But I don't get it. What's the "new drug"? Nicotine?
Lu
But I don't get it. What's the "new drug"? Nicotine?
Lu
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The Operational and Administrative System for Import Support(OASIS) reports that I posted above are Import Refusal Reports(IRR)s. Those companies on the reports had their product detained or halted all together depending on the outcome of FDA action. These reports are direct cooperation with US Customs officials.
INTRODUCTION TO FDA'S IMPORT REFUSAL REPORT (IRR)
The fact that it could take lengthy legal processes to stop the flow of E-liquid and Devices is not correct. They can stop the shipments directly from coming into the country.
First hint I'll be stocking up. I'm not in bad shape now... Good thing we have this wonderful resource with people that understand this stuff...
It's not even that it is a new drug itself. It is that it's a new form of a known drug, which falls under the category of a new drug. Because of this it requires an NDA.
http://www.fda.gov/cder/regulatory/a...s/NDA.htm#Laws
Last edited by Keltrey; 01-22-2009 at 01:33 AM.
Hey, Upstate New Yorkers!!! Buffalo, Rochester, Syracuse, Ithaca, Binghamton, Plattsburgh, Oswego and surrounding areas, check this out:
UpstateNYVapersClub
Come one, come all! Visit the forum above for further details.
I want to make something clear real quick. I am not attempting to flame anyone. I am just trying to show how fast a ban could occur in the US.
I hope he doesn't mind me saying it, but Tropical Bob has been right in warning about bans. It's not a matter of if, its about when. There have already been products seized by customs.
I feel that the need of awareness needs to be addressed. Australia has already felt the ban, UK almost did with E-Liquid. The US FDA already has its feelers out and is taking action quietly. If manufactures continue to disregard the regulations it won't be long before all import or even domestic production is halted.
The problem with NDAs is that clinical trials must be conducted, which could take years. During this time all of these products could be halted or seized upon entry to the US.
I apologize if I have offended anyone with my comments tonight, but I fear our beloved products are in jeopardy.
The best would be (if they do get banned) for there to be a possibility of using an already legal nicotine product and getting the nicotine from that for use in the e-cig.
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