FDA delivers Final Deeming Rule to OIRA

[DrMA]

Now is the time to appeal to OIRA and urge them to reject the FDA deeming of harmless, tobacco-free, and smoke-free vaping as a tobacco product.

http://www.reginfo.gov/public/do/eoDetails;jsessionid=A0988F2E80E1761AFEAAEAE9B4E602D0?rrid=125646

 

[AndriaD]

Follow the RIN to get to the actual document.

Not really. It just takes you to a page of links which don't mean anything to anyone who's not a gov't drone.

It's easy to see how our gov't has gotten so off the rails; they make dealing with anything governmental so impenetrable, you have to be psychotic to understand anything about it.

Andria

 

[sofarsogood]

A year ago there were about 15 smokers in my shop. Today there are 10 smokers and 5 vapers. The place has several different trades. Electricians, machinists, welders, builders, programers, designerrs, etc. All the people who switched, inclluding me, are in the electrical department. The solcal inflluence is evident. What's happening in my shop has to be happening in a lot of work places. Does the FDA really want to interfere with that? Where I work is in a 50,000 square foot area with a 30' ceiling. We are allowed to vape on the shop floor (I did tell one of the guys to turn down the watts, clouds too big). The non vapers say the impact on them is zero. Management is fine with it. One motive for management is if we aren't wasting money on cigarettes we live a lot better on what they can pay us. That might be the biggest benefit for all concerned.

When the OMB evaluates they are looking at what the government loses in taxes by allowing the Tobacco Age to end and what the public loses in all sorts of ways if more smokers keep smoking. To date no health consequences of vaping have been identified so they are left with a political calculation. An interesting cost/benefit tradeoff.

 

[philoshop]

Sometime I just feel like a mushroom. Kept in the dark and consistently fed government manure.

 

[sofarsogood]

I have 500ml frozen nic in the man cave freezer, about to double that. In an apt so tight now, liters are just not possible for space reasons. Have about 14 mods, mostly provari, some hex ohms and sigeleis. I would consider 10'to be quality enough to last a few years. A couple of kayfuns, some drippers

To me putting nic in the freezer is the same as house, medical and car insurance. Those three are thousands of dollars a year. 3 bottles of nic for $150 is a decade of protection and dirt cheap.

I did some more figuring. Starting with nothing I could spend $300 up front and be self sufficient for 3 years except, perhaps, batteries. In that same time I could spend $9,000 on cigarettes, a carton a week in Michigan. Vaping isn't cheap, it's free. Health issues will be debated ad nauseam. The economics are not debatable. I believe more people around the world will switch to save money than to protect their health. Lots of people have lots of money in the US so may be the economic advantage is not so obvioius.

Some more numbers. If 1.3 billions smokers are spending $800 billion a year that's about $600 per smoker. If they all switched to vaping and spent $100 per year the vape market would be $130 billion, an amount that includes no excise taxes, which would be hard to collect. This is what obsesses our dear governments, not our health.

 

[Stubby]

The usual suspect senators are pushing to get the deeming process as fast as possible.

http://www.merkley.senate.gov/news/...rettes-and-other-unregulated-tobacco-products

This is the critical part

We also implore that the final rule not move the “grandfather date” for new products (set at February 15, 2007). Altering this grandfather date would exempt a wide range of e-cigarettes and related products from any premarket review to determine whether they constitute threats to public health.

If the grandfather date is not moved the deeming is in reality a ban and essentially all current vaping products on the market will be gone. The premarket review is a catch-22 that makes it virtually impossible to do.

 

[zoiDman]

BTW - I just received this e-Mail from Vicy at cignot...


First, if you have not already done so, it is critical that you send an email to your Congressional representative and Senators asking them to support and co-sponsor HR 2058, a bill that would stop the FDA from banning 99%-plus of vapor products.

Second, please take a moment, on Wednesday, October 28th, to
Call the White House at 202-465-1111.

CASAA has provided talking points via the link.
http://blog.casaa.org/2015/10/national-call-to-action-tell-white.html

Third, please share this post with your friends (and feel free to copy/paste this text).

 

[Kent C]

I'm really not liking all the secrecy, doesn't seem to bode well imo. I've held off on panic nicotine purchases so far and I'm hoping I don't come to regret that.

The thing about nicotine purchases (if you know you'll continue to vape) is that there is no downside (except present time budget) - you're going to use it and it can last 5-7 years plus in a freezer and according to Kurt, who tests his regularly, it doesn't lose it's potency.

 

[zoiDman]

It's kinda Amazing, at least to Me, that a thread about Cotton ...

https://www.e-cigarette-forum.com/f...n-is-white-so-why-japanese-cotton-not.708776/

... has Twice as many Posts as this one does.

I guess How White cotton is, or Should Be, is More topical that the current state of the FDA Deeming process.

 

[zoiDman]

 

[Kent C]

But he's addicted to it. He 'needs' food.

 

[Katya]

Yet.....total silence on this document. Hmmmm............nobody EVEN ASKED.

Total silence???? Nobody asked????

The information came from TVECA (the Tobacco Vapor Electronic Cigarette Association):

http://www.tveca.com/

You may like or dislike TVECA, they have done some questionable things in the past, but the leak is from them undoubtedly. SmokeyJoe, the founder of this forum, started a thread about the leak, and I don't know anybody here who would question Smokey Joe's sources, credentials or his judgement.

https://www.e-cigarette-forum.com/f...le-of-contents-for-deeming-final-rule.709637/

 

[philoshop]

Nic is like ammunition: I don't go out of my way to hoard either, but I know that both will be useful to me at some point.

 

[navigator2011]

It's kinda Amazing, at least to Me, that a thread about Cotton ...

https://www.e-cigarette-forum.com/f...n-is-white-so-why-japanese-cotton-not.708776/

... has Twice as many Posts as this one does.

I guess How White cotton is, or Should Be, is More topical that the current state of the FDA Deeming process.

Maybe that many people feel that it doesn't make the slightest bit of difference what we, the vaping community thinks, the laws will be passed regardless. It seems to me that the FDA finds greater importance in stamping out vaping for fear of "renormalized smoking" than helping millions of smokers reduce the harm of using nicotine--they want to take us back to quit or die, without any middle ground. I think they've been pretty clear on that sentiment.

 

[AndriaD]

Maybe that many people feel that it doesn't make the slightest bit of difference what we, the vaping community thinks, the laws will be passed regardless. It seems to me that the FDA finds greater importance in stamping out vaping for fear of "renormalized smoking" than helping millions of smokers reduce the harm of using nicotine--they want to take us back to quit or die, without any middle ground. I think they've been pretty clear on that sentiment.

Which is why I have 5 yrs worth -- at the very least -- of nicotine in my freezer. Given my recent and current reduction in nic level, that actually stretches to about 10 yrs' worth. I make my own juice, build my own coils, and have quite a few RDA/RBAs, and a couple of mechs in case I'm no longer able to buy regulated mods -- and also some spare Kicks to put in them.

They can bite me. They sure as hell don't have the power to make me stop vaping.

Andria

 

[Lessifer]

Thanks @Stubby

Also:

"As you know, Executive Order 12866 limits to 90 days the period for OIRA review. Yesterday, an FDA spokesman stated that “[w]hile the office has 90 calendar days to review rules, the window could be extended to allow for further interagency discussions.” Finalizing this rule cannot wait until 2016. The proposed deeming rule was issued over eighteen months ago on April 25, 2014 and FDA, HHS, and OMB have had ample time to confer. "

Wouldn't want them to take their time and try to get it right, would we?

 

[xtwosm0kesx]

Don't worry everyone Steve has it all figured out, there's no threat to vaping, and we're all paranoid idiots with zero reading comprehension.

Glad we got that settled.

 

[pennysmalls]

When some act as if it is the end of the world there will be regulations affecting their non addictive nicotine e-liquid, I can't possibly think addiction is not involved...

You choose to see it that way. I see people who are angry that as adults decisions are being made for them that will result in disaster for some and loss of freedom of personal choice for others. Some of them are addicted and others are not.

 

[Jman8]

The Golden Era is coming to a close. It was (still is) a great era, but we all knew this wasn't going to last.

You favor a ban to minors? Then expect that to come bite you in the rear end. To act all surprised that it is not going to affect adult use and that the under regulated golden era is going to last forever makes me say, "welcome to ECF newbie, enjoy your stay!"

 

[Kent C]

SJ on the post in Regulation:

"I should mention this here...

There's some very odd smoke and mirrors coming out of TVECA. I'm not sure what they're up to, but they've "released" an FDA industry guidance document which, on closer examination, is an old document from 2014.

I attempted to find the 2014 doc... while the deeming doc does have some of the same stuff, the 'industry guide for applications' is another one - there is one from 2011 but without the extensive handling of ENDS, so I think the leaked doc is new.

skoony posted this:

http://thehill.com/regulation/258465-e-cig-firms-steel-for-legal-battle

which includes these statements:

"
In a statement to The Hill Wednesday, FDA rep Michael Felberbaum said the FDA has not yet issued its final rule, so any documents are still in draft form.

“As a matter of policy, the FDA does not share draft documents with outside groups while they are under review and the FDA cannot provide any further comment,” he said.

Story said the FDA’s top regulator
has called, asking for him not to release the rest of the language, but said he
was trying to spur action among e-cigarette makers.

“If they know for sure they do not have a future ... they’ll get motivated, call the White House, go to OMB and get proactive in demanding reliable, responsible regulation rather than this kill order,” he said, referencing the Office of Management and Budget.

If that fails, Story said he’s prepared to challenge the final rules in court.

And the Cigar Rights group also implies a change from the original doc:

The TVECA isn’t alone. Industry-backed Cigar Rights of America said it would also fight the rules in court.

“We’d have to,” said the group’s executive director, J. Glynn Loope.

If the table of contents the TVECA leaked is accurate, he said, the cigar industry would be regulated the same way the FDA is regulating other tobacco products.

When the rules were first proposed in April 2014, the FDA was weighing whether to exempt premium cigars from the regulations. The agency defined premium cigars as any handmade cigar without a tip or filter that costs $10 or more.

Loope was lobbying for that exemption.

So.... I have to believe this is a draft (perhaps not the final draft) since I doubt someone went to the trouble of creating the doc just scare people. (although that's a possibility, but not a probability, imo).