FDA FDA deeming regulation proposals
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Posted by pamdis here:
http://www.e-cigarette-forum.com/forum/fda-regulations/557605-economic-impact-analysis.html
This pdf explains some of what is being discussed here....
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM394933.pdf
http://www.e-cigarette-forum.com/forum/fda-regulations/557605-economic-impact-analysis.html
This pdf explains some of what is being discussed here....
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM394933.pdf
Lol...
Hmmmm... good 'ole Bill. Not too fond of him personally... although i'm a conservative individual.
Hmmmm... good 'ole Bill. Not too fond of him personally... although i'm a conservative individual.
The FDA has received over 4000 applications for new cigarettes. To date, they have approved 2. Anyone got 50k to bet on a 0.05% chance of success? How about on the 'streamlined' 25k process if we bow and scrape nicely to our betters?
To Hell with the FDA.
Roaring thunderously via Tapatalk...
To Hell with the FDA.
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"Dr. Carl V. Phillips. FDA has cherry-picked the available evidence, "
This is what I see in the deeming doc as well as the newer "Preliminary Regulatory Impact Analysis" doc.
They'll "give" that some people say they have been helped and how it ecigs may be less dangerous than cigarettes - but only in general terms. When they state the anti side, it reads like something from Glantz (and very well may be) - ie more detailed, using scaremongering terms, although they left out 'wild west'
Lol...
Hmmmm... good 'ole Bill. Not too fond of him personally... although i'm a conservative individual.
That could be why you're not too fond of him, but take solace - he hates libertarians
Chose to snip excerpts from these posts.
To me, these statements are very counterproductive. As you two aren't only people saying this sort of stuff, then I wish to make clear that I see this as unhelpful wherever it is stated, regardless of how elevated in experience or stature the person is who says or writes this.
From this perspective, I see no reason to submit a response to the FDA. If on the one hand, you see the current written proposal as "very bad" and "killing eCigs" plus also see no reason to trust the FDA, then what could you possibly say (to the FDA) that would be of any use to the vaping industry/vapers going forward? Under what context would you think they would be open to whatever it is you are saying in your response?
To me, if this is the general sentiment, and no leader can find a way to change that sentiment, then we need to avoid the FDA. Perhaps put out a public announcement on some web page that announces this, and plan a new course of action, such as writing to congress.
But then what about all the people that have no trust in Congress, as I understand their approval rating is around 15%? So, arguably, Congress is not the path to take regarding future market of eCigs.
Who here has full faith in current POTUS being the way for vaping to go? Anyone?
So then what. We do nothing and hope for the best?
(Parenthetically, I am compelled to add that I strongly disagree with this sentiment. I don't implicitly trust the FDA, but do see 'what is written' in a different light than these sentiments. I could be dead wrong, or naive, or what have you. But I feel it is critical to go over exact wording of proposal than toss out general statements of "as written it will kill eCigs." I'm not sure how to get around prevalent sentiments that have absolutely zero trust in government and FDA, but to me, it is fact that people will respond to FDA letter even if everyone that has ever visited ECF and/or is member of CASAA chooses not to. I'm also fairly certain CASAA will advocate for a response, and also mostly confident that people who say 'no reason to trust FDA' here on open forum, are actually going to write to the FDA. I do wonder why they would if trust is zero, but I guess this sort of rhetoric is actually just venting huge frustrations with past record of FDA and people will hope for the best going forward.)
"Dr. Carl V. Phillips. FDA has cherry-picked the available evidence, "
This is what I see in the deeming doc as well as the newer "Preliminary Regulatory Impact Analysis" doc.
They'll "give" that some people say they have been helped and how it ecigs may be less dangerous than cigarettes - but only in general terms. When they state the anti side, it reads like something from Glantz (and very well may be) - ie more detailed, using scaremongering terms, although they left out 'wild west'
He won't leave it out again. Mitch Zeller was using it this interview, his BFF Glantz gets it in the next interview.
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Hello kitty!
Spot on!
Hi there, good to see you, Katya.
Thank you.
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I find the message of Mitch in this video troubling.
But not new. I don't see anything stated here that couldn't have been said in 2013, 2012, etc.
What's new is that we have a FDA proposal to regulate eCigs (that we knew was coming for at least 3 years) and it is nowhere near as heavy handed as it could've been and as MANY were saying it would be.
Now, we can say, the ambiguity is much worse. I'm thinking in an alternate universe, where they got the heavy handed version, they are wishing for the one we got in this universe. And in another alternate universe, where they got one where FDA says "we love eCigs and everyone's approved" our counterparts are saying, "lies, don't believe them. Vaping is going to get killed. They just forced us back to smoking."
As I'm all on this limb by my lonesome, I'm not sure what else there is to say. I guess wait until your leaders come along tell you what to think and what to say to the FDA, and hopefully until then cooler heads will prevail?
Ruins it for whom?
BT & their e-cig affiliates seem pretty happy about it..
Be "forced" to spend $X million in order to gain control of a quickly growing $2 billion market?
Not a shabby ROI, my friend...
That last sentence pretty much explains the one before it. It's insulting, but you knew that.
It doesn't matter what you or I think, Jman. That's the most troubling part. It's all in their hands. First they deem then they regulate. Period. We won't know what the deeming regulations are until they are passed. And once they are passed, the FDA has full control over everything.
Those are the facts. Everything else is speculation, wishful thinking, fear mongering--whatever. It doesn't matter.
Exactly right. The FDA asking for comments, is akin to most TV hosts saying to email them - name and town, name and town.... thousands do and only a few that either make their point, or allow them to reiterate their point are the only ones used.
No, sounds like they're still working on the Call-to-Action.. No need to rush since they want to get it right...
"CASAA is preparing a response that will point out the flaws in the proposed regulations and is organizing its members and hundreds of thousand of other e-cigarette users in an attempt to persuade FDA about the harms this regulation would cause. Should that fail, it plans to fight the regulations in court."
I think it's safe to say that this thing is going to court...
Without doubt, it was a cheap shot.
To disagree with Him, apparently means we have left the only Righteous path of Wisdom.
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There are other ways to deal with that. Complying with state and local food handling laws would be a start. This doesn't need to elevate to this level of complexity. In fact I feel less safe with BT manufacturing cartridges in China. I'm exapggerating (I hope) but some melamie or other toxic substance could get slipped in, which has happened before. Industrial grade ingredients. I'd know less about the eliquid than I do now. As it stands, I have a choice. After FDA, there will be little choice.
That's the only force that has stopped the FDA in the past. Why should we fear using it now?
Let's dig deep and support CASAA as much as we can, so that our response to our enemies is well-funded.
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