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FDA News Release

Statement from FDA Commissioner Scott Gottlieb, M.D., on launch of ‘The Real Cost’ Youth E-Cigarette Prevention Campaign amid evidence of sharply rising use among kids

For Immediate Release:

In recent days, I’ve warned about an epidemic of use of e-cigarettes among teens. We’re in possession of data that shows a disturbingly sharp rise in the number of teens using e-cigarettes in just the last year. And none of the other metrics that we track when it comes to kids and tobacco are moving in a favorable direction.

Not the number of kids using traditional cigarettes, or cigars or chewing tobacco.

In short, there’s no good news.

We’ve had to start taking some actions before the final results of this data can be made public. We will make these results public very soon. But we have an obligation to act on what we know. And what we know is very disturbing.

Kids use of e-cigarettes has reached an epidemic level of growth.

I know there are some people who say kids will always experiment. And there will always be some teenage use. And in order to protect kids, we’re going to encumber adult smokers by putting in place restrictions that make these products less attractive, or harder to purchase by adults. These things may all be true.

But there’s a difference between some casual use by teens – a low level of use that we’ll never fully eliminate – and widespread abuse, misuse, and addiction, to nicotine by kids. The growth in use of e-cigarettes has reached a level that’s shocking.

And still, there’s a tiny fraction of people who will still say – so what. They’ll argue that nicotine use by kids is not a big deal if it’s delivered through an e-cigarette.

I am here today to say, they’re dead wrong.

We have data to show that use of e-cigarettes, while potentially posing much less harm than combusting tobacco, is not benign. It causes its own health effects. And nicotine use by kids is dangerous. It causes direct effects on their health and their brains.

Not to mention the risk of lifelong addiction.

There’s a large pool of nicotine users that’s being created among kids by these products. And some portion of them are at risk of transitioning to and risking addiction to cigarettes. The National Academy of Medicine report from earlier this year found that kids who use e-cigarettes are more likely to try combustible cigarettes. And that jeopardizes the extraordinary public health gains we’ve made in reducing smoking rates in this nation.

For all of these reasons, we’re committed to taking forceful steps to address the youth use of these products. And the manufacturers have a narrow window to act, or be acted upon. I’ll be meeting with the largest manufactures myself. And I’ll be delivering this message in person. I have broad support for the steps I’m taking. I won’t be deterred or obstructed. And I’m committed to seeing these actions to their conclusion. I won’t stop until this problem is solved. This may be the most important thing I can accomplish in my role as the agency’s Commissioner.

In the coming weeks we’ll be taking additional steps to confront these trends.

Among these steps, we’ll be continuing to investigate whether certain e-cigarette products are being unlawfully marketed.

And today we’re announcing another one in a series of actions we have underway.

More than a year ago, the FDA unveiled our comprehensive plan for tobacco and nicotine regulation. It was a broad policy to reduce the death and disease caused by smoking. We recognized then, and still believe, that e-cigarettes may present an important opportunity for adult smokers to transition off combustible tobacco products and onto nicotine delivery products that may not have the same level of risks associated with them. But at the same time, I’ve said all along, that opportunity can’t come at the expense of addicting a generation of kids on nicotine through these same products. And the numbers of kids now using these products is so large; it’s hard for me to understand how the manufacturers don’t know what we now know.

I’ve certainly heard from adult former smokers who say that they’ve switched to e-cigarettes.  I want to support these trends. But more and more I’m hearing from parents of kids who are addicted – telling me how easy it is for teens to buy these e-cigarettes, how the e-cig images are all over social media, how their kids tell them so many of their peer group in high school are using them. It’s not only the numbers I’m looking at; it’s the American families who are facing a lifetime of addiction and serious health risks for their kids.   

To address these trends, we’re expanding our Youth Tobacco Prevention Plan. We first announced that plan last April. It encompasses a series of steps to stop youth use of tobacco products, especially the rising use of e-cigarettes.

And it focuses on three key strategies.

First, preventing youth access to tobacco products.

Second, curbing the marketing of tobacco products aimed at youth.

And finally, educating teens and their families about the dangers of using any tobacco products.

Today, we’re advancing new actions to expand the third plank in that effort.

“The Real Cost” Youth E-Cigarette Prevention Campaign we’re launching today is a foundational component of the Youth Tobacco Prevention Plan, particularly in educating teens about the dangers of using e-cigarettes. It’s designed to communicate to teens in a compelling way about the risks of using e-cigarettes.

Research shows that, when done right, public health education campaigns are effective at reaching youth and educating about the dangers of tobacco. The new e-cig prevention effort builds off the FDA’s first youth tobacco prevention campaign, “The Real Cost,” which launched in 2014 to reduce teen cigarette smoking.

In its first two years, the youth smoking prevention campaign prevented nearly 350,000 teens from initiating cigarette smoking.

Half of these teens might have gone on to become established smokers.

Ultimately, the campaign saved these kids, their families, and society more than 31 billion dollars by reducing smoking-related costs such as early loss of life, costly medical care, lost wages, lower productivity, and increased disability.

The campaign will return $128 in cost savings for every one of the nearly $250 million in tobacco industry user fees invested.

These numbers are incredible. They’re clear indicators about the impact our public health education program is having on today’s youth.

But our efforts go beyond education. We’re also using our compliance and enforcement tools to target and restrict the sale and marketing of e-cigarettes to youth.

Just last week, we announced the largest coordinated enforcement effort in the FDA’s history. It resulted in the issuance of more than 1,300 warning letters and civil money penalty complaints to retailers who illegally sold e-cigarette products to minors during a nationwide, undercover blitz of brick-and-mortar and online stores.

The FDA also issued letters to the makers of JUUL, Vuse, MarkTen, blu e-cigarettes, and Logic. These are the five top-selling brands. They collectively make up over 97 percent of the U.S. market. We asked each company to submit plans within 60 days describing how they’ll address the widespread youth access and use of their products.

Their responses will be reviewed as part of our reconsideration of the current policy for noncombustible tobacco products such as e-cigarettes, particularly products with certain flavors, that extended the compliance date for submitting a marketing application until 2022.

Last week’s announcement was the first in a series of new steps that we’ve set in motion. And they build on the actions we’ve taken over the course of the past year.

In April, we issued warning letters to – and filed civil money penalty complaints against – more than 60 businesses that sold JUUL brand products to minors.

We also sent letters to JUUL Labs and several other companies requiring them to submit key documents to address the high rates of youth use, company marketing practices, and the problem of the youth appeal of their products.

In partnership with the Federal Trade Commission, we also targeted misleadingly labeled or advertised e-liquids resembling kid-friendly foods like juice boxes, candy and cookies.

Since then, the manufacturers, distributors, and retailers that were warned by the FDA have stopped selling products with the offending labeling and advertising. And last week, we sent a series of warning letters to other downstream retailers who continue to sell off these products.

We’re also exploring meaningful ways to make tobacco products less toxic, appealing, and addictive. These efforts focus on the youth appeal of these products. We’ll examine flavors and designs that appeal to kids and child-resistant packaging and product labeling to prevent accidental child exposure to liquid nicotine.

And the FDA issued an advance notice of proposed rulemaking (ANPRM) to seek public comment on the role that flavors in tobacco products play in attracting youth, while also determining their value to adults. We’re currently reviewing the comments on this and other ANPRMs. We’ll expedite the analysis of the comments on flavors.

Through these actions – and with more to come in the weeks and months ahead – we’ll drive down the rates of youth use of tobacco products, especially e-cigarettes.

We have to. The numbers of kids now using these products is unacceptable.

We can’t allow these trends to continue.

And remember, under the law e-cig manufacturers will basically need to show a net public health benefit in order to get authorization from the FDA to market their products. How challenging will that be for the e-cigarette products that are now being widely used by kids and given all the evidence of teen use?

These firms better take heed of these trends.

The problems seem to principally involve the closed cartridge systems, which have become popular among kids. To be clear, the FDA remains committed to the idea that e-cigarettes have the potential to help adult smokers transition away from combustible cigarettes. But we may have to narrow the off ramp for adults, to close the on ramp for kids. We make hard tradeoffs all the time. We’ll do it again if we must.

In closing, I want to commend the work done by our Center for Tobacco Products on this groundbreaking campaign. Our tobacco education program is one of the most impactful public health investments we’ve made at the FDA. I’m certain this campaign will play a central role in helping curtail the epidemic of youth e-cigarette use.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.



Michael Felberbaum

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