FDA Boehner asks FDA to move Grandfathering date to April 2014 or time of final rule

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Jman8

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Easily the biggest news in vaping community since 4/24/14. I am unaware of anything since that date that compares to this.

I recall Pamdis, Kent C. and myself broaching this topic after April 2014 and harping on it as a substantial item that could drastically change the playing field that FDA put forth. And noting that FDA says it cannot change grandfather date, saying that is up to Congress. Well, Congress has now weighed in telling FDA to do just that. Here in tail end of 2014, it is unlikely current makeup of Congress would go along with this, but also highly unlikely that FDA comes up with Final Rule by 12/31/14.

Whereas in a 2015 version of Congress where Pubs control both houses, I would say it is very likely as a result of this letter. Still possible it doesn't happen, but this would assume vapers do zero in relation to what we were just given as a very helpful tool to drastically change the playing field.

I would think we'd want to go with grandfather date that equals whatever date the FDA provides Final Rule and which has gone through all the necessary steps so that rule is Official. One of those necessary steps, as I understand things, is for it to be reviewed / sanctioned by Congress. Hence, if FDA decides no adjustment to grandfather date will be done (by them) because they don't think they can, then Congress would have opportunity to change it, and Boehner has now indicated he intends to have that adjusted if he has any say in it.

While this doesn't do everything that a politically aware vaper desires, it is most significant step I can think of with regards to the Federal jurisdiction over vaping, with exception of Congress exempting eCigs from FSPTCA or FDA authority. If vaping community for sure thinks we can get more than this, I'm up for pursuing that and giving it all we can, but not all that up for pie-in-the-sky thinking of what our tiny band of merry men feels is the only righteous path before we will agree to anything at all. I'm not saying anyone else is currently saying this, but to not recognize this as hugest item within vaping community since 4/24/14, makes me want to ask, very directly, what you feel is bigger and why is it better.
 

csardaz

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whatever date the FDA provides Final Rule and which has gone through all the necessary steps so that rule is Official. One of those necessary steps, as I understand things, is for it to be reviewed / sanctioned by Congress.

As I understand it - a new regulation can be stopped by congress via a Joint Resolution - Both houses passing a law basically, with majority votes etc. Seems extremelly unlikely for a cigar/ecig regulation that affects under 15% of their constituents. Hence you saw a lot of references last month to a conservative proposal to change this to the reverse - where both houses would need to approve a new regulation. However that would represent a congressional veto which has been struck down before by the high court. If congress gives the president or the head of HHS discretion over regulations, its already given up control - and most of the laws of the last 25 years seem rather delegatory like that.

The remaining steps are to - presumably digest the public comments from round 1, but theres nothing that actually makes them give them proper consideration? - propose the rule again, get OMB and OIRA - which are both under office of the president, approval, then publish the new rule as a regulation.

Congress could veto it with a joint resolution, they could hold hearings and make people sweat on camera, but practically they are limited to amending the current law with some little change stuck into an unrelated law. E.G. a budget may show up with a strange clause related to the grandfathering date on newly deemed tobacco products. A resolution that can be interpreted as weakening tobacco regulation, or a bill that does the same - very hard to pass - not worth it when 5-15% of constituents care.
 

AndriaD

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As I understand it - a new regulation can be stopped by congress via a Joint Resolution - Both houses passing a law basically, with majority votes etc. Seems extremelly unlikely for a cigar/ecig regulation that affects under 15% of their constituents. Hence you saw a lot of references last month to a conservative proposal to change this to the reverse - where both houses would need to approve a new regulation. However that would represent a congressional veto which has been struck down before by the high court. If congress gives the president or the head of HHS discretion over regulations, its already given up control - and most of the laws of the last 25 years seem rather delegatory like that.

The remaining steps are to - presumably digest the public comments from round 1, but theres nothing that actually makes them give them proper consideration? - propose the rule again, get OMB and OIRA - which are both under office of the president, approval, then publish the new rule as a regulation.

Congress could veto it with a joint resolution, they could hold hearings and make people sweat on camera, but practically they are limited to amending the current law with some little change stuck into an unrelated law. E.G. a budget may show up with a strange clause related to the grandfathering date on newly deemed tobacco products. A resolution that can be interpreted as weakening tobacco regulation, or a bill that does the same - very hard to pass - not worth it when 5-15% of constituents care.

I think a great many more than that care. For all of us recent-smokers-now-vapers, there are family members who care a great deal, that we should continue to have access to the technology that has allowed us to finally be free of tobacco. They may not really understand some of the finer details, but they see that vaping is the first thing to REALLY WORK for the vast majority of us, and if they love us, they'd probably like us to be around for a few more years, not to mention the vast boon to their own noses that we no longer reek of cigarette smoke. And then there are those who are opposed in principle to the gov't overreaching itself into areas in which it has no business, or the gov't lying to us to protect its own conflicted interest. I think a great many care about that.

Andria
 

Jman8

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All I know is with a CASAA CTA on the immediate docket, Boehner drawing a line in the sand, ANTZ likely gathering troops together, and vapers (and their friends and family) ready to do battle in a round 2 of FDA proposed regulations, it surely seems like things are coming to a head.

Have I mentioned that I'm really really glad Pubs will be in control of both houses soon? Knowing that, I no longer feel like the vaping community is stuck between a democrat rock and a hard (read as stubborn) president.
 

AndriaD

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All I know is with a CASAA CTA on the immediate docket, Boehner drawing a line in the sand, ANTZ likely gathering troops together, and vapers (and their friends and family) ready to do battle in a round 2 of FDA proposed regulations, it surely seems like things are coming to a head.

Have I mentioned that I'm really really glad Pubs will be in control of both houses soon? Knowing that, I no longer feel like the vaping community is stuck between a democrat rock and a hard (read as stubborn) president.

I agree, and the day after the election I breathed a tiny sigh of relief, that we'll soon be out from under all these busybody nannies. I know both sides are corrupt, but at least the Pubs are corrupt in terms of protecting their own pockets; the nannies are corrupt by lying to everyone "for our own good," which gripes me to no end -- I think at 53 I'm capable of knowing my own good without their lies and interference. I'm much too old to need a nanny.

Now waiting with bated breath for that CTA...

Andria
 

Bill Godshall

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Kent wrote:

I know all of that :) What I was addressing was the bold part in the Boehner letter: "...that the grandfather date for them be set at either April 25, 2014 (the date the proposed deeming regulation was published) or the date the final rule is published."

... and your reference in your one post to a possible "...2015/2016 final rule". And the 'scramble' that would happen with manufacturers mainly, of attempting to push proposed designs into reality before that prior rule, so as to set a 'predicate product' that might be easier to duplicate for future products and SE applications for those products.

If the grandfather date for newly deemed products is changed to the date FDA issues the Final Rule (which could occur in 2015 or 2016), of course it would be wise for e-cig manufacturers to get their newly developed products on the market before that date.

But nobody (except FDA and DHHS officials) would know the day, month or year (or even if) the FDA is going to issue the Final Rule (unless an FDA or DHHS staffer illegally leaked that info to tobacco or e-cig companies, or the news media).

Regardless, the filing of SE Reports (for e-cigs on the market prior to the grandfather date) won't occur until a year or two after the Final Rule is issued, and their purported purpose (which makes no public health sense but would be consistent with the precedent set by the FSPTCA) would be to ensure that the e-cig products marketed in 2017 are nearly identical to (i.e. no more hazardous than) the products marketed before the grandfather date.

But just one SE Report would have to be submitted to the FDA for each e-cig product.
 
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Kent C

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Kent wrote:



If the grandfather date for newly deemed products is changed to the date FDA issues the Final Rule (which could occur in 2015 or 2016), of course it would be wise for e-cig manufacturers to get their newly developed products on the market before that date.

But nobody (except FDA and DHHS officials) would know the day, month or year (or even if) the FDA is going to issue the Final Rule (unless an FDA or DHHS staffer illegally leaked that info to tobacco or e-cig companies, or the news media).

Regardless, the filing of SE Reports (for e-cigs on the market prior to the grandfather date) won't occur until a year or two after the Final Rule is issued, and their purported purpose (which makes no public health sense but would be consistent with the precedent set by the FSPTCA) would be to ensure that the e-cig products marketed in 2017 are nearly identical to (i.e. no more hazardous than) the products marketed before the grandfather date.

But just one SE Report would have to be submitted to the FDA for each e-cig product.

Short of a Chowdhury-type 'baseline predicate product,' that seems like the best scenario, short of no deeming at all. It would seem that such SE reports on new products beyond a 2015-2016 grandfather date would be much less onerous on manufacturers than the current assumption. And as I read you, it would be more about 'no more hazardous' than about specific design features - of which I was unsure.

So something that ensures better battery protection or as in the case of the Evolv DNA-40 that may prevent particulates, and eliquids that are diketone and formaldehyde-free, might be something that may be accepted over, say, a new mod build that can now reach 300 Watts or a new Red Hot Atomic Cinnamon flavor :)
 
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SeniorBoy

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Short of a Chowdhury-type 'baseline predicate product,' that seems like the best scenario, short of no deeming at all. It would seem that such SE reports on new products beyond a 2015-2016 grandfather date would be much less onerous on manufacturers than the current assumption. And as I read you, it would be more about 'no more hazardous' than about specific design features - of which I was unsure.

So something that ensures better battery protection or as in the case of the Evolv DNA-40 that may prevent particulates, and eliquids that are diketone and formaldehyde-free, might be something that may be accepted over, say, a new mod build that can now reach 300 Watts or a new Red Hot Atomic Cinnamon flavor :)

Ditto! :)

And of course the Dr. Farsalinos crowdfunded campaign/study plans to examine those issues and much much more. Unfortunately, with only a few short days left, the goal of 72K has still not been met. Please take a few minutes out of your busy day and review this valuable campaign at the Indiegogo web site.

:)
 
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Jman8

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So something that ensures better battery protection or as in the case of the Evolv DNA-40 that may prevent particulates, and eliquids that are diketone and formaldehyde-free, might be something that may be accepted over, say, a new mod build that can now reach 300 Watts or a new Red Hot Atomic Cinnamon flavor :)

All I want to hear a politician say is, "If you like your Red Hot Atomic Cinnamon flavor, you can keep your Red Hot Atomic Cinnamon flavor."
 

Sirius

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If you don’t move up the grandfather date, then the FDA is never going to [give premarket approval] for a flavored e-cigarette product - that will be their backdoor prohibition on almost all flavors,” he says. “Maybe they’ll approve a scotch or whiskey, but they won’t approve the flavors I like.”

Many e-cigarette users zealously defend their preferred candy- or fruit-flavored e-liquid against claims from politicians and health advocates that these options are intended to appeal to children.

A survey conducted earlier this year by the E-Cigarette Forum website found 79 percent of 10,000 respondents would "look to the black market" if products they use are banned. E-cigarette users can already blend their own flavors using commercially available food flavoring - a practice almost certain to expand in response to restrictions.

House Leaders Rush to Defend E-Cigarettes From Possible FDA Bans - US News

You might be asked to take a serve after reading this from the FDA..If so, my apology in advance.
 

AndriaD

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JustJulie

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Done!

Had to change some of the CASA nonsense writing so that it would fit with my CASAA sensibilities.

Methinks part of CASAA forgot the 2nd "A" in the message they constructed.

Oh, no . . . and you wouldn't believe how many times we proofed all of that. :(

Can you let me know in which document we have the typo?
 
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