Comments Please on AAPHP Petitions to FDA

[miss MiA]

So, you do alot of cooking (VG), or you spend alot of time at dance clubs around fog machines (PG), or both.

No crime in that. Sounds like you're a very active person... LOL.

I mean, seriously, what are they going to do? Get a search warrant and go through your house looking for e-cig hardware and juice?

I can see it now... you have your batteries stashed in remote controlled cars, cartridges and atomizers hidden the table lamp bases, e-liquid sitting in an olive oil bottle beside the stove, flavorings in the vanilla extract bottles in the cabinet... uhhh... dammit, where do we put the chargers?

lol nah, if social and establishment anti-ecig sentiment continues to grow, and insurers decided they didn't want to cover use of these untested, 'suspect' things, my guess would be that they'd be able to determine how much PG or VG could possibly end up inside ones' lungs via fog machine/cooking/etc. as opposed to the direct, concentrated, almost continuous inhalation of vaping. (Who knows, maybe other components of the liquid would be detectable in test results too.)

Again, given scenario is during lab tests for a respiratory problem; not implying warrants to seize bodily fluids. And no, they wouldn't search your house for supporting evidence, but like always, they could deny the claim based on what they did find in the tests, and make you go through h*ll if you want to try to overturn that. Which may not be possible if there is in fact no other way that much, or say a residue, of PG or VG could end up in ones lungs. (Warm fuzzy gov getting involved in insurance now, wouldn't let ppl be treated that way? Well they hate us as much as anyone else unfortunately... and will be needing to start cutting costs anyway...) I'm not a conspiracy theorist but to me anyway none of this sounds very far-fetched in today's world...

So I take it you don't think this was potentially too valuable of a giveaway to the Other Side re ways to further screw with us? Hehe came back here to wipe out the detail in my 'scenario' post above, in case those more familiar with how the sausage is made thought that best. (But you'd have to also, since you quoted it...) Yeah I know it couldn't be so brilliant that only I would ever have thought of it lol, but I think it's appreciated around here to avoid serving up any potential tactics on a platter to the other side anyway...)

Oh to clarify to anyone reading, I didn't raise this as an objection to the petition! I just wandered off into a general insurance topic after lizziebith brought insurance up above.

 

[StormFinch]

Alright, lets try this folks. For those questioning as to whether the FDA has or has not already classified e-cigarettes as a drug delivery system;

This is a Import Refusal Report found on the FDA's own web site. The form is dated December 30th 2009, less than 3 months ago. Import Refusal Report

In a nut shell, a shipment of e-cig kits and carts were refused U.S. entry because, and I quote, "The article appears to be a new drug without an approved new drug application." And, there are at least a dozen more just like it. If you do your own search make sure you click on 'include omitted results' at the bottom of the results page or you will only get one of these reports listed.

Basically put, it's happening now and will continue to happen until the FDA is told to stop. A couple of Appeals judges with family members in the American Lung Association and we're sunk.

Personally I'm perfectly fine with having e-cigs classified as a tobacco product. If they tax them here, I'll order overseas, if they cut out my flavors I'll add my own. I am not however giving up my e-cig, and realistically that is the only other option here.

 

[basic_atheist]

lol nah, if social and establishment anti-ecig sentiment continues to grow, and insurers decided they didn't want to cover use of these untested, 'suspect' things, my guess would be that they'd be able to determine how much PG or VG could possibly end up inside ones' lungs via fog machine/cooking/etc. as opposed to the direct, concentrated, almost continuous inhalation of vaping. (Who knows, maybe other components of the liquid would be detectable in test results too.)

Again, given scenario is during lab tests for a respiratory problem; not implying warrants to seize bodily fluids. And no, they wouldn't search your house for supporting evidence, but like always, they could deny the claim based on what they did find in the tests, and make you go through h*ll if you want to try to overturn that. Which may not be possible if there is in fact no other way that much, or say a residue, of PG or VG could end up in ones lungs. (Warm fuzzy gov getting involved in insurance now, wouldn't let ppl be treated that way? Well they hate us as much as anyone else unfortunately... and will be needing to start cutting costs anyway...) I'm not a conspiracy theorist but to me anyway none of this sounds very far-fetched in today's world...

So I take it you don't think this was potentially too valuable of a giveaway to the Other Side re ways to further screw with us? Hehe came back here to wipe out the detail in my 'scenario' post above, in case those more familiar with how the sausage is made thought that best. (But you'd have to also, since you quoted it...) Yeah I know it couldn't be so brilliant that only I would ever have thought of it lol, but I think it's appreciated around here to avoid serving up any potential tactics on a platter to the other side anyway...)

Oh to clarify to anyone reading, I didn't raise this as an objection to the petition! I just wandered off into a general insurance topic after lizziebith brought insurance up above.

No, I agree with you. It could be done through the tests. If a way can be found to cut you out of the insurance benefits, they will do it whenever they want to. And, I think they could look for PG residue in the upper respiratory system and run comparisons with other known e-cig users.

So yes, in that type of scenario, you would be pretty much screwed. They don't want a dying patient. They want someone who aims to be healthy and can continue to pay premiums.

Government insurance is a similar scenario. They want a living tax payer, not a dying one. They also want people who are easily controlled, but that's a different subject.

[P.S. - found out where to hide the chargers. Duct tape it in the air handler return vent behind the filter... ha ha ha]

 

[d21]

My .02.

I commented but don't necessarily support "drug device" or "tobacco product". Im ready for the gov't to back off me and my choices for a while and I let them know it. My principles will not allow me to decide which evil I hate less. I'm sick of that choice.

 

[m201]

After reading ALL of this thread (and several others) here is my FDA-2010-P-0095-0001 comment:


I switched from smoking cigarettes to vaping ecigs in January 2009. By April 2009, I was ordering NO NICOTINE cartridges. I have been smoke-free and nicotine-free for a year because of electronic cigarettes. I request that you reclassify electronic cigarettes from a drug to a tobacco product.

The satisfying enjoyment of vaping an ecig in my chosen flavor is the reason that I believe I continue to be tobacco-free and nicotine-free. If you take my ecig away from me, I know that I will succumb to buying and smoking 'cancer sticks' tobacco cigarettes again... we are talking about my life here! To QUIT smoking was impossible for me -- switching to vaping made it easy and very much preferable to ashes and fire chemically-ridden-cigarettes.

I feel they should still be classified as a tobacco product, because I would not have even tried them or been successful using them with NO NICOTINE in the beginning ... and that the possibility exists to save the lives of 4 to 8 million of my fellow adult American smokers who will otherwise die of a tobacco-related illness over the next 20 years.

I ask that the FDA propose a harm reduction initiative to current tobacco control programming by which current smokers are informed of the differences in risk profile presented by different types of tobacco products. From my personal experience, e-cigarettes appear to be the very-low-risk product likely to be acceptable to most current smokers.

With strict FDA regulation of manufacturing and marketing -- it should be possible to achieve this public health benefit without increasing the numbers of teens initiating tobacco use.

FDA regulation of this product as a drug would mean a de-facto ban until clinical trials not required of other tobacco products can be completed, which would be ridiculous since nicotine is not an ILLEGAL or PRESCRIPTION drug now.

Please reclassify electronic cigarettes as a tobacco product so that I may continue to enjoy my ADULT privilege of vaping.

Comment Tracking Number: 80ace4f8

 

[m201]

submitted regarding FDA-2010-P-0093-0001

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

It was unconscionable of the FDA in their lab report (http://www.fda.gov/downloads/Drugs/S.../UCM173250.pdf) to suggest that electronic cigarettes were more harmful than tobacco cigarettes.

Please publicly retract this flagrant mis-statement and advise that those who use electronic cigarettes are using a 'harm reduced' tobacco product!

If smokers try an electronic cigarette and are as successful as I and thousands of others in switching from tobacco cigarettes to an electronic cigarette, MILLIONS of lives will be saved!

Comment Tracking Number: 80ace937

 

[Janetda]

bump bump bump

 

[CES]

The site for FDA-2010-P-0095-0001 shows only 65 comments- but the comment I made on March 4th is not one of them.
Please check to make sure that your comments are posted.

Does anyone know how i can go about correcting this?

 

[Oliver]

Hmmn, that's a touch worrying. Anyone have any idea?

Anyone looked to see if their comment has been included and found it absent?

Do you get a receipt when you submit, by the way?

SJ

 

[CES]

There was a comment tracking number- but it didn't work to find my comment. I saved the comments and tracking numbers. I guess I'll just re-post my comments when i get home tonite- but I'd urge everyone who commented to make sure that it did get posted.

 

[kristin]

I made a comment on March 10th, got a confirmation number and mine wasn't posted.

 

[Mister]

I hope everyone will take the time to check if their comments are posted at the FDA site. You can check by going to Regulations.gov, then click on the checkbox named "Public Submissions", then select "250" in the "Records per page" dropdown, then search the page for your name.

My submission isn't published but I expected that because I'm not an American citizen.

However we're now seeing signs of something which may be a disturbing censorship of Americans' comments. Please post about it here if you submitted a comment and it hasn't shown up on the FDA docket within a week or so of your submission.

 

[Janetda]

Mine's not there either. So what do we do?

 

[CES]

My original comments and confirmation numbers are on my home computer. I'm going to email and re-post when I get home this evening. I may also try the "help" link on the website- but it's such an awful site that i don't expect much help from "help"

Should the AAPHP be contacted also?

edited to add: from the regulations.gov faqs page.

Why can't I see a comment I submitted?

Once your comment is received, the appropriate agency must process it before it is posted to Regulations.gov. Given the fact that certain regulations may have thousands of comments, processing may take several weeks before it may be viewed online.

Once processed, your comment is publicly viewable on Regulations.gov. The best way to find it is to enter your Comment Tracking Number in the search field on the homepage. You can also search by Keyword or Submitter Name.

If several weeks have elapsed and you still do not see your comment, it may be inconsistent with the agency's guidelines for posting comments.

Another reason your comment may not be shown is that certain agencies choose not to post any comments to Regulations.gov. Contact the Help Desk for this list of agencies.

For questions regarding a specific comment, contact the agency directly.

 

[Janetda]

I'm an idiot and didn't save what I wrote or the numbers. Who thought they wouldn't post? I'm sure anything I said was nice and polite.

 

[kristin]

You can search by your name, as well. I don't get why other comments made the same day and after are posted, but not mine. Well, I saved it on this thread, I'll try posting it again!

 

[Vocalek]

My comment on the Press Release/Lab Report was submitted March 3 and is not there:

80ab3df9

 

[Vocalek]

I resubmitted the comment, and received this message. If neither version appears within the next 3 days, I will be writing to my Senators and Congressional representative.

Success! Your Comment Has Been Submitted

Comment Tracking Number: 80ad5cf1

Thank you for submitting a comment on the following OTHER

Document ID: FDA-2010-P-0093-0001: American Association of Public Health Physicians, Tobacco Control Task Force (AAPHP) - Citizen Petition

May I suggest that the rest of you do what I have done above. Copy the text of the "Success Message" to include the Document ID line, and then paste in here as a response. This way, we have a record of all the comments that are being properly submitted and not being included.

NOTE: Please try to stay on topic with comments. The petition with "0093" in its number is the one asking them to correct the message delivered by their misleading press release, so saying "Please keep e-cigs legal" does not address the issue of this particular petition.

Also please note that the "anti-freeze" that was mentioned in the FDA press release referred to ~1% Diethylene Glycol (DEG) found in one of the cartridges and does NOT refer to the major ingredient in most cartridges, propylene glycol (PG). FDA never claimed PG was unsafe in its press release, so there's no need to defend PG as an ingredient.

The press release did, however, give the VERY false impression that e-cigarettes are highly toxic and carcinogenic. The truth is that e-cigarettes are no MORE carcinogenic than an FDA-approved nicotine patch*, and about a thousand times LESS cardinogenic and less toxic than the tobacco cigarettes you used to smoke.

*Based on the quantity of Tobacco-Specific Nitrosamines (TSNAs). FDA's report lacked a quantitative analysis of TSNAs -- just reported "Detected." Health New Zealand's report tells us that 1 ml. of 16 mg liquid in a Ruyan electronic cigarette contains 8 ng/g of TSNAs and that a nicotine patch contains the same amount! We also know that tobacco cigarettes contain from 5,500 to 11,000 ng/g of TSNAs.

 

[CES]

I've resubmitted my comments on both petitions. I'll also check back in the next few days.

 

[Mr_Phil]

Nope. Not there. Hmmmmm, I think a tinfoil hat may be in order.