Deeming Regulations have been released!!!!

[wiredlove]

I just sent another email to the Homeland Security and Governmental Affairs Committee.

Dear Senators,

Yesterday you should have received a response from the FDA to Sen. Ron Johnson’s letter regarding the burdensome e-cigarette regulations. I urge you to review the material very carefully. I suspect much of the response will be based on Final Regulatory Impact Analysis (Docket No. FDA-2014-N-0189).

I am a member of the Electronic Cigarette Forum, a web forum with over 244,000 members. Many of us have been analyzing the Final RIA line-by-line (as we have, and continue to do, with any other documents we find) and, honestly, the report is more complex, confusing and contradictory than the Final Deeming regulation.

Thank you in advance for having common sense.

Sincerely,

I sent them a much shorter comment, thanking them and the staffer by name. Also mentioned that the FDA was encroaching on my unalienable rights of life, liberty, etc.

 

[The Ocelot]

WHAT?! You're asian?!!?

I was pretty shocked he doesn't look like Sigmund Freud.

 

[HazyShades]

I just sent another email to the Homeland Security and Governmental Affairs Committee.

Dear Senators,

Yesterday you should have received a response from the FDA to Sen. Ron Johnson’s letter regarding the burdensome e-cigarette regulations. I urge you to review the material very carefully. I suspect much of the response will be based on Final Regulatory Impact Analysis (Docket No. FDA-2014-N-0189).

I am a member of the Electronic Cigarette Forum, a web forum with over 244,000 members. Many of us have been analyzing the Final RIA line-by-line (as we have, and continue to do, with any other documents we find) and, honestly, the report is more complex, confusing and contradictory than the Final Deeming regulation.

Here is a short list (I realize it’s actually long, but there are a lot of troubling statements in the document):

1) It is clear the FDA has little information on how many businesses the regulations impact. They seem pretty arrogant about it as well.

"In comments, the CEO of Vape World is cited as saying there are more than 3,500 independent vape shops in the U.S. Comments cited industry analysts estimating that there are 5,000 to 10,000 vape shops in the U.S. In comments, an individual from a trade association is said to estimate that there are 14,000 to 16,000 brick and mortar vape shops in the U.S. The Tobacco Vapor Electronic Cigarette Association estimates that brick and mortar stores will sell more than $1 billion in vaping equipment and products in 2014."

FDA response:

"As the comments describe, the industry is in a state of flux; during the time that the proposed rule was in review, and since the proposed rule was published, the ENDS industry has grown and additional vape shops have opened. The comments on the number of ENDS manufacturers did not provide concrete data sources, but rather industry estimates for which the bases were not given."

"In the RIA for this final rule, based on logo counts from trade association websites and FDA listening sessions, we estimate that there are 168 to 204 manufacturers of ENDS products, other than retailers who mix their own e-liquids, selling goods in the US market. We also estimate that there are 14 importers of ENDS products."

I don't see how "logo counts from trade association websites and FDA listening sessions" are more concrete data sources than industry estimates. All they have identified are manufacturers with logos who are members of trade associations.

2) The word “consolidation” appears 37 times in the report. According to my interpretation, it suggests Big Tobacco companies that can afford to comply with the regulations will buy-out smaller companies they forecast to be profitable. As for the rest, all they have to do is wait for the competition to exit the market.

The word “exit” appears 147 times.

“…consolidation and exit would be expected to occur under the baseline as successful firms represent an increasing share of market sales, market leaders perhaps absorb smaller firms and products, and smaller firms merge into larger entities or exit from the market). We expect a much larger share of ENDS products to exit rather than submit a premarket application.”

“We continue to assume a substantial amount of product consolidation and exit will occur as a result of regulation, as described in the final RIA.”

“[The] FDA acknowledged in the PRIA that premarket submission requirements could lead to significant product exit and reduced entry.”

“To the extent that smaller firms or firms in particular segments of the industry have relatively low sales volume per product, they will be disproportionately burdened…”

“…the growth we have seen in the ENDS market, we now forecast that a larger number of requests for marketing authorization will be submitted for e-liquids and ENDS delivery systems…”

“We also assume 54 percent of delivery systems and somewhere between 50 and 87.5 percent of e-liquids will not submit a marketing application and will exit the market after the initial compliance period for the submission and FDA receipt of PMTAs ends. The e-liquid share is particularly difficult to predict in view of uncertainties about the number of distinct products currently available on the market.”

3) The high estimate of smaller companies exiting the market it’s surprising when one considers:

“…at the low end of the average cost spectrum would be product lines of cartridge- or disposable e-cigarettes which have an identical underlying delivery system, flavor variants likely to share basic ingredients, and similar ingredients and constituents for which existing information can be used to support a PMTA. This case is assumed to have total costs of $285,656.”

“…at the high average cost end is a single open-system device requiring considerable original research and testing amounting to $2.6 million.”

It is clear these estimate gives an unfair advantage to the makers of cartridge or disposable e-cigarettes, which are what Big Tobacco companies currently have on the market.

I also have yet to find a specific definition of a “single open-system device.” Does that refer to the battery tube/box? The tank? The drip tip? The device I am using this very moment is made up of components from 5 separate companies. Does that really mean it would take 13 million dollars to bring the same configuration to market?

By using what I think is an “open system,” I was able to quit cigarettes 4 years ago after smoking for 40 years. I’m very worried about this situation as a consumer, a supporter of small businesses, and as person who wants other smokers to have options to stop using combustible tobacco.

Thank you in advance for having common sense.

Sincerely,

Very well written and to the point.
This really rubs against the grain of free enterprise.
Do you "expect" any positive outcome from the letter?

I'm thinking it's time to exit stage left...the Czech Republic looks better with each passing day

 

[The Ocelot]

Looking on twitter for any info about the response to Johnson's letter, came across this which indicates no response?
FDA Snubs Senate Inquiry as Expected, Committee Will Pursue

Great post! I guess my email to the Committee gave the FDA more credit than they deserve.

 

[HazyShades]

I sent them a much shorter comment, thanking them and the staffer by name. Also mentioned that the FDA was encroaching on my unalienable rights of life, liberty, etc.

Mentioning them by name is good, it makes it personal.
But I don't think life, liberty, ETC mean much to these guys..

Regards,
Hazy

 

[grandmato5]

I agree with your entire line of reasoning, that we needed to distance ourselves from tobacco earlier on in this debate, and also (I believe it was your point) about even distancing nicotine from tobacco and the whole issue with supporting age restrictions.

I also agree that we need to start looking forward (again) from our new position of peril - but I think we're failing again. I think, at this point, we need voices, as many voices as we can get, speaking of outrage and hypocrisy. We need so many voices, if we hope to get anything done, that we NEED non-vapers to be screaming as loud as those of us with a personal stake...but we're failing to even get the actual vapers to take notice. And, it's our fault.

The experience I had at one of my local B&Ms yesterday was almost the exact same I've had three times now. (Sorry in advance for the long story, but you've all probably figured out by now that that is how my brain works.)

It wasn't a shop that I frequent, because their prices are a little crazy, but the current step in my carefully crafted stockpile plan is to get several mech mods, and I've been hitting all the shops to see what they had.

While I was checking out the mechs, another customer walks in with a broken regulated box and starts talking to the shop keeper about a new one. The owner showed him some options and said the best one he had was a Subbox kit ($95!!?!?), which is what I had walked in with, so the owner asked me how I liked mine, hoping for a positive review that would help him.

I told him I thought it was a good upgrade to his broken box (not wanting to get into fixing the broken one, or the ridiculous price they had on the Subbox, out of respect for the shop), and the other customer asked if he'd need one of the battery tubes I was looking at, too; "is that like an extension or something?"

The customer had said that his broken box had only lasted a year, he was using an aspire tank with packaged coils, and that he wanted a new box that would work with his tank and his battery. It was pretty obvious he was a one-device, store-bought kind of guy, who got all/most of his info from the shop where he bought his coils and juice- the kind that will be most devastated by these new regs.

I explained that the "battery tube" was a separate mod, and that I was stockpiling extra gear in light of the upcoming regs/bans.

"What regs?"

So I did the "elevator-speech" version of what's happening that I've sort-of distilled after talking to so many casual-vaper and maybe-vaper friends/family/co-workers.

The customer was floored, but so was the shop owner. He stopped me and said "nothing's being banned, the government is just posturing..."

The guy was standing in front of one of the CASAA posters that says something like "This shop supports your right to vape...join CASAA", so I was a little confused that the owner, obviously affiliated with the advocacy groups in some manner or another, could understand the situation so poorly.

So, to try to help, I started to flesh out the points in the "elevator-speech" a little, and the shop owner stopped me again, getting a little agitated. He explained to me and the other customer the grandfather date, what the predicate product, if there really was one, would look like, the PMTA process, and even cited the Nicopure suit, and the injunction that was "sure to come".

...so the shop owner clearly was following the regs and the developments...

I countered that the litigation steps being taken might help, but there was no guarantee of victory, or even an injunction and...

He shut me down again. To the other customer, "Trust me. WE know what's going on. This thing is going to be tied up forever and nothing is going to happen."

I let it be, paid for what I'd picked out and left. His shop, his atmosphere, not my place to upset it.

But it bothered me.

This is the third time I'd had an experience similar to this one. Granted, the other two were not as hostile, but in both other cases, the shop owners wanted me and the other customers to rest easy and trust that "they" had it all under control.

They're the church, we're just the parishioners. Let the adults handle it.

I spent a good while thinking about it, and I suppose I can see some possible reasons why a retailer might want to downplay the concern, but it goes against everything I've learned about grass-roots advocacy.

In my industry, the retailers don't try to downplay the concern, they use it. When there is a new legislative attack, the gun shop owners will actually hang signs "get it while you still can", and run specials on products that are subject to new restrictions. They WANT every customer to know what the current threats are, when they walk in the door, whether they buy the thing or not, so that they will at least tell someone else after they leave.

My experience above is not unique, but is also not typical of my recent shopping experiences (I've visited A LOT of vape shops the last several months). I travel for work and visit as many local shops as I can find on each trip, and I've had a couple strong advocates (only a couple), a BUNCH of totally oblivious shops, and, then, three like the one I described above.

Why, in light of the fact that our life-saving "hobby" is facing a near-total ban, have I NEVER been asked, as soon as I walked in the door, if I was aware that my right to vape is being mortally threatened?

Never mind that it doesn't happen EVERY time, why haven't I heard it even once?

Is SFATA (I'm obviously not a member) sending out mailers to instruct retailers on the importance of informing their customers of what is happening? If not, why not?

Even if SFATA can't get their transmission in gear for a simple advisory like that, why are the retailers failing to see the importance of a well-informed customer base?

Most of my purchases have had a POS that asked for an email to send my receipt. Why hasnt SFATA asked their retailers for email lists, and handed them over to CASAA for daily call-to-action/donation-drive emails?

Why hasn't SFATA provided their retailers with ready-made email blasts for them to send out directly?

Why? Because of this industry's lack of maturity and focus that I've been ranting about for the last 400 pages.

Because, to the nexus point of your post and this one, with very few individual exceptions, this industry either doesn't want to, or just isn't capable of looking forward. They are, I'm afraid, going to continue fighting defensive battles that are already lost until they've defended their way right into losing the war.

I soooo agree with your post !!!

THE FDA has been telling us for 7 years that they were going to strongly regulate us one way or the other. Never once have they given us any other impression. And yet, there are so many people within the industry that still don't understand how serious this is Is it that so many of them have the additude of "Let someone else fight the battle so I don't have to bother???" Or is it " Nothing bad has happened in 7 years so it's never going to?" Whatever the reason, it's wrong and part of the reason we are where we are today.

 

[HazyShades]

Great post! I guess my email to the Committee gave the FDA more credit than they deserve.

You mean the FDA deserves credit..for what?

 

[HazyShades]

Is it that so many of them have the additude of "Let someone else fight the battle so I don't have to bother???" Or is it " Nothing bad has happened in 7 years so it's never going to?"

I'll bet 5 bucks on one and 5 on the other. Complacency. Laziness.
Fear. Don't forget fear. I forget whether it was on this forum or another
that I saw somebody talking about how admitting one uses tobacco products
like vaping to a government agency or anywhere where one self-identifies
by name might just get one's OBAMA CARE cancelled.

Regards,
Hazy

 

[The Ocelot]

Very well written and to the point.
This really rubs against the grain of free enterprise.
Do you "expect" any positive outcome from the letter?

I'm thinking it's time to exit stage left...the Czech Republic looks better with each passing day

It felt good to write and submit it. That was what I expected.

 

[ZeroedIn]

Looking on twitter for any info about the response to Johnson's letter, came across this which indicates no response?
FDA Snubs Senate Inquiry as Expected, Committee Will Pursue

 

[The Ocelot]

You mean the FDA deserves credit..for what?

I was giving them credit in advance for responding to the committee's request. I was wrong.

 

[zoiDman]

Looking on twitter for any info about the response to Johnson's letter, came across this which indicates no response?
FDA Snubs Senate Inquiry as Expected, Committee Will Pursue

I am Very Surprised that the FDA did not Reply or ask for More Time to Reply to Sen. Johnson "Request".

But am Happy that they Didn't. And I hope that it Sends a Clear message to Members of Congress that the current FDA Leadership feels it is Not Subject to Congressional Oversight.

 

[HazyShades]

It felt good to write and submit it. That was what I expected.

Good! Feeling good about one's self is the best motivation ever.

 

[Bronze]

Looking on twitter for any info about the response to Johnson's letter, came across this which indicates no response?
FDA Snubs Senate Inquiry as Expected, Committee Will Pursue

Here is a piece of that conversation with the Ron Johnson staffer...

"I asked him what the Committee’s specific powers were to enforce changes on the FDA’s ruling. A direct answer to this question is too complicated for a simple phone call, most likely over-complicated because of the two centuries of precedence fueled by political maneuvering. But the general summary I can give from our conversation is direct action by the Committee will likely not be necessary.

The Committee seeks first to expose information for the public. This information then becomes available to private interests who can and are filing lawsuits to stop the FDA. The Committee’s expectation is these lawsuits will be successful and they see their role as helping to bring relevant information to light to make these lawsuits easier to pursue."

I stated earlier when this questionnaire was first mentioned on this thread not to get overly excited about it. I said this because I saw many people jumping on this as if it was the magic arrow that would deflate the Deeming regulations. This staffer's response proves this is NOT a magic arrow as I stated. I was also accused of being somewhat of a "Gloomy Gus" for suggesting this would not be a magic arrow. I'm sorry, but I want to deal in reality. These questionnaires are standard procedure and rarely (if ever) force change in and of themselves. I hate to see anyone get all pumped up about something only to be let down when it does not produce the results they had hoped for. If this makes me a "Gloomy Gus" then so be it. At least what I say has credibility.

That said (and I said it before as well), this does NOT mean Senator Johnson's questionnaire is a waste of time or useless. It does have some merit as outlined by his staffer in his quote above. It does add to our quiver that can be used to make our argument. Just a small piece, but a piece nonetheless. For this, we should be thankful for Senator Johnson's efforts. But let's be sure we keep this action by Senator Johnson (and other actions) in their proper proportions so as to keep us continually focused on all things big and small and the attention each deserves. More than Senator Johnson's questionnaire, his activism beyond this questionnaire will likely be more impactful. It is nice to have advocates in the legislature and Senator Johnson appears to be taking a lead.

 

[HazyShades]

I was giving them credit in advance for responding to the committee's request. I was wrong.

Oce, you're about my age...giving credit to any government agency
is like expecting the VA to give a vet medical treatment...just my humble opinion

 

[Pamawoman]

Does anyone know anyone who lives in California's 50th Congressional District (it's inland from San Diego)? I want to find out what Rep. Duncan Hunter has to say about the new regs. I can't email him myself since his contact page doesn't accept messages from constituents outside of the district.

I tried that also. Maybe a letter?

 

[nicnik]

I forget whether it was on this forum or another
that I saw somebody talking about how admitting one uses tobacco products
like vaping to a government agency or anywhere where one self-identifies
by name might just get one's OBAMA CARE cancelled.

Or whatever other health insurance they may have, unless they disclosed their vaping in their application (and can afford the extra surcharge).

 

[Pamawoman]

Looking on twitter for any info about the response to Johnson's letter, came across this which indicates no response?
FDA Snubs Senate Inquiry as Expected, Committee Will Pursue

Took me to smokymountainvapes?

 

[HazyShades]

Or whatever other health insurance they may have, unless they disclosed their vaping in their application (and can afford the extra surcharge).

Right. I mentioned only Ocare because
all the gub'min computers play nice with each other when they actually work
(those old 286 dos boxes don't always work and share their massive database.

I took a chance and ran my mouth but I don't believe in
today's modern healthcare and if I ever get that sick I'll eat my piece..
so I don't really care if I lose my insurance
but many people do.

Regards,
Hazy

 

[HazyShades]

Took me to smokymountainvapes?

yea, the response is in there, just let yourself in, Sarge