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The Food and Drug Administration will begin regulating e-cigarettes and cigars the same way it regulates cigarettes and smokeless tobacco. About 2.5 million high school students or middle schoolers vaped at least once in the last month; now e-cigarettes can no longer be sold to people under 18. Hari Sreenivasan talks to Mitch Zeller of the FDA for more on the new policy.
There'll be no more e-cigarette and cigar sales to people under the age of 18. Federal oversight of the growing industry was announced today by the Food and Drug Administration.
They've been around since 2006, but until now, they were largely un-regulated. E-cigarettes turn nicotine into an inhalable liquid vapor, but without the tobacco in regular cigarettes.
With blue e-cigs there's no tobacco only vapor.
Ads for the products tout benefits, using celebrity endorsements, like this one from actress Jenny McCarthy. In fact, there's no scientific consensus on benefits, or potential harm.
But Health and Human Services Secretary Sylvia Burwell says the industry will now be regulated, citing its rapid growth among teens.
SYLVIA BURWELL, Secretary of Health and Human Services: Between 2011 and 2015, the percentage of high school students who smoke e-cigarettes has skyrocketed over 900 percent. Meanwhile, hookah usage has risen significantly among young people and cigar smoking continues to be a problem among high schoolers. Together, that means millions of kids are being introduced to nicotine every year, a new generation hooked on a highly addictive chemical.
Manufacturers, many of them small companies, will have to undergo a lengthy federal review in order to stay on the market.
In response, Gregory Conley, president of the American Vaping Association, said today, quote, "If the FDA's rule is not changed by Congress or the courts, thousands of small businesses will close in two to three years."
House Republicans have their own answer: a bill to curb retroactive safety reviews for e-cigarettes and cigars.
(TOBACCO FREE CALIFORNIA AD)
Meanwhile, some states have launched ad campaigns against teenage use of e-cigarettes. And yesterday, California became the second state in the nation, after Hawaii, to raise the smoking age to 21.
The use of e-cigarettes among youth keeps rising. The latest estimates from the CDC show about 2.5 million high school students or middle schoolers vaped at least once a month.
Mitch Zeller is the FDA's point person on today's decision. He's the director of its Center for Tobacco Products. And he joins us.
What's the exact health risk you're trying to prevent?
MITCH ZELLER, Food and Drug Administration: No child, no teenager should be exposed to nicotine. Nicotine is addictive. E-cigarettes have nicotine in them. Kids should not be inhaling those products into their lungs.
There is a separate debate about whether e-cigarettes have a public health benefit to some current cigarette smokers who might be able to use the product to transition away from harmful cigarettes, but there should be no harm reduction questions about kids. Kids should not be using e-cigarettes and today's action will take this product out of the Wild Wild West of unregulation into the world of being regulated.
But are you concerned it could have a chilling effect on the people trying to transition away from conventional cigarettes using this as a way to step down?
FDA is a public health protection and consumer agency and we will make policy where the science takes us. The fact is that 70 percent of all adult e-cigarettes consumers today are still smoking cigarettes together with their e-cigarettes. So, we don't know if they're transitioning away from e-cigarettes or if along the way, 70 percent of all adult e-cigarette users are still smoking cigarettes, they're losing interest in quitting conventional cigarettes.
So, how do we measure all this, where's the science behind exactly what's happening, how the behaviors are changing?
FDA is making a massive investment in what we call the regulatory science to get answers to two fundamental questions — who is using products like e-cigarettes and how are they being used? We are following 46,000 children and adults to get answers to questions which products are you using, why are you using them, and how our patterns of use changing?
So, the industry is also pushing back as expected. And saying, look, the fees and the process and structure you have for the applications is going to essentially close down some of those small businesses and small manufacturers and it's essentially going to protect the big tobacco companies that have shifted and you really will be giving them an advantage over the long haul.
This is a public health issue. Beyond e-cigarettes we're talking about the need to regulate cigars. Every single day, more teenage boys light up a cigar for the first time than light up a regular cigarette. So, between cigars and e-cigarettes, we have a lot of work to do to protect kids from the harms of tobacco products.
There are costs that are associated with becoming regulated. We have tried to address the concerns of small businesses. And I disagree with the assessment that this is an industry that's going out of business. They may have to transition away from the conventional model that we see in a typical vape shop, but there is time to submit the applications, time for us to conduct our reviews and we'll take it as it goes.
Some of the health advocates are saying, listen, there is almost too much time involved, there's up to three years and some of these folks can continue to sell their wares that they are selling today, knowing that at that point is when they have to sunset their business.
And that's what we've done today is reasonable and sensible regulation. We received over 135,000 comments as part of our rule making process. And on the issue of flavors in e-cigarettes, we got comments across the board, from public health groups that said flavors should be band, to users of e-cigarette who said, anecdotally, that's what got me off cigarettes.
So, we think we've struck the right middle of the road here. The key point here is that what FDA has done today is foundational. Finally, e-cigarettes, cigars and hookah will be regulated by the Food and Drug Administration.
If you know what attracts the young kids is the flavors, why not have something that addresses the flavors today?
We will be able to address the rule of flavors in each and every one of the applications that the companies submitted for marketing authorization, and they will have to answer our questions about what role are the flavors in your products playing in initiation by kids and initiation by anyone who's never used the product? We'll be able to handle that through the applications.
There is also concern there is a grandfather date going back to 2007. It's essentially saying we're going to start the rule making back then. Well, are you maybe protecting devices that were more dangerous and didn't have to comply with the rules that you're imposing today?
The grandfather date is a legislative and legal issue, and what we said is that, as a regulatory agency, we can't change the date by which certain products would receive grandfather status and be exempt from pre-market review. What some in industry are trying to do is advance the grandfather date in a way that we think and the administration thinks will be harmful to public health by forever exempting all currently marketed e-cigarettes and cigars from a pre-market review by the Food and Drug Administration. We think that would be bad for health.
If Congress can change the date in one direction, they can change it in the other. What happens to the entire force of the law if that grandfather date is moved to, say, 2016?
If that legislation passes, we think that public health will be harmed because one of the most important responsibilities that Congress gave FDA was to apply public health principles to determine which products would be authorized for marketing. If they received grandfather status and we don't have the opportunity to apply those public health principles, we don't think that's good for public health.
Mitch Zeller from the FDA — thanks so much for joining us.
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