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Speaker 1: The FDA preparing to order Jewel to pull its A

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Speaker 1: cigarettes off the market as early as this week. That's

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Speaker 1: a c NBC interview from the morning of June two

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Speaker 1: between Squawk Box host Joe Kernan and former f d

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Speaker 1: A Commissioner Scott gottlaib I suspect FDA is gonna look

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Speaker 1: beyond the application and look at the history of this product,

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Speaker 1: and that's going to be a factor in how they

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Speaker 1: weigh their decisions. So if they do reject Jewel um,

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Speaker 1: assuming it's not on some technical issue related to the

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Speaker 1: application itself, then I would my hunch would be that

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Speaker 1: it would turn on the legacy associated with this particular product.

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Speaker 1: Jewel has been selling its products here unregulated since it

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Speaker 1: took five years for the FDA to even request an

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Speaker 1: application and another two years for them to review jewels submission.

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Speaker 1: On the afternoon of June twenty three, just hours after

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Speaker 1: the Curran Gottlieb interview, the FDA finally announced that decision.

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Speaker 1: After a two year review, The US Food and Drug

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Speaker 1: Administration announced today that it will ban all vaping and

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Speaker 1: e cigarette products sold by Jewel. Some cheered, others booed,

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Speaker 1: but most just scratched their heads about the ensuing carousel

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Speaker 1: of perplexing plot twists, and since Jewel was a season

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Speaker 1: one fan favorite, we wanted to see how this new

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Speaker 1: news affects Jewels BS score. If you haven't listened to

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Speaker 1: the original episode, go check it out. We'll be right

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Speaker 1: here when you get back. In our initial investigation into Jewel,

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Speaker 1: we concluded that the E Cigarette Company was a bullshitter

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Speaker 1: worthy of a BS score of forty nine. Their stated

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Speaker 1: purpose to reduce the harm of cigarettes by giving smokers

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Speaker 1: a healthy your alternative had been overshadowed by their decision

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Speaker 1: to market directly to young people, which led to a

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Speaker 1: whole new generation addicted to nicotine their legacy. As former

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Speaker 1: FDA Commissioner got Lab called it, join us as we

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Speaker 1: welcome back a season one guest to decipher what this

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Speaker 1: means for Jewel and just what the heck is going

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Speaker 1: on at the f D. A Welcome to Calling Bullshit,

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Speaker 1: the podcast about purpose washing, the gap between what companies

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Speaker 1: say they stand for and what they actually do, and

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Speaker 1: what they would need to change to practice what they preach.

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Speaker 1: I'm your host, Time onto you, and I've spent over

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Speaker 1: a decade helping companies define what they stand for, their

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Speaker 1: purpose and then help them to use that purpose to

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Speaker 1: drive transformation throughout their business. Unfortunately, at a lot of

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Speaker 1: organizations today, they're still a pretty wide gap between word. Indeed,

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Speaker 1: that gap has a name. We call it bullshit. But

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Speaker 1: and this is important, we believe that bullshit is a

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Speaker 1: treatable condition. So when the BS detector lights up, we're

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Speaker 1: going to explore things that a company should do to

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Speaker 1: fix it. Okay, folks, I am very excited to introduce

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Speaker 1: Lauren Etter for her second time on the show. Lauren,

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Speaker 1: thank you for being here and welcome back to calling Bullshit.

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Speaker 1: Thanks for having me. Tie great to be here. So

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Speaker 1: just for our audience quickly, those who haven't listened to

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Speaker 1: the Jewel episode, it would be great to hear just

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Speaker 1: a little bit about your background. So I'm an investigative

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Speaker 1: reporter at Bloomberg News. I recently wrote a book called

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Speaker 1: The Devil's Playbook about Jewel, and I've been a reporter

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Speaker 1: for many years. So yeah, you were here the first

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Speaker 1: time to talk about Jewel. And it's a story in

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Speaker 1: which both Jewel and the f d A figured prominently,

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Speaker 1: and both of them, Jewel and the FDA have been

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Speaker 1: back in the news again lately. Can you walk us

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Speaker 1: through what happened? Absolutely, So, as your listeners might recall,

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Speaker 1: Jewel has been in the crosshairs of the federal government

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Speaker 1: and opponents of its product for many years. So since

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Speaker 1: it hit the market in the product came under a

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Speaker 1: lot of scrutiny both from regulators and from opponents who

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Speaker 1: blamed the company for essentially sparking a new youth nicotine epidemic.

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Speaker 1: So that was several years ago, and fast forward, the

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Speaker 1: f d A has been wayne whether or not to

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Speaker 1: allow Jewel to continue selling its product in the US market.

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Speaker 1: So for the past two years, the agency has been

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Speaker 1: reviewing a very voluminous application by Jewel that was essentially

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Speaker 1: the company's effort and way to say that this product

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Speaker 1: deserves to be on the market, it meets the regulatory standards,

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Speaker 1: essentially saying that it's a benefit to the public health

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Speaker 1: and it's going to ultimately help adult smokers quit smoking.

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Speaker 1: So this has been going on for a long time.

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Speaker 1: And as you might recall, Jewel reached unicorn status in

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Speaker 1: Silicon Valley. It was a multibillion dollar company that had

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Speaker 1: essentially garnered an investment from Altria, the maker of Marlborough's cigarettes,

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Speaker 1: and it was kind of a Silicon Valley darling for

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Speaker 1: a while, even though it had gotten all of this

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Speaker 1: bad press and negative reviews because of its public health problem. Yeah,

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Speaker 1: and I would say a lot of that criticism was

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Speaker 1: I think, in many ways fair. In the first episode,

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Speaker 1: you and I agreed, and I learned this from your book,

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Speaker 1: that there was no reason that Jewel had to get

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Speaker 1: negative press or feedback. But the fatal flaw was the

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Speaker 1: way that they marketed the product. That the product itself

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Speaker 1: would have been great for smoking cessation, getting people to

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Speaker 1: quit smoking, but smokers are generally older, and the marketing

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Speaker 1: of Jewel clearly, at least in the early going, targeted

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Speaker 1: young people. That's exactly right. So the founders of Jewel

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Speaker 1: created this product ostensibly to be an alternative to cigarette smoking,

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Speaker 1: and so that was what they said. But when the

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Speaker 1: product launched, initially, they introduced the product to the world

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Speaker 1: with a very splashing marketing campaign with images of very

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Speaker 1: youthful models in Times Square and all over social media,

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Speaker 1: and all of a sudden you saw a huge number

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Speaker 1: of middle schoolers, high schoolers starting to not only use

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Speaker 1: Jewel but become highly addicted to it. And that's the

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Speaker 1: key thing to remember about Jewel. It is a five

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Speaker 1: percent nicotine solution, which in each tiny little pod, the

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Speaker 1: amount of nicotine is equivalent to that in a pack

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Speaker 1: of Marlborough reds for examples. So it's a highly addictive product.

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Speaker 1: Young people with developing brains are uniquely predisposition to becoming

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Speaker 1: addicted to nicotine and it's extremely difficult habit to kick.

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Speaker 1: And this came on the keels of decades of actual

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Speaker 1: public health successes with youth smoking. Keen smoking rates have

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Speaker 1: been declining year after year after year, a real public

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Speaker 1: health coup, and then suddenly vaping and Jewel come along

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Speaker 1: and kind of blow that up and create a new

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Speaker 1: public health controversy. Right, So then the FDA has been

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Speaker 1: considering this and they rendered their opinion. What did they

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Speaker 1: have to say to Jewel? So it's a really surprising decision. Essentially,

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Speaker 1: the FDA many years ago set out a regulatory framework,

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Speaker 1: and that framework stipulated that any new nicotine product must

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Speaker 1: go through a rigorous scientific review process by the agency

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Speaker 1: before it was allowed to remain for sale. Essentially, so

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Speaker 1: Jewel has stood by its commitment and claims that this

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Speaker 1: product will help adult smokers. So they put together gigantic

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Speaker 1: package of information, and people ask me even a year ago,

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Speaker 1: you know, will Jewel get the FDA authorization? And I

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Speaker 1: really was under the impression that they likely would. I

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Speaker 1: I always said I would be very surprised if the

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Speaker 1: f d A denied their authorization. For a number of reasons.

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Speaker 1: Number one, the United States is trying to move smokers

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Speaker 1: away from cigarettes in general. They're taking steps to dial

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Speaker 1: down the amount of nicotine in combustible cigarettes. The Biden

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Speaker 1: administration has moved in the direction of banning mental cigarettes.

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Speaker 1: So the whole idea here is there's a bigger harm

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Speaker 1: reduction kind of framework that the US is looking at

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Speaker 1: right now, which would be let's figure out ways to

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Speaker 1: migrate adults smokers off of deadly cigarettes and onto something

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Speaker 1: that is potentially less deadly. So there's a continuum of

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Speaker 1: risk there. Smokers can quit cold turkey, they could use

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Speaker 1: a pharmaceutical drug like shantext, they could use the patch,

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Speaker 1: and then there's also these other products now that are

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Speaker 1: more popular, like the cigarettes. So the f d A

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Speaker 1: has in a way kind of embraced this idea that

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Speaker 1: there should be alternatives for smokers, adults smokers, including the cigarettes.

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Speaker 1: So given that whole context and backdrop, and knowing that

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Speaker 1: Jewel is the single largest maker of the cigarettes in

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Speaker 1: the United States, I thought it would have been surprising

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Speaker 1: if the f d A would move to not authorize

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Speaker 1: the product. Not only that, but Jewel is the only

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Speaker 1: product that Jewel makes essentially, so if the FDA were

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Speaker 1: to take them off the market, they would go bankrupt.

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Speaker 1: I didn't think that a company US, a federal agency

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Speaker 1: would be reluctant to do that. However, so fast forward

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Speaker 1: in June of this year, the FDA's long awaited decision

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Speaker 1: and much delayed decision by the way, finally came down

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Speaker 1: and they said, indeed that they were going to not

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Speaker 1: authorize Jewel to remain on the market, in essence banning

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Speaker 1: the product. It was a huge decision. It really took

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Speaker 1: everybody by surprise, even took people at Jewel by surprise.

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Speaker 1: And it has some very large and important ramifications. Right,

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Speaker 1: and my understanding is there's been a stay right that

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Speaker 1: Jewel petitioned the court to say, hey, don't make us

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Speaker 1: take the product off tomorrow morning, and that was granted.

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Speaker 1: Is that correct. Yeah, so it ended up in a

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Speaker 1: very unusual kind of space. So what happened was the

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Speaker 1: FDA makes this big splash the announcement, people who are

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Speaker 1: supporters of Jewel. Jewel people themselves kind of panic and

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Speaker 1: accused the f d A of not following the science,

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Speaker 1: of kind of veering outside their lane as a regulator

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Speaker 1: and arriving at this decision. And so a couple of

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Speaker 1: things should be pointed out. So one, the reason that

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Speaker 1: the f d A gave for denying their authorization was surprising.

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Speaker 1: You might have thought that it would have been, well, Jewel,

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Speaker 1: you caused this youth epidemic. We're going to punish you,

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Speaker 1: and we're not authorizing your product because your product is

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Speaker 1: not and further into the public health. However, that's not

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Speaker 1: what the agency said. The agency actually said, we are

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Speaker 1: not authorizing the product because Jewel did not provide enough

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Speaker 1: information to show that their products were not harmful. They

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Speaker 1: said that they did not provide enough science to back

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Speaker 1: up the claim that it wouldn't be damaging to human health.

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Speaker 1: In particular, they actually focused on the pod and said

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Speaker 1: that the pod could be leaching, and Jewel didn't prove

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Speaker 1: that it wasn't leaching and wasn't causing human health concerns.

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Speaker 1: So it's a very unusual decision that was surprising in

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Speaker 1: a number of ways. So not surprisingly, Jewel immediately sued.

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Speaker 1: They basically went to the U. S Court and asked

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Speaker 1: for an emergency stay, which would basically say, look, you

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Speaker 1: can't take our product off the market immediately. You have

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Speaker 1: to consider all these other factors, including the fact that we, Jewel,

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Speaker 1: we don't believe that the f d A did a

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Speaker 1: thorough and fair review of all of the science that

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Speaker 1: the company provided. So the court granted that emergency stay,

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Speaker 1: and then shortly thereafter, the f d A said, actually,

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Speaker 1: they walked it back and said, actually, we're taking the

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Speaker 1: application back and we're going to continue reviewing it in

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Speaker 1: light of all of this information that Jewel had brought forward. Yeah,

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Speaker 1: very very surprising and complicated the language they used. The

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Speaker 1: agency has determined that there are scientific issues unique to

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Speaker 1: the Jewel application that warrant additional review. Set off alarm

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Speaker 1: bells in my head. I don't know whether they set

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Speaker 1: off any in yours, but I'm trying to understand what

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Speaker 1: that means, you know, because I immediately went, well, there

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Speaker 1: has been some coverage about the pressure that the FDA

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Speaker 1: has been under from Congress to do something about jewel

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Speaker 1: and so it made me wonder, like, is the fix

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Speaker 1: in at the f d A? Is that why they're

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Speaker 1: walking it back because somebody got to somebody? Or do

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Speaker 1: you think that legitimately there are scientific issues that that

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Speaker 1: deserve to be reviewed. Well, I mean, I think there

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Speaker 1: would have to be a lot going on inside the

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Speaker 1: FDA to reach the conclusion that you know the fix

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Speaker 1: was in. I mean, certainly there are people who believe that.

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Speaker 1: I'm not one of them. I think that the agency

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Speaker 1: in general does and was acting in good faith. It's

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Speaker 1: just more than anything. To me, it indicates maybe the

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Speaker 1: agency has been overwhelmed with a number of applications, maybe

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Speaker 1: they're overworked. It's it just it's unusual. Doesn't quite make

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Speaker 1: sense to me. But I don't necessarily think the fix

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Speaker 1: was in. I think that they did have legitimate concerns.

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Speaker 1: And you must assume that the agency gave a thorough

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Speaker 1: review to their product. It was it was being reviewed

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Speaker 1: for two years, so I agree. I apologize for interrupting you,

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Speaker 1: but there's something about this story that just bothers me.

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Speaker 1: First of all, not to beat up on on the FDA,

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Speaker 1: but it took them a long time. They let Jewel

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Speaker 1: market to young people openly with impunity for many, many years,

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Speaker 1: and and genuinely have now addicted a new generation of

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Speaker 1: young people to nicotine. Then they reviewed the decision for

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Speaker 1: two years and they come out with this very strong

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Speaker 1: response for some people, maybe too far for others. But finally,

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Speaker 1: you know, there's some some action on the part of

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Speaker 1: the FDA, and then they walk it back like that

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Speaker 1: just seems bizarre to me. Well, I would agree that

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Speaker 1: the the way that the FDA handled the Jewel matter

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Speaker 1: does not engender confidence in the agency, that's for sure.

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Speaker 1: It raises a lot of questions about how they could

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Speaker 1: have botched this, Why they didn't review every piece of evidence, Why,

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Speaker 1: especially after having it under review for so many years,

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Speaker 1: did they miss this key that Jewel claims that they missed.

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Speaker 1: It's it's absolutely unusual and unsettling. I just don't have

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Speaker 1: the answer as to why exactly the agency is doing

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Speaker 1: it other than what they've articulated in their public releases

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Speaker 1: and in court finlines. Right, I'd be curious just to

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Speaker 1: hear whether you personally think this ban is going to

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Speaker 1: hold or whether you think they're gonna walk away from it, Like,

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Speaker 1: what do you think the future looks like? It's just

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Speaker 1: hard to know this. This issue now lives in a

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Speaker 1: very technical administrative legal world. It's all about the Administrative

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Speaker 1: Procedure Act and whether or not the agency upheld its

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Speaker 1: end of the bargain essentially to do an unbiased review.

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Speaker 1: And what I will say is that Jewel is certainly

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Speaker 1: ready and capable to amass a legal defense. This is

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Speaker 1: what the industry does and what they have been essentially

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Speaker 1: experts at for the past five decades or more. They

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Speaker 1: have a bunch of lawyers, they're ready to litigate. So

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Speaker 1: this is not going to get resolved anytime soon. And

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Speaker 1: it's hard for me, without having a crystal ball, to

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Speaker 1: know exactly what the agency is ultimately going to do.

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Speaker 1: But in the meantime, it's a status quo. The product

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Speaker 1: is still available, opponents of the product are still out

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Speaker 1: there really upset that the agency has done this. I mean,

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Speaker 1: it's it's an issue that doesn't seem to want to

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Speaker 1: go away, that's not going to go away anytime soon.

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Speaker 1: I know, as we said in the original program, if

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Speaker 1: they had not marketed it to youth initially. If they

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Speaker 1: had gone after actual smokers and tried to get them

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Speaker 1: to switch, it would have been a great service to

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Speaker 1: the world, like honestly, and it's just a shame that

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Speaker 1: they didn't do that, and now things continue to be

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Speaker 1: sort of vague and messy. Well, and I would be

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Speaker 1: remiss to not point out the reason that that happened

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Speaker 1: is because this was a Silicon Valley startup that chased

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Speaker 1: one thing only, and that was hyper growth. This was

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Speaker 1: a company that wanted to attain unicorn status that eventually did,

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Speaker 1: and there are a lot of investors that meet a

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Speaker 1: lot of money. Had they chosen to go a more

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Speaker 1: plotting kind of responsible path, they might have ended up

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Speaker 1: making jewel. But jewel might not have ever seen the

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Speaker 1: light of day because no investor in Silicon Valley would

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Speaker 1: have invested in a company that said, hey, ten years

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Speaker 1: from now, once we have our approval, or fifteen years

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Speaker 1: from now, once we have our approval, will have this

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Speaker 1: great product that people are gonna love. So I fall

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Speaker 1: Silicon Valley and the investors on that side. And it's

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Speaker 1: interesting because the Silicon Valley solved a really profound technological

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Speaker 1: challenge in creating Jewel in the first place, one that

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Speaker 1: the cigarette companies have been trying to solve for years

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Speaker 1: and failed. And so in a way, it had to

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Speaker 1: come from the Silicon Valley in order to get out

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Speaker 1: of this sort of group think of the traditional tobacco companies,

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Speaker 1: but it putting it in Silicon Valley's hands created a

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Speaker 1: whole host of new problems. It's such an interesting story. So, Lauren,

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Speaker 1: thank you so much for coming back on the show.

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Speaker 1: It was great to see you, and we ship you're

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Speaker 1: being here. Thanks for having me, folks. After looking at

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Speaker 1: all the new facts, I'm going to keep Jewels b escort.

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Speaker 1: At forty nine. Jewel has taken none of the actions

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Speaker 1: we talked about in the episode in season one, and

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Speaker 1: their product is still available in convenience stores across the

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Speaker 1: country and around the world, within easy reach of young consumers.

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Speaker 1: So whether or not they sincerely want vaping to be

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Speaker 1: a path to smoking cessation remains to be seen, and

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Speaker 1: if the last two years have been any indication, we'll

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Speaker 1: be waiting a while to find out. However, in this

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Speaker 1: new chapter of the Jewel story, it's the f d

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Speaker 1: a's actions that perplexed me the most. Taking years to

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Speaker 1: make a decision on Jewel, then making a strong ruling

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Speaker 1: against it, then immediately walking that decision back just doesn't

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Speaker 1: add up. It made me wonder is there some bullshit

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Speaker 1: to be found in side the f d A. That's

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Speaker 1: why this season we've decided to deploy our BS detectors

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Speaker 1: on the FDA itself. Look for that episode in your

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Speaker 1: feed very soon. Thanks for joining me on this b

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Speaker 1: S update episode, and a special thanks to Lauren Eder,

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Speaker 1: author of the Devil's playbook Big Tobacco, Jewel and the

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Speaker 1: Addiction of a New generation. If you think Jewels BS

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Speaker 1: score of forty nine needs to change, let us know

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Speaker 1: on our site Calling Bullshit podcast dot com or on

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Speaker 1: Twitter at Calling Bullshit Podcast and friends. I'd like to

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Speaker 1: ask for your help. If you enjoy the Calling Bullshit Podcast,

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Speaker 1: please take a second to rate and review us on

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Speaker 1: Apple Podcasts or on your preferred platform. And thanks to

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Speaker 1: our production team Hannah Beal, Amanda Ginsburg, d s Moss,

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Speaker 1: Hayley Pascalites, Parker Silser, and Basil Soaper. Calling Bullshit was

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Speaker 1: created by co Collective and as hosted by me time

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Speaker 1: anting you thanks for listening h