Thursday, July 24, 2014

Fourth Call to to Action for FDA Proposed Regulations - Submit Comment


UPDATE: We realize there are recent adopters of these products who may not have had time to familiarize themselves with the politics and what is at stake. In an effort to engage you and provide a means to have your voice heard, here is the link to the simplified version of our 4th FDA Call to Action.
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NOTE: After reading the instructions below, please go here to submit your comment to the FDA. Comments posted to this blog DO NOT go to the FDA. This is NOT a petition!



On Thursday, May 8th, 2014, CASAA released the Overview of its Action Plan Regarding Proposed FDA Regulations.  
As noted in CASAA's Action plan, this is not a battle that is going to be won based solely on comments to the proposed regulations. Accordingly, we are attacking this on several different fronts. Before the draft regulations were published, we had envisioned a single Call to Action with several suggested actions. However, upon seeing the details, we decided the best strategy to effect positive change is to prepare a comprehensive Action Plan which consists of several Calls to Action issued at staggered dates to maximize effectiveness, and extending beyond comments to the FDA docket.
  • On May 11, 2014, CASAA released the first of several Calls to Action anticipated in CASAA's Action Plan.  
  • On May 21st, 2014, CASAA released the second Call to Action.  
  • On June 13, 2014,  CASAA released the third Call to Action.
  • On July 17, 2014, CASAA released the first Call to Prepare.
  • On July 23, 2014, CASAA released the second Call to Prepare.
This is the Fourth Call to Action in CASAA's Action Plan.  


In the first Call to Prepare, you created a some comments that addressed several substantive points. In the second Call to Prepare you added more content.  Instructions on assembling that content and filing your comment to the FDA are listed below. Please note, the current deadline for submitting your comments is August 8th, 2014.

These guidelines are written for people who have used e-cigarettes for tobacco harm reduction. Obviously, we encourage comments from other CASAA members or other consumers, but much of this (it is obvious which parts) will not apply, and you will need to write more in third-person than first-person.


FIRST, some final notes on what you have already prepared:  
  • Review the paragraphs you have created according the the first and second calls to prepare. Check for editing errors and make sure you’ve made your points respectfully.  
  • If you have not done the preparation from the calls to prepare, go back and do that.  This call to action does not include suggestions about the substance of your comments.  That was in the calls to prepare.
SECOND, create a single word processor document that will be your comments. There is a web form that can be used for comments, but it is better for several reasons to include them as an attachment (most notably, the form has a fairly low character limit).  
  • Set up a header in either memo form (From: [Your Name], To: FDA Center for Tobacco Products, etc.) or in letter form (Dear FDA Center for Tobacco Products,), whichever you prefer to use.  Include the date.
  • Make sure to include in the header the following, “FDA, Docket No. FDA-2014-N-0189, Regulatory Information Number (RIN) 0910- AG38”  It can be the “Re:” line in memo form or just stand alone in letter form.
  • Make sure that you save a copy of your final word processor file because we will be issuing a CQ Roll Call campaign next week to enable you to share your comments with your state and federal legislators.
THIRD, assemble your content:
  • You should have already prepared, as suggested by the calls to prepare, one or a few paragraphs on each of the following:
    • Why you are the real stakeholder in this process
    • Your personal story of using e-cigarettes
    • The role of flavors in your e-cigarette use (optional)
    • What you would do if the proposed restrictions were put in place
    • [possible other content]
    • A closing paragraph
  • We suggest assembling them in that order (though, of course, if you wrote them such that they flow better in another order, feel free to rearrange).  The “other content” refers to anything you might have decided to write about the science or other observations that do not fit in one of the other points (totally optional, as we noted, and potentially tricky to pull off).
  • We request that you add somewhere in the first or final paragraph that you are a member of CASAA (assuming that is true; if not, join and then say it! -- it is free and numbers matter).
  • If you have any particular expertise, credentials, or experience that may distinguish your comments from others, be sure to note that in the first few sentences of your document.
  • If you followed the calls to prepare, you probably wrote the individual pieces in isolation, so they might not flow together naturally.  After putting them together, consider adding transition sentences between them or headers or thesis statements (e.g., “Were it not for flavors, I would have probably kept smoking”) to aid in the transition.  This may not be necessary.  This is your comment in your own words, so you can decide if you like how it flows or if you want to change the flow.
  • If your first paragraph is not a natural introduction as written, consider adding a sentence like “I am writing as a individual American citizen who quit smoking thanks to e-cigarettes and has been vaping for two and a half years.”
FOURTH, submit your comment:


INSTRUCTIONS ON HOW TO SUBMIT YOUR COMMENT
  1. You have already created a document containing your comment.  
  2. Access the comment form for the deeming regulation (FDA-2014-N-0189):  FDA Comment Form
  3. Click in the Comment field and type, “My comment is attached” or something to that effect. Immediately beneath the Comment box is a button labeled “Choose files” for uploading. Click on that box and select the document file containing your comment. (Regulations.gov accepts the most common word processor file types: .doc, .docx, .rtf, .txt, as well as .bmp, .xls, .pdf, .gif, .htm, .html, .jpg, .jpeg, .png, .ppt, .sgml, .tiff, .wpd, .xml, .xlsx, .pptx.)
  4. Click in the First Name field and type your first name.
  5. Click in the Last Name field and type your last name.
  6. If you wish to allow FDA to contact you, click to check the "I want to provide my contact information" box. Otherwise, leave this box unchecked. When you check this box, fields are displayed for you to enter your ZIP code and email address.
  7. Click to uncheck the box, "I am submitting on behalf of a third party."
  8. Click the arrow next to the Category field to display a menu.
  9. Select a category from the menu.  We recommend "Individual Consumer.”  
    NOTE: FDA has traditionally taken the position that "Individual Consumer" comments will not be published on the Regulations.gov website due to privacy concerns.  There has been some criticism of this position, and FDA has indicated that it will be publishing "Individual Consumer" comments on the website, although it intends to only publish the individual's first name.  Any identifying information you provide in the Comment field will potentially be visible on the website, so we recommend that you NOT include your name, address, phone number, or email address in the Comment field.
  10. Click the Continue button.  After clicking on the Continue button, you will have an opportunity to review your statement and, if you wish, edit it.  (The Edit button is just to the right of the Submit Comment button in the lower right-hand side of the page.)  If you have uploaded your comment as a file, you will obviously not have the opportunity to edit it on the website during this stage.
  11. On the Your Preview page, click to check the box "I read and understand the statement above."
  12. Click the Submit Comment button.
  13. After submitting your comment using the comment form, a confirmation page will appear with your Comment Tracking Number. We recommend that you print the page AND email this comment number as directed in Step 14 below.  (You may wish to copy the entire page into an email to yourself, which you can then forward as directed in Step 14 below.  Copying the entire page and emailing it to yourself will ensure that you have a copy of your comment number.  If you uploaded your comment as an attachment, you should verify on the confirmation page that “success” appears in green letters to the right of the file name under “Uploaded File(s).”)
  14. Please send the comment number to casaa.fdacommentarchive@gmail.com.  (You may, if you wish, include a copy of your comment, but that is not necessary because all we really need is the comment number.)


FIFTH, publicize the Call to Action anywhere there are vapers.  

Note that there will be two versions of this. The present version is for people who understand what is going on and are willing to spend some time to be maximally effective. But we recognize that not all consumers are even aware of the FDA’s proposed regulations and how those regulations will impact them.  

In an effort to reach as many consumers as possible, we will be issuing a streamlined Call to Action in the next day or two which will be designed for vendors to forward to customers. The streamlined Call to Action will facilitate comments from those consumers who might not otherwise know about the proposed regulations or are not willing to put in the effort described here.  Of course, we encourage anyone who can to complete the version described here rather than using the streamlined version.

100 comments:

Anonymous said...

This is extremely long and confusing. If we want to have our voices heard, and be maximally effective, please just provide links to who we should Tweet/email, or phone numbers? Calls to action 1-5 with TONS of text? Who has time to read/sort through all of this not to mention try to process it?

1. Find your reps
2. Write, email, call, tweet, repost
3. Share

Allison Taylor said...

Finding your reps, writing, emailing, calling, tweeting and reposting will not result in a comment being submitted to the FDA docket.

There will be streamlined guidance coming out in the next few days if you don't want to put the effort forth to follow these directions.

Anonymous said...

Agreed, simplify this and watch participation skyrocket.
Know your audience...which is the the vaping community first.

Anonymous said...

I have been following and preparing this document all along so it was not difficult for me to submit the entire comments. I do agree, however, most do not have the time or motivation to be able to complete all these steps and they can be overwhelming. I look forward to simplified guidance to pass on to others.

Anonymous said...

I'm all for strict Guidelines from the FDA on the production of E-Juice - E-Liquid. There are just too many people out there sitting at their kitchen tables in unsanitary conditions mixing, bottling and selling the product to the public to make a quick buck.

Anonymous said...

This is sad. Why is the vaping community so damn lazy?? Take some time out of your busy schedule (which for most include 8 hours of Xbox...stalking the mailman for vapemail and the rest of the time figuring out Rip Trippers "super dragon stovetop parallel sleeper coil" in your mom's basements because..well...YOU DON"T HAVE JOBS! Call of Duty can wait! This is about your RIGHTS and you will be the first ones to complain when all those rights get taken away. Just pathetic.

Nobody said...

Lmao. Where can I find one of those Rip Tripper super dragon parallel sleeper coils at? I'll be all over that.

Carl V Phillips said...

This plan is for people who care enough about vaping to spend a couple of minutes doing something that might actually matter. Those who just want to spend ten seconds venting to make themselves feel good, with no chance of accomplishing anything useful, can find plenty of others who facilitate that.

Carl V Phillips said...

Which is yet another reason to oppose the FDA regulations. They include no provisions about manufacturing practices.

Carl V Phillips said...

Um, no, the audience is FDA and those who might adjudicate in the future.

Anonymous said...

Done. Not sure how eloquent my arguments were, but I tried. :-)

Anonymous said...

The super dragon parallel sleeper when out like old news with that dinosaur Plume Veil which has already been out for 2 weeks man. STAY CURRENT! If you don't make that coil a stovestop, your buddies at the vape shop are going to think you aren't "rad" anymore. With the new coil you can piss off WAY more people in line at Walmart with much bigger clouds! SICK AS TITS!!!! (Wiping the dripping sarcasm off of my keyboard). :)

Carl V Phillips said...

Yeeeeah. You might want to read a little more, even to just inform your "I don't like to read" comments.

Anonymous said...

Shut up

Anonymous said...

Welcome to the future, things will go the way the big brother says they will go. Open your eyes, we as a country don't agree on much and even when we do you can't keep our attention for more than 2 mins..4 if there's boobs involved. We won't ban together, we won't read more than two lines of instruction and we certainly won't follow some painful process, this isn't just vapers...its everyone.....activist unite...and then get back to us.

Anonymous said...

LOL...Truth hurts. Thanks for making my point for me..and in such an eloquent manner..

Anonymous said...

The revolution of apathy will be EPIC! But not right now, we don't really feel like it. Maybe later.

Anonymous said...

its really not that hard to express your thoughts on the potential ban of basically all good vaping hardware. If u cant handle writing more than one paragraph, write at least one paragraph then and do your part. Just please do something, if this is really too much work for you, you are the reason every freedom we have is being infringed upon. Not just vaping, freedom of choice in general in a free market is dying. The sad part is the FDA is doing nothing to actually analyze the health benefits or harms of the ejuices they are simply leaving that up to the company who has to submit the costly application when they should rather just be out there making sure there is good juice practice in vendors in a real world just like they do at restaurants. this reg has zero public health benefits and actually will harm public health as its proven that vaporizers are "safer" than inhaling the tar in tobacco. chmon guys people have died for freedom, good people, at least take a few minutes out of your day to stand up for it.

Jackie Stallings said...

Knowing how important this is, I made the time to do it.

Anonymous said...

To the Troll who's sitting in Mommy's basement. If you don't want to write and it's too much trouble. Then don't do it! Just go away please!!! Leave the conversion for the adults in the room!

Anonymous said...

I started out giving my best effort. But this is getting ridiculous. I can't remember which call to actions I responded to. It is very confusing to the people who just want to quit smoking. Not everyone is playing XBox. There are people who work 10 hours a day, 6 days a week(or more). Every time I do my due diligents, I assume I've done my part. Then I get another email asking me to do something else. So now I'm lost. BTW, Why do we despise the way our Government works and our Freedom is slowly disappearing, then we wear Red White and Blue on Independence Day or chant U. S. A. to support a country that does nothing but find ways to get more of our money. ObamaCare! The cheapest I could find is $500/month(just for myself) then $40 every time I see a Dr., $150 for X-ray, $250 for MRI and so on. Sorry for ranting. I'm considering defecting to Canada or the UK just so I can get some decent healthcare.

Anonymous said...

I'm sure we could take up a collection for a one way ticket. TROLL

Debora Johnson said...

I have been preparing for the last few months so comment is submitted and I have sent you the ##.
Thank you CASSA for all you are doing for us. You have put a lot of effort and planning into this I appreciate it. I hope my comment and that of others will help us in this fight.

Anonymous said...

Wow dude, you really have NO reading comprehension. My point..for those who don't get sarcasm..was to piss people off enough to stand up and do something. Hell...nothing else seems to work! The more I read these boards, the more hopeless it feels. THIS is too "complicated" for people, but most of those same people have already taken the time to watch Busardo, Grimm, Rip, Ruby Roo, Suck My Mod and Twisted's new videos for the week and are on preorders for all the new mods that Joe is pimping! It's not hard to understand. We have to play the FDA's game with this. CASAA is showing people how to do it. I don't want to throw in the towel. But what we've been seeing over the past few months with all this apathy towards something that we all profess to love so much. It's PATHETIC. That was my point. Understand now or do I need to explain further??.

Anonymous said...

Thank you CASAA for your good work! Myself and others have completely been relying on you guys and your action steps to understand what to do. THANK YOU! I will be submitting a detailed personal letter to the FDA as recommended. I badly do not want the vaping marketplace to be destroyed. I just discovered it a few months ago, I rely on these products I found and don't know what I'd do without them, sincerely I don't. I am very concerned. I wish that thousands of people would do as you say, it takes a VERY loud voice for the government to listen.

Anonymous said...

http://freetovape.org/take-action.php

This site has been up for a while, and it seems like an innovative initiative. Is this a working model for a more streamlined process? It is a pre-emptively created form that helps you generate your letter and tracks how many users have submitted. Fill out a form, press a button and hope it adds to the case for us.

Anonymous said...
This comment has been removed by a blog administrator.
Anonymous said...

you're pathetic

Anonymous said...

"There are three types of people in this world: those who make things happen, those who watch things happen and those who wonder what happened."

Some of us vapers are self-sabotaging the cause by complaining or flaming each other. Stop it. It's bad enough that so many of us say nothing.

Many organizations, businesses and consumers will be impacted by the changes. The window of time for people to act is closing, and the bulk of the vaping community being consumers are relying on established organizations to lead the charge.. Organizations with not only similar interests and similar goals, but with resources and networking ability. Hopefully these organizations will support and endorse each other and continue to plan and coordinate their efforts as effectively as possible. It's 2014, let's make it simple. Use images, make a video. Get the major e-cig youtube channels (Busardo, Grimm, Rip, Ruby Roo, Suck My Mod and Twisted, etc...) on board and it will spread virally like wildfire.

It's sort of "Get it right the first time." or it will be "Too little, too late," so hopefully the method is truly the pinnacle of our potential to organize and mobilize against the oppositions facing our rights. For or against the e-cig industry, many have serious feelings about vaping, and for so many reasons. Lots of voices talking, trying to be the loudest, a lot of information and misinformation everywhere.

Let's hope that we can count on the right people to hear about these efforts in time and inspire them to act under these directions.. That we can rally the characteristically diverse demographic of the English speaking ex-smokers who have a 10th grade reading level or better, who really cared about vaping enough to follow along with all of this and possess the intelligence and willpower necessary to be motivated enough to consider taking part in something as complicated and complex as political activism, especially this late into the game. That statistic is probably tragically lower than we'd all like to imagine, so we'll have to use every technique in our disposal.

Anonymous said...

Thank you for sharing that! I just did that one, as well. I will do anything I can.

Anonymous said...

Umm, did you read the comment before you replied? Talking about CASAA's audience for the instructions. KISS, Keep It Simple Stupid

Anonymous said...

I don't understand why there are so many complaints. We've had months to prepare our comments and submitting it was is a piece of cake.

Fight to Vape said...

If you're genuinely interested, there's a rolling collection of analysis here: http://antithrlies.com/?s=fda

And, if you truly have something to contribute, I suggest you do it as more than a shadowy, anonymous, silhouette.

Anonymous said...

Okay I went there, did not see any of the FDA questions. Did not see analysis of those questions. Did find lots of stuff saying the FDA was wrong on the science. What about the FDA's questions, responding to them?

Robert McKnight said...

Your Comment Tracking Number: 1jy-8dem-ifw5

Anonymous said...

there is nothing in these regulations that govern how people make their juice. THATS THE PROBLEM! these regulations are going to put a lot of reputable business' with excellent manufacturing practices out of business because they cant afford the application process. as a result a black market will develop where people are making juice in their bath tubs and kitchens. COMMENT and let them know that

Anonymous said...

Agreed.

Anonymous said...

Done! It took less than ten minutes.

Anonymous said...

Come on, folks, let's slam them with letters! Let's clog up their computers with letters! Onward!

Anonymous said...

Thank you CASAA, there is nothing hard about getting multiple emails... one said. post this to extend comment period. the next was a forum style post. then we received notification to prepare our own personalized documents, then the 2nd email in that line gave us a little more direction on preparing that message. the last one is to help you submit the message. Read again if you still don't understand please as its really quite simple, they cant just completely baby everyone through it or nothing will get done, you personally have to do something, create a document with information, what you have seen, what you know about vaping and why this will hurt you so they see how many lives they could ruin and we give them at least something to show them we will not relent and will continue to vape no matter what.

Alexander Moreau said...

Took my ADHD ass about an hour to make sense of this, pretty simple though, I'll have to make a write up tomorrow.

Lordmage said...

comment :Number: 1jy-8der-xs52

Anonymous said...

I would have liked to seen the comment deadline date mentioned somewhere in this CTA.

Perhaps in a follow-up reminder. Thanks!

Fight to Vape said...
This comment has been removed by the author.
Alex Clark said...

The Deadline is August 8th. And - Updated.

Thank You.

karyyl said...

Ummm, does failure to respond to any of the 99 questions endanger our ability to complain later? Don't we need to give some answers? I realize the questions are likely to be nonsense because they are based upon false assumptions but if I had a lit of questions, I could address one or more of them based on Dr. Phillips's exposure of the false assumptions. Is there a list? Reading the whole doc was painful, I lost it after the first 12%. (And job stress was over the top until 2 days ago.)

VapinXsmoker said...

Done in over an hour and 30 minutes (I'm not a fast typer or reader) and comment number sent. All I had was my personal success story. I hope a lot of folks will take this call to action serious and submit a comment as requested in this and previous blogs.

bigdancehawk said...

There are no objective standards in the proposed regulations. None.

Anonymous said...

It really doesn't take that darn long. I even got behind because of chores/kids/inattention but caught up just a few minutes ago. My comment was submitted. Some things take actual work. Suck it up, Buttercup, and just do it. I know it's rough when it involves more than just clicking "like" but you can do it if it's important to you.

Alisha Christian said...

Completed.

bigdancehawk said...

I seem to recall that somebody did compile a list of the questions and posted it on ECF. Does anybody have a link?

bigdancehawk said...

Hey, could you two stop this please? Just for the sake of the children?

Anonymous said...

It took me about 30 min to gather my thoughts and type them up in a (hopefully) intelligent manner. Cassa has made it extremely easy for us to make our voice heard. Some of those folks who think it's complicated or too timely are those who are always looking for immediate gratification. Nothing wrong with that, I like fast food and microwaves too. But I really enjoyed rediscovering my love for vaping by writing my comments. So maybe those that think it's complicated or too time consuming might also find it rewarding.

bigdancehawk said...

Is this intended as a joke? Go away, Lerry.

KWP said...

To the OP, sadly you're 100% correct.
Although I'll be taking time to post my own thought-through comments, I feel that this battle is lost even before we begin to fight. Especially when 80% of this process will be dictated by those with money (ie; big tobacco, big pharma and anti-smoking orgs). But once my own comments are submitted I will again return to attacking the root of this problem and most others in federal government; Money in Politics.
http://www.wolf-pac.com
Please join me in the fight to take our democracy back!
(after you've submitted your FDA comments, of course)
;-)

KWP said...

^ Best. Post. Ever.

KWP said...

^ Best. Post. Ever.

KWP said...

Pbusardo's take on FreeToVape:
https://www.youtube.com/watch?v=CLWguCLtD1M

Sorry, there's no "easy way" when dealing with a government bureaucracy.

Steel Mage said...

Thanks to CASAA for the instructions on how to submit my comments. I found them most helpful. I spent about 4 hours putting together my full 3 page comment. Now I just hope someone at the FDA reads it.

bigdancehawk said...

Please help! I've been trying to rebut a few anti-e-cigarette comments on the FDA deeming regulations site. I'm up to about 10 rebuttals and then came across a comment by John Spangler, MD, MPH, a self-proclaimed tobacco control guy.

Here's his comment: "Adolescents do not use e-cigarettes as cessation aids, but rather use them in conjunction with conventional cigarettes (58-fold greater risk of use among smokers). These products should NOT be labeled as harm reducing, since they are not associated with either adolescents’ desire to quit smoking or their quit attempts."

To support this, he attached a link to an abstract of a study: http://www.ncbi.nlm.nih.gov/pubmed/24968185

The actual study hasn't been published, so we can't read it, know who funded it, evaluate the credentials of those who performed it, know what conflicting interests they may have, determine who (if anyone) reviewed it, or learn anything about the methodology.

Here's what the abstract says:
Lippert AM. Do Adolescent Smokers Use E-Cigarettes to Help Them Quit? The Sociodemographic Correlates and Cessation Motivations of U.S. Adolescent E-Cigarette Use. Am J Health Promot. 2014 Jun 26. [Epub ahead of print]
Abstract Purpose . To examine the sociodemographic traits of adolescent e-cigarette users and whether e-cigarettes are used as cessation aids among adolescent smokers. Design . The study had a cross-sectional design. Setting . Study setting was the United States. Subjects . A probability sample of 15,264 adolescents in grades 6 through 12 was used. Measures . The study measured self-reported lifetime e-cigarette use and recent conventional cigarette use, desire to quit, and number of recent quit attempts (among conventional cigarette smokers), and factors hypothesized to be related to e-cigarette use (e.g., race/ethnicity, age, friendships with smokers). Analysis . Logistic regression was used to assess e-cigarette use among (1) all adolescents and (2) conventional cigarette smokers as a function of quit desire and attempts. Results . Descriptive analyses show 3.2% of respondents had used e-cigarettes. E-cigarette use is significantly lower for females (adjusted odds ratio [OR], .70), non-Hispanic black youth (adjusted OR, .37), and Mexican-American youth (adjusted OR, .56), and higher for those who smoke conventional cigarettes (adjusted OR, 58.44) or have friends who smoke (adjusted OR, 2.38). Among conventional cigarette smokers, neither desire to quit nor recent quit attempts is significantly associated with e-cigarette use. Conclusions . E-cigarette use is more common among certain adolescent subgroups than others and does not appear to be part of a cessation regimen among conventional cigarette smokers wishing to quit. More regulatory and prevention efforts are needed, especially for certain adolescent subpopulations.

Now, I understand that just because most cigarette smokers at one time or another used an e-cigarette does not support the assertion that adolescents "use them in conjunction with conventional cigarettes."

I'd welcome any ideas you may have for rebutting either the comment, the study, or both, but what I'm most interested in finding out is whether the adjusted OR in the study of 58.44 supports the claim, "58-fold greater risk of use among smokers." I wasn't sure if ORs can be so easily be translated into probabilities.

bigdancehawk said...

The "Subscribe to: Post Comments (Atom)" link just yields a giant page full of code. Just sayin' in case somebody has the means and motivation to fix it.

bigdancehawk said...

1jy-8dgq-s465

Anonymous said...

1jy-8dn-4-ji15....done. Thank you CASAA for all you do in helping us by providing this format so our voices can be heard! I am one who realizes that nothing is easy when you are dealing with the government. To all whl read this--it really wasnt that difficult to do. Good Luck to all of us !

Kristin Noll-Marsh said...

1) The study author, Adam Lippert, is strongly linked to the Robert Wood Johnson Fundation, a front group for pharmaceutical giant Johnson & Johnson. (Robert Wood Johnson Health & Society Scholar, $22,400 grant given January 2014 for a different study.) That is a strong conflist of interest, since J&J makes products that directly compete with e-cigs.
http://www.hsph.harvard.edu/wp-content/uploads/sites/1637/2014/01/LippertCV.pdf

2) MOST e-cig users are still smokers. Only a small percentage of 45 million adult US smokers have even tried e-cigs, so it's logical that most who have tried them are still "transitioning." The same would be true of youth smokers. BUt they can't keep ignore the number of people who HAVE quit by using e-cigs.

3) Dr. Spangler seems to be confusing (either out of ignorance or purposely) cessation as the only true harm reduction. That's l;ike saying condom companies shouldn't be allowed to label as reducing risks of STDs because condoms don't get people to stop having sex.

4) E-cigarettes are marketed and sold as harm reducing products to ADULT smokers. Soon, every state and even the federal government wil have banned sales to minors. TO suggest a product intended for adults shouldn't be marketed as "harm reducing" because kids don't buy it (illegally) to quit is ridiculous. That's like suggesting Oxycotin shouldn't be marketed as an effective pain reliever because kids buy it illegally to use it for a different purpose.

Kristin Noll-Marsh said...

Regarding the "58-fold greater risk of use among smokers" they act like that is a bad thing. RISK of use by smokers? The product is INTENDED for smokers. This only proves that, even among youth, this product is mostly being used by smokers, not non-smokers. That hints that e-cigs are not likely a gateway to smoking, because hardly any non-smokers are even using them - including youth. In order for e-cigs to turn non-smoking youths into smokers, non-smoking kids have to start using e-cigs. Clearly, that is not happening in any great numbers.

And adding:
5) Many, if not most, smokers buy e-cigarettes for reasons other than quitting (lower cost, novelty, safer than smoking). They then become "accidental quitters." So, even among adult smokers, many buy them without them being a "part of a cessation regimen among conventional cigarette smokers wishing to quit."

Unlike with gum, lozenges, patches, and poducts like Chantix, smokers will try them even if they aren't trying to quit and then actually stop smoking. None of the pharmaceutical products can claim that smokers who AREN'T trying to quit buy their products. A pharmaceutical products cannot be "safe and effective" to help smokers quit if the smoker isn't purchasing it. E-cigs afre helping people quit even if they weren't really trying to quit!

bigdancehawk said...

Kristin, thank you for the excellent and thoughtful reply. I posted my comment on Dr. Spangler's comment before reading it. I think my rebuttal was adequate, but yours is better and I think you should post it on the FDA comment site. Here's a link to Spangler's comment: http://www.regulations.gov/#!documentDetail;D=FDA-2014-N-0189-42257

bigdancehawk said...
This comment has been removed by the author.
Blade Barrier said...

Sadly, I have to agree with the original comment, at least to some extent. The average vaper isn't a doctor, nor a lobbyist. There are very few clinical trials to really reference for either side. It's all about money, lobbying, and whose voice is the loudest.

Twitter brought down entire governments in a short span of time, and is the best method that I can think of, in order to make a voice go viral. I don't even have a twitter account, but I would gladly make one to promote our speech regarding the matter.

Unleash the storm of the internet masses as quickly and as furiously as possible, and I believe the community will be heard. Create a list of the twitter accounts for those involved, and direct the voices to those locations. People can copy and paste a quick comment to news sites, senators and congressmen, the FDA, and CASAA, all in a matter of minutes, and create a clatter. It's strength in numbers that is needed, not editorials.

Anonymous said...

Agreed.
A sampling of form letters we could then personalize and send would likely get far more responses.

Anonymous said...

I am a Sr. Scientist and I work for a CRO and I totally agree with this comment. There need to be strict regs in place for e-liquids. Nicotine is a toxic poison and EPA banned its's use as a "natural pesticed" by organic farmers this year. If you think compliance is expensive-try non-compliance. The QC in Asia is not like the QC in the USA. The e-liquids produced in Asis contain many of the same toxic materials as does mineral makeup produced there. I would not use mineral makeup laced with harmful metals on my skin and I would prefer to not put e-liquids that have no been screened for toxins in my lungs. Aren't you glad that USA pet food manufacturer's have quit buying ingredients from China as they contain harmful additives that kill pets? I am not getting the big uproar. If you want to go into the business of producing products that people, inhale, imbibe, eat, use on their skin then be prepared to meet the regulatory cost. Definitely too many people using kitchen chemistry, who are not chemists and have no access to chemical instrumentation/or the know-how to use it to make the determination that these products are safe. Kitchen chemistry is fine for your own private personal use, But when one uses that to profit/make a living then meet the regulatory. I do it ewvery day in my position and I have no issues with that.

Anonymous said...
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Anonymous said...

Done! Tracking Number: 1jy-8dhi-ujlr

Anonymous said...
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Anonymous said...

COULDN'T HAVE SAID IT BETTER MY...I'VE BEEN VAPING FOR 2 YEARS AND GET MY LIQUID FROM THE SAME SUPPLIER OUT OF COLORADO...BUT THIS IS SCARY.

Anonymous said...

Imagine a vaping black market which will someday exceed the current drug black market.... It's truly insane #1 that the FDA will ALLOW cancer causing cigs but want to choke those who switched to vaping as... Tobacco profits are doing down hills?

I think the big men are getting scared.. Power in numbers!

Anonymous said...

It's kind of sad RIP's followers... Are all sheep who crave attention. but besides that, that comment is right. I see some laziness here... I just switched to vaping 2-3 weeks ago and I've smoked a pack + a day for over 10 years. IT'S A GAME CHANGER the improvement in vaping as a safer alternative to smoking!

Anonymous said...

Yeah, canada sounds good then this fascist nazi country called 'merica! But truth be told, the older generation f*cked this country up. You believed the lies that were fed to you with the mass propaganda system and now the younger generation has to clean up your mess. It's not easy!!! I've been doing my part... Surly but slowly. It comes down to

Anonymous said...

RIGHT ON!!! Power in numbers

Anonymous said...

PLEASE EVERYONE SUBMIT COMMENTS! Do everything you can. Most of what I'm seeing of the comments submitted on Regulations.gov pertain to cigars. Of the e-cig comments, I am seeing mostly "save our kids" stuff from people completely, utterly uninformed about e-cigs. We MUST counteract, our comments MUST weight more. WE are the ones thinking rationally about vaporizers and we absolutely must get that across, in great numbers.

Anonymous said...

Nicotine has not been accepted by gardeners as a pesticide for a long time because tobacco carries diseases to plants they are sprayed on. I mix my own juice not just because it's cheaper but also so I know what's in it. I always wear gloves when mixing because I remember when a friend cut tobacco one summer and got nicotine poisoning from touching it all day. After tobacco dries the spray it to bring the nicotine levels back up to addictive.
I do see the bad business in local vape stores. Last time I was in one they tried to sell me some local juice. I'm vaping a 2% and the lowest they had was 6%. I told them I didn't want to go backwards. They didn't understand why I didn't want to keep my addiction.

Anonymous said...

Correct. There is no easy way and the freetovape.org, while worthwhile to some extent is not the same as submitting comments to the FDA. Do both, do as much as you can to protect YOUR right to vape. Nobody will fight this fight for you.

Luisa said...

I agree,but we used to be a Republic. So lets" take our Republic back!

Anonymous said...

Just do it now. You already know your story, type it up, save it and submit it. If not, be prepared to make your own stuff or pay a high price to someone that can.

Anonymous said...

DO NOT PASS THESE REGULATIONS....this is the only thing keeping me from smoking

Denise K. said...


I smoked for 23 years. I tried hypnosis, prescription meds and gums. The vaper cigarette is the only thing that works. I quit within 2 weeks and have been smoke free for 9 months. All the money that has been spent on anti smoking ads hasn't worked. Banning smoking in restaurants and other places hasn't worked neither has raising the prices on cigarettes. Tell me why after all this effort has been made to keep people from smoking the one thing that truly helps you want to cause problems? You should put the money towards a solution rather then making it a problem. Use your heads!

Anonymous said...

I quit lighting up on 9-20-13. I feel like a new woman thanks to vapor. I thought I'd never have the will power/courage to quit until I tried vaping. It's worked wonders. I can't stand the smell of cigarettes anymore. Nasty. I've gotten at least 5 people to quit smoking cigarettes. I smoked for 41 years and I'm so happy I found vapor. I wish all smokers would at least give it a chance. The government has their hands in every aspects of our lives. It's time they stopped I'm sorry that they aren't getting all that tax money. I'm sorry that RJ Reynolds & Phillip Morris have killed millions of people and the leaders of our country just want the tax money. How sad is that. Please leave vaping alone. It's saved many lives and come on ..do you really need money for the tax? We pay taxes just like everyone else in this country. If we live longer just think of how much more money will generate. Please leave us alone.

bigdancehawk said...

There is no point in posting your comments here. I hope you are posting them on the FDA comment site.

Anonymous said...

Changing from cigarettes to vaping save my life. 10 months ago I started vaping xrays that day showed my lungs were really black and nasty.10 months later yesterday xrays showed a 70 percent clear lungs so this should answer some questions does it work? Yes. Does the FDA agree no because the bottom line is money. I bet there are some FDA people that even vape. Thanx

Angela said...

If anyone is having difficulty understanding CASAA's call to action for the FDA deeming regulations and needs a visual please go to this video that shows you the steps on a computer screen.
You probably know them as Matt and V from, Suck My Mod.
http://youtu.be/n45Ntos0xQU?list=UUaABLqKOy33BcQBU0bG1mmA

Angela said...

If anyone is having difficulty with understanding the steps to CASAA's call the action for the FDA regulations and needs a visual please see this video that shows how to do it on a computer. It's easy once you see it!
And you probably already know Matt and V from Suck My Mod who made the video.
http://youtu.be/n45Ntos0xQU?list=UUaABLqKOy33BcQBU0bG1mmA

Anonymous said...

Vaping has saved my life my wifes life and is the best thing that has ever happened to me and her it should not be taken away alcohol and tobacco should be under the microscope for health concerns

Anonymous said...

Nicotine is present in naturally in potatoes, tomatoes, and eggplant. Eating just 2 ounces of eggplant will put about as much nicotine in your system as sitting in proximity to a moderate smoker for 2-3 hours. I get rather tired of people saying "Oh my! Nicotine is a deadly poison!". Well I've got news for you. A surprising array of products designed for consumption you encounter everyday in your home, can ALSO be a deadly poison if concentrated highly enough. It's funny that I don't hear people make the same type of statements about coffee, yet if you ingested a gram or two of pure caffeine, you'd be in deep dark trouble.

Anonymous said...

If it's suppose to be healthier america then we need to stop banning things that will help

Anonymous said...

Done!

DALE said...

DONE, BETTER LATE THAN NEVER!

Anonymous said...

I have a lot of friends who swear by these products. Most have quit cigarettes some still working on it. I believe these products do unmeasurable good and should be allowed to continue without any interuptions.

Katrina Banaski said...

Thank you, Carl. Spot on.

Unknown said...

Spend the time and money banning smoking, which is proven to cause health issues and death not a product that aids people quitting. Vaping has helped many of my friends quit after all other methods failed.

reaper zip said...
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