FDA FDA's Zeller: Let's Reframe Debate to Focus on Nicotine

[sofarsogood]

http://www.csnews.com/product-categories/tobacco/zeller-lets-reframe-debate-focus-nicotine

"It's something I spend a lot of time thinking about," Zeller noted. "It's time to start looking at nicotine differently."

Explaining this in more depth, the CTP director said "looking at nicotine differently" starts with addressing a few key points:

• Recognize there is a continuum of nicotine-containing products;
• Understand people smoke for the nicotine but die from the tar; and
• Acknowledge the public health opportunity to move tobacco users down the risk spectrum.
  
  At least it's not the usual propaganda but if he's trying to be helpful it's timid. It does remind me that it would be hypocritical to severely restrict vaping while gum and patches are available with no fanfare in the same places whee cigarettes are sold.

 

[Lessifer]

"Zeller acknowledges that it's a complicated concept because nicotine is not a completely "safe" compound; it is never safe for non-users or for youth. However, he said there are safe delivery systems for nicotine, like gums, patches and lozenges."
...
"What is the longer-term use for those who need it? Is there a potential need for a period of dual use and, if so, for how long? What are the unintended consequences? Where does the principle of harm reduction come in?"

It is the same old lip service. He refuses to acknowledge vaping as a safer delivery mechanism, and continues to view nicotine as an addiction that REQUIRES cessation.

 

[Kent C]

It is the same old lip service

Yep. In fact, someone, I forget whom now, quoted him in the Appropriation Committee - the quote from the Senate HELP committee, that almost every vaper latched onto without the full context :- ) I don't see anything that different here. But there was this:

"On that front, Zeller said he could not comment on when the final deeming rule — which was first proposed in April 2014 — will be published or what the rule will contain. However, he did say "it is really close and it will happen in this administration."

... which is interesting considering how long it may take for the Appropriation amendment to make it to a full bill.

 

[Lessifer]

"it is really close and it will happen in this administration."

... which is interesting considering how long it may take for the Appropriation amendment to make it to a full bill.

Yes, I noticed that as well. As far as I know though, it's not up to the FDA at this point when the regs will be enacted, that's up to the OMB. Unless, of course, everything is already final or close to being final and they just haven't released it yet.

 

[Katya]

ep. In fact, someone, I forget whom now, quoted him in the Appropriation Committee - the quote from the Senate HELP committee, that almost every vaper latched onto without the full context :- )

Including me. I start every letter to the legislators with this very quote from Zeller.

 

[Katya]

Yes, I noticed that as well. As far as I know though, it's not up to the FDA at this point when the regs will be enacted, that's up to the OMB. Unless, of course, everything is already final or close to being final and they just haven't released it yet.

It's #2 on Califf's agenda.

Priorities – Teamwork to Achieve Common Goals | FDA Voice

"In addition to this overarching priority, a number of specific critical issues are on my front burner this morning and will remain there for the foreseeable future:

• Pain. The present epidemic of opioid overdose deaths now exceeds deaths from automobile crashes. FDA cannot solve this problem on its own—and indeed, no single entity can—but we have a critical role to play, as described in our FDA Opioids Action Plan.
• Tobacco product deeming. Much effort has gone into developing the framework for the approach to the regulation of the broad array of tobacco products. FDA is working hard to finalize the deeming rule, which in its proposed form would extend FDA regulation over virtually all tobacco products, including electronic cigarettes, either all cigars or all but premium cigars, pipe tobacco, certain dissolvables that are not “smokeless tobacco,” gels, and waterpipe tobacco."

 

[Lessifer]

Including me. I start every letter to the legislators with this very quote from Zeller.

I just don't understand. How can you say we need to make the conversation about nicotine, and acknowledge a spectrum of nicotine use/harm, and then in the same breath, say we'll do that after we deal with e-cigs by making them a tobacco product regardless of their relative risk.

 

[Katya]

I just don't understand. How can you say we need to make the conversation about nicotine, and acknowledge a spectrum of nicotine use/harm, and then in the same breath, say we'll do that after we deal with e-cigs by making them a tobacco product regardless of their relative risk.

This is a rhetorical question, right?

 

[sofarsogood]

It sounds like this is just a power trip for him. I have the same amount of respect for him as he has for me. THAT is scary.

 

[Lessifer]

This is a rhetorical question, right?

Of course.

First let me say that I'm not making light of this subject by making this comparison. Articles like this make me feel like a battered spouse. We know how they are, but they keep saying things that make us believe that they're going to be different, but we all know they don't mean it, everyone knows they don't mean it.

If the FDA truly wanted to bring this conversation forward, the first step would be to scrap the deeming regs and explore a new regulatory framework that actually acknowledged the spectrum of risk. Oh yeah, they'd have to stop lying about the relative risks too. Instead, they make statements like this in attempt to cover their own behinds, because people are starting to wise up and say "How can you say all nicotine is bad, but approve and PROMOTE these nicotine products?"

 

[Katya]

almost every vaper latched onto without the full context :- )

For the record, I do understand the context fully well. But I still use the quote. Cynically. Hoping that my legislators don't understand the full context...

 

[skoony]

IMHO Zeller is just positioning himself to be available no mater which way
this goes. Though he is clearly a team player for the other side he is showing
he is flexible enough to switch leagues half way through the season.
Translation: He is being two faced.

Regards
Mike

 

[sofarsogood]

IMHO Zeller is just positioning himself to be available no mater which way
this goes. Though he is clearly a team player for the other side he is showing
he is flexible enough to switch leagues half way through the season.
Translation: He is being two faced.

Regards
Mike

They play with our lives and the lives of 100's of millions of other people. Something is wrong with this picture.

 

[nicnik]

FDA's Zeller: Let's Reframe Debate to Focus on Nicotine

"The debate has been about e-cigarettes. It should be about nicotine," he said, adding that "someone needs to step up to the plate" and reframe the debate.

What???? Zeller himself needs to step up to the plate, and stop throwing fastballs at the heads of everybody who does.

 

[edyle]

Califf's agenda
FDA is working hard to finalize the deeming rule, which in its proposed form would extend FDA regulation over virtually all tobacco products, including electronic cigarettes

Logical fallacy; begging the question.
The correct statement would be:
"FDA is working hard to finalize the deeming rule, which in its proposed form would extend FDA regulation to include electronic cigarettes by deeming them to be tobacco products"

 

[Lessifer]

What???? Zeller himself needs to step up to the plate, and stop throwing fastballs at the heads of everybody who does.

It would be funny if it didn't hurt so much. The one agency that has the power to step up to the plate and reframe the conversation, is asking someone to step up to the plate and reframe the conversation.

 

[sofarsogood]

I watched the Ag committee hearing where they proposed to change the deeming. It was called a non partisan measure but the vote was almost a perfect party line split. One of the Democrats told an outright lie. She knew everybody else knew she was lying and she didn't care.

If the tobacco market collapses world wide it will undermine political and economic stability in a lot of places because it amounts to a gigantic tax cut.

 

[SeniorBoy]

Obfuscate:

To be evasive, unclear, or confusing

/Nice try! Epic fail!

 

[Oliver]

I saw Zeller make the same point in two different venues almost exactly a year ago. And despite some sort of continuous noise about "continuums", and "the need to reframe nicotine" I would say that precisely nothing has happened.

In fact, both times I saw Zeller speak I submitted the same question, which he did not answer (no idea whether this was moderated prior to him seeing the question): "You've mentioned that there's an urgent need to reframe nicotine but no mention of whose responsibility that would be. Is this something the FDA can or should be doing?"

I don't know whether the FDA is allowed to do this. But the CDC certainly should - can't see that happening any time soon!

 

[Kent C]

I saw Zeller make the same point in two different venues almost exactly a year ago. And despite some sort of continuous noise about "continuums", and "the need to reframe nicotine" I would say that precisely nothing has happened.

In fact, both times I saw Zeller speak I submitted the same question, which he did not answer (no idea whether this was moderated prior to him seeing the question): "You've mentioned that there's an urgent need to reframe nicotine but no mention of whose responsibility that would be. Is this something the FDA can or should be doing?"

I don't know whether the FDA is allowed to do this. But the CDC certainly should - can't see that happening any time soon!

This explains Zeller's FULL position despite the lip service he gives such as 'ecigs are good for hard core smokers' and 'we should reframe the nicotine issue':

TVECA post table of contents for Deeming Final Rule

From the Senate HELP hearing:
"But our job as the regulator is to figure out what is going on at the population level and it includes the much larger group [collective] of smokers not like the first group I defined, a much larger group of smokers who are concerned about their health and who are interested in quitting and what happens instead of those people completely substituting with a non-combustible product, they start using both, and then along the way they wind up becoming less interested in quitting. So then we would say that might not be good for public health, and our job is to figure out what is the net of all of those possible behaviors including any initiation which would not be good for public health and then try to make public policy on top of that." (my emphasis).

If he actually cared for individuals, even one individual, then he'd stick with the first quote and not bother with the rest. But his collectivist view demands that he views the largest group - the 'net population' as he's said elsewhere, (ie. not the just hard core smokers) and it is on that where his true 'belief' lies.