Link to webcast of Dec. 17 FDA Public Hearing on NRT & Innovative Products

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DiNet

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We should really try to avoid humiliating situations like these... Has anyone advised the BlueMist guy in any way. He SHOUDN'T be there. He does harm to e-cigarettes right now.

Why? How? And maybe in their eyes it is not a statistic but I'm pretty sure that he helped to quit smoking to a lot of people.
And yes he is right about product - it just works, not like all the other crap.
 

elfstone

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Why? How? And maybe in their eyes it is not a statistic but I'm pretty sure that he helped to quit smoking to a lot of people.
And yes he is right about product - it just works, not like all the other crap.

Yes, but he can't prove it. And he can't even make a point about it.

Listen to the AEMSA guy - he actually makes good points and plays their game.

Nice presentation!!!
 

kristin

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So, some of you do not think that a PV is or can be considered a NRT - nicotine replacement therapy?

A NRT 'is the remedial administration of nicotine to the body by means other than tobacco, usually as part of smoking cessation.'

What other benefit comes from a PV than 'that it prevents cravings in a smoker whilst allowing him to abstain from tobacco—and thus avoid the harmful effects of smoking.'

Shiffman S, Rolf CN, Hellebusch SJ, et al. (May 2002). "Real-world efficacy of prescription and over-the-counter nicotine replacement therapy". Addiction 97 (5): 505–16. doi:10.1046/j.1360-0443.2002.00141.x. PMID 12033652.
Silagy C, Lancaster T, Stead L, Mant D, Fowler G (2004). "Nicotine replacement therapy for smoking cessation". Cochrane Database Syst Rev (3): CD000146. doi:10.1002/14651858.CD000146.pub2. PMID 15266423.
Stead LF, Perera R, Bullen C, Mant D, Lancaster T (2008). "Nicotine replacement therapy for smoking cessation". Cochrane Database Syst Rev (1): CD000146. doi:10.1002/14651858.CD000146.pub3. PMID 18253970.

E-cigarettes can fall under both categories at this point - tobacco or drug treatment. The FDA wished to make them ALL under the drug treatment category, which would mean that all e-cig and liquid companies would have to apply for FDA approval and go through years of clinical trials to prove that they work as a nicotine addiction treatment. The court ruled that the FDA couldn't classify e-cigs as drug treatments unless the e-cig company claimed to be a treatment, otherwise, e-cigs work like any other recreational tobacco product (or product made from ingredients sourced from tobacco.) Hence, ALL e-cig companies are currently considered tobacco products because none have been approved as NRT products.

This hearing is about FDA-approved NRT products and innovated products that will be tested to act like NRT - which, in spite of the technical definition of "nicotine replacement therapy" actually are treated as "nicotine REDUCTION therapy" to end nicotine addiction/use. That's why we didn't want to focus on e-cigarettes specifically in our presentations but more on supporting tobacco harm reduction, which is how most people actually use e-cigarettes, rather as a way to quit nicotine. Most people use these to quit smoking but not necessarily to quit nicotine.
 
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