FDA FDA response to lawsuits.

[Robino1]

Where the NRT angle makes sense is in regards to those nicotine inhalers. Similar delivery mechanism. I don't think those are OTC, however...

I don't see it. They've specifically stated that NRT nicotine products "do not appear to have significant potential for abuse or dependence."

Read the word Dependence. A mild form of addiction.

Nicotine in the rebuttal brief has the FDA stating that Nicotine is one of the Most addictive substances.

 

[TheMike21]

and now we know the mindset of the FDA,, wanna bet they released drugs to kill us via cancers/conditions etc

The government actually poisoned alcohol during prohibition so you never know.

 

[Buckeyevapen]

More science for the FDA to ignore:

Study: Smokers May Reduce Cancer Risk by Vaping - Vaping360

 

[zoiDman]

The person ultimately responsible is Barack Obama. Next down the ladder is the Secretary of the Department of Health and Human Services, Sylvia Mathews, who reports directly to Obama, who has no training or background in science or medicine and who had has never held a real job outside of government:

Edit: You asked about Cardiff, head of the FDA. According to Wikipedia:
"Califf worked very closely with pharmaceutical companies at the Duke clinical trials center "convincing them to do large, expensive, and, for Duke, profitable clinical trials."[10] He was a paid consultant for Merck Sharp & Dohme, Johnson & Johnson, GlaxoSmithKline,AstraZeneca, and Eli Lilly per ProPublica from 2009 to 2013. The largest consulting payment was $87,500 by Johnson & Johnson in 2012, and "most of funds for travel or consulting under $5,000", which has been called "minimal for a physician of his stature".[11] From 2013-2014 he was paid a total of $52,796, the highest amount was $6,450 from Merck Sharp & Dohme, followed by Amgen, F. Hoffmann-La Roche AG, Janssen Pharmaceutica, Daiichi Sankyo, Sanofi-Aventis, Bristol-Myers Squibb and AstraZeneca.[12] He was the Director of Portola Pharmaceuticals, Inc. from July 2012 to January 26, 2015,[11] Advisor of Proventys, Inc., Chairman of the medical advisory board of Regado Biosciences, Inc. and has been member of the medical advisory board since June 2, 2009, and member of the clinical advisory board of Corgentech Inc.[13] Forbes wrote that his close ties to the drug industry were the reason for him not being nominated for the FDA Commissioner position in 2009.[10]"

So if Zeller is working under the Control of the FDA Commissionaire Califf, and if the FDA works under the Oversight of the Health and Human Services Secretary Burwell, and the HHS answers Directly to the President, why does Mr. Zeller seem to be the Individual who gets All the Blame for the Deeming of e-Cigarettes?

I am very found of the say'n... "If something happens at the Circus that You don't like, don't yell at the Clowns. Yell at the Ring Leader."

BTW - I believe that Califf needed to be confirmed by the Senate before he could become the FDA Commissionaire. It was probably a Very Close vote to nominate him given his Questionable Monetary Ties to BP. Bet he just got in by the Skin of his teeth.

 

[DC2]

I see Mr. Zeller's name in media a Lot when it comes to e-Cigarettes. But the name Califf is seldom mentioned. And the name Burwell is virtually Non-Existent.

If you really want to get to the head of the snake, I don't think you stop with Obama.
But that's just my opinion.

 

[zoiDman]

If you really want to get to the head of the snake, I don't think you stop with Obama.
But that's just my opinion.

So what Higher Authority should we be Looking at then the POTUS?

 

[seminolewind]

The first problem in all this is if the FDA was actually well educated as they should be, they should have been able to see that e-cigs are not related to tobacco. If it's an alternative nicotine delivery system, it should be categorized as such. Ecig need to be categorized properly and correctly, which they were not. I resent the fact that BT was permitted to write these new tobacco guidelines and think they can include ecigs as tobacco products. We all know that all of BT and FDA are aware of the fact that ecigs contain no tobacco and can't be regulated as such. What they are doing in my eyes is illegal and think they can make an illegal lie to the entire USA and get away with it. Anyone of them knows the truth. They are not stupid . Just devious with protecting their "cash cow". They should all go to jail for lying to the public. In a sense they are getting away with murder.

 

[seminolewind]

So what Higher Authority should we be Looking at then the POTUS?

The supreme court

 

[zoiDman]

The supreme court

It's kinda a Sham (Oops, I meant "Shame") when the Supreme Court is the Only Check in a system based on Checks and Balances.

Because the Supreme Court hears So Few Cases a Year. And the (IMO) Inevitable outcome of this Presidential Race will effect the Supreme Court for a Very Long Time.

New thinking Leadership in the FDA/HHS in 2020, and a Congress that Actually has a Spine might be a Safer Bet than reliance on Supreme Court to fix Our e-Cigarette Problems.

 

[Buckeyevapen]

The Latest In The Never-Ending Assaults On Our Freedoms. One Of These Is Lethal

Another goodie!!

 

[Endor]

I don't see it. They've specifically stated that NRT nicotine products "do not appear to have significant potential for abuse or dependence."

Read the word Dependence. A mild form of addiction.

Nicotine in the rebuttal brief has the FDA stating that Nicotine is one of the Most addictive substances.

I follow your logic now... indeed something doesn't seem right there, except somehow nicotine is more addictive in vapor products than NRT. FDA "science" thinks so anyway.

 

[bigdancehawk]

Why would the head of the FDA be a person WITHOUT any experience in pharma, clinical trials, or consulting?

I'm curious what kind of back ground is acceptable?


I really am curious what kinds of background you guys think somebody who can become head of the US FDA should have........these are highly educated M.Ds. with quite a lot of immersion in the fields of pharma, clinical trials, research, studies, etc. Of course they are highly paid.....I don't begrudge them their consulting fees. When you pay for that much education, and go to school for 12+ years, then you command consulting fees in the 2 and 3 figure areas.

CEOs of famous companies, and politicians do too. That is what happens when you reach the upper most level of your profession. (2016 is going to be a banner year for the political consulting industry. Through early December, candidates from both parties and their affiliated super PACs have spent more than $160 million on consulting services.)

If your company hires anyone to do executive coaching, it costs about $725 an hour. $500 an hour is considered normal. According to Forbes, "A partner at a small management or IT consulting firm (maximum sales: $10 million) charges $294 per hour on average". Coastal and urban-based consultants can command about 25% more than that. For a large over $10million firm, of course the consultants are going to be paid alot more.

Marshall Goldsmith a well-known Ph.D. mathematician receives $100,000 and up per coaching assignment for a Fortune 500 CEO...McKinsey, Bain and BCG and those kind of firms get much (MUCH) more.

this is normal practice when people are at high educational and experience levels...throughout the corporate, medical, scientific, IT and mathematical world..

This is nothing more than a quote from Wikipedia. These are just facts about the man's career, posted without comment. I assume he was/is a fine cardiologist and I don't believe anybody has suggested he's overpaid. However, it is the FOOD and DRUG administration, so ideally I'd like to see somebody running it with a high level of expertise in human nutrition and/or pharmacology.

 

[bigdancehawk]

How long have NRT patches been on the market? How many studies done on them? About 3 decades.

Vaping has been around for less than 10 years. Can't really compare. At least, not yet.

I assume the FDA knows a lot more about nic patches than it does about vaping? That is how they have come around to changing the sheet on it.

This is all a process, as I have pointed out. I am not happy about it, but I don't actually take it "personally". I am trying to follow and understand the process, and with an open mind, not an angry, cynical pre-conceived one.

So do you agree that the FDA is going to hand over vaping to BT lock stock and barrel, based on what they have said so far? I sure don't see it.

You've completely missed the point. According to the FDA, nicotine in patches and gum doesn't lead to dependency and doesn't produce notably harmful effects; i.e., nicotine without the other chemicals in tobacco and tobacco smoke isn't particularly addictive, if at all. The FDA's approach to nicotine in vaping devices is entirely inconsistent with respect to the matters of nicotine addiction, "gateway effect," dual use, etc.

 

[englishmick]

This is nothing more than a quote from Wikipedia. These are just facts about the man's career, posted without comment. I assume he was/is a find cardiologist and I don't believe anybody has suggested he's overpaid. However, it is the FOOD and DRUG administration, so ideally I'd like to see somebody running it with a high level of expertise in human nutrition and/or pharmacology.

It's a Catch 22 deal. If they have the expertise, then they almost certainly have a financial stake in the outcomes they will be regulating. If not immediately, then in terms of the cushy job they will walk into after they finish their stint on the regulatory side. There may be some people with enough moral fiber not to be sucked into that trap, but I doubt such people get on the train in the first place.

 

[englishmick]

If you really want to get to the head of the snake, I don't think you stop with Obama.
But that's just my opinion.

Mr Bilderberg?

 

[sonicdsl]

If you really want to get to the head of the snake, I don't think you stop with Obama.
But that's just my opinion.

The Syndicate?

 

[Robino1]

The Syndicate?

The way everything is goin.....I wouldn't doubt that.

 

[Buckeyevapen]

So what exactly are the next steps in this process? Do the two sides present their oral arguments to the judge? Does the judge simply read the two briefs and make a decision? Are experts called?

 

[Semiretired]

So what exactly are the next steps in this process? Do the two sides present their oral arguments to the judge? Does the judge simply read the two briefs and make a decision? Are experts called?

I think it is up to the judge to decide at this point. He really is deciding if he wants to hear more - then it would go to trial.

 

[Buckeyevapen]

I think it is up to the judge to decide at this point. He really is deciding if he wants to hear more - then it would go to trial.

Well then, hopefully the brief is written well enough to present the judge with questions to which only moving forward would resolve.