FDA delivers Final Deeming Rule to OIRA

[zoiDman]

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? ...

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?

 

[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.

 

[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.

 

[pennysmalls]

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?

If I remember correctly I think what I read somewhere was that business's will be given a grace period for something...maybe to become compliant with labels or something like that. I wish I could remember. But I don't think that grace period applied to purchases made by customers.

 

[grandmato5]

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.

It's interesting to me how few post there have been around ECF on the topic since it got delivered to the OBM. I think there's an awful lot of folks that don't realize how close this brings us to actually having a Deeming Order in place.

 

[nicnik]

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.

Cotton is more relevent to vaping than the FDA is. The FDA projects a distorted view of it, while cotton is part of the real world of vaping.

While the FDA stalls and crawls at a snail's pace, vaping keeps moving forward, fueled in part by discussions on the internet.

 

[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.

 

[sofarsogood]

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.

It does mean that rules of some kind are almost certainly going to be appearing in the next 1-3 months but there are players with money on the other side and some court challenges are likely. I'd rather be using my energy to help end the Tobacco Age instead of bashing on my own government.

 

[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

 

[grandmato5]

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.

There are 9 steps in the rule making process to the Deeming Order and step 8 was taken this week. I guess it all depends on how one defines newsworthy, but in my world that is newsworthy. Certainly no where near as big of news as step 9 is going to be, but never-the-less still newsworthy.

 

[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.

 

[Lessifer]

There are 9 steps in the rule making process to the Deeming Order and step 8 was taken this week. I guess it all depends on how one defines newsworthy, but in my world that is newsworthy. Certainly no where near as big of news as step 9 is going to be, but never-the-less still newsworthy.

Okay, newsworthy, but not necessarily actionable. For now it seems like the best bet is still the Cole bill. I've already broadcast that CTA a number of times.

 

[madangus]

It's really sad to me that if it goes through, there will be so many fewer vapeversarys happening

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.

Of course if the apt were to flood or something i'm screwed. Hooefully sooner rather than later a house, but for now some kind of a big safe just won't work. But i am prepared as i reasonably can be.

Makes me so mad. Having to stock and prep and worry is just ridiculous. And all those people that might bever get the chance at all.

Hiss.

 

[skoony]

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?

The compliance date would be approximately 18 months from when the FDA issues its final ruling.
Some have said 2 years. Its at least 18 months as I recall.
Mike
PS, What Kent C posted.

 

[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.

 

[AndriaD]

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 if you want it to be. This gigantic disparity in cost and the ease of DIY severely complicates control, taxation, etc. Health issues will be debated ad nauseam. The economics 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 each per year the vape market would be $130 billion and that lower amount includes no excise taxes, which would be hard to collect anyway. This is what obsesses our dear governments, not our health.

Yeah... Have you seen the threads around here about how vaping costs more than smoking? Only to a person incapable of exercising restraint over the "shinyitis" bug -- for anyone with a grown-up approach to spending money, vaping is LOADS cheaper. Sure, I *COULD* spend a whole lot... but why? The setup I use now is absolutely perfect, I have no need to keep buying tons of crap just because it's shiny. Providing Innokin is still with us next year, I'll grab another couple of coolfire4's, just because I try to buy a few new mods every year as a hedge against electronics-death -- but so far, every one I've bought still works.

Andria

 

[Lessifer]

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.

Yeah... Have you seen the threads around here about how vaping costs more than smoking? Only to a person incapable of exercising restraint over the "shinyitis" bug -- for anyone with a grown-up approach to spending money, vaping is LOADS cheaper. Sure, I *COULD* spend a whole lot... but why? The setup I use now is absolutely perfect, I have no need to keep buying tons of crap just because it's shiny. Providing Innokin is still with us next year, I'll grab another couple of coolfire4's, just because I try to buy a few new mods every year as a hedge against electronics-death -- but so far, every one I've bought still works.

Andria

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.

 

[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.

 

[Kent C]

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. "

 

[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?