Deeming Regulations have been released!!!!

DaveP

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Here is the problem Anna, as we are moving as a nation toward socialised medicine, we are also moving toward government interference into anything we do which may or may not affect our health. When it's government which is most affected in a cost benefit analysis of smoking, then it's government who will need (yes, need) to enforce actions of the individual which will not be a drain on the system, otherwise the system will go broke.

When we invite government into our doctors examination rooms because we don't want to pay for the visit, we inadvertently invite them into our private decisions that can affect our health. It's simple logic.

I switched to Medicare about a year and a half ago. MC doesn't ask any questions about tobacco use. When I bought my supplemental policy for part B the agent asked me a series of questions, one of which was, "Have you smoked cigarettes in the last 6 months?". The honest answer to that was no.

People are living longer. I remember reading an article about government concerns with the costs of Medicare when it was first rolled out. They toyed around with different ages for eligibility and finally chose 65. Some European countries had higher ages that pushed the average life span of citizens.
 

Rossum

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JMO.

But I believe that the FDA had 2 Statements ready for Release. 2 Statements about the same Change in Policy. But differing depending of How Judge Jackson Ruled.

By Judge Jackson ruling that the FDA has the Authority under the TCA to Regulate e-Cigarettes, and by Deferring to their "Expert and Reasonable Judgment", this Allowed the FDA to Implement a revised tobacco Strategy.

If Judge Jackson had ruled in Our Favor on the Major Points, the FDA would have done the Same Thing, only by Judicial order. Which would have incurred Less possible Fallout.
Have you considered the possibility that Judge Jackson's ruling was no surprise to the FDA; that she ruled the way she did after being given assurances that that the new leadership would take a more relaxed approach to these regulations?
 

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I switched to Medicare about a year and a half ago. MC doesn't ask any questions about tobacco use. When I bought my supplemental policy for part B the agent asked me a series of questions, one of which was, "Have you smoked cigarettes in the last 6 months?". The honest answer to that was no.

People are living longer. I remember reading an article about government concerns with the costs of Medicare when it was first rolled out. They toyed around with different ages for eligibility and finally chose 65. Some European countries had higher ages that pushed the average life span of citizens.

No, they won't (and don't) ask about tobacco use but if your disabled they have full access to your medical records, and periodically all your records go up for review. If you deny access to the government of your medical records you will be denied benefits, as they use this to ascertain your disability. So for anyone on disability, they know whether or not you smoke, and whether smoking is a health issue for you and to what extent it is - and or whether it caused your disability to begin with.

I know that with Medicaid, they provide much end of life care and cancer care for those of lesser means, and again, I'm sure they have access to people's medical records, especially when paying for end of life and cancer care, and can largely determine if issues were created from smoking to begin with.

Also, with the VA, government again has full and unfettered access to medical records of individuals.

I think the case might be different (as far as needing access to medical records) in the elderly, although there may be some level of smoking related illness information relayed to the government even then, although that might be less individual and more private (just bulk information)..

But with disability, Medicaid and VA patients, they know exactly what they are spending due to smoking related illnesses.
 

Eskie

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Have you considered the possibility that Judge Jackson's ruling was no surprise to the FDA; that she ruled the way she did after being given assurances that that the new leadership would take a more relaxed approach to these regulations?

No. Federal judges are appointed for life. The only way to remove them from office is by impeachment,, just like the President, in the House of Representatives and the Senate. Not real common. As such, outside of their pre-office voting record which is reviewed at the time of their confirmation hearings, they are set up specifically to avoid political manipulation. Now that's how it's supposed to work, and I won't say every single judge follows that, but among Federal judges, I'm pretty confident that sort of collusion won't happen. Besides, it was a really well thought out decision that certainly wasn't worked out on the back of a napkin. She put real thought into it, whether you agree or disagree with her findings.
 

ENAUD

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Die hard smokers get thrown under the bus yet again, reduced nicotine cigs are just going to make them smoke more, trying to satisfy that craving, thereby increasing the harm they get exposed to through smoking.

If such a huge turn in direction can occur because of a few key positions, the opposite could also occur at some future point.

If at some point the leadership decided that they want to eliminate nicotine usage altogether, they will have the authority to regulate it so...by reducing nicotine concentrations allowed in electronic delivery methods. I don't trust the FDA, I've been screwed over by them via the orphan drug laws, in particular, colchicine, which went from an extremely inexpensive medication, to an approved product that overnight became unaffordable.

Vapor products should be removed from the tobacco classification, and regulated as an entirely new and novel adult consumer good product category.
 

Eskie

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No, they won't (and don't) ask about tobacco use but if your disabled they have full access to your medical records, and periodically all your records go up for review. If you deny access to the government of your medical records you will be denied benefits, as they use this to ascertain your disability. So for anyone on disability, they know whether or not you smoke, and whether smoking is a health issue for you and to what extent it is - and or whether it caused your disability to begin with.

I know that with Medicaid, they provide much end of life care and cancer care for those of lesser means, and again, I'm sure they have access to people's medical records, especially when paying for end of life and cancer care, and can largely determine if issues were created from smoking to begin with.

Also, with the VA, government again has full and unfettered access to medical records of individuals.

I think the case might be different (as far as needing access to medical records) in the elderly, although there may be some level of smoking related illness information relayed to the government even then, although that might be less individual and more private (just bulk information)..

But with disability, Medicaid and VA patients, they know exactly what they are spending due to smoking related illnesses.

While Medicare, disability Medicare (same plan, different standards to receive that are not age based), Medicaid, and even the VA do have data on the smoking history of those covered, none of those are allowed to charge more or offer different benefits for a smoker than a non-smoker. They're actually a great source of anonymized data extracted for statistical analysis not just regarding smoking, but tracking other illnesses and even determining what outcomes are most successful for a given condition with a given treatment.
 

zoiDman

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Have you considered the possibility that Judge Jackson's ruling was no surprise to the FDA; that she ruled the way she did after being given assurances that that the new leadership would take a more relaxed approach to these regulations?

A Big Surprise to the FDA? Probably Not... I think it was most likely Expected. But perhaps not in Totality.

That the Judge Jackson in some way had Improper Contact with the FDA? And that Her Decision was in some way Influenced by Assurances by the FDA or some another Government Party?

No. No I Do Not.
 

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While Medicare, disability Medicare (same plan, different standards to receive that are not age based), Medicaid, and even the VA do have data on the smoking history of those covered, none of those are allowed to charge more or offer different benefits for a smoker than a non-smoker. They're actually a great source of anonymized data extracted for statistical analysis not just regarding smoking, but tracking other illnesses and even determining what outcomes are most successful for a given condition with a given treatment.

Very much agree..
 

Bronze

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What is the status of the "no new products after 8/16", is that still in effect?
Are they going to enforce the ban on these products?
Is the requirement to register products by this November still in effect?
According to the article posted this morning there still is no green light on resuming new products but as stated in the article they don't know what enforcement policies would be in place if at all.
 

puffon

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    According to the article posted this morning there still is no green light on resuming new products but as stated in the article they don't know what enforcement policies would be in place if at all.
    This has to be a nightmare for honest vendors/US manufactures.
     

    Shawn Hoefer

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    What is the status of the "no new products after 8/16", is that still in effect?
    Are they going to enforce the ban on these products?
    Is the requirement to register products by this November still in effect?
    According to the press release I read, the FDA feels that things should be considered "business as usual." The only part of the deeming that was changed, however, was the registration deadline. There is still a ban on new items (post 8/8/2016), no free samples, labeling requirements, child proof bottles, etc.

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    leftyandsparky

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    Rossum

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    No. Federal judges are appointed for life. The only way to remove them from office is by impeachment,, just like the President, in the House of Representatives and the Senate. Not real common. As such, outside of their pre-office voting record which is reviewed at the time of their confirmation hearings, they are set up specifically to avoid political manipulation. Now that's how it's supposed to work, and I won't say every single judge follows that, but among Federal judges, I'm pretty confident that sort of collusion won't happen.
    Whereas I'm pretty confident that sort of thing has happened in certain other federal cases.

    That doesn't mean that I believe it did happen in this case, but I'm not going to rule out the possibility either, and it would explain some of the timing.

    No. No I Do Not.
    Wow; boldface. That's unusual for you. :)
     

    Rossum

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    This has to be a nightmare for honest vendors/US manufactures.
    I don't think so. US vendors & manufacturers were on death row, with execution scheduled for 2018. They just got a four year reprieve. Why would they consider than a nightmare?
     

    Shawn Hoefer

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    I don't think so. US vendors & manufacturers were on death row, with execution scheduled for 2018. They just got a four year reprieve. Why would they consider than a nightmare?
    Watching China pour new products into the marketplace while they're either stifled or forced to outsource.

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    puffon

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    I don't think so. US vendors & manufacturers were on death row, with execution scheduled for 2018. They just got a four year reprieve. Why would they consider than a nightmare?
    Right, but they are not supposed to produce and sell any product not on the market before 8/16
    Even the US vendors are in violation selling China products produced after 8/8/16.
     
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