FDA says it intends to propose deeming regulation this summer, to track all tobacco ads (including e-cigarettes)

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Bill Godshall

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FDA announces it expects to issue a deeming regulation in summer 2012 for unregulated tobacco products (i.e. small cigars, large cigars, pipe tobacco, shisha/hookah tobacco, electronic cigarettes, dissolvable nicotine, etc.).
https://www.fbo.gov/?s=opportunity&mode=form&id=8705583acfc3cdc53ed2747c6e169422&tab=core&_cview=0

FDA also announces its intent to contract to identify, collect, record, and track information on tobacco advertisements in electronic and hard copy publications (i.e., newspapers, magazines, alternative weekly papers, periodicals, trade journals, direct mails, and emails), including advertisments for e-cigarettes and other unregulated tobacco products.

 

sanjosse

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Bill,

This part of what the contractor is to do as part of their task seems a little vague;

1. Using established search criteria and keywords, identify all publications that sell, promote, market and/or advertise tobacco products to customers in the U.S.;

It would be nice to know what exactly those "established search criteria and keywords" are before they begin.
 

sqirl1

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we're screwed. let's face it. you can't reason with the FDA. it's all a huge kangaroo court, they ONLY listen to the ANTZ and they ONLY care about protecting big pharmas profits and furthering government corruption. they probably already have it written in stone what they're going to do. of course we'll keep fighting, I'm not advocating for giving up but anything we say to the FDA is only going to fall upon deaf ears... I say everybody should either learn DIY or use smokeless tobacco, which is already regulated anyway and probably won't be messed with anymore other than raising taxes, I was hoping they wouldn't do anything until after the election but.... that's clearly not going to happen. Better get that general mint before taxes go up.
 
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sanjosse

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If I'm reading this right, It's only a "Publications Surveillance" (witch hunt?) that covers all tobacco related advertisements, right? So, if all the vendors remove the words related to tobacco, like cigar, (e)-cigarette, etc., from their websites/advertisements…… we'll be off their radar and golden?

… for now …
 

sqirl1

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If I'm reading this right, It's only a "Publications Surveillance" (witch hunt?) that covers all tobacco related advertisements, right? So, if all the vendors remove the words related to tobacco, like cigar, (e)-cigarette, etc., from their websites/advertisements…… we'll be off their radar and golden?

… for now …

and they'd have to go 0 nic.
 

hoogie76

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If I'm reading this right, It's only a "Publications Surveillance" (witch hunt?) that covers all tobacco related advertisements, right? So, if all the vendors remove the words related to tobacco, like cigar, (e)-cigarette, etc., from their websites/advertisements…… we'll be off their radar and golden?

… for now …

This 'job' seems like it's in addition to, but not totally connected to the deeming regulation that will come forth. From what I can gather, the regulations will be proposed, there will be a comment period and then regulation will be imposed (speculation or course). The fact gathering mission Bill posted the link to looks like it lasts a year and is seperate from the deeming regulation that is coming.

hoog
 

Vocalek

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This 'job' seems like it's in addition to, but not totally connected to the deeming regulation that will come forth. From what I can gather, the regulations will be proposed, there will be a comment period and then regulation will be imposed (speculation or course). The fact gathering mission Bill posted the link to looks like it lasts a year and is seperate from the deeming regulation that is coming.

hoog

This is a two-step process. The "deeming" regulation simply makes a statement that the FDA will be regulating (name of product) under the authority granted by the Family Smoking Prevention and Tobacco Control Act.

‘‘SEC. 901. FDA AUTHORITY OVER TOBACCO PRODUCTS.
‘‘(a) IN GENERAL.—Tobacco products, including modified risk tobacco products for which an order has been issued in accordance with section 911, shall be regulated by the Secretary under this chapter and shall not be subject to the provisions of chapter V.
‘‘(b) APPLICABILITY.—This chapter shall apply to all cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco and to any other tobacco products that the Secretary by regulation deems to be subject to this chapter.

It is not clear whether there will be the usual public comment period before the deeming goes into effect. It may be that no public comment period is required sine the law itself gives the FDA permission to "deem" any tobacco product not specifically named as being subject to the law.

The next step of the process would be for the FDA to propose actual regulations for each product. These would need to be posted in the Federal Register and there would definitely be a period of public comment. After the period is up, the FDA will review the comments and then might (or might not) amend the regulations before putting them into effect.
 

Vocalek

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I knew if I babbled on long enough, somebody intelligent would come along and put in laymen's terms, Thanks Vocalek!

The credit goes to Bill Godshall. I didn't know any of this stuff about how regulations are made when I first began my advocacy work three years ago. I've learned all this stuff about the regulatory process from Bill.

And given all the stuff that is going on these days (and not just regarding tobacco regulation) I am getting a very thorough refresher course in civics. I got a Kindle for Christmas and have downloaded free copies of the Constitution and the Bill of Rights.

I highly recommend learning all you can about how our government works, and more importantly how it was designed to work. Knowledge is power.
 

zoiDman

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I think it is time rename our products, we have to drop e-cigarette because it is grouping us with tobacco, not sure what that new name should be but PV's isn't bad :) I think vendors need to change their wording asap :) bnrk

I wouldn’t Worry too much about the Hardware side of it.

I for one have 510 Threaded LED Lights which I plan to sell in a Post Apocalyptic Word as eGo e-Flashlights to get around any FDA Hardware Bans. Might even come out with a Lavatube VV LED e-Flashlight.

No. It seems the Real Threat to Vaping as we know it will be in the Form of Taxation and Regulation of Nicotine Base.
 
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bnrkwest

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I wouldn’t Worry too much about the Hardware side of it.

I for one have 510 Threaded LED Lights which I plan to sell in a Post Apocalyptic Word as eGo e-Flashlights to get around any FDA Hardware Bans. Might even come out with a Lavatube VV LED e-Flashlight.

No. It seems the Real Threat to Vaping as we know it will be in the Form of Taxation and Regulation of Nicotine Base.

Yeah you are probably right, we just have to pay taxes on everything with nic, but I would think only nic based filled cartos and nic ejuice, everything else like blank cartos couldn't be taxed because they are empty. This nicotine being from tobacco does open us up to taxation even tho nothing else is there from the tobacco plant. So are the nic gum, patches, lozenges also taxed or will they be?? Same source of nic right? bnrk
 

rober36

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My thoughts are that,

1. I highly doubt they will be able to ban the e-cig hardware. Just as you can buy paraphernalia in stores that are 'intended for tobacco use', they cannot say what I will use such a device for, therefore I doubt they will be able to ban it.

My solution is acquiring as many repairables and mods that I can, which should last a long time, batteries, fb/silica wick, ss mesh etc will always be available.

2. It's the nicotine will be the thing they nail. I expect there will be massive taxes on e liquid just as tobacco products.

I plan to stock up on pg/vg with nicotine. I will diy if this ever happens, I also doubt the flavoring could be banned, or maybe vendors will still sell liquid without nicotine and I could add my own. I cannot see how they could ban our e liquid if it does not have a controlled substance in it. As ridiculous as it sounds, it is my right to inhale pg or vg if I choose to.

3. I imagine that this regulation will take quite some time to come about, or at least I am hoping it will be a slow process so we can all prepare for it.

Maybe I am wrong, but I plan to stock up on enough pg/vg with nicotine hopefully enough to last me a few years, beyond that who knows what will happen. I had originally thought of my first e-cig purchase as a way to stop smoking slowly, soon after I realized that I really enjoy it, as well as feeling great, much better than when I smoked analogs, so if worse comes to worse I will do as I planned and slowly decrease my nic levels and eventually quit vaping as well.
 
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