Deeming Regulations have been released!!!!
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Good analogy!
Good luck.p.s. And watch that syrupy stuff. Could be harmful to your health.
Agreed. Either make sensible regs for everything or ban it all. Any other choice looks deceptive and gives room for conspiracy. Don't just reg one out of existence behind the kinda bs propaganda we've been seeing / hearing like this is for the benefit of "public health".
I think most everyone besides smokers who really enjoy smoking can agree that I'd rather keep an unknown danger around versus something that is definitely killing me like ciggerettes were.
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In my previous post I talked about the Two Click Rule but my post could have been much better. Call that a Senior Moment please. Azim is one smart cookie.
Extract from an attorney tiled "Current FDA Appears Not to Follow FDA’s Informal Two-Click Policy":
"During the Bush Administration, FDA had an unwritten and informal enforcement policy that allowed a website selling dietary supplements to link to scientific literature discussing nutrients in those supplements and diseases, provided that the page containing the scientific literature was at least “two clicks” away from product pages in question. That Bush era policy appears not to be followed in the Obama FDA. Under Commissioner Hamburg, FDA has not directly or indirectly explained its position on the informal enforcement policy, but it appears to us that the FDA no longer adheres to it. Enforcement action appears to occur against parties who attempt to rely on the two click separation without regard to the former, informal position of the agency."
Source
Extract from an attorney tiled "Current FDA Appears Not to Follow FDA’s Informal Two-Click Policy":
"During the Bush Administration, FDA had an unwritten and informal enforcement policy that allowed a website selling dietary supplements to link to scientific literature discussing nutrients in those supplements and diseases, provided that the page containing the scientific literature was at least “two clicks” away from product pages in question. That Bush era policy appears not to be followed in the Obama FDA. Under Commissioner Hamburg, FDA has not directly or indirectly explained its position on the informal enforcement policy, but it appears to us that the FDA no longer adheres to it. Enforcement action appears to occur against parties who attempt to rely on the two click separation without regard to the former, informal position of the agency."
Source
This shows how far the ANTZ is willing to go.......SMH
The Rest of the Story: Tobacco News Analysis and Commentary: IN MY VIEW: American Lung Association Would Rather Smokers Die than Save their Lives "the Wrong Way"
The Rest of the Story: Tobacco News Analysis and Commentary: IN MY VIEW: American Lung Association Would Rather Smokers Die than Save their Lives "the Wrong Way"
Just ordered an I VOTE I VAPE bumper sticker and a couple of more from Cafe Press. Gotta spread the word.
Maybe a 'contribution' to his personal pension fund ?
Maybe there's a pre-dated, already approved PMTA in a drawer somewhere ...
Careful now, fifth ace showing usually causes some irritation at the table ...
I got a little confused because he was talking about 0nic and synthetic/non-tobacco nic. So, until someone proves otherwise, I'm going to assume they will regulate 0nic if sold by someone who also sells vape gear, etc. unless they are challenged in court.
This is exactly correct and once again a (Supposedly) Good rule put in place to protect against such things as Pornographic access to minors Being Perverted to Block Access to Legal Advocacy Groups or hold Groups with legitimate Health Concerns Criminally Liable for Fraudulent advertising due to membership.
Yet, ALC and ALA are Free to Promote False Propaganda and out right LIES(proven) Directed Against the improvement of Public health.
Meanwhile through Lobbying, and possibly back room dealing, Pockets are filled................ for an opposing Vote.
They can, by their Associative ruling Regulate it Regardless of attempt of venue change. Reasonably presumed to be used for Vaping, and would be placed in a device Deemed to be a Tobacco Product to do so.
I Honestly, I do not understand why the SBA is not hauling them in front of someone that can Force them to comply and Answer allegations.
Has anyone of us written to the SBA?
Right, I meant it would need to be sold as something else, like a food additive, by someone with absolutely no ties to vaping. So you could sell a pg/vg/flavoring mix but it would have to have no ties to vaping whatsoever.They can, by their Associative ruling Regulate it Regardless of attempt of venue change. Reasonably presumed to be used for Vaping, and would be placed in a device Deemed to be a Tobacco Product to do so.
I don't remember seeing this letter before, but I spent a lot of time reading through it today. I know it is almost 2 years old and the FDA ignored a lot of the comments sent in response to the (proposed, at that time) deeming, but still, my shorts became twisted reading it.
They apparently feel they are above the rules set in place for them, how did they even pull this off? I wonder if they changed anything before it went to OMB, or if the OMB even LOOKED at the thing before they said, um, ok?
From page 24:
Since the enactment of the proposed rule would have a substantial impact on business, consumers and the economy, it is what the Office of Management and Budget defines as a “significant” regulation. This means that the FDA is required to perform a regulatory impact analysis (RIA) under the guidelines set out under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).
Under these provisions the FDA must not only determine if the regulation is necessary but must assess all costs and benefits of available regulatory alternatives to select approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). It also requires the FDA to among other things analyze regulatory options that would minimize any significant impact of a rule on small entities.
From pages 27 and 28:
"According to the Office of Management and Budget, there are 16 key elements that every Regulatory Impact Analysis needs to address.......In addition to these 16 items, a proper RIA must examine a number of additional impacts including international effects and the effects on small businesses."
"Simply put, the RIA performed by the FDA staff for the proposed rule is significantly lacking in respect to the provisions outlined by the OMB. .......the analysis of the effect on small businesses was so inadequate as to encourage the Small Business Administration to offer its assistance to the FDA in completely redrafting the RIA. Looking just at the provisions outlined by the OMB, the RIA fails to perform 14 of the 16 checklist items."
I don't know why these particular details struck me harder than the rest of them, but I'm glad to know that SFATA has these experts working with/for them. Sorry for the long post, thanks for listening. I have been following the thread since day one and will continue to follow, but this makes me so angry!
I
RIA Checklist
Includes:
- Does the RIA use an appropriate baseline (i.e., best assessment of how the world would look in the absence of the proposed action)?
- Is the information in the RIA based on the best reasonably obtainable scientific, technical, and economic information and is it presented in an accurate, clear, complete, and unbiased manner?
- Are the data, sources, and methods used in the RIA provided to the public on the Internet so that a qualified person can reproduce the analysis?
- To the extent feasible, does the RIA quantify and monetize the anticipated benefits from the regulatory action?
I use distilled water in my DIY. Can they deem distilled water as a tobacco product? Or is it enough that one could show that something has other uses as well?They can, by their Associative ruling Regulate it Regardless of attempt of venue change. Reasonably presumed to be used for Vaping, and would be placed in a device Deemed to be a Tobacco Product to do so.
If it is sold at a vape shop then yes. If there is any reason to suspect it will be used in e liquid, it is a "tobacco product"....
Edit : Can you imagine the 5000 hour rigorous test that they'll need to perform on distilled water.
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They Are.......De Facto
When one places an Ambiguous Requirement(PMTA) to accomplish an Impossible Goal(Approval) pending a Purely Subjective Decision to Validate, regardless of effort to comply and Validity of Compliance, that in and of itself is a Ban.
FDA - Center for Tobacco Products
Set in place through a Back room regulatory coalition of Government and Tobacco officials to Appease Public outcry and Protect Tobacco Business as usual.
Start with:
Tobacco Master Settlement Agreement - Wikipedia, the free encyclopedia
Fast forward to 2009(?)Pharma....... Ah, a possible new Product for Profit - Nicotine Vaporizers for Smoking Cessation..............
Quotes compliments of CASAA:
E-cigarette History
End Profitability for Big Pharma.
Regulatory Advancement of e-cigarette Control is sidelined................
A new plan must be put into place if a portion of profit is expected from E-cigarettes........ Perhaps tobacco Control.
Did Tobacco control really Jump on this as a Viable Control project?
This is where I disagree with just about everyone in the Industry.
I do not believe<At that time> the FDA was poised to do anything with the E-cigarette Market and had already dealt with Big pharma concerns(for profits)
FDA is just one more Over Rated Wheel in a poorly maintained Government Machine.
Over the Next Several Years, LIES over the Tobacco Settlement start to be Exposed, As Highly Financed Health Lobbiest build Exposure Campaigns - still going today. Tons of money to be made supporting the people in need...
Nice Cover:
Broken Promises to Our Children
My Theory!
To Be Continued:
Those aren't "good" reasons, like I was asking, but I'm aware that there probably aren't any, and your ideas here, sound very plausible and VERY disturbing.Maybe a 'contribution' to his personal pension fund ?
Maybe there's a pre-dated, already approved PMTA in a drawer somewhere ...
Careful now, fifth ace showing usually causes some irritation at the table ...
The little they do spend on what they try to justify as smoking prevention, seems to go mostly for deceitful anti-Tobacco Harm Reduction propaganda.
I found it:
Economic Impact Analyses of FDA Regulations
The Food and Drug Administration conducts economic analyses of all important proposed and final regulations. Each economic analysis includes an assessment of the costs, benefits, and cost-effectiveness of the action, as well as assessments of the costs, benefits and cost-effectiveness of the most promising alternative actions. The full economic impact analyses of significant FDA regulations are no longer (as of April 2012) published in the Federal Register but are available on this site.
Regulatory Impact Analysis
Deeming Tobacco Products to be Subject to the Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations Restricting the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Product Packages and Advertisements (Final Rule) (PDF - 1,173KB)
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM500254.pdf
ETA: I've only just skimmed the report, but I have a feeling the FDA will use it as a response to Sen Johnson's letter.
Economic Impact Analyses of FDA Regulations
The Food and Drug Administration conducts economic analyses of all important proposed and final regulations. Each economic analysis includes an assessment of the costs, benefits, and cost-effectiveness of the action, as well as assessments of the costs, benefits and cost-effectiveness of the most promising alternative actions. The full economic impact analyses of significant FDA regulations are no longer (as of April 2012) published in the Federal Register but are available on this site.
Regulatory Impact Analysis
Deeming Tobacco Products to be Subject to the Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations Restricting the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Product Packages and Advertisements (Final Rule) (PDF - 1,173KB)
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM500254.pdf
ETA: I've only just skimmed the report, but I have a feeling the FDA will use it as a response to Sen Johnson's letter.
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