CASAA blog: FDA releases e-cigarette rules

[Roger_Lafayette]

I DIY and have a ton of nic stashed and will fight tooth and nail for current & future vapers' rights.
Sitting on our asses isn't the correct way to cover them.

It's the people who have stashed nic. who are also most likely to be experienced vapers as well as successful quitters. Your help would be appreciated, but there are others as well (obviously).

Some of these folks don't seem to understand what it takes to build a mod out of a flashlight and a tin Altoids box. Or what the FDA is likely to do to the first vendor who starts sellling a "variable voltage flashlight with EGO threads" - wink, wink, nod, nod. (Can you say: "adulterated tobacco product" ?) Some of these vapers think that the gov't will let itself be defeated via childish word games. Not likely.

Equipment also provides us with some interesting ways to ask questions. What are the pubic health issues presented by glass drip tips (Trippy Tips)? Do they have to show that never-smoker/never-vapers will be less likely to smoke or vape as a result? Or to quit? Since Mitch Zeller mentions exploding batteries, what the public health issues associated with an Ego spinner? Do they have to do studies on how much nicotine the user of an ego spinner is likely to absorb? Is a 900 mAh ego a different "tobacco product component" from an 1100? Do they need to have studies concerning the appeal of brightly-colored egos to minors? Separate studies for each combination of color and battery life? And on, and on and on ...

At the very least, answers to these queries (or the lack thereof) may be fodder for any future litigation, if/when the FDA siezes a shipment of batteries or drip tips, on the grounds that they're "adulterated or misbranded [components of] tobacco products."

 

[pamdis]

The Economic Impact Analysis was just posted today and should also be analyzed before composing a final response:

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM394933.pdf

 

[Katya]

I have a question. I just went back to my email from Zeller--not sure why.

When I first got it, there were three links for responses:

The opportunity to comment on FDA's proposed rule is now open and comments are due on July 9, 2014. We encourage you to do so, and to provide any data and information you may have to support your comments.
Related links:
• See the proposed rule
• Submit a comment on the proposed rule

Tell us what you think about this response and We the People.

The first two (purple) links were clickable when I got the email--now they are dead. Error. Anybody knows why? And are (were) they the same?

The third link, blue above, asks to leave a comment about the response--there is a box for comment there. Should we respond to both? All three? What comment should we leave about the response (the blue link).

Since we're only allowed one response, I don't want to mess it up. Help!

I'm so confused.

 

[Brewlady]

I have a question....Should we respond to both? All three? What comment should we leave about the response (the blue link).

Since we're only allowed one response, I don't want to mess it up. Help!

I'm so confused.

Please be assured that as Kristin has stated, we are working on a detailed Call to Action. The proposed regulations are specific about what they are seeking comments on. We want to ensure that comments made by consumers address their specific concerns, so considering the length of the regs, this analysis takes quite a bit of thought and time.

In the next week or two, we will issue a Call to Action detailing how the proposed regulations affect consumers along with suggested actions so that consumers can respond most effectively. Please remember that a comment to the FDA regulations made on Day 1 is given no more weight than a comment made on Day 75. We urge the vaping community and others interested in opposing regulation that discourages tobacco harm reduction to await further analysis before acting. There is no benefit in acting or opining precipitously.

 

[Katya]

Please be assured that as Kristin has stated, we are working on a detailed Call to Action. The proposed regulations are specific about what they are seeking comments on. We want to ensure that comments made by consumers address their specific concerns, so considering the length of the regs, this analysis takes quite a bit of thought and time.

Thanks Brewlady, but my question is about two different kinds of responses that the White House email asks for--"comment on the proposed rule" and "Tell us what you think about this response and We the People."

I need help with Zeller's email that was sent to 36,000 of us.

I know that CASAA is working on the Call to Action.

 

[CES]

Katya, I went back to my email too. Two of the 3 links were still live.

The link from "Tell us what you think about this response and We the People" goes to a survey about the whitehouse.gov petition process, that happens to have a space for comments. It looks completely separate from comments about the regulations.

The link to the proposed regs comments went nowhere for me ("There was no response from the application web server for the page you requested.
Please notify the site's webmaster and try your request again later. ") and the link to the actual regs was still live and goes to the federal register page.

 

[kristin]

I cannot answer why the links are dead now, but presumably they linked to where you are supposed to submit your public comment of the proposed rules (which is what CASAA is working on a CTA for now.)

This response to the White House petitions on the FDA rules is pretty much what we expected. Petitions sent before the public comment period is closed will only receive one response: "If you have objections to the proposed rules, please submit a comment using the public comment form found on the FDA website."

The government expects us to follow protocol and submit objections and recommendations through the public comments system before sending them petitions. There is no reason for them to care about petitions while the public comment period is still open. They view the public comments as the way for us to officially submit our opinions (ie. just like a petition only it's actually part of the government process.)

Submitting a petition at this point in the regulatory process is like having an election petition calling for a ballot recount before the polls are even closed.

 

[kristin]

CASAA is shooting for releasing the Call to Action within a week.

In addition to working on the Call to Action, CASAA is also working on other related and important activities:

1) We are filing for an extention to the comment period, requesting it be increased to 180 days.
2) We are putting together a new e-cigarette user survey to provide statistical data for the official CASAA public comment, which requires a review of all of the requests for information made by the FDA in the proposed rules.
3) We are compiling a list of potential "asks" to petition Congress regarding the FDA's actions.
4) We are still working out facts of the rules vs. rumors/opinions (ex. definition of "finished product," actual costs of filing applications, number of comments allowed, etc)
5) We are still collecting information for the Call to Action, which will include instructions for submitting comments so they show up publicly, a summary of the rules and our objections and talking points for members to pick and chose from when submitting their story. (Note: the CTA will be written for individual comments, so it won't be asking members to submit comments with all of the technical and science facts like the CASAA comment will have.)

We know people are chomping at the bit, however, we cannot take the risk of "shoot first, ask questions later." CASAA has been gearing up for this for 5 years now and we aren't going to risk dropping the ball now. We continue to ask members to be patient and let us do this the right way. We are not leaving this to the last moment, so there is no need to worry that you will be under the gun time-wise after we release the Call to Action. Once we release the CTA, members will still have over 60 days to submit their own comments.

 

[KODIAK (TM)]

This folks, is why we organize and "hire out" the brains.

 

[Katya]

And in related news:

Over 100 ill with 'food poisoning' after attending FOOD SAFETY summit | Mail Online

Ironically, among those affected were members of the Food and Drug Administration and the Centers for Disease Control and Prevention.

 

[aikanae1]

Thx. I'd rather have CASSA take the time they need. Just within the last week there have been some dramatic shifts in opinion, so it's not easy. If someone wants to write, they can always write to their Congressperson or local reps too.

^ remind them of the spectacular job FDA is doing ^

 

[Mowgli]

Rolygate posted a link to this article on FB today. It has a reasonable version of regulation effects near the end.
I don't know if he wrote it but it's a very good read. Share it around

What Are E-Cigarettes ?

 

[Katya]

Electronic vapourisers are a tremendous gain for the individual; a huge and almost unprecedented boost for public health; and a near-disaster in economic terms for states.

Thanks, Roly! That pretty much explains everything, doesn't it?

 

[salemgold]

I am posting this link here just in case some of you subscribed to this thread for updates and missed this one.

CASAA: Overview of CASAA's Action Plan Regarding Proposed FDA Regulations

 

[OldtimeRocker]

Seems to me one of the first things that cheap and easy(ok maybe not that easy) things to do would be to identify all the analog smoker in the house and senate. Put a nice PV and addy kit together with batteries and a dozen sample kits. i mean some good stuff a 300 or 400 start up kit and go visit them. It would only take a handful of vaping lawmakers in DC to turn the tide. Yep is going to take some money you need a lobbyist with access to the congressmen but its done all the time.
Not sure how connected CASAA is in DC but this is money well spent and something a few vape manufacturer i would hope are already trying to do. Let face it its the vender,B&M and manufacturer with the money they need to spend some to keep their gravy train flowing.