Attention all quitters: Please share your story with The Doctors
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FDA has a problem with it because they aren 't in control of things. If something is being used to treat a disease, they want to regulate it in the same way they regulate pharmaceutical products: Keep it off the market until the manufacturers conduct exhaustive testing to proove the products are "safe and effective". This process costs up to a billion dollars and can take years and years. Healthcare Economist · Cost to bring drug to market: $802m
Even if a million of us said, "It's working," that's not good enough for the FDA because their standard New Drug approval process has not been followed.
All of the appoved "smoking cessation" products are geared toward the user giving up nicotine altogether. We users claimed that we were using it "recreationally" to REPLACE smoking, not to treat nicotine addiction. Therefore we did not want it regulated as a drug-delivery device combination, because we did not want the products removed from the market for years and years.
The FDA argued in court that it would be dangerous to leave the products totally unregulated. So Judge Leon looked at the wording of the Family Smoking Prevention and Tobacco Control Act (which was passed while the judge was considering the arguments in the SE & Sottera v. FDA case). In his opinon, Judge Leon the FDA that if it wanted to regulate the products, the agency could do so under the Tobacco Act because the products met the definition of "tobacco product" by being "derived from Tobacco." http://www.casaa.org/files/SE-vs-FDA-Opinion.pdf
The Agency continued to argue that e-cigarettes are not tobacco products, but after their two appeals were denied, they announced that they would do so. Regulation of E-Cigarettes and Other Tobacco Products
By the way, the FDA is the only entity that has defined "smoking" as a disease. All the diagnostic manuals talk about "nicotine addiction" or "tobacco abuse" as the disease.
So even though it is absolutely true that the product works well to help people quit smoking, vendors are not permitted to say so, because that statement will be interpreted as a medical claim. BTW, Judge Leon also stated that if an e-cigarette manufacturer wanted to make medical claims, they could submit a New Drug Application to the FDA.
So it would be possible for a product to have two (identical) versions, for the purpose of advertising and marketing: One version would be a "tobacco product" advertised for recreational purposes. The other version of the product would be advertised as a medical device after it went through the approval process. For that product, the vendors would be able to say that it helps people to quit smokng.
The only problem with this scenario is that technology evolves quickly. If Ruyan had begun by filing a NDA with the FDA and started conducting all the required tests, back in 2007, they would not have been able to make any changes to the product during those years, or they would need to start their testing all over again. For the prescription version, we would be stuck with the old Model RN 4081 that has leaky cartridges, batteries that only last a few hours on a charge, and that become unchargable after 3 to 6 months.
So if a manufacturer started out with the two hypothetical versions of an e-cigarette that I postulated above, by the time the medical device version was approved, it would be old technology, blown away by the recreational version.
I too submitted my story and thanks for all of your hard work and dedication. We really need people like you that are able to stand up for what is right! CASAA is doing an awesome job and we should all support it financially as well as writing letters when asked.
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I submitted this:
I smoked close to 2 packs a day for 45 years and tried everything on the market to quit. Every time I did I would experience horrible symptoms including depression and would always go back to smoking. Once I quit for a year and at the end of that wanted one as badly as I did the day I quit. It never got better for me until I bought an e-cigarette. It's now been 2 years since I've smoked a cigarette and I'm no longer addicted to nicotine. I can have it when I want or go without it with no ill effects. To me that's amazing because in the past if I had just one cigarette I would be back to smoking full time. For a hard core smoker like me switching to e-cigs for my nicotine delivery system was a great blessing and I hope others have the opportunity to experience it for themselves. After the first few days I actually FORGOT to smoke a cigarette! I would still be smoking if it weren't for the e-cig. And the best part is that I no longer have a desire to smoke. The e-cig is a much better way to get nicotine without burning tobacco and all the chemicals. Now it's 100% my choice if I want nicotine or not!
I smoked close to 2 packs a day for 45 years and tried everything on the market to quit. Every time I did I would experience horrible symptoms including depression and would always go back to smoking. Once I quit for a year and at the end of that wanted one as badly as I did the day I quit. It never got better for me until I bought an e-cigarette. It's now been 2 years since I've smoked a cigarette and I'm no longer addicted to nicotine. I can have it when I want or go without it with no ill effects. To me that's amazing because in the past if I had just one cigarette I would be back to smoking full time. For a hard core smoker like me switching to e-cigs for my nicotine delivery system was a great blessing and I hope others have the opportunity to experience it for themselves. After the first few days I actually FORGOT to smoke a cigarette! I would still be smoking if it weren't for the e-cig. And the best part is that I no longer have a desire to smoke. The e-cig is a much better way to get nicotine without burning tobacco and all the chemicals. Now it's 100% my choice if I want nicotine or not!
I submitted my story. Quit by accident after 40 years of 1 1/2 PAD.
And discovered BWB Malty.
Life is good.
And discovered BWB Malty.
Life is good.
I posted a quick short one, as we have only been smoke free for 10 days but it is fabUlous daHling !
I posted my story...I wasn't very good in kindergarten so I didn't do any cutting and pasting, but...I was a 29 year Pack+ per day until I was introduced to Vaping. Stopping smoking was as easy as changing brands. Now if I could just get my wife on board, she has been diagnosed with COPD but that hasn't pushed her into exploring better alternatives.Wow 29 years, great job! Well good luck with the wife.
Will post mine as soon as I get it up on here. Reading all these other success stories is sort of addicting.
One thing about ECF is that the success stories never end. They just keep coming and coming.
Done, And I'll share here as well. I'm fifty now and smoked for 30+. After the first 15 I ran thru most of the "I quit" scenarios with a success of 2 twitchy,craving haunted years. Too much temptation and I felt mightily deprived! This time around I quit analoges cold. Haven't had,craved,or touched one. I'm at 2 months+ and I'm calm,cool and collected. I'm down to 11mg on my secondary flavors and my main vapes are nicotine free. If these were around back then,I probably would have never started tobacco.
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