Tobacco 21 and Flavor Restrictions: What Actually Happened?

ROBERT JOHNSON:
This is Public Health Review. I'm Robert Johnson.

On this episode: a new law raises the age to buy tobacco from 18 to 21; also, the FDA takes action, but will continue to allow fruit-flavored e-liquid and widespread use of menthol.

DAVID DOBBINS:
We believe that when you're called The Truth, you have an obligation to tell the truth.

DR. JONEIGH KHALDUN:
There's no question—this is a public health emergency. I don't know of any rise such as this that we've see with youth for using e-cigarettes that we have across the country. If this were anything else, we would already have gotten it off of the shelf. And, unfortunately, we have a lot of different stakeholders who see things, I suppose, a little bit differently, but there's no question this it's a public health emergency.

DR. MARCUS PLESCIA:
It quite clear that tobacco industry has targeted cigarettes that are made from menthol to African Americans. They've done that through a wide range of different marketing practices, whether it's TV, radio, print, and now social media. And they've been very explicit about marketing these products in specific neighborhood where they know that their demographic, in this case African American, are likely to live and come in contact with those advertisements.

JOHNSON:
Welcome to Public Health Review, a podcast brought to you by the Association of State and Territorial Health Officials. With each episode, we explore what health departments are doing to tackle the most pressing public health issues facing our states and territories.

Today: a new age restriction on the sale of tobacco is considered a strong move toward reducing use among America's young people—is it good for the states? We ask that question, and we discuss what's next in the fight against e-liquid flavors not addressed in these latest federal action.

The new year opens with the new law that all agree will help in the fight to get young people to stop using tobacco products. Tobacco 21, or T21, was signed into law by the president just before Christmas. Follow up guidance in early January from the FDA directs retailers to pull from shelves flavored cartridge-based products by February 6th.

Not included in the directive are tobacco and menthol flavors. Also spared are flavored e-liquid and disposable e-cigarette products; those remain available to young customers. Given all of this, we are considering what's next.

Three guests join us to discuss the ups and downs of these actions.

Dr. Joneigh Khaldun is an emergency room physician who directs public health efforts in Michigan; she brings the state view.

Dr. Marcus Plescia is chief medical officer for ASTHO; he's along with a historical perspective on flavors.

But first, we visit with David Dobbins, chief operating officer for the Truth Initiative in Washington, D.C., now in its 20th year working to prevent youth tobacco use with research and campaigns like this one aimed at kids who vape.

[The following is an audio clip from an advertisement]
"REPORTER":
In a wild turn of events, animals are demanding JUUL not test on humans. Mario?

"MARIO":
No one knows the long-term effects of JUULing, so when a human uses one, they're being used as a lab rat. Thank you.

"REPORTER":
Fact: no one knows the long-term effects of JUULing. Do you?

DOBBINS:
So, you all may recall, at the end of the nineties all the states attorneys general got together and they sued the tobacco industry. And what they were suing them for was all the Medicaid costs they had paid due to tobacco industry fraud and the tobacco industry's products. Miraculously, that group of attorneys general got together and formed a big global settlement regarding tobacco; and then, we were talking primarily about cigarettes and smokeless tobacco.

That agreement included a provision that funded a national organization whose purpose was to keep kids from taking up tobacco use, and that organization was us.

Originally, it was called the MSA Foundation, and then the American Legacy Foundation; but in 2013, in a nod to the work we've done through the Truth Campaign, which is probably the most famous thing that we do—it is a youth prevention campaign, people see the messaging in the ads on TV and have for many years—we'd decided to rename the organization Truth Initiative.

JOHNSON:
Tobacco 21 is now law, was signed just a few weeks ago now.

What's your reaction to all of that? Overdue?

DOBBINS:
It's great to see Tobacco 21 to be law of the land, and we've known for a few years now that having a strong tobacco 21 policy in place is a tool for reducing youth smoking. One of the things that happens with youth tobacco use, and we see this a lot in e-cigarettes, is social networks provide the product. So, as long as you know somebody who's 18 or older, they buy it for you, they buy it for their friends.

We see a lot of purchasing by those older people in the high school cohort, and they go on and they either give them to their friends for free—social currency—or they just actually sell them—entrepreneurialism.

21 sort of breaks that chain, and it takes it back up into college, and gets those kids in high school out of the ability to buy for their friends. It's an important policy—it's only a small part.

The one thing I think we worried about—first, we worried there would be a bunch of exceptions, that there would be grandfather provisions, and that there would be exemptions for military, or exemptions for this and that. Those didn't materialize. This is a clean law and it applies to sellers—it's not a penalty for people to buy, it makes it illegal for people to sell to people under 21.

That's a good law and we're happy to see it in place, but it's not a solution by itself. You still have to do taxes, you still have to take on things like marketing, you have to take on flavors—and those are policies that we really think the ASTHO membership can have a huge influence on.

JOHNSON:
Enforcement is an issue as well, right?

I mean, without somebody checking and holding people accountable, the law is just something on paper.

DOBBINS:
Well, there are a few things.

The FDA has made it clear that they believe the law of the land right now is that you cannot sell tobacco products to somebody who is under 21, and that's regardless of what state you're in. The FDA has enforcement powers, they have indicated that they're going to exercise those enforcement powers in all 50 states. They do owe more guidance on what they're going to do.

The states themselves should be enforcing that policy; I think there's a little bit of confusion at the state level on whether they have to enact their own legislation. They should, and the law calls for them to do so if they want to keep receiving certain grant funds from the federal government; but there's nothing to prevent them from enforcing the 21 now, especially against retailers and people who are selling tobacco.

JOHNSON:
Talk about the exceptions again.

Run through those with folks because they're all working to process this: some in the public health community probably have it memorized; others maybe haven't had as much time to go through it.

So, help us with what's not included.

DOBBINS:
So, 21 is just an age of sale, so it doesn't include what kinds of products are being sold.

I think something a lot of us in the public health community are worried about are the predominance of kid-flavored e-cigarettes, and we see things like Fruity Pebbles, we see things like—I think people say it all the time—unicorn vomit. If you look at the company names that are selling these things, they often are appealing to kids.

So, it doesn't include marketing or flavors, and that's something that the states can do and take leadership on. And we've seen some movement in the states: Massachusetts was the first state to prohibit the sale of flavored e-cigarettes; New Jersey has taken up the measure, it's sitting on the governor's desk; and we've heard that California and New York are giving a serious look at those policies.

We think those are important and, of course, the 21 Age of Sale law doesn't do that by itself.

JOHNSON:
You thought the feds would do more on this issue, at one point.

DOBBINS:
We hoped—based on the announcement from the president himself—that they were going to take flavored e-cigarettes off the market. And I think what's important here is what we were expecting wasn't a unilateral executive ban forever. What we're expecting is enforcement of the law as written.

The law, as it exists now, requires the FDA to review new tobacco products before they go on to the market—not after, before they go on the market—to make sure that they're appropriate, for the protection of the public health.

That hasn't happened; and in the absence of that requirement being followed, we see now almost 30% of high school students are current last 30-day e-cigarette users—not ever used it in their life but used it in the last 30 days—and we know that one million kids in the United States use e-cigarettes every single day.

What we were hoping for is literally what the administration promised in September, was a market reset. We have a complete failure right now: youth are using the product, adults barely use it at all; and if the promise of the product was that adult smokers were going to switch completely, the way we've rolled it out has been completely antithetical to that goal.

JOHNSON:
The kids like the flavors. That's the whole thing, isn't it?

[The following is an audio clip from an advertisement]
SPEAKER:
Big Tobacco wants you to see grape. What they don't want you to see are the 3000 chemicals underneath.

DOBBINS:
Flavors bring you in and it makes it look appealing, it makes it easy to use.

We found that, in one of our earlier surveys, that two-thirds of kids didn't even know nicotine was in the product. They just thought it was a goof that you did at a party.

JOHNSON:
Candy.

DOBBINS:
Yeah, just like candy, just a goof. What they didn't expect was it was going to deliver a super high dose of nicotine and a good portion of them were going to become addicted.

And we see a million kids using it every single day. That doesn't mean today a million kids used it; it mean a million kids every single day are getting up and using an e-cigarette and they're going to use it tomorrow and tomorrow and tomorrow.

And, anecdotally, we are hearing from youth that they're waking up in the middle of the night, they're nervous when they can't get it, they have trouble concentrating—we have teachers telling us they have to get up out of class in the middle of class or else they can't pay attention.

This is a real problem, and we should have had a market reset and, frankly, we're quite disappointed that it isn't what happened.

JOHNSON:
Your research is showing that more and more kids are trying this.

This is not a problem that's going away on its own.

DOBBINS:
Every year for the last two years, we've seen increases.

I would be delighted to see that number going down, but we have no information or indication that it's going anywhere but up.

JOHNSON:
Does this remind you of the battle 20 years ago to get underage smokers off tobacco>

Are we experiencing a Groundhog Day sort of scenario here?

DOBBINS:
I would tell you, in many ways, it's worse.

When I started in this job—or, more accurately, when Truth Initiative started this in 1999—the youth smoking rate was around 23%. Well, that was a number that had been going down for a few years before then. We had a peak in the early '90s; but by the time we started in 1999, really the wind was at our back.

The rate was declining, leaders at the state and local level were adopting things like taxation and then, later, clean indoor air policies. The entire mindset towards cigarette use was taking it from a cultural icon—what used to be the Marlboro man—and turning it into something that very few people used.

Right now, we're going up, or not going down. E-cigarettes are popular among kids, they're viewed as cool; they haven't quite figured out that they're being manipulated through a combination of marketing and addiction to become lifelong-dependent profit streams for companies like JUUL.

I hope we get that number down soon, but I'm concerned.

JOHNSON:
If you were here in Washington, D.C. last year, in 2019, and—like me—reading an old school hard copy of the Washington Post, there were a lot of full-page ads paid for by various tobacco companies, or vaping companies, or whatever, supporting the increase in the age to buy tobacco from 18 to 21.

Why did so many people get on board with that?

Did they think that was going to address some of these other issues, or was it—pardon the pun—a smoke screen?

DOBBINS:
So, in 1964, when the United States attorney general definitively linked cigarette smoking to lung cancer, the response of the tobacco industry was to launch full page ads in the Washington Post talking about their deep concern of the issue, and how they were going to study it, and how the United States could rely on the tobacco industry to be a partner in public health moving forward.

Simply put, that was a lie. It wasn't a smoke screen, it was a PR strategy developed specifically for the purpose of obfuscating and confusing. What we're seeing now is a more sophisticated page of that playbook, but the exact same playbook. You don't have to go very far in history to understand what's happening.

And I think—you know, my belief is that the industry goal is if they can persuade politicians that checking off this 21 box is sufficient, they can avoid more stringent policies like flavor restrictions, like real efforts to restrict the retail market so it's not going to children.

JOHNSON:
So, what do states do about that if they don't like that solution?

DOBBINS:
If they don't like what the federal government's done? Well, they can take actions like are happening in, like I said, in Massachusetts and New Jersey. They can restrict the market on flavors themselves.

And one thing we were saying—this was in San Francisco and it happened early—it was represented as an e-cigarette ban in San Francisco, but that's not actually what happened. San Francisco said unless a product has gone through the required FDA pre-approval process, we won't allow it for sale in our city.

The FDA itself says, and said repeatedly in the guidance that just came out, that there is not a single e-cigarette in the United States that is on the market legally. None of them have gone through the required pre-market procedures.

One approach states might want to take is say, we're just aren't going to let these products that haven't gone through the appropriate pre-market review into our markets. I think we have to motivate the FDA, the administration, and the tobacco companies to work together to really make that pre-market approval process robust.

Another thing that states can do is to just say these flavors are just inappropriate, they just have no place in our state. I think that is a completely reasonable point of view.

JOHNSON:
At some point, when dealing with underage smoking and tobacco use 20 years ago, most people—as I recall—got on board with the idea that we really shouldn't allow minors to do this, and we should not have a system in place that encouraged it or somehow permitted it, looked the other way.

We're not in that same frame of mind yet today, are we?

DOBBINS:
I think people are concerned about youth use.

I think one of the problems we have is cigarettes are really, really bad for you, and there's still a lot of adult smokers; and it is true that if you were to switch completely from a cigarette to an e-cigarette—if you were a smoker—you would drastically reduce your cancer risk. There are other risks that e-cigarettes bring that are different than what a cigarette would bring; but as far as cancer risk goes, that would be a good switch.

So, this issue of whether they are an off-ramp—is the word we hear a lot—for adults has clouded the issue about look at this gigantic on-ramp for kids. And I've heard a lot of people saying, well, we need to find a balance.

I actually agree with that, but the balance we found in the past is you go through proper FDA approval, you have stringent restrictions on how you sell nicotine products, you understand that you don't make public policy games for adults on the back of a massive child addiction.

That's what needs to happen here. I think we need to find a way to get the FDA to engage with these products as a potential therapy for people who really, really need it, who are smokers—but the answer isn't to put them in every 7/11 in the country and throw your hands up when 30% of the kids are using them regularly.

JOHNSON:
You have been on this case a long time.

Wrapping up, how do you see this story ending?

DOBBINS:
Well, I think in the end we will win. My concerns are how quickly will we get there.

As I said, it's taken a little over 20 years to get the cigarette level down from 23% to under 4%. That is a great public health victory.

I don't think we need another 20 years. I think we should be acting quickly to reverse the massive gains in youth e-cigarette use. And if we're acting responsibly, we should have things down to a reasonable level within three or four years, not another 20.

So, I hope we'll all work together at the state, local, and federal levels to make sure that happens.

JOHNSON:
Dave Dobbins, COO of the Truth Initiative, thanks for the time and for the hard work you and the team, here in Washington and around the country, are doing to get this problem under control.

DOBBINS:
Well, thanks to your membership, who have been great leaders in this issue; and I think, as usual in tobacco control, state and local officials will lead the way.

JOHNSON:
Emergency room doctors see everything: pain, severe injury, and frightening illness. This is the lens through which Dr. Joneigh Khaldun views the fight to get kids off tobacco, away from vaping, and the chemicals that can cause serious problems—even death. She's the chief medical executive and chief deputy director for health at the Michigan Department of Health and Human Services.

KHALDUN:
I think there's no question that these e-cigarette products were allowed on the market without enough regulation.

I think there's no question that the flavors play a huge role in why you are using these substances. You have bubblegum and Fruit Loops and whatever else—you name the flavor, you can find it. And there's no question that it's been targeted, somewhat unchecked, towards youth.

And when you add to that the fact that these devices are often easy to hide—you can put it, you know, in your pocket, you carry it and it looks like a regular pen—they are very easy to disguise. I think that's partly why we've seen significant increase among youth.

And also, quite frankly, the method thing. I think a lot of youth have probably used these products and they don't even recognize how bad and addictive this nicotine is.

So, I think there's multiple reasons why we've seen this significant increase in use in youths.

JOHNSON:
Now, the minimum age for tobacco sales just went up from 18 to 21.

What I'm hearing you say is that might be fine when you're talking about buying cigarettes; maybe not so helpful when it comes to these e-liquids, these flavors.

KHALDUN:
Yeah, you know, I'm pleased to see that the FDA has passed T21. Again, it's been a public health initiative, something that we've been wanting to have in also, quite frankly, the state of Michigan for some time.

I think it's an important step forward, but we also recognize that passing age restrictions alone is really not sufficient to get these products out of the hands of youth and much more is needed.

JOHNSON:
You recently testified before the U.S. House of Representatives on these issues.

What was the reception from members of Congress when you were here in Washington, D.C.?

KHALDUN:
Yeah, I think it was—well, first of all, it was really an honor to be able to testify about the impact of this epidemic across the country and specifically in Michigan.

I think it was very well received and I was excited that our legislators at the national level are very interested in this topic. They want to do what they can do to address it. So, I think it was well received.

JOHNSON:
Of course, Washington isn't the only place where action can be taken. States are allowed to put their own bills on the table and pass legislation, make their own laws.

What sorts of steps do you think states ought to be considering or taking as we look to, as a nation, bring down this growing number of youth using e-cigarettes, vaping?

KHALDUN:
Yeah. So, as you know, the FDA just put out this enforcement guidance when it comes to how they will be enforcing regulations around e-cigarettes, and I think what's clear is that there are many loopholes.

First of all, it's only non-binding guidance and that's very clear, it's actually written throughout the document that it's not binding.

But also, there's just so many loopholes, including the fact that it excludes menthol flavors, the fact that there are only going to be targeting cartridge-based systems, the fact that these flavors—quite frankly—will still be on the markets, and—I think importantly—it actually exempts disposable systems. So, systems like balloons and Posh Disposable and others that actually are cheaper and easier to use—I have every reason to believe that youth are going to be going towards these products now, based on this FDA guidance.

So, I think there are a lot of opportunities, actually, for states to look at closing up some of the loopholes that were left by the FDA's recent guidance on their enforcement priorities.

JOHNSON:
Run through those again for us.

Let's talk about each one.

KHALDUN:
Oh, there's many.

So, there's obviously the flavor restrictions. So, again, The FDA guidance only exempts tobacco and menthol flavors, so there's an opportunity for states to actually look at including both mint and menthol in their approaches to addressing the epidemic.

And there's a host of other things. You could focus on disposable products, right, making sure that these disposable products—flavor products—also are not accessible to youths. There's other things around taxes and prices and internet sales and looking at nicotine concentration—those are all things that are out there for states to look at.

But again, every state will have to look at their current landscape and what rules are already—laws are already—on the books where they are and take action to move forward. But I would say, I think it's important for every state health official to be looking at this and trying to understand what they can do to particularly address the ongoing loopholes when it comes to FDA enforcement and regulation of these products.

JOHNSON:
Of course, if all 50 States don't do this, then there will still be places where youngsters can do whatever they please take advantage of these loopholes.

But would you say any state taking action—whether it's five, six, 10, or 20—is better than none at all?

KHALDUN:
I think this needs to be a top priority for every state health official.

And again, speaking to my colleagues across the country, it absolutely is—the environment is different, the laws that are on the books currently in every state are different, so every state health official will have to look at their own landscape—but there's no question that this is a epidemic across the country and every state should be looking at what potential things they can do to protect our youth.

JOHNSON:
You do some work occasionally, I read, in emergency rooms even now.

What is that like when a young person comes in and, it turns out, at some point you discover they have been vaping, and all of this could have been avoided?

KHALDUN:
Yes, I do still practice, have the honor of practicing emergency medicine in the city of Detroit. And, you know, it's a heartbreaking when you see youth come in and they're using these products.

I've seen people come in who actually have injuries related to use of these products. It can often be challenging when you're in an emergency department setting to be able to connect people to resources so that they can stop using these devices. But it's incredibly challenging.

The good thing is healthcare providers are now aware of the dangers of vaping and e-cigarettes among youth. And so, I think there's an opportunity there for us to capitalize on that and make sure that we're engaging our healthcare providers in this broader public health conversation.

JOHNSON:
Unfortunately, given the politics that surround this issue, sometimes those solutions are clear, but getting them into law is another story.

KHALDUN:
It is, it is.

I mean, every state's political landscape is different. I like to think that public health should not be political. It's about what we can do to protect public health—that's actually our mandate as public health officials.

It's unfortunate when, sometimes, the best thing for health becomes political. But, again, to reiterate, it will be different in every state. But I think it's important that everyone on both sides of the political aisle look at what can be done to protect the public's health.

JOHNSON:
Given all of the challenges and the pressures and the opinions about this issue, how difficult is it to get something done?

KHALDUN:
It can sometimes be challenging, and that's just in general when you're working in public health and trying to do the best you can to protect the public's health. And, specifically when you're talking about youth, sometimes it can be somewhat disheartening, as challenging as it can be.

But I think we need to all think about the things that we have in common, aligned goals—again, I don't think anyone wants youths to be using these products.

And so, I think it's important that everyone just remembers that it's really about the youths, and we need to make sure that we're bringing forward evidence-based strategies; we are recognizing what's the actual potential purpose of these products may be and, quite frankly, what the intended purpose of these products are not; and making sure that we’re using data when we talk about our strategies for moving forward.

But it can be challenging, depending on your environment and your state.

JOHNSON:
Because the fact is this is a public health emergency. You've said so.

KHALDUN:
Absolutely.

There's no question—this is a public health emergency.

I don't know of any rise such as this that we've see with youth for using e-cigarettes that we have across the country. If this were anything else, we would already have gotten it off of the shelf. And, unfortunately, we have a lot of different stakeholders who see things, I suppose, a little bit differently.

But there's no question this is a public health emergency. It's touching every area of our state. There is no question about why it has happened, and I think we really have to make bold moves when it comes to stopping this epidemic in its tracks.

Again, it's not just about the youth of today: we're talking about brain development; we are talking about ability to learn; we're talking about youths who will be at higher risk as adults of being addicted to certain substances. Again, we're talking about an entire generation that is impacted by this, and we can't just sit idly by and not take bold action to address it.

JOHNSON:
Finally, a history lesson about flavors and the harm they do, especially to African American populations.

Dr. Marcus Plescia, chief medical officer for ASTHO, explains.

PLESCIA:
Flavors have been a very, very important strategy from the tobacco industry as far as attracting a wide range, different populations to using various tobacco products. And, probably some of the facts that it's been used in the African American community are the most egregious. And this is where menthol comes into play.

It's quite clear that tobacco industry has targeted cigarettes that are made from menthol to African Americans. They have done that through a wide range of different marketing practices—whether it's TV, radio, print, and now social media—and they've been very explicit about marketing these products in specific neighborhoods where they know their demographics—in this case, African Americans—are likely to live and see those and come in contact with those advertisements.

This has been going on for decades and it's concerning because not only does menthol and this marketing of cigarettes with menthol make cigarettes more enticing, potentially, they also make the smoke less irritating and it makes people more likely to inhale that smoke deeply, which is much more harmful than when it's not inhaled as deeply.

JOHNSON:
We should be upset about that, shouldn't we?

PLESCIA:
Yeah. I mean, there are a lot of practices that the tobacco industry has used that we should be upset about.

But this is a particularly concerning one because, you know, we're seeing it play out now. We're seeing much higher rates of tobacco-related illnesses in African Americans, like higher rates of cancer, particularly lung cancer, we're seeing higher rates of heart disease—and, you know, this is in a group that, you know, previously actually had lower rates.

So, they've been targeted to try to get them to smoke more. They have things like menthol and use it as an added enticement. And it's worked, and it's worked to their detriment. It's affected their health.

JOHNSON:
There's been a lot going on around this issue with the minimum age being raised and some flavors being pulled off shelves as we speak.

But menthol escaped that fate—that's a problem, wouldn't you say?

PLESCIA:
Yeah, that is a problem.

There's a lot of stakeholders who are interested in keeping menthol in cigarettes, and the tobacco industry is the biggest stakeholder. But a while back, when the FDA decided what kind of flavor bans they were going to enforce in traditional cigarettes—combustible cigarettes—they excluded menthol ban.

And so, when the whole discussion came up around electronic cigarettes, a lot of the tobacco control advocates very concerned about that and really pushed hard to make sure that menthol was included. But in the end, it was not.

JOHNSON:
Are states doing anything to deal with this omission?

PLESCIA:
Yeah. That's where we think the opportunity is to begin to fix this.

States can come back in and look at the laws and regulations that are being put in place federally—and it's good that we're seeing these things. I mean, there's been some good things that have come out of some of the federal legislation that'll be very helpful. But they can come back in and pick up some of the problems that we see, and the biggest problem we see is menthol. In Massachusetts, the legislature just acted to ban flavored electronic cigarettes and included menthol in that ban.

And so, what we are encouraging other state governments to do is similarly pass legislation that will clean up some of these issues—particularly that will include the banning of menthol not just in electronic flavor but in combustible cigarettes and in a lot of these other tobacco products like cigars and other things that people are smoking; because we don't want to eliminate menthol from one thing and that just pushes people to use some other products that might be even more harmful.

JOHNSON:
So, we might expect, then, more states to get engaged here in the near future?

PLESCIA:
Yes, I'm quite certain we are going to see more action on this.

JOHNSON:
The bottom line here then, for you—history tells us that these flavors discriminate.

Is that a fair statement?

PLESCIA:
Yeah, that is a fair statement.

And I think it's disappointing—this issue with menthol—because this is one of the situations where this disparity that we see—a significant health disparity that we see in the African American population—really could be addressed if we would address the menthol issue; that sometimes it's so hard to really close the gap on the disparities, but here's a really good opportunity to do so and, so far, we've missed it.

JOHNSON:
Look for links to more information about the topics addressed in this episode in the show notes.

Thanks for listening to Public Health Review. If you liked the show, please share it with your colleagues.

And if you have questions or comments, we'd like to hear from you. Email us at pr@astho.dog—that's PR at ASTHO dot org.

This show is a production of the Association of State and Territorial Health Officials.

For Public Health Review, I'm Robert Johnson. Be well.