An idea for avoiding FDA approval or control

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solution42

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Dec 15, 2008
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Bad news for you guys, but while you've been extolling the virtues of various flavours and devices, the snowball that is the "nanny state" has been hatching a suprise.

You can't fight it, the logic is impenetrable. Who can possibly argue self harm over protection. The battle was over before it began.

The inaction and apathy displayed by the majority here towards the bans in Mexico and Australia merely cement how fragmented we all are, this is a lost cause. See you in the cancer ward.
 

Lithium1330

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Nov 22, 2008
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The bomb has been dropped, just wait and see... now pay attention to smoking everywhere look what they will do.

Take an eye on JC too.

The inaction and apathy displayed by the majority here towards the bans in Mexico and Australia merely cement how fragmented we all are, this is a lost cause. See you in the cancer ward.

I agree...
 
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GabbyD

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Dec 7, 2008
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Bad news for you guys, but while you've been extolling the virtues of various flavours and devices, the snowball that is the "nanny state" has been hatching a suprise.

You can't fight it, the logic is impenetrable. Who can possibly argue self harm over protection. The battle was over before it began.

The inaction and apathy displayed by the majority here towards the bans in Mexico and Australia merely cement how fragmented we all are, this is a lost cause. See you in the cancer ward.

You were right with the first statement. The battle was over before it began. The inaction and apathy is irrelevent, as neither would have had any impact on an FDA ban here. But the FDA held shipments as far back as November, from what I can see, and we still don't have an all out ban. I would imagine for a while, we'll see most of it get through. I doubt they are situated to block it entirely at the moment. We'll see. In any event, I continue to be "inactive" as there really is nothing I can do.
 

Bellinghamster

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Nov 20, 2008
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That's a shock, that's for sure. But lets just wait and see. That may be one local agent or supervisor speaking, and not FDA policy.

I agree Leaford, my shipments from China have been coming through real regular-like.

I think the argument over definitions/semantics could make some lawyers a lot of money and forestall the eventual ban by a few years. But I have every faith our corrupt, short-sighted, and morally bankrupt federal government will ban this eventually, and likely soon.

/end rant
 

riddle80

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Nov 25, 2008
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Do we have no defense against these claims? Would our actions be pointless? What should the next step be? I wonder if anyone else has received this same response. This was from 2 weeks ago, so many other shipments have came into the US since then.

I think we should start a new thread with this very important information so everyone can put their heads together.
 

Reign

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If I had a shipment held by customs...my first action would be a letter to my congressman requesting a congressional inquery to the customs agents. That gives them a small window of time to respond with what they did, why, and any other information you would need to know.

If they prematurely detained your shipment without any real lawful reason, that would be a huge step in the right direction for our side in the fight and could be used later in court.

If they do not respond to the inquery, people would lose their jobs and you would have your stuff immediately released to you as well as being something to be used later in the fight.

Get the governement on your side by starting with the small fish that need your individual votes to keep their jobs.
 

Kate

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Jun 26, 2008
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Anyone interested in getting organised and trying to move towards acceptance of vaping should have a look at Right to Vape, especially this thread - Who are the movers and shakers?

Please join in with your own contributions, anything constructive is beneficial. If we co-operate we can achieve more than we could if we just stay a fragmented community of complaining, powerless individuals.
 

TropicalBob

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Jan 13, 2008
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This is the first time we've seen an e-mail like this one, to my knowledge. This explanation is new. It's policy. I can't believe for even a second that a single agent would write that, without the full authority of the agency. No middle representative would write that and risk speaking for the agency. This is top-level content. It sounds very much like a prepared FDA statement. If that's the case, expect more such interceptions of e-smoking stuff and near-identical e-mails.

This is the sentence that stood my hair on end:

None of these so-called "electronic cigarettes" is covered by an approved NDA. Thus, the marketing of them in the United States would be subject to enforcement action, which is why your products have been detained.

How quickly and how vast will the enforcement action be? With that sentence, no e-cig is acceptable or exempt from "enforcement action."

The next move will be important, since at this time the FDA says only that the "products have been detained." Keep us posted, Smooth. Detained doesn't have to mean confiscated for good. What does the FDA want?
 

BiscuitSlayer

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Dec 28, 2008
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Probably the most interesting thing to watch from this point forward is what happens or doesn't happen to JC. Since they are operating within the US, they don't have to pass through customs to get to us, the end users. I foresee a "cease and desist" order coming down the pipe. The question is: When?

I would imagine that the shipments getting through customs are probably out of sheer luck rather than anything else. Everyone knows how well our government works in areas like these.

The one thing I was hoping that would not happen was FDA intervention. It is going to be next to impossible to get anything acknowledged or reversed by them. They don't give a damn about our opinions or what we think, and good luck with trying to fight them in court. If and when it is a case that can be won, it will be in the court system for years, during which we still won't be able to receive "goods".

I don't think that this was an isolated incident. I think it is a sign of what’s to come.
 

lintz69

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Can't we all get together and fight them? I mean I am new to vaping, so I would of course miss it. But not as much as a lot of you who have been vaping for much longer. But what REALLY REALLY pisses me off is our rights. Where the hell are our rights going? Come on people, we can't allow them to just keep taking away our rights whenever they choose. Whether these are safer or not(which I know they are) It should be our CHOICE. There has to be some lawyer out there who could fight this probono or whatever where it wouldn't cost alot. Let us all fight this. For once in our lives, we should stand up and say no. You are NOT taking away our rights.
 

BiscuitSlayer

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I know it is really hard to fight back and win, but what about the argument: "They can be used for vaping no-nicotine liquids"? then the devices has another porpuse, just like with paraphernalia

I started doing a bit of research, and I have found instances where the FDA has held up hardware, carts, and nicotine liquid in customs. The two reasons given were: Unapproved and Not Listed

Reason: UNAPPROVED
Section: 505(a), 801(a)(3); UNAPPROVED NEW DRUG
Charge: The article appears to be a new drug without an
approved new drug application.

Reason: NOT LISTED
Section: 502(o), 801(a)(3); MISBRANDING
Charge: It appears the drug or device is not included in a
list required by Section 510(j), or a notice or other
information respecting it was not provided as required by
section 510(j) or 510(k).

From what I can tell, this has been happening on a small scale since August of 2008. The "NOT LISTED" reason appears to be targeting devices which I found to be quite surprising. I always thought they would go after nic liquids/carts rather than devices. One instance I saw was declared as "Atomizers" with nothing else in the description. Here are a few examples of what I found. You have to parse through the other stuff that was denied entry past customs.

OASIS REFUSALS INDUSTRY 66

OASIS REFUSALS INDUSTRY 66

OASIS REFUSALS INDUSTRY 66
 

lintz69

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Well, I just emailed the following to Senator Casey:

Dear Senator,

I am writing you today about the FDA's involvement with electronic Cigarettes. In case you are unaware these Electronic Cigarettes were shown on "the Doctors" as one of 2009's top 10 health products. It allows you to smoke in a much more safer way as there is not the 4,000 chemicals and no tobacco, and no fire(thus no tar) and no cancer. I purchased one of these and started smoking. It still contains nicotine but I have been able to successfully switch from cancerous cigarettes to my safer alternative. I now read the FDA is trying to ban them. I don't think this is fair. Shouldn't we as Americans, have the right to choose if we want to be safer? I read an email in which FDA is holding someone's Electronic Cigarettes and stated they are illegal. How can this be? I have never got involved much with the government, but this has got me worked up. There are 1,000's of us Americans choosing this safer alternative. If we lose it, we are forced to go back to what we KNOW is not safe. How can this be fair to our health? Please, help.
 

Lithium1330

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Nov 22, 2008
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Can't we all get together and fight them? I mean I am new to vaping, so I would of course miss it. But not as much as a lot of you who have been vaping for much longer. But what REALLY REALLY pisses me off is our rights. Where the hell are our rights going? Come on people, we can't allow them to just keep taking away our rights whenever they choose. Whether these are safer or not(which I know they are) It should be our CHOICE. There has to be some lawyer out there who could fight this probono or whatever where it wouldn't cost alot. Let us all fight this. For once in our lives, we should stand up and say no. You are NOT taking away our rights.

We are trying: Who are the movers and shakers?
 

BiscuitSlayer

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Dec 28, 2008
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Acworth, GA
Let us all fight this. For once in our lives, we should stand up and say no. You are NOT taking away our rights.

Sorry for the double post, but Lintz69's comment was posted immediately before mine.

The problem is isn't them taking away our rights. The problem is that systematically over time, we have given up our rights by demanding more government intervention in the forms of protection from companies harming us. When something happens that is related to our health being compromised by a product or drug, people scream bloody murder that the government isn't doing their job by protecting us.
 

dc2k08

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May 21, 2008
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This looks bad. So how are the others getting their stock in, or more importantly how long will they be able to get their stock in? The only future for these is for Big Pharm to take over. Njoy now might take the whole market for themselves for a while if their new relationship to Miri Pharm means anything.

Here's an example of big pharma trying to interrupt another company from getting a product approved so easily. Since this product involves nicotine, I thought it interesting to read.

http://www.fda.gov/OHRMS/DOCKETS/dai...00001-vol1.pdf

Here's another mail from the Campaign for Tobacco-Free Kids people to the FDA about that nicwater too. I wonder if there were similar letters about e-cigs.

Public Citizen | Publications - Letter to FDA Commissioner Requesting Enforcement Against Maker of Nicotine Beverages (HRG Publication #1777)
 

Myk

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Jan 1, 2009
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The FDA earlier made a clear distinction between natural nicotine in a tobacco product and the derived chemical nicotine used in e-liquid. Makes no difference whether our nicotine comes from tobacco or eggplant or tomatoes. It's a drug when separated from a plant and sold in chemical form.

Course, before long, the FDA will get regulatory authority over all tobacco products, but that's another battle. Shipping via the Postal Service of any tobacco product is being proposed for a ban by Congress. Ditto for all private shipping not to a business address. So much for my Blatter Reserve. It's gotta be Carter Hall from my local store.

The ONLY argument that might stand any chance at all would be that nicotine, in normally consumed quantities, is no more a drug deserving a ban than caffeine now used in soft drinks, chewing gum and energy products. Both are stimulants with dangers. Both are widely used as found in their natural state.

Nicotine liquid will be regulated, of that we can be assured. But a ban is difficult to take. Set poison limits, as England did, and take it off the banned list.

It's hard to imagine the FDA paying attention to anyone, shyster lawyer or otherwise, who says that agency doesn't have authority to regulate and/or ban drugs!
So when you spit while chewing you could be arrested for dispensing drugs?
I don't think so.

Are all those herbal supplements in healthfood stores considered drugs even though the FDA tried to claim they are classified as "new drugs"? NO.

This is the FDA trying to get their mitts on a tobacco product against the Supreme Court.

The point of having a "shyster lawyer" is to use previous case precedent to show that this does not fall under the FDA's definition of "drug" it falls under the definition of tobacco product.
Did you even read their definition or did you simply dig out your Chicken Little script?

Maybe if people would start standing up to the government instead of running around claiming the sky is falling we wouldn't have a government that is ruled by large corporations and those with the ability to purchase senate seats.

This is the first time we've seen an e-mail like this one, to my knowledge. This explanation is new. It's policy.

This isn't the first time. In fact the exact same email has been posted before.
And as I recall you posted in that thread.

I know it is really hard to fight back and win, but what about the argument: "They can be used for vaping no-nicotine liquids"? then the devices has another porpuse, just like with paraphernalia

And we have a winner.
They tried to ban ephedra and couldn't do it.
They tried to ban pot pipes but couldn't do it.
They tried to ban herbal supplements and couldn't do it.
They banned nicotine water so it was reformulated to be a tobacco product.

We are a government of checks and balances not a government of agencies with dictatorial powers.
Precedence says that the FDA can't touch these without proof they are a danger or a "new drug". Innocent until proven guilty.
 
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