00:05 Steve Miller: Hi everybody!
My name is Steve Miller and I had one job
to do and that was to press 'record' at the
beginning of the webinar.
Well, I didn't do such a great job.
I hit 'record' late so I missed some introductions
and I missed the very first question.
In case you don't know, we have three presenters
in this webinar.
They are: Greg Conley, who's the President
of the American Vaping Association, Dr. Timothy
McAuley, and Dr. Michael Siegel.
Both of these guys are e-cigarette researchers.
So I apologize for that.
That's on me without a doubt.
And so I missed the very first question and
the first question that was asked that it
was to Greg Conley was, "What does the FDA
Deeming & Regs moving into the OMB mean in
plain terms?"
So we're gonna pick it up with Greg's response
to that question.
00:47 Gregory Conley: It means great danger
for the future of the e-cigarette industry,
the FDA's Deeming Regulation, which was put
out to the public about 18 months ago and
then was opened for public comment.
That regulation would impose such strict terms
on the e-cigarette industry that we could
very easily see 99.9% plus of the 100,000
plus vaper products available on the market
today end up banned.
The long story short of that is that they
want to require what's known as retroactive
pre-market review, and in English that means
that they want for every single nicotine vaper
product on the market a potentially $2 to
$10 million, maybe even more expensive for
e-liquid products, a $2-10 million application
just to have a chance of being able to stay
on the market.
So that regulation has moved to the Office
of Management and Budget at the White House.
We do not know if the FDA has changed it.
Now is a great time for e-cigarette companies
to take meetings with the OMB to discuss the
dangers of that and it also reflects the need
for a bill called HR 2058 in the House to
pass.
02:09 Speaker 3: Great.
Well, thank you for that information, Greg,
and we know we've been talking about the FDA
Deeming Regulations for some time now, but
it seems like they're finally coming to fruition
here.
Moving on to the next question, you were almost
weren't able to attend today because of a
city council meeting in Philadelphia.
Can you tell us a little bit about what's
going on there?
02:25 GC: Sure.
Philadelphia last year banned vaping everywhere
that smoking is banned.
Then they, shortly thereafter, closed off
a loophole that would've allowed bars to get
permission to allow vaping or smoking in their
establishments.
The next step in their renewed war on tobacco
and non-tobacco e-cigarettes is to ban the
sale of vaper products and tobacco in pharmacies
or any store with a pharmacy.
That seems to be the enriched CVS bill of
2015.
CVS chose to not sell tobacco products.
It appears now they're lobbying to make sure
their competitors can't do it either.
The good news though is that that hearing,
that was supposed to be today, was cancelled
so at least it would appear that maybe one
or two or three members of the council started
to push back against this ridiculous proposal.
[chuckle]
03:27 S3: And do you know if any other cities
have similar legislation pending?
03:33 GC: Pending, I don't know.
I know many cities have passed these sorts
of laws.
I think San Francisco has one.
Dr. Siegel would know, but Boston may have
passed something similar to that.
I may be wrong.
But it's a completely ineffectual policy that
just leads somebody to go down to the gas
station rather than the CVS to get cigarettes.
But that's the kind of thing tobacco control
likes.
[chuckle]
04:01 S3: Well, we all have heard about the
public health report out of England, which
is supporting that smokers switching to e-cigarettes.
They're saying that switching to e-cigarettes
is actually a healthy alternative than smoking
traditional tobacco and do you see this having
a positive impact on that fight here in the
US for e-cigarettes?
04:20 GC: Yes.
There are great positives to that report.
We have been slowly accumulating the great
deal of scientific evidence that we now have.
Public Health England's report as well as
the letter that was co-signed by 12 different
public health orgs in the UK, including Cancer
Research UK, Action on Smoking and Health,
and the Royal College of Physicians.
That is going to be helpful in getting legislators
to recognize that, "Okay, so the American
Lung Cancer, Heart, they're all aligned against
e-cigarettes and won't say one positive thing
about them."
But, over in England, perhaps the second best
health care system in the world and they'd
probably argue over in England that they are
the number one and we're the number two.
[chuckle]
05:10 GC: That they are taking a common sense
approach to this.
So we've already started to see that this
is having an impact.
Unfortunately, we can expect, just as we've
seen in the past year, where seemingly every
week a journal is publishing new junk about
e-cigarettes.
It's going to still be tough because it's
gonna be the Public Health England report
and maybe the one positive journal article
that comes out every month versus four to
eight to 10, maybe even more than 10 negative
articles that are going to be coming out.
05:43 S3: Geez.
Well, recently, you were testifying in front
of the Indiana State Legislator and in your
testimony you were discussing the Public Health
England report.
And they seem to be fixated on the fact that
it wasn't a USA-based report.
Now, are you finding that opponents dismiss
this report because it's not USA-based?
06:00 GC: Not typically.
That was fairly new to me, this idea that
it's not created in the United States therefore
it can't be taken seriously.
This person that was bringing that up, I believe,
is a liberal Democrat.
And a lot of the climate change data that
we have, a lot of the studies are coming from
overseas.
So perhaps in that area, he's okay with foreign
research, but that's mostly just a cop out
from somebody that, even if you put 100 US
studies in front of him, he wasn't gonna change
his mind.
06:37 S3: Yeah, his opinion is fixated.
06:39 GC: Yes.
06:40 S3: So you're on the front line of the
e-cigarette fight while traveling around the
country and advocating for people's rights.
Is there one myth or fallacy that you encounter
that bothers you more than any others?
06:51 GC: It would probably just be the flavour
argument because when I quit or rather when
I tried to quit smoking with an e-cigarette
in 2009, all I had access to were these little
Chinese cigalikes that were only available
in tobacco and menthol.
Those flavors just reminded me of how great
a cigarette would taste.
But I got the product in October and duly
used for a month or two and then quickly relapsed
back to smoking.
And it wasn't until August 2010 when I had
a watermelon flavored vaper product that I
was actually able to quit.
And so to go to these hearings and to just
hear these people throw out with no care or
regard recklessly that, "Well, they come in
flavors just to appeal to children.
These are the companies target marketing to
children."
And sometimes I'll confront those people in
the hallway and say, "Well, I'm standing next
to a business owner who lives 10 minutes away
from you and this business owner has a 100
flavors in their store and will you tell this
person straight to their face, 'You're marketing
to children'?"
And very quickly they disengage from the conversation
because it's a lot easier to just go forward
with hype and conjecture when speaking generally
than it is to actually look somebody in the
eyes and say, "You're marketing to children."
It's a fallacy.
08:12 S3: Well, great.
Thank you for that, Greg.
Post Deeming Regulations, what are some of
the avenues for advocacy that vapers can take?
08:20 GC: Well, now is the time for vapers
to go to casaa.org, C-A-S-A-A.org.
And go to the Call To Action page for HR 2058,
which is a bill in Congress that would force
the FDA to regulate all vaper products on
the market.
Rather than just take the easy route of banning
99.9% of them, we need to add co-sponsors
to that bill.
Our best chance for co-sponsors are Republicans
so if you have a Republican representing you
in the US House, take the extra step.
Make a phone call, go to your local vape stores,
try and get them educated because they're
the best people to actually have a physical
meeting with the congressman or his staff
to talk about how jobs will be lost in his
or her district if this bill is not passed.
09:13 S3: Great.
Thank you for that, Greg.
We're gonna open up the Q&A session now to
some of the attendee questions.
So we got another one here that kind of it's
on the same topic we were just talking about.
Is there any other avenues for vaping advocates
that once the Deeming Regulations come out,
they can continue to fight for e-cigs?
09:30 GC: If HR 2058 is not passed in the
budget deal at the end of the year, 2058,
the bill will remain alive throughout 2016.
And if you haven't read the Deeming Reg, which
I don't blame you for, there is a two-year
implementation window from the date that the
FDA finalizes the regulation to the date that
the deeming ban begins.
And so during that two years, we still need
to be pushing for the passage of HR 2058.
Without that bill, our advocacy efforts won't
mean much.
But regardless, at the state level, this industry
is still gonna be under attack because, even
if the FDA releases their final regulation,
the people that wanna destroy this industry
will still be able to say, "Oh, well, it's
two years from now.
God knows what could happen in the next two
years.
We need to take action now."
[chuckle]
10:26 GC: So we need to get more vendor groups
formed in states.
We need consumers to make sure that they vote
in the November election and that their elected
officials know that their vote is influenced
by how they voted in the past on vaper and
that their future votes will be influenced
by how they vote on vaper issues.
10:50 S3: Excellent.
Well, thank you for that great description
there, Greg.
We got another question here.
Can you describe the work that the ABA does?
And how do you differ from the other advocacy
groups?
11:01 GC: Sure.
Essentially, ABA is not a trade group.
I work a lot with SFATA.
I'm a huge fan of theirs as a trade organization.
I have helped set up chapters in different
states for them and helped them train and
advise their lobbyists day to day when they're
facing threats.
So we do not represent the industry nor do
we really represent consumers.
That's CASAA's job.
ABA is the media mouthpiece for policy, promoting
policies that encourage the growth of small
businesses in this industry, not because we
represent them but because as a public health
advocate I believe that the best path forward
for helping more and more smokers quit is
for innovation to happen and innovation happens
under small businesses.
11:52 GC: With ABA, we put out press releases
that get picked up oftentimes by large newspapers,
large websites about new studies on e-cigarettes,
the consequences of taxes, usage bans, research
that has been dishonest.
We often use Dr. Micheal Siegel, Dr. Farsalinos,
other people like that as primary sources.
And then part of my job is flying around the
country, meeting with vendors, meeting with
vapers, educating them on issues.
I was just in Washington DC yesterday where
I gave a presentation at the Food and Drug
Law Institute conference on tobacco about
e-cigarettes in a post-deeming world.
Hoping to do more of those type of conferences
outside the e-cig world.
But essentially, I'm on the front lines.
And one of the nice benefits of not representing
the industry is that whereas SFATA rightfully
has to be nice in most of their communications
I can, like Dr. Siegel, be a little more hard-edged
when appropriate and when people are really
lying and harming public health.
13:07 S3: Great.
And we certainly appreciate the stern advocacy
for the e-cig industry.
We have another question here and it relates
back to the public health report out of England.
And it being an England report, is there any
reason to discredit the England-based reports
solely on the fact that it was produced in
another country?
13:26 GC: No.
No.
I could see people in third world countries
perhaps saying that science is not valid.
I don't know if would understand that, but
when it comes to England, where it's the first
or second best health care system in the world
with some of the most premier academics in
the world, it simply doesn't make sense to
discredit the report based off of that.
There have been other attempts to discredit
the report.
There's a part of me that wishes that they
had not said 95% less hazardous than smoking
and just instead just said, "Far, far less
hazardous than smoking," so then we wouldn't
have had this war between academics about
whether or not that figure was appropriate.
But, no, long story short, there's absolutely
no reason to discredit a report simply because
of the country of origin.
14:21 S3: Yeah, it kind of started a debate
about percentage points and not the actual
evidence that was included in the report.
14:26 GC: Yes.
I had a conversation yesterday with Dr. Michael
Eriksen, who is an FDA grantee, runs School
of Public Health in Georgia, and that was
one of his contentions.
I think we may disagree.
I think he may think that 95% is too low,
whereas I think 95% is too high.
Or rather I think it's more 96, 97, 98 and
he might think it's lower than 95.
But regardless, the debate may have been a
little differently coming out of that report
if it just made clear, "Look, these aren't
safe, but they are far, far, far less hazardous."
[chuckle]
15:09 S3: Exactly.
Well, Greg, I definitely appreciate the information
you've given us here.
It's been very informative.
Before we move on to the next panelist, we'd
like to see if any of the other panelists
wanna comment on the questions that were asked
previously.
Alright, well, I think we're good.
We're gonna go ahead and move on.
Our next speaker is an expert in Air Quality
and Human Health Exposure and Risk Assessment.
In addition, he is a Multi-Award-Winning Environmental
Expert and World Renowned Environmental Leader
and the Chief Executive Manager of CHANGE,
Dr. Timothy McAuley.
Dr. McAuley, thank you for joining us today.
15:41 Dr. Timothy McAuley: Sure.
Thank you.
15:43 S3: So, Dr. McAuley, you are an expert
in Air Quality and Human Health Exposure and
Risk and you have done extensive work in secondhand
vapor exposure, especially with how it compares
to tobacco smoke.
So how does e-cig vapor compare to the secondhand
smoke of traditional tobacco?
16:00 DM: In general, vapor has a substantially
less amount of particulate.
That's generally because vapor is actually
it's not a combustion process.
So you're actually producing a vapor that
quickly volatilizes and therefore has a rapid
dissipation, whereas something that's more
of a combustion-based product would tend to
exist longer, generate other types of particulates
that can actually pose secondary exposures,
such as PM2.5 and things that you don't see
in electronic cigarette vapor.
16:38 S3: Oh great.
Well, thank you for that explanation there.
Do you believe that e-cigarettes pose any
risk to public health in terms of secondhand
vapor?
16:45 DM: Oh, I'm not gonna say that they
don't pose any risk.
As Greg mentioned, that from the research
that I've done and been involved with with
various panels from the American Heart Association,
with the National Heart, Lung, and Blood Institute
and the research that we've looked at in my
discussions with Jon Samet, who is a global
health leader in his own right, again I think
the jury is still out.
The big question is, "What's the research
doing now to show what those levels are?"
I do agree that, at this point in time, it's
very difficult to put percentages on what
we feel is safe versus unsafe.
The main question that always stems from is
the current policy of EPA with nicotine to
say that there is no safe level.
17:31 DM: From the research that I've been
involved in, we've effectively demonstrated
that although it's been a few years since
we've done and the new research we're about
to do, the amount of nicotine contained within
the liquids has substantially dropped from
when we did our research.
So I would expect, even with the lower levels
that we found in comparative analysis against
a standard high-nicotine cigarette, that those
levels would be even lower now.
So bringing me back to the point that we can't
definitively ever say that they are completely
not safe.
However, the level of risk that we found originally
actually is substantially lower in terms of
adverse health effects when compared to an
actual cigarette.
18:19 S3: Thank you for that, Dr. McAuley.
We all want to know that it's risk aversion.
We wanna stay away from risk as much as possible.
18:26 DM: That's right.
18:27 S3: Limit that exposure.
We're hearing an awful lot about reports about
chemicals found in e-cigs, specifically formaldehyde,
and I was just curious that, in any of your
studies, have you encountered high level of
formaldehyde in some of these e-liquids?
18:39 DM: We have not.
And again, part of the research that I've
been involved in, I mean, a big question that
sort of goes against a little bit about with
what Greg was mentioning is that there's a
lot of questions that need to look at, not
only just the liquids themselves, but what's
going into them in terms of flavorings 'cause
we're...
Part of the concern here is that aerosol science
says when you're dealing with public health
is the fact that you're not always dealing
with the primary constituent of that air toxin
or air contaminant, but you're also dealing
with the secondary by-products that can be
formed.
And so in some of these cases, when we mention
about the toxins and things that are later
on air containments, we're talking about regularly
commercially available products that people
can purchase and those kinds of things.
We're not talking about people in the basement
making up different formulas and so forth.
So I wanna make sure that that point's clear
because it always does come up to say, "Well,
what if I buy it off a friend who...
"
19:38 DM: That's totally different.
We're talking about people coming into a store
or a vendor that has to sell similarly approved
products.
So you have to understand that with those
different types of components and things like
that, we didn't see typically high levels
of formaldehyde, but we need to also understand
more, which is an area of research that we're
looking into.
Also, to understand the organic, potentially
inorganic and other types of bottles or aldehydes
or carbonyls that may exist in different concentrations
in various types of liquids because again
there isn't just one type of strawberry, one
type of vanilla.
There are thousands of different types so
it would take some good comparative studies
to assess that, to be sure.
20:28 S3: Great.
Thank you for that answer, doctor.
Now, you did some work with the American Heart
Association.
What was involved with that work and what
were the conclusions did you draw from that
work?
20:38 DM: Yeah, I was a part of a panel of
experts last year, though I think there was
about 10 of us.
We were asked to put together a policy statement
that essentially was published in Circulation,
which is a journal of the American Thoracic
Society.
You can find it on Google.
And basically, what it was, it was about a
three-month panel.
We met a couple of times every couple of weeks
and really evaluated, "What's the status of
the literature?
What do we know from an international perspective?
Who's doing what?"
And we were really able to sift through a
lot of the research studies that people did
that we just found weren't...
Even though it was published, were they credible?
Do they actually have a good basis for their
research?
21:25 DM: And so from the ones that were compiled
that we found that were actually scientifically
sound, we actually also had a couple policy
analysts on the committee and really the idea
was to evaluate the public health aspects
of the electronic cigarettes, the social aspects,
the psychometric aspects, policy statements.
Where's the replication between what we're
seeing versus potential inclusion to already
smoke-free laws set by the FDA for regular
cigarettes?
Where should all this go and where should
we been?
And, overall, part of the conclusion that
we found were essentially that we need to
do more research.
We need to get better answers.
For the time being, it was the recommendation
of the American Heart Association and that
of the panel that electronic cigarettes, at
least for the inclusion, for those areas that
are not definitive, to just simply say, "You
know what?
It's okay.
Put these under these smoke-free laws."
That doesn't include state, county, town bans.
This is just in general.
With the caveat that, as research becomes
available and as we are doing more and more,
that there is this caveat that we will be
able to revisit this and that those laws can
then be lifted.
22:47 DM: So this is not in stone, but that
was the outcomes really of the panel and that
there's again more investigative research
that needs to go into teen addiction and teen
social aspects and peer pressure on electronic
cigarettes and the whole psychometric relations
of, "Are electronic cigarettes used as gateway
drugs or gateway devices?
Or does it keep people hooked on smoking versus
so they just quit period?"
And, despite the evidence, that there has
been reductions in lung cancer related...
So, all these things were summarized and then
our thoughts were put together into the paper
and published.
23:27 S3: Yeah, it seems like it's such a
new product, it's such a new device on the
market, that we really need to take the time
to get this research done and let all this
be collected.
23:35 DM: Yes, that's correct.
And the hard part here is that you're working
on a moving target.
This is a very dynamic industry.
This is not static by any means.
And as you start to begin doing research in
one area, suddenly you start to notice that,
"Hey, there's a new take on the market.
There's three dozen new liquids that just
came out or there's...
" All these things that, as researchers, you
need to really get that 30,000 foot view.
And, thankfully, there are other researchers
out there like Dr. Siegel and all the colleagues
of mine that are also looking at other pieces,
so that collectively...
Although we may not be talking every day about
who's doing what, but papers are getting published
and people are able to find those and start
to put things together and that helps drive
new research initiatives.
24:31 S3: Great.
Thank you for that, doctor.
Now, we may have heard reports about the National
Park Service recently classifying electronic
cigarettes as a tobacco product and then banning
them in all areas where smoking is prohibited.
Do you have any thoughts on that legislation?
24:45 DM: Well, again, people in general right
now are going to default into what's already
regulated because the amount of money that...
For example, the National Park Service or
any federal agency, they are not gonna spend
the time and effort right now to go against
the regular policy aspects of what's in place.
They're just gonna go with the flow because
they can.
And so if you start to think about the amount
of...
And again, this is not a positive thing.
But if you are a federal agency and you're
trying to mandate something, what's gonna
be easier for you?
Stick it under something that already exists
or actually say, "You know what?
No, no, no.
Let's start funding.
Let's start putting out all this money and
let's stop and look...
" You're just gonna have to take the easy
way out.
And that was, again, going sort of coming
back to the policy statement that was written.
Yes, it was part of the recommendation that
we made.
It wasn't that the panel was saying any federal
agency, "Please, put this under a smoke-free
law."
It's more of, "Look, for the ease of not having
to worry about battling over what should go
where from individual components, now we leave
it open to the research to then dictate what
laws should then be lifted and what regulations
put in place."
26:06 S3: Great.
Now, some have countered that by saying that
burning charcoal contains far more harmful
toxins than e-cigarettes do and even cigarette
smoke and therefore they should also be prohibited
in parks.
26:17 DM: Yup.
And most of them are.
Technically, they are.
You can't go to a Class 1 area at a National
Park and decide to have a charcoal fire.
It's a protected region.
So there are specific areas inside parks that
you are not allowed to do that.
So all these different sources are taken into
account for the protection of the environment
and public health.
26:40 S3: Great.
Well, we're gonna move on to some questions
from the attendees now.
So we have a few rolling in here.
We have one question: "People think about
secondhand smoke and secondhand vapor as something
that lingers in the air, but what is the risk
of residual nicotine or chemicals left behind
surfaces that vapor touches?"
27:02 DM: Well, there's always...
That's really the main component of what we
call basically 'third party exposure' where
you can get the deposition of a vapor on furniture,
clothing, walls, and things like that.
A lot of that is subject to concentrations,
air changes per hour in the particular room
or area that we're talking about, the volume
of the room.
If you have somebody coming in to a room and
they're standing there once a week for five
minutes and vaping, chances are you're gonna
be able to go in there and really detect any
kind of incidence?
Probably not.
If it's somebody who's living there and they're
spending three or four hours there a night
we often get that kind of stuff and they're
vaping the entire time they're there, chances
are that you will have the ability to actually
detect, through wipe samples and things like
that or bulk analysis, actual various chemicals
that would be derived from the actual vapor
themselves.
28:00 S3: Great.
Thank you for that, Dr. McAuley.
We've got one more question here for you and
then we're gonna move on to our next presenter
so give me one moment to get that question
up.
Let's see, what is it gonna be?
Okay.
"Dr. McAuley, it seems that the most salient
arguments we encountered are made without
comparison of risk and what can we look forward
to in scientific literature that directly
demonstrates the risk to the end-user and
bystanders?"
28:29 DM: Well, the end-user is...
That's a separate entity in a lot of the research
that needs to be done.
Those are various inhalation toxicology studies,
deposition modeling, various things to actually
look at the transport of the vapor and the
constituents into the lung tissue, coming
from epithelial into the blood and things
like that.
There's a lot of things that take place on
that and those are typically much more of
a control-based risk study with a certain
amount of known going in, how much is retained,
how much is exhaled.
The general basis that we know at least from
the amount of the users, given that the vapor
and the amount of water and things like that
can actually be generated, also with the function
of relative humidity and temperature, we know
the lungs have more humidity and things like
that.
We expect a higher retention rate of the vapor
than what's actually exhaled.
29:24 DM: So when you're dealing with understanding
the risk, part of it also goes to the bystander
is that's a big data gap right now.
That is an area of research that is certainly
a focal area.
My overall risk perspective again depending
on the bystander is much, much lower than
that of a comparison to an actual cigarette
or to the user, so we often can't.
It's no different than basically trying to
look at the user.
We know they're being exposed, we know their
exposure risks are higher, but as far as bystanders
and people in other areas, it's really a function
of environment, meaning where you are, what
are you doing and things like that.
If you're standing in an urban center and
heavy traffic at 7:00 AM in the morning and
you're directly downwind of a major intersection
and you're standing there, chances are somebody's
standing next to you with an e-cig who's blowing
it and is coming to you versus what you're
breathing in from the traffic, it's extremely
negligible to what you're actually inhaling
from all of the actual combustion products.
So, again, depends on where you are, what
your environment is, and what your overall
exposures are to other sources.
30:35 S3: Well, thank you for your time today,
Dr. McAuley.
We really appreciate it.
It's a lot of informative information.
We got some more questions rolling in and
we may reach out to you via email to respond
to some of those questions?
30:45 DM: Yeah.
Anytime.
30:46 S3: And then at the end, we're also
gonna do another general Q&A, so if you have
time, we'd invite you to stick around for
the remainder of the webinar.
30:52 DM: Certainly.
No problem.
30:53 S3: Great.
So our final speaker today is a Professor
in the Department of Community Health and
Sciences at Boston University School of Public
Health.
He also has been a researcher in the tobacco
control area for the past 25 years.
He writes a popular tobacco policy blog with
the rest of the story where he provides commentary
and insight on the current tobacco policy
issues, Dr. Michael Siegel.
Dr. Siegel, thank you for joining us today.
31:17 Dr. Michael Siegel: Well, thanks for
inviting me.
31:18 S3: We're glad to have you here and
thank you again for taking time out of your
busy day to be with us.
So we got a few questions rolling in so we're
gonna jump right into a couple of them here.
Actually, did you wanna make a few statements
before we started that?
31:30 DS: Well, I just wanted to very...
I wanted definitely to leave most of the time
for questions.
I do wanna address two issues that I think
are really critical.
I wanna make sure everyone understands.
And the first one is "What exactly is entailed
in this new application?"
So according to the proposed FDA Deeming Regulations,
every electronic cigarette product will have
to submit a new application.
And I wanna talk just briefly about what's
in that application because as Greg Conley
mentioned it's very expensive to do these
applications and the fear is that it would
literally put so many vaping stores and smaller
businesses out of business.
I just wanna explain why that is so people
understand.
32:18 DS: The new application standard, by
statute, by law, is that you have to show
that your product will be beneficial to the
public's health.
And that's the exact standard you have to
show.
And you have to show not only that it's beneficial
for the users, but that it won't be harmful
to non-users.
So, in other words, you have to not only show
that the product is much safer than cigarettes,
you also have to show that youth or other
non-smokers are not gonna start using the
product.
And as Dr. McAuley explained, the research
is rather complex.
It's not that easy to do this research.
You have to have large-scale studies, clinical
trials to show the effectiveness of the product
in getting people to quit smoking.
You have to do large population studies to
find out whether kids are progressing to smoking
after experimenting with e-cigarettes.
And so it's incredibly expensive and complex
to do these studies.
33:19 DS: So the requirement for a new application
is essentially a death sentence I think for,
I would say, most businesses that aren't trained,
aren't qualified, and don't have the resources
to do this kind of thing.
If you're a small vape shop owner, how are
you gonna put this complex application together?
And you may not even understand the research
issues involved.
So I think that and I've been arguing for
a long time that this general approach that
the FDA has taken makes no sense.
What it would do, if these Deeming Regulations
turn out to be the same as what they proposed,
is it would essentially hand the entire industry
to maybe 1% at the very top.
Mainly, the tobacco companies and maybe the
largest of the independent electronic cigarette
companies.
34:12 DS: The second thing I just wanna briefly
touch upon is the way that the FDA is regulating
the marketing and communications.
What can e-cigarette companies say about their
products?
And, unfortunately, it looks like the approach
that the FDA's gonna take has two major problems.
The first is that they're not allowing any
health claims to be made because if a health
claim is made, the FDA's gonna interpret that
as meaning that the product is to be regulated
as a drug rather than a tobacco product, which
makes it almost impossible to do.
You have to a minimum of about eight years
of clinical research to get it approved as
a drug.
So you, basically, can't make health claims,
which means that you can't tell customers
the very basic truths about the product, that
these products were intended to help smokers
quit, that they are highly successful for
many, many thousands of smokers to help them
quit.
Unfortunately, that's something that you can't
say.
35:13 DS: But to make the problem even worse,
the FDA also looks like they're going to apply
the FD Modified Risk Regulations to these
products.
What that means that you can't even tell customers
that these are safer than cigarettes, can't
make a comparative claim between these products
and any other tobacco product.
And to make things completely ridiculous,
you can't even tell people that there's no
tobacco in the product.
Because if you say that there's no tobacco,
that's what's viewed as a reduced exposure
claim and that's not allowed without pre-approval.
And the procedure to get approval is essentially
impossible.
And so I think perhaps the worst part of the
FDA, the proposed regulations at least, is
that it would prohibit electronic cigarette
companies from telling the truth to their
customers about the two main benefits of this
product: First, that it can help you get off
cigarettes.
And, second, that it doesn't contain tobacco
and therefore is much, much safer.
36:18 S3: Well, thank you for that, Dr. Siegel.
And in the customer service department here
at White Cloud, we deal with that every day
on a firsthand basis.
So I appreciate you mentioning that.
We have a few questions rolling in here.
In your recent blog, you discussed the anti-tobacco
movements treatment of e-cigarettes and do
you have any thoughts on why anti-tobacco
groups are so negative about e-cigarettes?
36:38 DS: Well, this is a question that I
have been thinking about actually for the
past four years.
So I've had a lot of time to think about it.
And I, finally, have come up with what I think
is the most logical answer, and I think what
it has to do with is the fact that this is
a movement that is concerned about its prestige,
and we didn't think of this.
This is not an idea that we thought of and
I think that is a huge thing.
I think that if this had come out of the tobacco
control community, for example, if Stan Glantz
had come up with this idea of having a noncombustible
alternative to cigarettes that would be a
lot safer and he had been the first one to
come up with the idea, I don't think that
we'd be seeing the opposition we're seeing
today.
I think a lot of it is because this is not
something we thought of, that this is something
coming from outside industry that, in some
cases, involves tobacco companies to make
it even worse.
37:42 DS: And so I think it's really a threat.
I think these products are really a threat
to anti-smoking groups because I think deep
down they realize that this is a game changer.
I think, subconsciously, they recognize this
is a game changer.
This could completely transform the market
and that's scary to them because they can't
claim that they were the ones who did it.
They would have to say, "You know what?
We failed and these other companies came in
and they came up with a solution that none
of us thought of."
And that's why I think this is such a threat
and that's why I think they're ignoring or
misrepresenting all of the research showing
the benefits of these products and that they're
demonizing them because I think that it may
not be conscious, but I think subconsciously,
this is a real threat and they're gonna do
everything they can to try to keep their prestige
and to clear their self-esteem.
I think that's really what's going on here.
38:39 S3: Well, Dr. Siegel, to expand on that
a little bit more, what are the dangers of
the continued negativity of these groups towards
the e-cigarettes?
38:46 DS: Well, I think there's two major
issues and one of them has nothing to do with
electronic cigarettes.
It actually just has to do with smoking.
The groups claim that their goal here is to
try to lower rates of smoking.
And, in fact, one of the main arguments they're
using about e-cigarettes is that these products
are gonna cause people, especially youth,
to start smoking.
But, ironically, the danger of what they're
doing is they're really undermining the public's
appreciation of how bad cigarettes are because,
by comparing cigarettes to e-cigarettes and
by basically saying, "E-cigarettes, it's just
as bad as e-cigarettes," or...
I'm sorry, "E-cigarettes are just as bad as
real cigarettes," they're really undermining
the public's appreciation of just how bad
cigarette smoking is.
And, by failing to acknowledge that there's
a major difference between a product that
contains and combusts tobacco and a product
that actually has no tobacco in it whatsoever
and involves no combustion, it's completely
distorting the public's appreciation of why
cigarettes are so bad.
39:48 S3: They're bad for two reasons: One,
because they involve burning and, two, because
they involve tobacco.
And if you take those two things away, you
automatically are gonna have a much safer
product and these groups are undermining that
knowledge.
And, in the long run, I think it's actually
gonna lead to more people smoking.
People are gonna get scared.
They're gonna maybe instead of trying to quit
with e-cigarettes, they'll decide, "You know,
it's not worth it.
If these things are almost as bad as cigarettes,
why should I bother?"
And the second thing that I think is harmful
about these misrepresentations is that it,
I think, is leading to policy that doesn't
make sense.
I think that, by putting out this misinformation,
policy makers are really getting the wrong
information and they're using that wrong information
to make policy and, of course, the greatest
example is the FDA and everything that we
just [40:42] ____.
40:44 S3: Well, now, the American Lung Association
in the Upper Midwest recently said that smoking
tobacco may be no more harmful than e-cigarettes.
How do you respond to that egregious claim?
40:55 DS: Well, I think that it's...
We respond to it by basically pointing it
out and saying that this is just absolutely
wrong.
That this is a lie and I've done that repeatedly
on my blog.
What's frustrating to me is the fact that
some of the mainstream organizations are saying
things that just aren't true.
We can go right to the top and the CDC itself
is basically stating that electronic cigarettes
are a tobacco product.
There is nowhere on the CDC site, and I've
gone through it extensively.
There is nowhere on their entire site where
it actually acknowledges that e-cigarettes
do not contain tobacco.
If you did not know that and you're a member
of the public or even a vaper or a potential
vaper who's looking at their site for information,
there is nowhere where they actually say it
doesn't contain tobacco.
And, in fact, by classifying as a tobacco
product, I think they're misleading people
into thinking that it does indeed contain
tobacco.
So I think this problem goes all the way to
the top.
It's not just a local, in the Midwest, some
branch of the American Lung Association.
This is really coming out of national groups,
such as the CDC.
And, to me, that's what's so disturbing about
it.
This is the nation's leading public health
agency and they're not even willing to acknowledge
that electronic cigarettes don't have tobacco
in them.
42:20 S3: Well, thank you for that explanation,
Dr. Siegel.
Regulations are designed to help keep the
public safe and healthy, but at what point
do regulations begin to have the exact opposite
of the intended effect and begin to do more
harm than good?
42:33 DS: Well, I think that they begin to
do more harm than good when they essentially
violate the science.
In other words, when policy is evidence based,
then I think it does protect the public's
health.
When policy loses that evidence base and when
other factors, such as politics or ideology,
start to influence the policy, that's when
I think that it really can have adverse effects.
And I think that with e-cigarettes, that's
exactly what we're seeing.
The FDA, itself, has stated that they're not
sure that e-cigarettes are any safer.
It's actually in the Deeming Regulation itself.
It actually states that they're not sure that
e-cigarettes are any safer than smoking.
And so if you're starting from that base,
where you basically are ignoring overwhelming
evidence, you're not gonna come up with policies
that actually protect the public health.
And, in this case, the entire approach that
the FDA is taking, by requiring these new
product applications rather than simply setting
safety standards for e-cigarettes, I think
it's actually gonna harm the public's health
rather than protect it.
43:45 S3: Well, that's a great explanation
there, Dr. Siegel.
We're gonna open up to a general Q&A.
So we're gonna bring all of the panelists
back in, open the mics up, and we're just
gonna fire out some questions from the attendees
here and whoever would like to chime in on
these questions, please feel free to go in.
We have a first question here, and it's about
a drug like Chantix, was approved so easily,
yet they cause harm to the user where e-cigarettes
really haven't been seen to do that.
Would anybody like to comment on that discrepancy
there?
44:14 DM: I'm not sure I understand the question.
44:18 GC: How do you justify Chantix getting
approved so easily?
44:19 S3: Yeah, how do you justify Chantix
getting approved so easily and e-cigarettes
having such a fight to get approved?
44:28 DM: Well, you wanna go ahead, Dr. Siegel?
Before I...
44:31 DS: No.
No.
Go ahead.
You start.
I'll...
44:33 DM: First of all, with any drug that's
passed through, I'm not...
I, first of all, would be skeptical...
Not that I wouldn't say that I wouldn't use
the word 'easy.'
All drugs go through a very intense clinical
trial period, things in those lines, at least
they're supposed to.
As far as...
Again, I think part...
From the electronic cigarette, it goes back
to the point of a very dynamic industry.
Things are constantly changing and so how
you're monitoring that and how you're trying
to track that back is extremely difficult.
And Chantix doesn't have several different
types of derivatives and formulas and things.
It's a drug and that kind of stuff.
So that's what we're facing here is you're
looking at really it's a sort of an apple...
It's not really an apple to apple comparison
versus trying to identify...
Just understand what Dr. Siegel...
He's right.
And one of the biggest things that we, as
people in the research field, say is "Science
has to drive policy here."
And just a lot of what's going into drug development
so far there's science in terms of just looking
at drug interactions and so forth.
45:49 DM: So in this field of e-cigs, it's
a very difficult field.
And so I think overall, the more evidence
that we can put out there, you will start
to get people looking and I've seen enough.
I've seen people that when I first started
doing this research, who just literally were
like, "Oh, this is a drug delivery device.
This is just gonna kill people."
Who are actually like, "You know, Tim, the
research you guys are doing, this is actually
really interesting and have changed our mode
of thinking."
And these are highly known scientific experts,
so it's just a matter of time.
46:24 S3: Great.
Thank you for that, Dr. McAuley.
Dr. Siegel, did you have anything to add about
that question?
46:28 DS: Yeah, just to add one thing to what
Dr. McAuley said and that's that I think it's
important to recognize that a lot of the side
effects of Chantix, in terms of these psychological
or psychiatric effects, such as suicidal ideation
or suicide, weren't really recognized until
the post-marketing surveillance.
In other words, after the drug was already
approved.
And the same is true with a lot of drugs that
have been taken off the market, like Vioxx
is a great example where, when it was approved,
they didn't know about these side effects.
So I don't think we can blame the FDA for
approving Chantix in the first place.
The problem is that when you have these post-marketing
adverse effects that are [47:11] ____, because
the drug is already on the market, the burden
of proof is really to lean towards keeping
it on the market unless the side effects are
so bad because the drug is already having
benefits for people.
47:28 DS: I think the interesting thing about
electronic cigarettes is that, in a way, with
most drugs, they're not put on the market
until they're approved, but electronic cigarettes
have basically been on the market in the United
States for at least eight years now.
And so, in a sense, we actually do have a
post-marketing surveillance period that's
taken place and we haven't seen any major
acute health effects from the product.
If people were dying of pneumonia or pulmonary
embolisms or heart attacks, we would see these
kind of major events happening because we
have some experience with millions of people
using it for five, six, seven years.
With anything, I think that experience leads
to a more optimistic investment of where e-cigarettes
are compared to where most drugs are at the
time that they're approved.
48:22 S3: Great.
Thank you for that, Dr. Siegel.
Mr. Conley, would you like to add anything
on that question before we move on?
48:28 GC: I think Dr. Siegel and Dr. McAuley
covered it sufficiently.
48:32 S3: Great.
Well, we have another question here and this
one's directed actually at Dr. Siegel.
Aside from the PHE study, can you point to
two or three other leading studies that advocates
can use in their work to educate policy makers
on the best science behind e-cigs and vaping?
48:48 DS: Well I think the most convincing
study that's out there is the study that Dr.
Riccardo Polosa did where he basically took
asthmatic patients, patients, smokers with
asthma and he gave them electronic cigarettes
and some of them switched completely to electronic
cigarettes, others only partially, and then
he monitored their lung function before and
afterwards with spirometry testing and he
also asked them about respiratory symptoms
and his findings were pretty amazing.
What he found was that both the subjective
symptoms of the smokers and their...
I'm sorry.
Both the subjective symptoms of the smokers
and the objective evidence from the spirometry
completely improved after they switched to
electronic cigarettes and this was after only
about a month period.
So it was a very short-term effect.
49:49 DS: And the most interesting thing to
me was that this improvement was seen not
just in those who switched completely to e-cigarettes
but also in the newer users who reduced the
amount that they smoked by a large amount.
And so, to me, this is the strongest evidence
that you can use to convince policy makers
because it's actually direct clinical evidence.
How could smoking be as bad as electronic
cigarettes if asthmatic smokers who switched
to e-cigarettes had a dramatic improvement
in their health?
So I think that's the type of study that I
think is being ignored by so many people,
so many of the opponents of electronic cigarettes.
50:30 S3: Great.
Thank you for that, Dr. Siegel.
And after the webinar, we'd like to get a
link to that study so we can send that around
to all the participants as well.
We have another question here that's directed
towards Mr. Conley.
What, if anything, can be done to move the
public health community, as a whole, towards
acceptance of tobacco harm reduction through
the use of vapor products?
50:52 GC: I think that we need to look at
a place where the approach has worked in large
part, England.
Where you have very passionate consumer vapors
as well as passionate members of industry,
reaching out and trying to develop relationships,
trying to lightly challenge them without being
too harsh unless they're too far gone.
I got to sit down, I got to talk to a few
people yesterday that are in the middle on
the e-cigarette issue, but they are very important
voices.
There are some that will never be reachable.
The government relations people at the American
Cancer, American Heart, those people can't
be reached.
People have tried.
But there are opportunities at your local
health departments, state health departments,
attorney general's offices.
Those are great places to start.
52:08 S3: Great.
Thank you for that, Mr. Conley.
We got one more question here before we have
to end the webinar and this one just simply
states, "Is Big Tobacco scared?
Is that why they're getting into e-cigarettes
and do they possibly see that this is the
way of the future and they want to cash in
on this?"
And this question is open to any of the panelists.
52:32 DS: Well, I guess I'll start and just
say that absolutely the answer is yes.
The big tobacco companies I think, unlike
much of the public health community, understand
that non-combustible tobacco products are
gonna be the wave of the future.
Anti-smoking groups, like it or not, this
is where the future is gonna go and the tobacco
companies wanna be in the game.
They realize that there's a limited shelf
life for combustible tobacco products, in
the United States at least.
And that, as smoking rates continue to decline
and decline, what you're seeing is that its
lowest level historically among both adults
and youth today and it keeps going down drastically.
53:18 DS: So I think they realize that the
combustible market is declining and they wanna
be in on the action to make sure that, as
the forms of nicotine delivery change, that
they're in the game.
And, unfortunately, it's kind of sad to me
that ironically the tobacco companies are
the ones who wanna play this game changing,
they wanna be in this game changer, where
the anti-smoking groups, who you think would
be the ones who would actually want to transform
the entire market from a combustible market
to a much safer alternative nicotine delivery
market, you would think that they wanna play
ball with this, but they're trying to stop
the game.
And to me, that's probably the greatest irony
in public health of my time.
54:07 DM: I think a lot of that, just to add
to that very point, is the fact that again
often people that are advocating against these
have the least amount of information to be
able to critically review and criticize in
terms of a scientific aspect.
So that's part of what we're dealing with.
As Greg said earlier, you're dealing with
so much information that's coming out that's
just pure junk from people who aren't really
qualified to be doing science that's getting
the ears and attention of those people that
are able to actually...
That are publishing good research.
So it's really just a matter of ensuring that
good science is done by those that are doing
it so that you have that evidence to then
drive that policy forward rather than...
I think you'll eventually see people fall
off once...
54:56 DM: Once you put something peer reviewed
in front of people, that science is backing
up that policy, suddenly you'll start to notice
a lot of mouths in the crowd shut because
you can't argue with it because that's the
benefit of doing peer reviewed research, not
white papers, not things just putting out
in the general public, but research that is
published in journals that's publicly accessed,
but has passed a very critical piece of a
process that has shown...
So you know what?
This work merits publication that came to
their use.
That's how the National Ambient Air Quality
Standards for environment public health are
set.
They're set after research.
Do they always get to the levels we may want
'em?
Maybe not, but that's the idea behind it.
The NAAQS were not set based off recommendations
from advocacy people.
They were set from researchers, people doing
the work, looking at the health effects, looking
at the impacts on the environment.
That's what we have to do here is to ultimately
get enough research out there that's gonna
drive that policy home.
You will start to see everybody off just fall.
55:58 S3: Well, thank for that, Dr. McAuley.
We've had a lot of great content here in this
webinar.
Unfortunately, we're running short on time
now.
We also got a lot of questions that we didn't
get a chance to get to during the webinar,
and I just wanna reassure everybody that we
are gonna respond to these questions via email
in the next couple of days.
We'll respond to those questions via email
in the next few days.
So thank you so much to all of our panelists
and all the attendees who came in today, and
we just wanna let everybody know that we're
gonna continue with this web series and that
we hope everybody can join us again for the
next one.
So thank you again everybody for attending
and hope everyone has a great day.
