FDA issues Brief Summary of “Not Substantially Equivalent” Determinations delineating why deeming reg would ban all e-cigs

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aikanae1

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OMB's two biggest concerns are probably preventing the Justice Dept from losing another lawsuit filed against FDA, and preventing Obama's approval ratings from further declining below their all time low of 39% this week.

As such, OMB may not allow FDA to propose the deeming reg.

I was referring to this comment. The FDA appears to be self-inclusive and independently run, not dependant of who is in the whitehouse - unless they were so inclined to dismantle it and I haven't heard anyone say the FDA was on the radar for that. Heck, they can't even touch wall street regulation and that IS on the radar. I get tired of hearing FAUX bs.
 

Exhaler

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I was referring to this comment. The FDA appears to be self-inclusive and independently run, not dependant of who is in the whitehouse - unless they were so inclined to dismantle it and I haven't heard anyone say the FDA was on the radar for that. Heck, they can't even touch wall street regulation and that IS on the radar. I get tired of hearing FAUX bs.

The FDA is looking out for everybody's health and probably is fairly independent, but they still work for the administration and political appointees. They do good things for us, it is true, but I just am too darn independent for anyone to tell me what I can or cannot eat, drink or smoke. Let them issue their advisories and warnings and let ME decide if I want to heed them or not as I sit here vaping, eating salty chips and drinking a Monster.

What they have done with testing prescription drugs is also a very good service they provide, so while some of us want to pounce on them about regulations on ecigs, they have done many very beneficial things.
 

DC2

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The FDA appears to be self-inclusive and independently run, not dependant of who is in the whitehouse
Not at all.

The FDA is run by presidential appointees.
And like all government agencies, they are usually changed out when a new president is elected.

Not only are they not independent, they are the very definition of partisan.
 

aikanae1

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The FDA is looking out for everybody's health and probably is fairly independent, but they still work for the administration and political appointees. They do good things for us, it is true, but I just am too darn independent for anyone to tell me what I can or cannot eat, drink or smoke. Let them issue their advisories and warnings and let ME decide if I want to heed them or not as I sit here vaping, eating salty chips and drinking a Monster.

What they have done with testing prescription drugs is also a very good service they provide, so while some of us want to pounce on them about regulations on ecigs, they have done many very beneficial things.

I wish. The FDA has been mired in scandals, particularly it's prescribtion oversight, for decades. My original focus has been watching them attempt to control vitamins (nutrional suppliments), advertising campaigns that they aren't good for us, don't know what's in them, all because some pharmecetical companies prefer the money in their pockets. It was this way before Bush. Changing presidents hasn't affected the FDA anymore than it's caused any change in the Treasury dept.

I'm sure not everything the FDA is bad, but it's a good idea to do your own research in professional literature before making a decision. Chantix is a bad drug and there are multiple reasons for it to be taken off the market. Yet many doctor's still consider it first line for smoking cessation and are not aware of the recent class action settlement largely because most of their information comes from industry supported information (common). That doesn't sound very healthy to me. Chances are that's similiar to the information that Congress gets. So who's really in charge?

 

DC2

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DC2, do you know if the director of the Center for Tobacco Products (Zeller) is a political appointee?
Given that the head of the FDA is always a Presidential political appointee, then yes he is.

Here is me, trying to find links other than the wikipedia link provided earlier...
http://tobaccoanalysis.blogspot.com/2013/02/pharmaceutical-consultant-appointed-to.html
In my view, this is an inappropriate appointment because it creates an unacceptable conflict of interest, thus mixing corporate politics with science and federal regulatory policy. This is precisely the type of appointment that President Obama promised to avoid when he stated in his first inauguration speech that it was time to take politics out of science.

Washington D.C. has become a virtual revolving door between corporate lobbyists/consultants and politicians/policy makers. This revolving door was what President Obama stated he would close in order to reduce corporate influence in the capital.

Now, however, we have an extreme example of conflict of interest and corporate influence. A pharmaceutical consultant is taking over a center of the very agency which regulates pharmaceuticals!

All other links I am finding just call him an appointee without mentioning who appointed him.
But I will admit to only looking at the first page of Google results.
:)
 

aikanae1

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I looked at your links. But history says that there isn't any change even if they are appointed. Laws and regulations may say a lot of things, but what counts is how they are applied. There's a good chance that the appointment was made from a short list and any kind of drastic change would have resulted in the appointment being stalled in congress.

For the most part, Obama has carried out all of Bush policies, Bush followed most of Clinton's, and so on. They attempted to get some oversight back into the financial market and that was turned into a battle. Anytime the status quo is challenged, it's a battle. For the most part, the president is a figure head when it comes to these industry-run agencies.
 

drtwain5

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It is an issue of taxation (easy revenue for easy wasting), fanaticism, and quite frankly, imbecility. There is no doubt that views against nic are pervasively purulent. Even though nic is a naturally occurring pesticide, found at relatively high levels in tobacco (~ 50 mg/g - therein its evolutionary success) and low levels in other veggies such as eggplant (~100 ng/g), EU-wide bans spearheaded by ideologues have gained support. Big pharma has managed approval as replacement therapy, and if regulators have their way, vaping will become as expensive as a single nic inhaler (~$250 in the US currently for 10 mg dose). As considered previously, this is death to vaping by a thousand cuts.
 

aikanae1

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One of the problems is that vaping is challenged by the BT industry. For too many years, BT claimed cig's were not harmeful while they altered cigarettes to be more addictive. They also pioneered the development of funding phoney "grass roots" groups (I remember those mailings). Now when people stand up for vaping and ecigs, many ASSUME vapers are another front group funded by BT and attempting to do what they tried 20 years ago. It's hard to create a enough seperation of the past so that they will listen with fresh ears.

And sure enough, in a interview in NYT, one of the ecig makers (NJoy?) made a comment about experiments to make their product more appealing and addictive. It was pretty discouraging.

The PACT act eliminated the RYO market for one reason; states said that was a "loophole" to get out of taxes. Over 4,000 business' went belly up overnight and few said a thing. I think over 85% of the price of a pack of cigs are taxes.

There's a number of consumer groups that are mad because tobacco settlment taxes are not being put to use the way the original agreements implied. Instead they are ending up in general funds, going to education and programs like CHIP. That is dangerous policy. It pits the states AGAINST seeing smokers quit via any means. States need to rethink their reliance on tobacco taxes if they are serious about public health. There are a number of websites tracking where the money is really going.

FDA may be setting about to issue deeming, however cities and states still will have carte blanch to issue any regulation they see fitting. They can do that now and after whatever deeming has in store. They can also use our tax money to fund grants to anti-smoking groups that want to ban ecigs. So we do have to raise our voices and make our case - loudly and proudly.
 
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Cool_Breeze

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Another player/beneficiary of the tobacco tax circumstance are some bond holders. Some of the governments that were to benefit from the taxes, sold off the rights as bonds. While I won't presume who may be the holders of such bonds, but note that there may be influences outside of government, and the pharmaceutical and tobacco industries.
 

Petrodus

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FDA_Monkeys_zps71542455.jpg
 

salemgold

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The FDA is looking out for everybody's health and probably is fairly independent, but they still work for the administration and political appointees. They do good things for us, it is true, but I just am too darn independent for anyone to tell me what I can or cannot eat, drink or smoke. Let them issue their advisories and warnings and let ME decide if I want to heed them or not as I sit here vaping, eating salty chips and drinking a Monster.

What they have done with testing prescription drugs is also a very good service they provide, so while some of us want to pounce on them about regulations on ecigs, they have done many very beneficial things.


Have you seen any of the commercials on TV lately about all of these "FDA Approved" meds and the lawsuits from the harm that many of them are doing? :confused:

It's all about the money. Not our health.
 

Petrodus

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Have you seen any of the commercials on TV lately about all of these "FDA Approved" meds and the lawsuits from the harm that many of them are doing? :confused:
It's all about the money. Not our health.
Every drug that has been recalled by the FDA
was first proven to be "safe and effective" by the FDA.
:laugh:
 

Orb Skewer

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Every drug that has been recalled by the FDA
was first proven to be "safe and effective" by the FDA.
:laugh:

So, if they get it wrong, they get it right next time (with sometimes life changing and catastrophic collateral damage in between)
Why not get it right the first time FDA?
Vaping is 'orders of magnitude safer than smoking'

 
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