Deeming Regulations have been released!!!!

[skoony]

But who were the one(s) Paying that 300B?

This is the 64 dollar question. Between the ages of 40-60 generally these cost
are paid by individuals and their insurance plans. After 60 more and more of
the costs start shifting to the public sector. Today and into the future more of
the costs will be picked up by the public sector as the pool of decent paying jobs
shrinks and those qualified and trained to do them also shrinks.(hint we do not need
more people with BA degree's)

How the actual costs breakdown is uncertain. Some claim most is paid by the
individuals and their insurers well into their retirements. This probably still holds
true today but will not be in the foreseeable future as private retirement plans are
changed,modified or simply run into the ground or simply not offered in the first place.
One must also take into consideration so called incidental cost's such as lost wages,
which can be quantified and lost production,which can't. If Ford needs 5000 Focuses,
Ford will make 5000 Focuses.

Generally when the State or Federal governments cite costs as an expense in certain
area's such as Health,Education and,Welfare they are referring to all cost's from private
and public sources. NHE in 2014 was 3 trillion dollars.(17% of GNP) 300 billion reportedly
for smoking related illness. You can already see a discrepancy. Smokers are only incurring
10% cost to the total health care expenditures or they are paying 90% of the cost on their
own. 1.1 trillion in Medicaid and Medicare costs.Roughly 1 trillion paid by households.
17% from state,local,and other agencies.
So the short answer is,who knows.
NHE Fact Sheet - Centers for Medicare & Medicaid Services

Regards
Mike

 

[KODIAK (TM)]

I really hope some lawyer ties up a Judges time for weeks Explaining the over complicated and absolutely ridiculousness of Product inclusion and Cross regulation to assure - vaping - NOT tobacco, OR Nicotine - Is appropriate for FDA Regulation.

Let's not forget that back in 2010 when the FDA was seizing our stuff at customs the judicial process recommended vaping products be classified as tobacco.

 

[herb]

There is clearly no experienced Psychiatrist's or Neurologists in this discussion or they would of immediately corrected the extremely ignorant and ridiculous statement about ADD and ADHD being just normal childhood behavior .

It's a very real condition and effects every aspect of ones life in a very negative way. The only thing true is that many kids do show these types of behavior and are misdiagnosed as having ADD or ADHD when they do not have it.

But it is a legit condition and brain scans of people with and without it clearly show it.

Sorry for the derailment and this is the only thing i wanted to clear up . If somebody wants to argue about it contact me via PM not in this thread.

 

[skoony]

Let's not forget that back in 2010 when the FDA was seizing our stuff at customs the judicial process recommended vaping products be classified as tobacco.

This has been a source of confusion to me. The judge did say that if the FDA wanted to
regulate e-cigs they could do it as a tobacco product. Which are legal consumer goods
and, the FDA had the authority to regulate tobacco products. Where I get a disconnect
is why do some interpret this to mean she ordered the FDA to do so or,gave tacit
consent for them to do so.

I am under the assumption she was just pointing out that e-cigs were clearly not
medical devices and tobacco was the closest thing the FDA had to assert its
regulatory authority over.

One wonders when considering how the deeming regulations were written if the
FDA is giving the Judge the proverbial finger or taking her advice to literal extremes.

Regards
Mike

 

[zoiDman]

This is the 64 dollar question. Between the ages of 40-60 generally these cost
are paid by individuals and their insurance plans. After 60 more and more of
the costs start shifting to the public sector. Today and into the future more of
the costs will be picked up by the public sector as the pool of decent paying jobs
shrinks and those qualified and trained to do them also shrinks.(hint we do not need
more people with BA degree's)

How the actual costs breakdown is uncertain. Some claim most is paid by the
individuals and their insurers well into their retirements. This probably still holds
true today but will not be in the foreseeable future as private retirement plans are
changed,modified or simply run into the ground or simply not offered in the first place.
One must also take into consideration so called incidental cost's such as lost wages,
which can be quantified and lost production,which can't. If Ford needs 5000 Focuses,
Ford will make 5000 Focuses.

Generally when the State or Federal governments cite costs as an expense in certain
area's such as Health,Education and,Welfare they are referring to all cost's from private
and public sources. NHE in 2014 was 3 trillion dollars.(17% of GNP) 300 billion reportedly
for smoking related illness. You can already see a discrepancy. Smokers are only incurring
10% cost to the total health care expenditures or they are paying 90% of the cost on their
own. 1.1 trillion in Medicaid and Medicare costs.Roughly 1 trillion paid by households.
17% from state,local,and other agencies.
So the short answer is,who knows.
NHE Fact Sheet - Centers for Medicare & Medicaid Services

Regards
Mike

And this is Why sometimes citing a Single numerical statistic Doesn't always tell the whole story.

 

[HazyShades]

So a man walks into a bar, orders a non alcoholic beer and bag of peanuts and bar tender asks for his ID to check age. Does this happen in bars? Is a non alcoholic beer really alcohol because it is sold in a bar and are peanuts alcohol because they are used or sold in a bar? Should we do away with flavored drinks because they attract children? Peachy and pineapple drinks with little umbrellas most kids would like more than a straight shot of whiskey for instance. It is just so crazy! Edit just trying to apply FDA logic to vaping and there is no logic!

Of course there's logic involved..money logic.
if P>Q=$
Seriously though, I was hoping this was a joke when I read the first sentence.
And it is a joke, nothing the gub'min ever does is either logical or funny.
It's a bad joke.

My old lady's grandson overdosed on some bipolar meds prescribed for
his mother's brother because they look and taste just like M&M's.
He was out for hours and had to have his 5 year old tummy pumped.

Not funny. But I bet the pharmaceutical company's lobbyists
paid much money to the FDA...

 

[bnrkwest]

Just Curious.

But who were the one(s) Paying that 300B?

They didn't specify but about half of that was loss do to second hand smoke illness and loss of work etc. I did find another source article in Reuters, that said $170 billion in yearly smoking related illness was the cost and 6o% of that cost is paid for by US Gov't, Medicare, Medicaid, VA, etc programs. So smoking does cost the gov't quite a bit annually. If they only make 8.5 billion thru tobacco tax it just does not make tobacco profitable.

 

[crxess]

Most governments do rely on it, especially state governments in the US. Tobacco taxes, combined with MSA money from the tobacco companies, amount to a large chunk of revenue. Many contend this is why several states that have borderline deficit budgets (like California) are so against vaping, even to the point of running primetime ads like the California DPH "Stop Blowing Smoke" ads.... there has to be a "man behind the curtain" that justifies that spend.

At what Additional COST to the people of Cali.? Planning/Advertising Expense, Hours Creating/Promoting Bills and cost in Getting bills passed plus cost of indefinite enforcement, Job Loss and increased unemployment as well as sustained HIGHER Health cost.

Those laws were introduced by republicans, and passed by republicans. AFAIK, it is one of the most draconian laws in the entire U.S., at least it was when it passed.

Exactly and Proof it is As much Individual as Party.......NJ for instance, a One Man show on dictatorship. Judge/Jury and Executioners all in one.

Let's not forget that back in 2010 when the FDA was seizing our stuff at customs the judicial process recommended vaping products be classified as tobacco.

Where I get a disconnect
is why do some interpret this to mean she ordered the FDA to do so or,gave tacit
consent for them to do so.

Exactly - A recommendation, NOT based on judicial research at the Time. Merely the possibility of another avenue to pursue.

* As to health Cost vs Tax intake, let us NOT Forget Australia - Senator Thanks Smokers for their TAX Contributions!
Politician THANKS Australians for smoking in extraordinary speech

 

[ZeroedIn]

Well I tried to find actual same years costs, revenue but not sure I did. Tax page said in 2010 Fed brought in 8.5 billion in tobacco revenue, but CDC says it costs $300 billion yearly in health care for tobacco illnesses. If that is true, the revenue from tobacco tax is no where close to cost treating tobacco illness. So anyone with a brain would see that a lower tax on harm prevention products would be much more Fed $'s long term because the drain on health care would not be so great. It's basic economics

Since when has Washington been able to balance a checkbook?

 

[zoiDman]

They didn't specify but about half of that was loss do to second hand smoke illness and loss of work etc. I did find another source article in Reuters, that said $170 billion in yearly smoking related illness was the cost and 6o% of that cost is paid for by US Gov't, Medicare, Medicaid, VA, etc programs. So smoking does cost the gov't quite a bit annually. If they only make 8.5 billion thru tobacco tax it just does not make tobacco profitable.

Oh I am sure that Smoking does cost the system More than e-Cigarettes. Just not sure what are Good Numbers to quantify it with?

---

I worked at a Company a Long Time ago when the Extra Insurance Premiums for Tobacco Use things was just starting to hit. I remember this Insurance rep was giving her presentation to the Owner/VP/Department Heads as to why we should go with her company.

She used that Smoker's incur more sick days than Non-Smokers rational. So Look at all the Money we wouldn't be Paying out for Sick Days. The Owner and VP kind nodded in agreement and the Insurance Rep got a Big Smile.

But then I stopped her and mentioned that we were going to do that Pay-Out anyway. She looked Confused. And the Owner/VP were like "Say What?".

I Explained that it didn't matter if an Employee was Sick or Not. Because they were going to use their Sick Days by the End of the calendar year No Matter what. So saying we were going to Somehow save money on Sick Days was kinda Misleading.

Don't think the Rep Liked me much after that.

LOL

 

[KODIAK (TM)]

I am under the assumption she was just pointing out that e-cigs were clearly not
medical devices and tobacco was the closest thing the FDA had to assert its regulatory authority over.

Exactly - A recommendation, NOT based on judicial research at the Time. Merely the possibility of another avenue to pursue

A recommendation I think the FDA will beat like a drum during litigation. Over and over. I certainly would.

 

[bnrkwest]

They didn't specify but about half of that was loss do to second hand smoke illness and loss of work etc. I did find another source article in Reuters, that said $170 billion in yearly smoking related illness was the cost and 6o% of that cost is paid for by US Gov't, Medicare, Medicaid, VA, etc programs. So smoking does cost the gov't quite a bit annually. If they only make 8.5 billion thru tobacco tax it just does not make tobacco profitable.

Found a source at tax foundation.org
That says after the tax hike in 2009 tobacco revenue doubled to over $17 billion, but has since declined as more people quit, so for 2015 the revenue was down to around $13 billion? or so, and projected revenue is a decline for every year. But even $17 billion tax revenue compared to $170 billion health care costs, 60% paid by gov't, it is just bad business. Tobacco is a drain on our gov't coffers.

 

[ZeroedIn]

One wonders when considering how the deeming regulations were written if the
FDA is giving the Judge the proverbial finger or taking her advice to literal extremes.

Regards
Mike

...a little of both?

 

[VNeil]

Found a source at tax foundation.org
That says after the tax hike in 2009 tobacco revenue doubled to over $17 billion, but has since declined as more people quit, so for 2015 the revenue was down to around $13 billion? or so, and projected revenue is a decline for every year. But even $17 billion tax revenue compared to $170 billion health care costs, 60% paid by gov't, it is just bad business. Tobacco is a drain on our gov't coffers.

Or perhaps the govt does not believe their claimed smoking cost numbers??????

I've seen credible assessments suggesting smoking is an overall medical cost savings due to shortened lifespans requiring less very long term old age care for things like Alzheimer's. So not being facetious here.

And besides,. I see no reason to believe govt smoking cost estimates after studying all the lies and egregious distortions coming out of govt funded vape "research"

 

[wiredlove]

This has been a source of confusion to me. The judge did say that if the FDA wanted to
regulate e-cigs they could do it as a tobacco product. Which are legal consumer goods
and, the FDA had the authority to regulate tobacco products. Where I get a disconnect
is why do some interpret this to mean she ordered the FDA to do so or,gave tacit
consent for them to do so.

I am under the assumption she was just pointing out that e-cigs were clearly not
medical devices and tobacco was the closest thing the FDA had to assert its
regulatory authority over.

One wonders when considering how the deeming regulations were written if the
FDA is giving the Judge the proverbial finger or taking her advice to literal extremes.

Regards
Mike

From the 32 page brief from Judge Leon. Worth a read just for the verbal smackdown they got in 2010:

"Furthernore, now that FDA has regulatory power over electronic cigarettes through the Tobacco Act, any harm to the public interest or to third parties caused by an injunction that merely forbids FDA from regulating electronic cigarettes as a drug-device combination is greatly diminished.

<snipped>

CONCLUSION This case appears to be yet another example of FDA's aggressive efforts to regulate recreational tobacco products as drugs or devices under the FDCA. Ironically, notwithstanding that Congress has now taken the unprecedented step of granting FDA jurisdiction over those products, FDA remains undeterred. Unfortunately, its tenacious drive to maximize its regulatory power has resulted in its advocacy of an interpretation of the relevant law that I find, at first blush, to be unreasonable and unacceptable. I am mindful, however, that the purpose of preliminary injunctive relief is merely "preventative, or protective; it seeks to maintain the status quo pending a final determination of the merits of the suit." "

https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-54

Also of interest, just because of historical reason(s) and the flip-flopping of the ANTZ:

Judge Leon’s decision was not popular with tobacco prohibitionists. Matt Myers, president of the Campaign for Tobacco-Free Kids, seethed: “"Nicotine in products currently regulated as drugs and devices is derived from tobacco products, but that doesn't make them tobacco products.” The federal court, thankfully, found otherwise.

According to the New York Times, Myers was a primary author of the Tobacco Act. His goal was to cast the regulatory net widely and subject all tobacco-related products to FDA control. It is therefore ironic that the court has interpreted his legislation to free a potentially broad array of recreational nicotine products from the most stringent categories of regulation.

Tobacco Truth: Federal Judge to FDA: E-Cigarettes Are Tobacco Products, Not Drugs or Devices

 

[Lessifer]

From the 32 page brief from Judge Leon. Worth a read just for the verbal smackdown they got in 2010:



https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-54

Also of interest, just because of historical reason(s) and the flip-flopping of the ANTZ:



Tobacco Truth: Federal Judge to FDA: E-Cigarettes Are Tobacco Products, Not Drugs or Devices

I think it's a bit of a toss up as to which category is more stringent at this point. In terms of products that actually receive approval, pharma wins hands down. Not that want vaping classified as pharma.

 

[bnrkwest]

Or perhaps the govt does not believe their claimed smoking cost numbers??????

I've seen credible assessments suggesting smoking is an overall medical cost savings due to shortened lifespans requiring less very long term old age care for things like Alzheimer's. So not being facetious here.

And besides,. I see no reason to believe govt smoking cost estimates after studying all the lies and egregious distortions coming out of govt funded vape "research"

I checked out alcohol tax revenue compared to health cost and oh my way worse than tobacco! Why FDA is wasting their time on vaping, a tobacco risk reduction product when they could focus on more important issues is beyond me! They money they are wasting on this deeming issue and law enforcement to enforce it is so ridiculous someone needs to make a movie on it, a comedy of course where is Michael Moore LOL!

 

[ZeroedIn]

Or perhaps the govt does not believe their claimed smoking cost numbers??????

I've seen credible assessments suggesting smoking is an overall medical cost savings due to shortened lifespans requiring less very long term old age care for things like Alzheimer's. So not being facetious here.

And besides,. I see no reason to believe govt smoking cost estimates after studying all the lies and egregious distortions coming out of govt funded vape "research"

Is there an Actuary in the house..., anyone....Bueller?

 

[wiredlove]

I think it's a bit of a toss up as to which category is more stringent at this point. In terms of products that actually receive approval, pharma wins hands down. Not that want vaping classified as pharma.

The point being, at the time, Judge Leon was merely stating that Congress had conferred possible regulatory power via the TCA, not that they should, but they could - and even so, they were continuing to press forward with the case against them. If you read the whole thing, you will find that they probably irritated him, it is certainly within the subtext of his response.

Even more boldly, FDA also argues that its import decisions are committed to agency discretion and thus are not subject to any judicial review. Judicial review is not permitted under the AP A where "agency action is committed to agency discretion by law." 5 U.S.C. § 701(a)(2). FDA contends that the authority to refuse imports is committed to its discretion by 21 U.S.C. § 381(a)(3), which authorizes FDA to refuse admission of a drug or device if it "appears" from examination or "otherwise" that the drug or device is "adulterated, misbranded, or in violation of section 355." For FDA, Congress's use of the term "appears" is dispositive. By authorizing FDA to refuse admission to any product that "appears" misbranded or adulterated, "Congress empowered the agency to exercise its discretion in a broad and flexible manner." (FDA Opposition [#14] at 29). FDA's argument goes much too far. Agency action is committed to agency discretion by law only where "the statute is drawn so that a court would have no meaningful standard against which to judge the agency's exercise of discretion." Heckler v. Chaney, 470 U.S. 821, 830 (1985) (emphasis added).

[emphasis added by me] same document, just maintaining the citations
https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-54

 

[skoony]

Found a source at tax foundation.org
That says after the tax hike in 2009 tobacco revenue doubled to over $17 billion, but has since declined as more people quit, so for 2015 the revenue was down to around $13 billion? or so, and projected revenue is a decline for every year. But even $17 billion tax revenue compared to $170 billion health care costs, 60% paid by gov't, it is just bad business. Tobacco is a drain on our gov't coffers.

That's still only 5.6% of the total health care expenditure of 3 trillion dollars Americans paid in
2014. Half of these estimates are bogus because the long term studies are showing second
hand smoke is not the health risk we have been led to believe. By the time one reaches 65
the smoking rate is 10% or less of the adult population half of which will not get a smoking
related illness if the governments own figures are to be believed. Smoking rates have declined
by over 50% since the 1960's. Where is the health cost savings? Even if you include the
second hand smoke there should be significant quantifiable cost savings. Fewer smokers,
less second hand exposure.

I am not saying smoking is with out risk. I am saying the risk has been blasted way
out of proportion to reality. Having lived for 60 years when I look back on it all the
figures do not add up. There appears to be a whole lot of sick people and not enough
smokers to account for them all.

Regards
Mike