October 5, 2022 • 21 mins
The FDA's recent sequence of decisions has Juul fighting to keep its pod charged. Some clap. Others boo. Most are left scratching their heads. Will this help teens quit vaping or just open up the market for more competitors?
As a Silicon Valley startup, Juul’s focus on hyper-growth targeted toward young people put them in hot water. But, the reason the FDA gave for taking their product off the market may surprise you. And now Juul is ready to defend their purpose to transition adult smokers away from combustible cigarettes and fight back in court.
Join us for a Season 2 update episode with Lauren Etter, a reporter at Bloomberg News & Author of “The Devil’s Playbook: Big Tobacco, JUUL, and the Addiction of a New Generation”.
If you love the show, rate and review us on Apple Podcasts. Find out more at https://callingbullshitpodcast.com/.
See omnystudio.com/listener for privacy information.
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Speaker 1 (00:05):
The FDA preparing to order Jewel to pull its A
cigarettes off the market as early as this week. That's
a c NBC interview from the morning of June two
between Squawk Box host Joe Kernan and former f d
A Commissioner Scott gottlaib I suspect FDA is gonna look
(00:25):
beyond the application and look at the history of this product,
and that's going to be a factor in how they
weigh their decisions. So if they do reject Jewel um,
assuming it's not on some technical issue related to the
application itself, then I would my hunch would be that
it would turn on the legacy associated with this particular product.
Jewel has been selling its products here unregulated since it
(00:49):
took five years for the FDA to even request an
application and another two years for them to review jewels submission.
On the afternoon of June twenty three, just hours after
the Curran Gottlieb interview, the FDA finally announced that decision.
After a two year review, The US Food and Drug
(01:11):
Administration announced today that it will ban all vaping and
e cigarette products sold by Jewel. Some cheered, others booed,
but most just scratched their heads about the ensuing carousel
of perplexing plot twists, and since Jewel was a season
one fan favorite, we wanted to see how this new
(01:32):
news affects Jewels BS score. If you haven't listened to
the original episode, go check it out. We'll be right
here when you get back. In our initial investigation into Jewel,
we concluded that the E Cigarette Company was a bullshitter
worthy of a BS score of forty nine. Their stated
(01:55):
purpose to reduce the harm of cigarettes by giving smokers
a healthy your alternative had been overshadowed by their decision
to market directly to young people, which led to a
whole new generation addicted to nicotine their legacy. As former
FDA Commissioner got Lab called it, join us as we
(02:16):
welcome back a season one guest to decipher what this
means for Jewel and just what the heck is going
on at the f D. A Welcome to Calling Bullshit,
the podcast about purpose washing, the gap between what companies
say they stand for and what they actually do, and
(02:39):
what they would need to change to practice what they preach.
I'm your host, Time onto you, and I've spent over
a decade helping companies define what they stand for, their
purpose and then help them to use that purpose to
drive transformation throughout their business. Unfortunately, at a lot of
organizations today, they're still a pretty wide gap between word. Indeed,
(03:03):
that gap has a name. We call it bullshit. But
and this is important, we believe that bullshit is a
treatable condition. So when the BS detector lights up, we're
going to explore things that a company should do to
fix it. Okay, folks, I am very excited to introduce
(03:27):
Lauren Etter for her second time on the show. Lauren,
thank you for being here and welcome back to calling Bullshit.
Thanks for having me. Tie great to be here. So
just for our audience quickly, those who haven't listened to
the Jewel episode, it would be great to hear just
a little bit about your background. So I'm an investigative
reporter at Bloomberg News. I recently wrote a book called
(03:51):
The Devil's Playbook about Jewel, and I've been a reporter
for many years. So yeah, you were here the first
time to talk about Jewel. And it's a story in
which both Jewel and the f d A figured prominently,
and both of them, Jewel and the FDA have been
back in the news again lately. Can you walk us
(04:11):
through what happened? Absolutely, So, as your listeners might recall,
Jewel has been in the crosshairs of the federal government
and opponents of its product for many years. So since
it hit the market in the product came under a
lot of scrutiny both from regulators and from opponents who
(04:34):
blamed the company for essentially sparking a new youth nicotine epidemic.
So that was several years ago, and fast forward, the
f d A has been wayne whether or not to
allow Jewel to continue selling its product in the US market.
(04:54):
So for the past two years, the agency has been
reviewing a very voluminous application by Jewel that was essentially
the company's effort and way to say that this product
deserves to be on the market, it meets the regulatory standards,
essentially saying that it's a benefit to the public health
(05:15):
and it's going to ultimately help adult smokers quit smoking.
So this has been going on for a long time.
And as you might recall, Jewel reached unicorn status in
Silicon Valley. It was a multibillion dollar company that had
essentially garnered an investment from Altria, the maker of Marlborough's cigarettes,
(05:36):
and it was kind of a Silicon Valley darling for
a while, even though it had gotten all of this
bad press and negative reviews because of its public health problem. Yeah,
and I would say a lot of that criticism was
I think, in many ways fair. In the first episode,
you and I agreed, and I learned this from your book,
(05:57):
that there was no reason that Jewel had to get
negative press or feedback. But the fatal flaw was the
way that they marketed the product. That the product itself
would have been great for smoking cessation, getting people to
quit smoking, but smokers are generally older, and the marketing
of Jewel clearly, at least in the early going, targeted
(06:21):
young people. That's exactly right. So the founders of Jewel
created this product ostensibly to be an alternative to cigarette smoking,
and so that was what they said. But when the
product launched, initially, they introduced the product to the world
with a very splashing marketing campaign with images of very
(06:41):
youthful models in Times Square and all over social media,
and all of a sudden you saw a huge number
of middle schoolers, high schoolers starting to not only use
Jewel but become highly addicted to it. And that's the
key thing to remember about Jewel. It is a five
percent nicotine solution, which in each tiny little pod, the
(07:02):
amount of nicotine is equivalent to that in a pack
of Marlborough reds for examples. So it's a highly addictive product.
Young people with developing brains are uniquely predisposition to becoming
addicted to nicotine and it's extremely difficult habit to kick.
And this came on the keels of decades of actual
(07:24):
public health successes with youth smoking. Keen smoking rates have
been declining year after year after year, a real public
health coup, and then suddenly vaping and Jewel come along
and kind of blow that up and create a new
public health controversy. Right, So then the FDA has been
considering this and they rendered their opinion. What did they
have to say to Jewel? So it's a really surprising decision. Essentially,
(07:49):
the FDA many years ago set out a regulatory framework,
and that framework stipulated that any new nicotine product must
go through a rigorous scientific review process by the agency
before it was allowed to remain for sale. Essentially, so
Jewel has stood by its commitment and claims that this
(08:13):
product will help adult smokers. So they put together gigantic
package of information, and people ask me even a year ago,
you know, will Jewel get the FDA authorization? And I
really was under the impression that they likely would. I
I always said I would be very surprised if the
(08:33):
f d A denied their authorization. For a number of reasons.
Number one, the United States is trying to move smokers
away from cigarettes in general. They're taking steps to dial
down the amount of nicotine in combustible cigarettes. The Biden
administration has moved in the direction of banning mental cigarettes.
(08:55):
So the whole idea here is there's a bigger harm
reduction kind of framework that the US is looking at
right now, which would be let's figure out ways to
migrate adults smokers off of deadly cigarettes and onto something
that is potentially less deadly. So there's a continuum of
risk there. Smokers can quit cold turkey, they could use
(09:17):
a pharmaceutical drug like shantext, they could use the patch,
and then there's also these other products now that are
more popular, like the cigarettes. So the f d A
has in a way kind of embraced this idea that
there should be alternatives for smokers, adults smokers, including the cigarettes.
(09:38):
So given that whole context and backdrop, and knowing that
Jewel is the single largest maker of the cigarettes in
the United States, I thought it would have been surprising
if the f d A would move to not authorize
the product. Not only that, but Jewel is the only
product that Jewel makes essentially, so if the FDA were
(10:00):
to take them off the market, they would go bankrupt.
I didn't think that a company US, a federal agency
would be reluctant to do that. However, so fast forward
in June of this year, the FDA's long awaited decision
and much delayed decision by the way, finally came down
and they said, indeed that they were going to not
(10:22):
authorize Jewel to remain on the market, in essence banning
the product. It was a huge decision. It really took
everybody by surprise, even took people at Jewel by surprise.
And it has some very large and important ramifications. Right,
and my understanding is there's been a stay right that
(10:44):
Jewel petitioned the court to say, hey, don't make us
take the product off tomorrow morning, and that was granted.
Is that correct. Yeah, so it ended up in a
very unusual kind of space. So what happened was the
FDA makes this big splash the announcement, people who are
supporters of Jewel. Jewel people themselves kind of panic and
(11:06):
accused the f d A of not following the science,
of kind of veering outside their lane as a regulator
and arriving at this decision. And so a couple of
things should be pointed out. So one, the reason that
the f d A gave for denying their authorization was surprising.
You might have thought that it would have been, well, Jewel,
(11:27):
you caused this youth epidemic. We're going to punish you,
and we're not authorizing your product because your product is
not and further into the public health. However, that's not
what the agency said. The agency actually said, we are
not authorizing the product because Jewel did not provide enough
information to show that their products were not harmful. They
(11:50):
said that they did not provide enough science to back
up the claim that it wouldn't be damaging to human health.
In particular, they actually focused on the pod and said
that the pod could be leaching, and Jewel didn't prove
that it wasn't leaching and wasn't causing human health concerns.
So it's a very unusual decision that was surprising in
a number of ways. So not surprisingly, Jewel immediately sued.
(12:14):
They basically went to the U. S Court and asked
for an emergency stay, which would basically say, look, you
can't take our product off the market immediately. You have
to consider all these other factors, including the fact that we, Jewel,
we don't believe that the f d A did a
thorough and fair review of all of the science that
(12:35):
the company provided. So the court granted that emergency stay,
and then shortly thereafter, the f d A said, actually,
they walked it back and said, actually, we're taking the
application back and we're going to continue reviewing it in
light of all of this information that Jewel had brought forward. Yeah,
(12:57):
very very surprising and complicated the language they used. The
agency has determined that there are scientific issues unique to
the Jewel application that warrant additional review. Set off alarm
bells in my head. I don't know whether they set
off any in yours, but I'm trying to understand what
(13:20):
that means, you know, because I immediately went, well, there
has been some coverage about the pressure that the FDA
has been under from Congress to do something about jewel
and so it made me wonder, like, is the fix
in at the f d A? Is that why they're
walking it back because somebody got to somebody? Or do
you think that legitimately there are scientific issues that that
(13:45):
deserve to be reviewed. Well, I mean, I think there
would have to be a lot going on inside the
FDA to reach the conclusion that you know the fix
was in. I mean, certainly there are people who believe that.
I'm not one of them. I think that the agency
in general does and was acting in good faith. It's
just more than anything. To me, it indicates maybe the
(14:08):
agency has been overwhelmed with a number of applications, maybe
they're overworked. It's it just it's unusual. Doesn't quite make
sense to me. But I don't necessarily think the fix
was in. I think that they did have legitimate concerns.
And you must assume that the agency gave a thorough
(14:29):
review to their product. It was it was being reviewed
for two years, so I agree. I apologize for interrupting you,
but there's something about this story that just bothers me.
First of all, not to beat up on on the FDA,
but it took them a long time. They let Jewel
market to young people openly with impunity for many, many years,
(14:52):
and and genuinely have now addicted a new generation of
young people to nicotine. Then they reviewed the decision for
two years and they come out with this very strong
response for some people, maybe too far for others. But finally,
you know, there's some some action on the part of
the FDA, and then they walk it back like that
(15:13):
just seems bizarre to me. Well, I would agree that
the the way that the FDA handled the Jewel matter
does not engender confidence in the agency, that's for sure.
It raises a lot of questions about how they could
have botched this, Why they didn't review every piece of evidence, Why,
(15:36):
especially after having it under review for so many years,
did they miss this key that Jewel claims that they missed.
It's it's absolutely unusual and unsettling. I just don't have
the answer as to why exactly the agency is doing
it other than what they've articulated in their public releases
(15:57):
and in court finlines. Right, I'd be curious just to
hear whether you personally think this ban is going to
hold or whether you think they're gonna walk away from it, Like,
what do you think the future looks like? It's just
hard to know this. This issue now lives in a
very technical administrative legal world. It's all about the Administrative
(16:19):
Procedure Act and whether or not the agency upheld its
end of the bargain essentially to do an unbiased review.
And what I will say is that Jewel is certainly
ready and capable to amass a legal defense. This is
what the industry does and what they have been essentially
(16:40):
experts at for the past five decades or more. They
have a bunch of lawyers, they're ready to litigate. So
this is not going to get resolved anytime soon. And
it's hard for me, without having a crystal ball, to
know exactly what the agency is ultimately going to do.
But in the meantime, it's a status quo. The product
is still available, opponents of the product are still out
(17:03):
there really upset that the agency has done this. I mean,
it's it's an issue that doesn't seem to want to
go away, that's not going to go away anytime soon.
I know, as we said in the original program, if
they had not marketed it to youth initially. If they
had gone after actual smokers and tried to get them
to switch, it would have been a great service to
(17:25):
the world, like honestly, and it's just a shame that
they didn't do that, and now things continue to be
sort of vague and messy. Well, and I would be
remiss to not point out the reason that that happened
is because this was a Silicon Valley startup that chased
one thing only, and that was hyper growth. This was
(17:46):
a company that wanted to attain unicorn status that eventually did,
and there are a lot of investors that meet a
lot of money. Had they chosen to go a more
plotting kind of responsible path, they might have ended up
making jewel. But jewel might not have ever seen the
light of day because no investor in Silicon Valley would
(18:07):
have invested in a company that said, hey, ten years
from now, once we have our approval, or fifteen years
from now, once we have our approval, will have this
great product that people are gonna love. So I fall
Silicon Valley and the investors on that side. And it's
interesting because the Silicon Valley solved a really profound technological
(18:29):
challenge in creating Jewel in the first place, one that
the cigarette companies have been trying to solve for years
and failed. And so in a way, it had to
come from the Silicon Valley in order to get out
of this sort of group think of the traditional tobacco companies,
but it putting it in Silicon Valley's hands created a
whole host of new problems. It's such an interesting story. So, Lauren,
(18:54):
thank you so much for coming back on the show.
It was great to see you, and we ship you're
being here. Thanks for having me, folks. After looking at
all the new facts, I'm going to keep Jewels b escort.
At forty nine. Jewel has taken none of the actions
(19:15):
we talked about in the episode in season one, and
their product is still available in convenience stores across the
country and around the world, within easy reach of young consumers.
So whether or not they sincerely want vaping to be
a path to smoking cessation remains to be seen, and
if the last two years have been any indication, we'll
(19:35):
be waiting a while to find out. However, in this
new chapter of the Jewel story, it's the f d
a's actions that perplexed me the most. Taking years to
make a decision on Jewel, then making a strong ruling
against it, then immediately walking that decision back just doesn't
add up. It made me wonder is there some bullshit
(19:59):
to be found in side the f d A. That's
why this season we've decided to deploy our BS detectors
on the FDA itself. Look for that episode in your
feed very soon. Thanks for joining me on this b
S update episode, and a special thanks to Lauren Eder,
author of the Devil's playbook Big Tobacco, Jewel and the
(20:21):
Addiction of a New generation. If you think Jewels BS
score of forty nine needs to change, let us know
on our site Calling Bullshit podcast dot com or on
Twitter at Calling Bullshit Podcast and friends. I'd like to
ask for your help. If you enjoy the Calling Bullshit Podcast,
please take a second to rate and review us on
(20:42):
Apple Podcasts or on your preferred platform. And thanks to
our production team Hannah Beal, Amanda Ginsburg, d s Moss,
Hayley Pascalites, Parker Silser, and Basil Soaper. Calling Bullshit was
created by co Collective and as hosted by me time
anting you thanks for listening h
The FDA preparing to order Jewel to pull its A
cigarettes off the market as early as this week. That's
a c NBC interview from the morning of June two
between Squawk Box host Joe Kernan and former f d
A Commissioner Scott gottlaib I suspect FDA is gonna look
(00:25):
beyond the application and look at the history of this product,
and that's going to be a factor in how they
weigh their decisions. So if they do reject Jewel um,
assuming it's not on some technical issue related to the
application itself, then I would my hunch would be that
it would turn on the legacy associated with this particular product.
Jewel has been selling its products here unregulated since it
(00:49):
took five years for the FDA to even request an
application and another two years for them to review jewels submission.
On the afternoon of June twenty three, just hours after
the Curran Gottlieb interview, the FDA finally announced that decision.
After a two year review, The US Food and Drug
(01:11):
Administration announced today that it will ban all vaping and
e cigarette products sold by Jewel. Some cheered, others booed,
but most just scratched their heads about the ensuing carousel
of perplexing plot twists, and since Jewel was a season
one fan favorite, we wanted to see how this new
(01:32):
news affects Jewels BS score. If you haven't listened to
the original episode, go check it out. We'll be right
here when you get back. In our initial investigation into Jewel,
we concluded that the E Cigarette Company was a bullshitter
worthy of a BS score of forty nine. Their stated
(01:55):
purpose to reduce the harm of cigarettes by giving smokers
a healthy your alternative had been overshadowed by their decision
to market directly to young people, which led to a
whole new generation addicted to nicotine their legacy. As former
FDA Commissioner got Lab called it, join us as we
(02:16):
welcome back a season one guest to decipher what this
means for Jewel and just what the heck is going
on at the f D. A Welcome to Calling Bullshit,
the podcast about purpose washing, the gap between what companies
say they stand for and what they actually do, and
(02:39):
what they would need to change to practice what they preach.
I'm your host, Time onto you, and I've spent over
a decade helping companies define what they stand for, their
purpose and then help them to use that purpose to
drive transformation throughout their business. Unfortunately, at a lot of
organizations today, they're still a pretty wide gap between word. Indeed,
(03:03):
that gap has a name. We call it bullshit. But
and this is important, we believe that bullshit is a
treatable condition. So when the BS detector lights up, we're
going to explore things that a company should do to
fix it. Okay, folks, I am very excited to introduce
(03:27):
Lauren Etter for her second time on the show. Lauren,
thank you for being here and welcome back to calling Bullshit.
Thanks for having me. Tie great to be here. So
just for our audience quickly, those who haven't listened to
the Jewel episode, it would be great to hear just
a little bit about your background. So I'm an investigative
reporter at Bloomberg News. I recently wrote a book called
(03:51):
The Devil's Playbook about Jewel, and I've been a reporter
for many years. So yeah, you were here the first
time to talk about Jewel. And it's a story in
which both Jewel and the f d A figured prominently,
and both of them, Jewel and the FDA have been
back in the news again lately. Can you walk us
(04:11):
through what happened? Absolutely, So, as your listeners might recall,
Jewel has been in the crosshairs of the federal government
and opponents of its product for many years. So since
it hit the market in the product came under a
lot of scrutiny both from regulators and from opponents who
(04:34):
blamed the company for essentially sparking a new youth nicotine epidemic.
So that was several years ago, and fast forward, the
f d A has been wayne whether or not to
allow Jewel to continue selling its product in the US market.
(04:54):
So for the past two years, the agency has been
reviewing a very voluminous application by Jewel that was essentially
the company's effort and way to say that this product
deserves to be on the market, it meets the regulatory standards,
essentially saying that it's a benefit to the public health
(05:15):
and it's going to ultimately help adult smokers quit smoking.
So this has been going on for a long time.
And as you might recall, Jewel reached unicorn status in
Silicon Valley. It was a multibillion dollar company that had
essentially garnered an investment from Altria, the maker of Marlborough's cigarettes,
(05:36):
and it was kind of a Silicon Valley darling for
a while, even though it had gotten all of this
bad press and negative reviews because of its public health problem. Yeah,
and I would say a lot of that criticism was
I think, in many ways fair. In the first episode,
you and I agreed, and I learned this from your book,
(05:57):
that there was no reason that Jewel had to get
negative press or feedback. But the fatal flaw was the
way that they marketed the product. That the product itself
would have been great for smoking cessation, getting people to
quit smoking, but smokers are generally older, and the marketing
of Jewel clearly, at least in the early going, targeted
(06:21):
young people. That's exactly right. So the founders of Jewel
created this product ostensibly to be an alternative to cigarette smoking,
and so that was what they said. But when the
product launched, initially, they introduced the product to the world
with a very splashing marketing campaign with images of very
(06:41):
youthful models in Times Square and all over social media,
and all of a sudden you saw a huge number
of middle schoolers, high schoolers starting to not only use
Jewel but become highly addicted to it. And that's the
key thing to remember about Jewel. It is a five
percent nicotine solution, which in each tiny little pod, the
(07:02):
amount of nicotine is equivalent to that in a pack
of Marlborough reds for examples. So it's a highly addictive product.
Young people with developing brains are uniquely predisposition to becoming
addicted to nicotine and it's extremely difficult habit to kick.
And this came on the keels of decades of actual
(07:24):
public health successes with youth smoking. Keen smoking rates have
been declining year after year after year, a real public
health coup, and then suddenly vaping and Jewel come along
and kind of blow that up and create a new
public health controversy. Right, So then the FDA has been
considering this and they rendered their opinion. What did they
have to say to Jewel? So it's a really surprising decision. Essentially,
(07:49):
the FDA many years ago set out a regulatory framework,
and that framework stipulated that any new nicotine product must
go through a rigorous scientific review process by the agency
before it was allowed to remain for sale. Essentially, so
Jewel has stood by its commitment and claims that this
(08:13):
product will help adult smokers. So they put together gigantic
package of information, and people ask me even a year ago,
you know, will Jewel get the FDA authorization? And I
really was under the impression that they likely would. I
I always said I would be very surprised if the
(08:33):
f d A denied their authorization. For a number of reasons.
Number one, the United States is trying to move smokers
away from cigarettes in general. They're taking steps to dial
down the amount of nicotine in combustible cigarettes. The Biden
administration has moved in the direction of banning mental cigarettes.
(08:55):
So the whole idea here is there's a bigger harm
reduction kind of framework that the US is looking at
right now, which would be let's figure out ways to
migrate adults smokers off of deadly cigarettes and onto something
that is potentially less deadly. So there's a continuum of
risk there. Smokers can quit cold turkey, they could use
(09:17):
a pharmaceutical drug like shantext, they could use the patch,
and then there's also these other products now that are
more popular, like the cigarettes. So the f d A
has in a way kind of embraced this idea that
there should be alternatives for smokers, adults smokers, including the cigarettes.
(09:38):
So given that whole context and backdrop, and knowing that
Jewel is the single largest maker of the cigarettes in
the United States, I thought it would have been surprising
if the f d A would move to not authorize
the product. Not only that, but Jewel is the only
product that Jewel makes essentially, so if the FDA were
(10:00):
to take them off the market, they would go bankrupt.
I didn't think that a company US, a federal agency
would be reluctant to do that. However, so fast forward
in June of this year, the FDA's long awaited decision
and much delayed decision by the way, finally came down
and they said, indeed that they were going to not
(10:22):
authorize Jewel to remain on the market, in essence banning
the product. It was a huge decision. It really took
everybody by surprise, even took people at Jewel by surprise.
And it has some very large and important ramifications. Right,
and my understanding is there's been a stay right that
(10:44):
Jewel petitioned the court to say, hey, don't make us
take the product off tomorrow morning, and that was granted.
Is that correct. Yeah, so it ended up in a
very unusual kind of space. So what happened was the
FDA makes this big splash the announcement, people who are
supporters of Jewel. Jewel people themselves kind of panic and
(11:06):
accused the f d A of not following the science,
of kind of veering outside their lane as a regulator
and arriving at this decision. And so a couple of
things should be pointed out. So one, the reason that
the f d A gave for denying their authorization was surprising.
You might have thought that it would have been, well, Jewel,
(11:27):
you caused this youth epidemic. We're going to punish you,
and we're not authorizing your product because your product is
not and further into the public health. However, that's not
what the agency said. The agency actually said, we are
not authorizing the product because Jewel did not provide enough
information to show that their products were not harmful. They
(11:50):
said that they did not provide enough science to back
up the claim that it wouldn't be damaging to human health.
In particular, they actually focused on the pod and said
that the pod could be leaching, and Jewel didn't prove
that it wasn't leaching and wasn't causing human health concerns.
So it's a very unusual decision that was surprising in
a number of ways. So not surprisingly, Jewel immediately sued.
(12:14):
They basically went to the U. S Court and asked
for an emergency stay, which would basically say, look, you
can't take our product off the market immediately. You have
to consider all these other factors, including the fact that we, Jewel,
we don't believe that the f d A did a
thorough and fair review of all of the science that
(12:35):
the company provided. So the court granted that emergency stay,
and then shortly thereafter, the f d A said, actually,
they walked it back and said, actually, we're taking the
application back and we're going to continue reviewing it in
light of all of this information that Jewel had brought forward. Yeah,
(12:57):
very very surprising and complicated the language they used. The
agency has determined that there are scientific issues unique to
the Jewel application that warrant additional review. Set off alarm
bells in my head. I don't know whether they set
off any in yours, but I'm trying to understand what
(13:20):
that means, you know, because I immediately went, well, there
has been some coverage about the pressure that the FDA
has been under from Congress to do something about jewel
and so it made me wonder, like, is the fix
in at the f d A? Is that why they're
walking it back because somebody got to somebody? Or do
you think that legitimately there are scientific issues that that
(13:45):
deserve to be reviewed. Well, I mean, I think there
would have to be a lot going on inside the
FDA to reach the conclusion that you know the fix
was in. I mean, certainly there are people who believe that.
I'm not one of them. I think that the agency
in general does and was acting in good faith. It's
just more than anything. To me, it indicates maybe the
(14:08):
agency has been overwhelmed with a number of applications, maybe
they're overworked. It's it just it's unusual. Doesn't quite make
sense to me. But I don't necessarily think the fix
was in. I think that they did have legitimate concerns.
And you must assume that the agency gave a thorough
(14:29):
review to their product. It was it was being reviewed
for two years, so I agree. I apologize for interrupting you,
but there's something about this story that just bothers me.
First of all, not to beat up on on the FDA,
but it took them a long time. They let Jewel
market to young people openly with impunity for many, many years,
(14:52):
and and genuinely have now addicted a new generation of
young people to nicotine. Then they reviewed the decision for
two years and they come out with this very strong
response for some people, maybe too far for others. But finally,
you know, there's some some action on the part of
the FDA, and then they walk it back like that
(15:13):
just seems bizarre to me. Well, I would agree that
the the way that the FDA handled the Jewel matter
does not engender confidence in the agency, that's for sure.
It raises a lot of questions about how they could
have botched this, Why they didn't review every piece of evidence, Why,
(15:36):
especially after having it under review for so many years,
did they miss this key that Jewel claims that they missed.
It's it's absolutely unusual and unsettling. I just don't have
the answer as to why exactly the agency is doing
it other than what they've articulated in their public releases
(15:57):
and in court finlines. Right, I'd be curious just to
hear whether you personally think this ban is going to
hold or whether you think they're gonna walk away from it, Like,
what do you think the future looks like? It's just
hard to know this. This issue now lives in a
very technical administrative legal world. It's all about the Administrative
(16:19):
Procedure Act and whether or not the agency upheld its
end of the bargain essentially to do an unbiased review.
And what I will say is that Jewel is certainly
ready and capable to amass a legal defense. This is
what the industry does and what they have been essentially
(16:40):
experts at for the past five decades or more. They
have a bunch of lawyers, they're ready to litigate. So
this is not going to get resolved anytime soon. And
it's hard for me, without having a crystal ball, to
know exactly what the agency is ultimately going to do.
But in the meantime, it's a status quo. The product
is still available, opponents of the product are still out
(17:03):
there really upset that the agency has done this. I mean,
it's it's an issue that doesn't seem to want to
go away, that's not going to go away anytime soon.
I know, as we said in the original program, if
they had not marketed it to youth initially. If they
had gone after actual smokers and tried to get them
to switch, it would have been a great service to
(17:25):
the world, like honestly, and it's just a shame that
they didn't do that, and now things continue to be
sort of vague and messy. Well, and I would be
remiss to not point out the reason that that happened
is because this was a Silicon Valley startup that chased
one thing only, and that was hyper growth. This was
(17:46):
a company that wanted to attain unicorn status that eventually did,
and there are a lot of investors that meet a
lot of money. Had they chosen to go a more
plotting kind of responsible path, they might have ended up
making jewel. But jewel might not have ever seen the
light of day because no investor in Silicon Valley would
(18:07):
have invested in a company that said, hey, ten years
from now, once we have our approval, or fifteen years
from now, once we have our approval, will have this
great product that people are gonna love. So I fall
Silicon Valley and the investors on that side. And it's
interesting because the Silicon Valley solved a really profound technological
(18:29):
challenge in creating Jewel in the first place, one that
the cigarette companies have been trying to solve for years
and failed. And so in a way, it had to
come from the Silicon Valley in order to get out
of this sort of group think of the traditional tobacco companies,
but it putting it in Silicon Valley's hands created a
whole host of new problems. It's such an interesting story. So, Lauren,
(18:54):
thank you so much for coming back on the show.
It was great to see you, and we ship you're
being here. Thanks for having me, folks. After looking at
all the new facts, I'm going to keep Jewels b escort.
At forty nine. Jewel has taken none of the actions
(19:15):
we talked about in the episode in season one, and
their product is still available in convenience stores across the
country and around the world, within easy reach of young consumers.
So whether or not they sincerely want vaping to be
a path to smoking cessation remains to be seen, and
if the last two years have been any indication, we'll
(19:35):
be waiting a while to find out. However, in this
new chapter of the Jewel story, it's the f d
a's actions that perplexed me the most. Taking years to
make a decision on Jewel, then making a strong ruling
against it, then immediately walking that decision back just doesn't
add up. It made me wonder is there some bullshit
(19:59):
to be found in side the f d A. That's
why this season we've decided to deploy our BS detectors
on the FDA itself. Look for that episode in your
feed very soon. Thanks for joining me on this b
S update episode, and a special thanks to Lauren Eder,
author of the Devil's playbook Big Tobacco, Jewel and the
(20:21):
Addiction of a New generation. If you think Jewels BS
score of forty nine needs to change, let us know
on our site Calling Bullshit podcast dot com or on
Twitter at Calling Bullshit Podcast and friends. I'd like to
ask for your help. If you enjoy the Calling Bullshit Podcast,
please take a second to rate and review us on
(20:42):
Apple Podcasts or on your preferred platform. And thanks to
our production team Hannah Beal, Amanda Ginsburg, d s Moss,
Hayley Pascalites, Parker Silser, and Basil Soaper. Calling Bullshit was
created by co Collective and as hosted by me time
anting you thanks for listening h
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