FDA Looking for Talking points for FDA Comment letters

[MrsAngelD]

Personally I've never been very good at "Writing My representatives" I have done so but I normally have help or with permission borrow a "template" from someone else. With this being such big issue I was hoping we could have a thread which would list important talking points to include in such letters and/or comments so that myself and others like myself might have a leg up on doing what counts.

Thank you,
Angel

 

[Rickajho]

Hey Angel - long time no see!

Right now I'm waiting on CASAA for more of a lead on this. No one has had sufficient time to digest the entire FDA release at this point. This is what CASAA has to say after a preliminary read, with a more detailed analysis to follow on Monday:

CASAA: CASAA Assessment of FDA Deeming Regulation, April 25, 2014

 

[MrsAngelD]

Hey Angel - long time no see!

Right now I'm waiting on CASAA for more of a lead on this. No one has had sufficient time to digest the entire FDA release at this point. This is what CASAA has to say after a preliminary read, with a more detailed analysis to follow on Monday:

CASAA: CASAA Assessment of FDA Deeming Regulation, April 25, 2014

Hi I've been around, just lurking mostly. Real life has kept me far too busy for my own good...lol.

Thanks for the link, though I'm aware they asked us to wait, I figured it couldn't hurt to start building a list and be prepared.

 

[Rickajho]

Yeah, I hear what you are saying - this thing has caused a lot of anxiety now that it has finally been released. But it's huge, it's unclear, and it's hard to figure out right now where the points are that need to be made. Just the one "big picture" issue alone - what will and will not be impacted by proposed regulations isn't certain. The preliminary reads of the FDA proposal seem to be vague if not downright contradictory on many points. If I'm gonna get my talking points in I want to have a better idea what needs to be emphasized.

May want to keep an eye on here as well: FDA Regulations

 

[MrsAngelD]

Yeah, I hear what you are saying - this thing has caused a lot of anxiety now that it has finally been released. But it's huge, it's unclear, and it's hard to figure out right now where the points are that need to be made. Just the one "big picture" issue alone - what will and will not be impacted by proposed regulations isn't certain. The preliminary reads of the FDA proposal seem to be vague if not downright contradictory on many points. If I'm gonna get my talking points in I want to have a better idea what needs to be emphasized.

May want to keep an eye on here as well: FDA Regulations

I understand, and I always keep on this subforum, I've even posted Several PSA's to reddit informing users that they should keep an eye on it

 

[Jman8]

IMO, a key talking point that has already emerged in our discussions is the "application for market approval."

While this mainly affects vendors in the immediate future, it will have significant influence on availability of product (selection) for consumers.

FDA proposal seeks commentary on this, among other things.

IMO, this is one of those type of things to do your homework on. Thus far, our (so called) vaping leaders are spinning this as 'complete disaster' and putting forth message(s) that say if this regulation goes into effect, it'll stifle / kill the industry as we know it. I disagree, based partially on homework and what proposal says.

A talking point, IMO, would be along lines of urging FDA to consider ways to make application process easier / less expensive for smaller or new businesses as they a) don't have same resources as larger company and b) don't have as much to lose due to less avenues for distribution (when first entering the market, or working with small business budget).

 

[ClippinWings]

we need clarification on the "components vs accessories" issue.

A mod is not akin to the paper in a cigarette... it is more comparable to a tobacco pipe... which is NOT regulated by the FDA.

It seems that the only tobacco product, that fits the FDAs definition of a tobacco product, is the eliquid.

But the proposed Regs, don't imply that is the approach they will be taking.

 

[Robino1]

Moved to FDA Regulations per OP request

 

[cbrite]

I read on the CASAA FB page that once they have digested all of the info in the FDA ruling that they will provide some talking points, so I am waiting to hear what they feel are essential points to make. I read somewhere that each person may comment only once during the comment period, so I want to make sure that my comment counts for something and is logical vs emotional.

 

[Katya]

IMO, this is one of those type of things to do your homework on. Thus far, our (so called) vaping leaders are spinning this as 'complete disaster' and putting forth message(s) that say if this regulation goes into effect, it'll stifle / kill the industry as we know it. I disagree, based partially on homework and what proposal says.

With all due respect, our "so-called" leaders (if you mean CASAA) have not issued a call to action yet so I have no idea what exactly you're disagreeing with. You are free to petition anybody and have your own opinion, but please do not belittle those who have been working hard on behalf of this community for years. CASAA has very sharp lawyers and I'm eagerly awaiting their interpretation of the proposed deeming regulations and I will follow their suggestions as to what we should do next.

United we stand.

More from "so-called' leadership:

http://www.e-cigarette-forum.com/fo...eeming-proposal-please-wait.html#post12970978

 

[Jman8]

With all due respect, our "so-called" leaders (if you mean CASAA) have not issued a call to action yet so I have no idea what exactly you're disagreeing with.

I'm disagreeing with those who spin new tobacco product application process/regulation as a complete disaster, or akin to that.

Like from the CASAA Assessment, posted 4/25/14:

The filing requirements that would be imposed on manufacturers would put small-sized, and probably medium-sized, companies out of business.

Not 'could' or 'might' but would. And it isn't only CASAA saying this. In fact, when I wrote 'so-called' leaders, I wasn't just referring to CASAA assessment.

I find that sort of spinning counter productive, and sounding emotionally driven. Like petitions that went up prematurely and weren't exactly written well.

I see it as a reasonable concern, and an item that will absolutely be addressed in many responses to FDA proposed regulation. Assuming a leader isn't advocating for rejection of FDA proposal, then I feel confident they will make this a key talking point for what to address in the response.

But my point, as it relates to this thread, if for one to think for themselves, do their own homework, and be willing to seek guidance from say CASAA, on talking points.