You can't sue the FDA.
why not?
You can't sue the FDA.
1. Your firm does not test each batch of drug product to determine conformance with final specifications (21 C.F.R. § 211.165(a)). Specifically, your firm does not test each batch of drug product prior to release.
2. Your firm has not established written procedures designed to prevent microbiological contamination of drug products not required to be sterile (21 C.F.R. § 211.1 13(a)). For example, your firm has not set microbial limits for your firm's oral liquid drug products, nor have you demonstrated preservative effectiveness.
3. Your firm has not conducted specific identification testing when components are accepted based on the supplier's report of analysis (21 C.F.R. § 211.84(d)(2)). For example, your firm accepts a Certificate of Analysis (COA) from the supplier of components. However, your firm does not conduct identity testing on your components or appropriate verification of the supplier's test results.
4. Your firm does not have a written testing program designed to assess the stability characteristics of drug products in order to determine appropriate storage conditions and expirations dates (21 C.F.R. § 211.166(a)). For example, your firm does not have a stability testing program for your firm's components and finished drug products.
5. Your firm's drug products do not bear an expiration date determined by appropriate stability data to ensure they meet applicable standards of identity, strength, quality and purity at the time of use (21 C.F.R. § 211.137(a)). For example, your firm does not have the stability data to support expiration dating for these products.
But the FDA has unlimited resources, paid for by you and me.
And they love spending resources, and don't care about using more resources (money) to get what they want.
Paid for by you and me.
But yeah, it could very well be that there is a limitation to their resources.
And if so, then they might be backing off a bit.
That is certainly something to hope for.
My apologies if this has already been addressed, I can't be bothered to read through every post. Anyway, with all this talk of the FDA needing time to evaluate e-cigs and deem them as safe keeps leading me to the question I've had since day one... When did the FDA evaluate the contents of analogs? When did they deem them as safe?
They DIDN'T ever deem them as safe and that is where my largest annoyance over all of this really comes into play.
FDA : There has not been enough lab work and testing involving Electronic Cigarettes to deem them as safe products. They "MAY" be harmful to your health and due to this we take a firm stance against the product.
FDA : On the other hand, we have done plenty of research on Tobacco Cigarettes and have found that they will indeed kill you!
FDA : Therefore, we suggest everybody set aside the product that "may" be harmful and go back to the Analogs that are proven to be a detriment to your health!
I agree. If only because the word prohibition carries the taint of phrases like McCarthyism, or New Formula Coke. What is possible--or what I fear is possible--is what, frankly, got me here to begin with: the de facto prohibition on cigarettes by means of prohibitive taxation.
My point exactly...They DIDN'T ever deem them as safe and that is where my largest annoyance over all of this really comes into play.
FDA : There has not been enough lab work and testing involving Electronic Cigarettes to deem them as safe products. They "MAY" be harmful to your health and due to this we take a firm stance against the product.
FDA : On the other hand, we have done plenty of research on Tobacco Cigarettes and have found that they will indeed kill you!
FDA : Therefore, we suggest everybody set aside the product that "may" be harmful and go back to the Analogs that are proven to be a detriment to your health!
My point exactly...
Annoying on so many levels. Maybe we should all learn DIY and then those .......s won't get as much as sales tax from e-cigs. I'll vape one way or another, I simply don't give a bleep. The worst part is what this will do to all of our beloved retailers. I've never seen such great customer service, ever.Yeah I wasn't suggesting you didn't already know that.
This entire situation is so agitating. After reading over some of those letters, I found that in many cases they faulted companies over what E-Cigarette users have said and not by any official claims made by those companies. If you look at the letter to Johnson Creek they quote various COMMENTS made by us within the vaping community on individual products. Comments such as "I love this juice and it helped me stay off E-Cigs" and so on and so forth.
This type of crap is going to make my head explode and end up on Mars.
Better than a cherry from an analog falling on your lap...And a few minutes after my last post I ended up having the top of my syringe pop off and squirted E-juice directly into my eye..... And it was a citrus flavor! Luckily I had one of those chemical eye rinse kits and used it.
Anyhow, I blame the FDA for annoying me and making me be a little too forceful when refilling a cart.....![]()