Help me understand the "Ban"

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LaceyUnderall

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Dec 4, 2008
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What I still struggle with is the fact that anyone can go to specialty shops and buy Hookahs and bongs, even though they are a drug delivery device that is not approved by the FDA.

So, what is the difference with PV's?

Personally, I think the main difference is that our PV's offer an alternative to tobacco cigarettes and pharmaceutical forms of nicotine that the other products (hookahs and water pipes) don't and that down right pisses them off.

With hookahs and water pipes, you use tobacco so at least they are still selling tobacco. With ours... they get no cut of the business and that "they" can be a number of people/groups/agencies/etc.
 

dibbyb

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Apr 14, 2009
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If you are such an expert, sir, would it be possible for you to tell us why most all of the supplier's juices and parts have been held up in customs and don't seem to be going anywhere soon? In addition, why is a major company suing the FDA over this exact issue? Just curious and thought you might want to explain what you are in-the know about better to us. :)

My comment stems from a search of news outlets and finding NO other reports of these dire warnings anywhere but on this site. If someone is going to put out something as fact then they should be able to cite where they got it from so I (and others) can go read them for myself. I don't believe half of what I read in the morning paper, why should I believe everything that's written in this forum? For that matter, why should you?
As for stuff getting held up in customs, this happens all the time for reasons as mundane as somebody shredded the paperwork or a label is illegible (damn chinamen should learn english).
You also forget that claims of customs holding things are coming from retailers who may have something to gain by getting people worried enough to double their next order. Customs also is a good scapegoat for a retailer that is waiting for enough orders to get the next higher quantity discount and needs something to tell an irate customer.
As for a "major company" suing the FDA, who's their law firm? I'd like to ask them a question or two. What court was the lawsuit filed in?
We will all see tomorrow when the FDA has their mythical news conference, won't we? ;)
 

yvilla

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As for a "major company" suing the FDA, who's their law firm? I'd like to ask them a question or two. What court was the lawsuit filed in?
We will all see tomorrow when the FDA has their mythical news conference, won't we? ;)

Here you go - Smoking Everywhere's verified complaint for declaratory and injunctive relief and temporary restraining order, filed in US District Court in DC:

http://ronbenvenisti.com/SEFDA1.pdf
 

ISAWHIM

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www.isawhim.com
To get an idea of the FDA's potential involvement and the expected outcome...

Lolli-pops and chap-stick that was "Banned"... Same reasons...
FDA WARNS SELLERS OF NICOTINE LOLLIPOPS & LIP BALM THAT THEIR PRODUCTS ARE ILLEGAL

Nasal spray approved... Notice the specific studies...
FDA APPROVES NICOTINE NASAL SPRAY

Drugs... Ones which require FDA approval... Any drugs not listed, need to apply for approval. The "Synthetic" nicotine used in some of these devices, is NOT on the list.
Enter "Nicotine" as your search...
Drugs@FDA

Here is an interesting item...
FDA GRANTS CITIZEN'S PETITION SEEKING UNAPPROVED DRUG CLASSIFICATION FOR "NICOTINE WATER"
FDA GRANTS CITIZEN'S PETITION SEEKING UNAPPROVED DRUG CLASSIFICATION FOR "NICOTINE WATER
Because nicotine addiction is considered a disease, FDA requires safety and efficacy data to support any claims intended to treat this disease.

Just to let you know where we stand, and what we can expect...

Time for the sellers and manufactures to step-up... or step-down. They will NOT be allowed to operate as they are now. Blind, without care, without concern, without proof, without labels, without registration, and without rules.

Seems the investigation is just in the red-tape process. However, with the claims mentioned by the FDA... I don't know how cigarettes are allowed to sell, as the FDA stated that nicotine addiction is a disease, and thus, cigarettes must be a medicine, since they contain drugs that treat this disease. (Yet amazingly, tomatoes and potatoes don't qualify either?!?! Nor do patches or gums, which do not need a prescription to treat this disease, as seen by the FDA.)
 

dibbyb

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Apr 14, 2009
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I found this here: usnews.com/blogs/risky-business/2009/4/16/possible-e-cigarette-ban.html. It's not too new, but it explains the border issue.

"The agency (FDA) has opened an investigation and has refused to allow e-cigarettes, e-cigars and e-pipes to cross the border because they're considered new drugs that require FDA approval."

I tracked this back to the original e-mail from the FDA that has since been disowned by Heather Zawalick.
Hit & Run > FDA to Ban Electronic Cigarettes - Reason Magazine

It is helpful and gives more authority to see other sources quoted.
Now we (meaning all of us here on the forum) can see that its possible the FDA is backtracking since the lawsuit was filed.

Thanks
 

Kate

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Jun 26, 2008
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"... the marketing of them in the United States would be subject to enforcement action, which is why your products have been detained."
Legal interpretation of the FDA letter

The FDA said a while ago that they wouldn't allow ecigs because they need approval as new drugs. They have been selectively enforcing a ban.

Some people say it's not a ban - ask the traders who have had their shipments stopped. Semantics :rolleyes:
 

LaceyUnderall

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FindLaw | Cases and Codes

"Justice O'Connor delivered the opinion of the Court.

This case involves one of the most troubling public health problems facing our Nation today: the thousands of premature deaths that occur each year because of tobacco use. In 1996, the Food and Drug Administration (FDA), after having expressly disavowed any such authority since its inception, asserted jurisdiction to regulate tobacco products. See 61 Fed. Reg. 44619-45318. The FDA concluded that nicotine is a "drug" within the meaning of the Food, Drug, and Cosmetic Act (FDCA or Act), 52 Stat. 1040, as amended, 21 U. S. C. §301 et seq. , and that cigarettes and smokeless tobacco are "combination products" that deliver nicotine to the body. 61 Fed. Reg. 44397 (1996). Pursuant to this authority, it promulgated regulations intended to reduce tobacco consumption among children and adolescents. Id. , at 44615-44618. The agency believed that, because most tobacco consumers begin their use before reaching the age of 18, curbing tobacco use by minors could substantially reduce the prevalence of addiction in future generations and thus the incidence of tobacco-related death and disease. Id. , at 44398-44399.

Regardless of how serious the problem an administrative agency seeks to address, however, it may not exercise its authority "in a manner that is inconsistent with the administrative structure that Congress enacted into law." ETSI Pipeline Project v. Missouri, 484 U. S. 495, 517 (1988). And although agencies are generally entitled to deference in the interpretation of statutes that they administer, a reviewing "court, as well as the agency, must give effect to the unambiguously expressed intent of Congress." Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc., 467 U. S. 837, 842-843 (1984). In this case, we believe that Congress has clearly precluded the FDA from asserting jurisdiction to regulate tobacco products. Such authority is inconsistent with the intent that Congress has expressed in the FDCA's overall regulatory scheme and in the tobacco-specific legislation that it has enacted subsequent to the FDCA. In light of this clear intent, the FDA's assertion of jurisdiction is impermissible. "

= The FDA does not have jurisdiction over any product with nicotine in it and Congress has said this to be so. The FDA going and "saying" they have control over nicotine is not the same as an act of Congress.

What is happening is exactly what SE is claiming: The FDA has no right to stop products with nicotine in them. What is interesting here though, is that the FDA shouldn't be upset with those marketing the ecig as healthy/quit but shouldn't it be the FCC? Who regulates the marketing of tobacco products in general?
 

LaceyUnderall

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Kate

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They've written formal statements that say it's a new drug - that is their considered position. So you can dispute the word 'ban' and the word 'formal' but the fact is that they currently have the power to do what they want. That might be overturned or seen as not valid in due course but for now they are the highest authority and they've issued a ban.

They've banned shipments into the US ... it doesn't get much clearer than that. That's not just an idle threat.
 

BalancedGoat

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Apr 29, 2009
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The FDA does not have jurisdiction over any product with nicotine in it and Congress has said this to be so. The FDA going and "saying" they have control over nicotine is not the same as an act of Congress.

The flaw in your reasoning is the idea that "tobacco product" and "any product with nicotine in it" is interchangable. Under that reasoning the FDA would be unable to regulate many common foods that contain trace amounts of the alkaloid.

Of course it also raises a few questions. Does the lack of jurisdiction also extend to derivative products? If so, does that mean that with regards to the FDA's jurisdiction that whether or not they could regulate nicotine would be entirely dependant on where the nicotine came from?

It seems to me that the issue is not as clear-cut as some here would like it to be.
 

LaceyUnderall

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The flaw in your reasoning is the idea that "tobacco product" and "any product with nicotine in it" is interchangable. Under that reasoning the FDA would be unable to regulate many common foods that contain trace amounts of the alkaloid.

Something for me to chew on...

Of course it also raises a few questions. Does the lack of jurisdiction also extend to derivative products? If so, does that mean that with regards to the FDA's jurisdiction that whether or not they could regulate nicotine would be entirely dependant on where the nicotine came from?

It is interesting you point this out. When I was doing some research on nicotine and how it is extracted, I about threw up when I saw how pharmaceutical nicotine was extracted. Chemicals this... chemicals that in order to strip the nicotine from the plant. Then, it goes through this crazy process to make it "nicotine". I am extremely curious to learn more about water extraction techniques and pressing. Using what comes from the plant as it is.

I can completely see where David Kessler (former head of the FDA) came up with his argument in 1994 to regulate tobacco and nicotine. He stated that the cigarette companies do so much concocting to get the nicotine as powerful as it is that it is almost something that a scientist/pharmaceutical company would do more so than a tobacco company. Makes total sense. So for the ecig industry, I would hope that we could find more "organic" ways for nicotine extraction. Now... this means that we might all have to accept nicotine for the strength it has in it's natural form, which it is my understanding is weaker when chemical intervention is not done.

It seems to me that the issue is not as clear-cut as some here would like it to be.

No. This is definitely not a clear cut issue.
 
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Ispy

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Apr 22, 2009
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OK... Here is MY problem...

Like an idiot... I was NOT aware of this "possible ban" and...

Placed an order for over $ 2,000.00 with bestecig.com... (in china)

Order took about 6 days total to hit USA... Now since 5/14/09 it is being held by customs...

Can anyone tell me... How long is it the NORM for customs to hang onto a shipment before it is released for delivery or should I ALREADY be worried?

Forgive my ignorance but I am not accustomed to ordering over seas and just the WORD customs gets me a bit worked up on a $ 2,000.00 order.

Any info you could give would be greatly appreciated!

THANKS A MILLION!

Ispy


Your item was handed over to Customs(UNITED STATES OF AMERICA USORDA) at 2009-05-14 21:54:00


Timing Site Status
  2009-05-08 17:00:00 XIAMEN Posting
  2009-05-08 19:51:16 XIAMEN Arrival at Sorting Center
  2009-05-08 20:20:39 XIAMEN Despatch from Sorting Center
  2009-05-09 12:15:12 XIAMEN Despatch from Sorting Center
  2009-05-09 12:35:09 XIAMEN Arrival at Sorting Center
  2009-05-09 17:45:35 XIAMEN Arrival at Sorting Center
  2009-05-09 20:22:26 XIAMEN Despatch from Sorting Center
  2009-05-10 18:35:00 GUANGZHOU Arrival at Sorting Center
  2009-05-10 20:25:00 GUANGZHOU Despatch from Sorting Center
  2009-05-14 21:53:00 UNITED STATES OF AMERICA USORDA Arrival at Sorting Center
  2009-05-14 21:54:00 UNITED STATES OF AMERICA USORDA Handed over to Customs
 
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