FDA Spokesperson Rita Chappelle Shoots Down Both the Device and The Nicotine For a Ban

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b00stzx3

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Just a side note.. I find it extremely ironic that the only product (the e-cig) that actually helped me stop smoking regular cigarettes after 15 years (tried patches, gum, cold turkey, etc.) is going to have to be specifically labeled that it is not intended to be used as a smoking cessation device.

Just....WOW.


Thats because the powers that be deicided it was more profitable to put it into gum and patches, and have enough lobbyists to blow competition to kingdom come!
 

skex

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Tropical Bob is right.

All this bellyaching about how this is government overreach and other utopian libertarian claptrap is just hot air.

The reality is that the FDA has a legal obligation to enforce U.S law regulating safety standards of foods and drugs sold with in the borders of the United States.

Cry all you want about Chantix the fact is that the manufacturer jumped through the requisite regulatory hoops to get approval. Further it requires a prescription to get which implies that there will be monitoring by a trained medical professional (the prescribing physician) which is the furthest thing form some **** that's sold off a random website by some anonymous individual. Sure it has side effects many of which may not have shown up in the limited testing that was required by law.

Remember all the drugs that get pulled after approval? That's because the FDA has a continuing obligation to manage these products after their innitial approval and if some horible side effect only shows up after the drug is approved it the agency is still obligated to take action.

I find it mind blowing that the companies marketing these devices didn't do their due dilegence in the first place by contacting lawyers to research this matter and putting into motion the necesary steps to get these devices approved.

By sidestepping those procedures they have demonstrated an intent to try to ignore the law which is hardly going to play in their favor from either a legal or a public relations standpoint.

You may disagree with the rules but they are there to create a level playing field for all players. These manufacturers are intentionaly breaking the law and that begs the question of why?

The best that could happen now would be for the manufacturers to finally get off their asses and start going through the needed regulatory steps. I still suggest that the suppliers form a tradegroup and fund a legal defense team to file an injunction to delay enforment of any ban. Ideally such action could tie the ban up long enough in the court system to allow the manufactures to go through the requisite due dilegence to acheive approval.

It would also be worthwhile for consumers to continue to contact their representatives to try and gain popular support for a delay on the ban while proper testing is done.

But be perfectly ****ing clear here. The FDA is well with in their authority to regulate these devices in fact they have a legal obligation to do so. Further if they do not take action on these devices they will be the ones people will be mad at for any negative consequences.

These regulations were not created simply because people in congress were bored one day. They were created to protect us the citizens from irresponsible individuals and companies who are interested in nothing but short term profit.

Myself I want to know that the product I'm using has gone through the appropriate due dilegence to be as safe as is reasonable for it's intended purpose. I want to be sure that the only poison in my e-liquid is nicotine that I am not ingesting some unknown such as say arsenic or some other highly toxic substance.

If all all the things we believe and have been told about these devices are true then we have nothing to fear from following the proper regulatory framework other than some slightly increased prices. Personaly I'd be happy to pay a little more and know what I'm getting rather than simply trust that my supplier is a stand up guy on nothing more than faith.
 

OutWest

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. . .
The best that could happen now would be for the manufacturers to finally get off their asses and start going through the needed regulatory steps.
And how do you suggest we force manufacturers in China to do this? 50% of their adult male population smokes. That means they dont need U.S. customers, they already have plenty of potential customers in their own country.
 

skex

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And how do you suggest we force manufacturers in China to do this? 50% of their adult male population smokes. That means they dont need U.S. customers, they already have plenty of potential customers in their own country.

That's a bunch of nonsense. They may have the population and the smokers but they don't have the money. Which is why they sell all the cheap plastic **** to us in the first place.

The fact is that no CEO will ever believe that they have enough money or a big enough market.

The United States represents a huge market with people who have far more disposable income than those in China to spend on these products. Simple supply and demand.

So the suppliers need to get with the manufacturers and get things going. Ruyan has already shown that some companies are willing to do the leg worlk

Even better the suppliers here in the States can start ordering the devices as parts and do the final assembly and packaging in CONUS which I suspect would qualify them as manufacturers and give them standing to get the testing done.

I still suggest a trade group so the suppliers can pool their resources to gain approvals.
 

Hangar

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What I don't understand is how come none of the major U.S. based players, who already have all the resources necessary to get this product properly & legally to market, seem to have an interest in it as of yet? With the potential for billions in revenue, why are they ignoring the e-cig?...could it be they've already done private testing and found it to be dangerous?...it just doesnt make sense to me. Or perhaps they seem to somehow know that the FDA already owns this project and has made it their own, complete with pre-defined private invitations only made out in the name of some pharm. company?

I think after an official announcement that this thing will either be truly dead in the water, or the private invitation holder will be part of the announcement.
 

analog2digital

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Technically, I have 'quit' smoking. I have not had an analog cig since I got my ecig. The same analogy could be applied as it does to the 'smoking bans', as I technically am no longer smoking.

Now, is nicotine a drug that can be regulated? I would have to say I agree with TBob on that -unfortunately. However, nicotine patches are sold over the counter, so it wouldn't/shouldn't be different if deemed safe.

I hope they do not ban (or tax the crap) these, or I too will probrably be a criminal!
 

Hangar

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yes but WHY has the patch been approved for OTC?...it was originally available by prescription only...so did they change the amount of nicotine in them....or did tests conclude that absorption was no more harmful than inhalation?...im not educated about the subject enough to know the answer...but i would assume that once the FDA makes a decision publicly known that it will likely follow the same course as the patch...available by prescription only...at least for awhile. I'd be shocked to hear anything more liberal than that.
 

Smokingfreely

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I posted these ideas elsewhere without the links to back it up I have found them, but still can't post links so follow my directions to find them. Nicotine is allready in the orange book (search in the orange book online "niccotine" in the OTC category. So, someone ought to be able to file an Abreviated New Drug Application rather than a full-blown NDA - much quicker and cheaper. Someone with the vision to see the value of investing this time and money could make quite a bit of money out of it. So the obvious objection is well, that's great, but you have other additives and a new formulation, so you have to do an NDA, but I'm not so sure that's true - go to Walgreens (insert any drug store name here, really) and get a children's liquid, and they will offer to flavor it for you, and it's not a new drug. Guess what's in that - flavoring and propylene glycol!! I'm still not allowed to post links, so go to pubmed and at end of the address, add articlerender.fcgi?artid=1770927. If you can legally add flavoring and propylene glycol to a drug, you just need to get an OTC approval for niccotine, again allready a reference listed drug, so no need for a full-blown NDA.

Vicks, that's not being devil's advocate. That's telling the honest truth.

Bottom line: The FDA is charged with regulating drugs in America. You want to introduce a new drug? Big Pharma does all the time. Fine, then you follow the procedure to thoroughly test that drug, in clinical trials, you obtain scientific results and you present an application for your new drug. When you mix nicotine (Vicks has an accurate description) with other chemical ingredients and market the mixture to be vaporized and inhaled - well, you've got yourself a new drug. One that does not have approval.
 

seminolewind

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I can't believe what I'm hearing. First off, how much regulation is there on cigarettes? How much regulation on drug paraphenalia? On alcohol?
How much drugs do the feds actually keep out of this country?
You know this all smacks of politics and money. If alot of people quit smoking, the cigarette cartel would collapse. The government would probably collapse as well, not getting all that tax money. Then the hospitals would collapse (AMA). So then e-cigs would collapse all the biggest money makers in the US except the insurance companies. These conglomerates are such liars. I think they advertise not smoking, ban smoking, raise tax on cigarettes, but they really don't want people to all stop smoking. They would all go broke. Think of all the times your parents told you not to do something. Didn't it get more exciting to be sneaky and do it? That was the fun part.
It all boils down to the same thing. Can they regulate pv's and nicotine juice to the point where they can make a buck on it?
 

Wally

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yes but WHY has the patch been approved for OTC?...it was originally available by prescription only...so did they change the amount of nicotine in them....or did tests conclude that absorption was no more harmful than inhalation?...im not educated about the subject enough to know the answer...but i would assume that once the FDA makes a decision publicly known that it will likely follow the same course as the patch...available by prescription only...at least for awhile. I'd be shocked to hear anything more liberal than that.

It is not only the patch that is available OTC in the US--also gum and tablets (Commit, Nicorette Microtabs, etc.). Inhaled nicotine (like the Nicotrol Inhaler) are still Rx items. This may be a marketing plan from the pharm companies--the decision to ask for OTC approval or prescription-only approval is often part of a "marketing concept" and the FDA will often go along with this. Inhaled nicotine is also more addictive than slower forms of administration because of the fast blood level rise. Inhaled nicotine also shows faster blood level declines (half life) and this also enhances addictiveness. (Slower forms of administration continue administration over longer periods and offset the short half life.)

Wally
 

jamie

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yes but WHY has the patch been approved for OTC?...it was originally available by prescription only...

F.D.A. Approves Sale of Nicotine Patch Without Prescription - The New York Times

SNIPPED said:
July 4, 1996
F.D.A. Approves Sale of Nicotine Patch Without Prescription

The Food and Drug Administration approved the first nicotine patch for sale without prescription today to help smokers give up their habit.

Smokers can already buy nicotine-laced chewing gum over the counter, but have called for nonprescription patches as well because they can send stronger doses of nicotine into the bloodstream.

...prescription sales of the nation's four nicotine patches and Nicorette, the nicotine gum, have stagnated in recent years as smokers became frustrated with the relatively low success rate in quitting.

Drug makers are hoping that switching the products to nonprescription sales will revive the market, saying 70 percent of would-be quitters do not want or cannot afford to see a doctor for help.

The F.D.A.'s approval lets McNeil beat Nicoderm, made by Hoechst Marion Roussel, a subsidiary of Hoechst A.G., to the market.

Nicotrol by prescription has not been a cure for the cravings smokers experience as they try to quit, and the over-the-counter version will not be either, the F.D.A. warned.
 

J W in Texas

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Didn't Ms. Chappelle say that "None of the products have been submitted for inspection or approval"? Well, I could swear that she said in another statement she made that all of these products that were submitted have been seized (can't remember the actual word in the other statement). Of course it may have been the other FDA gentleman who said that, but still...it's darned inconsistent. Sounds like the FDA right hand doesn't know what the FDA left hand is doing.

I know I read it on this forum and some of our more knowledgeable members here probably remember what thread it was on and what the statement actually said.

NM...It was Kevin M. Budich of the FDA who stated that they have detained and refused importation for some of these devices but it doesn't say that any were submitted for approval. But we do have Ludo saying that Janty has asked the FDA to state what the rules are and that the FDA has not responded. I think that's why he said "What rules? There are no rules". If my interpretation is correct, then the FDA is demanding that the mfg. follow the process and when the mfg. ask what the process is so that they can comply, the FDA can't or won't advise. That just sounds like stacking the deck in favor of only a select and secretly chosen few who can get ahead in the process. Similar to a manager required to post a job opening and 50 people show up filling out applications but they don't know that the manager had already promised it to his nephew.

Maybe it's just the way I read it but it's another view *sigh*
 
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LaceyUnderall

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But we do have Ludo saying that Janty has asked the FDA to state what the rules are and that the FDA has not responded. I think that's why he said "What rules? There are no rules". If my interpretation is correct, then the FDA is demanding that the mfg. follow the process and when the mfg. ask what the process is so that they can comply, the FDA can't or won't advise. That just sounds like stacking the deck in favor of only a select and secretly chosen few who can get ahead in the process. Similar to a manager required to post a job opening and 50 people show up filling out applications but they don't know that the manager had already promised it to his nephew.

Maybe it's just the way I read it but it's another view *sigh*

Here is the big issue. Show me anywhere in the law where the FDA has jurisdiction over nicotine. They don't. Do they have jurisdiction over nicotine used in products making health claims? You betcha. Why? Not because of the nicotine, but because of the claims.

Electronic cigarettes DO NOT have to be submitted for new drug applications unless they make a claim. Now. Is the FDA stopping people because they want to regardless of claims? Sounds like it. But what does that mean? It means that it is the responsibility of the supplier to call them out for over stepping their bounds. If the supplier can prove that they do not in fact make any health claims or quitting claims, then their lawyer should have an easy time proving that the FDA is in fact, overstepping the law.

Does anyone else think it is wrong that a government agency is asserting more power than provided to them by law?
 

LaceyUnderall

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That's going to be tricky. It seems like the chinese market and regulators have accepted the fact that they *are* healthier, even if the US hasn't. So getting them to stop making health claims is probably not going to happen.

Is it possible they are recognizing the studies that have been done thus far and by their definition and laws, they are healthier?

Crap. Now I have another mission. Find something that is marketed one way in China and another way in the US that falls into FDA regulations. Prove that it doesn't matter what the manufacturer says, it is what the US based business is claiming.
 
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