Weekend Law: Redistricting Frenzy & FDA Allows Flavored Vapes

30 May 2026 · 37 min · 18 chapters

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In short

Episode topic: Alabama congressional redistricting litigation after the Supreme Court’s Calais Voting Rights Act decision, plus an FDA policy shift allowing sale of certain unapproved flavored e-cigarettes and nicotine pouches.

Guest backgrounds

Richard Brafalt, elections law expert and Columbia Law School professor. Harry Nelson, healthcare attorney and partner at Leach Tishman Nelson Hardiman.

Key claims

Calais makes vote-dilution claims harder, but Alabama’s latest map was still found to involve intentional racial discrimination and unlawful vote dilution. The Supreme Court may be more likely to stay the injunction than reverse it, given tight timing and “Purcell” disruption concerns. Separately, FDA guidance deprioritizes enforcement against some unauthorized vaping products, effectively creating a “gray market,” despite youth appeal of fruit flavors.

Notable examples

Alabama’s 2023 map (six white-majority, one black-majority) versus a court-imposed two–black-majority-district map used in 2024. South Carolina declined to redraw its map. Florida litigation over DeSantis-era partisan maps. FDA authorized mango and blueberry fruit-flavored vapes; Durbin questioned NIH director Jay Bhattacharya.

Written by AI. May contain mistakes. Listen to the episode to check what was said.

Chapters

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Protests Against Redistricting in Alabama

0:31 to 1:08

A discussion on the protests and legal battles over Alabama's redistricting.

“Your team's feedback is scattered across emails, chats, and sticky notes.”

Protests Against Redistricting in Alabama

1:55 to 3:40

A discussion on the protests and legal battles over Alabama's redistricting.

“Are you ready to vote like you've never voted before because your lives depend on it?”

Legal Context of Alabama's Congressional Maps

3:40 to 7:30

Analysis of the legal history and implications of Alabama's congressional maps.

“So this latest Alabama case really is the ongoing saga of endless litigation following the 2020 census and Alabama's redistricting.”

Supreme Court's Influence on Redistricting

7:30 to 10:00

Exploring how recent Supreme Court decisions impact Alabama's districts.

“That was the result of the legislature's vote in early May.”

Implications of the Calais Decision

10:00 to 13:40

Discussing how the Calais decision affects voting rights in Alabama.

“Do you think the panel's findings will hold up under Supreme Court review?”

Implications of the Calais Decision

14:02 to 14:27

Discussing how the Calais decision affects voting rights in Alabama.

“Adobe Acrobat uses AI to take all your documents and generate a presentation with a single click.”

Integrating AI in Business

14:31 to 15:03

Discussion on how IBM integrates AI into their workforce operations.

“At IBM, we work with our employees to integrate technology right into the systems they need.”

Redistricting and Voting Rights

15:03 to 16:39

Analyzing the implications of the Supreme Court's recent decision on redistricting.

“Rights Act has set off a new wave of frenzied redistricting in states across the South, with Republicans scrambling to erase majority black U.S.”

Alabama Voting Map Controversy

16:39 to 19:26

Examining Alabama's emergency request regarding its voting map amidst legal challenges.

“That's effectively what they did three years ago.”

South Carolina's Redistricting Decision

19:26 to 22:40

Exploring South Carolina's decision to not redraw voting districts amid pressures.

“However this election is going to happen, I think the administrators need to know this already.”
Show all 18 chapters

Florida's Gerrymandering Issues

22:40 to 24:21

Delving into Florida's gerrymandering controversies and court decisions.

“But still, the judge said there was insufficient evidence of impermissible intent.”

Future of Redistricting Challenges

24:21 to 26:59

Discussing potential future redistricting efforts and their implications in various states.

“It could go to the Florida Supreme Court.”

Future of Redistricting Challenges

28:24 to 29:26

Discussing potential future redistricting efforts and their implications in various states.

“Being a small business owner isn't just a career, it's a calling.”

Future of Redistricting Challenges

29:29 to 29:39

Discussing potential future redistricting efforts and their implications in various states.

“The Chase mobile app is available for select mobile devices.”

FDA's New Guidelines on Vaping

29:40 to 34:08

Explore the implications of FDA's relaxed rules on flavored vapes.

“New FDA guidelines allow companies to sell unapproved electronic cigarettes and nicotine pouches, and that includes the fruit-flavored vapes that are especially appealing to kids.”

Impact of New Vaping Rules on Youth

34:08 to 39:44

Discuss the potential consequences of relaxed vaping regulations on young people.

“Hasn't the FDA resisted approving fruit flavored or candy flavored vapes?”

Mifepristone and FDA Authority

39:44 to 42:00

Examine the ongoing legal battles over the abortion pill Mifepristone.

“The same exact claim that was made in this case that the FDA improperly loosened the risk evaluation and mitigation studies, REMS, restrictions.”

Discussion on FDA's Political Pressures

42:00 to 42:18

Learn about the complexities the FDA faces in navigating political pressures and implications post-midterms.

“So, you know, the FDA is clearly under competing political pressures, and it's clearly a much more complicated landscape than a lot of people anticipated.”
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Transcript

Automatic transcript. May contain errors.

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1:51This is Bloomberg Law with June Grosso. From Bloomberg Radio. Are y 'all ready for this fight? Yes! Are you ready to use your voice? Yes! Are you ready to vote like you've never voted before because your lives depend on it? In Montgomery, Alabama, the city considered the crucible of the civil rights movement, thousands of people rallied this month to protest against the state's efforts to dismantle congressional districts that have black representatives. Civil rights leaders, Democratic members of Congress from across the country, union leaders and pastors denounced the Supreme Court's Calais ruling, which eviscerated the landmark Voting Rights Act, and set off a frenzy by southern states to reshape voting districts with large minority populations.

2:46New Jersey Democratic Senator Cory Booker compared Calais to past Supreme Court decisions like Dred Scott and Plessy v. Ferguson. You see, we have seen this before, where some people in black robes try to deny or take away our rights. But this week, a stunning legal victory for Democrats, as a panel of federal judges refused to let Alabama use a congressional map it adopted three years ago because it intentionally discriminated on the basis of race. The years-long legal fight over Alabama's maps includes several interventions by the Supreme Court, and Republicans are asking the court to intervene again and reverse this week's decision.

3:34My guest is elections law expert Richard Brafalt, a professor at Columbia Law School. Rich, there have been so many twists and turns in the fight over Alabama's congressional maps. Give us some of the background. It's incredibly confusing. So this latest Alabama case really is the ongoing saga of endless litigation following the 2020 census and Alabama's redistricting. Alabama has seven House seats. That didn't change as a result of a court decision some decades earlier. Basically, it has a white majority in six seats and a black majority in one. This was as of 2020, although the state is about 30 percent black.

4:14A Voting Rights Act case was brought challenging that. A three-judge court, that's the kind of court that's created when challenges to her districting are brought, found that Alabama had violated the Voting Rights Act, that it engaged in a legal vote dilution and ordered a new map. But the Supreme Court stepped in before the 2022 election and said, no, it's too close to the election, although it It was actually quite a number of months before. It was, I think, in the spring. But they said it was probably too close to the primaries. And so that case ultimately went to the Supreme Court. And many people surprised the Supreme Court by a vote of five to four in, I think it was 2023, voted to affirm what the Free Judge Court had found and just concluded that Alabama had violated the Voting Rights Act and indicated that Alabama probably should have two voters called opportunity districts, where black voters have a real opportunity to elect their candidate of choice.

5:05It went back to the legislature. The legislature, however, did not do that. The legislature basically came up with another plan, which was essentially six white majority, one black majority district. That was then challenged. And the three-judge court said, no, you have not complied with our ruling. This still is both dilutive. And we actually think it's unconstitutional because it reflects intentional racial discrimination. So they enjoined this new map that's sometimes called the 2023 map. And a special master created a map which created two black majority districts. One, I think, is just under majority, one just over in Alabama for the first time since Reconstruction elected two black representatives in 2024.

5:46Then at the end of April, the Supreme Court severely weakened the Voting Rights Act in the Calais decision. Tell us how that affected the fight in Alabama. The Supreme Court significantly, I think the word the court is using is updated its analysis of vote dilution claims under Section 2 of the Voting Rights Act, making it much, much, much harder for them to prevail. At that point, Alabama came in and said, you know, we want to reopen this case. And so what the Supreme Court had done in the earlier Alabama case is basically sustained the injunction that the lower court had issued barring Alabama from using its own legislatively adopted map.

6:25So they went to the Supreme Court, this is in either late April or very early May, and asked the court to lift the injunction on the legislature's 2023 map. The court agreed and said, we're sending this back to the lower court for them to reconsider their decision in light of our decision in Calais. They didn't say the lower court was wrong, but they just said, obviously, the legal rules have changed. We want the lower court to reconsider. While that was happening, the governor of Alabama called a special session of the legislature. At this point, primaries were already ongoing for the Alabama candidates for Congress.

7:00Basically, the governor said and got the legislature to agree to stop the primaries in four of the districts, the two black majority districts and adjacent districts, which would be most likely impacted by this and said, we really want to go back to the 2023 map. So they've now stopped the primaries in those four districts. And the legislature basically thinks that with the injunction lifted, the 2023 map, which is the legislature's map, which would be six majority white, one black majority district, and also for partisan purposes, likely six Republican and one Democratic. That was the result of the legislature's vote in early May.

7:38The plaintiffs who brought the original case then went right back to court before the three-judge court, which had imposed the map that was used in the last election. Will you explain the decision of the three-judge panel, which, by the way, consisted of two Trump appointees and one Clinton appointee? And that court issued a 103-page opinion where they concluded that the legislature's recent action was both unconstitutional and violated the Voting Rights Act, even under the Calais standard. And the court basically said the Supreme Court did not say that we were wrong before. They just said you've got to reconsider.

8:16And the court went through the entire process by which Alabama adopted the 2023 plan, including its refusal to create a second black majority district, the kinds of considerations it considered in its deliberations, and concluded that that was intentional racial discrimination. They then also applied the Calais standard and said Calais doesn't mean you never can prove vote dilution. And they found that given that there was intentional racial discrimination and given other factors and given just how much this appears to be driven by race and how much race is dominant in Alabama politics, that this really was more race than party and therefore violated the Voting Rights Act, too.

8:54And they also had some analysis about what's called the Purcell principle, which is the idea that courts should not step in and change the voting rules on the election. But of course, they pointed out it's kind of a mess as to what's the baseline here. Is the baseline the 2024 map, which is what the state was using up until early May, or is the baseline the map that the state has just reimposed? And the court said, going through the analysis that that case requires, we think the disruption is so great if the state's going to go back to that old 2023 map and that there's actually less disruption if they stick with the 2024 map.

9:30So they also felt that justified the injunction, just to kind of sum it up. In granting an injunction like this, the court has to consider both the substantive merits, but also whether an injunction is wise. And they said, yes, on the substantive merits, the Alabama plan is both unconstitutional and violates the Voting Rights Act. And on the rules for an injunction, we think actually that this is really preserving the status quo rather than disrupting it on the eve of the election. So 102 pages of opinion. Do you think the panel's findings will hold up under Supreme Court review? I think they did a good job.

10:06I mean, the real question at this point is how deeply is the Supreme Court going to get into reviewing this decision? I mean, the time really is tight here. And, you know, they make extensive findings of discrimination. Is the Supreme Court really in a position to reject those right now? They've done that in other cases. So I don't want to say they won't. There was a recent case from Texas where they basically rejected the lower court's findings without really much discussion. But they would have to do that. They would have to say that the finding of discrimination is wrong. And, you know, it's the Supreme Court.

10:44They could do it on the shadow docket in a precarious opinion with long dissents. They could. But I do think that the three-judge court went through the process by which Alabama did this in 2023, which is the map that would come into effect in great detail and spent a lot of time basically making their case for both intentional discrimination. and for trying to comport with Calais. And so they were seeking to be faithful to what the Supreme Court did. They were not saying, you know, we're not going to follow. They actually said that Calais gives greater weight to making sure the Voting Rights Act is closer to the Constitution.

11:22That really should only be applied in cases where there's reasonable suspicion of intentional discrimination. And they make that case. They also spent a lot of time trying to make the case that this was race and not party, even though the two are intertwined by talking about how in Alabama, even white Democrats find it hard to vote for a black candidate, how black Republicans don't do very well with Republican voters, and how there are many relatively socially conservative black Alabamians, but they vote Democratic because of the party's position on race issues as opposed to the Republican Party.

11:55So I think it's a struggle. The Supreme Court standard in Calais saying you have to show its race and not party is an incredibly difficult standard. And we'll see if the Supreme Court finds what this court did is persuasive. But they certainly spent some pages trying to make that case. The Supreme Court can't make new findings of facts. So what's the review process then? They'd have to decide what their weight is. The court went through blow by blow the process by which the legislature in 2023 enacted the map. It's kind of a funny case because the case comes up to the Supreme Court based on what the legislature did just like a couple of weeks ago.

12:32That's the one that basically said we're putting off the primaries. But it was the Supreme Court, by lifting the injunction, that put the 2023 map back into effect. So this case is very much about the 2023 map. And what this court gives a lot of weight to the fact that the legislature in 2023, when it was told to remedy a vote dilution finding, didn't really do that. That and the process by which they did it and the factors they cited and the findings they issued all smacked of intentional discrimination. So it's kind of weird because in some ways it's not really a review of what the legislature just did.

13:08It's a review of what they did three years ago. And the law has changed since then with Kelly. So it's kind of like putting yourself back into what things were like then and trying to figure out, was the legislature acting unconstitutionally when it did what it did in refusing to create the black majority district that they had been more or less directed to do? Okay, Rich, you're going to stay with me. Coming up next, we're going to discuss a possible easy Supreme Court out here and the frenzied Republican redistricting in the South. I'm June Grosso, and this is Bloomberg. What if you could have even more and more and more help to pursue your goals?

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14:24Do that. Do that. Do that with Acrobat. Learn more at adobe.com slash do that with Acrobat. So there's a lot of noise about AI, but time's too tight for more promises. So let's talk about results. At IBM, we work with our employees to integrate technology right into the systems they need. Now, a global workforce of 300 ,000 can use AI to fill their HR questions, resolving 94 % of common questions. Not noise. Proof of how we can help companies get smarter by putting AI where it actually pays off. deep in the work that moves the business. Let's create smarter business. IBM. The Supreme Court's decision last month severely weakening minority protections under the Voting Rights Act has set off a new wave of frenzied redistricting in states across the South, with Republicans scrambling to erase majority black U.S.

15:19House seats before the midterms. The only southern state that seems to be bucking the pressure from President Trump is South Carolina, where the Republican-led state Senate shot down an effort to redraw House districts. South Carolina Senate Majority Leader Shane Massey said there was no reason to redraw the state's maps. We are not Louisiana. We are not Alabama. We are not Mississippi. Our map is not unconstitutional. Legal challenges are continuing over redrawn maps in Alabama, Florida, Louisiana, Missouri and Tennessee. I've been talking to Columbia Law School Professor Richard Brafalt. Rich, let's go back to the Alabama fight.

16:05Alabama officials are making an emergency request to the Supreme Court to reinstate a Republican-drawn voting map after a panel of judges rejected the map for the third time as the product of intentional discrimination. against Black voters. Wouldn't it be an easier road for the justices to turn down the emergency request rather than reversing the panel's decision in what would be the first major test of the new standard that they've set in the Calais decision? On the other hand, they could, of course, stay it, which they've been known to do. That's effectively what they did three years ago. In the Milligan case, they stayed the court's decision, striking down the 2021 map, And then a year and a half later, they sustain the lower corporate after having blocked their decision for a year and a half.

16:54It is not out of the question, given that history, that they might stay this injunction, allow the election to go forward on the 2023 map, and then conceivably this case comes up on the merits next year. I mean, I don't want to predict that, but it's not out of a question that they would simply stay this, possibly on Purcell grounds. Purcell was the one about not acting too close to the election. But that itself is just a mayor's nest because, you know, that's always kind of figuring out what's the status quo. And is the status quo the 2023 map or is the status quo the 2024 map, which this would put back in?

17:35It's surprisingly complicated. Surprisingly complicated and seemingly never-ending. But as far as the Purcell principle is concerned, does the Supreme Court even consistently follow that? I mean, the Calais decision came down at the end of April, and look at the mess it's causing. They've been very vigorous about it sometimes, but it's not clear that they think it applies to them. It really is very much about lower courts. I mean, after all, Calais itself, as the mess we've seen in Louisiana and Alabama, Calais itself is kind of inconsistent with the Purcell principle. If they were serious about it, they would have said we're not going to apply it to this year or they would have decided much earlier or they would have waited until the election season was over.

18:18And because the Alabama governor has moved the special primaries to August, does that give the Supreme Court a little more breathing room? I guess, yeah. But they don't have a lot of time, I think. Because in order to have that primary in August, I mean, a lot of the opinion and a lot of the trial testimony in this case on this injunction was about how easy or hard is it going to be for the election administrators to redraw the lines and to basically to move around all of the voter information and make sure voters are in the right place, what their precincts are, and that they're voting in the right place.

18:52And normally this is a process that takes several months, but it would have to be done very soon because of the primary might not be until August. Candidates have to file before that. I don't know the details of the Alabama process, but we're now three, three and a half months before that primary. Typically, candidates need to file before then and know what districts they're running in. And the election commissioners, the state and local election boards need to have that done ASAP. And so I think, actually, if the court's going to do something here, I expect it'll be next week. I mean, they really don't have much time.

19:26However this election is going to happen, I think the administrators need to know this already. I mean, they need to know it yesterday. They said they need to know it very soon. And the candidates need to know it so they know where they're running. So hopefully, I mean, what day of the week is this? I mean, they really should do it over the weekend, but early next week. And obviously, this is while they're also doing all of their other major cases. And the three-judge panel heard testimony from Alabama's director of elections, who acknowledged that when the voter reassignment process is rushed, voters may accidentally be assigned to the wrong district and provided the wrong ballot.

20:01That's apparently happened before. And, Rich, there's been a lot of criticism of the Supreme Court calling the conservative justices out for this Calais decision. And it was 6-3 with the Democratic appointees in dissent. And if the Supreme Court reversed this Alabama decision, wouldn't it open them up to more claims of partisanship? Yeah, I mean, and again, I think maybe less likely to reverse it. I think a stay is more plausible, because in some ways that comes across as well. I mean, in some sense, it almost makes sense we don't have time to think about this. And it just really turns on what you think the status quo is.

20:38I think it would be hard for them to reverse it on the shadow docket because there's a lot of substance here. That doesn't mean they won't. I think a stay is more plausible because the state can emphasize, you know, the fact that these are hard issues, but that there's an election happening. And that the baseline is the 2023 map, which the state legislature did adopt, where the 24 map was imposed by a court or special master. and the Supreme Court has tended to prefer maps that were adopted by the legislature as opposed to court-imposed ones. So it would not surprise me if there was a stay. I think a substantive reversal would be a lot more work.

21:14Since the Calais decision, Southern states have been in a sort of frenzy to reshape voting districts to eliminate House seats held by Black representatives. But this week, South Carolina state senators adjourned without drawing up a new map to eliminate that state's one majority Black House seat. Five Republicans joined Democrats, basically saying it was too late because tens of thousands of votes had already been cast. And what would they do about that? Remember, it had already started in Louisiana when the state changed it. And I think it was about to start in Alabama. I do wonder about South Carolina, whether one thing is it may be that it's so late that Trump can't primary them, as he did the Republicans who didn't go his way in Indiana.

22:02And the other, of course, the district it's getting rid of was Jim Clyburn. He's in his 80s. He's an icon of South Carolina. It may be that they're kind of banking on him retiring or that it may be easier in a future year, like next year, to get rid of it. They might change it for 2028. And maybe at that point, it would give him kind of a signal to retire. And it would be more of a blank slate. They may not want to be seen as taking out, you know, kind of a longstanding, important figure in the state. And then it might be easier if he retires. Or if they rewrite the map, that might persuade him to retire.

22:38Right now, it's too late. And in Florida, where there are four seats that DeSantis created for Republicans, a judge who's a DeSantis appointee ruled that the state could continue to use those maps, even though they have a law against partisan gerrymandering, and even though a DeSantis aide who drew the new map said that he had done so based partly on the partisan breakdown of voters. But still, the judge said there was insufficient evidence of impermissible intent. And he also cited the Purcell principle to keep in place the map that just was made in May. That is a problem with the Purcell principle, is that it only applies to courts.

23:22It doesn't apply to legislatures. So they can do whatever they want. And indeed, you see the Alabama three-judge courts sort of basically saying, well, the reason we're doing this is at this point, we're concerned about the disruption caused by the legislature. So we're not so concerned about our disruption, because for one thing, also, the plaintiffs came to court instantly. The other thing that I found troubling is that he raised some questions about, in some sense, the constitutionality of the Florida constitutional provision that bars partisan gerrymandering because it was enacted as part of a general provision dealing with districting, and it provided for some attention to race.

23:57And he suggested, well, maybe that's unconstitutional now after Calais, which I don't know that that's right, but he raised that question. And if that's the case, the whole amendment fails. I mean, again, it's a pretty audacious argument to say that both the tension to race that the Florida Constitution has is unconstitutional, but then to say that the fact that that part might be taints the entire amendment. And so you can't even enforce the anti-partisan part, leaving aside his factual finding. Now, he is only an intermediate judge. It could go to the Florida Supreme Court. Again, they have the same timing problem.

24:31And of course, again, it is a court. I think all the judges are Republican and many of them, if not most of them, were probably appointed by Governor DeSantis. Yes, all of the judges are Republican, and six out of seven were appointed by DeSantis. So that looks like an uphill battle. Finally, once the primaries are over, do you think candidates that lost their seats because of this redistricting to eliminate black majority districts have any challenges they can raise? I mean, I think these litigations are all going to be resolved very soon. Courts are going to stop hearing them, and it is May going into June.

25:08I don't think that's going to be the issue. I think whoever wins is going to win. I do think we may see still more redistricting next year for the ones that was too late this year. You know, I think Maryland, where the Democratic legislative leadership declined to get rid of the remaining Republican seat after what happened in the other states. And after Calais, they now seem inclined to do that. It's possible that New York will do it. I think we will see at the end of the current legislative session, New York would require a state constitutional amendment that requires action by two legislatures and a voter approval.

25:42I think we will see your New York state legislature pass several alternative constitutional amendments. And then next year, which is the year they really have to make up their minds, pass one of them and send it to the voters in 2027, which would allow changing the congressional districts in New York. Maybe now Indiana, now that Trump has gotten rid of some Republicans, they might come back and get rid of a Democratic district. And maybe South Carolina will change. So I think we're not done. And what about in Virginia, where the state Supreme Court there voided a statewide referendum? Can Democrats try for a redo there?

Read the full transcript

26:19They might try again. I mean, I think it was a Herculean effort in Virginia to get through what they got through and then to have the court throw it out. I would say technicality was a real technicality. I mean, very technical, somewhat similar to the New York issue about it has to have been done between elections. It's conceivable, but it was really hard for them not to pass it in the first place. So who knows? But they might try again. Yeah. So I don't think we're done on this. I think we may hear more from the blue states. This is one area where you can directly see the effects of Supreme Court decisions over the years, weakening protections of the Voting Rights Act.

26:54Thanks so much, Rich, for your insights in this complicated area. That's Professor Richard Brafalt of Columbia Law School. Coming up next on the Bloomberg Law Show, for the first time, the FDA allows the sale of unapproved e-cigarettes. I'm June Grosso, and you're listening to Bloomberg. Sending a file is easy. Making sure your clients understand the file is the hard part. But with PDF spaces in Adobe Acrobat, you can give your clients the full picture with custom intros, audio summaries, and a helpful AI assistant to your docs. So if you want to stop the endless follow-ups, do that with Acrobat.

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29:16Their online resources are always available to give you the solutions you need to help your business thrive. See how your business can get stronger and go farther with Chase for Business. Learn more at chase.com slash business. Chase for Business. Make more of what's yours. The Chase mobile app is available for select mobile devices. Message and data rates may apply. JPMorgan Chase Bank N.A. Member FDIC. Copyright 2026. JPMorgan Chase and Company. New FDA guidelines allow companies to sell unapproved electronic cigarettes and nicotine pouches, and that includes the fruit-flavored vapes that are especially appealing to kids.

29:58This breaks with longstanding FDA policy requiring scientific verification before any new products are introduced. Senior officials in the agency's tobacco center were blindsided by the new guidelines, according to the Associated Press. And earlier this month, the FDA authorized the sale of mango and blueberry-flavored vapes, the first time fruit-flavored vapes have been authorized. At a hearing last week, Democratic Senator Dick Durbin of Illinois questioned the director of the NIH, Dr. Jay Bhattacharya, about the FDA's actions. Do you realize that the announced policy of this administration within the last two weeks is going to make it easier for these companies to peddle fruit monster vaping, candy king vaping, raspberry slushy vaping to our children in junior high and high school now?

30:53Senator, I think that vaping for for kids is a dangerous thing. And I think that the role of the NIH isn't to set policy, it's to do research to document the ways to address these health problems. But you've conceded the obvious. They're peddling flavors that attract children, children who don't have the maturity to make the decision, and they become addicted to a product which is dangerous to them. Of the more than 1.6 million middle and high school students who currently vape. Nearly 90 % use flavored e-cigarettes, with fruit flavors being the most popular. My guest is healthcare attorney Harry Nelson, a partner at Leach Tishman, Nelson Hardiman.

31:35Harry, tell us about these new rules. So we have this law, the Tobacco Control Act, which requires that new tobacco products can't be legally marketed without pre-market authorization. And the law gives the FDA the power to deny this pre-market authorization unless there's a showing that the product would appropriately protect the public health. And so what's happened now is that the FDA put out a guidance statement that it's not going to prioritize enforcement against certain unauthorized e-cigarette products and nicotine, oral nicotine pouch products. Meaning the government basically said, even though these products are not legally on the market, the government is not going to go after them.

32:19And this breaks with the FDA policy of requiring scientific verification? Yeah, this is definitely a relaxation of the federal policy of being tough on tobacco products and being concerned about public health. And it's basically the FDA saying this is a low priority. And even though what you're doing is not legal, let's call it at best gray market, These products can stay on the shelves of stores, even though they're still in scientific review, even though the FDA has not ruled on them. And this is really a flip from where we were just a year and a half ago, where the FDA rejected the idea that having an application on file was sufficient to create a safe harbor to allow these products to be out there.

33:03So previously, the FDA would not allow these products to be on shelves. And now it sounds like the enforcement climate has really completely gone 180 degrees. And the FDA is going to basically soften this position and allow a new lane kind of for gray market tobacco products. I mean, is this odd timing because it was posted just days before the former FDA commissioner resigned? Yeah, it definitely seems like this kind of reflects a little bit of the chaos that is going on in the FDA. A lot of the reporting around the story has emphasized that the senior leadership and the staff within the FDA tobacco center were basically blindsided and that this appeared just before Commissioner Macari resigned.

33:50So there seems to be a lot of upheaval and a little bit of chaos at the FDA. And certainly nobody who's in the tobacco regulation group at the FDA saw this coming or seems to be supportive of this new relaxed action. So the FDA spokesperson said this approach strengthens protections against youth nicotine addiction while supporting evidence-based alternatives for adult smokers seeking to move away from combustible tobacco products. Yeah, it's interesting. Certainly, even the folks in the administration who are supporting the relaxation of tobacco are trying to emphasize that this is for adult products and that they are not loosening standards on tobacco products that are being used by minors.

34:35So they're trying to, you know, still reserve the right to be more aggressive in enforcement against products that appeal to teens and to focus on just letting adults have more leeway and just not investing enforcement dollars into this product market. Hasn't the FDA resisted approving fruit flavored or candy flavored vapes? Because those are the flavors that attract kids. I mean, the Supreme Court even heard a case and upheld the agency's authority to deny marketing applications for fruit and dessert flavored e-cigarettes. So why now? Right. By the way, there's something like over 40 e-cigarette products and already 20 of these like flavored pouch varieties out there.

35:22I think the FDA has been trying to walk a line and I think the line shifted a little bit this week. But I think even now, you know, the administration's position is that protecting teen smokers from products that are clearly appealing to kids is still a problem and still something they're going to pursue. But the real message that they're trying to emphasize, I think, was loosening the rules on adult tobacco products. The number of underage vapors has gone down. Still about 1.63 million middle and high school students currently vape. That's a decrease from 2.13 million in 2023. I don't know if that plays any part in this.

36:03A lot of the efforts of the last couple of years have definitely reduced use, particularly in and around schools. There was a lot of attention, obviously, to the nicotine addiction risk, the potential effect on brain development of anxiety and ADD, ADHD, mood issues coming up from these and just the kind of significant marketing. And we saw a lot of schools crack down on this. We saw like social media, you know, sort of really tamping down. So it would not surprise me if there has been a reduction, although I think there still is clearly a significant use of flavored disposable vapes among teens and still a problem of social networks being used to get kids who are too young, getting them vapes.

36:48There still is a problem of illegal retail sales happening. And I think, honestly, one of the big pieces of the story is that we're going to see states particularly filling the void. You know, as we've seen in other areas of federal enforcement, when the federal government sort of steps back a little bit, we're going to see many states kind of step up and crack down much more on this. Harry, I'm wondering if these new rules have anything to do with Trump, who, when he came to office, promised that he would save the vaping industry and big tobacco companies have made contributions to Trump and his causes.

37:26There's no question that this is a case where the federal government is sort of throwing a bone to the tobacco industry, that they're really giving them a little bit of room here to ramp up sales and signaling kind of a more permissive environment. So I do think this is clearly a big win for big tobacco and a setback for everybody invested in, you know, public health sort of anti-tobacco efforts. So, you know, particularly companies that have applications pending are going to benefit by being able to promote those products more. They don't have to be as nervous about the unapproved status of their applications.

38:03So those are going to be the biggest winners within the tobacco industry. Because I can't think of any reason to do this as far as public health is concerned? You know, I think this is a little bit of a signal that the federal government is kind of moving out of, I don't know what you want to call it, the nanny state. A lot of the public health protections where we've seen federal stepping back have been about individual choice, even where it's not consistent with public health, right? We've seen that with like federal rollbacks on environmental and climate regulation, Right. I think we see that the states are getting more aggressive and in a lot of directions, the federal government's moving in the opposite direction.

38:44And I think it partly is about some skepticism about broad federal administrative power. And when people particularly on the right are talking about smaller government, part of what that means is less activist laws limiting commerce. Right. I think this is one of those examples. Harry, let's turn to another issue around FDA approval and the authority of the FDA concerning Mifepristone, the most widely used abortion pill. And about two weeks ago, a divided Supreme Court continued to allow Mifepristone to be dispensed by mail. But the fight over Mifepristone is going to come back to the court, isn't it?

39:23I mean, my read on the Supreme Court decision is that clearly the Supreme Court does not want to revisit this. But clearly, you know, the states remain very actively involved in it. And so this is definitely not going to be the last case where the Supreme Court is dealing with mifepristone. The states are still going to keep arguing that the FDA is exceeding its authority under the Food, Drug and Cosmetic Act. The same exact claim that was made in this case that the FDA improperly loosened the risk evaluation and mitigation studies, REMS, restrictions. And we're going to see, you know, continued fights, right, about how much deference the court should give the FDA on its scientific judgment.

40:06And we're still going to see activist states, abortion restrictive states, arguing that they have the right to second guess the FDA and that they can override kind of a national drug approval based on their state policy. So we're still in this environment where the states are increasingly trying to compete in their different, you know, regulatory frameworks for this. And we're going to continue to see a number of states trying to be more restrictive, blocking mailing, blocking telehealth access. And this issue is not going anywhere. And, you know, I think for people on the reproductive rights protection side of this fight, I think it is good news that the Supreme Court is at least holding true to what it said when it repealed Roe v.

40:50Wade, which was that it really wanted to send this issue back to the states and wasn't going to, you know, to intervene to support broader restrictions. So this is at least one way in which the Supreme Court has lived up to that signal that it gave. And so I do think it's a positive sign that the Supreme Court is not wanting to get in the way of the FDA, not wanting to get in the way of pharmacies. And how many studies were done showing that mifepristone is safe? But now the FDA is doing a new study. And Bloomberg News reported in December that the FDA was slow walking its safety study until after the midterm elections, although Health and Human Services denied the report.

41:34Yeah, it's very interesting. This is clearly a place where the administration is not in a hurry to create political upheaval. Obviously, this issue has been such a galvanizing one in past election cycles. You know, I think a lot of people have thought that this administration would reverse on the safety and effectiveness of mifepristone. It's been, by the way, 26 years since clinical review, and really there is no record of serious adverse events. So, you know, the FDA is clearly under competing political pressures, and it's clearly a much more complicated landscape than a lot of people anticipated.

42:09I guess we'll find out more about that after the midterms. Thanks so much for joining me, Harry. That's health care attorney Harry Nelson. And that's it for this edition of the Bloomberg Law Show. Remember, you can always get the latest legal news on our Bloomberg Law podcast. You can find them on Apple Podcasts, Spotify, and at www.bloomberg.com slash podcast slash law. And remember to tune into the Bloomberg Law Show every weeknight at 10 p.m. Wall Street time. I'm June Grosso, and you're listening to Bloomberg.

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