Proposed rule on e-cigs being reviewed by OMB

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Barbara21

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I'm obviously paranoid about the whole thing but sounds to me like they may be interested in the impact of revenue gains too?

Edit: and doesn't it also mean that the FDA has decided what its going to do already and submitted that to OMB for impact study?

Well, count me as paranoid too because I read it the same way.

So now we're waiting for the OMB??
 

hlk

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Here is the latest:

FDA Misses Deadline for E-Cig Regulations
Following up on our post from last Thursday, the Food and Drug Administration (FDA) has announced that it will not meet its midnight deadline to submit proposed tobacco regulations. The FDA will also miss deadlines to publish a consumer-friendly list of dangerous chemicals found in electronic cigarettes (e-cigarettes or e-cigs) and testing / reporting requirements for tobacco ingredients and additives. Unfortunately, the FDA is not required to abide by the deadlines that it sets for itself, nor is it assessed any penalty for missing such deadlines.

Current E-Cig Regulations
575984_45217350 (1)

Notwithstanding the foregoing, based on this morning’s press release, the proposed regulations, which will likely target the e-cig industry, are near completion and can be expected for public comment and scrutiny in the near future.

To recap another recent post, the following statements from the FDA’s website provide us with insight as to the FDA’s opinion regarding the highly unregulated e-cigarette industry:

As the safety and efficacy of e-cigs have not been fully studied, consumers of e-cigarette products currently have no way of knowing whether e-cigarettes are safe for their intended use, how much nicotine or other potentially harmful chemicals are being inhaled during use, or if there are any benefits associated with using these products.
Currently, e-cigarettes that are marketed for therapeutic purposes are regulated by the FDA Center for Drug Evaluation and Research (CDER). The FDA Center for tobacco Products (CTP) . . . intends to regulate other nicotine-containing products, including electronic cigarette products that do not make a therapeutic claim, in the future.
FDA E-Cigarette Regulations Are Imminent
The fact that the proposed e-cigarette regulations were not handed down today should not be interpreted as the FDA backing down from regulating the industry, as it did in 2010. Given the growth of the e-cigarette consumer base and the amount of pressure the FDA is receiving from state legislatures demanding regulation, e-cigarette regulations are imminent and those engaged in the industry should prepare for dramatic changes in the way they conduct their operations.

The development of the FDA’s new e-cigarette regulations should be of interest to anyone involved in the e-cigarette industry and those interested in online or digital marketing in general.



FDA Misses Deadline for E-Cig Regulations
 

Uncle Willie

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It's pretty clear it's headed for Taxation and heavy regs.
Don't know who will be left standing other than BT with the deep pockets it's going to take to comply.

I'm trying to stay positive but history has shown how the FDA operates.

I firmly believe the larger vendors that have been the backbone of the Industry from the get go have all planned for a worst case scenario .. these are business people that knew since the Smoking Everywhere / NJOY case came down that the writing was on the wall .. the smaller Mom and Pops and the start ups that have sprung up like weeds in the last 18 months, not so much ..
 

hlk

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UW, They have a bigger Warchest for sure. I can imagine a huge annual licensing fee and unreasonable standard as a way to limit how many vendors can make the juice.. If that happened, vape stores would just buy wholesale from these places and profit margins lowered.
At least they could still be in Biz.. I am not sure how it will play out on the hardware side.. As another poster mentioned, if it was "illegal" to sell, the CC processing companies would not process the transactions. Sort of like online gambling.. I am hoping the hardware will be available with no hassles when all is said and done.
 

Uncle Willie

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UW, They have a bigger Warchest for sure. I can imagine a huge annual licensing fee and unreasonable standard as a way to limit how many vendors can make the juice.. If that happened, vape stores would just buy wholesale from these places and profit margins lowered.
At least they could still be in Biz.. I am not sure how it will play out on the hardware side.. As another poster mentioned, if it was "illegal" to sell, the CC processing companies would not process the transactions. Sort of like online gambling.. I am hoping the hardware will be available with no hassles when all is said and done.

In most States, the fee to sell analogs is minimal .. the States get their money from the tax added per pack as well as the sales tax .. the required standard for gear and liquid, who knows .. as long as it's not considered a smoking cessation device / method, it could be minimal .. treated like food with an ingredient list ..
 

ennagizer

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Here is the latest:

FDA Misses Deadline for E-Cig Regulations
Following up on our post from last Thursday, the Food and Drug Administration (FDA) has announced that it will not meet its midnight deadline to submit proposed tobacco regulations. The FDA will also miss deadlines to publish a consumer-friendly list of dangerous chemicals found in electronic cigarettes (e-cigarettes or e-cigs) and testing / reporting requirements for tobacco ingredients and additives.

FDA Misses Deadline for E-Cig Regulations

Just wondering where Klein Moynihan Turco LLP read that announcement.
Was there an announcement published that passed us by? I can't find it.
Is it actually the FDA that missed their self imposed deadline (again), or did they meet the deadline this time, but it's held up for review by the OMB?
 

hlk

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Just wondering where Klein Moynihan Turco LLP read that announcement.
Was there an announcement published that passed us by? I can't find it.
Is it actually the FDA that missed their self imposed deadline (again), or did they meet the deadline this time, but it's held up for review by the OMB?

I could not find the press release either ennagizer. I'm thinking it may have been posted earlier regarding another deadline now. If so, my bad but still decent info.
 

flowerpots

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Just wondering where Klein Moynihan Turco LLP read that announcement.
Was there an announcement published that passed us by? I can't find it.
Is it actually the FDA that missed their self imposed deadline (again), or did they meet the deadline this time, but it's held up for review by the OMB?

I can't find it either...so not sure how valid that link is.
 

ennagizer

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I could not find the press release either ennagizer. I'm thinking it may have been posted earlier regarding another deadline now. If so, my bad but still decent info.

It's not your bad at all. The law firm stated there was an announcement, not you :)
Personally, I don't see where the FDA will step up and announce "we missed it again" :p I think the last few times they missed their "deadline" it came and went quietly with another date set. The public had to seek out the information at reginfo.gov.
 

Cool_Breeze

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Here is the latest:

FDA Misses Deadline for E-Cig Regulations
Following up on our post from last Thursday, the Food and Drug Administration (FDA) has announced that it will not meet its midnight deadline to submit proposed tobacco regulations. The FDA will also miss deadlines to publish a consumer-friendly list of dangerous chemicals found in electronic cigarettes (e-cigarettes or e-cigs) and testing / reporting requirements for tobacco ingredients and additives. ...<snip>

I'm a little confused, but that's nothing unusual.

SmokyJoe posted late last month...
Yup, I've heard from several sources that the deeming regs were left with the OMB some time shortly prior to the shutdown.

The date of the information as represented by the excerpt at top is April, 2013.

Perhaps I'm lacking the proper context to understand the original post containing info from the law firm.
 

patkin

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Been thinking a bit about this OMB thing: Of course an impact study has to be done. Its going to cost a lot of money enforcing these new regulations. I don't know the inspection processes for smokes but I would bet money the inspection of juices, vendor sales and facilities will be tighter for ejuices. I think that's already being hinted at with the statements they've already made about vapers not knowing for sure how much nic they're getting or how safe it is. All-in-all they're just going to create more big government expenses and try to offset those with higher revenue intake plus make a big-govt profit. But the point is: the FDA has already decided what its going to do and has submitted it to OMB for cost analysis.... makes "talks" a joke.
 

flowerpots

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Been thinking a bit about this OMB thing: Of course an impact study has to be done. Its going to cost a lot of money enforcing these new regulations. I don't know the inspection processes for smokes but I would bet money the inspection of juices, vendor sales and facilities will be tighter for ejuices. I think that's already being hinted at with the statements they've already made about vapers not knowing for sure how much nic they're getting or how safe it is. All-in-all they're just going to create more big government expenses and try to offset those with higher revenue intake plus make a big-govt profit. But the point is: the FDA has already decided what its going to do and has submitted it to OMB for cost analysis.... makes "talks" a joke.

I love how they increased student loan percentage rates and removed food stamps from people who need them to feed kids, but they can afford to fork over the billions of dollars that will be necessary to get involved and saves us all from harm.
 
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