AP: FDA Sending Warning Letters

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Poppa D

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If these regulations are already in place, wouldn't it be easy enough to implement them?

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.
 

PoliticallyIncorrect

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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.

That reminded me of something I'd read recently--took me awhile to find it: Egg Recall, Drug Approval Time Raise Questions About FDA Resources

The gist of it has to do with a flurry of cases (egg scare, chinese drugs, etc.), too many too soon: "PBS' NewsHour reports. "For the past few years, it's been one food safety scare after another. There was E. coli-laced spinach, salmonella-tainted peppers. ... There have also been problems with drugs. The ingredients in a contaminated blood thinner came from China. And whether the tainted products are from abroad or the United States, it's the Food and Drug Administration's job to make sure they're safe for American consumption. The FDA has received some new money from Congress to police food and drugs, $141.9 million last fiscal year alone just for food safety."

Margaret Hamburg, commissioner of the FDA, however, says the agency lacks the necessary resources to do its job."

I'm grasping at any/every straw of hope I can dredge up.
 
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fmx

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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?
 

Hudsonkm

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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!
 

JerryRM

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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!



Yup, which will make BP, BT and the states (excise tax) very happy.
 

LowThudd

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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.

Traces of prohibition still exist today, but we can't discuss that here. It honestly isn't as far a stretch as you may think. The UK never banned alcohol, yet they are banning/attempting to ban nicotine. A bit polyannaish if you ask me. lol
 

HeatherC

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OK everyone here's an idea Don't know if it's a good one... but it can't hurt either. Everyone take a few minutes out of the day tomorrow to call the commissioner of the FDA (301)796-5000 and let him know what we think of them trying to make a mockery of the appeals process. The appeal has been granted and a stay of the previous verdict is in place. As far as I know this does NOT give them the right to regulate them as drug delivery devices. Just because the decision has been appealed and a stay has been granted doesn't mean they won. (if the legal minds present know of a better way to put this please do)
 

G_Jones

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It is an abuse of public funds to have a federal agency spending time on such a benign industry. I have heard of infomercials and radio advertisements selling "e-cigarettes" as a stop smoking device. Bad idea to market these as such (even though it is true). I think everyone can figure out that is one possible use for a PV, but not the only purpose.

I guess we ought to be making sure every elected official who smokes cigarettes gets a gift of a nice PV starter pack.
 

fmx

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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...
 
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RedForeman

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It's all about regulating to create profit and tax revenue on a product that a relatively powerless minority of people will buy at any price.

I agree with others predictions - when (not if) that happens with eCigs and the supplies, you can either pay tobacco price + tax for the convenience of ready to use products, or expend the effort it will take for you to DIY using unregulated component parts and ingredients. Just like you have a choice to grow your own tobacco and roll your own analogs with it.
 

Hudsonkm

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My point exactly...

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.
 

fmx

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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.
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.
 

Hudsonkm

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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..... :p
 
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fmx

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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..... :p
Better than a cherry from an analog falling on your lap... ;)
 

GtrSoloist

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After reading this entire thread and many of the letters and articles that are linked to, I've decided to weigh in on this issue. I'm sure my opinions will raise the ire of many reading this board, but I think they need to be voiced:

1) The FDA: I worked in government long enough to know that the FDA and organizations like the FDA are in someone's pocket. They (as our government) are ran for the profit, gain, and protection of corporations-- not the people of this country. The previous statement saddens and frustrates me to no end, but make no mistake that the United States is a fascist government.

It's pretty obvious to see who will benefit from the attempted banning of e-cigs and e-juice: Federal and State Government, BP and BT in that order.

2) For Those who got Letters: If I were Johnson's Creek or one of the other companies who received that FDA Letter, I think I would be talking to the ACLU to prepare a legal defensive. The FDA is a pit-bull, and as far as I can tell, the only way JC for instance could comply with the FDA is by stopping the sale of all his products, until he has proved they are safe by testing and trials and has revamped the website to remove the offending claims. This would effectively put him out of business due to the length of time and money required to comply.

From my point of view the alternative appears to be that if he doesn't cease all sales, he will likely have everything seized, be heavily fined, and face possible criminal charges. This situation is very serious.

3) What this means to Vapors: I'm honestly not sure, but it is not looking good. I can see everything from skirting various claims and keeping one step ahead of the FDA, to full and outright bans on the PV's and the juice. I think suppliers will be targeted one by one.

That being said, we can still get the ingredients needed to make our own juice. If I were an e-juice distributer I might start looking at marketing juice as a "great tasting" pesticide since nicotine is classified as such anyways through 2014... but that of course opens another can of worms and probably isn't a good idea.

The sky isn't falling yet...

4) CASAA: Where are they? No I'm serious here people. I've seen them on this board. Why don't I see them elsewhere on the Internet? On TV? On the Radio? In the Paper, or talking to the press? They need to do something already.

5) What should be done:

A) Lobby: The E-cig manufacturers (Device and Liquid) need to form their own Lobbyist group and start ponying up money if they don't want to be ground under the foot of the FDA and the BT and BP lobbyists who are pressing for bans.

B) Grass-root Effort: Mid-term elections are approaching. Various candidates should be given info on the current state of PV's and be pressed for a stance. This could also be made into a campaign issue. (So uh back to point 4... why hasn't the CASAA done this long before now?)

The Vaping community needs to assemble a voting block.

It may be too late to make PV's a real issue for this coming election, but I still think that a couple great questions to ask a Candidate would be:

"Are you in favor of the FDA killing people," and "Do you support the FDA pressuring people into smoking cigarettes?"

What I'm getting at is that it's time to be ruthless. It's also time to organize and take a stand while you still can.

C) Letter writing campaigns: I believe the CASAA put together a nice info packet on PV's. (Credit where credit is due I'm not anti-CASAA I just don't see them doing much.) If vapers are serious, you should start putting hand to keyboard and writing out letters to mail (not email) to your state and federal representatives.

When you get the form letter reply, start calling and start making appointments to talk to them face to face. This issue could make someone a political rock-star.

6) Calling a Spade... a Spade: The simple fact is that people use e-cigs to replace smoking. It is a nicotine device. I think everyone agrees that it's safer than cigarettes aside from those who have a financial stake in seeing the product banned.

It should be tested, and it should be regulated. However the testing and regulation should be done in a manner that keeps the product available to adults and it's same reduced cost. (In comparison to cigarettes.) This way the thousands of people using them won't be forced into smoking cigarettes again.

The potential of this product is a game changer. A cheaper, healthier alternative to smoking cigarettes. This product saves lives. Let's try not to lose sight of this, or let the FDA, the press or anyone else lose sight of it either.

Hey FDA, Why don't you prove it's more dangerous than Cigarettes? Why don't you prove it's as dangerous? Yeah not gonna happen, your paychecks are blood money, grow a conscience and quit your corrupt job like I quit mine.

Guess I'll just make another tasty salmonella omelette, thanks for doing such a wonderful job.

These are just my opinions and should be taken as such.
 
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