Really great to hear that news. Thanks for talking to him on our behalfSome hopeful news from Oklahoma - Visited with Senator Coburn (or Dr Coburn? The Honorable Doctor Coburn? Just what *do* you call a U.S. Senator who is also a doctor?) for a brief moment (caught him walking to his car since I didnt get a chance to ask my question during the townhall meeting). And, he told me that he is firmly against the Waxman/Family Smoking Prevention and tobacco Control bill. It was unclear as to whether he is against it because of putting the FDA in charge of a cancer causing substance (tobacco) is ludicrious, if it was because it would effectively ban safer alternatives to tobacco, or if it was both. But he said that he was against the bill.
I wish I could have gotten more time with him, but that's better than nothing. And, at least we have one that we now know is against it, regardless of the reason. Also, he's known for using holds to kill bills. Tom Coburn - Wikipedia, the free encyclopedia Hopefully he will do that to this one if it becomes needed.
Despite the relatively good news, I would still write letters to the Senators, the more our voices are heard, the better. It does make me feel better about the whole thing, though.
(B) any modification (including a change
14 in design, any component, any part, or any con15
stituent, including a smoke constituent, or in
16 the content, delivery or form of nicotine, or any
17 other additive or ingredient) of a tobacco prod18
uct where the modified product was commer19
cially marketed in the United States after Feb20
ruary 15, 2007.
section, but that's very broad.(I) is substantially equivalent to
6 a tobacco product commercially mar7
keted (other than for test marketing)
8 in the United States as of February
9 15, 2007;
^ youre welcome![]()
A special thanks to BandBsMom for posting about the townhall meeting tonight; thank you B&BsMom, it's very much appreciated!
Fenez, you ever watched an hours worth of tv before? There are lawyers everywhere suing new drug companies every day for the effects that an FDA approved drug had on the masses. FDA approval doesn't affect your liability.Ok sublime, let me put it this way so all the suppliers understand this. If I the user gets cancer or anything else from your product are you going to like being sued by the user? Are you understanding what I am getting at you guys are opening yourself up to huge liabilities, approval is an absolute must, nicotein is a drug and like all drugs is the U.S it should be regulated so we know exactly what we are inhaling. If anyone gets ill or worse there will be massive lawsuits and all the suppliers will then take a big step back and say " I don't make it I only sell it"
The location of the manufacturing of these products keeps coming up as if that has some bearing on their ability for an NDA submission. Most of the drugs for sale in this country come India, Israel, etc. This has no bearing on anything at all. Neither does the location of the corporation. Many approved drugs are imported from foreign facilities by foreign companies. I don't understand what the point is that is supposed to being made by pointing out that these products are produced in China. ????The problem is that the product isn't being manufactured in the USA and it is the responsibility of the manufacturer to file with the FDA. This puts the FDA between a rock and a hard spot when it hasn't received anything from a US manufacturing company that wants to sell the device. I'd imagine that manufacturers in Hong Kong and China have their hands full filling their own country's legal requirements right now before moving onto foreign requirements.
Looked back over this, and maybe I see what you're saying, but you can get an NDA without being the original manufacturer - many of the drugs out there today are contract manufactured. I used to work for a generic pharmaceutical company that didn't own a manufacturing facility anywhere, but we were listed in the Orange Book. This makes no difference either.The problem is that the product isn't being manufactured in the USA and it is the responsibility of the manufacturer to file with the FDA. This puts the FDA between a rock and a hard spot when it hasn't received anything from a US manufacturing company that wants to sell the device. I'd imagine that manufacturers in Hong Kong and China have their hands full filling their own country's legal requirements right now before moving onto foreign requirements.
Our current average NDA approval time is now around 12 months, six if it's expedited (Jonesing smokers is not cause for expediation....) The FDA doesn't publish submissions for NDAs until they're approved. How do you know no one has an application right now. On the right to vape site, someone located an RJ reynolds patent that appears to describe an electornic cigarette, Ruyan supposedly has lawyers on staff that specialize in dealings with the FDA - how do we know that there are no applications in right now. My money's on RJ Reynolds, but seriosuly, anyone could, and it really doesn't matter if they're a US based company or not.what i cant understand about all this is why havent any major U.S. manufacturers tried to get FDA approval on this yet?...what is stopping them?...why isnt anyone interested?...and why isnt Big Tobacco trying to monopoly the situation...id think instead of outlawing it theyd prefer if losing a smoker, to lose a smoker to an ecig which they manufacture. They look good by providing a way to quit and they make money for smokers who are quitting due to high taxes and health issues.
Yet ive heard of no major U.S. manufacturing interest...im dumbfounded!
Our current average NDA approval time is now around 12 months, six if it's expedited (Jonesing smokers is not cause for expediation....) The FDA doesn't publish submissions for NDAs until they're approved. How do you know no one has an application right now. On the right to vape site, someone located an RJ reynolds patent that appears to describe an electornic cigarette, Ruyan supposedly has lawyers on staff that specialize in dealings with the FDA - how do we know that there are no applications in right now. My money's on RJ Reynolds, but seriosuly, anyone could, and it really doesn't matter if they're a US based company or not.