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Author Topic: Legal interpretation of the FDA letter  (Read 2051 times)
katink
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« Reply #15 on: March 10, 2009, 04:51:30 PM »

That goes toward something like a class-lawsuit then ? Or prying loose information, if FDA would for instance not stand in the way of personal imports (for own use)? What could we do to get the harm-reduction angle firmly on the agenda?
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jrobo1980
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« Reply #16 on: April 26, 2009, 09:34:21 PM »

That goes toward something like a class-lawsuit then ? Or prying loose information, if FDA would for instance not stand in the way of personal imports (for own use)? What could we do to get the harm-reduction angle firmly on the agenda?

I was wondering myself if those of us in the states could actually take the FDA to court. I think the hardest thing would be to find a lawyer to take the case.
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LaceyUnderall
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« Reply #17 on: May 07, 2009, 07:16:43 PM »

My understanding is that the FDA is an agency within the US government.  They are given special permissions to do certain things by Congress.  Congress must enact legislation that must be signed into law by the President.  In 2000, the US Supreme Court ruled that the FDA does not have power over tobacco products.

What I think makes the ecigs a gray area is that even though they aren't technically a tobacco product, in that they do not contain leaves or stems, they aren't necessarily a new drug either, unless you want to make a health claim or a quitting claim.  Unfortunately, there are some suppliers who have taken this route which means that they do fall into jurisdiction of the FDA.

What has happened is that the FDA is getting pressure from anti-smoking groups, for instance, Tobacco Free Kids.  Tobacco Free Kids gets a lot of donations from pharmaceutical companies who want to offer the nicotine products that do not contain leaves or steams.

If the FDA had been smart about this, they would have done exactly what they were supposed to do and start researching what companies were making these health/quit claims and stopped only their products.  But with this pressure from the anti-smoking lobby AND the mass amounts of products coming in, I think things got a little out of their control.  Plus, they currently don't have any leadership (and I don't mean this in a rude way... but they literally don't have a person in charge and that means, everyone is pretty much running around doing as they wish).

You are absolutely right though with your last statement.  If SE loses this battle, then this will definitely set presendence for a future ban.  BUT, SE still has the ability to go to a higher court, which is what happened in 2000.  Once a higher court rules, then that ruling will go into affect.  This could go on for years!  And in the meantime, someone should definitely correct me if I am wrong, we would all still be in Limbo, crossing our fingers until the Supreme Court of the US finally gets this and passes final ruling.

The other wrench is that a tobacco law could be passed through Congress and signed into law by the President, making this entire SE suit null and void (and effectively really piss off the FDA).

Then again, the FDA, could learn a valuable lesson from all of this, get a good Director and make the ecig easily obtainable to users and make the regulatory process that much easier for suppliers than going through the rigors that the pharmaceuticals have to in order to make claims.  AHH!
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seminolewind
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« Reply #18 on: July 24, 2009, 07:41:27 AM »

" BUT, SE still has the ability to go to a higher court, which is what happened in 2000.  Once a higher court rules, then that ruling will go into affect.  This could go on for years!  And in the meantime, someone should definitely correct me if I am wrong, we would all still be in Limbo, crossing our fingers until the Supreme Court of the US finally gets this and passes final ruling."---quote by Lacey

Lacey, you are right.  This could go on for years, and that would work in our favor.  Good point.

BTW, where is the ECF and where is there rebuttal?Huh?
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LaceyUnderall
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« Reply #19 on: July 24, 2009, 09:59:50 AM »

The ECA?  The ECA rebutted quickly and now... we are just waiting on nJoy, who has released to the court that they did in fact do their own study, by a very highly respected US lab and the findings were not what the FDA found.  So as soon as their lawyers determine to release that... which I pray to god is sooner than later, then we will have some scientific data to release in dispute.  

The ECA's initial response was:  http://www.ecassoc.org

IMHO- I think it is a good sign that the Judge has called for a meeting and a review of the case.  This will give nJoy the ability to get their stuff together, scientifically pull apart the FDA findings, which they will, and possibly (fingers crossed) put a bad taste in the mouth of the judge regarding the FDA.  (i think SE has some serious issues and am waiting to see how they get out of this one.)  I think a split decision will occur.  - Please note this is my opinion and not that of the ECA's.
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LaceyUnderall
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« Reply #20 on: July 24, 2009, 10:22:13 AM »

I think the judge will find for nJoy and find against SE... which he can do.

Why?  Because SE has made health claims which does give the FDA jurisdiction to stop importation of their product until it has been approved by the FDA.  nJoy has not made these claims, which according to everything I have read, means the FDA cannot stop these products from being imported and sold.  This has been the grounds that the FDA has been arguing all along:  Products that are marketed with claims are new drugs if they are not approved yet.  This is also why, IMHO, they have not been able to enforce a full out ban on the industry as a whole.

As far as the testing done by the FDA, with the new nJoy test that can be compared, that was done in a third party lab and not by one of the parties involved in the litigation, it could be possible that the judge would review and compare the studies and the FDA's study proves the nJoy product to be what they say it is (no DEP's) and the SE product is not what they say it is as even though only 1 of 18 samples found it, but it was still there.

Things are stacking up against SE and for nJoy.
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taz3cat
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« Reply #21 on: July 24, 2009, 10:49:41 AM »

Lacyunderall, you always do great work and make things clear. I am glad to see your posts again on this forum. cat
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LaceyUnderall
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« Reply #22 on: July 24, 2009, 11:06:32 AM »

Thanks Taz!  Much appreciated.

As soon as Jack gets me a copy of the study that was done, I will most definitely put it up so we can pick at it Smiley
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seminolewind
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« Reply #23 on: July 25, 2009, 06:45:06 PM »

I second that, Lacy, you do good work, and I am grateful too.
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LaceyUnderall
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« Reply #24 on: July 25, 2009, 06:58:31 PM »

 animal-smiley-040  Thanks!  How cute is this dancing ele?
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