I spoke with the FDA yesterday

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robw

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I know the FDA is already "looking into" e-cigs, and I wanted to find out exactly what they were doing.

I had a nice conversation and learned a bunch about the process they go through.

The first thing I learned is the only way the FDA can approve a product is if someone actually submits one to them to review. This means the vendor who wants to sell the product has to send them one. It is not so simple though, the submission needs to be combined with some pretty detailed studies and details regarding the manufacturing of the drug. He said nicotine is in some foods, and if the chemical is in food and being marketed as such then the procedure is different than if nicotine is in drug form and being marketed as a drug.

The FDA told me that the packaging is the key here. If a product is being sold as a quit smoking device then it is considered a drug. If it is being sold as a Cigarette then the governing body is the ATF. So I asked the ATF if they would consider the E-cig a Cigarette, and they said no, because it has no tobacco. I had asked the ATF prior to speaking with the FDA and told him what the ATF said, and he said he knew that the ATF would say that.

I asked him straight out, if the ecig is marketed as a cigarette and that brings it under the ATF, then the ATF does not see it as a cigarette then who is responsible? He said it would then fall under the "no regulation" category. He said the FDA can only regulate something if it is being marketed as a drug. The bottom line though is the FDA is eventually going to classify the e-liguid as a drug product the same way the patch and gum are classified. He told me that eventually someone will submit the product and the real work will begin.

I asked him what steps if any is the FDA taking to monitor or control the e-liquid side of this product. He said the only area they are concerned about is the importation to the United States from other countries. The China products are of great concern to the FDA in light of recent national headlines regarding lead paint and poisons in the consumer products that have been finding their way into the American market place.

The fact that the products are being imported allows more control for the FDA and the law enforcement community. Products that are manufactured here in the USA are not enforced as much because the consumer has more legal rights against US based manufacturers.

So to finish my questions to the FDA I asked for a realistic time frame when consumers might see a real answer as to the legality of purchase/manufacture and use of e-liquid. The FDA said these things if pushed through clinical trials and heavy finacial backing from the prospective manufacturer can go to market legally in 2 or less years. The back log of cases though in reallity puts it closer to 10 years.

So does this mean the products will not appear in the stores until the FDA approves it? Absolutly not. The FDA can only remove the products from the shelves if there is a complaint against the seller that completes an investigation in to the allegation of the complaint and finds in favor of the complaintant. Due process of law prevails.

My hope is as follows. I feel so strongly that the E-cig is the holy grail of quitting smoking devices, that the population through word of mouth and smart marketing will put the Tobacco companies out of business and save millions of lives. By the time the FDA acts, the possitive results of the e-cig will have made the population hail the e-cig as a "to good to fail"
 

robw

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Ya Steve, they are or seem to be not so worried about the stuff already being in the country. I guess the worry will come when the first complaint comes.

The amount of products that enter the country or are manufactured in the country that can be considered drugs is astounding. He and I talked specifically about herbal drugs such as the male enhancement pills and things you might see on TV adds late at night. We also talked about the stuff you find in health stores. These are prime examples as to where the e-cig is being placed. It is a product that if used as directed provides no harm and can be a good product. When manufacturers start making false claims however that is when complaints happen. The complaints about the above mentioned enhancement pills is a prime example. The companies were not pulled from the market, but they were forced to disclose that the product does not work.

We can only hope the American manufacturers are smart and follow the "truth in advertising" premise. Which seeing you and Shawn in action seems to be the case and is bringing the industry in the right direction. The customer service the both of you provide is also great, and the result will be a satisfied consumer who does not go and start trouble by blowing up a simple customer service issue into a health and safety issue that could create problems in the industry by involving the FDA.
 

dablackanarch

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robw ...

Very nice info bud ... I have had the same conversations with both the FDA and ATF. Although, my conversations were more along the lines of, "The stuff is already in the country, so now what!" :)

I love ya, Steve! So, now what? LMAO

robw, this is good work you're doing. Just remember, while e-cigs have been used to quit smoking, they DEFINITELY should not be marketed or sold as NRT or devices for quitting smoking. I bought mine to have a 'safer' substitute for smoking, not to quit.

I personally think that suppliers and manufacturers who claim that e-cigs can help you 'quit' are not doing us a favor. There is a myriad of ways, all legitimized by the FDA to quit smoking. The fact that even the best of them only have about a 40% success rate after six months is immaterial.

To all suppliers: Please, PLEASE, stop selling these devices as 'stop smoking' devices. You're attracting the notice of one of the biggest bureaucracies in the world and are doing real harm to people who want to use these devices as a 'safer' means of nicotine delivery.
 

dc2k08

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Well done for doing this. amazing that you were able to get through to someone to field your questions. you got great information too. shows that the elctronic cigarette really occupies a kind of limbo in definition and probably not on purpose either. this quote worries me.

The FDA can only remove the products from the shelves if there is a complaint against the seller that completes an investigation in to the allegation of the complaint and finds in favor of the complaintant. Due process of law prevails.

i think i have an idea who might want get up to some complaining.
 
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robw

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i think i have an idea who might want get up to some complaining.

Of course. Big tobacco is the largest threat to the e-cig industry. The power they have monetarily as well as politically is beyond anyones imagination.

My suggestion, Talk to your congressman and senator. I am involved in politics heavily. I know that the only way to fight the big tobacco is a preemptive strike. That strike is to make Washington praise the ecig before they are bribed to destroy it. The one thing a politician hates to do is flip flop on an issue. It is bad PR
 

TropicalBob

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Good information to keep us up to date. But I think the "complaint" will come from those very congress people you suggest talking to. One will rise to note that a new threat to the children of America has been unleashed by China in the form of a highly addictive device that can be ordered, without proof of age, over the Internet and delivered by the U.S. Postal Service! Say what? his colleagues will blurt out. And they will call for an FDA investigation of this hazardous, yet unregulated, drug being imported to these shores.

That's how it will come down. Big Tobacco I think would be third on any list of potential complainers. Government reps are number 1; Big Pharmaceutical is number 2. They are likely to bend an ear that their NRT products faced years of expensive study before winning FDA approval, yet this "step down" device - using the same nicotine they use -- has had no study. And they'll have a point. Nicotine is a drug. A food? That's been tried, and rejected, in other countries and even here with Nicowater. It's not a food. No nicotine liquid will qualify as a food. Our devices deliver a drug to addicts.

The economy is so poor that action might be delayed on many matters. And the FDA has a plate full already. But if some newly elected member of Congress shouts out a dire warning about saving the children ... the FDA will begin to investigate.
 

robw

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Honestly there is an opportunity to do something amazing.
I read this artile
A Smoking Tradition Snuffed Out By Pelosi - washingtonpost.com

In the article is said Rep. John A. Boehner was the heaviest smoker in congress. This is the guy who can spear head the preemptive campaign to promote esmoking. If he smokes them in congress, everyone will ask what it is, and he will feel strongly about its merrits.
 

TropicalBob

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It's a very good idea. We've posted before that the good California governor should be given a Ruyan Vegas e-cigar. Also, the Republican majority leader who spoke after the bailout vote (can't remember his name!!) is said to be a heavy cigarette smoker. There are bound to be a few who would benefit from e-smoking in public places. Keep at it.
 

dc2k08

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your spot on bob, i might call a few in ireland too. Our minister of health was very proud to announce ireland as the first country in the world to ban smoking in the work place back in 2004 even while being cursed by many pub owners. Still, i dont see the government instigating any regulations of its own accord regarding electronic cigarettes unless WHO or the EU call for it. we're too small a population and any muscle big pharm or big smoke want to flex will be flexed elsewhere first. then it will be a matter of following the lead of either the UK, america, germany or france.
 

fsu1dolfan

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Heres another angle coupled with the FDA and congress....Celebrities! At this point it's all Word of Mouth and most people have never heard of it much less even seen one. I got lucky and heard through a friend. Plus i have been telling everyone one that wants to learn. But like it was mentioned before its going to take a massive spike in popularity and acceptance for it to overthrow big tobacco. What better way to reach a massive audenice then some A list celebrity vaping during an interview...plugging it and explaining the positives before some government controlled media ...... tries to put a negative spin on it! Cash is out in Cali....you should try to grab a celebrity and boost your sales and interest nation wide.....positives all around!
 
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