FDA Congress can stop this thing?

[Stosh]

I think that since the FDA has 'requested comments' on that an a bunch of other things, that if there's a preponderance of comments regarding changing the grandfather date, that is something they could bring to Congress' attention. Not counting on it, but it's a possibility. In the light of some 'easing' we are seeing abroad - not 'ideal', I agree, and there seems to be some slowing in the all out attack by the media - again 'some' (not all), this might be an 'out' for them if they want one.

And the latest figures that are available for 'percentage smokers' is 2012. I'm wondering if they've peeked at the more recent results yet. I can't imagine it not being down 2 or more percentage points due to the trend since 2010 and a bit before even. That could be a factor - that, along with the decreasing cig sales. Again, 'something' has changed and it isn't Chantix, gum or patches which have all been around before 2010. The only real 'culprit' is ecigarettes.

Neither the congress or the FDA had sufficient information, studies or even short term effects to begin regulating e-cigs intelligently, it's never stopped them before, and the reputable science seems to fall on too many deaf ears now.

The long term effects seem to be very much in favor of vaping, if it survives in it's current form for the data to be collected. Changes in smoking rates are still being attributed to the CDC / FDA / AMA Stop Smoking advertising programs, high taxes and sales restrictions. I've always pictured their meetings as sitting around a table holding their ears, shouting "nah, nah, nah, I can't hear you"...

 

[Kent C]

Neither the congress or the FDA had sufficient information, studies or even short term effects to begin regulating e-cigs intelligently, it's never stopped them before, and the reputable science seems to fall on too many deaf ears now.

The long term effects seem to be very much in favor of vaping, if it survives in it's current form for the data to be collected. Changes in smoking rates are still being attributed to the CDC / FDA / AMA Stop Smoking advertising programs, high taxes and sales restrictions. I've always pictured their meetings as sitting around a table holding their ears, shouting "nah, nah, nah, I can't hear you"...

It's natural for them to want to take credit - it's been their 'life's work' (unfortunately). But one really must ask - "What changed?" and the answer to that isn't just more advertising - they've been doing that for years - and without much effect. Taxes are a factor, but again, they've been around and smokers went DIY with tobacco before quitting. The answer is ecigs. That's 'what changed' and it tracks with both the reduction of smokers and the drop in cig sales as well as the boom in ecig sales.

 

[pamdis]

Instead of pushing for alternative # 3 - Changing the Grandfather Date, why not push for one of the first two:
1. Deeming only; exempt proposed deemed products from all labeling changes and premarket submission requirements
2. Enforce premarket submission requirements only for machine-made cigars

 

[Kent C]

Instead of pushing for alternative # 3 - Changing the Grandfather Date, why not push for one of the first two:
1. Deeming only; exempt proposed deemed products from all labeling changes and premarket submission requirements
2. Enforce premarket submission requirements only for machine-made cigars

Those are good too. It was in the alternative #3 where they said specifically: pg 69 - "The table shows the reduced burden for cigar manufacturers but this alternative would provide even greater relief for small businesses producing electronic cigarettes."

I'm guessing the labeling is more of a given from their other 'extended remarks' on no sale to minors and labeling.... but maybe not.

There's no specific wording dealing with ecigarettes in alternative 1. pg 56-57. Although it does state:
"...but would exempt the proposed deemed products from enforcement of the labeling change requirements and new product submission requirements that would otherwise apply under the FD&C Act."

So I would think that ecigs would be included. But I focused on where ecigs were specifically mentioned.


Even under 'alternative 2':
"However, we assume that when premarket requirements are not enforced, fewer electronic cigarette products would exit the market because costly premarket submissions would no longer be required. Therefore, in analyzing this alternative, we assume that all electronic cigarette products would incur the cost of changing labels to comply with this rule."

That's why I went with alternative #3.... but I'm open to other suggestions of course.

 

[Jman8]

Instead of pushing for alternative # 3 - Changing the Grandfather Date, why not push for one of the first two

What Kent said.

And, for me, in this thread, it is not an either-or proposition. I'd be wording it as, "In addition to pushing for alternative #3, why not also push for the first 2 as well?"

All three of these mention "reducing cost" which one would think in today's day and age would be popular with any congressperson that isn't overtly ANTZ.

 

[Kent C]

I just want to acknowledge pamdis for originally bringing up the Economic Impact Analysis doc. Before that I was:

After:

 

[wv2win]

Your other thread is highly relevant to this thread, and parts of it deserve to be quoted here. But do wish to say that the partisan stuff that occurred there won't be tolerated here as much, as I am OP and really just don't care for a political point if it can't be tied to vaping (directly) within 2 to 3 posts.

Anyway, you provided the link, so I'm going to provide the quotes.



So fair to say (part of) Congress is not in favor of FDA taking any action relative to electronic cigarettes.



For me, this is the biggest take away. It is possibly first time I've heard anyone at national level, with authority, express this.

It does make me want to (again) write my own state's congresspeople and see if they have this awareness and share the concern. Also seems like the sort of thing that a CTA is ripe for. To have many ECF'ers writing and getting as many as possible known to us who do share this concern.

What I said in post #18 of this thread would be where I would be headed with this, and is part of the reason I hesitate in writing. I'd want to mention moving the grandfather date, but hold off writing at all, because I feel like that is so underplayed in the vaping community that I feel like I'd be possibly barking up wrong tree. For me, it is the most viable tree, but the idea of 'kill the bill' is more tempting to go for and seems to be getting slightly more play at this time.

If I and say 5 other people go to FDA and say do this or that, they have default rhetoric of "sorry, we are not legally permitted to do so." But if x amount of congress people started saying, "either we kill this or you move the grandfather date," then we are talking about a different game. Or as I like the chess analogy, we'd be putting FDA into check on this issue (but not checkmate).

And yet, the most spoken about strategy at this point is: a) delay comment period and b) delay FDA action enough until there is change in Congress and hope for the best. I honestly do not like this more than what I mentioned above as "most viable," but as this one leads to "kill the bill" it is hard to take a firm stance against it.



Even more reason to write to own Congresspeople. Currently shows up to many ECFers, and I would guess most in vaping community, that we don't have Congress in our corner. Likely Burr, probably Alexander, and now Isakson. Perhaps other congresspeople are known to other citizens, but would be nice for us simple laypeople to know as we fret daily about what FDA will surely be doing very soon. Yet, can't really do if Congress speaks up and expresses their concern with what FDA is up to in light of FSPTCA that Congress came up with.

CASAA has directly hinted at this as overarching strategy going forward. So writing is on the wall really. But I do wonder if writing ought to be on the forum. We have CASAA forum for this, and perhaps ought to have place where not all 'visitors' eyes' can see what we are up to. At same time, I'm thinking it is better to stay open on this and let the other side feel the frantic part of this, realizing that both at national and state level they have very visible and vocal opposition that will stand up to the deceptive campaign they are clearly waging.



Another type of hearing in DC would be great. One that speaks to THR as front and center issue. And one that has umpteen small business vendors expressing their legitimate concerns to national and federal personnel so that isn't so easily downplayed by our opposition. Yet, this is ultimately up to Congress and/or media to bring this to forefront.



Second biggest take away for me, even while I have serious concerns about how it could play out.

My concern is why go for cessation claims (only) when THR and significant reduction in smoking are truth for most vapers and don't dance on line that some vapers rather not dance on?

My takeaway and like for this is to hear as many people as possible nationally who express that eCigs worked (to reduce/stop smoking). The more the merrier, and the more that are in Congress, the better.



As much as I have been vocally optimistic since 4/24/14, I do have issues with the 'hurry up and wait' approach. Wait for comments to be extended, which you may not know about until 2 weeks before the comment period ends, and wait for midterm elections to change things and eliminate our concerns, which you may never know about until next people in Congress tell us what their position is exactly. When all FDA has to do is establish regulatory framework that has already been proposed. I feel confident that if I had been expressing the 'hurry up and wait' approach with these 2 specifics in mind during the week or two after 4/24/14, it would have lead to harsh criticism as something to hang our hat on. But if Bill G. or Isakson say it, suddenly it is a viable option and seemingly no criticism warranted about that strategy going forward. I dunno what to say on this really as it gives support to the optimistic position and I'm all cool with that.



Said what I needed to say above this quote, and with this one just wish to reiterate my appreciation to wv2win for communicating with Isakson's staff, sharing that with us, and contributing to a new way of understanding this significant issue going forward.

Jman, first, thank you for your "thanks" on my efforts.

Second, I think you make some very good points. I have some of the every same concerns that you have. I am feeling somewhat uneasy with what appears to be a "wait & see" perspective from those in the forefront of the vaping community. Here are some idea's that have been rattling around in my head:

1. The vaping community needs to attack the Deeming Regulations on more than one front or issue. In communicating with elected officials we need to specifically:

A. highlight the positive science in support of the safer alternative of vaping
B. highlight the harm reduction aspect of vaping
C. highlight the job creation aspect of vaping
D. highlight the negative effect on jobs and small business growth as a result of these regulations
E. highlight the resultant return to smoking for a large segment of the vaping community due to
these regulations
F. highlight the founding principle of our democratic tradition to allow people to live their lives with
minimal government interference
G. Propose a change in the "grandfather date from 2007 to 2016 if the regulations move forward

I believe we all need to be well versed on these points and communicate them to any and all elected officials repeatedly.

I also don't believe we can "hang our hat" on any one solution to the problem, such as a change in the leadership of the senate. That change in leadership may not happen.

2. I think our vaping leadership both from a consumer standpoint and a vendor standpoint, need to start thinking about a true "grass-roots" effort. Organizing locally under the umbrella of one or two national organizations with a coordinated agenda and activities. It would require many of us who are regulars on ECF, for example, to get much more involved in trying to organize local chapters that would disseminate information, write letters to congress, try to interest local media and even do a march on Washington at some point.

There is much truth to the old adage that the "squeaky wheel gets the grease". We need our "squeak" to be intelligent and loud.

 

[wv2win]

Is now the best time for that?

You want an influx of comments from vapers.
A Call To Action.

Asking Congress for the opportunity for the FDA to change the Grandfather date is a move that can happen at any time, no need to wait as far as I can see.
So a Call to Action targeting our representatives asking for such might be a good move any time now.

On that I can agree.

My only concern with "changing the grandfather date" is what effect it may have on the future of vaping. What if some new, wonderful vaping invention/method comes along after this date? Or would anyone even bother to research any new, great advancements in vaping if the odds of it being approved are nil? From what I understand, there have been hundreds or even thousands of applications for new cigarette products that go nowhere.

 

[Jman8]

My only concern with "changing the grandfather date" is what effect it may have on the future of vaping. What if some new, wonderful vaping invention/method comes along after this date? Or would anyone even bother to research any new, great advancements in vaping if the odds of it being approved are nil? From what I understand, there have been hundreds or even thousands of applications for new cigarette products that go nowhere.

I would say this is a legitimate concern. Yet, hard to predict how it would play out as we today can't really imagine what this new invention may look like. If grandfather date changes, and it looks like vaping, then it has predicate product from which to submit application. If date changes and it is 'nothing like vaping' but just as wonderful, then it is plausibly new product, needing new product application (and new studies / data to establish its 'safety').

I think part of reason applications haven't gone anywhere is FDA was intentionally avoiding them if it wasn't already an 'obvious' tobacco product, and if it was essentially a combustible, I think that was receiving lots of scrutiny. I'd say undue scrutiny and some might agree, but I think majority (even on vaping forum) would disagree. I don't know what exact reason was, but IMO, this makes some sense and in some ways helps FDA going forward. To the degree that it doesn't, then it really helps vaping IMO. If it takes 4 years to approve 5 out of 3000 applications and FDA has said vaping product can remain on market until FDA rules on it, then at this rate, we are talking about sometime around 3827 when certain vaping products will be ruled on.

Another thing I wonder about is of what interest is it for a manufacturer to submit an application to be registered with the FDA? I get that BT and BV will comply or die trying, but it is challenging to understand the benefit to other manufacturers especially if they are making products that don't contain nicotine and may or may not be used to vape nicotine. Most of me does think these won't be regulated nor aggressively pursued for regulation. But part of me isn't sure and it then becomes a question of how aggressively will they actually be pursued, and on what grounds? Imagine manufacturing a product today that from your own intentions / pre-marketing assessment is not targeted to vapers, and yet orders are pouring in from vapers who see this as great way to circumvent (hypothetically) strict regulations while having a product that 'does the trick.' Let's even say ANTZ is onto this sort of thing. But manufacturer has never ever advertised their product as intended to be used for eCigs, and honestly didn't consider it in pre-market planning. Who would then decide that is an 'unregulated tobacco product' and on what grounds? Now, I ask all that, because it sets up a whole bunch of situations where crafty manufacturers can say they never intended it (when in reality they did) but why would they want to submit application when it can be shown that their products can be/are used for something other than what constitutes a finished tobacco product? Presumably, the people that will submit applications are the type that do want to advertise / market themselves as product intended mainly for vaping nicotine. And yet, curtailing advertising is significant part of this proposal. So, of what benefit is it to manufacturer to comply? With all that said, I realize there are people that will read all this and try to sell readers of this thread/forum on idea that cost of not complying will be far worse for that business. IMO, with how poor the regulations are written showing utter lack of understanding of vaping products by FDA, that scenario is a decade away. At minimum. But like all things in this discussion, I guess we'll just have to wait and see, to determine why any business (that is not BT/BV) would seek compliance when reality is they probably won't need to, if product they manufacture doesn't contain nicotine, nor needs to, to function properly.

 

[Kent C]

And yet, wiki reports that the actual Act was HR1268...

correction:HR1256