Link to webcast of Dec. 17 FDA Public Hearing on NRT & Innovative Products
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I think some need to focus on the panels repeated assertion that "we need empiracle evidence of the EFFICACY of any given NRT" They will approve any method that can be "proven" to result in an individual's reduction in dependance on cigarettes.
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 tobaccoand 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): 50516. 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.
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read my last comment it isn't that it isn't a form of nrt but that the gevernment is not allowed to see it as such
I dont think anyone in here believes that, or has implied that.
Bah my broadband is slower than hell and I only get one word in every three.
The captions don't help much either - more confusing than helpful :/
The captions don't help much either - more confusing than helpful :/
God forbid! NO! NRT = nicotine replacement therapy. I don't want e-cigarettes to be regulated as medical devices and e-liquid as pharmaceutical.
In fact, get this straight, nicotine containing products such as smokeless tobacco and e-cigarettes are and should remain reduced harm recreational nicotine products.
There are to points of relationship with NRTs:
1) NRT producers see NCPs as their worst nightmare - if consumer grade nicotine products that are safer than cigarettes smoking become mainstream, their products will lose their place. NRT manufacturers want to maintain the status quo whereby NO consumer grade nicotine product is a safe alternative to smoking, and whereby nicotine 'addiction' is a disorder that requires therapy, hence their product.
2) However, many of the arguments that make NRTs 'safe and effective' can easily be transitioned to recreational smokeless nicotine use and may be used as weapons in making consumer recreation NCPs mainstream.
3) In fact, ironically, BT are closer to our cause in this as they are interested in promoting NCPs and in the relaxation of requirements for misleading safety statements and labeling on their NCPs.
The purpose of the hearing is to allow GSK and J&J to market NRTs for long term, ultimately indefinite use.
The incredibly twisted logic and moral compromise of that is obvious - there is no magical difference between NRT and NCP. The only basis for segregation is the assumption that nicotine 'addiction' is a disorder.
If we don't understand these points, all the efforts are useless.
OK, I stand corrected from that particular post. I will clarify. This hearing isn't about e-cigarettes officially, but the outcome can affect how e-cigarettes are regulated or viewed as THR in the future. But this is NOT officially a hearing about e-cigarettes. It is officially a hearing about the long term use of FDA-approved NRT and innovative smoking cessation products. When they say "smoking cessation" and "NRT" this means NICOTINE CESSATION. E-cigarettes are PRIMARILY not being used as a way to treat nicotine addiction nor are they FDA-approved for that purpose. This hearing is specifically about currently FDA-approved products and new products intended to treat nicotine use.
See above. Not for the purposes of this particular hearing.
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