Proposed rule on e-cigs being reviewed by OMB

[hlk]

It probably won't be long now till we know. The intent to classify e-cigs as a tobacco product is pretty clear.
This quote tells the story:

“Electronic cigarettes are battery-operated products that turn nicotine, which is highly addictive, and/or other chemicals into a vapor that is inhaled by the user. The FDA regulates electronic cigarettes that are marketed for therapeutic purposes as drugs or devices. The FDA intends to propose a regulation that would extend the agency’s “tobacco product” authorities — which currently only apply to cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco — to other categories of tobacco products that meet the statutory definition of “tobacco product.” Further research is needed to assess the potential public health benefits and risks of electronic cigarettes and other novel tobacco products.”

TEMECULA: Proposed rule on e-cigs to be reviewed by OMB

 

[skoony]

ah so that's there endgame.
cartridges leak.might get spilled.(don't get any on ya.)
could harm the environment,children,and most importantly of all,our pets.

they never mentioned all the kabillions of cigarette butts already dumped into
the landfills.let alone strewn about everywhere helter skelter.
they contain more harmful things than nicotine.

dont they know that ecigs are 100% safer for,er..umm,never-mind.

start the stock piling now regards,
mike

 

[DetraMental]

I don't like the looks of this. Definitely gonna get prepared, well I have been preparing. This just makes me nervous nonetheless.

 

[Exhaler]

Too many state's AGs have communicated to the FDA that they want regulations. Strict ones. I think the FDA had no choice in the matter except to issue the regulations no matter how much good press and studies are available. There are just too many anti-tobacco/nicotine screamers that will get their way when it comes to vaping which they consider just as bad as smoking. No one will ever convince them that ecigs are better than analogs. They only believe in zero usage of any product containing nicotine. These are the people who the politicians listen too, the noisy ones. If a Congressman or Senator supports ecigs, he or she will be labeled pro tobacco and a campaign will be lodged against them claiming that they are against public health and for cancerous causing smoking. Big money is behind these anti-nic types, the same funds which back most progressive views. While a good campaign was lodged to keep ecigs open to purchase, readily available for consumption and free from high taxes, too much anti-smoking sentiment and political power will be it's freedom of use demise.

 

[Cool_Breeze]

Methinks my fellow vapers paint a quite dark picture.

 

[Bill Godshall]

Anyone who wants to keep e-cig products legally accessible and affordable, please go to following thread and contact your Congressman.

Action Alert: Urge Congress to prevent FDA from banning e-cigarettes again and to stop FDA from giving the e-cig industry to Big Tobacco
http://www.e-cigarette-forum.com/fo...op-fda-giving-e-cig-industry-big-tobacco.html

 

[BobbyJohn]

I've been doing a lot of reading today and from what I understand they had to come to a ruling by the end of today. Is that correct?

Also, when a ruling is declared, where will the information be published first? The FDA's website?

Thank you

 

[ennagizer]

I've been doing a lot of reading today and from what I understand they had to come to a ruling by the end of today. Is that correct?

Nope. The FDA does not need to abide by any so called deadlines it sets for itself. I think this is the fifth time the FDA has not met their self proposed deadline, although the government shutdown may have something to do with it this time.

Read this post Bill Godshall made the other day and you'll see how far behind the FDA is.
http://www.e-cigarette-forum.com/fo...eeming-reg-would-decimate-e-cig-industry.html

 

[Cool_Breeze]

My understanding what that the FDA needed to send proposed regulations to the OMB by the end of October. Elsewhere in ECF there is indication that this has happened already, perhaps as long as a month ago.

The OMB is to make a ruling on the FDA proposal. There may be some back and forth for clarification and/or fine-tuning. I don't know the time frame for OMB to provide a ruling.

Nor do I know if/when the content of the FDA proposal might be made public, if at all. Will we see anything before OMB makes a ruling?

Those who can clarify or amend the above are welcome to post.

 

[ennagizer]

I found some info on reginfo.gov on this page: DASHBOARD - EO - REGINFO.GOV
It states that the proposed rule was received on 10/01/2013 with no legal deadline.
Search for the word tobacco on the page and it should take you to the entry.

I believe any results will be published in the Federal Register first, https://www.federalregister.gov/

 

[TUC]

It's all about the mula...just like big tobacco companies have begun to get their foothold, the FDA has been, and will continue, until they get theirs. Period!

 

[Plumes.91]

In other unrelated news, I just heard NY (or it might just be NYC) is moving to raise the smoking age to 21. So I'm assuming this could potentially either directly effect vapers, or it could be used as an argument for e-cig regulation if shops continue to sell to 18-20'ers.

 

[AgentAnia]

I found some info on reginfo.gov on this page: DASHBOARD - EO - REGINFO.GOV
It states that the proposed rule was received on 10/01/2013 with no legal deadline.
Search for the word tobacco on the page and it should take you to the entry.

I believe any results will be published in the Federal Register first, https://www.federalregister.gov/

Removing one layer, here's the FDA section of the Federal Register: https://www.federalregister.gov/agencies/food-and-drug-administration

My understanding is that once OMB and FDA have ironed out any kinks between them, FDA will publish the proposed rule in the FR and call for comments from the public. That's when we'll need to get busy. Not sure if there's a mandatory comment period; I've seen anywhere from 30 to 90 days mentioned.

 

[Myrany]

I found some info on reginfo.gov on this page: DASHBOARD - EO - REGINFO.GOV
It states that the proposed rule was received on 10/01/2013 with no legal deadline.
Search for the word tobacco on the page and it should take you to the entry.

I believe any results will be published in the Federal Register first, https://www.federalregister.gov/

following these instructions eventually led to View Rule

some interesting stuff there
Regulatory Flexibility Analysis Required: Yes Government Levels Affected: Undetermined
Small Entities Affected: Businesses Federalism: Undetermined
Included in the Regulatory Plan: No
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: Yes
Agency Contact: (omitted because I don't know if I can post it here)

 

[BobbyJohn]

following these instructions eventually led to View Rule

some interesting stuff there
Regulatory Flexibility Analysis Required: Yes Government Levels Affected: Undetermined
Small Entities Affected: Businesses Federalism: Undetermined
Included in the Regulatory Plan: No
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: Yes
Agency Contact: (omitted because I don't know if I can post it here)

That was a Spring 2013 ruling. Its unclear exactly what they were targeting here. Could have been ecigs or some other "tobacco" product.

 

[BobbyJohn]

Removing one layer, here's the FDA section of the Federal Register: https://www.federalregister.gov/agencies/food-and-drug-administration

My understanding is that once OMB and FDA have ironed out any kinks between them, FDA will publish the proposed rule in the FR and call for comments from the public. That's when we'll need to get busy. Not sure if there's a mandatory comment period; I've seen anywhere from 30 to 90 days mentioned.

In your link I searched the page for "tobacco" and they are looking for qualified medical professionals for "Tobacco Products Scientific Advisory Committee". They stop taking applications as of Dec 30. So I am maybe thinking they are taking on professionals to evaluate ecigs. https://www.federalregister.gov/art...-a-public-advisory-committee-tobacco-products

 

[AgentAnia]

In your link I searched the page for "tobacco" and they are looking for qualified medical professionals for "Tobacco Products Scientific Advisory Committee". They stop taking applications as of Dec 30. So I am maybe thinking they are taking on professionals to evaluate ecigs. https://www.federalregister.gov/art...-a-public-advisory-committee-tobacco-products

The Tobacco Products Scientific Advisory Committee is an ongoing committee that promotes its prohibitionist propaganda... er, that advises... the CTP. Tobacco Products Scientific Advisory Committee

Looking at the membership roster (Roster of the Tobacco Products Scientific Advisory Committee) I see that a number of terms are expiring as of Jan. 2014, so I look on those solicitations as simply getting ready to fill upcoming vacancies.

(While we're on the subject, I'll point out again that they are obliged by law to include "a member of the public" on the committee, and that their "member of the public" is the Vice President of the Black Hills Center for American Indian Health with expertise in public health and epidemiology. Not quite how I would define "the public" but maybe that's just me...)

 

[patkin]

This is the first I've heard of OMB involvement. Maybe all the talk of FDA deeming regulation talks was understood to involve OMB by others more knowledgeable on how government works but it escaped me. So what the *&)) does Management and Budget have to do with what the FDA decides impacts health or not? Isn't their role the "management" and "budget" of Presidential Programs? My understanding is: The Mission and Structure of the Office of Management and Budget | The White House. Obviously I'm confused. Will someone clear this up for me as its getting stickier than I thought.

 

[WorksForMe]

from the OMB website

3. Coordination and review of all significant Federal regulations by executive agencies, to reflect Presidential priorities and to ensure that economic and other impacts are assessed as part of regulatory decision-making, along with review and assessment of information collection requests;

It sounds like OMB has to make sure that new regulation fits into White House policies.

J.R.

 

[patkin]

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?