The Real Scoop on FDA & eCigarettes!

[Liberate_Yourself]

Uhm...

Did you actually read that block of text?

The words "electronic cigarettes" are in the first sentence.

Also in the first sentence are the words "we have reviewed".

Unless the guy that pasted this is pulling it out of his ..., the FDA knows EXACTLY what they are and they're looking for them.

Let me also tell you this. You can "mislabel" your shipments all you like. Hell you can have the people in Shenzen write "kitten guts" on the box if you want. If that gets it through customs, wonderful for you. Here's the problem, though. What you're doing is misrepresenting the contents of a package or packages for the sole and exclusive purpose of evading customs seizures in the act of bringing federally regulated materials and or products into the United States.

You made a post in another thread (Smoking in school) talking about how people that have the attitude of "I'll smoke where I want" (or something to that effect) are the same kind of people that caused all of the smoking bans and issues in the first place.

Are you going to be the one that says "I'll evade customs and lie to the federal government to get my product into the country if I feel like it, because I don't want to fill out some forms and legitimize my business!"? If so then you're exactly the kind of person that's going to help bury the electronic cigarette industry in the United States and force people like me to go back to tobacco.

Good job, that. Go hang out with Jon from TheSafeCig. You guys'll make a hell of a team.

Whoa whoa whoa, slow it down a bit bud. You are putting words into people's mouths. And quite frankly, unless you are involved with the FDA, you are acting on speculation, quite like the rest of us. I didn't notice a supplier tag under your name, so there is really less of a need for you to be stressing out about the situation. Take a chill pill, and go yell into a pillow or something.

Too much tension on the forum these days.. lol

 

[LaceyUnderall]

Uhm...

Did you actually read that block of text?

The words "electronic cigarettes" are in the first sentence.

Also in the first sentence are the words "we have reviewed".

Unless the guy that pasted this is pulling it out of his ..., the FDA knows EXACTLY what they are and they're looking for them.

Let me also tell you this. You can "mislabel" your shipments all you like. Hell you can have the people in Shenzen write "kitten guts" on the box if you want. If that gets it through customs, wonderful for you. Here's the problem, though. What you're doing is misrepresenting the contents of a package or packages for the sole and exclusive purpose of evading customs seizures in the act of bringing federally regulated materials and or products into the United States.

You made a post in another thread (Smoking in school) talking about how people that have the attitude of "I'll smoke where I want" (or something to that effect) are the same kind of people that caused all of the smoking bans and issues in the first place.

Are you going to be the one that says "I'll evade customs and lie to the federal government to get my product into the country if I feel like it, because I don't want to fill out some forms and legitimize my business!"? If so then you're exactly the kind of person that's going to help bury the electronic cigarette industry in the United States and force people like me to go back to tobacco.

Good job, that. Go hang out with Jon from TheSafeCig. You guys'll make a hell of a team.

No. I am sorry. Maybe I wasn't clear. There is a way to mark the boxes properly and for what they are. Using the words "health" "quit smoking device" and "cigarette" are not what they are.

Also - please don't compare me to any of the other "claimers". I have made very clear what my intentions are around here... I am working for all of us to ensure that we have our e-cigs until the day we die. I am doing everything I can to make sure that we can all enjoy our e-cigs safely and not having to hide in our basements or closets. Have you come up with any assistance for the homeopathic idea that I am working on? Nope. But I wish you would focus your energy on that for me.

 

[LaceyUnderall]

I wonder if there might be a misunderstanding here.

Lacey might be saying that 'electronic cigarette', 'healthier' and 'quit smoking device' are mislabelling?

If any such label or claim is used for importing then the FDA can stop the shipment because they have jurisdiction.

If no claims are made and the devices are labelled something like 'personal vaporisers' (which is what they are) then the FDA do not have jurisdiction?

What about flavoured liquid nicotine intended to be inhaled, how can that be honestly labelled and imported?

Yes. This is what I meant. Terraphon... I by no means condone any "claims" marketing or mis-labelling or anything like that.

 

[SupplierX]

If the FDA were after e-cigarettes, we would have already been shut down or all of the suppliers would have atleast recieved a threatening letter. A simple google search would provide the FDA with every US supplier, making it very easy to shut us down. We are all still here. I cannot speak for the rest of the suppliers, but I have yet to be contacted by FDA.

 

[Kate]

We've been around this one before Taley - http://www.e-cigarette-forum.com/fo...unning-into-problems-customs-3.html#post99435

They are stopping some shipments coming into the country, it would be a bigger job to enforce the rules with products already on sale.

 

[LaceyUnderall]

And... as you can see from Kate's link (and there are even more on ECF I will be happy to dig up if we need too...) many, many suppliers have weighed in on this and we are just not having the problems with the FDA.

 

[Terraphon]

Whoa whoa whoa, slow it down a bit bud. You are putting words into people's mouths. And quite frankly, unless you are involved with the FDA, you are acting on speculation, quite like the rest of us.

Actually, in this case I'm acting off of quoted law. There's no speculation to be had there, really. I'm just taking what the FDA said and going with that. Here's what they're saying.

(a) Necessity of effective approval of application

No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) of this section is effective with respect to such drug.

Here's what this means; If you want to sell e-cigs in the U.S. you MUST have an application to do so submitted and approved. If you don't they can burn you.

If you'd like information on how to file such an application, I'll be happy to provide that.

I didn't notice a supplier tag under your name, so there is really less of a need for you to be stressing out about the situation. Take a chill pill, and go yell into a pillow or something.

Too much tension on the forum these days.. lol

No supplier tag != no investment in the industry. I, at this time, have not only a financial but also an emotional and physical stake in the industry. What happens with e-cigs directly affects me and that means that I'm going to do what I can do to help legitimize the devices and the industry as a whole.

No. I am sorry. Maybe I wasn't clear. There is a way to mark the boxes properly and for what they are. Using the words "health" "quit smoking device" and "cigarette" are not what they are.

I see, now. I misunderstood part of what you were saying which then cascaded in to me mis-reading the whole post so I got a bit frisky. I was actually on the complete opposite side of what it actually seems you're saying and was under the impression that you were saying that mislableing shipments is the way to go.

You have my apologies.

Also - please don't compare me to any of the other "claimers". I have made very clear what my intentions are around here... I am working for all of us to ensure that we have our e-cigs until the day we die. I am doing everything I can to make sure that we can all enjoy our e-cigs safely and not having to hide in our basements or closets. Have you come up with any assistance for the homeopathic idea that I am working on? Nope. But I wish you would focus your energy on that for me.

Again, this was based on a misinterpretation and my statement holds no water. I'm going to edit my original post to reflect that.

When I f.ck up, I say I f.cked up and...in this case...I f.cked up.

Don't get used to it

Yes. This is what I meant. Terraphon... I by no means condone any "claims" marketing or mis-labelling or anything like that.

Gotcha

If the FDA were after e-cigarettes, we would have already been shut down or all of the suppliers would have atleast recieved a threatening letter. A simple google search would provide the FDA with every US supplier, making it very easy to shut us down. We are all still here. I cannot speak for the rest of the suppliers, but I have yet to be contacted by FDA.

They're not "after" e-cigs. What they want is consistency and compliance with U.S. code. Those who choose to not follow that code are asking for a world of hurt.

 

[Kevin]

Actually, in this case I'm acting off of quoted law. There's no speculation to be had there, really. I'm just taking what the FDA said and going with that. Here's what they're saying.

(a) Necessity of effective approval of application

No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) of this section is effective with respect to such drug.

Here's what this means; If you want to sell e-cigs in the U.S. you MUST have an application to do so submitted and approved. If you don't they can burn you.

If you'd like information on how to file such an application, I'll be happy to provide that.

What new drug might you be talking about? I'm I missing something here.

 

[LaceyUnderall]

Terraphon - No worries. I appreciate your making good

 

[Kate]

Have a read Kevin - http://www.e-cigarette-forum.com/fo...-real-scoop-fda-ecigarettes-2.html#post101904

 

[Terraphon]

What new drug might you be talking about? I'm I missing something here.

Kevin :

Per the FDA and U.S. Code :

Since we are not aware of any data establishing that such products are generally recognized among scientific experts as safe and effective for these "drug" uses, they are "new drugs," as defined by section 201(p) of the Act (21 U.S.C. § 321(p)) requiring approval of an application filed with FDA in accordance with section 505 of the Act (21 U.S.C. § 355) to be legally marketed in the United States. None of these so-called "electronic cigarettes" is covered by an approved NDA. Thus, the marketing of them in the United States is subject to enforcement action.

 

[nicowolf]

What new drug might you be talking about? I'm I missing something here.

We are talking about nicotine in the form of e-liquid that we use in our e-cigarettes. The FDA is calling it a new drug because it does not fit under any of their established drugs.

 

[Terraphon]

Also, just as a heads up for people...

The process of applying for approval to distribute "new drugs" can take as long as 180 days. In that time it is possible that the FDA could institute controls which makes it a crime for someone that does not have an approved application on file to distribute e-cigs.

If you're interested in FULLY legitimizing your U.S. operation, it's probably a good idea to go ahead and file, now.

In reading the law it's obvious that foreign manufacturers would have to apply for approval in order to "deliver for distribution" but the suppliers would also do well to submit an application just so they can't hammer you. Start working with domestic e-liquid suppliers who can show processes and facilities used for creation of their product and 90% of the battle is won.

Just a thought.

 

[Kevin]

Have a read Kevin

Thanks you Kate, I missed that. Interesting...

 

[RonFrank]

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

 

[devonschmoker]

And that is a perfect example why they are called "personal vaporizers". For example: They would refuse a shipment of "Bongs" but they would accept shipments of "Water Pipes". Government rules and regulations hinge on what an item is called. As long as you stick to what it should be labeled you will be fine.



Also I think it is quite interesting that no one has gotten a straight answer out of the FDA about exactly how they view this device. All anyone has gotten is fairly vague answers. If this and that it might be classified as a new drug. They haven’t made an official statement that it is classified as a new drug. They are making it harder to do business because it threatens big pharm and that would affect the shipping screeners “Pay Scale”. I have not seen ANY official report or memo saying that it is classified as a new drug and is not approved for import.

 

[brandeeashlynn]

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.

 

[Sun Vaporer]

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.

Brandee--If Suppliers put an Application in for a New Drug, I will meet you back here in about 4 years--that is the Nicotine Water shuffle. Yicks--No studies for FDA to approve with. But it probably will come to that--who knows. I do know that all I hear is bad news on the doorstep everyday with our devices---Sun

 

[RonFrank]

Perhaps I should have been clearer in my previous post.

The significant thing is that FDA is requesting 510K from both manufacturer and recipient & a MDL for the delivery device.

This indicates they have classified the named e-products as MEDICAL DEVICES which raises a whole new set of issues.

Ron

 

[brandeeashlynn]

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