FDA Call to Action: Submit comments on FDA’s “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.
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 April 15, 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;
79 FR 55815, September 17, 2014, Docket No.
FDA-2014-N-0001
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 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; 79 FR 55815, September 17,
2014, Docket No. FDA-2014-N-0001
Date:
I am a consumer, writing on my own behalf. .
I am writing to comment on “Electronic Cigarettes and the Public Health; Public Workshop; 79 FR 55815, September 17,
2014, Docket No. FDA-2014-N-0001.”
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 benefited from expertise that exists in the consumer community. Many e-cigarette consumers, like myself, watched the workshop presentations. The simpli stic 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:
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 tryi! ng 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.
