Can anyone give me cliffnotes on when the FDA thing goes down and what is going to happen when it does?
thanks
thanks
FDA cliff notes on fda?
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There are people on this forum who could do a better job, but I'll take a stab at it:
It will be over a year before it goes into effect. It has not been finalized. Unless it is changed or ruled unlawful by the courts, most if not all existing and future e-cigarette products will have to undergo a very costly approval process. This includes e-juice, cig-alikes, mods, tanks, RDAs, RTAs, etc. There will almost certainly be litigation in the federal courts challenging the regulations.
The approval process will be so costly that very few companies will be able to afford it. Thus, the entire U.S. market will probably end up being controlled by Big tobacco and one or two other players. The FDA has not established any performance or other objective standards. Until and unless they do, applying for approval will be an expensive game of craps. It is unlikely that any objective standards will be adopted in the near future. Among other possibilities based on "concerns" expressed by FDA officials, flavors that might appeal to children could be prohibited, nicotine strength could be restricted, and electrical output could be limited.
The proposed regulations permit manufacturers of products which were being marketed as of Feb. 15, 2007, to be "grandfathered," which means they would not be required to undergo a rigorous approval process. However, I know of no product now on the market which existed on or before that date. John Boehner, Speaker of the House, Kevin McCarthy, Majority Leader, and Fred Upton, Chairman of the Energy & Commerce Committee, have written a letter to the FDA asking that the date be moved to either April 2014 or the date the final rule is published.
Questions?
It will be over a year before it goes into effect. It has not been finalized. Unless it is changed or ruled unlawful by the courts, most if not all existing and future e-cigarette products will have to undergo a very costly approval process. This includes e-juice, cig-alikes, mods, tanks, RDAs, RTAs, etc. There will almost certainly be litigation in the federal courts challenging the regulations.
The approval process will be so costly that very few companies will be able to afford it. Thus, the entire U.S. market will probably end up being controlled by Big tobacco and one or two other players. The FDA has not established any performance or other objective standards. Until and unless they do, applying for approval will be an expensive game of craps. It is unlikely that any objective standards will be adopted in the near future. Among other possibilities based on "concerns" expressed by FDA officials, flavors that might appeal to children could be prohibited, nicotine strength could be restricted, and electrical output could be limited.
The proposed regulations permit manufacturers of products which were being marketed as of Feb. 15, 2007, to be "grandfathered," which means they would not be required to undergo a rigorous approval process. However, I know of no product now on the market which existed on or before that date. John Boehner, Speaker of the House, Kevin McCarthy, Majority Leader, and Fred Upton, Chairman of the Energy & Commerce Committee, have written a letter to the FDA asking that the date be moved to either April 2014 or the date the final rule is published.
Questions?
Cliff Notes:
Lord MacBeth (The FDA) Has declared that all e-cigs must die, because Lady MacBeth (CDC, ACS, etc.) has been constantly harping on the Lord, primarily because her concubinus's (Big Pharma) have refused to offer her more $love unless she do their bidding.
King Lear (Several US Senators) have told the FDA to back off.
Romeo and Juliet (us vapers) are star-crossed lovers; we've found something we love, but suspect that it will not end well for us.
I had a Midsummer Night's Dream that it all worked out well in the end. Then I woke up.
Lord MacBeth (The FDA) Has declared that all e-cigs must die, because Lady MacBeth (CDC, ACS, etc.) has been constantly harping on the Lord, primarily because her concubinus's (Big Pharma) have refused to offer her more $love unless she do their bidding.
King Lear (Several US Senators) have told the FDA to back off.
Romeo and Juliet (us vapers) are star-crossed lovers; we've found something we love, but suspect that it will not end well for us.
I had a Midsummer Night's Dream that it all worked out well in the end. Then I woke up.
- Apr 2, 2009
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bigdancehawk wrote:
The FDA cannot establish standards for e-cigs unless/until the FDA first issues the Final Rule for the deeming regulation (which would ban nearly all e-cigs now on the market). That's why FDA hasn't established any standards for cigarettes or smokeless tobacco yet (even though the FDA has had the legal authority to do so since 2009).
If/when FDA proposes/imposes standards for e-cigs, the expensive game of craps will become even more expensive (for the half dozen tobacco companies that will be making all of the FDA approved e-cigs).
The FDA cannot establish standards for e-cigs unless/until the FDA first issues the Final Rule for the deeming regulation (which would ban nearly all e-cigs now on the market). That's why FDA hasn't established any standards for cigarettes or smokeless tobacco yet (even though the FDA has had the legal authority to do so since 2009).
If/when FDA proposes/imposes standards for e-cigs, the expensive game of craps will become even more expensive (for the half dozen tobacco companies that will be making all of the FDA approved e-cigs).
Thanks
Do you think hardware (apv's, mods, clearomizers, rba's, etc)and accessories will just end up being sold as not for "nicotine/e juice" just like ....b0ngs are sold as "water pipes" at head shops? Or will that stuff just vanish from the internet all together?
I know nicotine is going to end up being hard to get but I'm set on that.
Yes, it will be wildly expensive, but one would think that the outcome should be less unpredictable.
This will be something for the courts to decide. There is a good argument to be made that the statute which allows the FDA to regulate these products only gives them authority to regulate products which actually contain nicotine derived from the tobacco plant. The statute gives the FDA authority to regulate "tobacco products," defined as: "any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)."
This definition is seriously flawed for several reasons, including the fact that it includes the very term it is trying to define. So is a Provari or a drip tip a "component, part or accessory of a tobacco product"? The FDA seems to think so. I don't think the courts will agree. However, I'm not a federal judge.
Zeller stated that if the nicotine is not derived from tobacco the FDA has no way to regulate e-cigarettes in a question and answer session right after the deeming regulations were dropped.
It is their worst nightmare as at that point they would have to go to Congress to get authorization to regulate it as the courts have said it can't be regulated as a drug.
(good luck with that)
If nothing else we would have an a good while to get studies together and tobacco control could be told to go fly a kite.
Zeller stated that if the nicotine is not derived from tobacco the FDA has no way to regulate e-cigarettes in a question and answer session right after the deeming regulations were dropped.
It is their worst nightmare as at that point they would have to go to Congress to get authorization to regulate it as the courts have said it can't be regulated as a drug.
(good luck with that)
If nothing else we would have an a good while to get studies together and tobacco control could be told to go fly a kite.
Yep, but at present it's not economically feasible to derive nicotine from other plants or to synthesize it.
I would bet that with $2.5 billion and climbing in sales that someone in this technologically advanced field is working hard on this now.
The Cliff Notes version depends on many different factors, and whom you choose to believe.
Unfortunately, understanding each factor requires more than Cliff Notes.
As for myself, I have over 10 years worth of nicotine in the freezer.
And when I see what the writing on the wall says AFTER the regulations are finalized, I may choose to stock up on the equipment.
Unfortunately, understanding each factor requires more than Cliff Notes.
As for myself, I have over 10 years worth of nicotine in the freezer.
And when I see what the writing on the wall says AFTER the regulations are finalized, I may choose to stock up on the equipment.
Cliff Notes:
1) Genie gets out of the bottle circa 2003
2) FDA tries really hard to put genie back in bottle circa 2009
3) Courts say - not so fast FDA, you have no such authority.
4) Hell hath no fury like the FDA scorned, er I mean FDA seeks to gain authority by deeming eCigs tobacco, taking 1001 nights to come up with a proposal
Okay, so that's old news.
5) FDA thing goes down when FDA feels it understands Genie and finds way to coax Genie to jump back into bottle. FDA leans heavily on ANTZ studies to get a grasp on things. To me, this means another 1001 nights before FDA deems eCigs tobacco in an official way.
6) Republicans, God bless them, will likely intervene in some fashion to limit FDA's authority, and to allow Genie to roam more freely.
7) FDA likely presses ahead as best it can, cause hell hath no fury like....
8) FDA comes up with Final Rule circa 2017, which by this time Genie is so pervasive the Final Rule will be passe. Though some (Democrat leaning) local/state jurisdictions likely find ways to control Genie but with limited authority.
9) Courts weigh in again on all the ridiculous overreaching of authority, FDA likely gets scorned again
10) Between actions of GOP, BT, BV, courts and underground market, Genie realizes He will be alive and well for about 500 or so years. So circa 2525, Genie will go back into His bottle and the great great great great great granddaughter of the last remaining ANTZ will, on that day, declare victory.
1) Genie gets out of the bottle circa 2003
2) FDA tries really hard to put genie back in bottle circa 2009
3) Courts say - not so fast FDA, you have no such authority.
4) Hell hath no fury like the FDA scorned, er I mean FDA seeks to gain authority by deeming eCigs tobacco, taking 1001 nights to come up with a proposal
Okay, so that's old news.
5) FDA thing goes down when FDA feels it understands Genie and finds way to coax Genie to jump back into bottle. FDA leans heavily on ANTZ studies to get a grasp on things. To me, this means another 1001 nights before FDA deems eCigs tobacco in an official way.
6) Republicans, God bless them, will likely intervene in some fashion to limit FDA's authority, and to allow Genie to roam more freely.
7) FDA likely presses ahead as best it can, cause hell hath no fury like....
8) FDA comes up with Final Rule circa 2017, which by this time Genie is so pervasive the Final Rule will be passe. Though some (Democrat leaning) local/state jurisdictions likely find ways to control Genie but with limited authority.
9) Courts weigh in again on all the ridiculous overreaching of authority, FDA likely gets scorned again
10) Between actions of GOP, BT, BV, courts and underground market, Genie realizes He will be alive and well for about 500 or so years. So circa 2525, Genie will go back into His bottle and the great great great great great granddaughter of the last remaining ANTZ will, on that day, declare victory.
yes all juice 0 nic or not and all hardware associated with vaping.
a cigarette is a derivative of tobacco.
our juice and gear are derivatives of a cigarette a tobacco product.
head shop gear gear can be used for tobacco hence are considered
like tobacco pipes which where not regulated by the FDA even though
the FDA has the authority to do so. i forgot the reasoning behind that.
regards
mike
Zeller stated that if the nicotine is not derived from tobacco the FDA has no way to regulate e-cigarettes in a question and answer session right after the deeming regulations were dropped.
It is their worst nightmare as at that point they would have to go to Congress to get authorization to regulate it as the courts have said it can't be regulated as a drug.
(good luck with that)
If nothing else we would have an a good while to get studies together and tobacco control could be told to go fly a kite.
Zeller is wrong or is lying.
nicotine obtained from any source will be deemed a derivative
of tobacco as it is a component of a tobacco product.
Derivative Synonyms, Derivative Antonyms | Thesaurus.com
as you can see the use of the word derivative allows the FDA
to do pretty much as they please.
regards
mike
I think Zeller knows that trying to say nicotine derived other than tobacco will be a big loser for them. Hence, his repeated call for FDA needing to come up with a "comprehensive nicotine policy". He states that this policy will allow him to regulate "along a continuum of risk", but it's really a red herring. The so-far undefined comprehensive policy will be designed to bring all nicotine under his control regardless of source.
they don't have to.
the word derivative covers that.
nicotine is in tobacco ergo nicotine from
any source or substitute there of can and
probably will be deemed a tobacco product.
synonyms of derivative include:copy or substitute.
regards
mike
Sorry, I think you are wrong this is the kind of thing that gets tied up in courts for decades and the FDA knows it. With their record on court cases involving this they don't want to go there.
I only use 1ml per day of 12mg liquid, so a 500ml bottle of 100mg will last me 10 years.My freezer's full of frozen food. Please buy another 10 years worth and store it for me.
But I might get a second bottle so I have a nice buffer.
i am not sorry. the FDA will use my definition to ensnare the entire
market.
there is no getting around the derivative wording.
regards
mike
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