some stock left.
And I will be offering it at a good price to people like Vapeatron & its customers first.
Update soon!
As far as the industry, well it's an old story really!
My father was a GS-13 (WD-8) Civil Service Gov't Employee.
He worked on the Nuclear Submarines, he was a Ship Surveyor for the 6th fleet in Italy and Europe. Of course he had a Top Secret clearance also.
One thing he always told me.
"Son, the Government relies on Dis-information. That is, and always will be, a standard practice..."

It is so true. Everyone may have delusions of gradure, but in the morning, the fact remains, that you are not in control, even though they may have let you think so for a while. In the end the Government will make up its mind and there won't be anything you can do, except file your paperwork like the rest of us. You see, that's how they win.
They tell you to file a lawsuite, claim, etc. Knowing it will take you a long time to repeal ANY decision they make!
Hate to be gloomy, but that's the way I see it!
Thanks everyone....P.C. Out....

optmaxx

I just found this video over at ECF. I wanted to start a new thread for it but the site would not let me so I will post it here

Healthcabin

It sounded bad. Hope it will not happen.

Thank you very much for keeping us informed.

Joan Poulton

As far as having no idea of why FDA detained your shipment if you are the importer of Record you would have been issued an FDA hold, then an FDA detained notice. In the detention notice they would have clearly outlined the law thought to be in violation. You would have at least 1-2 weeks to answer the detention notice and give the required information to may proceed your load. If you were unable to supply the required information you would be issued a CF4647 notice to destroy or redeliver to the country of export. You would have 90 days from the refusal date to either work with FDA to destroy or Direct export on an IE bond under the supervision of customs.

LaceyUnderall

Just an update: On May 5th, nothing happened! Thank the lord... (kind of as some resolution would be nice!)

Either way... still waiting to hear the outcome of the SE/nJoy lawsuit against the FDA.

Joan Poulton

I can tell you based on the information that I have access to (US Customs broker) is not that of FDA but of the mfg and importers. They have to go through the proper channels of FDA. You have to understand that although you might be feeling some issues with FDA they only enforce the laws. Currently the E cigarette it's self is under review to be considered a medical device (501K registration required). The nicotine is considered a drug and the E cigarette administers this drug thus the requirement for registration. Remember it's not FDA it's the actual manufacturers that have to stop dragging and get this registered so that you can use this devise.
You can not compare with actual tobacco cigs because they are governed under another government agency ATF so FDA does not govern.
Keep in mind FDA if there to protect the US Consumer and make sure that everyone is in compliance with the laws. Non compliance will be refused.
When you read the label of your nicotine juice does it tell you what's in it? If not than how do you know what is in it. Trust me I have seen a lot of stuff refused by FDA for good reason.
Having to be FDA registered is not going to increase your price of the product only the safety of what you are taking. Currently I do not smoke (2 years smoke free) but I actually found out about this through a shipment and my husband uses it so I hope that it is safe, I just don't know.
The key is understanding why things are being held. Everyone likes to blame customs or fda but forget to finish the rest of the story. Do visit FDA website at U S Food and Drug Administration Home Page. It's a great site that will keep you the consumer in the know.

LaceyUnderall

Joan - I completely agree that the FDA has every right to stop shipments to those who make claims. Claims are definitely a part of the FDA's jurisdiction. However, in the case of nJoy, they haven't made claims. SE... entirely different story.

What I find interesting with the US FDA website is that for over a year now, I have checked that site on a regular basis and they are still to make any statements regarding the ecig. There is the OASIS reporting, which in all cases, I thank the FDA and Customs for stopping stuff because some of the labeling on packaging is just completely false.

But... this all does come down to what is actually the basis of compliance? If this isn't a quit smoking device (which nicotine products would need to be approved as) but a smoking alternative, then what is one to do? It's interesting. Up until 2 months ago, when nicotine was searched on the FDA website, it directed you to your "best bet" and that was the ATF website. As of late the FDA website appears to have undergone (a very nicely done) facelift and user accessibility upgrade.

Another interesting point is if this is about the nicotine, then what are they going to do about the non-nicotine solutions? Do you think it will end up like Health Canada ruled and non-nicotine liquid sold with the hardware makes the hardware not a medical device and the non-nic liq not a drug?

Being a customs broker (and the spouse of someone currently using an ecig) your comments are greatly appreciated.

Joan Poulton

A couple of things you have to look at in regards to the governing of this product. First you must remove the ATF from this. They govern only the tobacco aspect not the liquid nicotine so this puts them out of the picture.
Second this has been a hot topic in many countries. This product has been banned from 11 countries to date and more recently Hong Kong which would draw more attention to the product.
Now I read the manual which on my husbands. It tells how it is a tool to help in the stop smoking process. When reading it's main function was to help you stop smoking improving your over all health.
The goods are inspected, sampled and reviewed by FDA. First they must address the labeling that apparently are making false claims. They would be able to relabel and come into compliance but enters the liquid nicotine for human consumption. This puts them in full view of FDA. The human inhales this into their bodies. FDA has to ask the questions. Is this just nicotine or is it a mix of other products (no labels on the bottles to tell them what it is). Is this a danger to the health of the human? Is this considered a drug?
The last one is the kicker, yes it is a drug for human consumption. The mfg would have to get the product approved as a drug with FDA and the label approved by FDA. Then comes the E cigarette. It would be considered a medical devise to the drug liquid nicotine. So the E cigarette would have to be approved as a medical device and registered as such.
It not impossible to have the goods improved but it takes time. Ultimately it should be the mfg that should be doing what they have to this product approved. They would also have to ensure prior notice with FDA prior to the shipment entering into the US. You can not image the laws that have been circumvented with this product.
Lets remember about the tooth paste, pet food, and many other products that have harmed both people and animals.
I do not want to see my husband go back to smoking and hope that they can get this product approved but the mfg have to get on this. The only way they wouldn't is if they knew something that you do not.
Also remember laws for our children have to be put in place with this product. It is a drug and we need to keep it out of the hands of our children.
Nicotine is an addictive drug.
Trust me the mark up price that you and everyone else currently pays to have this product is beyond what you can imagine.
Do not try to import this product or any other product on your own from outside of the USA, you may find out you get more than what you thought. Many fines and penalties have been issued.

godling

It's not about the nicotine, it's about those people who think they know better than I do about how to raise my own child or about how I should live my own life. Too many people simply won't allow something on the market unless there are laws in place that restrict its usage to match their personal beliefs. Unfortunately, e-cigs ARE used with nicotine ... so those people DO have a way of getting them regulated.

LaceyUnderall

My issue is that the only way the FDA can approve them is if they are a quit smoking device. What does that mean? It means that clinical trials need to be carried out to determine the maximum length of use for the user, like that of the patch with the step down program... and for the first few years out of the gate, after all of the approval is done, the ecig will be RX only. If this is the case, then tobacco cigarettes should also go through the same approval and be by RX only. (Especially since the FDA may get control over tobacco here in the next few months if Altria's plan works out )

Again, it will be interesting to see how the case with SE/nJoy pans out. Did the FDA overstep their bounds and did they not follow proper procedure? To date, there is still no comment on their website regarding an official "ban" of the ecig. Personally, I think it is because nicotine falls into this "grey" area and since it isn't a tobacco product, the ATF doesn't want/get control and if there aren't claims made, nicotine doesn't fall into the FDA's jurisdiction. One of those loop holes that everyone is very well aware of... just can't do anything about because it takes an act of Congress close it.

Godling - I am right there with you. As a responsible adult and parent, I am getting kind of annoyed with a government telling me what I can and cannot do and how I should parent.

LaceyUnderall

dbl post sorry!

dib

Hiya to all out there.
i am from the UK and have been looking at reselling these cigarettes over here and am still trying out lots of different brands until I find the one that looks right and gives you the 'kick at the back of the throat' but on the note of the FDA in the states trying to ban these and the reasons they are using leads to the question. Whose pocket is been lined with silver to push this through? You can bet your bottom dollar that the tobacco industry is bank rolling this action. Funny how, when we all know how much damage that normal cigarettes cause that all governments around the world have not decided to ban all tobacco, but that said, they can not do that as, apart from losing millions in duty, the big boys in the tobacco industry would no doubt stop the free holidays and perks that they give out. There will be those of you out there that will say I am talking rubbish but I am entitled to express my views. I have been a smoker for over 35 years and know how addictive nicotine is and although, at this moment in time, it is not my intention to stop, it is nice to be able to 'get my fix' with smelling like an ashtray. The FDA should stop bowing to pressure and see the benefits of these and promote them accordingly. If you want to reduce your nicotine intake, these will allow you to do so in a controlled way. End of rant!

godling

I was just told by a supplier in China that 36mg juice will no longer be available from them. The didn't go into detail, but dropping the strong stuff is part of what they have to do to be in FDA compliance.

It's exciting to me because this is the first I've heard of the manufacturers working with the FDA to keep us all vaping.

LaceyUnderall

I have heard this too... from several suppliers. This is a good sign!

And Dib - what you say is not rubbish... it is right on.

Cl0ud9eSm0kes

hmm.. I ordered 250 bottles of eLiquid from China about 2 weeks ago and I did not receive the shipment... I am of the opinion that US Customs is holding the shipment.... I did not receive a notice from the US Customs declaring that my shipment was held....
So, I am slightly confused....

Not to derail the thread, but is there something that can be done to verify if the shipment was held by US Customs?

Joan Poulton

Who is the responsible party for the shipment. Was it coming air or ocean?

Cl0ud9eSm0kes

It is from some China distributor. They have a site up called bestesmoking.com

I do not know for sure which method was used to deliver the good, but they used EMS to ship. I do not know if they use Planes or Boats.

I received all the ecigarette devices, but no eLiquid..... The EMS tracking page only states that the shipment was delivered.

Currently, when I send emails to the person(lintony) I was dealing with in China, I do not receive any responses.... whereas prior to placing the order, 'Lintony' was bugging me everyday.

I am not sure if I have been duped, or if US customs has destroyed the shipment, or if US Customs will release the order in about a week....

LaceyUnderall

Cloud - You would have heard something by now. And, if customs/FDA would have stopped your shipment, you would have something in it noting that they did take a portion of your shipment.

EMS works, but isn't completely reliable so if they did send it, I wouldn't be surprised if your missing portion shows up later. Maybe with the recent Chinese holiday your contact is a little behind?

Maybe try contacting him/her again. (remember to be patient in your writing style and non-aggressive. There is already a language barrier and sometimes tone does not translate well... I have heard of folks/suppliers getting saucy and then not hearing another word from their Chinese counterparts)

Khadijah

I ordered from Bestecig.com on the evening of June 3. I received my order on the morning of June 9. Sooo fast! It was shipped by air. I was able to track the shippment from China to Customs in San Fransisco where it sat for 3 or 4 days and then to a town near me where it was proceessed and delivered to me a couple hours later.

My order was small, 6 bottles of e-liguid, 4 batts, 1 atty, and 10 blank carts.

If it is, or becomes illegal to import the stuff, I will attempt to anyway. I love vaping even more then I loved analogs.

I'll take my chances, after all the FDA and U S Gov, really don't have any control over what foriegn businesses do, other then to confiscate their merchandise as it enters the U S...if they catch it! But with thousands of packing coming in every day, I really doubt that Customs inspectors can check each and every package.

I recently imported a non-approved cancer drug from Mexico. It's been banned in the U S since around 1982. (I have non-smoking related cancer). I had no trouble ordering it and reveiving at my door by the Post Office. They can't possibly check EVERY package. Maybe the BIG orders they can, but not the all of the small personal orders. (At least I hope not!)

Also, my order from China, with shipping was $190. Yesterday I placed a small order with the same company for $55. It's already in the air and headed to the U S. I tracked it already.