IMPORTANT - email from FDA to a supplier.

[TropicalBob]

I see NO HOPE for unregulated e-liquid. From China. Even the words are scary.

I'm not familiar with any source of information telling us where manufacturers are in the process of seeking approval. And the FDA said such information is privileged between applicant and agency. So they won't put it on the Web. And manufacturers are an uncommunicative bunch if ever one existed.

 

[dEFinitionofEPIC]

Let's all just face it. We're screwed. No way around it. Like TB said...to make these legitimate it will take a LONG time. I understand everyone wanting to have a voice and make a difference.... but in all practicality, this doesn't look good and we're just going to have to let this take its time passing through the system. Logic doesn't apply. Freedom doesn't apply. What matters is that nicotine is a drug and the regulating bodies are going to do what regulating bodies do. They're going to regulate. I think we all, including myself, need to pull our head out of the clouds and just accept the inevitable. What we should all be talking about is what our plans are when our access to e-juice and supplies are indefinitely cut off. Because I, for one, have not really thought about that very much at all....

 

[kinabaloo]

TBob - "Even the words are scary."
What words?

We are just going to roll over ?

We can easily extract nicotine from patches and make our juices, We can make a simple drip-feed atomiser. But we will lose the right to vape except in secret - that's the killer. Or perhaps law enforcement would leave the individual alone once closed down the industry and closed the doors to imports.

How long did it it take for the patch to get approval? I don't see why the approval should take a long time. Maybe it's just a matter of getting the juice registered and taxed.

 

[Duckies]

TBob - "Even the words are scary."

What words?

"unregulated" "nicotine" and "China"

In the US, "unregulated" and "China" are enough. Lead in toys, melamine in milk/chocolate - you name it. "Chinese made" is a code phrase here for unregulated poison.

Not undeserved.

 

[Duckies]

I see NO HOPE for unregulated e-liquid. From China. Even the words are scary.

I'm not familiar with any source of information telling us where manufacturers are in the process of seeking approval. And the FDA said such information is privileged between applicant and agency. So they won't put it on the Web. And manufacturers are an uncommunicative bunch if ever one existed.

Understood. Thanks.

 

[Venuvious]

That's like saying if Mtn Dew was found to cause cancer because of the lemon lime flavoring, than every other carbonated drink whether it contained caffeine or not should be banned since caffeine is an addictive drug and the other drinks are used in a similar way to Mtn Dew. The bottles would be banned as well.

Yes, I have been, up until now, working with my supplier and manufacturer on offering a full line of Healthy-Liquids. One now contains no Nicotine, but does contain Gensing, Vitamin A, C, & D. I also have trying to develop a full range of other flavors in non-nicotine versions for those who want to be done with the addiction once and for all.
However, these last few weeks have greatly discouraged me! The FDA is saying, "We are stopping anything to do with e-cigarettes, it doesn't matter what is in them!"
So now I have to ask myself, what is the point of investing time and money on something that if held at customs will not be released anyway!?
I had a fellow dealer tell me, "You need to start putting Child Safety Caps on the bottles, and Labels with the ingredients, and a separate dropper..."
Well a customer said it best to me,"Why would you go through all that? There are no 'Safety Caps on Nicorette gum!? No safety Caps on the Patch!? I mean, I can walk into a Tobacco store and buy a Crack Pipe and a water ....!? So why is this such a problem?"
Good point! I don't see those 3,000 chemicals on the side of a Cigarette Carton! I don't see a label on a Crack Pipe saying,"Not intended for smoking Crack! Must be 18 to smokewhat ever it is you are smoking out of this and are old enough and legally able to do!?"

Well you get the idea. I feel like I am standing in a round room with 20 people from the Government all saying, "If you have to go, please go in a corner!"

"If a problem can be fixed, there's no need to worry about it;
If a problem cannot be fixed, worrying will do no good!"
-D. Llama

 

[kinabaloo]

I am more angry at the ignorant dimwitted bs in some of the comments here than in the FDA's letter. Some of you deserve to have your Chinese goods cut-off.

 

[gep]

I don't know about ya'll but I'm taking notes from the modder's forum. If they deem that the devices are illegal to import and sell then I guess I'll have to learn how to solder.

 

[deewal]

I can't read any more of this thead. Seem's to me this is the End.
We are now Criminals.

 

[kinabaloo]

gep - i'm sure the modders can up with something simple enough for anyone to make, hopefully without any soldering.

deewal - if people really were to be arrested off the street for vaping while others are smoking, that's really too insane.

 

[strictlybusiness]

What about the intended use of 'water pipes'? Everyone knows what those are being used for. Everyone. Somehow those people managed to redefine their product and are now safely off the radar. You can buy a 'water pipe' at a convenience store!

This is true. I recently purchased a "water pipe" from a dealer in Amsterdam and it made it past customs. An agent even opened the box and inspected it, repackaged it and sent it on its way to good ole PA. Seriously though, if a .... can make it through customs why can't an e-ciggy survive the travel? This whole "FDA approval" event is understandable, but they need to quit playing hardball and accept this revolutionary product. Theres too many conservative old heads running this country and it has to change. Just my two cents.

 

[KDMickey]

Alright, do we have any lawyers here? It's time to bring a suit against the FDA and appeal the decision that it is a "drug delivery device." Damages: The cost of treating lung cancer, emphysema, COPD, etc.

But in all seriousness, I cannot see the FDA managing to defend this position in the court of law.

 

[ChainSmkr]

Hello all, the supplier in question has asked to remain anonymous but has given me permission to reprint in full the email he received from the FDA.

Included is his response - I will update as soon as he receives a reply.

That's the best post I've read all night! Now I understand how the FDA is thinking.

 

[KDMickey]

That's the best post I've read all night! Now I understand how the FDA is thinking.

The FDA is THINKING!?

I'm going to go eat some PEANUT BUTTER and PISTACHIOS now. 8-o

 

[klum]

I see NO HOPE for unregulated e-liquid. From China. Even the words are scary.

I'm not familiar with any source of information telling us where manufacturers are in the process of seeking approval. And the FDA said such information is privileged between applicant and agency. So they won't put it on the Web. And manufacturers are an uncommunicative bunch if ever one existed.

I emailed a couple of suppliers from China and got some vague answers about them trying to get FDA approvals for their products. One said that they wanted to find a US supplier that could help them through the process and the other said that they are working on FDA approvals. The second mentioned that many other suppliers are attempting to do the same thing. Neither seemed to be too far along the process. I would think that with all the bans and the FDA crackdowns, they will start to push faster, otherwise they are going to lose a lot of money.

 

[dc2k08]

There are a few ways the FDA can go about classifying a product as a 'new drug'

• If the product makes Health claims
• If it contains an active ingredient that has already been approved as a drug for other products.

Nicowater have been down this road. They have tried all the options. They have tried calling it a dietry supplement, but because nicotine is legally sold over-the-counter in FDA-approved smoking cessation aids, federal law prohibits it also being sold as a dietary supplement.

They replaced nicotine with nicotine polacrilex or nicotine base bitartrate but still this did not impress the FDA. As long as e-cigs contain nicotine and have not undergone expensive clinical trials, they will remain on the blacklist. Big Pharm want to own your addiction and they have everything in place to allow them to.

A hug chunk of the foods Americans eat are from China: Apple juice, dried berries, Hog guts, bladders, stomachs for sausage casings, sea food, candies for children.

All of these products are manufactured in unregulated factories in china. None of these require clinical trials before market. Some arrive and are tested by the FDA and sent on their way. The majority just pass on through. It could be no different for e-cigs. The liquid could arrive, some checked that it does not contain diethylene glycol and what ever else and sent on it's way... only for the fact that it contains nicotine..

Don't forget that you and your children eat candies from China with a lot more chemicals than is found e-liquid. There are no calls for clinical trials or calls to have them manufactured in regulated factories in America. Add nicotine into the mix and there would be. It's all about the nicotine...nothing else.

 

[Mohave]

Should you have further questions concerning the manufacturing and labeling of drug-device combinations or drug products, I recommend that you retain the services of a consultant with specific expertise in these matters.

In reading these discussions I've had the feeling something is peculiar about them, a vague sense of something oddly missing, and now comes the “d'oh” moment. Where is the spokesperson, go-to dude for a quick pithy media quote or referral to professional sources, the debunker, lawyer, consultant, lobbyist, researcher, fixer, cheerleader & guru & baby-sitter for this business whose job it is to generally prevent the industry from being raped? Because if you have any kind of business enterprise at all and do not have access to full-time professional representation like that you WILL be raped. Typically manufacturers of a product will have a trade association, and the smaller businesses of distributors and vendors will join in, and that association's staffer will help encourage and guide support from customers, fans, potential allies and other interested parties to keep them informed and defend them before the potentially destructive exercise of coercive governmental authority.

Now, I generally hate the fact that the modern world requires this so much. It adds to the cost of everything and reduces access for everyone that in order to put up a damn lemonade stand you've got to have consultants to get you through the multiple processes required, and often very little of it is really useful for any broader public purpose in the end. But that is the way it is, and without someone who is knowledgeable about how the game works a political amateur just trying to run their business providing something some customers want is inevitably going to become the guest of honor at a party of the most vulgar crude destructive manifestation of populist democracy in action: a coyote, a rattlesnake, and a bunny rabbit voting on what's for dinner. Are the producers of the product interested in continuing to exist? Where is their trade association representative?

 

[esmok-e]

I am leaving the supplier anonymous for now, but this is real:

Quoted from a suppliers website:

"The products have also been certified by the following domestic and international authoritative agencies:

US Food and Drug Administration (FDA)."

From the same site:

"Nicotine Replacement Therapy (NRT)

Nicotine replacement products help relieve some of the withdrawal symptoms people experience when they quit smoking. There are several nicotine replacement products currently available over-the-counter in the United States, including two nicotine patches, nicotine gum and nicotine lozenges. A nicotine nasal spray, inhaler (Zyban) and the recently approved nicotine-free tablet (Chantix) are available only by prescription. To be most effective, nicotine replacement products should be used in conjunction with a behavior change program."

From the same site (I assume it's their retail sign):

Is this wishful thinking or are they on to something?

 

[dogsteve]

What about the intended use of 'water pipes'? Everyone knows what those are being used for. Everyone. Somehow those people managed to redefine their product and are now safely off the radar. You can buy a 'water pipe' at a convenience store!

Ask Chong Marin how that went over.

 

[esmok-e]

I asked Chong, he referred me to the Fabulous Furry Freak Brothers.