FDA 8/8/14 Comment/Letter to FDA by 29 state attorneys general
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"Capitalism" per se isn't behind these regulations. Look up the definition of "crony capitalism."
Thank goodness someone honest is there! When KC is mentioned the first thing that comes to my mind is the stories my grandfather would tell about having to leave KC in the middle of the night in fear for his life cause Boss Pendergast's gang were going to kill him if he didn't collude with them to swap ballot boxes the next day. These kind of things are imprinted on people (myself one of them) and result in a stereotyping of politicians that is hard to shake.
I'm late to this thread, but I need to make a correction here...
Congress does not have to approve the FDA deeming regulations.
If Congress does nothing, then the deeming regulations go into force.
Congress DOES have the opportunity to STOP the regulations, but only if they take action to do so.
You mean, congress has to do something in order to keep the regulations from becoming final?
Yup, we're doomed
You mean, congress has to do something in order to keep the regulations from becoming final?
Yup, we're doomed
DC2 is correct. 100% Just tripled checked. Here is a little historical perspective on the Congressional Review Act (CRA) and the resolution of disapproval. Bolded my MOI
"What congressional actions have been taken under the CRA?
Under the CRA, Congress can pass a joint resolution of disapproval relating to a rule. 5 U.S.C. §§ 801(a)(3)(B), 802. Since 1996, 43 resolutions have been introduced in the Senate or House of Representatives and two of those resolutions have passed one house of Congress. Only one rule, the Department of Labor rule on ergonomics (65 Fed. Reg. 68,262), has been disapproved by Congress (see Public Law 107-5)."
Source direct from the GAO: Congressional Review Act (CRA) FAQs
Yes, I see... and again,
I still wonder if the regulations can be overturned in court. Does anyone have an opinion on that? I don't know much about law, but there's a lot in the deeming that just smells fishy to me. I wonder if much of it is even legal. Or if it can be overturned in court on the grounds that it is not reasonably enforceable. Anyone?
However.....
The Agencys draft final rule
would need to be approved by OMB
before being promulgated (with a stated
effective date soon thereafter). This
rulemaking process could potentially
take years.
http://www.khlaw.com/Files/18449_Chowdhury - FDLI Article on Tobacco Deeming Regulation.pdf
... but that's the White House OMB so it should be a layup for the FDA.
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Just saying that if an Article say something is Years away, but the Article is a Year Old, then what the Author thinks will happen is going to happen Sooner that what is in the Article.
BTW - Has "June 2015" popped up in any Threads yet?
https://www.federalregister.gov/art...-food-drug-and-cosmetic-act-as-amended-by-the
Not sure what kind of Time Line the FDA is Holding? Or if this Document is Obsolete.
That 'timing' was incidental - I was responding to DC2's comment. Although it doesn't have to be approved by Congress, it does need approval from OMB - just another agency to contact
No it's not obsolete and there was a more recent 'guess' at 'summer of next year' for the final rule - hence my "prediction"
And if I understand correctly - it is from there that the "24 months" for applications might begin, although that could be earlier for some anticipating.....No it's not obsolete and there was a more recent 'guess' at 'summer of next year' for the final rule - hence my "prediction"
That's Kinda the Timeline I have been Told/Guesstimating.
But one Thing that People Should Never Forget. And that is Once the FDA Rules are Final, the FDA will have the Power to Enforce much of them.
Sure, they can Fiddle Fark around with Hardware Applications. But what Would/Can Stop the FDA from Capping Nicotine Levels to say 18mg once the Rules are Final? Or to Include Face-to-Face Only Sales of ALL e-Liquids?
Nothing much as far as I can see. Once the rule is final that's where the interpretations/implementations (partisan 'tampering') begin. We've seen that in numerous other agencies, going beyond even what Congress authorized - to the point where even sponsors of the bills say - 'That's not what we intended!' .... but nothing is done.
1. How many times have states attorneys general submitted letters to the FDA regarding ecigs? Forty of them did in 2013. Have some changed their minds?
2. I'm also trying to get perspective on how heavily they influence final decisions.
In November of 2013, 29 state AGs asked the FDA to reconsider its approval of a drug called Zohydro ER, a very potent opioid, because of its potential for abuse. (My interest stems from years of working with persons suffering extreme chronic pain and their advocates, who are concerned with the increasing difficulty around access to adequate medication.) The FDA basically ignored it. In Spring of 2014 the governor of Massachusetts banned the drug in his state; it went to court and he lost.
Parallels to e-cig regs are obviously very limited here (we're talking Pharma), but the restrictions suggested in that letter are so over-the-top absurd (like someone else here, I noticed that they're easily read as parodic) that I do wonder how much credibility and clout these guys actually have with the FDA.
Of course to the extent that we're actually just talking big money games, credibility has nothing to do with it. Still - this thing is so nuts that I think the average person in the street who know nothing about ecigs would find it bizarre.
Yeah, I know. Still.
2. I'm also trying to get perspective on how heavily they influence final decisions.
In November of 2013, 29 state AGs asked the FDA to reconsider its approval of a drug called Zohydro ER, a very potent opioid, because of its potential for abuse. (My interest stems from years of working with persons suffering extreme chronic pain and their advocates, who are concerned with the increasing difficulty around access to adequate medication.) The FDA basically ignored it. In Spring of 2014 the governor of Massachusetts banned the drug in his state; it went to court and he lost.
Parallels to e-cig regs are obviously very limited here (we're talking Pharma), but the restrictions suggested in that letter are so over-the-top absurd (like someone else here, I noticed that they're easily read as parodic) that I do wonder how much credibility and clout these guys actually have with the FDA.
Of course to the extent that we're actually just talking big money games, credibility has nothing to do with it. Still - this thing is so nuts that I think the average person in the street who know nothing about ecigs would find it bizarre.
Yeah, I know. Still.
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Wow, I thought congress had to approve. So we have no representation. Or do we just need one friend in congress to submit a bill?
What the AG letter does is say (basically) "we've got your back" i.e. won't challenge regulation / seal of approval. They also embolden states to take similar actions. Zeller is concerned about legal challenges and this was a guarentee he wouldn't get them if deeming went into effect quickly / half written. IMO it's a reference sheet for studies and citations supporting each aligation (sheet as in piece of paper and not waste byproduct).
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Thanks aikanae, that clarifies function.
How about my first question, anyone? Have there been defectors? (Sorry if I should know this, can't remember a discussion.)
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