The Vape Cloud Hanging Over the FDA

0:04The Food and Drug Administration saw a huge shakeup in leadership today. Today, the FDA commissioner, Dr. Marty Makary, resigned. And how big a deal is that? I think it's a huge deal. Our colleague Liz Essley Whyte covers health policy. He had a tumultuous tenure full of intrigue and palace drama and politics and conflict in a way that we haven't really seen with any other FDA commissioner. President Trump called McCary, quote, a terrific guy, but added that he was having some difficulty. McCary, a surgeon by training, was sworn in as commissioner over a year ago, with promises to usher in a new era at the FDA.

0:54He started phasing out artificial food dyes and cut down on the time it takes for drugs to get FDA approval. But McCary also faced a lot of headwinds throughout his tenure. Patients, oncologists, and biotech investors have been pressing Commissioner McCary over a string of drug rejections, none more contentious than Replimune. He's managed to make a lot of critics in the pharmaceutical industry who view him as unsympathetic to the cause of rare disease patients. I don't work for Replimune. I work for the American people, and I stand by the scientists at the FDA. The White House has also blamed McCary for a mess of bad PR from people he brought on who then quickly left the agency.

1:36That's according to people familiar with the matter. The highest profile was Dr. Vinay Prasad, who was hired, fired, and then rehired as the FDA's vaccine chief. Prasad ultimately stepped down in March. Beyond the personnel issues, McCary has also been criticized for not moving fast enough on issues important to the GOP. He has been targeted by anti-abortion advocates who called for his resignation after he promised a review of the safety of the abortion pill and has not produced it.

2:15But the vaping argument is what really catalyzed the movement towards, let's go ahead and pull the plug here. Why, of all things, vaping? Why was this the thing that caught the president's attention? Well, the president made a commitment to the vaping industry in his 2024 presidential campaign. He ran on a platform of Let's Save Vaping. His advisors had identified that constituency as important to his base. They viewed it as a way to reach young MAGA voters. There were a lot of factors that led to this moment, but the vaping situation seems to have been an accelerant on the firestorm here. It is what seems to have sped up his ouster.

3:10McCary didn't respond to requests for comment. Welcome to The Journal, our show about money, business, and power. I'm Jessica Mendoza. It's Tuesday, May 12th.

3:28Coming up on the show, the vaping firestorm that ousted the FDA commissioner.

3:39Amazon Health AI presents Painful Thoughts. Why did I search the internet for answers to my cold sore problem? Now I'm stuck down a rabbit hole filled with images of alarmingly graphic sores in various stages of ooze. I can clear my search history, but I can never unsee that. Don't go down the rabbit hole. Amazon Health AI gets you the right care, fast. Healthcare just got less painful.

4:16We have a problem in our country. It's a new problem. It's a problem that nobody really thought about too much a few years ago, and it's called vaping. That's President Trump speaking from the Oval Office in 2019. In his first term, Trump was clearly anti-vaping. Especially vaping as it pertains to innocent children. and they're coming home and they're saying, Mom, I want to vape. Trump's comments were responding to a panic that was sweeping the nation. There was a real panic about these flavored vaping products and e-cigarettes that, you know, you'd walk into a high school bathroom and it was just a cloud of vape.

5:00You hid your vape underneath your pillows. Yeah. And this was really bad to, you know, get all these kids addicted to nicotine. And you would come and smoke how often? Oh, I couldn't go longer than like 10, 15 minutes without hitting it. And then there was a time period where there was kind of an outbreak of lung disease and respiratory issues. In tonight's Health Watch, more disturbing news about the dangers of vaping. And people became increasingly concerned that something was going on with these products or they had been contaminated in some way that we're harming the lungs of our young people.

5:38The vaping industry was marketing its products as a healthier alternative for adults who want to kick smoking cigarettes. But public health advocates were concerned that vaping and e-cigarettes were also being marketed to young people who had never smoked before, and that getting kids started too early could lead to a lifetime of nicotine addiction. This concern even spread to the Trumps themselves. The First Lady urged more regulation of vaping products. At the time, the Trump's youngest son, Barron, was in middle school. We had reported at the time that Trump's wife, Melania Trump, was an influential figure during this time and being concerned about her own son's health and safety and talking to her husband about that.

6:24At the end of 2019, Trump signed legislation that raised the age limit for all tobacco products from 18 to 21. Early the next year, the FDA enacted a ban on vape flavors that would appeal to kids. But the agency allowed flavors that might appeal to adult smokers trying to quit. And they ended up with sort of a compromised position where they said, we will allow menthol and tobacco-flavored vapes to remain on the market, but everything else is getting the boot. So menthol and tobacco products were going to be allowed, but it sounds like there was a concern over flavoring specifically. Yeah, the flavoring is thought to be more appealing to children and to teenagers.

7:06The thought is, you know, you're not going to go try a tobacco-flavored vape as a 13-year-old, but maybe blueberry would sound really fun. Or maybe, you know, watermelon Fantasia would sound amazing or things like that. The ban on fruit-flavored vapes stayed in place through the Biden administration. But a black market emerged, flooded by competitors from overseas who were not operating under FDA rules. These Chinese vapes, you know, that were illegal and possibly contaminated were just everywhere at any gas station. And there are a lot of people who say, we don't really even know what's in these products.

7:44So there was really no healthy, robust, regulated market. It was mostly an illegal market that had sprung up. They are in gas stations. They are in smoke shops. You know, it is not hard to get your hands on a flavored vape. This frustrated the U.S. vaping industry. They publicly argued that the FDA's unwillingness to authorize flavored products meant more demand for illegal Chinese vapes. Over the course of the 2024 presidential campaign, Trump went through an evolution on vaping. He saw an opportunity to reach an important voting bloc by supporting vaping and other nicotine products. We know that his advisors really identified vaping as a way to reach young men who were a key constituency in the MAGA coalition.

8:34And it appealed to Trump's brand of, I'm going to do, you know, what's right for the American people. You know, I'm not going to basically let big government trample on your rights. You know, skepticism of the public health establishment that followed the pandemic. In September of 2024, Trump posted on social media, quote, I saved flavored vaping in 2019, and it greatly helped people get off smoking. He ended with the quote, I'll save vaping again. Supporters of the MAGA movement have also embraced nicotine products. Tucker Carlson talked about enjoying nicotine while promoting his own brand of nicotine pouches.

9:15I mean, you throw it in like you would a dip of tobacco. Okay. But you just let it sit there and then it suffuses your nervous system with life-giving nicotine. And it really does feel like the hand of God is massaging you. Okay, so, you know, 2024, Trump is reelected with a different position on vaping. How do vaping and e-cigarette companies respond to this new environment? Yeah, I heard a lot of optimism at the beginning of the administration. But then there wasn't much action. You know, there was very little movement from the FDA. And my understanding as the industry came to the conclusion that the person standing in their way was Dr.

10:04Marty McCary. After the break, a power struggle at the FDA and a flood of new nicotine products.

10:23Zootopia 2 has come home to Disney+. Let's go! Get ready for a new case. We're going to crack this case and prove we're the greatest partners of all time! New friends. You are... Gary the Snake. And your last name? The Snake. Dream Team. New habitats. Zootopia has a secret reptile population. You can watch the record-breaking phenomenon at home. You're clearly working at it. Zootopia 2, now available on Disney Plus Rated PG.

11:17Go to V-A-N-T-A dot com slash com.

11:28The test case for the new nicotine-friendly Trump presidency came from a vaping company called Glass with one S. It had been trying to get FDA approval for a new product since 2021. In its application, Glass said it had developed a vape that was almost impossible for teens to use. You have to have an app on your phone, and you have to prove your age, and you can't use the device without it being near the phone, and it'll randomly at other times make you kind of reprove your age. Because the device worked so well, Glass argued to the FDA, they should be able to sell fruity flavors with it. In addition, they had a range of flavors that they were seeking approval for.

12:11So they had tobacco flavors, menthol flavors, and they had what they called gold and sapphire flavors, which were mango and blueberry. This February, Glass met with FDA representatives who apologized for the delays and promised news was coming, according to Liz's reporting. After that meeting, an agency document shows, a key FDA scientist signed off on the Glass application. But after that, a memo came from the commissioner's office. And the memo said, actually, you know, we need more time. We're not really sure about whether this age-gated technology is adequate. So the application was ultimately stalled by FDA Commissioner Marty McCary.

12:55Yes. Yeah. And, you know, this is years into this process for this company. and it was viewed as this kind of abrupt turnaround from them working with the FDA closely, they were feeling like this was political interference. In a 2024 study, the CDC found that e-cigarette use among teens had dropped to its lowest level in a decade. But McCary, a physician, wanted to avoid approving fruit flavors because he was worried about the public health risks. According to the people I've talked to, McCary thinks fruit-flavored vapes are a huge public health risk, and children should not have any access to them.

13:39He doesn't want to be seen as the doctor who allowed those onto the market. He's worried that the statistics around youth vaping are inaccurate, that it's actually really bad still. It's not gotten better in the years since the 2020 ban. and he sees kids who are potentially going to be addicted to nicotine. And, you know, his thinking is, why would we do that? That's a terrible policy. So McCary puts his foot down, gets in the way of Glass's flavored vape application. How did this issue get on Trump's radar? Yeah. So earlier this month, according to people we talked to, We know that Trump was having a weekend away and he started talking to some people and got upset and frustrated about the vaping issue and the slow pace of change at the FDA.

14:35And he started calling advisors and saying, you know, what do you think about this Marty guy? Like, what's going on? What's the deal with the vaping situation? And getting pretty spun up and frustrated. And then we saw that following week on Tuesday, the authorization for those flavors that McCary had previously stalled. So mango and blueberry from glass got approval. The four newly approved e-cigs come in mango, blueberry and menthol flavors. This major shift comes after months of appeals to President Trump by the vaping industry. And then how did we get from the approval of the glass application to McCary potentially getting fired?

15:19We knew going into that weekend where Trump got upset about vaping that there were already people in the vaping industry and the pharmaceutical industry who had become so upset about certain actions that McCary had taken that they were already willing to call for his firing. They wanted him out. It appears that there were enough concerns inside the administration that, you know, officials did, you know, come up with this plan to oust McCary and got the initial sign-off from Trump. The news about McCary's potential firing overshadowed another significant change on nicotine products, which the FDA announced last Friday.

16:00We had a big policy announcement from the FDA that said, hey, tobacco industry, if you have an electronic nicotine product or a pouch product that you've already filed an application for, you can go ahead and market it and we're not going to enforce against that. We're not going to come after you, basically. So even while you're waiting for our official pre-market approval, you can move ahead with selling these products. And industry experts think this is going to be a flood of new products in coming months. Wow. So essentially, vaping products that are waiting for FDA approval can now go on the market.

16:44Seems like a pretty big shift. Yeah, it's a big shift. You know, they're saying, well, this is not a guarantee of authorization. that the stated intention of the policy is to move the market from a, you know, dominated by unregulated Chinese vapes to a more regulated market where most of what you see in the vape shop is stuff that the FDA has signed off on. It is clear that this was a response to the frustration that President Trump exhibited on this issue the other weekend. They were, moving quickly to try to carry out this aim of the Trump administration in a way that they had not previously done.

17:26And what about public health experts? What have they said about this policy change? Depending on where you sit, that could be a good thing that could help smokers who want to quit, or it could be a really bad thing. It could introduce people to nicotine addiction who didn't need to be addicted. And I talked to a former tobacco regulator at the FDA, Mitch Zeller, and he is very concerned about the substance of the policy because it's allowing all these products that have not been scientifically authorized by the FDA onto the market in a way that is not the intent of the law. And that's very concerning because now people will be potentially able to get products where the risks might outweigh the benefits.

18:20So he's very worried. And in addition, we have seen some vape retailers express assurance that there would be a lot more products coming their way. So according to Mitch Zeller, that could mean hundreds, thousands, or tens of thousands new products in the coming months. With McCary out, the White House has appointed Kyle Diamantis as the acting FDA commissioner. Diamantis is an attorney who'd been in charge of the agency's food division. He's actually proven quite popular with FDA staff. He's known as a level-headed operator. And what do you think the administration will be looking for in whoever runs the FDA next?

19:06I think it's pretty clear that the next FDA commissioner is going to have to be on board with carrying out this vision for vaping. This promise that the Trump White House has made to the vaping industry of saving vaping is not something that is going to be negotiable for the next commissioner.

19:39That's all for today, Tuesday, May 12th. The Journal is a co-production of Spotify and The Wall Street Journal. Additional reporting in this episode by Natalie Andrews, Laura Cooper, and Josh Dossie. Thanks for listening. See you tomorrow.

19:59Starting a business can seem like a daunting task, unless you have a partner like Shopify. They have the tools you need to start and grow your business. From designing a website, to marketing, to selling and beyond, Shopify can help with everything you need. There's a reason millions of companies like Mattel, Heinz, and Allbirds continue to trust and use them. With Shopify on your side, turn your big business idea into... Sign up for your$1 per month trial at shopify.com slash special offer.