The Document you posted is 18 Days short of being 2 Years Old. And as I understand it, was sent back to the FDA for Changes.
Do you Have/Know of anything more current?
FDA FDA's leaked guidance for PMTAs confirm deeming reg would ban >99.9% of nicotine vapor products
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The Document you posted is 18 Days short of being 2 Years Old. And as I understand it, was sent back to the FDA for Changes.
Do you Have/Know of anything more current?
You as well as I know that as far as any one knows whatever the official
documentation at the OMB is right now there is no indication it is substantialy
changed from what I linked too.
http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM394914.pdf
Federal Register | Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products
Everything seems to point right back to what we have already seen.
Regards
mike
Au contraire Mr. Mike.
I don't know what changes, be them Significant or Minor, have been made by the FDA? But seeing that it has been 2 Years, it is, perhaps, and Indication that they were Not Minor Tweets.
The unfortunate thing is that we don't have the details of the deeming regs that are in front of OIRA/OMB.
Trust Me Mike, If I knew Exactly what was going on and had Links, the ECF would be the 1st Place I would Post them.
I hear from some people I corresponded with that the FDA is Not going to be as Oppressive as some think. And the weight of Scientific Data has tempered much of their thinking.
And I hear from others that it is going to be a Kick In The Gut with a size 14EE Boot. And will make some of the Doom-n-Gloom predictions that I have seen here Look Optimistic.
About the Only thing that there seems to be any Agreement on is the Max Level of Nicotine (mg/ml) has been a Hotly Contested Issue. But I know of No actual numerical Values.
I predict that the final reg will be nearly exactly the same as the proposed one, and it will use the option exempting premium cigars. Keep in mind that in the proposed regulations, the actual proposal isn't until section VIII, on page 109, and uses up less than 10 pages of the document's total 241 pages. The majority of those 10 pages was used up in explaining the cigar options as well as the various compliance dates. The rest of the document was justifying the rule and asking for comments that will help them justify other things they want to do, like how to apply the definition of a cigarette to vaporizers so they can apply the flavor ban to them.
The past two years have not been spent revising the regs, but in addressing all the comments. Look in the Federal Register when other final regs have been posted. There is a substantial section that addresses all the comments with a response. So, for example, there will be a section for each major comment, like "Many comments mentioned that vaping hasn't killed anyone yet. FDA's response: Not yet, but it might", and "Many commentors mentioned that vaping helped them quit smoking. FDA's response: There is no scientific proof this is true" and "Many comments worried about vaping being a youth gateway to smoking. FDA's response: Based on the on the oh-so-careful and overwhelming science they submitted, we believe them".
When they are criticized for the delay in issuing the rule, they say it's because they are addressing the unprecedented number of comments. We misunderstand mightily when we assume this means they are changing the rule based on the comments. What they actually mean is reading them all and compiling cleverly worded responses dismissing the validity of the opponent's concerns and playing up the nonsense the proponents have submitted.
The past two years have not been spent revising the regs, but in addressing all the comments. Look in the Federal Register when other final regs have been posted. There is a substantial section that addresses all the comments with a response. So, for example, there will be a section for each major comment, like "Many comments mentioned that vaping hasn't killed anyone yet. FDA's response: Not yet, but it might", and "Many commentors mentioned that vaping helped them quit smoking. FDA's response: There is no scientific proof this is true" and "Many comments worried about vaping being a youth gateway to smoking. FDA's response: Based on the on the oh-so-careful and overwhelming science they submitted, we believe them".
When they are criticized for the delay in issuing the rule, they say it's because they are addressing the unprecedented number of comments. We misunderstand mightily when we assume this means they are changing the rule based on the comments. What they actually mean is reading them all and compiling cleverly worded responses dismissing the validity of the opponent's concerns and playing up the nonsense the proponents have submitted.
If we were as influential as premium cigar smokers we might have a chance. Money talks once again here in Ameerica.
AMEN BROTHER! This entire fiasco is and has always been about the money! Health, Children be damned!
Does this mean if congress changes the grandfather date that instead of everything after
the 2007 date there will not be pre-market hurdles so the FDA will directly regulate them
off the market?
Regards
Mike
Considering the FDA's performance, can we really trust them to do otherwise? Is there anything short of disbanding them and reorganizing the activity into an otherwise constructively functional entity that will suffice? They are not concerned about enforcement of the monstrosity of "deeming" regulation as they have no real expectation of achieving conformance. That is evidently not its purpose. Instead, to pose an insurmountable deterrent to the e-cigarette industry leaving it in unprofitable state of disarray and uncertainty as to expire by attrition.
Two pathways I think as CASAA described to either encourage Congress to repeal the objectionable deeming authority extended [to the FDA] under the FSPTCA or it's replacement under alternative legislation specific to the unique class of consumer product comprised by the e-cigarette. This favors the public in the light of day to see accountable elected representatives…do their job.
Frankly, I've never understood how accepting a "grandfather" date is anything more than asking for permission to keep the money you have in your pocket…while throwing future value in the sewer. I'm pleased that the FDA played their cards with such unbridled assurance that business and the public can truly see the face of the enemy. At last we can dispense with the pretense that they are an actor in good faith in our behalf.
Personally, I'd build the wall. Until Congress can demonstrate itself accountable for its encroachment on millions of Americans with their irresponsible legislation, the mission must be repeal. Before this situation gets totally out of control, and it will. Hopefully legal action will yield the necessary hiatus for us all to return to a state of reason and compel this inevitable change at the right time.
You simply can't depend upon a solution that involves collaboration when there was never an intention to afford reciprocity by the FDA. The sooner that the industry and vapers realize this, the sooner we may dispense with the present unlawful bureaucratic dictates.
Were we to build our own vaping industry independent from the omnipresent threat of government intrusion development of rational technical and consumer standards would flourish apace. An evolution by the industry itself is likely to be far superior and effective than anything government could conceive with it's shallow, narrow and biased understanding of what real risks are overall and what is of value to vaping consumers.
Good luck.
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What we need is a whistle blower who will come forward and let the world know what really was being said in those back rooms.
Maybe Snowden has a cousin working for the FDA.
Maybe Snowden has a cousin working for the FDA.
"A network of small, complicated rules. It does not break wills, but softens them. It does not tyrannize, it hinders, represses, stupefies, and finally it reduces each nation to being nothing more than a flock of timid animals, of which the government is the shepherd."
Alexis De Tocqueville - "Democracy In America", 1840
Alexis De Tocqueville - "Democracy In America", 1840
There are multiple online petitions requesting that the US Government speed up human exploration of Mars.
Good luck.
We the Vapers thank you.
I'm going to stop obeying red lights when there are no other cars in sight. If enough people do likewise, they won't be able to stop us.
If nobody pays their fines, what are they gonna do?Good gawd man, don't you know they'll just install cameras! ???
Currently, there's probably no country on earth that won't interfere with vaping. I don't think the US will be the first to get out of the way, but it's the one you and I live in, so I guess we should try here and reassess if no success after 5 years.
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