FDA delivers Final Deeming Rule to OIRA

[Oliver]

I think it's fair to say that TVECA have something. Whether it's the final proposal or not is anyone's guess - and it was pointed out to me by Julie at CASAA that these documents are not static, but constantly evolving.

But, if they do indeed leak it (I don't believe they will), we'll have somewhat of a better understanding of the FDA's position than we've had previously.

 

[zoiDman]

How to Participate in the Rulemaking Process

Outside parties may provide written comments to the OIRA Administrator on a rule that is under review. If a rule is at OIRA for review, interested parties can provide comments by email at OIRA_submission@omb.eop.gov. In the email please specify the name of the rule and the regulatory identification number (RIN) as specified in the docket for the rule on www.reginfo.gov.

https://www.whitehouse.gov/omb/oira/about

 

[Lessifer]

Do I have it right that whatever the FDA proposes there will be a grace period where it's business as usual for several years? May be vapers believe there will be time to get supplies if the interference is eventually draconian? Can the FDA abruptly start a drug war in 60-90 days? My position is I don't want any interference with my access to ecig products. I might compromise that position a bit if it meant more smokers would switch or if there was an obvious health risk that has yet to be disclosed. The FDA keeps saying they are science based. What science is there to justify a significant change in the status quo?

Some People believe this will happen with Hardware. Not sure if it will or if it Won't.

And I know that Some people have even Extended this Mindset to Include e-liquids. Based of exactly what... I'm not sure?

BTW - Do Many people believe that there will be a 2 Year "Grace Period" which would allow for Non Face-2-Face transactions (Net Sales) to continue to Occur for e-Cigarettes/e-liquids?

I think the grace period idea comes from their past compliance guidelines, where manufacturers are allowed a grace period to come into compliance. It's hoped that the same will apply here, and that's what I've heard from people more in the know than me, that there is a hope that there will be a grace period.

However, even if there is a grace period, that does not mean that everything will continue to be available. Many vendors could determine it is more practical to close shop than to try to comply with whatever comes out.

As for the reaction to this particular bit of news... Well, it's important, but really how much is there to say. The final rule was submitted to OIRA, we still don't know what they are, or when they will come into effect.

I have been thinking about just how to phrase this when I broadcast it to the 40k+ signees of the petition, as I think it is important. However, it's not all that newsworthy.

 

[AndriaD]

This is the double edged sword of vaping though. I vape on the cheap. I don't DIY but even without that I only spend a few hundred annually on gear AND juice. It is incredibly difficult to have a growth industry when people don't have to buy stuff. Yes you can DIY for pennies a day, but if everyone did that, what would happen to the juice vendors that provide for the newbies and those who don't want to DIY? It's great that vaping on the cheap is an option, I just hope, for the sake of the industry, that most people find a balance.

Of course, if the industry gets regulated down to pre-filled carts/tanks, the DIY market will explode.

It certainly will. And I know, there are some people who either don't want to DIY, or who've tried it and haven't (yet) had their 'eureka!' moment.... some people couldn't cook if their life depended on it. But you're right, if those idiots really restrict vaping liquids to those pre-filled cartos... we're soon going to have a whole world of ejuice virtuosos.

As for hardware... I do buy some, from time to time -- I buy cheap (clones for attys, inexpensive brands for mods) -- but I do still buy. But the people who say that vaping costs more than smoking.... someone really needs to confiscate their credit card, because it's really not vaping that is the problem.

Andria

 

[Stubby]

The federal government is pretty much shut down for the year concerning things like this. Next year is a campaign year, so nothing drastic will happen. I'm guessing Hillary will push the FDA in 2018 to do something...

That really has nothing to do with the deeming regulation. This very likely will happen late this year or early next year, and it certainly will not be stretched out until the next administration.

Thanks for the link @Stubby

Given I just quit smoking by going to vaping I am seriously bothered by this bit:

...the Senators also urged OMB to ensure that the final rule includes strong regulations to help prevent youth tobacco ... including a minimum age standard, limits on advertising, health warnings on the products, bans on the use of flavorings...

If the worst thing that happens is a ban on flavors, some labeling and childproof guidelines, a ban on advertising similar to cigarettes, and no sales to minors, we would have to consider ourselves very fortunate. Far worse is a ban on everything, which is what the original proposed deeming was. We shall see if it has been changed. There are fairly easy workarounds for the flavors using unflavored liquid. It is pretty hard to do workarounds when there is nothing to work with.

Listen up folks, lets keep the chatter about how many liters of liquid you have in the deep freeze out of this thread. This isn't about you, this is about the 40 plus million folks who still smoke, and if the deeming is a bad as originally advertised that number will essentially remain unchanged.

 

[xtwosm0kesx]

Addiction does influence one's thinking... When Twinkies were going to stop being made, I didn't go out and buy cases of them, but I wasn't addicted to them, either...

Just go away.

You contribute nothing but misinformation, and passive-aggressive condescension with 99% of your posts on this forum (the other 1% being provape related).

If you honestly think you're smarter than the majority of the people on this forum, including people who are in the trenches fighting a battle you don't seem to think even exists, you truly are living in fantasy land.

 

[Kent C]

They're never going to admit a mistake, even in the face of otherwise reasonable evidence. But, hey, that's politics. Right?

Right.

To the public and survivors:
"It's the video!"

To PM's of Egypt and Libya (and daughter)
"We know the video had nothing to do with it."

 

[AndriaD]

It is worse than I anticipated. As it includes eLiquid, and if a de facto ban is a result, then the 99.5% is (way way way) conservative of a number, given there are way way way more flavors than all other product types combined.

At same time, the genie is out of the bottle. The legal market will take the hit, and that assumes zero law suits and no political fight over it. But to think an underground market / DIY won't flourish is (as you said) just plain ignorant.

I agree! There are a LOT of us with a nice freezer stash of nicotine, and if members of our family or friends want to give it a try, we'll help them. And there may even be those perfectly willing to "bootleg" that stashed nicotine for outrageous prices -- anyone who thinks that WON'T happen needs to study 1920's history a lot more closely.

As long as there are any of us out here vaping visibly, vaping is NOT dead, it's just being oppressed -- the oppressed have a way of making comebacks.

Andria

 

[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've had calls from several people doubting the veracity of the Table of Contents, but on the whole I'm satisfied it's genuine. Tveca are also saying now that they'll release the whole document 100 pages at a time - who knows, perhaps they will - I'll keep this thread current if they do.

Regardless, now is the time for vapers to cause a stink. The deeming is on the desk of OMB, and I've spoken to someone who has seen the whole thing, and who says unequivocally that it's "worse than the previous proposal"."

 

[FishingBuffalo]

It has just been submitted to the Office of Management and Budget for review to see how expensive this will be to implement. Kinda means they know what they are going to do, but no one will see actual Final Rule until they deem it expensive but necessary.

 

[zoiDman]

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. ...

Then they have Already Won.

 

[Kent C]

FDA is proposing to extend the compliance period for submitting a marketing
application under this pathway to 24 months following the effective date of a final rule.

FDA is also proposing a 24-month compliance period for the submission of premarket tobacco applications (PMTAs). In addition, we intend to continue the compliance policy pending review of marketing applications if those applications are submitted within the 24 months after the final rule's effective date.

 

[Stubby]

For the last 3 years, the FDA was set to 'ban' vaping tomorrow. I don't believe anything will happen anytime soon...
Advertised by who? Fearmongerers and vendors? I think most have not even read the proposals...

Holy crap Steve, what planet are you living on.

The FDA has not been set to "ban vaping tomorrow for the last three years". If that is what you think has been happening then you have completely misread it. What has happened is the FDA has been going through the process of regulating vaping. That process is now in step 8 of 9 steps. It is not fear mongering, its reality.

We have already seen the original proposed regulation, and that regulation would for all practical purposes be a ban on all currently available products. The only question is if there are any real changes in the current proposal and what the while house is going to do with it.

 

[Stubby]

Reality...
I have read and understood the proposals and know nearly all the speculation concerning them is simply fear mongering and addiction driven paranoia...

You are going to have to clue us all in Steve, with your great knowledge and insight, on how having a grandfather date of February 15, 2007, and nothing allowed on the market that wasn't on the market before that date without going through an essentially impossible regulation process, is somehow fear mongering. That is exactly what the original proposed regulation would do.

I will trust the knowledge of folks like Bill Godshall and the people at CASAA over your other rather bizarre vague generalizations.

 

[Stubby]

That's not how the proposal reads, but I have read it and understand it...

You mean the one who set the model for anti vaping legislation and sentiment by trying to ban cigarettes and smoking?
I do understand the fear mongering is great for donations and sales, however...

Okay, so now you are accusing CASAA of fear mongering for the sake of donations. Of course they are in it only for the money, even though the staff makes no money and put in many long hours. How can you expect anyone to take you serious when you show blatant ignorance of the subject at hand and attack the people with the most knowledge who are working there backsides off to advocate for us.

I would have to say at this point you appear to be a plant from the anti's. On rereading you post I am pretty certain of it. Calling anyone who disagrees with you as fear mongering and addiction driven paranoia...

You have lost all credibility.

 

[zoiDman]

Everybody who vapes might be concerned about how the FDA might limit access to products and/or increase the cost of vaping. ...

Once I leave the Ethereal Realm of the ECF, I Don't see that at all.

The Vast Majority of the Vaper's I encounter in the Wild have No Clue what is Going On.

 

[skoony]

If the worst thing that happens is a ban on flavors, some labeling and childproof guidelines, a ban on advertising similar to cigarettes, and no sales to minors, we would have to consider ourselves very fortunate. Far worse is a ban on everything, which is what the original proposed deeming was.

The original deeming proposal is what they are working on right now. There is no indication as to
what if anything has changed. As of right now I believe the proposal will be issued pretty much
as it was proposed with only minor clarifications and changes in wording that would tighten their grip
on e-cigarettes as opposed to loosening the proposed regulation.
I am now thinking forward to the day the deeming regulations are finally issued and the real battle
of our times begins. If the regulations are issued pretty much as proposed Congress will be the only
way to derail them. If Congress chooses to do nothing this will set the precedent for future regulatory
policy for generations to come. The end result being complete cradle to grave regulation of our
very lives in the future.(insert your chortles here) It hasn't taken that long for hate crimes to
evolve in some people seriously requesting that global warming deniers be prosecuted under
the RICO ACT. This is what happens when you allow thought crime.
For any of those people that believe regulations are needed and necessary be careful
of what you wish for. You will get it with sugar on top. Come to think of it,I believe
sugar is up next.

Regards
Mike

 

[zoiDman]

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.

Oh Yeah... I'm putting all my Faith in steve.

 

[Kent C]

Fear, paranoia and hoarding seem to be pretty clear symptoms, no?

I store extra food and ammunition (for those who didn't :- ) Does that mean I'm "addicted" to food and ammo? We recently had a flood where the stored food and bottled water came in handy. And yeah, we shared with some neighbors ... who weren't as 'addicted' evidently, as we were. There's a difference between prudence and paranoia. You actually know this, but still push the paranoia line for some reason - I'm guessing 'agitation'. Which I obviously understand from your point of view or I wouldn't have written this post.

 

[Kent C]

I see nothing but irrational fear and paranoia driven by addiction.

When that is all you see - when there are other reasonable alternatives - it says more about you than the people you accuse. But then you admit the addiction so the rest must follow. Too bad.

I've given you more attention on this that you actually deserve, so I'm taking the "don't feed the troll" advice. But as you know, there is a fresh batch of newbies every week, who have never read your posts, so my guess is you won't starve - your diet relies on them when others just quit feeding you.