We need to beat the FDA to the gate!

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CJsKee

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Check out HR1256 9.11(g)(4). These are the criteria that need to be reviewed.


I think that we would fall under 9.11(g)(4)(E). Paragraph (2) shows how a product could be marketed and sold without scientific data, contingent on scientific data being provided at a point in the future. I guess they just go by anecdotal evidence on that accord?

I don't know, SM, it seems like we should be able to at least make a decent case for the overall idea, and then just have specific manufacturers submit their own apps and data. It's awfully ambiguous as to whether the law applies to new technology or new products (to me, anyway). I still say that we band together and get some testing done. At the very least we'll be better informed about what is going into our bodies, and that's NEVER a bad thing.

This refers, in numerous places, to "the tobacco product that is the subject of the application". Are our e-cigs a "tobacco product" as SE has contended in their lawsuit, or, like the FDA has said, are they medical delivery devices. I think someone somewhere needs to decide this before any thing else. IMO, if the FDA comes out on the winning end, i.e., medical delivery devices, the row is gonna be a really long one to hoe.
 

vaportiger

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Jimmy Carter can be contacted at:453 Freedom Parkway, Atlanta, GA, 30307.

Phone: 800-550-3560
404-420-5100
Fax: 404-331-0283

His email address is : carterweb@@emory.edu

I was told to write or fax would be the best way to contact him. The email is screened by someone that might not get it to him.

Let us go on the attack and remember to praise him for his prophetic insight into safe cigs. And what a great president he was? (I guess a little white lie is ok)
 

Surf Monkey

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I don't know, SM, it seems like we should be able to at least make a decent case for the overall idea, and then just have specific manufacturers submit their own apps and data.


That seems like a valid read of the legislation to me. I think the issue then becomes who will pay for testing, what testing would need to be done and what retailer would be willing to submit the application and accompanied results. It sounds simple, but it could be more complex and costly than it looks on the surface.
 

TheIllustratedMan

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SM- As I wrote in my uber-long post (sorry about that, again):

Funded by: us + doctors + suppliers + our loved ones who don't want us to die + anyone else you can convince to throw in a few bucks.

What testing to be done: depends on how you're trying to classify it, but basically the liquid, vapor, and device all need safety testing, and the claims of no-second-hand need to be evaluated.

What company?: depends on if the FDA needs to approve a new technology or a new product. If the former, then whoever. If the latter, then all of them.
 
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