Wednesday, May 21, 2014

Second Call to Action for FDA Proposed Regulations - Consumer Comment on Paperwork Reduction Act

UPDATE 5/27/14:  Part IIB of this Call to Action has been updated to ask that you use a DIFFERENT SUBJECT LINE in your email to OMB/OIRA.  If you have already submitted your email to OMB/OIRA, we are suggesting that in an over abundance of caution, you resend the email with the new subject line (see below Part IIB).

On Thursday, May 8th, CASAA released the Overview of its Action Plan Regarding Proposed FDA Regulations.  On May 11, 2014, CASAA released the first of several Calls to Action anticipated in CASAA's Action Plan.   This is the second Call to Action in CASAA's Action Plan.


There is an interim deadline for comments on the deeming regulation.  Specifically, any comments on the Paperwork Reduction Act aspects of the proposed regulation are due on Tuesday, May 27, 2014.  To a large extent, these are comments that merchants and manufacturers should be making rather than consumers, and we understand that the vendors are being mobilized to do it.  However, we have determined that it would be useful for consumers to make one particular comment in response to that, as appears below.

For those who do not know, the Paperwork Reduction Act is intended to force regulators to consider the costs of merely doing the paperwork and such needed to comply with a regulation (i.e., not the actual substantive requirements of the regulation).  We believe that FDA has used completely inappropriate estimates for the paperwork costs of this regulation.  In particular, they have estimated that there will be only 25 applications for premarket review of new tobacco products filed in connection with e-cigarette products. They have estimated very low numbers for the various other filings -- not as low as 25, but far fewer than there are merchants and products.

We all know that these numbers are far below the number of actual e-cigarette products on the market, and we need comments that make that known.  Basically FDA is either wrong about their estimates or are explicitly saying that all of the other products will be driven off the market.  While consumers cannot effectively comment on the question of whether that is accurate, you can definitely make the point about what you would be losing and that perhaps their estimates are na├»ve.

This Call to Action consists of three parts.  The first part (Part I) is preparing a comment. Part II described how you make the comment (Part IIA contains instructions on how to comment to FDA and Part IIB contains instructions on how to comment to OMB/OIRA--both are necessary). Part III asks you to share this Call to Action with others.


PART I.  
SUGGESTED LETTER COMMENTING ON PAPERWORK REDUCTION ACT ASPECTS OF PROPOSED REGULATIONS 
YOU SHOULD EDIT AS APPROPRIATE

Please count up the following and insert the numbers into the comment below (which, of course, you can edit in any way you want).
  • Number of different e-cigarette liquids you have purchased in the last year, counting each flavor variation, each strength, and each PG/VG mix as a different liquid.  (So if you used both bubblegum and cherry flavors, and used them each in 1.8% and 2.4% strength, that would be 4).
  • Number of different pieces  of hardware you purchased in the last year, adding up each different model of battery, tank, atomizer, wick, etc.
  • If you purchased disposables or prefilled cartridges that include both hardware and liquid, count up each different model/variety you purchased (again, counting each variation in flavor and strength separately).  If you did not purchase these, just delete the sentence that refers to them.
  • Estimate how many different products your favorite vendor or vendors sell.  Again if you cannot do this or do not wish to, please just delete the relevant sentence.
We realize that most of your estimates will be quite rough.  You should just use phrasing like “over 100” or “about 30” and not worry about getting the count exactly right.

Be sure to include the title line, which is required for the OIRA filing (see below).
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 [FILL IN] different varieties of e-cigarette liquid over the last year.  I have used [FILL IN] different pieces of e-cigarette hardware.  In addition, I have used [FILL IN] different products that combine liquid and hardware.  I would estimate that my favorite vendor sells [FILL IN] 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. 
[INSERT A BRIEF PERSONAL NOTE HERE. SOME SUGGESTED LANGUAGE TO USE (BUT ONLY USE IT IF IT DESCRIBES YOU ACCURATELY, OF COURSE – OTHERWISE CHANGE IT:  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. 
PART II.
INSTRUCTIONS ON HOW TO MAKE THE COMMENT

We are asking you to BOTH (1) submit a comment (Part IIA below) and then ALSO (2) email a copy of that comment to OMB/OIRA (Part IIB below).  It is important that you take BOTH STEPS.

Part IIA - Comment to FDA

  1. Create a document with your comment.  You can use the above sample letter as a template and edit to make it your own.  (KEEP A COPY OF THIS DOCUMENT BECAUSE YOU'LL NEED IT FOR PART IIB BELOW.)
  2. Access the comment form for the deeming regulation (FDA-2014-N-0189-0001):  FDA Comment Form
  3. Click in the Comment field and copy and paste your comment from Step 1 into the box.
  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" for individuals wishing to request an extension personally and not on behalf of any business or group.

    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.)
  11. On the Your Preview page, click to check the box "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. (You may wish to copy the entire page into an email to yourself.)
Part IIB - Email to OMB/OIRA


The next step is to take a copy of your letter and copy it into an email to oira_submission@omb.eop.gov 

The subject line of the email should be: FDA Proposed Regulations Deeming Tobacco Products, Agency Docket No. FDA-2014-N-0189; RIN: 0910-AG38.

Please ensure that the title of your letter from Part I remains in the body of your email:
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.


Part III.
Let Others Know About this Call to Action, Including Vendors You Patronize


Our understanding is that industry organizations such as SFATA will be issuing guidance to their members regarding commenting on the Paperwork Reduction Act, which may include suggesting that members of industry request an extension of time to comment. Given that the timeframe on this is so short (deadline for comment on Tuesday, May 27, 2014), we're asking our members to let their vendors know about this issue and suggest that they seek guidance from industry leaders.

202 comments:

  1. Where is this deadline published? I can't seem to find it and I am trying to hep a vendor put together a comment but have not seen any official vendor guidance.

    Thanks!

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    1. deadline for comment on Tuesday, May 27, 2014

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  2. Happily completed!

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  3. Make these links open in a new tab!

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    1. right click the link and open in new tab

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  4. Parts 1 & 2 - Done and done.

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  5. ALL DONE, Parts 1 and II.... I hope many many more people join this fight!!

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  6. What is the upload function for? Would this be a good place to add pictures of my liquids and hardware?

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    1. The upload is for documents such as multi-page comments and research papers.

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    2. I suppose you could, but mainly it's to submit your commend as a .doc or other file.

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    3. UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460
      OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES
      CERTIFIED MAIL
      Dear Registrant:
      This is to inform you that the Environmental Protection Agency (hereafter referred to as EPA or the Agency) has completed its review of the available data for the antimicrobials propylene glycol and dipropylene glycol. The Reregistration Eligibility Decision (RED) was approved in the form of a decision memorandum which summarized the regulatory decision for propylene glycol and dipropylene glycol on September 30, 2004. Based on its review, EPA is now publishing its Reregistration Eligibility Decision (RED) for propylene glycol and dipropylene glycol and its associated human health and environmental risks. A Notice of Availability will be published in the Federal Register announcing the publication of the RED.
      The RED and supporting documents for propylene glycol and dipropylene glycol will be available to the public in EPA’s Pesticide Docket EPA-HQ-OPP-2006-0831 at: http://www.regulations.gov.
      Please note that the attached RED document pertains only to propylene glycol and dipropylene glycol. This RED presents the Agency’s conclusions on the dietary, drinking water, occupational and ecological risks posed by exposure to propylene glycol or dipropylene glycol alone. This document also contains product-specific data that the Agency intends to require in Data Call-Ins (DCIs). Note that DCIs, with all pertinent instructions, will be sent to registrants at a later date. Currently, there are no generic data requirements. Additionally, for product- specific DCIs, the first set of required responses will be due 90 days from the receipt of the DCI letter. The second set of required responses will be due eight months from the receipt of the DCI letter.
      As part of the RED, the Agency has determined that propylene glycol and dipropylene glycol are eligible for reregistration. Sections IV and V of this RED document describe product- specific data requirements.

      http://mnvapers.com/2014/04/epa-fda-vapor-harmless-children/

      The link to the actual paper is a PDF link in that story.

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    4. Rosetta Graham Wilson · Tech at Providence Medical Center Anchorage

      For all uneducated people out there JESSICA LUNTZ
      HEALTH, LEGISLATION, POLITICS, STUDIES, VAPING

      EPA & FDA: Vapor Harmless to Children

      APRIL 3, 2014 , 47 matt black

      In the continued war on e-cigarettes, we hear about the “potential dangers” of e-cigarette vapor and the “unknown public health risks.”

      First, I find it absolutely absurd that we’re attempting to pass laws based on unknowns, but what makes it even more absurd is the fact that there’s very little that isn’t known about e-cigarette vapor at this point. The primary ingredient of concern to those who wish to see e-cigarettes banned is the propylene glycol vapor, which has been studied for over 70 years.

      I recently came across a document titled, “Reregistration Eligibility Decision For Propylene Glycol and Dipropylene Glycol“, which was created by the United State Environmental Protection Agency (EPA).

      Catchy title. I was intrigued.

      This quote caught my eye:

      Propylene glycol and dipropylene glycol were first registered in 1950 and 1959, respectively, by the FDA for use in hospitals as air disinfectants. (page 4, paragraph 1).

      In a previous post, I had shared the summary of research that had been done in 1942 by Dr. Robertson regarding the antibacterial properties of vaporized propylene glycol, but I had never heard that the FDA wound up approving it for the purpose of an air disinfectant in hospitals.

      Indoor Non-Food: Propylene glycol is used on the following use sites: air treatment (eating establishments, hospital, commercial, institutional, household, bathroom, transportational facilities); medical premises and equipment, commercial, institutional and industrial premises and equipment; (page 6, paragraph 2)

      Continued…

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  7. Completed and posted to our customers / blog readers here: http://www.bigdvapor.net/blogs/news/14209217-casaa-call-to-action-for-fda-proposed-regulations-if-you-vape-you-must-read-this-and-act-now

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  8. DONE AND DONE
    Your Comment Tracking Number: 1jy-8c7v-va96

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  9. Done
    Thanks for making this process easy to follow!

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  10. Your Comment Tracking Number: 1jy-8c7v-w27o

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  11. Done from Deans Dreams

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  12. Done. I took the liberty of adding: "In short, I have personally purchased and used many more e-cigarette products over a one year period than the FDA's estimate for the total number of new e-cigarette product applications they will receive from the entire industry in a one year period."

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    1. Our products purchased may surpass the quantity of autos GM has had to recall in just one year :)

      Deb

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    2. I kinda said that too: that I was only one consumer but it took this many separate products to keep me off of killer cigarettes.

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  13. HHS Economic Analysis http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM394933.pdf

    "A single online retailer, myvaporstore.com, claims to sell over 1,000 unique products . FDA analysts counted over 150 unique products among just the top 5 brands."

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  14. Incidentally, their estimates are ludicrous and demonstrate how disingenuous or completely out of touch with reality they are. Perhaps both.

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  15. This is very deliberate. No currently available NON CIG-A-Like has the slightest, most infinitesimal chance of being approved. So that means there are about 25 + or - currently available Cig-A-Likes that might be close enough to pass exemption.(all big tobacco devices). As there is no current research showing that ecig's are legitimate smoking cessation device as the current language of the deeming proposal clearly states any device needs in order to even be considered. The only way anything good can come of this is to get the whole document shot down. if ANY part of this passes as it is, the industry will be irreparably damaged.

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    1. Which is why We The People are not gonna let that happen. Not based on no facts!
      REASONABLE regulation, but NOT at the sin tax levels true cigarettes have EARNED

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  16. Done and Done, But it still baffles me WHY we have to defend something that has helped millions!

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  17. Done and done. Spread the word guys!

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  18. I think the FDA's involvement in this case is doing nothing to protect the American consumer, it's simply looking for a way to stifle innovation in a rapidly growing market.

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  19. Done. I'm mad as hell!

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  20. Says pick a category, what category?

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    1. What category are you? Usually it's "individual consumer"

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  21. Done and done, waiting for the next call to action.

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  22. Done and Done

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  23. Done and done 1jy-8c7x-bko5

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  24. done 1jy-8c7y-14zc

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  25. Both have been sent.
    Your Comment Tracking Number: 1jy-8c7z-jxjo

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  26. Done, but the comments' number is way too low at reg.gov. The only way we have a chance to stop this, or at least slow it down and have the FDA make changes, is a show of force by the public. If there not 10s of thousands of comments saying NO to this, the FDA will push it through as-is and we will all be sucking on Big Tobacco's crappy hardware and liquids. Get the word out please, and thank you CASAA!!

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  27. done as individual (1jy-8c7z-vn8f) and vendor (1jy-8c7z-zmxj)

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  28. Comment submitted and email sent.
    Shared as well

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  29. Done, done, and shared. Thank you!

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  30. This comment has been removed by the author.

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  31. And another CTA

    ~Accomplished~

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  32. It's so good to see how many people are activated now is our fight. Never saw the comment sections so big before. I also want to call out a few Vendors that I so appreciate for stepping up to plate. (Nic Vape, Ginger's E-Juice, Vapor Alley they are sending letters urging customers to do these calls of action, that is just awesome. Thank you to all of us each and everyone for vaping, using smokeless tobacco and doing everything we can to keep it going, for those smokers out there that could be robbed of what we have been blessed to have this past 6 years. (y)

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  33. Parts 1 & 2 - Done and done.

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  34. done- Comment Tracking Number: 1jy-8c80-r0v5

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  35. 1jy-8c81-cw0t comment tracking number. Done and done. Thank you CASAA

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  36. Done Thank you CASAA

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  37. Done, both parts. 1jy-8c81-573q

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    1. Done and done tracking 1jy-8c9e-dmOk

      I like how they say after agency review, quote:
      which may be an indefinite amount of time
      We can but hope :)

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  38. I would like to see a section of these types of letters dedicated to what the community DOES want in regulation. We must voice this. If not, the FDA will have very little reason to listen to us, as we will seem more like an angry mob than a group of passionate activists.

    In my mind, we stand for the ban of sales to minors. We stand for the regulation of what we put into our juice. We do not stand for the expensive process involved in regulation, but what do we propose instead? This is the key question. The industry will be regulated whether or not we like it, and no products can be sold in the future if it is not.

    Lets brainstorm! Lets make our desires and proposed solutions heard!

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    1. I get what you're saying and for the most part I agree with you, However, I think the problem with the proposed regulation is bigger than just the prohibitive costs associated with it. Right now, they are basically making the claim that they have the authority to regulate the vaping industry and that all the provisions of the FSPTCA apply to all tobacco products. This process of "deeming" will ultimately require congressional approval before it is finalized. Assuming it is passed, any further regulations that they want to enact won't require this. They will issue a "product standard" and that will more or less be the end of it. At least that it my understanding of it. If I misspoke anywhere, someone please correct me.

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    2. i.e. continue writing to congress and educate them.

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  39. Can someone please point me to where the FDA made the estimate of 25 products for premarket review? I don’t recall seeing that in the proposed deeming regulation. I don’t doubt that they said this but it is absurd for them to think that, unless there are some really underhanded shenanigans going on behind the scenes (which I’m fairly certain that there are). I would just like to read it for myself.

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    1. Usually it's linked but seems to be missing here. I assumed it came from HHS Economic Anyalsis from OMD, but I'm not sure. They also talk about small and medium sized business will exit rather than file applications.

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    2. The estimate of 25 is contained in Table 9 of the proposed regulations.

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  40. Done, Done spreading the word everyday!

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  41. Done & done & posted - Keep up the fight & thanks CASAA - My Comment Tracking Number: 1jy-8c83-gj7z

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  42. DONE & DONE !!

    OMG!!!!! 113 people including myself!!!! WTF people spread the word or we can kiss this market "GOOD BUY" Post the link of FB, Twiter, myspace... Any and every social media site you can think of... Have your children, grandchildren, spouses, friends and family comment!!!! Anyone you know that values your health, your life, and your god given rights as an American consumer! I am printing hundreds of fliers to give away in my store. This could be the end of safe, great flavors that have given us the ability to quit killing ourselves while making the tobacco giants filthy fucking rich!!! And I myself after being a slave to R.J. Reynolds for 30+ years would rather be a criminal making my own DYI in my kitchen, than give one more red cent to the companies that profit from killing!!!! People are we really worried about the independent stores crafting great flavors with tasty results? OMG every hand crafted specialty house juice I have ever japed was great! And trust me I have a nicotine testing kit and tested over 200 flavors and not one had more than one percent over or under the nicotine count on the label! I've never been in a Vape Shop and met one owner or worker that wasn't a vaper themselves. And trust me they're not selling anything that they are afraid to vape themselves!!! Now can you say that about the Tobacco Giants?? Hell NO! They have been found guilty of adding more addictive and toxic chemicals to the tobacco they sell than humanly conceivable! And they continue to try and control us at every turn. Imagine only being able to buy 10 aproved flavors and having to Trust that the ingrediants in them are nothing more than VG/PG/Flavoring and nicotine! There's your list of current ingredients!!! I can only imagine the list the FDA would approve for Phillip Morris?? And the monopoly?? who would ever consider buying a vape device if a bottle of juice was the cost of a carton of smokes? Its a sad sad day when we realize that our government founded on freedom takes it away under the guise of protecting us! Bullshit it has nothing to do with us, and everything to do with big business and greed!!!! Okay i'm sorry for the rant.... steeping down from my soap box wiping away the tears and shame.....

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    1. Kudos Nate and well said. I agree with you 100%. :)

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  43. Done and Done, working on getting wife and other relatives happy to see me quit smoking involved.

    Anything in the works for vendors to post as well. I have a modified version of this in the works with research documentation and multipage comments from current customers planning to go up on May 26th.

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    1. Mad Props to you Beau!!!! Ans everyone else!!!! May we Vape On Freely!!

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  44. I included a .doc that has two tables of columns of numbers. It's more pictorial. But no place to put it here. Can I CC my reps?

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  45. Both parts completed this morning. :)

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  46. Your Comment Tracking Number: 1jy-8c8b-mp0q. tweeted, sent the e-mail, posted on FB and ECF. we need more people doing this!!

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  47. Done and Done.

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  48. Done
    Your Comment Tracking Number: 1jy-8c8g-mtj9

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  49. Done and Done! :) 1jy-8c8g-s6eo

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  50. Done, thanks CASAA

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  51. Happily Done and done! 1jy-8c8h-2289

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  52. All done 1jy-8c8h-ri92. Spread the word! Fight for our right to live!

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  53. Spread the word! Public Advertising
    1jy-8c8j-ksu7

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  54. Done and done. 1jy-8c8l-i2hb

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  55. Done and shared!!! Vape on!!!

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  56. DONE & DONE! �� ��������

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  57. Done & Done! 1jy-8c94-jyqz

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  58. Done. Comment ID sent via email as in the previous CTA.

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  59. Done and shared

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  60. Your Comment Tracking Number: 1jy-8c96-fh9r
    Done

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  61. Your Comment Tracking Number: 1jy-8c9c-b4mk
    Done

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  62. This particular article focusses on vaping nyc the usage of products that can help in ensuring that the Electronic Cigarettes results are good enough and the individuals can start using Electronic Cigarettes Kits the electronic versions. It has the heath benefit to its credibility and other usages cheap electronic cigarette in any public places. This particular piece helps in covering Electronic Cigarettes Brooklyn all such important and essential areas.

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  63. Done & Done! Thanks for the easy to follow directions.

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  64. Done 1jy-8c9u-nns1
    Thanks

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  65. Done.......It's great to see everyone taking a stand against this.

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  66. Done...1jy-8ca1-uw7f

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  67. Done! And a big "Ditto" to Nate Keller. I commented about the same. Keep up the great work everyone....your fabulous. Keep Vaping!!!!

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    1. Oops.....forgot. Tracking # 1jy-8ca4-x7g4

      Delete
  68. Done - 1jy-8ca2-ua46 Thank you for all that you are doing for ex-smokers/vapers. keep up the good work, and fight the good fight!

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  69. Done and Done!

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  70. done. steps I and II. Your Comment Tracking Number: 1jy-8cat-gd72

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  71. done and done! Thank you for all that you do!!!

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  72. Done (1jy-8cb5-ce0e) and done.

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  73. Done! Thanks CASAA, as always!

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  74. Yes i will have it fone today.

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  75. Your Comment Tracking Number: 1jy-8cbt-iqa0

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  76. Your Comment Tracking Number: 1jy-8cbu-q6pq. DONE.

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  77. Done, done and done

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  78. Glad to get it done.

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  79. Done and done!!!

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  80. Done and Done!

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  81. Done, Done and emailed to 5000+ other vapers around the nation. My Comment Tracking Number: 1jy-8cbz-toev

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  82. DONE Come on people reading the forums. Print the instructions, click the link and DO IT. They will bury us!

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  83. i WILL VAPE TIL i DIE...i DONT EVEN SMOKE NICOTINE. yOU CANNOT REGULATE WHAT ISN'T EVEN AN ISSUE.

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  84. do it please. everyone who want's to live will do this.

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  85. Done again on 5/29.

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  86. Done and Shared on FB
    1jy-8ce5-63eo

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