FDA Zeller Actually Lets the Truth Slip Out - Let's Pay Attention

[Freedombadeaux]

Contact Tom




I do not like this guy! Like adults are not allowed to like sweet things. And since when do kids own credit cards?? Why didn't they show mods? Kids can't afford them, nor do they have access to them!


Here's his other page...https://www.facebook.com/senatorharkin

 

[Bobbilly]

Mr. Zeller is between a rock and a hard place. The facts concerning vaping do not matter in this struggle, he is a pawn that is being pushed from both sides from Congress, big business, and the public. I do not defend him by saying that, but there is nothing in this world that would convince me to be in his shoes.

He's put himself in there. If he truly followed science he'd have less problems. Where we don't know find out.

 

[Freedombadeaux]

https://www.facebook.com/tomharkin?filter=2

 

[zoiDman]

Mr. Zeller is between a rock and a hard place. The facts concerning vaping do not matter in this struggle, he is a pawn that is being pushed from both sides from Congress, big business, and the public. I do not defend him by saying that, but there is nothing in this world that would convince me to be in his shoes.

I definitely Agree with your 1st Sentence.

He is in a Tight Space. But I Don't so much agree with the Second Sentence. It is why I Like and have Respect for Mr. Zeller.

Because I DO Think that the Facts Matter to Him. And I DO Think that he sees that e-Cigarettes Do have a Huge Benefit to those Seeking Harm Reduction from Combustible Tobacco.

I also Think that he is a Realist.

And knows that No Matter what Age Requirement Restrictions are Placed on e-Cigarettes, that Minors are still going to Use Them. Just Like Minors are Using Cigarettes Today.

The Big Problem is He Can't Come Out and Say this. Because All it would do is Give the "Save the Children" Litany more Credence. So he Has to Walk a Very Fine Line.

He Also Isn't Even the Head of the FDA. And sometimes people who do Not have the Final Say in a Decision/Policy will Except that they Can't Have All of what they Want. So it is Better to Except some of what they Don't Want to Get Some of what they Do Want.

I think in the Big Scheme of Things, have Mr. Zeller where he is Much More of a Good Thing than a Bad Thing. Because Face It. e-Cigarette Regulations are Going to Happen. And we Aren't going to like them.

The Question should be...

Would it be Worse if some like Dr. McAfee from the CDC was in Mr. Zeller's Shoes?

or

Or what if someone like Harkin was?

 

[zoiDman]

Contact Tom




I do not like this guy! Like adults are not allowed to like sweet things. And since when do kids own credit cards?? Why didn't they show Mods? Kids can't afford them, nor do they have access to them!

I would like to Meeting Harkin and be able to Ask him what his Favorite Ice Cream is?

Unflavored?

 

[zoiDman]

He's put himself in there. If he truly followed science he'd have less problems. Where we don't know find out.

I think he has put Himself there because he is Sincere that he can Improve Public Health.

As to Science. Will Science be Allowed to be the Deciding Factor in All This? Will it Trump all other Factors.

BTW - Mr. Zeller Does have the Final Say in what Happens Anyway. People should start Thinking about Margaret Hamburg and Sylvia Mathews Burwell instead of Focusing on Mr. Zeller.

 

[Nate760]

My reaction: when the FDA guy is the closest thing to a voice of reason, that really tells you something about the amount of stark raving insanity that was concentrated in that hearing room.

 

[Roger_Lafayette]

I definitely Agree with your 1st Sentence.

He is in a Tight Space. But I Don't so much agree with the Second Sentence. It is why I Like and have Respect for Mr. Zeller.

Because I DO Think that the Facts Matter to Him. And I DO Think that he sees that e-Cigarettes Do have a Huge Benefit to those Seeking Harm Reduction from Combustible Tobacco.

I also Think that he is a Realist.

And knows that No Matter what Age Requirement Restrictions are Placed on e-Cigarettes, that Minors are still going to Use Them. Just Like Minors are Using Cigarettes Today.

The Big Problem is He Can't Come Out and Say this. Because All it would do is Give the "Save the Children" Litany more Credence. So he Has to Walk a Very Fine Line.

He Also Isn't Even the Head of the FDA. And sometimes people who do Not have the Final Say in a Decision/Policy will Except that they Can't Have All of what they Want. So it is Better to Except some of what they Don't Want to Get Some of what they Do Want.

I think in the Big Scheme of Things, have Mr. Zeller where he is Much More of a Good Thing than a Bad Thing. Because Face It. e-Cigarette Regulations are Going to Happen. And we Aren't going to like them.

The Question should be...

Would it be Worse if some like Dr. McAfee from the CDC was in Mr. Zeller's Shoes?

or

Or what if someone like Harkin was?

Zeller seems to have won you over. May I ask why in particular, other than based on a few comments he made at the hearing?

 

[Gato del Jugo]

You have to keep in mind that the FDA is a business..

They have an annual budget, i.e., revenue, of around $4.7 billion

Almost half of that comes from BP, alone...


"The FDA's federal budget request for fiscal year (FY) 2012 totaled $4.36 billion, while the proposed 2014 budget is $4.7 billion. About $2 billion of this budget is generated by user fees. Pharmaceutical firms pay the majority of these fees, which are used to expedite drug reviews."

Food and Drug Administration - Wikipedia, the free encyclopedia


Now imagine if tens of millions of (potentially) sick & dying smokers suddenly became healthy vapers..

What do you think would happen to all that BP money -- and as a consequence, to the FDA?

 

[zoiDman]

Zeller seems to have won you over. May I ask why in particular, other than based on a few comments he made at the hearing?

I'm not sure if "Won me Over" describes how I feel.

And Don't really foresee being Thrilled with the Final Regulations/Actions that the FDA Takes.

But I see Mr. Zeller as someone who Still Believes that Science, Real Science, should play a Role in Regulations. And that Emotional Hype and Political Agendas shouldn't be the Primary Driving Force with regards to e-Cigarettes/e-Liquids.

If you do a Quick and Dirty Google Search, you can find things that Mr. Zeller has written and Interviews he has given. I have kept upon some of what Mr. Zeller has Said/Done since I learned from Bill G. that he would be in the Position he is at the FDA

But let me Get Back to something I keep Mentioning but No One seems to think is Pertinent.

Doesn't Margaret Hamburg have something to say about How e-Cigarettes/e-Liquids are Regulated? Why does her name not get Mentioned Much?

What About Sylvia Burwell? Isn't she Zeller's Boss's Boss?

 

[Roger_Lafayette]

I'm not sure if "Won me Over" describes how I feel.

And Don't really foresee being Thrilled with the Final Regulations/Actions that the FDA Takes.

But I see Mr. Zeller as someone who Still Believes that Science, Real Science, should play a Role in Regulations. And that Emotional Hype and Political Agendas shouldn't be the Primary Driving Force with regards to e-Cigarettes/e-Liquids.

If you do a Quick and Dirty Google Search, you can find things that Mr. Zeller has written and Interviews he has given. I have kept upon some of what Mr. Zeller has Said/Done since I learned from Bill G. that he would be in the Position he is at the FDA

I hold Zeller responsible to some extent for the FDA's draft of the deeming regulations, and found what C.V. Phillips says about the role of science therein to be illuminating: Scientific claims in the FDA deeming regulation (part 1 of ???) | Anti-THR Lies and related topics

I also thought it was noteworthy that Zeller lumped vaping in with other "tobacco products" in his News Hour interview with Judy Woodruff, which was the only video interview that I believe he gave (or has given?) since the introduction of the proposed rule. In fact that was his opening sentence - "tobacco products" kill 400,000 Americans a year.

For some reason, he failed to mention that vaping hasn't yet killed anyone. Although he did go out of his way to single out charger fires, and the poison control center calls. Needless to say, I found all three of those facts noteworthy.

But at the end of the day, I think focusing on one individual may be unilluminating, no matter how much integrity one may attribute to that person. (And I say that because I suspect that you view Zeller as a man of great integrity: someone whom vapers can trust.)

***

But let me Get Back to something I keep Mentioning but No One seems to think is Pertinent.

Doesn't Margaret Hamburg have something to say about How e-Cigarettes/e-Liquids are Regulated? Why does her name not get Mentioned Much?

What About Sylvia Burwell? Isn't she Zeller's Boss's Boss?

I don't know how much of a role the Commissioners play in each of the divisions. Sylvia Mattews Burwell was the head of OMB when OMB originaly kicked the draft reg.s (also produced under Zeller) back to the CTP. And also when OMB approved the reg.s. Since no one knows what - if any - differences exist between the two versions, it's hard to say much.

And like the FDA, OMB has a lot of moving parts. OIRA is only one.

Again, I prefer not to view at this through the lens of individual personalities. I look at the CTP's actions and proposed actions as if it were a kind of monolith. My perspective would be little different if I thought Mitch Zeller was Jesus Christ, Mahatma Ghandi and Mother Teresa all rolled into one. And the same goes for Burwell and Hamburg.

That said, I can't see Jesus, Ghandi or Mother Teresa as a lobbyist for Glaxo (makers of NRT, who have been well and duly busted in their efforts to influence the EU's TPD). In general, it stinks when a former lobbyist for one industry is put in charge of regulating a competitor.

 

[Fitzie]

Re: Hamburg and Burwell. I imagine they might have a lot to say, but they're telling it to Zeller. When it suits them they'll go public, like Hamburg's recent letter to the NY Times.

Think about it. FDA's main focus isn't tobacco. And HHS has tons of stuff on it's plate (with the ACA probably still a major focus right now). Zeller's the head of the CTP so he's the guy who's the public face of federal tobacco regulation. We'll never know what Zeller personally thinks about vaping. He could even have relatives or friends who vape for all we know. He's paid to say what he's been told to say by his bosses, up to and including the President. Given his position, I'm sure it's not a short leash, but he does know what his parameters are.

 

[zoiDman]

I Trust People in Government Positions as Far as I can Throw Them. And I didn't say I agree with Everything that Zeller has Said or Done.

But here are Two, Simple Hypothetical Question...

Which would you Rather have in Mr. Zeller Position? Mr. Zeller? Or Dr. McAfee of the CDC?

Which would you Rather have in Mr. Zeller Position? Mr. Zeller? Or Sen. Harkin?

Sometimes the Lessor of Two Evils is Just That. The Lessor of Two Evils. But the Great of Two Evils is a Worse Choice.

Face it. No Vaper is Going to Like the Regulations that are Coming. But I can at least take some Solace from it Probably Could be a Lot Worse.

 

[Bobbilly]

I have had more faith in any of this if the one and only issue was addressed not all the strawmen fallacies. Is there a net benefit to health? The charger issue is a battery issue ( could have the issue if there is or isn't nicotine) the poisoning a is an awareness issue. How many calls to poison centers are due to fear mongering with respect to quantity? Bottles could be labelled similar to any other substance.
Studies 'science' has demonstrated there are many times less contaminates then smoking indicating safer. Even if it was found that long time use could cause some loss of lung function that is better than death

 

[Roger_Lafayette]

I Trust People in Government Positions as Far as I can Throw Them. And I didn't say I agree with Everything that Zeller has Said or Done.

But are Two, Simple Hypothetical Question...

Which would you Rather have in Mr. Zeller Position? Mr. Zeller? Or Dr. McAfee of the CDC?

Which would you Rather have in Mr. Zeller Position? Mr. Zeller? Or Sen. Harkin?

Sometimes the Lessor of Two Evils is Just That. The Lessor of Two Evils. But the Great of Two Evils is a Worse Choice.

Face it. No Vaper is Going to Like the Regulations that are Coming. But I can at least take some Solace from it Probably Could be a Lot Worse.

I believe I once heard Glantz respond tol an interviewer who pressed him about vaping.

His point was that smoking combustible tobacco is like jumping off the top of a 50-story building, whereas vaping is like jumping out of a window on the 10th floor.

I don't agree with this statement as regards vaping (obviously).

But if that's your point about Zeller vs. Harkin or McAfee, I'm with you

 

[zoiDman]

...

But if that's your point about Zeller vs. Harkin or McAfee, I'm with you

Yeah... That's my Point.

Better to have a Few People who at least will Consider a TPSAC Study or weigh the Big Issue of "Do I help More People by allowing e-Cigarettes to Exist or do I Hurt More People f they Don't" than to have None.

Because if it was Up to the Dr. McAfee's or the Harkin's of the World, even BT Wouldn't be Allowed to Sell e-Cigarettes.

 

[DeadbeatJeff]

You have to keep in mind that the FDA is a business..

They have an annual budget, i.e., revenue, of around $4.7 billion

Almost half of that comes from BP, alone...


"The FDA's federal budget request for fiscal year (FY) 2012 totaled $4.36 billion, while the proposed 2014 budget is $4.7 billion. About $2 billion of this budget is generated by user fees. Pharmaceutical firms pay the majority of these fees, which are used to expedite drug reviews."

Food and Drug Administration - Wikipedia, the free encyclopedia


Now imagine if tens of millions of (potentially) sick & dying smokers suddenly became healthy vapers..

What do you think would happen to all that BP money -- and as a consequence, to the FDA?

Sometimes to act we need to act AS IF what we are doing has the potential to work.

And sometimes this faith/delusion is the catalyst that makes that potential a reality.

Sometimes there is no other way. Even if history and pragmatics seem to dictate impotence, I for one refuse to be cowed.

So I'll protest and discuss and spread the word on the ground, and try everything that can be tried.

Like always.

 

[DeadbeatJeff]

Sometimes to act we need to act AS IF what we are doing has the potential to work.

And sometimes this faith/delusion is the catalyst that makes that potential a reality.

Sometimes there is no other way. Even if history and pragmatics seem to dictate impotence, I for one refuse to be cowed.

So I'll protest and discuss and spread the word on the ground, and try everything that can be tried.

Like always.

 

[Roger_Lafayette]

Yeah... That's my Point.

Better to have a Few People who at least will Consider a TPSAC Study or weigh the Big Issue of "Do I help More People by allowing e-Cigarettes to Exist or do I Hurt More People f they Don't" than to have None.

Because if it was Up to the Dr. McAfee's or the Harkin's of the World, even BT Wouldn't be Allowed to Sell e-Cigarettes.

I do not believe that the FDA has signaled any willingness to treat the science fairly. They'll look at it, but they'll dismiss it. That was C.V.s point right here: Scientific claims in the FDA deeming regulation (part 1 of ???) | Anti-THR Lies and related topics

So I'm afraid we'll have to agree to disagree on that. Just because there are still some recognizeable body parts after someone jumps out of a 10-story window (as opposed to off the roof - 50 floors up), doesn't mean they aren't just as dead.

My own guess is that BT's cigAlikes will be temporily permitted, because FDA will just sit on the application. This is what they've done with the SE tobacco cigarette applications submitted prior to the March '11 date. These products can remain on the market until the application is reviewed. (That 21-month window between the passage of the FSPTCA and the March '11 date for SE applications, combined with the policy of not requiring pre-market approval, looks a lot like the current proposed rule for vaping.)

Whether cigAlikes will survive in the long run is another question, and Zeller will be long gone by then anyway. But permitting cigAlikes in the meantime allows the CTP to have the one type of vaping product associated with dual users.

And dual users are a net loss, because they continue to smoke tobacco cigarettes, and therefore 5% of them won't quit every year.

Once the data is in for cigAlikes, FDA can then review their applications, pull them from the market, and let BP step in with their version of the very same advanced devices that we currently use today. We know they work, BP knows they work. And that's why they're going away soon.

Except BP can get them approved as cessation tools, and charge ten or a hundred times as much as we pay.

Mitch may have a very nice villa in Florida by then.

 

[DeadbeatJeff]

Is smoking officially classified as a disease?