Tuesday, March 17, 2015

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

(Updated 4-16-15)

  • FDA extended the comment period to July 2, 2015. We have updated this Call to Action to reflect the new due date and provide the new docket number for submissions.
  • We have also prepared a Call to Action for the Second Workshop Regarding E-Cigarettes held in March 2015. 
  • The third and final workshop will be held in June 2015, and we will prepare a call to action for that workshop shortly after its conclusion.



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


In December 2014, the FDA held the first of a series of “workshops” in which “experts” are invited to inform them about the physical characteristics of e-cigarettes. It should be no surprise that the people who were granted time to speak were largely non-experts and that consumer representatives were closed out of this meeting. This is your opportunity to help remedy that. If you watched the workshop, you know what we are talking about. If you did not, all you need to know is that FDA sought the opinion of people who presented information at about the level you might see in a magazine article on e-cigarettes. (You can read the transcripts and view the workshop here.)


Please note that the comments we are asking you to submit are for the first workshop (December 10 and 11, 2014). The second FDA workshop last week was much the same. The speakers were somewhat more expert, but still could have learned a lot from a consumer representative, and yet our application to include CASAA experts on the program was refused. We will have an opportunity to comment on that meeting later.


FDA claims that these workshops have nothing to do with their decision about whether and how to impose the “deeming” regulations and are only to inform the eventual regulation, but this is ridiculous. Whatever information flows now will obviously affect both.


The good news is that consumers and other experts on e-cigarettes have an opportunity to comment on this matter.


We know that the vaping community -- which includes everyone from small manufacturers, to DIY modders, to consumers who make themselves expert on the hardware or liquid -- has more collective expertise than FDA and their supposed “experts.”  We need to collect examples.


1st - Please try to recall your favorite writings on the relevant topics from: threads on ECF or other forums; informative blog posts by consumers, consumer advocates, or vendors; how-to videos; etc.  Keep in mind that the topic at hand is characteristics of e-cigarette hardware and liquid, including variations, modding options, etc.

  • This includes:
    • product engineering (how the devices work, new innovations, how to optimize them, etc.),
    • physics,
    • chemistry,
    • the toxicological (effect of chemicals on health) implications of those.
There are tens of thousands of great threads and posts out in the world that cover these topics, providing consumers with useful information about the products. **Please make sure that the material is high-quality. (A few bad posts on a forum thread are inevitable, of course, but keep in mind that you are demonstrating that we are more expert than their “experts.”) Also, please do not include material that is primarily about smoking cessation or other behavioral issues; this is specifically about physical characteristics of the devices, liquids, and vapor.


2nd - Collect a list of these – at least one or two of them -- and ten or a hundred if you want – and make them part of a comment (talking points provided below).
  • **Please note:  It is far better to create a PDF of the material you are referencing and upload as additional files or append it to your comment; if you just send a link, they will probably ignore it, but if you send the content, they are required by law to take the time to read it.


3rd - Submit your comment here. The Deadline is July 2, 2015.


Required and Suggested Talking points -


  • (Required) Include the following information at the very top of your comment:
    • I am commenting on Electronic Cigarettes and the Public Health; Public Workshop, Docket No. FDA-2014-N-1936-0003.
  • 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. (It is not relevant to this docket, as noted, but it does not hurt to remind them.)
    • 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 to go HERE and join. It is free and important.)
  • The material presented at this workshop would have benefited greatly from consumer input.
  • I am commenting to call attention to some of the enormous body of knowledge and expertise that exists in the consumer community.
  • Thank You.


Sample Letter -


To: U.S. Food and Drug Administration
Re: Electronic Cigarettes and the Public Health; Public Workshop, Docket No. FDA-2014-N-1936-0003
Date:
I am a consumer, writing on my own behalf.  <DESCRIBE YOURSELF>. I am writing to comment on “Electronic Cigarettes and the Public Health; Public Workshop, Docket No. FDA-2014-N-1936-0003” This docket follows up on a workshop you held in December 2014 that was intended to hear expert presentation about physical and performance characteristics and variations of e-cigarettes and their toxicological and other implications.
It was apparent from the material presented at that workshop that the event could have greatly benefitted from expertise that exists in the consumer community. Many e-cigarette consumers, like myself, watched the workshop presentations. The simplistic assessments coming from many (if not most) of these hand-picked “experts” were  so inexpert and so clearly politically motivated that it was actually insulting.


I am commenting to call attention to some of the enormous body of knowledge and expertise that exists in the consumer community. Please consider the following material that came from consumers and/or small producers who are close to the consumer community:
1. <http:…>
2. <http:…>
3. <http:…>
4. <http:…>
5. <http:…>
6. <http:…>
7. <http:…>
For convenience I have provided copies of the content from these links as part of this comment.
Once you review this material and similar material from other consumers, it should be apparent that FDA’s level of expertise, and that of its supposed experts, is inadequate. FDA should be reading what is already known in the world, not trying to reinvent the wheel. FDA should get itself up to speed on this material, which already exists, before it presumes to judge who is even expert enough to comment, let alone before it bans 99.99% of the products on the market, as it is currently proposing.


Thank you for considering my comments.

____________________________________




For a tutorial on how to make a comment, including how to create a transcript from a video and how to upload attachments, you might find the following video helpful:

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