Thursday, April 16, 2015

Call to Action: Submit comments on FDA’s Second Workshop Regarding E-Cigarettes.



FDA Call to Action: Submit comments on FDA’s Second Workshop Regarding E-Cigarettes.


  1. The first of three FDA Workshop was held in December 2014, and you have until July 2nd, 2015 to submit comments.  Please see: CASAA Call to Action for First FDA Workshop for details and instructions.


  1. This Call to Action includes instructions for commenting on the Second Workshop Regarding E-Cigarettes held March 9th-10th, 2015.


  1. The third and final workshop will be held in June, 2015 and we will issue a new call to action shortly after it concludes.
Updated 4-28-15 to provide information in Part C on how to upload your comment as a document instead of copying/pasting into the comment box.


The second workshop (March 9-10, 2015) focused on issues related to individual health. While the presenters showed greater average expertise than the abominable ignorance from the first workshop, there was still a great deal of useful knowledge missing thanks to the absence of consumer representatives. A few individuals affiliated with industry presented some consumer points of view, but it was still quite limited. You can view transcripts of the second workshop here.


There are three parts to this Call to Action:


  1. If you want to do a fairly quick and simple (but useful) comment, follow the instructions for Part A (“Simple Submission”), then skip down to Part C (“Submission Instructions”) and you’re done.


  1. If you’re feeling more ambitious, you may choose to also follow the instructions for Part B (“Optional Additional Submission”).


  1. Part C provides instructions on how to submit your comment.


You can make as many comments as you wish, so if you’re feeling overwhelmed, just pick something to comment on from Part A or Part B, then skip to Part C for submission instructions . . . and then when you have more time, come back and pick another topic to comment on.



PART A (“Simple Submission”)


The most useful role for consumers commenting on this will be to challenge the simplistic picture of use behavior that FDA seems reliant upon. The "experts" seem to not understand that vaping is a relatively new behavior and devices are ever-changing, and thus exactly how a particular consumer uses her e-cigarette is likely to change from month to month. You can help inform them of what information they are missing by describing your own usage behavior and especially how it has changed over time or when you have changed devices or liquid.


If you want to make a very simple (but useful) comment, you can simply include information about the following and then skip down to the bottom for instructions on how to submit your comment:


  • How often do you vape, how many puffs do you take at a time, how long are your puffs, how deeply do you inhale, etc.
  • How any of those have changed during the course of your vaping. (For example, do you vape less often, do you use a lower nicotine concentration, do you inhale more slowly, do you take fewer puffs at a time, etc.?)
  • If you’ve used various different devices and/or liquid flavors/strengths over time, you should consider sharing that information with FDA. If you can remember how you used those devices differently, you can report that too.




PART B (“Optional Additional Submission”)


SECOND, IF YOU ARE FEELING INSPIRED, there are additional things you can choose to comment on. This workshop included discussions of “abuse liability” (their word for “how much people like it”) and dependence, short- and long-term health effects in users, considerations for high risk or vulnerable populations, and human factors. We think it is entirely appropriate for consumers to share with FDA information about their personal experiences that speak to those issues. Feel free to comment on any one or more of the following topics:


  • Share any health improvements you have experienced, especially those that have been documented by your physician or other health care provider.
  • If you feel your dependence on nicotine has lessened over time while using e-cigarettes, explain that to FDA. For example:
    • Have you reduced your nicotine intake over time?
    • Do you find yourself less anxious and/or irritable if you are unable to vape for a period of time (as compared to when you were a smoker and unable to smoke)?
    • If when you were smoking you used to wake up in the middle of the night to smoke, do you still experience this as a vaper?
    • Do you wait longer for your first vape of the day as compared to when you smoked?
  • If you self-identify as a person in a “high risk” or “vulnerable” population, you should note that in your comment.
    • Of course, these terms are not defined, but it certainly applies to people with significant health problems (asthma, COPD, cancer, compromised immune system, etc.). This also is often used to refer to anyone who is not a white straight man; if you are not in that category, you might want to address whether you feel it is proper to consider you “vulnerable.”
    • If you have any major health issues (e.g., diabetes, obstructive pulmonary disease, cardiovascular disease, cancer, mental health issues, ulcerative colitis, etc.), you should consider explaining to FDA how e-cigarette use has affected those conditions.
  • FDA is asking for information on how flavorings may enhance the “abuse liability” of e-cigarettes. We think this question completely misses the point. For many vapers, flavors are what help distance themselves from their former smoking habit. If you are a vaper who believes your use of non-tobacco flavors helps you reduce or eliminate your smoking habit, you should explain that to the FDA.
  • FDA has asked what evidence is available that e-cigarettes promote current smokers to completely switch as compared to continuing “dual” or “polytobacco” use.
    • As you, a consumer, consider this question, you should understand that this question is typically phrased as loaded and misleading, implying that “dual use” is harmful. But in reality, dual or polytobacco use doesn’t in and of itself increase risk, (2) smoking is what causes the significant health risks and using an e-cigarette also does not affect the impacts of smoking, and (3) non-combusted forms of tobacco and e-cigarettes are estimated to be 99% less hazardous than smoking.
    • We’ve heard from many vapers that it wasn’t until they found non-tobacco flavors and/or more sophisticated devices that they were able to completely transition from smoking to e-cigarette use. If this describes your situation, you should explain this to the FDA.
    • We know that some smokers do not find e-cigarettes to be a completely satisfactory substitute for smoking.
      • If you have not made a complete transition to vaping but have significantly reduced your smoking, you should explain to the FDA how you feel that e-cigarette use has helped you reduce your smoking.
      • If you use smokeless tobacco in addition to e-cigarettes, you should explain to the FDA how the use of both of these products has helped you significantly reduce or eliminate your smoking habit.


  • FDA has asked what information consumers need to adequately understand the product and mitigate risk. The workshop focused entirely on ways to dissuade people from use rather than effectively communicate with them.


    • You should let FDA know that you expect accurate and truthful information so you can make informed decisions.


    • If you believe that FDA (and/or CDC) has confused the issue, given misleading information, or has otherwise failed in their duty to honestly inform consumers about e-cigarettes, then you should let FDA know that.


  • FDA has also asked about product labeling strategies to communicate information and user risks. CASAA believes that warning labels should be honest and not overstate the dangers associated with use.


    • We are mindful that the large tobacco companies are now providing warning labels for their cigalike products that are actually longer and scarier than what they provide in connection with their combustible cigarettes. For example, the warnings for Altria’s MarkTen and RJ Reynolds’ Vuse cigalikes are detailed here. We think this is not good for consumers, is not genuinely helpful, and in fact actually has the effect of making e-cigarette use appear to carry risks similar to smoking.


    • If you agree with CASAA on this issue, you should let FDA know that you want labels that do not overstate the risks and do not confuse consumers into believing that e-cigarette use carries similar risks to smoking.

Part C (“Submission Instructions”)


Whether you’re doing Part A, Part B, or both, here are the instructions on how to submit. (You might find it helpful to review FDA's Tips for Submitting Effective Comments.)


  1. Make sure that you include the following statement at the very top of your comment because it is required:  
    • I am commenting on Electronic Cigarettes and the Public Health; Second Public Workshop; Docket No. FDA-2014-N-1936-0003.


  1. Make sure that somewhere in the comment you describe yourself a bit:
    • Mention if you are an e-cigarette user and how long you have been using e-cigarettes. Go ahead and mention how long ago e-cigarettes allowed you to quit smoking if that describes you.


    • If you are a CASAA member, please mention that to remind them that there is an organized consumer voice they should be listening to. (If you are not, please go HERE and join. It is free and important.)
    • Mention that the material presented at this workshop would have benefited greatly from consumer input.


  1. Consider including in your comment something to the effect of, “I am commenting to explain how much of the research and opinion presented at the workshop is based on an overly simplistic view of real vaping behavior and to provide real-world information about the issues addressed in the Second Public Workshop.”


  1. Close your comment with a simple, “Thank you.”


  1. Submit your comments here. (If you have a long comment, you may get an error message if you try to copy and paste your comment into the comment box. In that case, type "My comment is attached" in the comment box, and then upload the document that contains your comment. To upload your document--immediately beneath the comment box is a button labeled "choose files" for uploading. Click on that box and select the document containing your comment.)

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