CASAA blog: FDA releases e-cigarette rules

[kristin]

Today the FDA finally released its long-awaited proposed rules on e-cigarettes.

On its face, it appears that it is not as bad for consumers as it might have been, but there are still serious concerns. The FDA approval process is very complicated, and the details matter. Unlike some commentators, we are not prepared to say much more until we have a chance to examine them and consider them in the context of existing institutions.

It's important to remember that the recently published rules are only proposed rules at this time.The next step for the FDA will be to open a docket for public comments, which will last for 75 days. After analyzing the 240-page document, CASAA will issue a Call to Action for its members detailing any consumer concerns, instructions for submitting public comments and possible talking points.

To download a copy of the rules...

CASAA: FDA releases e-cigarette rules

 

[Anjaffm]

thank you for posting this.
240 pages? I'll wait for the movie.. uhm... the analysis by the qualified people of CASAA.
Thank you for all you do for us!

 

[Katya]

Thanks Kristin!

Time to make a donation to CASAA!

Please let us know how you read those regulations and what you want us to do next!

 

[dshgr]

Glad I bought a lot of nic last week.

 

[kristin]

Yesterday’s FDA draft deeming regulation regarding e-cigarettes, other smoke-free alternatives, and other products is not as bad on its face as it might have been. However, a full review -- in the context of background knowledge and institutional analysis -- reveals that the proposed regulation is inappropriate, ill-founded, and potentially devastating for consumers.

1. The proposed regulation of non-combustible tobacco products, particularly including e-cigarettes, does almost nothing to address any real problems.

With the exception of ingredient labeling requirements, which benefit consumers, and bans on sales to minors, which we also support, this appears to be a classic case of a solution in search of a problem. FDA presents only speculative claims of harms or risks from smoke-free products. To the extent that they identify potential problems, there is no reason to believe that the proposed regulations will address them.

READ MORE>>

NOTE: We expect to provide further analysis on Monday, April 28th, 2014. 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]

Thanks Kristin!

We desperately need guidance. I'm eagerly awaiting CASAA's Call to Action.

ETA: I like Bill G's suggestion--but I'm sure you've read it by now. Post #37.

http://www.e-cigarette-forum.com/fo...-cig-industry-big-tobacco-2.html#post12967695

The best tactic to delay the regulatory process is to request more than 75 days to submit public comments (especially since it took dozens of FDA staff and lawyers nearly three years to write the complex 241 page proposal).

 

[Roger_Lafayette]

It would be great if CASAA could take a position on the scope of the deeming rule. I.e. what is the FDA asserting authority over?

Clearly they are not asking to regulate Provari tee shirts (accessories) - assuming there are any

However there do seem to be a few posters who genuninely believe that the FDA is only asserting authority over e-liquid that contains (tobacco-derived) nicotine, and/or anything sold with e-liquid that contains it.

It's reasonable to guess that there are many vapers out there (at least in absolute numbers) who might be less helpful to our cause, if they believed that. For ex., nic-free vapers might incorrectly believe that their APVs are safe.

Most of us think the language in the PDF and the statute are fairly clear, not to mention Zeller's answer to Greg's Q at 14:05 in the teleconference: FDA Deeming Teleconference 4/24/2014 - YouTube

Namely: the FDA is asserting that it has the authority to regulate virtually all equipment that is intended to, or anticipated to be used uniquely for vaping applications. They probably won't touch rubber O-rings, but the fact that a spinner can be used as a paper weight and lacks nicotine doesn't matter in terms of the authority that they're deeming to exercise in the proposed rule.

Clarification from CASAA on this point might help get more folks on board.

 

[Katya]

I'm sure that CASAA's sharpest attorneys are working on this as we speak.

I really want to hear their take on the entire proposal, its scope, and its legality.

 

[Mowgli]

It would be great if CASAA could take a position on the scope of the deeming rule. I.e. what is the FDA asserting authority over?


Clarification from CASAA on this point might help get more folks on board.

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

Taking Action.

It is our current assessment that these proposed regulations are not in the best interests of consumers. They include some good provisions, but do far more harm than good. They are based on arbitrary claims and rationalizations. Should the regulations be finalized as currently formulated and implied, we are prepared to marshal our resources to file a lawsuit on behalf of consumers.

We expect to provide further analysis on Monday, April 28th, 2014. 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.

 

[aikanae1]

It would be great if CASAA could take a position on the scope of the deeming rule. I.e. what is the FDA asserting authority over?

Clearly they are not asking to regulate Provari tee shirts (accessories) - assuming there are any

However there do seem to be a few posters who genuninely believe that the FDA is only asserting authority over e-liquid that contains (tobacco-derived) nicotine, and/or anything sold with e-liquid that contains it.

It's reasonable to guess that there are many vapers out there (at least in absolute numbers) who might be less helpful to our cause, if they believed that. For ex., nic-free vapers might incorrectly believe that their APVs are safe.

Most of us think the language in the PDF and the statute are fairly clear, not to mention Zeller's answer to Greg's Q at 14:05 in the teleconference: FDA Deeming Teleconference 4/24/2014 - YouTube

Namely: the FDA is asserting that it has the authority to regulate virtually all equipment that is intended to, or anticipated to be used uniquely for vaping applications. They probably won't touch rubber O-rings, but the fact that a spinner can be used as a paper weight and lacks nicotine doesn't matter in terms of the authority that they're deeming to exercise in the proposed rule.

Clarification from CASAA on this point might help get more folks on board.

I have no doubt that is what FDA's intentions are, but there's some mushy areas when it comes to application. One of the questions that I keep thinking of is that nicotine is not the only legal substance pv's are used for anymore and that legal substance can go where ecigs couldn't.

From Paypal to Groupon to Ebay, "dry herb atomizers" are perfectly acceptable and ecigs are not. When SF drafted their vaping ban, they went out of their way to avoid banning anything associated with "dry herb" use. There's also an essential oil homepathy that uses similar type devices. I haven't seen these addressed by the FDA or the respective communities and I'm not sure they are aware that what they use could be jeapordized by FDA regulations. I just think the FDA is expectng a clean line between what vapers use and what other industries use, which is not the case.

 

[CES]

As I wait for the call to action, some thoughts that crossed my mind were the lack of guidance and clarity in the proposed regulations, the obvious potential for creating a black market (expressly identified as a no-no in the tobacco act?), and the potential for an undue regulatory burden on small businesses. These thoughts are on top of my continued annoyance with the fact that the FDA continues to ignore the science that exists, is asking for proof of negatives, yet is still willing to consider exempting certain high end cigars.

 

[kristin]

We are working hard to scrutinize the proposed rule, so as to not miss any potential issue. We are also discussing the rules and potential courses of action with other advocacy and industry groups.

It is very easy to make snap judgements at a glance, which many armchair advocates seem to be doing, but the more we CAREFULLY get into our review, the more we see. We believe cautious and methodical dissection of these rules is what we owe the CASAA membership and they'd expect nothing less. There would be far more outcry over us missing something and giving the wrong advice than there is currently, asking why CASAA doesn't "do something" immediately.

I would also remind people that this isn't CASAA's first rodeo regarding FDA comment periods. There are things going on behind closed doors, so-to-speak, and we ask our membership to be patient and continue to trust us on knowing the process and seeking expert council where we don't.

The second part of our assessment should be posted tomorrow.

 

[Talyon]

We are working hard to scrutinize the proposed rule, so as to not miss any potential issue. We are also discussing the rules and potential courses of action with other advocacy and industry groups.

It is very easy to make snap judgements at a glance, which many armchair advocates seem to be doing, but the more we CAREFULLY get into our review, the more we see. We believe cautious and methodical dissection of these rules is what we owe the CASAA membership and they'd expect nothing less. There would be far more outcry over us missing something and giving the wrong advice than there is currently, asking why CASAA doesn't "do something" immediately.

I would also remind people that this isn't CASAA's first rodeo regarding FDA comment periods. There are things going on behind closed doors, so-to-speak, and we ask our membership to be patient and continue to trust us on knowing the process and seeking expert council where we don't.

The second part of our assessment should be posted tomorrow.

I have every bit of faith and respect to CASAA for what they do and are currently doing in this matter. TY Kristin etal...

Vape for Freedom.

 

[CES]

Thank you for taking the time to do the detailed analysis. My head wants to explode when i try to read it.

 

[pamdis]

Unfortunately, there are already 538 comments posted at regulations.gov

I can only imagine....

 

[carlvphillips]

Unfortunately, there are already 538 comments posted at regulations.gov

I can only imagine....

I am sure it is quite helpful for FDA to get very early comments. They know that they can ignore them.

 

[Katya]

We are working hard to scrutinize the proposed rule, so as to not miss any potential issue. We are also discussing the rules and potential courses of action with other advocacy and industry groups.

It is very easy to make snap judgements at a glance, which many armchair advocates seem to be doing, but the more we CAREFULLY get into our review, the more we see. We believe cautious and methodical dissection of these rules is what we owe the CASAA membership and they'd expect nothing less. There would be far more outcry over us missing something and giving the wrong advice than there is currently, asking why CASAA doesn't "do something" immediately.

I would also remind people that this isn't CASAA's first rodeo regarding FDA comment periods. There are things going on behind closed doors, so-to-speak, and we ask our membership to be patient and continue to trust us on knowing the process and seeking expert council where we don't.

The second part of our assessment should be posted tomorrow.

We can't be too careful with our analyses. Whether we like it or not, the deeming regulations, once enacted, will become a seminal piece of legislation for years to come. That legislation will affect everyone in this country and have a ripple effect throughout the world. The FDA hopefully realizes this and that's why they are so cautious and non-committal in their first draft. They can't, of course, proclaim that vaping is a perfectly safe and innocent pastime, but they have the chance to send a signal that they acknowledge that vaping is safer than smoking by taking their legislative foot off the accelerator--just a bit.

We should very strongly argue that the 2007 date is a non-starter because the hardware that was in use at that time simply doesn't exist anymore; Zeller himself opened the door by consenting that that date is problematic. If they could find a way to grandfather existing hardware and take it from there that would be very nice.

As for nicotine, well, it's already present in tobacco and in all NRT products and even ANTZ advocate NRT use.

Vaping is a revolution in tobacco harm reduction and should remain legal and easily accessible to all smokers who wish to quit their deadly habit. Furthermore, vaping has been so successful that it has the potential to eradicate smoking altogether and hence should be encouraged and allowed to improve and develop in the future.

 

[Roger_Lafayette]

<snip>

Yes, I had already seen that when I did my post. I must be missing something in yours.

1) Are you saying: "Whoa! Calm down now. CASAA will address this on Monday!"

If so: my response is: "Great. I just wanted to be sure they picked up this one point." (Which is why I did my post in which I wanted to be sure that I explained precisely why I felt it was salient. So far, it hasn't been addressed by many folks who might be in a position to speak authoritatively on the matter.)

2) Or is the answer to my question (regarding the scope of the deeming), already present in what you quoted?

3) Or are you just quoting this section for general informational purposes?

I'm lost.

As long as I'm posting, I'll add one more point. There are many folks at ECF who DIY, and who have lots of nic. in their freezers. I know at least one of them is absolutely convinced that they will not be affected by any reg.s the FDA enforces as a result of this rule (since they already have nic.). That's the kind of reaction that will not help our cause, particularly if it's not based on fact.

 

[aikanae1]

Thank you for keeping us updated. I agree that getting this right the first time is essential in that once finalized, the regulations would take an act of Congress to change - as in never. It also seems that reps from tobacco firms and Zeller have hit the streets with a publicity tour, re-energizing misleading claims ("it's in anti-freeze") and both are heralding the FDA as a "science based organization" over and over and over again. At the same time a handful of people don't see much change. It's very frustrating to passively watch from the sidelines. Meanwhile local bans march on with Calif's ban with online sales coming up this week.

I have no idea how you all do it, I'm just glad you do.

P.S. I thnk Roger brings up a valid point that there is a significant number of hobbyist's in vaping; woodworkers, glass, mods, drip tips, in additiion to DIY. That tends to fall in line with cigars exempted being their artisian based.

 

[Mowgli]

Yes, I had already seen that when I did my post. I must be missing something in yours.

1) Are you saying: "Whoa! Calm down now. CASAA will address this on Monday!"

If so: my response is: "Great. I just wanted to be sure they picked up this one point." (Which is why I did my post in which I wanted to be sure that I explained precisely why I felt it was salient. So far, it hasn't been addressed by many folks who might be in a position to speak authoritatively on the matter.)

As long as I'm posting, I'll add one more point. There are many folks at ECF who DIY, and who have lots of nic. in their freezers. I know at least one of them is absolutely convinced that they will not be affected by any reg.s the FDA enforces as a result of this rule (since they already have nic.). That's the kind of reaction that will not help our cause, particularly if it's not based on fact.

this ^#1

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.

Looking forward to what CASAA has to say tomorrow.