Fantastic letter, Bill! Thanks, as always, for all of your help to keep us and future users smoke-reduced and smoke-free!
FDA CASAA Blog - copy of letter to OMB/OIRA re PRA & FDA Reg Proposal
- Thread starter sonicdsl
- Start date
- th_trl_thread_readers 0
- Status
Fantastic letter, Bill! Thanks, as always, for all of your help to keep us and future users smoke-reduced and smoke-free!
I think it takes much longer to read and consider a well though out comment. However if you notice what time of year it is, the College Interns are plentiful in D.C. right now. So they can certainly toss a lot of logs on the fire.
Given what I see in the Deeming, the more or less conceded some items, the 24 months before enforcement stuff, and the rest of it was pretty much a mechanical interpretation of the law. Blu wrote a fairly detailed asking for more time, citing statutes, and that they wanted to complete a study. But then there is the 2 year thing, so the study is not going to cause a delay. Certain Congressman are barking to not give a delay. Because of this, and nobody gets upset if the tobacco companies complain, I think there is only a 1 in 5 chance of the Deeming being delayed. I do not think there is too much legal recourse of they don't extend it. Nothing a Judge will over turn.
What I could see possibly is that they will cut off the time clock, and say that they will accept late comments as they process through the others.
Bottomline, I think the 75 day clock will not be extended, its the safest assumption, get the comments in.
Since we can send multiple comments I'm tempted to send at least one full on why do you want to increase my chances of dying early from smoking rant just for the slight guilt trip it might put someone on. They do have to read them all.
I consider that tame.
I'll go ahead and call them murderers if I go on a rant.
And it's a rant I've used many times over the years to a number of politicians.
I believe in attacking from all angles.
Currently formulating in my head I've got no less than 4 different themes (scientific; personal; etc.) that I'll be submitting as separate comments..
And keep in mind when composing yours that there's a 5,000-character limit for each comment.. Goes by quicker than you might think...
If it's this one then no..I didn't see the re-submit post in time:
Re: The Food and Drug Administration Deems Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations Restricting the Sale and Distribution of Tobacco Products and Required Warnings for Tobacco Product Packages and Advertisements.
I am writing to comment as an individual consumer on the Paperwork Reduction Act aspects of the proposed regulation. I expect to file a separate comment on other aspects of the proposed regulation later.
The Paperwork Reduction Act aspects of the proposed regulation indicate that FDA expects there will be a very small number of applications for e-cigarette products. Speaking from my own experience, this would probably include only a fraction of the products that I use and that are important for me avoiding returning to smoking.
I have used 8 different varieties of e-cigarette liquid over the last year. I have used 11 different pieces of e-cigarette hardware. In addition, I have used7 different products that combine liquid and hardware. I would estimate that my favorite vendor sells 100 or more different products.
Either FDA's estimates for the number of filings under the Paperwork Reduction Act are a huge underestimate, or FDA is admitting that the paperwork burden will drive most of these products off of the market. If it is the latter, the burden of the paperwork would fall not just on the merchants, but on myself and other consumers.
I was able to quit smoking and not return to it because of the variety of products available. If I had been limited to just a few products, I would have probably returned to smoking. I am 56 years old and tried many different ways to try to stop smoking. Pills, patches, and cold turkey didn't work for me. I had a 40 year cigarette habit. I started smoking at 16 years of age. Thanks to e-cigarettes, I feel better about myself because I don't smoke.
Kind regards
.......... ......
Re: The Food and Drug Administration Deems Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations Restricting the Sale and Distribution of Tobacco Products and Required Warnings for Tobacco Product Packages and Advertisements.
I am writing to comment as an individual consumer on the Paperwork Reduction Act aspects of the proposed regulation. I expect to file a separate comment on other aspects of the proposed regulation later.
The Paperwork Reduction Act aspects of the proposed regulation indicate that FDA expects there will be a very small number of applications for e-cigarette products. Speaking from my own experience, this would probably include only a fraction of the products that I use and that are important for me avoiding returning to smoking.
I have used 8 different varieties of e-cigarette liquid over the last year. I have used 11 different pieces of e-cigarette hardware. In addition, I have used7 different products that combine liquid and hardware. I would estimate that my favorite vendor sells 100 or more different products.
Either FDA's estimates for the number of filings under the Paperwork Reduction Act are a huge underestimate, or FDA is admitting that the paperwork burden will drive most of these products off of the market. If it is the latter, the burden of the paperwork would fall not just on the merchants, but on myself and other consumers.
I was able to quit smoking and not return to it because of the variety of products available. If I had been limited to just a few products, I would have probably returned to smoking. I am 56 years old and tried many different ways to try to stop smoking. Pills, patches, and cold turkey didn't work for me. I had a 40 year cigarette habit. I started smoking at 16 years of age. Thanks to e-cigarettes, I feel better about myself because I don't smoke.
Kind regards
.......... ......
I kinda feel like I'm the only person that submitted the number of products as 'millions' and yet I believe that is accurate, especially based on items that Bill G. has posted before. There are millions of flavor combinations that would arguably change characteristics of eLiquid.
I wish I knew Vegas odds on this as it currently shows up to me as 50/50. Many of these comment periods traditionally get extended and with how poorly this one is written, in light of Impact Analysis, I'd think it would have to be extended. But given that our well funded and politically influenced opposition wishes for strict cut off time, then it seems like no extension.
If I had to put money on it, I'd go with it will be extended.
I wish I knew Vegas odds on this as it currently shows up to me as 50/50. Many of these comment periods traditionally get extended and with how poorly this one is written, in light of Impact Analysis, I'd think it would have to be extended. But given that our well funded and politically influenced opposition wishes for strict cut off time, then it seems like no extension.
If I had to put money on it, I'd go with it will be extended.
Too bad we can't take bets on this. I'm betting it'll be extended too. There are far more voices pushing for extension than against it in this case. I think all the tobacco companies are for it. It also covers a huge array of diverse products and some sections admit that more is coming later. I think there was a push to get these published and I bet they are hoping some of the pressure will be relieved. Just the question of menthol was extended 2 or 3 times so it's not unusual. Menthol's been delaying from final regulation since 2010 in the name of science. I think the ticket is that "we" have to work at it to get similar results. It won't be in our favor if we don't. The squeeky wheel gets the grease here.
Last edited:
Forget about an extension! This document is a Crime. Comments shouldn't be extended, it should be destroyed as currently written!
In less than 7 years this industry has evolved into something that's barely recognizable from 2009, and wasn't even imaginable in 2007. There's a chance that if development continues (with a little focus) that what we use 4 years from now, probably won't fall under deeming regulations.
You can't convinence me that a device outside of US FDA and EU and CA regulations won't become a driving developmental design factor....
One thing I can count on is that gov't will always be 10 steps behind.
I'm still laughing.
I want that quote on a Tshirt.
Last edited:
Is that guy the last living CAVEMAN or something? WHY is a guy like that in ANY elected office???
When someone like Harkin say's thing like this, some believe that it is Proof that Evolution is a Fact. And that if Mr. Darwin had found Harkin on Easter Island, that there would Never have been Any Doubt.
Galapagos Islands..he found Harkin on Galapagos eating a raw Iguana.
Yeah... You are Right.
But I still think that the 3rd Dude from the Left is a Spitting Image of Harkin.
Coincidence? Or Maybe Proof that Aliens have Visited Earth?
Yeah... You are Right.
But I still think that the 3rd Dude from the Left is a Spitting Image of Harkin.
-------------------Is that the Slantzz I spy in this lineup? ---------------^^?
- Status
Similar threads
- Locked
