Good afternoon thank you for joining us
for yet another very interesting
interview, I'm Patricia Kovacevic, general
counsel and chief compliance officer at
the Nicopure labs. I'm here today with
Jeff Stier who is the senior fellow at the
National Center for Public Policy
Research. He is the head of the risk
analysis division and also a non
practicing attorney. Happily non
practicing attorney. Good afternoon and
thank you for joining us. Thanks for
having me.
We're here to talk about the recent U.S.
Surgeon General's report and a couple of
other developments regarding the vaping
industry. As you all know, a few weeks ago,
the U.S. Surgeon General has
published its report on electronic
cigarettes and some of the conclusions
drawn in that report are concerning. In
your opinion Jeff, what is the
significance of this report and what can
you tell us about the timing of it.
Well, it wasn't simply a report
by the Surgeon General. It was a Surgeon
General's report which has historical
significance because in 1964, the Surgeon
General released a report on smoking and
that was a very important and bold
document at a time when people didn't know
that smoking was horrible.
This surgeon general's report on vaping,
vaping and youth is actually not only
doesn't only lack the
bold approach of that original Surgeon
General's report. It's actually
purposefully misleading because it only
focuses on youth and there is no
controversy in the scientific community,
in the vaping community, anywhere!
Kids shouldn't use e-cigarettes whether
they have nicotine or not
period end of story. There is no
controversy.The Surgeon General didn't
solving problems. His report only
confused people by suggesting
e-cigarettes are so dangerous and such a
problem when we know kids shouldn't be
using them in the real area where the
public needs more information and more
education is how can e-cigarettes be
used, if at all, to reduce harm from
smoking. The Surgeon General would have
been wise to follow the report of Public
Health England, the largest landmark
government study on these
to date, which of course said kids
shouldn't using cigarettes but talked
about how they are a potential boon to
public health. The Royal College of
Physicians similarly, also way ahead of
the Surgeon General, obviously agreed
kids shouldn't use e-cigarettes but the
Royal College of Physicians suggested
doctors encourage their patients who
smoke to quit smoking using e-cigarettes
because they can help people reduce
their risk.They're ninety-five percent
less harmful than smoking and they're
not a gateway to smoking, so the Surgeon
General who claimed he had two years of
work on this had a hundred and fifty or
more experts advising him seem to only
be able to focus on an area where there
is no debate.
Furthermore, legislation at the state
level and now federal level since
the deeming rule in fact bans the sales
of vaping products to minors and we know
that FDA in fact has done some work in
enforcement in the area of retail age
verification and sales to minors, so
clearly that is the premise that the
industry as well as public health start
from kids should not have access to
nicotine containing products which is
clear but what this report seems to fail
to address is in fact by omission the
true value that these products could
present in harm reduction and it also
fails to address what basically FDA is
doing to really protect kids from the
dangers of smoking. That's an
important point I think that shows the
fact that the Surgeon General only looked at youth
use and didn't get into the potential
benefits of e-cigarettes as a tool for
harm reduction to get adult smokers not
to smoke anymore, I think the fact that
he only focused on the Surgeon General
of the focused on youth and vaping is
because this is part of the Centers for
Disease Control ideological campaign
against e-cigarettes and instead of
giving us a full picture in the full
story he focused only on youth because
it's very clear you can't see much bad
about e-cigarettes and adult smokers we
want them to switch so this is the
reason he only focused on kids was
because this was a Surgeon General's
report which is a Surgeon General's report is
and is supposed to mean something
was being used as a political tool to
advance the Obama administration
campaign against e-cigarettes to support
the FDA's deeming regulation to support
the Center for Disease Control campaign
against e-cigarettes. I think this was a
parting shot from the Obama
administration's Surgeon General.
What measures should the new administration
take in order to at least mitigate some
of the communication damage that this U.S.
Surgeon General report has in fact
accomplished?
Well first and foremost, the Surgeon
General has a four-year term. He was
appointed two years ago so we've got
about another two years left in his term
yet the Surgeon General can be fired by
the president for cause, for doing
something wrong, for not doing his job
right. I will argue that and I will argue
in the upcoming administration that this
report is cause. This report proves that
the Surgeon General has been acting in
the political way and and the office of
Surgeon General was supposed to be above
politics and this report unfortunately
shows that he was just a yeah this
Surgeon General was a supporter of
President Obama before he was appointed
Surgeon General. He was actually an activist
in favor of president Obama, supporting his
ideological campaigns and this shows
that the new administration needs to
fire this attorney general this Surgeon
General we know he likes firing people
apparently but this is an opportunity
for the administration to say we're
going to put the politics of this aside
and get a fresh start with Surgeon
General. There's a lot of the new
administration can do that may require
five more podcast but with regard to the
Surgeon General, he hasn't done much. He
did this and he shouldn't keep his job.
More importantly if you go to the
Surgeon General's web page there is an
infographic that if if you're not a
vaper, if you're not really very
familiar with vaping and you're a smoker
and perhaps want to quit if you go
through that through that
click through web page through talking
about children mainly but you would I
think reach the conclusion
that vaping is outright dangerous, should
be avoided any cost, and it's a gateway
to a lot of other really bad forms of
addiction. Is there really any evidence
to that? I think we can all agree with
what we could quibble with some of the
the science and some of the strength of
the science behind it, we got all agree
unequivocally that kids should not use
e-cigarettes whether they have nicotine in
them or they don't.
The Surgeon General of course pointed
out that nicotine is bad for the
developing brain. I don't think anyone's
going to disagree that kids shouldn't
the kids unquestionably without any
hesitation should never use any
e-cigarette product but to kind of say
that e-cigarettes are so bad because of
the nicotine, apparently even for adults
then that raises questions why should
someone quit smoking and switch to
e-cigarettes if they're also
really bad so the government's approach
and that for the new administration my
advice is to treat different products
according to their risk. Focus on adult
smokers, give them the information based
on science that they need to make
informed decisions about their health
about the choices they make. That's the
only way to get people to change
behavior is to give them information
where they can make decisions on their
own. I don't know of any kids
who are going to quit smoking because of
the Surgeon General's report on smoking
or I don't know any kids who aren't
going to quit vaping if they vape based on
the Surgeon General's report. We need to
give people accurate science-based
information so they can make informed
decisions and the Surgeon General
instead focused on politics. And did a
great disservice in fact to public health
through this reckless report if you say so.
Yeah, it was also a missed opportunity
because there is one Surgeon General's
report on smoking. There is one, you
update it.
There's one Surgeon General's report on
vaping. This report was a huge missed
opportunity to have a little bit of
nuance, I think with the budget he has,
with two years to work on it and with
over a hundred and fifty experts he
could have given us that more nuanced
report and say vaping is bad for kids
kids shouldn't do it and then talk about
the opportunities to dispel some of the
misinformation so many Americans still
think wrongly obviously. Some of the
Americans still think that smoking and
vaping are equally
dangerous. If the Surgeon General is
to do anything it is to add a little bit
of science to the discussion about this
and explain how dangerous cigarette
smoking is, why it's so dangerous and
then it's easy to conclude that you the
use of e-cigarettes by adult smokers can
dramatically reduce their risk, just as the
Royal College of Physicians and Public
Health England have been telling people
based on the science. On the heels of the
U.S. Surgeon General report, only days
after a new report came out monitoring
the future which discusses trends in
teenagers of different addictive
substances and interestingly the the
numbers in that report tell an
interesting story.
Yeah and this is a National Institute of
Drug Abuse funded study at University of
Michigan that has been reporting every
every year or every two years on the use of
tobacco products, on the use of also
e-cigarettes. I still refuse to call them
tobacco products and in previous years,
it showed an increase in the use of
e-cigarettes among youth. Now obviously
there's been an increase in the use of
e-cigarettes among youth over the past
five years because there weren't, there
was no popularity of these products.
That's like saying. They didn't exist 7 or 8 years
ago.
That's like saying the use of iphones
has gone up a hundred percent in the
last four years, six years.
Well, when you go back 10 years there
were no iphones, so of course the numbers
have gone up but interestingly Patricia
this year the use of e-cigarettes among
teens has gone down and while the number
of e-cigarette while the amount of
e-cigarette use was going up over time
among kids even though this year it went
down, while that number was going up it
is interesting that their smoking
rates went down. All along. During that
time period. Now is it possible that kids
who were on a trajectory to begin using
to begin smoking actually instead of
using e-cigarettes as a gateway
toward smoking actually use them as an
off-ramp to smoking and didn't smoke as
a result of e-cigarettes. That's
something that the report
didn't draw a conclusion about previous
years. This year e-cigarette use among
teens went down. I think that's
significant and I think it it takes away
from the argument that the Surgeon
General made in his report which was
that we ought to have sin taxes on
e-cigarettes to keep kids from vaping
because he argued there's been this huge
increase. Well now there is not an
increase, there is actually a decrease. I don't
think the Surgeon General can change his
opinion on that because it wasn't based
on science, it was based on ideology but
I think it's important to note that this
report which was drafted, which was
written by these experts at University
of Michigan, no friends of vaping came
out the way it did. But at the end of the
report in spite of the numbers showing
downwards trend in electronic cigarettes
and the downward trend in even in
smoking and to follow up on what you
said as a cohort you would have expected
to see maybe an optical smoking if truly
e-cigarettes were a gateway.
However, in spite of these reassuring
numbers one of the authors of the report,
the lead author, actually drew a
very puzzling conclusion.
Yeah well he said in in this is in the
press release and this is common. You
know I deal with a wide range of public
health policy topics not just
e-cigarettes. Public health, food safety,
nutrition, obesity, environmental health,
and one thing that I see all the time is
a scientific report that reaches a
certain conclusion and then a press
release that draws entirely new
conclusions that I'm not sure where they
got them from. This is sadly a very good
example of it. The lead author of the
press release, the lead author of the
scientific report said quoted in the
University of Michigan press release
something along the lines of while
vaping may cause social networks that
people become friends from vaping and
then they could eventually go on to
smoke so vaping is a problem. Excuse me?
It would be very difficult to come to an
actual scientific conclusion based on
data that simply asks people how much do
you vape, maybe where you vape and so on.
It will be very difficult to draw those
conclusions. So I think the one conclusion
that you could draw is that the lead
author of this report is not a friend of
vaping. Yet even his own study tells us
that youth vaping rates have gone down.
To me that totally takes away any
argument that the Surgeon General has to
back up his political claim that we
ought to be taxing cigarettes and by the
way for the Surgeon General in a
scientific report to be making these
types of policy recommendations raises
questions, but let's leave that aside. The
basis for that political argument that
we should have a cigarette taxes to
preventing youth justified by the fact
that teen use has gone up
that's no longer there anymore so the
new administration is going to take a
fresh look at this have to take a fresh
look at all of the science done by the
Obama administration and actually look
to people who have been doing the
science looking at the actual data
looking at U.S. exposure, U.S. use and
looking at other countries such as
England where they actually have good
science backed up by data where you
actually have significant numbers of
people quitting smoking as we do in the
U.S. and then actually turn that into the
science to make good policy on it and
we're not doing that here in the U.S.
Maybe things will change. We hope so.
Another another surprising fact for all
of us in the industry when we see these kind of
statements, who really holds their feet
to the fire when a scientist makes a
statement that is completely unfounded
or even when when people announcing the
Deeming Rule stated that it was the most
revolutionary act to to protect the
children the children from nicotine and
in fact the only child friendly
provision in the deeming rule is the age
verification provision, how can people
get away with saying things that are not
supported by science and and there are
really purely speculative and nobody
really calls them onto that? What should
be done? You know I asked this very
question to Mitch Zeller, the head of
tobacco control of the FDA at a
conference where he was celebrating
ironically i believe it was two years
ago at the 50th anniversary of the 1964
Surgeon General's report they had
held a big event to say what a great
thing they had done, and Mitch Zeller was
there to celebrate it and the head of
the the former head of the tobacco
products scientific advisory committee
was there and he had said in a report
published in I believe in California
newspaper that were worried about
nicotine worried about nicotine because
not only can you become addicted to it
by smoking or using e-cigarettes but if
there's nicotine on the upholstery then
through exposure to the skin, your body
can absorb nicotine and even if you're
not a nicotine user you can become
addicted to nicotine. It's such an absurd
argument not backed up by any science
and I had this opportunity where Mitch
Zeller was standing next to at a press
conference the person who was quoted as
saying that I took the opportunity to
ask the scientist who said that in the
release was quoted as saying that
newspaper was that a misquote? I'm hoping
that was a misquote and he said no, well it's
fact, there's science that if nicotine and dermal
exposure through the skin.
Somehow that got him to reach that
conclusion and I was giving him the
opportunity to say no it was misquoted and
he doubled-down Patricia. He said no, it
can happen and then I had the
opportunity to look Mitch Zeller in the
eye and say as a scientist who is
affiliated with with the FDA, I know it's
your job as a regulatory agency to
crackdown on industry if they say anything
unscientific. Does the FDA have an
obligation to tell the public and if
there is scientific misinformation
certainly from one of its tip sack
members, from a scientist that the FDA
engages with, does the FDA have an
obligation to correct the record and
tell us that no you can't become
addicted to nicotine through a couch? And
he looked me in the eye and he said our
role at the FDA is to have
authority over the industry. Congress
gave us that authority and that is our
obligation. In other words they have
authority with industry but not over the
tobacco products scientific advisory
committee whom FDA appoints. Nor does
the FDA recognize that it has an
obligation to actually give
science-based information
to the public. Look the industry is not
allowed to talk about lower-risk
products without going through all
the FDA approval processes. The industry
can't make a low risk claim. If there are
government officials, if there are respected
scientists saying this in the media, if
the industry can't do it, I was asking
Mitch Zeller, well doesn't the FDA see of
its obligation to correct the record to
make sure that people can make informed
decisions about the choices they make?
Apparently not. That leaves it to your
viewers Patricia, that leaves it to the
people watching this video to educate
themselves and to engage in the process
because industry can't do it and the FDA
has stated it won't do it.
It's up to the people to engage, to educate
themselves, and then to actually
recognize that the obligation is on them.
Don't count on industry and don't count
the FDA. In all fairness to Mr. Zeller,
he did state on numerous occasions that
nicotine is not the problem and he even
conceded that to the individual
switching to a product such as vaping
would be beneficial to the individual,
him or herself, but didn't really go
further and in fact that in itself was
always quantified or qualified by a
statement about public impact of use of
nicotine products where really the
waters are going to be muddled
inevitably because there are so many
patterns of use, still use, switching
back, relapse and so on. Of course, time will
tell what truly the population level
impact will be of these product but
there are really no indications that the
the trends are not there to show this
immense uptick in smoking or some
other bad influences of or results.
Increase in nicotine use overall. No, it's not there.
but i would make the point
that you know that you correctly pointed
out that Mitch Zeller has talked about
the fact that the dangers of smoking is
not from the nicotine, it's from the use
of combustible tobacco. He has said that.
But then he said that you know if that's
the case then why are these Deeming
Regulation so bad he has said that
Congress gave him a certain Authority
and he has to regulate within the
authority given to him by Congress. We
can disagree with his interpretation but
if that's the FDA's interpretation
of the of the law, well then there's a
fix. There are two possible fixes. One through
litigation which your company has boldly
been out in front of and two, change the
law. We don't need bad policy if we have
laws that give us better policy, we can
challenge those laws in court. If the law
is not being applied right or if the law
is being applied right if the court says
no the FDA is doing just fine then we
can change the law.The only way we can change
the law is if the people engage if the
people go out and vote make sure they
have people elected that can change the
law. A lot of that's been done. I think now
it's up to the people to educate the
people they elected to make sure that
the laws are changed in a way that
protects public health, that give people
a choice, information to make informed
decisions.
it's not going to happen on its own. It's
not let sit back and wait.
The only way to do it is to educate
yourself to speak out and then to
actually get involved and do it because I
guarantee you the FDA isn't interested
in promoting harm reduction. That's not
appear so at least from from some of
their statements. More importantly also
Mitch Zeller said that this is not a spectator
sport and everybody has to get in the
ring and we agree with that. We do
see an opportunity now with the new
administration, hopefully one of our
future webinars will talk about what are
the options. As a conclusion
what do you see a timeline more or less
for four more aggressive communication
on the side of the government on this
issue?
In an ideal world
with a new FDA Commissioner in place
what should they change and I'm not
talking discreet you know rules
regulation but what should they change
in their approach to really truly serve
public health with respect to this issue
the opportunity presented by vaping
products versus conventional smoking? I
think the FDA by law has freedom to
share scientific information with the
public.
I think the FDA needs to re-engage
on the Deeming Regulations and you
know many times we see regulatory
agencies lobby Congress to change the
law because it feel like it doesn't have
enough power it feels like a lot
restrained them too much. I think the new
FDA needs to go back to Congress
and say you know this law that you gave
us that we've got the FDA has been
implementing not such a good law it
wasn't really written for you figure out
that didn't harm reduction in mind and
the agency and the agency doesn't like
to admit this unless its lobbying. The
agency has the authority has the ability
to go back to Congress and so you know
our authority should be changed and
educate Congress about how that
authority should be changed. So I believe
that the FDA should take a proactive
approach to harm reduction if there are
any laws that limit the administration's
ability to advance public health, then it
needs to fix the law and the agency can,
you know the new administration can
use its ability to educate the public
and to educate Congress to advance a
harm reduction approach and I believe
that the new administration should and
optimistically I believe they will do
that. Very well and of course we all know
that changing the law takes bipartisan
support and it takes a long time. There
of course was many priorities in in our
Senate and Congress for sure.
In the meantime, however, of course FDA
can exercise enforcement discretion on
a number of provisions of the Deeming
Rule, which also will be an avenue that
is more immediate. FDA exercises
enforcement discretion all the time on a
number of matters and the regulated
product. Time will tell.
Of course, we will continue to keep you
updated on all developments.
Just recently, we also saw that FDA
already extended some some deadlines
that were stipulated in the Deeming Rule
and that is a positive sign that they
understand how onerous the compliance is
for the small, in particular the
small players in the industry.
Thank you very much for your time. We
really hope to see you back in a few
months and we hope to be able to discuss
the new administration and its impact on
on public health and on FDA as it
pertains to vaping. Thank you for having
me on Patricia. Looking forward to having
you as our guest for a future webinar
and thank you very much for your
continued attention.
For more infomation >> ThatTutorGuy.com
For more infomation >> Suoni Della Natura Rilassanti - Rilassanti Suoni Della Natura Per Dormire E Meditare - Duration: 4:25:16. 
For more infomation >> Como os humanos tornaram a Malária tão fatal? | Minuto da Terra - Duration: 2:04. 
For more infomation >> Hwarang Ep4 legendado PT/BR Parte 1/4 - Duration: 15:10. 
For more infomation >> DIY. Earrings made of beads and beads on the hangers. - Duration: 9:03. 
For more infomation >> Efipe- OitentAK (part. ElRaiz & Decker) prod. EdwBeats - Duration: 3:52. 
For more infomation >> Rayman 3: Hoodlum Havoc #05 - LES MARAIS CRAPOTEUX & BÉGONIAX ! - Duration: 16:43. 
For more infomation >> Attack on titan: Solo mettendo i sottotitoli è sub ita(il gigante che parla) - Duration: 3:52. 
For more infomation >> Present Me Event - December 2016 Giveaway : Umbrella - Duration: 0:10. 
For more infomation >> P2P-Kredite: Eine sinnvolle Geldanlage? - Duration: 9:43. 
For more infomation >> Citroën Berlingo 2.0 HDI 600, Trekhaak / Achterdeuren met ramen / E - Duration: 0:47. 
For more infomation >> Peugeot 108 1.0 E-VTI ACTIVE, 5-Deurs / Airco / Bluetooth / LE - Duration: 0:59. 
For more infomation >> Opel Zafira 1.8-16V Maxx - Duration: 1:10. 
For more infomation >> Opel Insignia Sports Tourer 2.0 T 220pk Cosmo/ Panoramadak/ Stoe - Duration: 1:52. 
For more infomation >> Opel Corsa 1.0T S&S 66KW EDITION 3DR - Duration: 1:15. 
For more infomation >> NFL star gives fan huge surprise - Duration: 0:48. 
For more infomation >> Ford Grand C-Max 1.6 TDCi Titanium 7pers., navy, pdc v+a, cruise, t - Duration: 1:55. 
For more infomation >> Top 8 des preuves que tu es un serial killer - Duration: 4:16. 
For more infomation >> Kobi Balulu Stand Up - Israel VS Palestine - Duration: 1:49. 
For more infomation >> Toyota "Chi-muwa-ku" - A Stop-Motion Short - Duration: 2:55. 
No comments:
Post a Comment