FDA -- Unapproved yet, but remain on the market until replaced by an approved version

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Letzin Hale

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I cut the piece below from an earlier post I sent to the WTF.

I envisage a situation where ecigs will be given a stay of execution with a time limit to conform to certain standards but it would take a year at least for any Government body to be set up, investigate and report. Then there would be questions about the report, then revisions and finally new legislation would be drawn up - or existing legislation amended to include ecigs. So, 2 years for all that then a year to comply, by which time the Pharmacy companies and Big T will have their products on the market all tested and licenced and will possibly have exercised their influence to make the qualifying standards so high and stringent that many will not be able to meet them. Then again, I'm a cynical ******!!:rolleyes:
Alan.
 

Fox3

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Mar 24, 2009
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I cut the piece below from an earlier post I sent to the WTF.

I envisage a situation where ecigs will be given a stay of execution with a time limit to conform to certain standards but it would take a year at least for any Government body to be set up, investigate and report. Then there would be questions about the report, then revisions and finally new legislation would be drawn up - or existing legislation amended to include ecigs. So, 2 years for all that then a year to comply, by which time the Pharmacy companies and Big T will have their products on the market all tested and licenced and will possibly have exercised their influence to make the qualifying standards so high and stringent that many will not be able to meet them. Then again, I'm a cynical ******!!:rolleyes:
Alan.

If you are, you aren't the only one :). All you got to do is watch the show they put on in general and that will make you cynical...
 

WillPower

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Mar 25, 2009
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So my njoy distributor is technically afoul of the law, but I can order from Ruyan and other overseas suppliers without worry? Hmmm, sounds very regressive to me, in an economy where we want as many people on our OWN shores making money as possible!

~~Cheryl

njoy and SE are way out there in the middle of gangland with bull's eye tattoo'ed on their forehead. 8-o Puresmoker seems to sanitize their site quite a bit. I think it would be difficult for FDA to go after them.

Speaking of the economy, could any American come up with a better, user friendly e-cigs or accessory? I like my DSE901, but I can't imagine this is as good as it gets.. 2 ml liquid reservoir plus Trog's SD like battery system... you know...

I think some guy in China owns the patent to e-cig. Maybe it's the time for Americans to starting ripping off Chinese patent/copyrights. They have been doing that to us for decades...:rolleyes:
 
I think some guy in China owns the patent to e-cig. Maybe it's the time for Americans to starting ripping off Chinese patent/copyrights. They have been doing that to us for decades...:rolleyes:
Is there some kind of agreement between countries to honor patents? I would think that a patent filed in the USA could be enforced here, but not overseas. And this is SUCH a fertile market -- I've had four people this week ask me to send them more info on how they could get their own! This is America, dammit -- we can do this, and so much better than the Chinese!

~~Cheryl
 

Faethe

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Feb 12, 2009
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I read these threads and keep thinking "Stockholm Syndrome". Still, the FDA are in a position to do us all a lot of good if only they would stop with the power grabs.

I read the internet and think most American commenters have stockholm syndrome.

Marijuana is a weed you can grow in your yard. It's not something that requires processing. But if you grow it you go to prison.

These ecig things or 'pv's you decide to use based on your own research and experience. Somehow that's less than what a government agency determines.

Many people die in this country because therapies, drugs and treatments are denied to them. It's not like there is a warning about it - to get these things will result in prison. It's one thing to warn, another to confiscate and punish.

We live at the behest of what a government agency thinks and this agency is far from neutral. Influences are brought to bear on it that sway decisions. To accept that is to accept that you do not know what is best for yourself, or that a professional you've engaged does not know best.

These agencies were created to warn, not substitute your own intelligence. Everytime you see logic in the irrational behavior they exhibit, you sacrifice your own determination. You are an adult. You are responsible for your own decisions. No one else is.
 

WillPower

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Mar 25, 2009
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Pardon me.. I am going to rant and vent a bit here...

I hate government intervention. I can't think of anything ran by government that did well. Granted, however, they did sometimes stop a few things from getting really bad (didn't make them great).

Having said that, I am sure everyone has bought and seen this, e-liquid bottle that labelled like "marl-bro" or "Coffee 11mg." Cooooome-OOOON, suppliers! YOU CAN DO BETTER THAN THAT! How about little warning, better label, or something?

Don't get me started on age verification. Paypal is all it takes to buy e-cig and e-liquid. It is even worse than wine.com! It takes only a few pictures on newspaper or a few minutes on 60 Minutes, that shows a bunch of teens and pre-teens casually enjoying their e-smoking, to make any lawmakers sorry the day that support e-cigs!

YES. Minors could smoke analogs too, but at least that's enforcement problem. Lawmakers didn't give a moratorium or exemption so that tobacco companies can do whatever they want to do, well at least not recently.

So, do us all a favor. Next time you order something from e-cig vendors, send them an email asking them "Help us help you keep e-cigs on the market. Please say YES to self-regulation!"

Mr. and Ms. Suppliers! We are on the same boat. How about start rowing toward the same direction?

:D oooh .. I feel better. I just had to get that off my chest. Don't mind me.. Nothing to see here..:) Move on...
 
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b00stzx3

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Feb 10, 2009
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I've often repated this, but here it goes: They're are PLENTY of things banned by the Gov/Fda whoever, but thanks to the marvels of international commerce and the internet, you can get anything you want, ban or not. How do people order ...... online? Painkillers? Counterfeit Prada bags, counterfeit Oakleys, Mod chips (piracy!!), overseas NRTs? Some of my nicotine gum came from other countries, and different brands that aren't sold in America. I've seen arguments that Customs/FDA can stop E-cigs from coming in. If so, how come they can't stop all the before mentioned goods from coming in? Counterfeit goods are illegal, and yet I can order "Foakleys" or "Faybans" or a "Burberry" purse for my sister that are all obviously counterfeit and they come right to my house, no problem. Water pipes as well, which are Drug Paraphenelia. If E-cigs were labeled drug paraphenelia, any head shop could sell them without abandon. Maybe the tax issue and threat to the govs tobacco money could be a drastic flaw between e-cigs and the other "banned" items, but I don't see them being able to stop everyone wanting e-cigs from ordering them online and them coming in no problem. Just my .2 cents, I'm no expert, just going on what I know. My old neighborhood had 4 "tobacco" shops that have been openly running for years. Anyone who says you use a 4 foot muilti colored tobacco pipe is lying, but they allow them to sell it. Whats the diffeerence in a 6 inch personal vaporizer? Oh yeah the tobacco shops sell plenty of vaporizers for "herbs or tobacco". In our case, were actually using a vaporizer for legit purpose! Where's the FDA on that stance? .... makers don't have a lobby, or at least a powerful one. Maybe I'm wrong, haven't seen it yet though.
 
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ISAWHIM

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Apr 15, 2009
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The FDA does not approve things, unless they are submitted for approval. However, they ban things, for protection, when shady manufactures bring certain dangerous items to mass-production consumer markets.

Don't get me wrong, I am all for FDA approval. However, going after the FDA is like winning lotto.

You need to go after the manufacture, and let them know there is a strong "American desire for the product, which requires FDA approval."

To date, I have not heard of any company holding submission for FDA approval. As if they did, they would publicize that they are pending FDA approval.

To submit the product for approval requires more than just sending the product. You need to include the use of the product, as that will be part of the FDA approval.

EG... (SAMPLE FDA APPROVAL)

The FDA approves this product for use as directed.

Directions: *One single dose (Mouth-full), of no more than 32mg nicotine per five minutes, for no longer than 20 doses within an hour period.

*Dose based on 180 lb individual who previously smoked 1 pack (20 cigarettes) a day. This dose-level is not intended as a prescription, but provided as a limit of use, which is not to be exceeded by any individual.

Precautions: The FDA has cited that nicotine may be addictive at levels over 300mg of consumption per day. The FDA has also cited that nicotine levels over 600mg of consumption by a 150 lb individual, may be toxic or poisonous. The FDA has also cited that nicotine may cause some birth-defects, and should not be used during breastfeeding or while pregnant. Consult a doctor if you find that any symptoms which may be related to addiction or health. Discontinue use if any problems persist beyond one week.

This product is not intended as a quitting aide, safe cigarette, for use by a minor under 18, or for casual first-time use. This device is only to be used as an oral-flavor delivery device, or for an alternative supplement for those who can not use ignition/flame based delivery devices for vaporized liquids. (Not all liquids contain nicotine, and may contain other chemicals for flavor or effect or longevity, and may not be consumed by the lungs.)

__________________________________________
End of sample...

That is what the FDA wants. You can tell them it is a potpourri device, like a glade-plug-in room scent device. (But you could not market it as a device which goes into your mouth, to inhale.) And that would pass FDA approval... For that use.

EG,...

My tattoo inks are FDA approved... (The only ink with FDA approval.)

However, the FDA has only approved them for fish and game, wild-life. (EG, for tagging animals as a form of identification.)

However, the FDA did not show any significant ill-effects, with the approved use, on those animals.

Technically... You/we are all proof, or part of the approval process. If you report to a doctor, and have it documented that you use this product, and have, of yet, not had any ill-effects. (Recording your use, does, weight, build... etc...)

I would do that any-ways... just in-case ten years from now... or five... there IS some issue. You need to prove that you were sold the device before FDA notice. (Of all the smokers, only those before any published FDA warnings got money from cigarette settlements. The same thing will happen here. There will be issues, there always is. Record it, while it is still possible.)

Vaporizers are nothing new, an neither are any of these home and consumer recipes. However, now they are becoming casual and popular. The BAN is to stop it from becoming a full epidemic, if it does lead to something bad. The company will not pay for billions in damages, which will leave everyone suffering, or the government paying the bill. The USA does not like it when foreign companies use us as guinea pigs. (Not when 23 other countries have flat-out banned the devices. Though I suspect that is because similar issues.)
 

WillPower

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Have you ever wondered how many times people can have the same discussions over and over and over again?

Yes. It's like Groundhog Day, isn't it? Didn't I read these or posted these in the other thread? :)

I think the problem is that a lot of people are pulling others with rhetoric and fear, but none of these directions appears to be of our interest or not viable, just serves them.

Take an example, Godshall person so subtlely pushed us to move to classify e-cigs as cigarettes. Okay! Good for his agenda, Not so hot for us.

Some suppliers want us to write to congress. Ask for what? Total de-regulations (exemption) -- wild wild west, anything goes? Extremely unlikely and that won't good for us either.

Moratorium -- As ISAWHIM said, is anybody even trying NDA (new drug application)? Who has the patent anyway? It won't make sense for people don't have the patent to go through NDA.

FDA can't pull all e-cigs off the market anyway, unless people start dropping like flies. It has to be done case-by-case and they don't have the resources for this.

As a rat in the maze once said: dude, keep the cheeze, just show me the way out of this thing. :rolleyes:
 
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