IMPORTANT - email from FDA to a supplier.

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yvilla

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Kate51, please watch your terminology. Nicotine is NOT a controlled substance, not now, and I would wager all I had, not ever.

The term "controlled substance" is a very specific and loaded one, referring to substances that are not only illegal to sell, but also to possess, with pretty severe criminal sanctions for violating those prohibitions. Here is the list:

Controlled Substances in Alphabetical Order

Nicotine is not on that list. It is regulated, but nonetheless freely and lawfully available in cigarettes and other smoking and smokeless products, and in "drug" form in NRT products, both over the counter and by prescription. And hopefully, we will see it's continued availabilty for and with our ecigs, but it does us no favors at all to constantly be confusing and associating nicotine with controlled substances.

I don't mean to single you out, but I've seen that done here so many times, unfortunately, that I'm on a "mission" (not very successfully, alas) to stamp it out.
 
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yvilla

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Did you not read what congress was doing today, ref., making nicotine a controlled substance.
Hey, I'm not an attorney, but you can bet if FDA needs more ammunition, it's only a tip-off away, and it will be done in a way that will not raise any interest.

No, that's not what congress is doing. They are entertaining legislation that would give the FDA the authority to regulate cigarettes and tobacco products, a power they have never had up to now.

And in case you didn't know this part, the bills under consideration would allow the FDA to regulate the amount of nicotine in tobacco products, but specifically prohibit the FDA from banning all nicotine content. The bills also have plenty of "grandfather" provisions for existing products (Philip Morris's influence there).

The reason we need to be campaigning against the bills being offered, or at least for amendments favoring ecigs and other new harm reduction products, is that the impact of them as currently written would be to protect existing cigarettes, but make it nearly impossible to get approval for things like ecigs!

So please, no more talk of "controlled substances" in the same breath as nicotine.
 

Flip7990

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Since I cannot yet post links, the WashingtonWatch website has the HR1256 written out, and after reading it, I did not see anything that e-cig users would need to worry about. The only thing on it that would come close to our e-cigs was this part:
"Requires the Secretary to consider: (1) designating products for smoking cessation, including nicotine replacement products, as fast track research and approval products; (2) approving the extended use of nicotine replacement products for the treatment of tobacco dependence; and (3) evidence for additional indications for such products."

Everything else was purely tobacco related. Please correct me if I am wrong.
Thanks
 

yvilla

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Flip, it appears that the problem centers around the high probability that the FDA would proceed with its determination that ecigs are new "drug delivery" devices, thus requiring expensive and lengthy clinical trials before they could, if ever, be marketed. The American Association of Public Health Physicians has prepared a document explaining exactly why they believe the bill, if not amended, will in fact constitute a de facto ban on new harm reduction products, including ecigs. That can be read here:

http://www.aaphp.org/special/2009/20090505SenateFDATobcAmend.pdf

Dr. Nitzkin also discusses this in the interview with him posted on the forum, in this post:

http://www.e-cigarette-forum.com/fo...g-fda-no-banter-here-please-6.html#post219932
 

Krakkan

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I really cant see how they could ban the E-cig,
Banning E-juice with nicotine I could see (not like but see)
But seeing as the E-cig can and is being used with No-nicotine juice, What legal reasoning can the FDA bring against it?

They been basing it upon intended use of the device so far... God Knows why but I figure once I label my juice as Head Cleaner and put not for Human Consumption lol they wont bother me :p

At least thats what the head shops do to sell stuff that they weren't allowed to market.
 

nibb

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the bottom line is how long will the manufacturers continue to produce before they determine the market is dead?

US is not the only market. E-cigs are sold all over the world.

So the FDA is going to read our letters and petition and say, "Wow, we sure were in error about the electronic cigarette. We see how great they really are and we now approve and allow sale and importation of these products. We're sorry our rules got in the way."? Does that seem realistic?

E-cigs are banned. What e-smoking needs now is one manufacturer -- it almost certainly has to be Ruyan -- to step forward and submit a proper application for FDA approval as a medical device using nicotine liquid. In the process, everyone will learn exactly what information is needed and demanded.

Without it, pleas will fall on ears closed to all but scientific proof.

Cigarrettes arent medical devices either. So it e-juice is banned so will cigarrettes. I dont want to use my e-cig to quit smoking. I want to use the same way people use cigarrettes. Pleasure maybe?

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....

What matters is that e-cig is competition to cigarrettes. Once America and the public figures out this they will not only defend e-cigs but promote then just to do harm to tabaco companies. People need to find out that FDA, and all this persons that say they want to the e-cgi controlled are the same that dont say anything about cigarrettes.

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.

Well, anything can happen. In Europe you can be arrested for having certain books. So freedom in democracy is nothing more then bull****. Laws are made to control and nothing else. If you can be charged or fined for reading things or saying things they can control what you breath.

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.

Neither can I. From a legal point of view they have no argument. If they ban e-cigs they have to necesarry ban cigarrettes as well as they do more harm and are easier to get. Nobody died from smoking an e-cig yet.

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.

No. They will just push to other markets. US is not the only country that smokes. The whole world does.

I wonder what Ruyan is doing about this.

They are probably looking for alternatives and let this to be resolved locally. They cannot fight tabaco companies. People, american have to stand up form themselfs. They will just look open markets as its just business anyway.

I think that the only thing they are really latching onto is the fact that the vaporizer itself looks like and resembles a cigarette. I dont see they have a leg to stand on other wise. You can buy personal vaporizers that dont look like a cigarette but are small and compact. You can buy liquid herbal extracts to smoke in your personal vaporizer. So its not like they are actually going to stop anything except people using vaporizers that look like cigarettes. Its not illegal to vaporize herbs and inhale the vapor.

Thats even worst. If they dont like cigarrettes they are going to say its a drug device like they say now. Even people that never saw an e-cig are going to get that impression. The first think people ask is if they look like a cigarrette. I would try even to change its form. They they will have a better argument for ban them. As now they look like cigarrettes which can be smoke in some public places and are seing as normal by other people.

What really seems the most ridiculous to me in that FDA letter is the line that says:


"And, like the conventional tobacco products, they are intended primarily for the delivery of volatilized chemical substances to affect the body's structures and functions and/or to mitigate or treat the symptoms of nicotine addiction through a chemical or metabolic action on the body."



Ok...so let me get this straight? E-cigs are considered a new drug that must go through a drug approval process and be proven safe prior to being marketed because, like conventional tobacco products, they are intended primarily for the delivery of volatilized chemical substances to affect the body's structures and functions and/or to mitigate or treat the symptoms of nicotine addiction through a chemical or metabolic action on the body.

(that's funny, I don't remember conventional tobacco products being proven safe through any drug approval process...do you?)

I dont remember that either. We all know how is behind this ban. Is companies that want to protect their products against china competition.

What has happened to free America? Now the FDA gets to decide that nicotine addiction is a disease? Huh? Does that mean that I have a disease? I think I have another disease too. I am addicted to coffee. Crazy.

Also, I don't believe the statement, "no shipment they've discovered has been cleared to delivery", is true. I have heard from other suppliers who had shipments stopped and released.

And so they should for tea, cholocate, coffe, etc. Nicotine a drug? What a joke. How come they discovered this now and not 5 years ago?

Not only that, but you can also buy vaporizers right next to the water pipes in many places, for the same purposes... And I believe you can also vape tobacco in them just fine.

The e-cig should be legal easily, if disassociated with nicotine. It can vaporize many things.

It's the drug nicotine that the FDA grabs onto.

Its not the drug but the threat it represents for analog cigarrettes. You could put orange juice in them and they would try to do the same. They are getting them because people are quitting cigarrettes to go to e-cgis

It seems to me that the real issue here, the issue that gives the FDA jurisdiction (so to speak) is that selling a "drug-device" without approval is illegal. A "drug device" is a device defined as follows (taken for the Act quoted in the FDA letter):

(h) The term "device" (except when used in paragraph (n) of this section and in sections 301(i), 403(f), 502(c), and 602(c)) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is--
(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

therefore, if personal vaporizers are not "intended to affect the structure or any function of the body of man or other animals" then they cannot be regulated by the FDA according to the referenced Act.

Furthermore, Nicotine has many other uses - as a pesticide for instance.

Personal Vaporizers could have an excellent novelty use:
Perhaps one might buy a "personal vaporizer" as a nifty party gadget intended to blow "fog" out of one's mouth.

If someone were to put a flavored "pesticide" in it and inhale the vapor, well that would certainly be an unintended use for the device, no?

My point here is that I believe there is a way around FDA regulation here. Just like water pipes my friends.

The FDA has no stand point at all. If they are concerned about public safety why dont they do anything against cigarrettes but are attacking e-cgis? And why now? They care about consumer. If they would they would ban both or the ones that is worst. In this case cigarrettes

You know, reading the e-mail from the FDA is damned depressing. It sounds like they're not going to buy that "it's just a personal vaporizer" line. They sounds like they do not care that the device doesn't always contain nicotine. They sound like they are insisting it's a "drug device" even if you're going to use it with PG and flavors.

I don't think any amount of wording and marketing adaptation is going to change the FDA's mind about their stance. It pretty much seems written in stone. All that's left for us is to speculate on why they're coming down so hard on these devices and seem hellbent on associating them with smoking cessation. Seems they're trying to pigeonhole our PV's into their regulatory jurisdiction and there's no way around it. If I had the money I'd buy beaucoup spare parts and liquid right about now...

Other people have mentioned "tobacco water pipes" (aka "bongs") being legal even though they're primarily used to smoke weed in. I think the difference is that those devices aren't a clear threat to the tobacco industry or Big Pharma.

There's big money to be made by cornering us into going back to analogs or using Big Pharma's high priced solutions. A lot of money is made treating smoking related diseases and if tomorrow, no one smoked a damned thing there'd be a lot of corporations out of a lot of money.

Perhaps it sounds a bit paranoid. However, I have very little trust in giant corporations and the government. Both have proved time and time again that they are easily corruptible. Capitalism doesn't exist but on the backs of the weak and poor.

I also feel that the personal vaporizer manufacturers in China will not feel a great loss of our business. They have no desire to try and tangle with the FDA here in the US, that's why their responses have been weak at best. The factories will just be refitted and they'll still be sending whatever else they end up manufacturing, here in the US. The ones that don't refit will still have their colossal market in China itself.

Thats correct, they will just sell to other markets.

People keep mistakenly referring to the regulatory issue as if it were a criminalization issue.

Eg, KDMickey, just above you said: "It's probable that we will lose this round and we will all become 'criminals'".

And goobenet, you just said: "they'll be outlawed, the tech will go underground, and be treated like pot, or it'll be legalized and taxed to death".

Well, that's simply not the issue, and it really confounds things and makes it worse to present it like that!

When the FDA claims ecigs are illegal to market, they mean just that - that it's a civil legal issue/fight over whether they can be advertised and sold in the US. They do not, and never could, claim that they are or will be illegal in the penal law context like controlled substances, such as ....... or ....... Nicotine is not a controlled substance, and it could never be criminalized without at the same time instantly criminalizing cigarettes as well, and we all know that is just not ever going to happen in the US!

So please people, be aware that if we loose this round it means we'd be looking to source our ecigs (or maybe just the liquid) from outside the US, but it doesn't mean we'd be "criminals" for possessing or using them!

I think that is what people feel right now. Frustrated with such a corrupt goverment that puts money first in place of public health.
 
FDA Letter = alot of Government Mumbo-Jumbo.

I think there are a few high up's (Sen Lautenberg and others) who are in bed with Big Tobacco.

And just look around in this forum....and look at sales numbers from suppliers and try to imagine how much in TAX DOLLARS that our US government is missing out on?

Not buying analogs means no tax moneys to support the SCHIP crappola. Not to mention more money in our pockets.

Good for us!
 

happily

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This is gonna get ugly..........tobacco industry has billions and govt officials in their pockets, cancer society, lung association and heart association are most likely funded by chantix, nicotine patches, nicotine gum etc, and you can be sure the FDA doesn't care about healthy or not healthy. They want their fingers involved in regulating this whether it's for taxation or other motive.


better make plans to go black market with this stuff unless you can get ACS,ALA AHA or some other giant to work with you on capitol hill
 

robbiehatfield

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I was watching TV tonight and noticed that on yet another one of those inappropriate ads talking about male enhancement that the drug they were hocking obviously effects a structure of the body *do I need to say it? LOL* and has not been tested or approved by our illustrious FDA. Why? Isn't over-population a big problem too these days? For example, when two people from ASH get together and spawn, their offspring uses up resources and the last time I checked, this effects others just like secondhand smoke. LOL

Robbie
 
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