FDA CASAA's Comment to the FDA Deeming Reg's

[sonicdsl]

Last night, CASAA submitted their 53-page comment on behalf of consumers to the FDA regarding their deeming regulations.

Here is a link to their blog post about it (with highlights):
CASAA: CASAA Submits Comment to FDA on Behalf of Consumers Regarding FDA Proposed Deeming Regulation

Here is a link to the PDF of the entire comment:
http://casaa.org/uploads/CASAA-FDA-Comment-8-7-14.pdf

 

[Gato del Jugo]

I'm only part of the way through so far, but they did an awesome job with it..


Totally ripping the FDA & our opposition a new one -- but with that "lawyer-ese" finesse...

I'm literally LOL'ing, here..


This is a must-read, folks...

 

[Gato del Jugo]

You know, I can't say for sure either way..

But given the fact that CASAA has been reading & even participating at this FDA Regs board here at ECF from day-1 of its creation, upon (still) reading their submitted comment I can't help but think that many of us here, via posting & discussing along the way, helped play a role in the drafting of such an aggregated, honed & clarified official response, whether we even realized it at the time...


In which case: Job well done, peeps!

 

[dragonpuff]

I'm reading it on and off, I've made it to page 23 so far. It's got that delectable mix of cold hard truth and biting sarcasm that I long for in politics and legalese very nice job CASAA!

 

[Gato del Jugo]

I'm reading it on and off, I've made it to page 23 so far. It's got that delectable mix of cold hard truth and biting sarcasm that I long for in politics and legalese very nice job CASAA!

I'm a bit ahead of you, and I assure you that they just keep cranking it out..

 

[Gato del Jugo]

From pages 34 & 35...


"FDA is asserting that it has sufficient expertise to regulate businesses and millions of consumers in this sector. Yet it presents scientific evidence in the naive manner of a child writing his first research paper, treating any assertion that is written down as if it must be correct."

 

[Gato del Jugo]

Finished!

Really good stuff.. Very impressed...


Anyway, I just sent them a small financial donation via PayPal at their website: CASAA - The Consumer Advocates for Smoke-free Alternatives Association (under the "Get Involved" tab at the top)..


I included a quick note, which I think is also important:

Thank you for all your time & effort spent composing your FDA-submitted comment. Truly awesome writing! To show my appreciation, I'm donating $1 per page, for a total of $53. Thanks again, and please keep up the excellent work!


You might want to consider doing the same, whether it's 10 cents per page or $10 per page, or whatever you can afford at the moment.. I, for one, think they truly earned it..


You also get a nice thank-you message afterwards, explaining why this is so important for them, for us, for all the future vapers out there, and even the non-vapers in our lives...


Thank you for your contribution to CASAA!

As you may already know, CASAA has no membership dues and we don't conduct fundraisers. We rely on freewill donations from the community and we're grateful every time someone has stepped up to the plate to support the work that we do.

We need that support now more than ever and your gift is a timely one. The battle we're facing right now with the FDA is our biggest one yet, and we're not going to be able to do what we need to do on a shoestring budget.

Again, thank you for your support of our work. I can assure you that your donation will be put to good use in our battle on behalf of consumers, to ensure the availability of effective, affordable and reduced harm alternatives to smoking.

Julie Woessner, President
CASAA

 

[aubergine]

It's tremendous. CASAA is terrific and I'm endlessly grateful for them. It's hard to think that so much intelligent effort, straightforward and thorough argument and simple truth might not receive a fair hearing. I very much wish that it would carry the weight in those deliberations that it should. And yeah, I know. And still, I do.

 

[dragonpuff]

On page 41:

"Perhaps what is most notable in this collection is CTP’s palpable sense of frustration about how
complicated the available information about e-cigarettes is. Several authors practically concede
that they wish more of the information was spoon-fed to them, and that they are unable to deal
with a world in which all knowledge is not collected into a small number of indexed papers..."

I'm dying!

 

[Kent C]

On page 41:

"Perhaps what is most notable in this collection is CTP’s palpable sense of frustration about how
complicated the available information about e-cigarettes is. Several authors practically concede
that they wish more of the information was spoon-fed to them, and that they are unable to deal
with a world in which all knowledge is not collected into a small number of indexed papers..."

I'm dying!

Perhaps they should spend some time in the New Members forum.


Wait..... never mind

 

[dragonpuff]

Perhaps they should spend some time in the New Members forum.


Wait..... never mind

I don't think they can handle the new member's forum, it is far beyond their intellectual capabilities ha ha!

 

[Kent C]

I don't think they can handle the new member's forum, it is far beyond their intellectual capabilities ha ha!

That was part of the 'never mind' - the other was the 'pollution' it would create

 

[dragonpuff]

That was part of the 'never mind' - the other was the 'pollution' it would create

I agree, our ANTZ infestation is bad enough, where's pest control when you need it??

 

[Kent C]

I agree, our ANTZ infestation is bad enough, where's pest control when you need it??

They banned it!

 

[dragonpuff]

They banned it!

Argh!!

 

[Bill Godshall]

I think CASAA has submitted one of the best comments to FDA (especially from economic and scientific perspectives).

While my comments delineated many of FDA's (and DHHS') intentionally misleading claims about e-cigs since 2009, CASAA's delineated many of FDA's intentionally misleading claims in its proposed Deeming Regulation.

 

[Kent C]

I think CASAA has submitted one of the best comments to FDA (especially from economic and scientific perspectives).

While my comments delineated many of FDA's (and DHHS') intentionally misleading claims about e-cigs since 2009, CASAA's delineated many of FDA's intentionally misleading claims in its proposed Deeming Regulation.

Out of the one's I've read, CASAA's is a stellar example of hitting the right points with the right importance. The part on the black market is incredibly detailed and could be prophetic.

I applaud this: "Part of the explanation for FDA’s apparent lack of understanding about the role e-cigarettes and other tobacco products play in consumers’ lives, as well as what will actually happen if these regulations are implemented, is the lack of consumer involvement. There are many people who could have explained these matters to the CTP, but they were intentionally excluded from the process."

Showing the willful and blatant ignoring of information that would be necessary for the FDA to have any regulation that would be tailored to the products they would be regulating. And also points out how they wouldn't have a clue as to what would happen in the black/shadow market.

Part of my comment after suggesting the use of Azim's 'baseline predicate product' from:
http://www.khlaw.com/webfiles/What_To_Expect.pdf

"You can work with vendors, consumers or vendor groups and consumer groups, such as CASAA, AEMSA, and others, who have had the input from us users, and the self-regulating actions that we have done to make the e-cigarette even safer than when it was first introduced - something that it, if the deeming goes as is planned, will revert to, in the form of cigalikes, and virtually eliminate all the knowledge and experience we have had, moving away from those products to products that are now much safer and more effective at moving people from cigarettes to e-cigarettes and from, in some cases, addiction to nicotine to no nicotine at all."

 

[JustJulie]

I apologize for taking so long to visit this thread and thank people for their comments on our comment. It should come as no surprise to anyone that the primary author of our comment was Dr. Carl Phillips, and he did a masterful job in addressing the economic and scientific issues from the consumers' perspective.

And Bill is correct--our comment was prepared with the expectation that this matter will ultimately wind up in the courts. In fact, our Call to Action was prepared with the same expectation . . . and a big thank you to those who took the time to respond to CASAA's Call to Action . . . your comments, particularly in connection with the effects of the black and shadow markets, will be very helpful in that regard.

As important as the comment process is, it is certainly not the end of our battle. CASAA's Action Plan will continue, and we'll be releasing a new campaign next week.

 

[Kent C]

I also wanted to say that I thought it was significant and insightful for CASAA to reject the idea of setting the grandfather date to the date of the final rule. Now having said that, I have also 'advocated' exactly that (and other comments from noted groups have done so also) but for me, it was like voting - the lesser of two evils. And in my own comment I supported Azim C.'s idea of a 'baseline predicate' and throwing out any grandfather date, where using a date is arbitrary, but using a 'model' is more realistic.

CASAA's comment on this issue strikes at the absurdity and how using the final rule date vs. the proposed one, while it allows the benefits that have accrued since 2007, it brings to a halt, or as they say "freezes" all the creativity and ingenuity that would necessary follow to improve safety, reliability, workability and also reduce cost. It would be like stopping portable phones at this stage:

 

[Jman8]

CASAA's comment on this issue strikes at the absurdity and how using the final rule date vs. the proposed one, while it allows the benefits that have accrued since 2007, it brings to a halt, or as they say "freezes" all the creativity and ingenuity that would necessary follow to improve safety, reliability, workability and also reduce cost.

I don't see how new grandfather date equals freeze on all (improved) products. Is the assumption that because it costs a gazillion dollars to submit/have approved applications that this is why all (new and improved) products would be done away with?

I'm still a bit amazed that we can't trust FDA on anything in proposed regulations, but we can trust them on the high cost for product applications.