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FDA UPDATE 07-20-2014

We anticipate issuing the Second Call to Prepare early next week, which will provide guidance on further refining draft comments.  The Fourth Call to Action (requesting consumers assemble their prepared thoughts and submit the comment to FDA) is expected to be issued towards the end of next week.



First Call to Prepare for FDA Proposed Regulations - Prepare Draft Comment

 

On Thursday, May 8th, 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 thethirdCall to Action.
 
This is the first Call to Prepare in CASAA's Action Plan.  This Call to Prepare is your opportunity to begin laying the groundwork for your formal, substantive comment to the FDA.  Consistent with our earlier instructions, we are asking consumers to continue to wait to file substantive comments for a few more days, but now is the time to prepare part of your comments in earnest.  For now, write up a few paragraphs on each of these three points so it is ready to assemble into your final comments.


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.
 
FIRST, if you haven't already done so, please begin preparing your personal story.  While it is tempting to provide a long narrative, we believe that for most people, limiting the personal story to perhaps 3 paragraphs will be more effective.  In preparing your personal story, please consider including information about
 
  • How many years did you smoke and how many cigarettes a day did you smoke?
  • Do you still smoke?  If so, how many cigarettes do you currently smoke now that you are vaping? (In other words, have you eliminated or reduced your smoking habit by using e-cigarettes?)
  • How long have you been using e-cigarettes? If you no longer smoke or have substantially reduced your cigarette consumption, how long ago did you do that?
  • How many times did you try to quit using FDA-approved methods?  List the products/methods you tried, as well as provide a number of quit attempts and note how successful/unsuccessful those attempts were.
  • What health benefits have you experienced since using e-cigarettes as a complete or substantial replacement for smoking?  
SECOND, please  explain to the FDA how you will personally respond if the only e-cigarettes available for purchase are “cigalikes” produced by a few big companies, probably limited to a few cigarette-like flavors.  (As CASAA members know, the proposed regulations in their current form would devastate the e-cigarette industry, with the paperwork burden driving more that 99% of producers out of business or into shadow markets.  This will almost certainly leave only “cigalikes” produced by the largest companies available in the FDA-regulated market.  It is also likely that nicotine-containing liquids for refillable devices will be unavailable except for on the black or shadow markets.  While flavors are not explicitly banned by these proposed regulations, it is widely believed that the FDA will seek to eliminate flavors other than tobacco and menthol in the future.)   
Before answering, please read Predicting the Black Market in E-Cigarettes to better understand the real-world consequences of the proposed regulation and think about how you will react to the black/shadow market scenario we predict.  
  • Will you use the regulated mass-market cigalike products that the FDA approves?
  • Will you vape zero-nicotine e-cigarette liquid?
  • Will you return to smoking?
  • Will you switch to another nicotine source (e.g., snus) and perhaps continue to vape zero-nicotine liquid?
  • Will you continue to buy/modify hardware, and purchase nicotine-containing e-cigarette liquid on the black market?
  • Will you continue to buy/modify hardware and try to make your own nicotine-containing e-cigarette liquid, either by mixing pure nicotine or higher strength nicotine liquid with flavored liquid, or making liquid from scratch?
Specifically, if you intend to continue to use nicotine-containing liquid, explain how you fear that creating a black or gray market will (1) increase your risk since you will no longer be able to purchase from reputable companies who stand behind their products and follow good manufacturing processes, and (2) force you, an otherwise law-abiding citizen, to break the law.  
If you do not feel that you will purchase supplies on the black or shadow market, explain whether you believe that limiting yourself to the types of products that are likely to be approved by the FDA will cause you to consider returning to smoking.
If you believe you will simply comply with the FDA and buy whatever is approved, describe how that will lower your welfare (i.e., make you less happy).
[Note: depending on how militant you feel about this, you might not want to tell the government “I intend to break the law.”  If you wish to avoid saying that, choose your exact words carefully, perhaps by saying “I expect people like me will...”]
THIRD, while e-cigarette flavors are not limited by the proposed regulations, FDA is specifically asking for information about the connection between flavors and e-cigarette use by children.  The questions posed by the FDA in connection with flavors are leading and thinly-veiled.  They suggest it is likely that if FDA gains regulatory control over e-cigarettes, FDA will later seek to ban all flavors other than tobacco and perhaps menthol.  In fact, FDA has specifically stated that the current proposed regulations are only the first step in their attempts to regulate e-cigarettes.
Please explain how a ban on flavors (other than tobacco and menthol) would impact you.  
  • Do flavors help distance you from your former smoking habit (assuming you have completely or substantially replaced smoking with e-cigarette use)?
  • Do you find flavors make e-cigarette use more enjoyable than smoking?
  • Does the variety in available flavors help keep you interested in e-cigarette use as opposed to smoking?
  • Are you willing to purchase flavored nicotine liquid on the black market if flavors are banned?
  • Will you try to make your own flavored liquid?


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