FDA TVECA post table of contents for Deeming Final Rule

[pennysmalls]

(It would be a lot easier to give up vaping if tobacco was also banned. Why don't they do that too. I might even support that combination.)

snipped

That's huge. I can't even address it.

 

[Katya]

You all know that AMESA was formed by ECF owners and moderators.

I don't know about owners and moderators, but I know for a fact that at least two prominent ECF members were involved with AEMSA from day 1.

AEMSA Launches

The purpose of creating AEMSA was first and foremost self-regulation.

http://www.aemsa.org/wp-content/uploads/2013/08/AEMSA-Standards_Version-1-7-1.pdf

Purpose
The purpose of these Standards is to create a responsible and sustainable practices and process for the safe manufacturing of
“e-liquids” used in electronic cigarettes. Our members believe we have a responsibility to self-regulate the e-liquid manufacturing
process based on professional criteria. AEMSA aims to accomplish this by creating, implementing and upholding standards for
the manufacture of e-liquids. One of AEMSA’s primary goals is to provide consumers with higher degrees of confidence our
members’ products are manufactured with professionalism, accuracy and safety

AEMSA standards are established based on the following Core Beliefs:
• We have a responsibility to verify the accuracy of any nicotine content in the products we distribute.
• We have a responsibility to ensure the quality and safety of all ingredients in our e-liquids.
• We have a responsibility to prepare our products in a clean, sanitary and safe environment.
• We have a responsibility to ensure our products are packaged and delivered in a safe manner.
• We have a responsibility to provide a level of transparency into the monitoring and verification process.

However, AEMSA also created a lot of controversy here and on other e-cig fora and in blogosphere. Easily searchable.

I just hope we can all keep our eyes on the ball--and the real enemy--instead of turning against each other. Yeah, it's tempting, sometimes, especially when one feels so helpless, but that would be a very bad thing for all of us.

 

[Kent C]

No Arguments here.

BTW - I wonder How Much of All this does Mr. Zeller have Complete Control over? I mean, he Doesn't even run the FDA.

Right?

Right. He's head of the Center of Tobacco Products (CTP) but responsible for much of the deeming.

New head of FDA: Robert Califf

Who is Dr. Robert Califf, the New Head of the FDA?

 

[Katya]

I Also think he Understand the He is a Cog in a Very Large Piece of Machinery.

Just following orders?

Surely not in the U.S. of America? Anybody can refuse to follow unjust orders here. Most certainly people like Zeller. It's not like he's gonna go to jail or his family will be sent to Siberia.

I don't much care what he knows or thinks--it's what he does that matters. And so far, I'm not liking any of what he's doing.

 

[Katya]

Sylvia Mathews Burwell

She's a hack. That's all.

 

[zoiDman]

Right. He's head of the Center of Tobacco Products (CTP) but responsible for much of the deeming.

New head of FDA: Robert Califf

Who is Dr. Robert Califf, the New Head of the FDA?

I will say One Thing.

I do like People who are Forth Coming about Financial Disclosure.

"In an interview with TIME earlier this year, Califf said less than half of his yearly salary comes from research funds from the pharmaceutical industry. Califf told TIME in the interview that he was divesting his holdings in two privately-held pharmaceutical companies."

Less than Half. LOL

 

[zoiDman]

Just following orders?

...

Not so Much that. Just that Mr. Zeller doesn't have All the Say in what is Done.

I think if it was Completely up to Him, that Science/Health would play a Greater Role in how e-Cigarettes/e-Liquids are considered.

But it Isn't completely up to him. And there are Many Fingers in the Pie.

 

[Katya]

Not so Much that. Just that Mr. Zeller doesn't have All the Say in what is Done.

True. But he could have made a clear statement in favor of science and, if necessary, refuse to participate in this witch hunt. His denouncement of the regs as written or his resignation wouldn't have gone unnoticed. Many anti-tobacco activists had the courage to embrace vaping and the concept of THR. Why couldn't he?

 

[Ca Ike]

I've tried that. Ended up with a current candidate

Ok, ok. Maybe it's time to vote John Q. Public or Joe Average as a write in [emoji23]. Yea that's it!! Vote for Joe Average and Jane can be first lady[emoji23][emoji23]

 

[Lessifer]

I respectfully and strongly disagree.

To which part?

Going by previous guidance documents, etc. the new product PMTA sets a pretty impossible standard.

http://www.fda.gov/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM273425.pdf

with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account ─ (A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (B) the increased or decreased likelihood that those who do not use tobacco products will start using such products.

The more detailed descriptions starting on page 16 explain it better, but it's a lot to copy and paste into here.

Of course that guidance is from 2011 so who knows what has changed, if anything.

As I see it, the rules for tobacco products are:
1. can't be shown to attract non-users to start(which they all inevitably do)
2. Can't be shown to prevent someone from quitting tobacco altogether, if that's possibly what they would have done otherwise.

Number 2 would be the sticking point with vapor products, I think.

 

[Oliver]

You all know that AMESA was formed by ECF owners and moderators. Yeah it makes money for them but is nothing more than paying for Kosher certified through the Jewish mafia. RTS has forgot more than AMESA knows. Their fee of $5,000 per month to RTS, based on volume, is ridiculous for a group that adds no value. We have been working all year to get FDA certification which really matters.

Not true Randy - I've never had anything to do with AEMSA save for announcing its formation back in 2012. I know Lou personally and count him as a friend, but AEMSA has always been his endeavor, and ECF has had no part in its formation or continued operations.

I also do not believe Lou Ritter (or anyone) has ever profited from running AEMSA. As far as I'm aware, he formed it to try to help steer the industry towards standards, and runs it on a purely voluntary basis.

 

[skoony]

Please site were whatever you are Referring to. And Please Clarify what you are trying to say when you Used the term "Out Sourced".

---

And Yes. Seriously.

Sorry Zoid. I was using the kindle at the bar. I don't know what happened but, those are not the quotes
I was commenting too. there not even close. As I remember the first quote was to Kent and the second
was some one else. Any I apologize for the screw up. I'm new to touch screens.
Regards
Mike

 

[zoiDman]

Sorry Zoid. I was using the kindle at the bar. I don't know what happened but, those are not the quotes
I was commenting too. there not even close. As I remember the first quote was to Kent and the second
was some one else. Any I apologize for the screw up. I'm new to touch screens.
Regards
Mike

No Problem Mike. I have had my Kindle do some Unusual things before.

 

[zoiDman]

...

As I see it, the rules for tobacco products are:
1. can't be shown to attract non-users to start(which they all inevitably do)
2. Can't be shown to prevent someone from quitting tobacco altogether, if that's possibly what they would have done otherwise.

Number 2 would be the sticking point with vapor products, I think.

Does the PMTA Guidance say that something "Can't be Shown"?

Or is it seeking the Likelihood in which Lower would be Better?

 

[Lessifer]

Does the PMTA Guidance say that something "Can't be Shown"?

Or is it seeking the Likelihood in which Lower would be Better?

Well, here are the guidelines for the "public health" study portion of the PMTA, it's more about HOW to conduct them though. For the acceptable thresholds, I suppose you could try to view previous PMTA applications that have been approved and compare them to those that haven't, if those are available. I think they might be, but I also seem to recall seeing one that was severely redacted.

A. General Principles for Scientific Studies Under section 910(c)(4) of the FD&C Act, your new tobacco product will be evaluated to determine whether the product is appropriate for the protection of the public health considering the risks and benefits, including the health risks of the product and the likelihood of changes in initiation and cessation rates. These considerations will allow for an evaluation of the impact of the new tobacco product on morbidity and mortality for the population as a whole. In demonstrating the public health impacts of the product, data from your well-controlled scientific investigations should address, among other things, the following questions:

(1) How do the health risks associated with your product compare to the health risks of other products on the market? How do the health risks of switching from another tobacco product to your product compare to the health risks associated with quitting the use of tobacco products? How do the health risks associated with your product compare to never using tobacco products? Accordingly, your scientific studies regarding health risks of your new tobacco product should allow for a comparison of the health risks of your tobacco product to the risks associated with quitting, using other tobacco products, and never using tobacco products.

(2) How will your new tobacco product affect the likelihood that current tobacco users will cease using tobacco products? In making this evaluation, you should address the attractiveness of your product and product labeling to current tobacco users (especially to those users interested in quitting smoking), the addictiveness and abuse liability of your product, and cessation rates associated with users who switch to your new tobacco product. Additionally, you should provide evidence regarding the likelihood that your new product will be used concurrently with other tobacco products currently on the market. Your evaluation of the impact of the introduction of your new tobacco product on cessation rates should provide data on the attractiveness, addictiveness, and cessation rates of your new tobacco product as compared to other tobacco products currently on the market.

(3) How will your new tobacco product affect the likelihood that never-users and former-users of tobacco products will use your new tobacco product? In making this evaluation, you should address the attractiveness of your product and product labeling to never-users and former-users of tobacco products (especially to those segments of the population that may be particularly likely to initiate or reinitiate tobacco use), as well as the addictiveness and abuse liability of your product. To provide a full evaluation of the impact of your product on the market and on the population as a whole, your scientific evaluations should provide data on how the attractiveness and addictiveness of your product compares to that of products currently on the market. You should specify what product features may enhance the attractiveness/appeal of your product to children and adolescents and what product features may minimize the attractiveness/appeal of your product to children and adolescents.

All of your scientific evaluations should use control groups of comparator products and use various tobacco use levels sufficient to address the questions and considerations above. For example, in evaluating the health risks of your product, clinical studies should provide data on biomarkers for users of other tobacco products as well as biomarkers for quitters and never-users. Similarly, product chemistry evaluations should compare your new product’s chemistry to other tobacco products currently on the market. In addition, your studies should follow a pre-specified statistical analysis plan for data analysis to ensure the validity of your conclusions.

FDA encourages persons who would like to study their new tobacco product to meet with the Office of Science at the Center for Tobacco Products to discuss their investigational plan prior to distributing the product for investigational purposes (see section VII, below).

 

[navigator2011]

I am wondering if the President is required to act within the 90-120 days, once the regulations have been submitted to the OMB. Or, is it possible for the proposed regulations to sit in the White House indefinitely, or for at least longer than 120 days?

 

[zoiDman]

Well, here are the guidelines for the "public health" study portion of the PMTA, it's more about HOW to conduct them though. For the acceptable thresholds, I suppose you could try to view previous PMTA applications that have been approved and compare them to those that haven't, if those are available. I think they might be, but I also seem to recall seeing one that was severely redacted.

I think that e-Cigarettes present some Unique Challenges to the Existing Framework of the PMTA.

Because the Existing Framework, on average, has dealt with "Tobacco Products" that curtailed a much Higher Risk of Use.

 

[zoiDman]

I am wondering if the President is required to act within the 90-120 days, once the regulations have been submitted to the OMB. Or, is it possible for the proposed regulations to sit in the White House indefinitely, or for at least longer than 120 days?

I know of No Requirement for the Office of the President to act on any OMB Submission.

As I understand it, if the Submission is considered "Significant", then the OMB is not under any Time Requirements.

And I Imagine that a Rule Set that will Dictate All Aspects of a 7 Billion Dollar Industry effecting 3.5% ~ 15% of the Entire Adult Population would be deemed Significant.

 

[Lessifer]

I think that e-Cigarettes present some Unique Challenges to the Existing Framework of the PMTA.

Because the Existing Framework, on average, has dealt with "Tobacco Products" that curtailed a much Higher Risk of Use.

True, but there is the existing framework of Modified Risk Tobacco Product, and that one works so well...

Sorry, I'm not really trying to be a downer, just not feeling all that hopeful at the moment. Maybe I should go read some testimonials and get my spirits back up.

I did read today that the CDC estimates about 9 million vapers in the US, I just wish we could get at least half of them to participate.

 

[haleysdadda]

All this is making me want to throw up! Not for the new rules but because of what our country has become, (fill in your complaint here) a bunch of "Representatives" that chase money & popularity instead of doing what is right for the people they represent!