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The U.S. Food and Drug Administration announced today that it intends for the first time to regulate the ever-growing business of electronic cigarettes. Sales have grown to $3 billion a year. And some public health experts are worried about its rise.
The number of middle and high school students using e-cigarettes doubled between 2011 and 2012. Under the new rules, sales would be banned to anyone under the age of 18. Companies would have to register their products and ingredients with the FDA, but they can continue marketing to adults.
New regulations would also apply to cigars, pipe tobacco and hookahs, or water pipes, for the first time.
There are many questions about the agency's approach.
Mitch Zeller is the director of the FDA's Center for Tobacco Products. And he joins me now.
Welcome to the NewsHour.
MITCH ZELLER, Director, Center for Tobacco Products, Food and Drug Administration: Thank you, Judy.
So, right now, there aren't regulations governing electronic cigarettes. Why was it necessary to put some on now?
Congress put FDA in the business of regulating cigarettes, smokeless tobacco in 2009, and has a definition of a tobacco product in this law that didn't include e-cigarettes, cigars, pipe tobacco, but gave FDA the authority, through rule-making, to expand its jurisdiction to meet other products that meet that definition of a tobacco product.
What we did today was a historic announcement that says we're proposing to expand our authority to cover e-cigarettes and these other categories?
So we know research is still under way. You at the FDA talked about that today. But what is known right now about the health concerns around these electronic cigarettes?
It's the Wild, Wild West. It's buyer beware.
We have e-cigarettes that are exploding in car chargers, e-cigarettes that are exploding in wall sockets at home when people try to recharge them. We have e-cigarette users who are saying, this is the greatest thing that I ever had. It has helped me get off cigarettes.
And, as you said, we have a doubling of the number of middle and high school kids who used the e-cigarettes between 2011 and 2012. It's going in all different directions. And there's absolutely no regulation of manufacture, sale of distribution of these products.
So what effect do you think rules — and, granted, there's a reaction period, a comment period.
But once these are effect, assuming they go into effect, what will change, do you think?
FDA is a science-based independent public health agency.
And when this rule goes final, we will be the gatekeeper standing between the companies, their product developers, their marketers and consumers. And we will be the ones to make the decisions on whether health claims can be made. We will be the ones to make decisions reviewing evidence on whether new products can come to market.
Right now, none that is in place because these products aren't being regulated.
So, let me just — there is a lot of comment already about what was said at FDA.
Let me just read you a couple of comments. This is someone who is normally a friend of the administration, Senator Dick Durbin, Democrat of Illinois. He had been pushing the FDA to do something about e-cigarettes. He called your announcement today — and I'm quoting him — "a political compromise with the tobacco industry."
Is he right?
Well, the senator is obviously entitled to his position.
What we have done today with this proposed rule is foundational. We can't get to issues like advertising on television or what to do about the flavors in e-cigarettes until we have jurisdiction over them. And we can't have jurisdiction over them until we complete this rule-making. This is a very important first step.
So are you saying this was as far as you could have gone right now?
This is as far as the regulatory science can take us.
Think of it as a foundational step that will enable to us address all the other aspects of e-cigarette sales, cigar sales, etcetera.
And I ask that because another — another part of Senator Durbin's comment, he talked about the fact that you — there's still going to be marketing of these candy-flavored electronic cigarettes that children, young people will be exposed to.
And he basically said — in fact, again, quoting — "Parents across America — across America lost their best ally in protecting their kids from this product."
Well, I really respect the senator's point of view.
But there needs to be an understanding that in order to ban flavors in e-cigarettes, that requires an entire separate rule-making, which we can't do until we have regulatory authority over these products. We are concerned about the marketing and the appeal of e-cigarettes to kids. We need the regulatory authority over the products in the first place to address those kinds of issues.
We — you also today — in addition to e-cigarettes, you issued regulations surrounding cigars, as we mentioned, pipe tobacco, hookahs, the name for the water pipes. Why move into that area, an area that FDA had not been in before?
There is good news from a public health concern.
The consumption of cigarettes is down. The bad news is, the consumption of all these other products is up. And none of these other products are being regulated by FDA. Our job is to regulate all the products that meet the definition of a tobacco product, and that's we have proposed to do that today.
But you didn't — I was reading that you excluded, for example, certain kinds of hand-wrapped, hand-rolled cigars. How did you decide what you wanted to impose regulations on and what you wouldn't?
Well, with cigars, we have actually proposed a series of options.
Under one option, all cigars would be included. And in response to things that we heard about something that might be unique about premium cigars, different pattern of use that might have different impacts on public health, we put another option out there that would exempt premium cigars. But these are all regulatory options for the public to comment on.
I just finally want to ask you — again, in reading what manufacturers had to say, a number of them said they are concerned, they're worried, concerned about what this could mean. But several of them said they don't have a problem with this.
One I saw called this very encouraging. Does it is a something that some manufacturers think it's a good idea what you did today, that maybe it's not tough enough?
I leave that for others to judge. And it's a proposed rule, and any interested party can comment on it.
The bottom line is tobacco use remains the leading preventable cause of death and disease in this country. And when these rule goes into effect, we will be doing more to protect the public from the harms of tobacco use than ever before.
Mitch Zeller, you are the director of the Center for Tobacco Products at FDA.
We thank you very much for being with us.
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