E-Cig FDA Deeming Regulations with Dr. Michael Siegel



Hi. Thank you everybody for joining us today.
I'd like to welcome everybody to another edition of E-Cigs DeMISTified. My name is Bob Engel.
I'm the Customer Service Manager here at White Cloud. The news we've all been waiting for
is here. The FDA's deeming regulations have been released. This was a long time coming
and there is much to discuss. We will do our best to continue to bring you great speakers
as they are available. So we have a lot of viewers in with us today. Not surprising since
everybody was waiting for this information to come out and we have built a good amount
of time for questions and answers in this webinar, so please feel free to send us any
questions that you do have. You can click the Q&A button down there on the bottom of
the screen. We anticipate a lot of questions, so we may not be able to get to all of them.
If you ask a question and we cannot get to it to answer it live in the webinar, we will
respond to you via email. Also, if you'd like to follow along or ask questions on Twitter,
you can use the hashtag demistified, that's D-E-M-I-S-T-I-F-I-E-D. We're going to spell
that out for you in the chat box as well so, if you want, you can just copy it from there
and paste it into your Twitter search.A quick note before we get going. We have spoken with
some of our past presenters and are currently working on having more webinars like this
in the not-too-distant future. We do have one webinar confirmed with Joe Barnett, the
Director of the Vaping Militia, and that's scheduled for May 26. So let's jump right
into things. Our speaker today is Dr. Michael Siegel. Dr. Siegel is a professor in the Department
of Community Health and Sciences at Boston University School of Public Health. He has
been a researcher in the tobacco control area for the past 25 years. Dr. Siegel has published
extensively on a wide range of areas in tobacco, including health effects, second-hand smoke,
evaluation of tobacco policy, and national strategies to reduce tobacco use. Dr. Siegel
has also been writing about the recent FDA deeming regulations on his tobacco analysis
blog and wrote an op-ed piece for The Wall Street Journal. Dr. Siegel, thank you for
joining us. Thanks for having me on.All right. So your
initial blog discussing the FDA deeming regulations–it referred to them as a, "Disaster for public
health." After a few days to digest, has your opinion changed or has anything changed? Well,
actually it has changed a little bit in that it's now very clear to me that it's going
to be literally impossible for most of the e-cigarette manufacturers, except for maybe
a very small number of the largest companies, to put together a pre-market application successfully.
The FDA, at the same time that it issued the deeming regulations, also issued a guidance,
a draft guidance, which basically explains what they were looking for in these pre-market
applications and, after going through that, it's become clear to me that the level of
detail and the level of scientific rigor that they're looking for is really way more than
any moderate sized company is going be able to afford and I've estimated that the cost…
We're looking at more than a million dollars easily per application and I just don't see
how most manufacturers will be able to sustain those kind of costs to put these applications
together. So, if anything, my opinion is even more strongly entrenched that this is just
going be a disaster for public health.Aside from the cost for the pre-market applications,
are there any other burdens associated with the PMTA? Well, the scientific burdens are
huge. In other words, what you have to show is that the product is going to be beneficial
to the public's health, but in doing that, you have to look at not just the users of
the product, in other words, smokers who might switch to your product, but you also have
to look at the fact that there may be non-smokers, especially youth, who might take up the product.
You have to answer the question of whether former smokers might relapse to your product.
Whether or not former smokers, who then relapse, will then go back to regular smoking. For
youth, you have to not only understand whether they're going to use your product, but what
are the chances that they will go on to use regular cigarettes after that. These are detailed
questions that can only really be answered with epidemiologic studies, observational
studies, and clinical trials, and the cost of conducting those studies is literally in
the millions of dollars. So both from an economic perspective and from a scientific perspective,
I just don't see how most manufacturers are going be able to do this.What are the modified
risk claims that they're alluding to in these deeming regulations?So, unfortunately, the
FDA did decide to apply the modified risk provisions to vaping products. And so what
that means is that the e-cigarette companies will not be able to claim that these products
are any safer than smoking. They will not be able to inform consumers that these products
contain lower levels of any particular constituents. They will not even be able to say that these
are smoke free. Basically, and I think most problematically, I don't think they'll even
be able to say that these are tobacco free. Basically, you cannot make any comparison
between your products and another product, saying that your product is safer or contains
lower levels of a particular substance. And the only way to be able to make those claims
is to submit an application that the FDA would have to approve.The problem is that in order
to submit such an application, you have to be able to do studies that are definitive
studies, showing that your product is safer, which I think, again, is going to be prohibitively
expensive. And even if you want to make a reduced exposure claim, which is to just say,
"Hey, this product doesn't have smoke," or, "This product doesn't have tobacco," or, "This
product has lower levels of whatever component," you actually have to show that consumers will
not perceive that it means it's a safer product. And I believe that's literally impossible
because, of course, consumers are going to believe it's safer if it doesn't have tobacco
in it or it doesn't have any particular carcinogen in it and, besides, why would you… The whole
point of making a modified risk claim is so people understand that the product is safer.
So it makes no sense for the FDA to, basically, be telling these companies that you cannot
tell the truth to your consumers.It
seems like limiting what we can say to the consumers could create a market outside of
the regulations and normal consumer buying habits. Do you see these regulations creating
a potential for a black market? There's no question about it. It's already started. I
know that many vapors are already starting to stock up on e-liquids, different flavors
to make sure that they'll have access to them. Some have started to buy their own nicotine
to make sure that they have access to that. So there's no question there's going to be
a black market here, and, in some ways, I think that undermines the whole point of the
regulations because the point of the regulations is to try to have quality control standards
and if everybody starts buying things in the black market, that negates the whole point
of having these uniform standards for all the products. So there's no question there's
going to be a black market and the question really is whether or not the variety of products
that are going to be available is enough for most vapors to be able to continue vaping
the products that they've become used to.Well, Dr. Siegel, what are your suggestions for
how we can avoid the public health disasters that these regulations could cause? So I think
there are two things that people can do. There are two pieces of legislation that are working
their way through Congress. One is called the Cole Amendment and that is an amendment
to the House budget to the Appropriations Bill and the Appropriations Committee has
already approved that and it's now going to the House floor and what that amendment would
do is to change the grandfather date. It would, essentially, grandfather all existing vaping
products as of the time of the regulations, which is basically this August. So any vaping
product on the market as of this August will be allowed to stay on the market and would
not have to submit any application for an approval to the FDA. So this is a very important
amendment that I think would… It doesn't solve the problem, but at least it would allow
the current products on the market to continue to stay on the market.There's also a bill
called HR 2058, which is another bill being considered by the House of Representatives,
and this bill does pretty much the same thing, although this bill is focused just on the
grandfather date, changing the grandfather date. So I think that what everyone can do,
who is concerned about this, is to write, call, or email their Congress members, especially
in the House of Representatives right now, and let them know that this is going to lead
many people back to smoking and that, for the interest of public health, we're asking
them to prevent the FDA from taking this action.If any, what regulations would you like to see
the FDA enact? Well, I think what the FDA should be doing is directly setting uniform
standards for vaping products. I think that this is something that many of the e-liquid,
many of the e-cigarette companies have already been talking about. AMSA has already put out
standards for e-liquids. I don't think it's that complicated for the FDA to just sit down
with vaping companies, e-cigarette manufacturers, vape e-liquid manufacturers and just say,
"Look, let's put together a set of standards that everyone should follow," and to simply
promulgate those standards rather than going through this really ridiculous system, where
companies have to put together these expensive and burdensome requirements just to stay on
the market. So that's what I'd like to see them do. Get rid of the new product approval
requirement and just promulgate a set of safety standards.Thank you for that, Dr. Siegel.
Will e-cig companies be able to continue selling their products during the PTMA process or
will they be required to pull all products from the shelves pending approval? So, luckily,
the FDA will allow products to remain on the market during this process, at least up till
three years after regulations go into effect. So the effective date of the regulations will
be August 10th, 2016. So manufacturers will have two years from that date to submit their
pre-market tobacco applications or PMTAs. Assuming that you submit your application
within two years, then you can stay on the market for one more year while you're waiting
to hear back from the FDA. So if you haven't heard back from the FDA for an additional
year, you can continue on the market for that year. However, after that three-year period
is up, so 36 months from this August, if you have not heard back from the FDA, you are,
essentially no longer authorized to have your product in the market. So FDA could, if they
choose to, enforce the rule and basically force you to take the product off the market.
If you hear from the FDA earlier, in other words, if they review your application and
they decide that they're not going to accept your application, then you would have to take
your product off the market at that time.Thank you, Dr. Siegel. Now, with the recent recommendation
of the Royal College of Physicians to recommend e-cigarettes for smoking cessation, we see
a widening gap in how England and the US view e-cigarettes. What do you attribute to the
vastly different views towards e-cigarettes between England's public health and the establishment
here in the US? I think that one difference is that, what we have in England that we don't
have here are public health groups that are embracing harm reduction. Some of the main
groups in the UK, for example, the group that is essentially the equivalent of the campaign
for tobacco-free kids here, the equivalent of that in the UK actually came out in support
of harm reduction using e-cigarettes. So I think that what happened in the UK is that
the health groups, if anything, were pushing for more lenient regulations and embraced
the idea of harm reduction. Here in the US, every single one of the mainstream anti-smoking
and health organizations has come out vigorously against electronic cigarettes and vaping products
and, essentially, against harm reduction and so because of that political cloud and political
pressure, the regulators, I think, in some ways have been forced to take a hard line.
So I think largely the main difference has been that in the UK they have health groups
that are enlightened and understand the importance of harm reduction and here in the US we just
don't have that.Great. Thank you for that, Dr. Siegel. Now, on Page 22 of the FDA’s
document is some confusing language regarding nicotine-free vapor products. The ruling states,
"The alternative warning statement for products that do not contain nicotine, i.e. 'no nicotine
at detectable levels,' is revised to read, 'This product is made from tobacco.'" But
then goes on to say, "E-liquids that do not contain tobacco or nicotine or are not delivered
from tobacco or nicotine do not meet the definition of covered tobacco products as described throughout
the final rule and will not be required to carry an addiction warning or to submit a
self-certification." Will you please explain what that means and how the deeming rule will
affect nicotine-free vapor products? So this is a very complex aspect of the regulation
and it's something that I've had to go over many times to try to understand, but my understanding
is, basically, that if you sell any liquid that doesn't contain nicotine and it's not
intended to be used with a nicotine containing liquid, then you are, essentially, exempt
from the regulations. There is a self-certification process, meaning that you have to submit to
the FDA a certification stating that your product does not contain nicotine, and you
have to demonstrate that it doesn't have nicotine. So, presumably, that means you would have
to submit chemical testing results, showing that there's no nicotine in your product.
If you do that, then your product is essentially exempt from the regulations. You wouldn't
have to put the warning labels on. You wouldn't have to seek pre-market approval. If your
liquid is something that's meant to be mixed with other liquids that may have nicotine
in them, then you would no longer be exempt from that requirement.Before we really know
exactly what's going to happen, what would be the approximate time products would be
going away if producers are not able to comply with the FDA regulations? Are we looking at
one year? Are we looking at two years? How long can we expect? Well, I don't think anything
will really happen before about three years because it's two years before the applications
have to be submitted and, assuming that companies submit the applications, even if they're not
sufficient applications, they'll have another year, unless the FDA reviews the application
earlier and tells them that it's rejected. But, because I expect that these applications
are so complicated and that the FDA will literally have their hands tied trying to go through
all these applications, I don't think that they're going to get through them before about
another year is up. So I think most manufacturers are going to have about three years before
we really start to see products going off the market, and so I don't think it's desperate.
I don't think vapers need to be running out there and stocking up on supplies immediately.
We do have some time and, hopefully, with either Congressional intervention with one
of these bills that I talked about, there may be litigation against the FDA. Hopefully,
there will be something that will overturn the regulation so that this won't come to
fruition. But, assuming that none of the Congressional legislations pass and that there's no litigation
that's successful, we're looking at about three years before we really start to see
the disappearance of some of these products.Thank you, Dr. Siegel. Yeah, we started getting
question from our customers immediately when these regulations came down. One of the thing
we've been saying is, "Nothing immediately is going to happen." So it's great to hear
you echo that statement, as well. Another question I have here: We hear the FDA say
over and over, "Nicotine from tobacco. Nicotine from tobacco". When they're talking about
e-cigs, are they hinting at the fact that maybe synthetic nicotine or nicotine from
another source, like eggplant, would be cleared for use and would avoid these rules? Actually
that's true. That is the case because according to the statute, a tobacco product is defined
as a product that contains a substance derived from tobacco. So if a company were able to
synthesize or obtain synthetic nicotine or obtain nicotine from another source, then
it would not be subject to the regulations because it would not be a tobacco product
as long as that company didn't market it as a drug and didn't make therapeutic claims;
then, essentially, they wouldn't face regulation under either of the acts. The problem though
is that synthetic nicotine is quite expensive and to produce it in the kinds of quantities
that would be required to distribute to massive amounts of e-liquids is quite expensive. So
other sources of nicotine, like potatoes and tomatoes and things like that, again, it's
just prohibitively expensive to do that right now. So I'm not sure this is something we
are going to see right away, but it is true that at some point if somebody can develop
technology that's able to synthesize nicotine in a cost effective way, that could be a way
to skirt around these regulations.Thank you for that, Dr. Siegel. That's a great explanation
of that. We're going to jump in to some viewer questions now that we're getting into the
Q&A portion here. The first one I have: "I would like to know what DIY regulations would
be? Also, where the recording for the webinar would be… " We'll answer that one later,
but is there any sort of DIY regulations that we could get in to? So there are no regulations
on retailers or consumers. So, in terms of the DIY, there are no regulations on what
you can or cannot do. There are no regulations actually on the retailers. So vape shops,
for example, that are selling products, as long as they're not mixing their own juice,
they are not subject to the regulations. It's the manufacturers of the products that are
subject to the regulations and that must submit these applications. Now, the one exception
I should make clear is that the retailers are subject to the sale to minors part of
the regulations. So just to make that clear. But, in terms of submitting these applications
for products to stay on the market, that is the burden on the manufacturer of the product.
However, if you are a vape shop owner and you're mixing your own juice, you are actually
classified as a manufacturer under these regulations, so you would have to submit an application
unless you… Obviously, the other choice would be to just not mix you own liquids anymore.
So it's the maker of the finished product, the manufacturer of the finished product,
that would be responsible for submitting these applications.Thank you, Dr. Siegel. We have
another question here from the viewers: "You highlighted the conflict of interest in the
recently published tobacco control papers. How do you see the issues of corporate influence
in higher education affecting public health?"I think that there's a huge aspect of corporative
what's going on here. I think the biggest part of that is the fact that the FDA is,
essentially, funded by, or exists for, pharmaceutical companies and has a long relationship with
those companies and the entire way that the FDA thinks about products is in terms of the
pharmaceutical model. And, essentially, what the FDA has done with these regulations is
apply the pharmaceutical model to electronic cigarettes. Reading through the draft guidance,
this is going to be the absolute safest product ever put on the market, if anybody actually
follows these guidelines. They are so strict and what you have to submit is so incredible
complex that this will be the safest product you could ever use, or at least the most documented
safety aspects that we've ever had. So they're applying this detailed pharmaceutical model
to a product that is really intended as a recreational product. This is an alternative
to smoking. It's not intended to be a drug.I think that the fact that the Commissioner
of the FDA comes from a pharmaceutical setting, he had actually been a consultant for pharmaceutical
companies for many years before he joined the FDA, and the fact that the current FDA
Commissioner also has a long history of working with and for pharmaceutical companies, I think
this has had a huge influence because they're, essentially, using that pharmaceutical model
to apply to these products and the end result is it's giving pharmaceutical companies a
huge financial advantage because what otherwise would have been vigorous competition for vaping
products for the smoking cessation market is now being, essentially, reserved just for
the big pharma products.Yeah, it always comes back to the money doesn't it, Dr. Siegel?
The next question we have here: "How does the FDA plan on enforcing any of these new
regulations? The magnitude of the task that large seems rather impossible."So, I suppose
you could say that that is one of the good things, is that it is a task that does seem
impossible with so many different manufacturers out there, so it is going to be difficult
for the FDA to enforce this. I think that the… For the most part, my feeling is that
most companies are interested in complying with regulations and it'll be relatively self-enforcing.
I think that many companies are just going to make a decision as to whether they can
or cannot comply with these regulations and companies that decide that they can't do it
or don't want to put the expenditure in, I think, are going to just make a decision to
get three years more out of what they can get here and then find another business to
go into.I don't think that we're going to see a lot of companies that are just trying
to hide or keep looking around the corner to see if the FDA is coming. But I do think
it's a legitimate point in that the FDA resources are being completely diverted to vaping products
and it's insane because it's the cigarettes that are really killing people and what they're
essentially doing is forgetting about cigarettes and they're putting all their eggs in this
one basket. It's an incredible amount of resources and time that are going to go into reviewing
these applications and helping companies with the applications and enforcing the e-cigarette
rules. Essentially, they have abandoned their mission, which is to regulate tobacco products,
and they're turning it into a single-handed focused crusade on vaping products.It does
seem like we're getting a lot of attention from the FDA right now and none of that attention's
being diverted over to the tobacco industry. We’ve got a lot of questions rolling in
here Dr. Siegel, bear with me: alright, well, the Cole Bishop amendment passed 31 to 19.
Are you encouraged by the passing of this amendment or more frustrated by the members
of Congress that voted against it? Well, both, but I think that what we need to look for
is the positive side of it right now and understand that it got through the committee and that's
all that matters despite the vote being close. I think that if there's any silver lining
in the cloud of these FDA deeming regulations, it's that they're so bad and so onerous that
it makes it very easy for us to argue to Congress that they need to intervene. If the FDA had
taken a middle ground approach and put out regulations that were somewhat burdensome,
but not absolutely ridiculous, it may have been harder to make this argument, but right
now these regulations are so ridiculous and the extent to which they're asking e-cigarette
companies to go just to keep their products on the market compared to what cigarette companies
have to do, which is literally nothing, I think gives us an incredibly strong argument
to go to Congress and say, "Hey, this is ridiculous. This is just completely contrary to the public's
health. It makes no sense." And so I think we have a legitimate chance. I really do.
I think that, if anything, I think these regulations make it easier for us to make the case that
this is over-regulation at its worst.It seems like they're coming down on every aspect of
the e-cig industry. Now to go back to the Cole Bishop amendment there, in a recent blog
post, you mentioned that opponents of the Cole Bishop amendment claimed that it would
hinder the FDA's ability to regulate vapor products. What is the reality of this claim?
I think it's exactly the opposite. I think that if the FDA were freed up from having
to create this huge bureaucratic institution that basically does nothing other than help
companies putting together these applications and then reviewing the applications and then
enforcing the denial or approval of applications, I think if they put their resources instead
into just setting standards for these products, that not only would it be better for the public's
health, but it would actually be better for the safety of these products because I think
they can directly regulate aspects of the products that are most important for consumer
safety, such as battery safety, protecting against over-heating of the liquids, quality
control standards for the liquid manufacturer. These are things that could be done directly
and I think if the Cole Bishop amendment passes, it would actually help the FDA. It would force
the FDA to focus its time on setting these standards, rather than focusing on this bureaucrat
nightmare. So I see it as exactly the opposite. It doesn't hinder the FDA. It actually forces
the FDA to focus on actually regulating product safety.Thank you for that, Dr. Siegel. Now
to redirect back over to the FDA, in relation to the warning labels that they're proposing:
when do retailers have to make sure all products we sell have proper labeling? So retailers
will have two years… I'm sorry. One year. It's 12 months from the effective date of
the regulations for it to get these warning labels in place and, or for the non-nicotine
products to submit their self-certifications stating such products don't have nicotine
in them.Thank you for that. Another one here: "What exactly is being included in the tobacco
accessories under the regulations example, 'batteries, cotton, wire, etcetera.' So is
it looking at all the individual components of an e-cig or is it looking at the total
unit as one package?"So it depends on what you sell. So, essentially, any aspect, any
component of the product that actually affects the function of the product in terms of the
delivery of the aerosol is considered to be a component of the product. Now, if you sell
a component of the product that is later manufactured into a finished tobacco product, then you
are not considered to be subject to these regulations. It's the ultimate finished product,
the manufacturer of the finished product that is regulated. So, for example, if you are
a battery manufacturer and you simply sell your batteries to a company that then incorporates
the battery into a system, then the battery manufacturer doesn't have to submit an application.
The company that is producing the finished product has to do that.If you are a manufacturer
of glass vials that are used to store e-liquids, you do not have to submit a market approval
application, but the company that then uses your vials to put the e-liquids in to then
sell has to submit an application. And the quality of those vials, because that's part
of the product, that's an accessory of the product, that company would have to verify
the safety of those vials. That would be part of their pre-market approval. So it's complex,
but the ultimate way to think about it is that if you are selling a final product that
is going to be purchased, anything that is ready for purchase by the consumer, that is
subject to regulation.It's an interesting point when you're thinking about it as a one
unit and the individual pieces that go into those e-cigarettes. Now going back to the
e-liquid, is it the same thing for the e-liquid? Would the flavoring components not have to
meet the approval? So if you… Again, if you are a manufacturer of a flavoring and
the intention is for that flavoring to then be purchased by companies that are making
the liquids and to use those flavorings in liquids, then you, as a flavoring manufacturer,
do not have to submit any application. It would be the e-liquid manufacturer that's
using that flavoring that would be subject to the regulation. On the other hand, if you
are a flavoring manufacturer who's selling a flavor directly to the consumer with the
intention of having that flavor be used in making e-liquids, then you would be subject
to the regulations. So it all depends on the intended use of the product, the intended
sale, what it's for, and if the intended sale is to the consumer, then you are subject to
the requirement, but if the intended sale is to the manufacturer who's gonna further
process that material, you are off the hook.Great. Thank you for that, Dr. Siegel. Now, sticking
with the flavor components and the e-liquids, specifically regarding those flavors, how
much do you think it will cost to get a SKU through the PMTA, if we had to go through
the approval process? So let me just give an example of the type of testing that would
be required, because I think by actually understanding exactly what the FDA is recommending, people
will understand why this is so expensive and why it's so ridiculous. So, basically, any
combination of flavoring and nicotine strength is considered a separate product. So if you
sell 10 e-liquids and each of them come in three different nicotine strengths, that's
30 different products, and that means that every one of those 30 products needs to be
tested separately to figure out the components that are present in the e-cigarette aerosol.
But it's more complicated than that because you have to test that e-liquid at all of the
different voltages that can be used with that product. So you can't just test your e-liquid
in one vaping device. You would have to use a range of devices at a range of different
voltage settings, or power settings, to see what the aerosol constituents are under each
of those settings. Not only that, but you're asked to test the constituents at different
levels of use, including low, medium, and high use of the product. And you're also asked
to test at least three different batches of the e-liquid with at least 10 replicates from
each batch.So that means for every combination of nicotine strength and flavoring in your
e-liquid, you would have to do 30 separate tests for the e-cigarette aerosol to figure
out what is in there and to document that there's reliability from batch to batch and
from sample to sample. But it doesn't end there because the FDA further asks that you
do a test on the stability of the product over time. So you're asked to test the e-liquid
at different stages along its shelf life. So if you have a product that you feel has
a one-year shelf life, you will need to actually not just test the product at the baseline,
but sit it on the shelf for a year and then come back and test it again to see if there's
any change in the constituent levels.So you can see how this is planning out. If you make
100 e-liquids coming in different strengths, literally, you're going to have thousands
of tests that you're going to need to run on the product. These tests, by the way, are
expensive. The lowest price I could find in any website was about $300 per test. And so
if you're talking about a minimum of 1,000 tests, and that's a conservative estimate,
literally, we're running into the millions of dollars and we haven't even gotten past
just testing the constituents in the product. We haven't gotten into the safety of the product
or the safety any of these constituents. So you can see how ridiculous this is and how
it's just absurd, the idea that you have to go to this extreme to test and certify your
product to stay in the market. It's really insane.It does seem like a daunting task,
especially for some of the smaller manufacturers and, speaking of the manufacturers and tobacco
accessories as something you see a lot in this legislation, and then under the regs
examples of tobacco accessories are batteries, cotton, wire, etcetera, how will the regulations
affect a shop that sells DIY supplies or if they build coils for customers, would they
be considered a manufacturer? So it depends on what they're doing with the coils. So,
if they're just getting the coils from a supplier and selling direct to the consumer and then
the consumer is, essentially, putting together their own product, that would not have to
submit an application because it's the manufacturer of the coil that's being sold that would have
to. In other words, if a manufacturer is selling a coil with the intent that consumers would
take that coil and incorporate it into a product, then that manufacturer is the one that's going
to need to submit a pre-market application. But, if the vape shop owner, for example,
is buying the coils and then assembling them into a unit, then that vape shop owner, unfortunately,
is going to be the one with the burden of the application. It's an incredibly complex
way to think about this and very difficult and confusing to try to figure out who's responsible
for what, but the most important thing to think about is: Is this product being sold
for final use by the consumer or is the retailer doing something with the components to make
it into a finished product? And if that's the case, then they're a manufacturer.And
it seems like there's a lot of gray area here and room for interpretation. One of the other
things we hear a lot about is the grandfather date of 2007. Does the 2007 grandfather date
seem to only benefit the big tobacco companies? Well, clearly, this entire regulatory scheme
benefits the big tobacco companies because they're the ones who have the money and the
scientific expertise and the laboratory facilities to be able to successfully do what's being
asked by the FDA. So there's no question that this favors the big tobacco companies. But,
I want to note, to their credit, the tobacco companies have actually opposed these regulations.
They've opposed the grandfather date being pushed back to 2007 and they're actually supporting
changing the grandfather date to be the current date of the regulation, the effective date
of the regulations.So… And you may ask, "Well, why is that, if it's such great benefit
to the tobacco companies to get rid of all the competition? Why are they supporting this?"
And I think that there are two things that are going on: One is I think the companies
really want to see a vigorous vaping market. Obviously, they want to have a large market
share within that market, but they want to see a vigorous market. And the second thing
is that I think the companies understand that if these regulations go through as they are
and there's no change made, that the overall market is going to shrink and, even though
the tobacco companies will have a larger market share, having a large market share of a small
market is probably not as good as having a smaller market share of a huge market. And
so I think it's to the tobacco companies’ ultimate advantage to see this market thrive
and if gets to be, as it was predicted, to be a $10 billion industry and the companies
have 40% of it, that's four billion dollars right there and if it's only a one billion
dollar industry and they have 50%, then that’s only half a billion. So I think that they
see that these regulations are going to not only contract the market in terms of the market
share, but that it's also going to contract the overall vaping market.Yeah, it seems like
we have a lot of changes going on in the landscape of the vaping industry. We have another question
here from the audience and this one, I believe, captures the general feeling of our customer
base. Why do we have to prove that it's beneficial to health for e-cigs, when the big tobacco
companies didn't have to prove tobacco cigarettes were beneficial to health? Well, that is a
beautiful question and I think that is the exact question that needs to be asked in Congress.
If you have one talking point to go to Congress with, it would be exactly that. I think that's
the game winning strategy to try to get these bills passed. So that is an incredible question
and I think that is exactly the question we need to ask of Congress. Every Congressperson,
every House member we have to ask, "Do you feel that it's appropriate to make the e-cigarette
companies go through all these hurdles to prove that they're safe to stay on the market
when tobacco cigarettes, which we know kill hundreds of thousand people a year, don't
have to do anything to stay in the market?" That is a travesty to the public's health.
That is not protecting the public's health. It's inappropriate and I think that's the
winning strategy to get the House or the Congress to intervene.Thank you for that, Dr. Siegel.
We have another question here about the FDA. Do you think that the FDA's creation of the
tobacco master files concept could provide a viable avenue for smaller e-cig manufactures
to register products via the less data intense substantial equivalent pathways? I think that
the master files are helpful to some extent because it allows a company to, essentially,
use data that another company provided on their products and so I think that it will
help with substantial equivalence applications because if you have a predicate product and
all the information has already been submitted, then it becomes less burdensome for you to
show that your product is substantially equivalent to that. But, in terms of these new applications,
I don't see these master files as being really helpful because nothing has been approved
yet. So, they're not immediately helpful. I think where they're going to be helpful
is three years, four years down the road. If you have a product and you want to say
that it's substantially equivalent, then it's going to be helpful. But, by then, the damage
will already be done. So, I think these master files will be a great thing at some point
down the road, but for the next three years, I don't see this as really easing the burden
for these new product applications.Great. Thank you for covering that, Dr. Siegel. We’ve
got about 15 minutes left here. I just want to remind the viewers. We have a lot of questions
coming in so please keep sending them in. If we don't get a chance to get to all your
questions, we will be responding after the webinar concludes. Now, the next question
I have here, to me, it's a funny one. Is payment required at the time of submission for the
PMTA or are we gonna be able to pay after the process is complete? I don't know. Despite
all the reading of 499 pages, I don't know the answer to that question. So I'm sorry
that I can't help with that one.No worries. I'm sure that we'll know soon enough once
those regulations come down. We have another one here: Since the FDA is an extension of
the Executive branch, how does the change with the POTUS affect FDA and their regulations?
I'm sorry. The change in what? The President of the Unites States of America.Oh, okay.Alright,
well I think that if a democratic candidate were to win the election, I don't think anything
is going to change. I doubt that any of those candidates would really change direction.
On the other hand, if the other candidate were to win, I think there could be changes.
Obviously, the FDA is under the Executive Branch. The President, ultimately, is the
head of the Executive Branch and so that is a possibility, that a new President could
come in and could make some changes and so that's a possibility. Even so, it is still
unusual for a President to come in and drastically change the way executive agencies have been
operating. Executive agencies tend to have a life of their own that is somewhat independent
of the Commander-in-Chief over time. So it's not immediately clear to me that would necessarily
make a huge difference.Thank you for clarifying that, Dr. Siegel. What is the likelihood deeming
regulations would ultimately be altered by House bills, that is, the likelihood that
maybe things that don't look so good now could change for the better in the future? Well,
I wish I knew. I don't… It's impossible to predict. At first, when these bills were
introduced, I think everyone agreed that it was a real long shot. When the Cole Amendment
was first introduced, everyone I talked to from inside the industry from even the health
groups, everyone saw that as, essentially, just a long shot. Now that the regulations
have been released and they're so terrible and burdensome, I actually think that increases
the chances a little bit that we do have a serious chance to get these passed.I think
a lot of it depends on the outpouring of protest and opinion from the vaping community, not
only manufacturers, not only retailers, but consumers–vapers. The vapers, I think, have
potentially a huge voice, a very powerful voice, and with the kinds of arguments, like
I've already heard from the question you asked before from some of your customers, I think
that if they can get those messages across to Congress, I think there is a serious chance
that we could get Congressional intervention here. So let's say that I'm a lot more hopeful
today than I was four or five weeks ago that we can actually make a change here.Great.
Thank you for that Dr. Siegel. We got another question from a viewer here who's wondering
if nicotine and e-liquids are going to be allowed to be sent via USPS in 90 days, is
there going to be any restrictions on labeling e-liquids or e-cigarette products in the future?
Well, there are labeling requirements so those labeling requirements, which take place within
12 months, those will need to be followed. So in selling e-liquids through the mail,
you will have to have a warning label on that. And that starts at the level of the wholesaler
and goes all the way through the whole process. So that's one aspect of the regulation that
actually affects all aspects of the chain from the wholesaler all the way down through
the distributor to the retailer to the consumer. Most of the other aspects of the regulation
are only affecting the manufacturer, but, yes, to sell nicotine or e-liquids through
the US mail, you would have to have a warning label on it.Great. I know a lot of our customers
get their products through the mail. We ship a lot of things out of the warehouse here
so they're very concerned about that as well. One more question here, Dr. Siegel. Do we
need to ask Congress for separate vapor regulation outside of the deeming regs? If so, what agency
should regulate vapor, if not the Center for Tobacco Products? Well, that's a great point
because even if the Cole Amendment were to pass or this bill HR2058 were to pass, those
bills will still contain this new product application for new products so the existing
market will be grandfathered in, but any new products on the market will have to go through
this extensive application and it will, essentially, take away the incentive for any innovation.
So the ultimate solution here is to ask Congress not to simply change the grandfather date,
but to completely put e-cigarettes under a separate regulatory system that doesn't involve
these new product applications and that an agency would simply set standards for it.
Realistically, I don't see another agency being given jurisdiction over the product.
The only one that I can think of would be the Consumer Product Safety Commission because
for most consumer products, it's the CPSC that is involved with setting standards and
making recalls and things like that. I just don't see that happening. I think at this
point the FDA is too deeply entrenched in the issue.However, there's no reason why a
statute can't simultaneously give the FDA Regulatory authority, but at the same time,
force the FDA to put e-cigarettes under a separate regulatory framework and I think
that's what really is ultimately needed. The Commissioner, or the Director of the Center
for Tobacco Products, Mitch Zeller, has stated multiple times that he believes in a continue
of risk and he does believe that products should be regulated based on their risk. Obviously,
when you look at the different regulations, they do nothing of the sort. In fact, if anything,
they do just the opposite. I think his argument would be, "Well my hands were tied because
the statute doesn't allow me to change the grandfather date so I have to deem these products
subject to all of the regulations." I don't agree with that, but if that's his viewpoint,
I think that's what we're stuck with.And so I think that if we can get Congress to pass
a law that changes the statute that basically says,"E-cigarettes are to be regulated in
a separate framework. They're not to be subject to the same requirements of cigarettes". I
think that is the ultimate solution here and that is what we should be pushing for, as
long as it doesn't jeopardize the passage of the Cole Amendment.And to go back to the
Cole Bishop Amendment, are you optimistic that that amendment is going to pass? Again,
I just can't predict it. I don't have magical powers of prediction. All I can say is that
it definitely has a chance. Six months ago, when that bill was first introduced, I would
have said that it's a complete long shot and the chances of it seeing the light of day
are almost nil. And, today, I would say it has a chance—there is a chance. I'm not
giving up hope on it, but I think the vaping community can have a big impact on it. If
the vaping community is loud and Congressmen or House Members hear from your customers,
I do think it could have an impact.Great, thank you for that, Dr. Siegel. We have time
for just one more question here: Can you please explain the implications of the verbiage in
the final rule of the FDA's intended or reasonably expected catch-all? Yes, it's true. That is
a catch-all. They say that hundreds of times throughout the regulations and that is a vague
term. It's a vague term and it's subject to interpretation. It’s essentially a judgment
call. It's a judgment call and it's based on the bulk of the evidence of what a product
is intended for. And so if
you're producing an e-liquid that is being sold and the intention is for vape shops to
mix it in with other products, it's going to be hard to argue that it wasn't your intent
or vice versa. If you're selling it to consumers it's not being changed, as in it's not being
manufactured into a different product, it's going to be hard to make that argument.So
I don't know how to answer that question, except to say that it's very vague and that
this is also why it's going to be time and resource intensive for the FDA to enforce
because the rules aren't cut and dry–they're not black and white. And this is going to
take a lot of resources and a lot of time for FDA to be looking into every one of these
situations and figuring out how we define what the intended use is or the reasonable
expectation. I think the only thing I can say is that by adding that clause about reasonable
expectation, I think what the FDA is protecting itself against companies claiming that they
have no intention of the product being used for some purpose, but then seeing that consumers
are using it for that purpose. And then for those companies to say, "Oh, well, we didn't
know that they would do that." So I think the FDA is giving itself an out here, that
if consumers are using it for a particular purpose, then you're not going to be able
to get out of it by saying, "Oh, our intention was not for them to use it in that way." So
I think they've covered their butts there by including both of those clauses in there.Thank
you Dr. Siegel. Well, we're actually out of time for questions now. We've had a lot coming
in. I want to personally extend a great thank you for spending an hour out of your day,
Dr. Siegel, to be with us and explain some of these grey areas for us here, as well.
So, wow. Thank you again, Dr. Siegel and everyone who attended. There were a lot of questions
and, unfortunately, we could not get to all of them and will be responding to your questions
via email. So make sure you follow Dr. Siegel on Twitter @mbseigel and follow his tobacco
analysis blog. We'll have some links out after the webinar concludes and we are also going
to be scheduling more of these webinars in the very near future, so follow us on Twitter
@wccigs and thank you, everybody, again for attending. Dr. Siegel, thank you for spending
an hour with us and we'll be back soon. Have a great day.

26 Comments

  1. the FDA doesnt even REGULATE the chemicals and 4,000 drugs added to commerical ciggarettes!!! Otherwise they would be forced to LIST EVERY SINGLE ADDITIVE AND CHEMICAL in them!!!

  2. vapeing help to keep me off the cigarette for 6y now

  3. They want to kill us with the chemicals in cigarettes that's why they are against evape

  4. why not more views?

  5. i had a question. you guys said that nicotine obtained from another source like eggplant (example given) would be exempt. however i have also heard that the FDA is going to require even products that have ZERO nic to be labelled as "this product is made from tobacco" (a completely non-factual statement). which one is it?

  6. he said, 'it's in the tobacco industries interest to see the vape market thrive' big tobacco is not against vaping, why? because 1) they sell vaping/ecigs and 2) they know that if the vape market is strong, that traditional cig market is also strong, people switch back and forth

  7. I started a petition to have Mitch Zeller removed as Director for the Center of Tobacco Products for allowing these deeming regulations. If you would like to sign it here is the link. If we cannot trust the FDA to work in the best interest of the American public then we need to remove and replace those people who violate that trust. We are being sold out to big tobacco. Here is the link.

    https://www.change.org/p/deborah-roth-removal-of-a-mitch-zeller-from-office?recruiter=24280649&utm_source=petitions_show_components_action_panel_wrapper&utm_medium=copylink

  8. "Follow the money", this saying TRULY applies to these regulations. Am I implying the fix is in? In my humble 64 years experienced opinion, YES. Is my opinion that the people passing and those getting these regulations passed dishonest and/or on the take in one form or the other, YES. No entity not of our law making government body whether private or corporate should be allowed to draft or have a direct hand in drafting Federal Law. I mean that's just bribery in my opinion.

  9. so pretty soon vaping will cost just as much as good ole cigs that's just great.

  10. can you say POPULATION CONTROL! The fact is, all the leftists and progressives that are packed into these unconstitutional legislating authorities are more concerned with growing there power than anything else. there is no power in saying YES! Margret Sanger said " The greatest sin is bringing a child into this world". the children that escape murder in the womb , the big tobacco companies will take care of. much sooner than GOD intended.

  11. FINALLY a channel is actually talking about whats in the bill not just begging for support thanks for the information!! 🙂

  12. The good news is people with money to spend usually get what they want eventually. Double or triple the price of ejuice. Small makers need to make friends amongst themselves quickly and consolidate. Butts were 1.80 now it's 10.60 . It'll cost like 40 bucks a whack for 10mg ejuice you wait. It wont go away, just go up , like everything else.

  13. well i guess i will return that new vape i got coming in the mail. i like my nicotine but, im not balls deep in being addicted to it. so might as well stop now before i really regret it in 1-2 years when the shelves go dry and im lying down in my bead twitching,sweating, and throwing up from withdraw.

  14. wheeling and dealing ejuice in school xD

  15. that's my question if a company does submit their paperwork to the FDA who's the say that the FDA won't reject every one of them from every single company

  16. That was my first suspicion twenty minutes into this webinar. How did tobacco products get through the screening? Aren't they currently selling e-cigarettes?

    This is basically big public dissemination about e-cigarettes facts so . . . HUGE publicity. These innovations are how America was able to keep up with other countries. You shouldn't stop it, but allow it to grow so safer, greater inventions can promote better technology. It is very obvious that this would outweigh the harmful consequences of smoking cigarettes.

    This also reassures me the maliciousness of having Lobbies.

  17. This is maybe an extremely weird question but how old are you? You look super young but have very gray hair and beard. I am asking cuz I'm young but am going very gray and am a little self conscious about it. 🙂

  18. why doesn't the media get nore involved with the reviews we have on you tube providing evidence that the  e-cig is so much helalthier for you and it saves lives ARE THEY PAID OF BY THE BIG TABBACO COMPANIES TOO AND BY THE CHEMICAL COMPANIES TOO? WHAT is more important saving lives? or tabbaco and chemical companies make their billions? so they can have their big house's and fancy cars?

  19. Hello black market! Call on all the smart ones to reverse engineer regulated mods, manufacture mech mods with simple materials, pg, vg, nicotine, flavoring, kanthal, titanium, nickel, ss wires. Go underground, starve out the fda, tobacco companies, local, state and federal governments from tax dollars of these finished products. How could they ever think the people or a FREE market can be controlled?

  20. Ok, so we can still buy Vapes/vape juices from Aug 10th 2016 till about Aug 10th 2018?!? If so, then I will accept that…that'll give me enough time to build a good stress/anxiety reduction regimen where is after Aug 10th 2018 I would no longer need to 'vape'.More 'Vapers' should do the same, especially since it deems there is no real way the vaping industry in the USA will be around for too many more years   : (       Big tobacco got exactly what they wanted I suppose and that is for their ex customers to return to big Tobacco so their ex customers can continue to fill their lungs with cancer and continue to die horrid deaths! That way they can complete their elite population control agendas as well as fill up their bank accounts bunch of greedy, lousy maggots they are!!!!

  21. Not true Dr. Siegel
    It is written in the 499 pages that if the nicotine is derived from a vegetable source, but intended use is for use in a vaping component, then it is still considered a tobacco product! I read it yesterday. Just clearing that up.

  22. how can we get people to fight these regulations

  23. I wonder if Methodone had to go through such rigorous testing and discrimination, for taking heroine addicts off of heroine? I bet a large amount of money was given to politicians as it is going to be done now, to ensure that dirty tobacco companies can continue slinging sticks with fire at a steamy solution.

  24. OK so…from my understanding the Cole-Bishop amendment "passed". Not sure what this refers to, is this something that the president will have to sign? Since it passed, was the grandfather date moved up? I don't understand what exactly the passage of Cole-Bishop means to the FDA deeming regulations.

  25. Great video. I just plastered it on my social media sites.

  26. the fda is prob in the pocket of big pharma and tobacco trying to destroy the vaping industry

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