FDA Responding to FDA deeming proposal - Please wait!!

[Oliver]

Dear all,

We each have until July 9th to comment on the FDA's deeming proposal, and the FDA will simply reject anything that isn't backed up by supporting evidence.

The proposals were only released on Thursday, and countless experts are currently pouring over it, trying to establish exactly what the proposals mean for the future of vaping.

Accordingly, I strongly urge everyone to hold off submitting comment to the FDA until such a time as we have some real understanding of what the regs entail.

In the meantime, there are some very good initial write-ups linked below:

http://blog.casaa.org/2014/04/fda-regulation-of-e-cigarettes-huge.html

CASAA: CASAA Assessment of FDA Deeming Regulation, April 25, 2014

http://tobaccoanalysis.blogspot.com/2014/04/fda-gives-huge-gift-to-combustible.html

http://rodutobaccotruth.blogspot.com/2014/04/federal-e-cigarette-data-awol.html

http://www.e-cigarette-forum.com/forum/fda-regulations/556486-answer-what-do-i-do-now-question.html
More to come - please PM me any you see so I can add them.

Many thanks,

SJ

 

[mimi0725]

I've been off analogs for over a year, and I won't go down without a fight! I just joined CASAA, and I strongly suggest we stand together on this! I will continue to read here for all my info on FDA regs! We have to protect our rights!

 

[badwolf91]

Please post any updates from CASAA as a sticky if possible.. I haven't seen anything new yet as what they have come up with after a quick look at the site. (also a member just to clarify ) planning on trying to donate soon as they are helping immensely

 

[DC2]

Please post any updates from CASAA as a sticky if possible.. I haven't seen anything new yet as what they have come up with after a quick look at the site. (also a member just to clarify ) planning on trying to donate soon as they are helping immensely

Here is one that hasn't been posted yet...
CASAA: FDA regulation of e-cigarettes: huge costs, little or no benefit, says CASAA

 

[sonicdsl]

Please post any updates from CASAA as a sticky if possible.. I haven't seen anything new yet as what they have come up with after a quick look at the site. (also a member just to clarify ) planning on trying to donate soon as they are helping immensely

Keep an eye on this forum you're in now (FDA Regulations) - there are lots of topics in here now - as well as the CASAA Forum.

 

[badwolf91]

as posted above, I had not been checking the actually CASAA forum for updates

Thank you sonic

http://www.e-cigarette-forum.com/fo...-plan-regarding-proposed-fda-regulations.html

I have posted the question as to rather this idea that we only get 1 comment is true as it seems it may not be, please refrain from posting a comment until we know for sure but general consensus is that we need an extension on the amount of time as the FDA has put many years and posted a 250+ page document with supporting docs and we only get 75 days... this is inadequate. just thought I should share for people who are only looking at this area of the forums for info on how to respond to the FDA as the CASAA form is a great place to check (as noted above) as well as they are going to be the ones to help unify us instead of tons of comments going different directions getting us nowhere.
Also like posted on other threads, start looking in depth at your local senators and above and when the elections come around later this year make sure we are contacting them and telling them if they want our vote that we need their stance on things we care about dearly that are being attacked, for me it will be gun control and vaping majorly along w/ tax's and transparency. (though my list could go on and on) as I believe I have the right to a safer alternative that is not a cigalike and that this thriving industry that has become so innovative is the reason people are quitting cigarettes as many I tried blu and was still a smoker for the week I had my blu, then got a vv PV ego style and was done smoking that same week and have not had a stinky for 6 months.
Also just to be clear I around gun control, I feel that a good citizen should always have access to bear arms and carry as the people doing things like robbing and killing are generally guns bought black market anyway and a restrictive law on a good citizen will do more harm than good IMO as we should have the ability to protect ourselves and our fellow people, also it is just a great and fun hobby and completely safe if taken seriously, there is always room for error but that comes with anything. but that's for a whole different conversation in a different place just wanted to clarify myself to any readers.

 

[Freedombadeaux]

I have no idea if this will give us any info but I just requested the info for clinical trials near me. When I worked I collected clinical data for AMI, CHF and Pneumonia. Within those statistics we collected smoking cessation. I'm hoping this will give us some added info and proof that e-cigs have worked for people. I can't say for sure if they collected e-cigs as data but hospitals usually do things before the public knows. That's what these clinical trials are for...Here's the link, if you are interested.
http://www.clinicaltrials.gov/ct2/results?term=smoking+cessation
These statistics are public information.

 

[Freedombadeaux]

I'd like to know what the internet based INTERVENTION is...think I called a few friends!

 

[nate_]

Email/call your senators and representatives. Who know if it'll do any good but I can't see how it can hurt, unless you say something dumb. I would suggest at least let them know that e-cigs are the reason you do not smoke tobacco today (if that it true for you). What the FDA says about e-cigs not being a cessation alternative is CRAP and our congress needs to know how many of us actually quit because of e-cigs. I would also suggest that we let congress know we are FOR banning e-cig products to minors as well as manufacturers listing ingredients in e-juice (I mean, we ARE for that right?). Also use Facebook to help.

 

[tombaker]

At this point its a mistake to not comment. Some people are waiting until the very last moment of the current period to comment, before they even give a view on what should be specifically said. Sure comment again when various entities put out suggestions. But more is better on comments, because the FDA is looking for UNIQUE comments, they are not doing a count. Congressmen will do a count, elected officials, but the FDA is looking at only specific issues. Unique issues.

If the extension is granted, sure that give more time, but US Senators are already pressuring the FDA to not grant an extension, and they are under no obligation (or risk really) if they do not.

Its going to be the end of the Summer when lots of people are on vacations, when the current comment period expires, two weeks before the deadline has more people gone. So its a real question if delayed comments result in no comment from a person on vacation.

The most important thing is you can comment as often as you want. Daily if you want. It not use it like a single vote. So if someone has a comment that nobody else has thought of, its a risk that they will wait, and it won't be reflected.

Comment, and comment often. And it goes without saying to comment in a well mannered and thoughtful way, there are a horde of interns sorting them out.

 

[Talyon]

Ok ill wait, im ok with that. Good things come to those who wait.

 

[DrMA]

The ANTZ strategy has changed: they are going for "quantity at the expense of quality" for their own comments (not that their comments had and quality to begin with, other than the color brown that is): http://www.e-cigarette-forum.com/forum/fda-regulations/581696-antz-suggestions-fda-comments.html

In light of these developments, I've decided to submit single-issue micro-comments (1 page or less) to the FDA docket on a daily basis, from now until the comment period is closed. Of course I will also continue to participate in the CASAA commenting efforts, in addition to my own micro-comments.

Here are a few examples of single-topic comments that I plan to send in the next few days, and the scientific evidence that exists to debunk TCI myths and reinforce the facts:
- Gateway: the ASH findings from England, Wales, and Scotland + the Harvard study ... √
- Toxicity of juice: ECITA ejuice report ... √
- Cardiac effects: study by Dr.F ... √
- No evidence: recent study by Zyoud
- Exposure to users and by-standers: Burstyn systematic review
- Flavors: Dr.F's study
- Financial conflicts of interest: TMSA and tobacco bonds
- Big Pharma Conflicts: lobby against ecigs and ads
- Lying politicians: for the children
- Exhaled vapor: Romagna 2012 study
- Risk: inappropriate regulatory action
- Appropriate policy response: Nitzkin commentary
- Junk Science from TCI: Bernd Mayer blog, and Dr.F
- Youth Smoking: survey from France
- Nicotine is not addictive: per the post below by DC2


Here's the link to the comment page:
Regulations.gov

I'll add more items to the list above as I think of them, but please feel free to make suggestions. And definitely I urge you to submit your own micro-comments.

A few examples will be posted on my blog: http://www.e-cigarette-forum.com/forum/blogs/drma/

 

[DC2]

I'll add more items to the list above as I think of them, but please feel free to make suggestions.

Some research on the seemingly minimal addictive potential of nicotine when divorced from tobacco...

Here is information from a study by an Arizona State professor emeritus...
Professor: Nicotine does not cause cigarette addiction | The State Press - An independent daily serving Arizona State University

“It’s time to get our heads straight,” Killeen said. “What causes the tremendously addicting power of cigarettes is the drug cocktail of nicotine,” he said, not nicotine itself.

And here is a recent study from the Institute of Environmental Science and Research...
Nicotine Is Not the Sole Addiction Causing Agent in Cigarettes

Penelope Truman, from ESR (Institute of Environmental Science and Research) presented a study at this week's Smokefree Oceania conference in Auckland, New Zealand. She conducted this study on rats using pure nicotine and tobacco particulate matter (TPM) along with cigarettes and roll- your-own RYO/TPM and found that the rats were more eager to get a dose of non-nicotinic cigarette especially RYO/TPM than doses of cigarettes containing pure nicotine.

And you might want to check these out too...

Growing List of Positive Effects of Nicotine Seen in Neurode... : Neurology Today

Obviously the results of small studies often aren't replicated in larger studies, but at least nicotine certainly looks safe. And we've seen absolutely no withdrawal symptoms. There doesn't seem to be any abuse liability whatsoever in taking nicotine by patch in non-smokers. That's reassuring.”

Nicotine treatment for ulcerative colitis

No withdrawal symptoms suggesting nicotine addiction have been reported either after 4–6 weeks of therapy in short-term studies, or after a period of up to 6 months in the only long-term study available.

 

[Kent C]

Great stuff DC2 and Doctor

 

[DrMA]

Excellent idea, DC2! added to the list above. Thanks and keep them coming.

 

[NorthOfAtlanta]

Clearsteam study.

http://clearstream.flavourart.it/site/wp-content/uploads/2012/09/CSA_ItaEng.pdf

 

[DrMA]

Looks like I can't edit my post above anymore... so I'll add new topics in new posts.

- Regulation as consumer products: new publication by Dr. F

 

[Oliver]

Hey doc, If you want to start a new thread for this, I'll sticky it. Might even be a good one to set global in the next week or two.

Cheers,

SJ

 

[DrMA]

Thanks, SJ.

Is it possible to split this thread at post #12 and make the subsequent posts (12 and up) the new thread?

Otherwise, please use this thread as the sticky: http://www.e-cigarette-forum.com/fo...fda-deeming-comments-im-starting-worried.html

 

[Oliver]

I'll sticky the "I'm starting to get worried" thread, and if you don't mind, will add your "single-issue comments" to your OP.

Can you clear this up for me, though....

The difficulty here is with respect to comment volume. From what I understand, there's no point having thousands of comments by vapers in the FDA comments, since these will simply be ignored/consigned to a generic "pile", unless they can assert new evidence, or assert existing evidence in a different fashion.

The only real reason for adding to the FDA is if any new evidence can be added. So, I'm going to submit our research data, since this is new, primary data and anyone who feels they can add to the evidence base should do the same thing.

I would submit, therefore, that any data that industry members can give should be included - consumption trends and so forth could well be important.

The real bulk of vapers' activism should be, in my opinion, contacting their members of congress asserting that the PACT is not appropriate for e-cigarettes.