FDA TVECA post table of contents for Deeming Final Rule

[zoiDman]

I've had a lot going on recently, medical issues, the va, so on. I've gone from 3mg to 5mg with the stress.
Haven't had . ..a chance to read up to the 40 pages this is right now, can someone bring me up to speed real quick? Sounds like this has gotten worse....
My income is not going to handle stocking up in the next few weeks, Will I have a chance to? Thanks, hope someone can get me back up to speed on this....
I'm hoping I don't have to go all Ted Kazinski soon...lol Government is pushing too many things too hard the wrong way.... Psychological test to work for the government needs to be revamped. Damn!

The Quick-n-Dirty version is the FDA has Submitted what it would like to be the Finial Version of their Rule Set to the OMB/OIRA.

The OMB/OIRA then has to Review it. They can OK it. Or they can say that Changes need to be made. And many feel that it will take, being that we are in November, about 70 or 120 Days to do so.

So Don't feel like you should Not Pay the DirecTV Bill this Month because you want to Stock up on Nicotine Base/Hardware.

 

[Nuggit]

Ok, point taken. True that we want to know what is in the things that we put in our bodies, and that they are safe. Regulating the Chinese e-liquid from gas stations and such will keep things safer. I admit that, I'm sure folks on ECF will readily agree.
That said, vaping and the desire to stop tobacco is a mental shift toward safety, and paying attention to what is going into ones body. I've seen it. Vapors, rreputable juice vendors, and equipment manufacturers actually are paying attention to safety and purity of product. It's an amazing process that many of us have taken notice of. Without the help of big Gov, big T, and big P. Wow huh. I think the big issue most have here, is that big G, big T, and big P don't do as good a job as this community has done on it's own. I for one have ZERO faith that they even could no matter how hard they tried. And I have NO doubt that getting their hands in the money is a paramount priority. Not our safety. It's their excuse, not their goal. Next problem, is that after they get their hands in it, we will pay out the nose. I believe the issue with supporting products that are FDAhole approved, is cementing their position, and the idea of not getting the product is a way to protest, even if it's a small protest, at least it's something. It's ez to feel powerless in this kind of situation. And Americans don't like having a government upon us. Period. I hope that clarifies the issue for you. If this goes down the way it looks like now, I'll do everything in my power to go around it as much as possible. Bring on the vaping black market. Lets push back against all oppressors, especially if it's a government. Our forefathers would be planning revolution, oh wait, they did, didn't they?

 

[Racehorse]

Lets push back against all oppressors, especially if it's a government.

Last time I left the country I was out, socially, and made a few political comments. Those comments were about the place I was visiting, as they had a local election coming up.

Apparently, the wrong person overheard my comments.

Because a few days later was "called in" by one of the beaurocrats of the smallish place I was visiting (long-term one year), reminded that I was a "guest" in their country, and that my temporary visa could certainly be shortened.

Shortly afterwards, I was called in to "present" my finances, ie. you had to show that you had enough money to continue your stay ---- and then "coincidentally" I had a care package from home rifled thru pretty badly by the local "customs agent" to the point where nothing was salvage-able, although I had to pay duty on the package to even receive it to find that out.

Kinda made me appreciate getting back home, where I can speak freely. Just sayin'..........

 

[Nuggit]

Thanks zoidman, that's what I needed to know. Last post was not aimed at you, it just timed that way. Lol
I was ranting to the point brought up by zabolee. Zabolee, it wasn't aimed at you either, but at the point you brought up. We all need to stick together, now more than ever, but this is a hot issue. I for one get riled by it. I wish it wasn't a "battle" of the people and the government, but it seems that our government has a different perspective of their responsibilities than they should. I'm a former service member, and would serve again in a heartbeat if needed, I love this country, but so did our forefathers, gotta fight for freedom, it's not really free. I should change my name to "ranter" lol

 

[Katya]

Thank you for your service, Nuggit.

 

[Zabolee]

I'm desperately trying not turn this into a political discussion, because I have a feeling we are on very opposite sides of that coin.

I agree that the community can do a lot. And we have. Many toxic ingredients that were once in liquid are no longer used by USA vendors. But I disagree that the gov't is only in it for the money. They do care about the health of people. Democrats, more so. But they are woefully behind in their research, and are trying to make decisions before all of the facts come in. Rutgers U just came out with a study claiming that E-cigs help reduce teen smoking. That should be something brought to the gov't attention.

I'd also like to point out that our community can't regulate ourselves efficiently. I've known for about a year to not trust P4Y. When I was looking to get my first box mod, I knew not to get the IPV3. And I heard tons of people ranting about them, and many saying to not buy their products. That didn't stop the IPV4 and 4s to come out.

I know many people won't like to hear it, but I am willing to lose a few potential products in order to know that what I am using has some standards. By that I mean products that haven't hit the shelves yet.

All that said, I would like the standards to be set to more modern equipment. Why go back to the stone age of vaping when I've been successfully and safely using temp control for over a year?

 

[Mikedin]

Just saw this tooNew CDC Data Blows Away Popular E-Cigarette Criticism

 

[Mikedin]

And who would have seen this coming in Malaysia the other day the ecig shops are raided , now they hike analog prices 40 percent

Cigarette prices up 40% tomorrow, industry shocked by drastic move - The Malaysian Insider

 

[Mikedin]

I just did mine here's a link for others to leave their testimonial on how vaping has helped improve your life and quit smoking Submission Form | CASAA Testimonials

 

[snork]

So the doc went from the FDA to the OMB and "somehow" TVECA got a hold of it. IF they "gained access" - from WHOM did they gain that???

It's seems like instead of attacking their 'enemy', they should do an internal audit to find the 'leaker'. That's where the real crime is - disseminating confidential information. The press gets that type of stuff all the time, without consequence (exceptions noted).

In the full text of her letter, it *seems* that's what she's complaining about. Of course that doesn't mitigate the fact that the rules are being withheld from the public in the first place.
Murray Calls on HHS Inspector General to Investigate Potential Leak of Confidential Information on E-Cigarette Regulations | The U.S. Senate Committee on Health, Education, Labor & Pensions

 

[skoony]

Can any one of us really admit that knowing what is in our products is a bad thing?

Many of us here do know whats in our e-juice because either some make it themselves
and the rest of us have been paying attention.

True that we want to know what is in the things that we put in our bodies, and that they are safe. Regulating the Chinese e-liquid from gas stations and such will keep things safer.

So far there is no credible evidence that anyone's e-juice is in fact harming any other wise healthy
individual. There have been some potential issues involving Chinese e-juice but, even the ethylene glycol
found was way below toxic levels and wouldn't have harmed anyone. Any one that thinks China was the only
source of these issues is mistaken. PEG 400.

Regards
Mike

 

[SeniorBoy]

I have a question about the OMB review procedure. I'm a bit embarrassed that I never thought of this issue before so please humor me. I've watched the OMB centric vid and listened to the Podcast by the Greek Geek /lol with Bill G. and the attorney. Both make mention of the role of the OMB as a "ombudsman" and the cost and benefits issue. I understand that. I get it.

My question concerns actually verifying the actions of the OMB in this regard. Where can I find documents or articles on the Web from independent sources which tell me that the OMB actually performed these beneficial actions with a regulatory agency? Links please? Yes I understand that their is some back and forth but I would prefer to see proof that the OMB actually helps consumers and businesses from independent sources? Perhaps this actually resolves around the "transparency" issue but at this point I'm not sure?

Thanks in advance!

 

[Nuggit]

Thank you, Katya, it was my pleasure.
Skoony, I was just agreeing to a common point, I'm sorry I put Chinese, gas station e-juice in the middle of it.
Scathing message sent to Murry regarding gov transparency.
What a mess. I have noticed that when shark attacks are preavalent on the news, our gov is trying to pull something on us. Weird.

 

[Kent C]

Where can I find documents or articles on the Web from independent sources which tell me that the OMB actually performed these beneficial actions with a regulatory agency?

That might be a tough one to get - these people don't admit mistakes and transparency isn't held at a high standard, even though the PR says it does. Here's something:

Oversight of the Office of Information and Regulatory Affairs | Testimony

Detailed but worth it, imo:
http://object.cato.org/sites/cato.org/files/serials/files/regulation/2013/6/regulation-v36n2-4.pdf

"Consumer savings | Consistent with economic theory, the
guiding presidential executive order governing regulation
states that “agencies should promulgate only such regulations
as are … made necessary by compelling public need, such as
material failures of private markets to protect or improve the
health and safety of the public, the environment, or the wellbeing
of the American people.”

This philosophy recognizes that private markets are generally
efficient at providing for the health and welfare of the public, and
that regulatory intervention is appropriate only when private
markets demonstrably fail. Yet recent RIAs [Regulatory Impact Assessments]
derive significant benefits not from correcting market failures, but from allegedly saving
businesses or consumers money by constraining their choices."


This last - "saving money" by basically taking ecigs off the market would be considered a plus and as we know, won't save money for those who return to or continue to smoke (or never know about ecigs) because the ecig industry is severely regulated or banned.

"In principle, a benefit-cost analysis should be “complete.” It
should include all the significant consequences of a policy decision:
direct and indirect, intended and unintended, beneficial and
harmful. In practice, all such analyses must to some degree fall
short of completeness. The problem with the methods described
here is that agencies do not appear to be approaching the problem
objectively.

On the benefit side of the equation, they quantify
or list every conceivable good thing that they can attribute to a
decision to issue new regulations, while on the cost side they only
consider the most obvious direct and intended costs of complying
with the regulation. Thus, in setting stringent utility emissions
standards, the EPA dismisses risks associated with reduced
electric reliability, the competitiveness of the U.S. economy in
international trade, or the eff ect that higher electricity prices
will have on the family budget."

also interesting:
OIRA Watch

 

[SeniorBoy]

That might be a tough one to get - these people don't admit mistakes and transparency isn't held at a high standard, even though the PR says it does. Here's something:

Oversight of the Office of Information and Regulatory Affairs | Testimony

Detailed but worth it, imo:
http://object.cato.org/sites/cato.org/files/serials/files/regulation/2013/6/regulation-v36n2-4.pdf

"Consumer savings | Consistent with economic theory, the
guiding presidential executive order governing regulation
states that “agencies should promulgate only such regulations
as are … made necessary by compelling public need, such as
material failures of private markets to protect or improve the
health and safety of the public, the environment, or the wellbeing
of the American people.”

This philosophy recognizes that private markets are generally
efficient at providing for the health and welfare of the public, and
that regulatory intervention is appropriate only when private
markets demonstrably fail. Yet recent RIAs [Regulatory Impact Assessments]
derive significant benefits not from correcting market failures, but from allegedly saving
businesses or consumers money by constraining their choices."


This last - "saving money" by basically taking ecigs off the market would be considered a plus and as we know, won't save money for those who return to or continue to smoke (or never know about ecigs) because the ecig industry is severely regulated or banned.

"In principle, a benefit-cost analysis should be “complete.” It
should include all the significant consequences of a policy decision:
direct and indirect, intended and unintended, beneficial and
harmful. In practice, all such analyses must to some degree fall
short of completeness. The problem with the methods described
here is that agencies do not appear to be approaching the problem
objectively.

On the benefit side of the equation, they quantify
or list every conceivable good thing that they can attribute to a
decision to issue new regulations, while on the cost side they only
consider the most obvious direct and intended costs of complying
with the regulation. Thus, in setting stringent utility emissions
standards, the EPA dismisses risks associated with reduced
electric reliability, the competitiveness of the U.S. economy in
international trade, or the eff ect that higher electricity prices
will have on the family budget."

also interesting:
OIRA Watch

Great work Kent and thanks so much. This helps. I need to absorb what you posted.

I did find the following which is actually a "flip" in some respects and IMHO, makes for some interesting reading:

“It’s OMB once again protecting corporate bottom lines at the expense of protection for public health,” said Plunkett. “Testing is critical to verification. I don’t think a preventive food safety system can be effective without it. Unfortunately, OMB bean counting of the wrong costs results in a less effective prevention program and ultimately continuing food safety problems.”

Source: Documents Show OMB Weakened FDA’s Food Safety Rules

 

[MacTechVpr]

That might be a tough one to get - these people don't admit mistakes and transparency isn't held at a high standard, even though the PR says it does. Here's something:

Oversight of the Office of Information and Regulatory Affairs | Testimony

Detailed but worth it, imo:
http://object.cato.org/sites/cato.org/files/serials/files/regulation/2013/6/regulation-v36n2-4.pdf

"Consumer savings | Consistent with economic theory, the
guiding presidential executive order governing regulation
states that “agencies should promulgate only such regulations
as are … made necessary by compelling public need, such as
material failures of private markets to protect or improve the
health and safety of the public, the environment, or the wellbeing
of the American people.”

This philosophy recognizes that private markets are generally
efficient at providing for the health and welfare of the public, and
that regulatory intervention is appropriate only when private
markets demonstrably fail. Yet recent RIAs [Regulatory Impact Assessments]
derive significant benefits not from correcting market failures, but from allegedly saving
businesses or consumers money by constraining their choices."


This last - "saving money" by basically taking ecigs off the market would be considered a plus and as we know, won't save money for those who return to or continue to smoke (or never know about ecigs) because the ecig industry is severely regulated or banned.

"In principle, a benefit-cost analysis should be “complete.” It
should include all the significant consequences of a policy decision:
direct and indirect, intended and unintended, beneficial and
harmful. In practice, all such analyses must to some degree fall
short of completeness. The problem with the methods described
here is that agencies do not appear to be approaching the problem
objectively.

On the benefit side of the equation, they quantify
or list every conceivable good thing that they can attribute to a
decision to issue new regulations, while on the cost side they only
consider the most obvious direct and intended costs of complying
with the regulation. Thus, in setting stringent utility emissions
standards, the EPA dismisses risks associated with reduced
electric reliability, the competitiveness of the U.S. economy in
international trade, or the eff ect that higher electricity prices
will have on the family budget."

also interesting:
OIRA Watch

CATO nails it. Demonstrably beneficial and necessary. Anything beyond this is theft. Well done K and thx.

Good luck all.

 

[Kent C]

Great work Kent and thanks so much. This helps. I need to absorb what you posted.

I did find the following which is actually a "flip" in some respects and IMHO, makes for some interesting reading:

“It’s OMB once again protecting corporate bottom lines at the expense of protection for public health,” said Plunkett. “Testing is critical to verification. I don’t think a preventive food safety system can be effective without it. Unfortunately, OMB bean counting of the wrong costs results in a less effective prevention program and ultimately continuing food safety problems.”

Source: Documents Show OMB Weakened FDA’s Food Safety Rules

Found this interesting as well.

"OMB also added a year to the date by which farms would have to comply with the new rule. According to the documents, FDA had proposed allowing very small businesses three years to comply with the rule, small businesses two years and all other companies one year. During its review, OMB changed the time allowed for compliance to four years for very small businesses, three years for small businesses and two years for all other farms."

Whether that will be applied to ecigs is another question :- )

Few other things - Cass Sunstein was the OMB tsar before leaving in 2012? Howard Shelanski is now tsar - Berkeley grad.... guessing not much has changed. Still 'nudging' us toward their view of 'acceptable behavior'.

"Cost-Benefit Analysis" should be changed to "cost-AND-unintended consequences-benefit analysis" - just to emphasize the point - which in the reality of regulations in all spheres appears to be the biggest downside - from limiting choice for consumers, businesses and ruining the economy, and in some instances creating black markets where the 'solution' becomes a bigger than the original problem - I give you drugs for just one example. Billions toward DEA and other agencies as well as prisons - the effect of prison population to the general public when released - certain prejudices fostered in prison for basic survival, go to the streets and into the general population, where before those prejudices were isolated in really extreme, but small groups. (made larger than they are by the media).

 

[skoony]

Somehow I get the impression that the way all these Federal Agencies and the
over sight organisations they inter act with have the rules structured in such
a way as to find any and all the loop holes necessary to achieve their goals.
Pssst. Don't mention the chillin´.
Regards
Mike

 

[Wow1420]

Have I gotten this right? The current read on the proposed regulations now includes a real possibility that no-nicotine liquids will be deemed a tobacco product and regulated as well?

My brain explodes at the idea.

 

[zoiDman]

Have I gotten this right? The current read on the proposed regulations now includes a real possibility that no-nicotine liquids will be deemed a tobacco product and regulated as well?

My brain explodes at the idea.

If it Isn't Marketed/Advertised as an e-Cigarette, or Part of an e-Cigarette, or Included in a "Kit" that contains an e-Cigarette or and e-Liquid that Contains Nicotine, I don't see how the FDA can Regulate a Non-Nicotine Product.