Editor's Note:
Tobacco is clearly in the news! On February 4, the US Food and Drug Administration (FDA) launched a major anti-tobacco campaign aimed at teenagers. Teens are the focus of much tobacco advertising and serve, unfortunately, as "replacement customers" for the adults who have quit the habit.
According to an American Academy of Pediatrics (AAP) press release praising this FDA effort, studies show that almost all smokers have their first cigarette before the age of 18 years. Each day, 3200 children and teens in the United States smoke their first cigarette, and 2100 youth and young adults become daily cigarette smokers. Each day, the tobacco industry spends almost $23 million on advertising and promotions. The campaign is the first of several scheduled to be launched over the next 2 years that will target at-risk, rural, gay, African American, and American Indian youth.
On the heels of this announcement, CVS Caremark Corp said that it would stop selling tobacco products at its 7600 stores by October 2014, becoming the first US drugstore chain to take cigarettes off the shelf. Public health experts and the broader medical community applauded the decision by the #2 US drugstore chain, calling it a precedent-setting step that could pressure other stores to follow suit.
Medscape spoke with Mitch Zeller, JD, Director of the FDA's Center for Tobacco Products, about the campaign and other efforts to end use of tobacco.
Medscape: Can you speak about the broad parameters of this new campaign and the evidence used in its creation? What strategies are being used to reach teenagers? How will the impact be assessed?
Mitch Zeller, JD
Mr. Zeller: FDA has launched The Real Cost Campaign for one fundamental reason: Ninety percent of all adult smokers started smoking before the age of 18 years, and we know how harmful tobacco use -- and in particular cigarette smoking -- is. It remains the leading cause of preventable deaths and disease in the United States. Every single day, more than 3200 kids light up a cigarette for the first time. Every single day, more than 700 kids have made that progression to becoming regular smokers and that's why we call this collection of at-risk 12- to 17-year olds the replacement customers, if you will, for the addicted adult smokers who die or quit every day.
With the recent release of the 50th Anniversary Surgeon General's report, we now know that even more people are dying each year from tobacco use than ever before, because of the additional tobacco-related diseases that have been added to the list. We now know that the annual death toll from tobacco use -- and these are preventable, avoidable deaths-- is over 480,000. Between now and mid-century, there are going to be almost 18 million preventable deaths in the United States from tobacco use. So if we can break through and reach those replacement customers with compelling and persuasive messaging about the health consequences of what they're doing, whether they're thinking of taking that first puff or they're thinking of continuing to smoke, we can make a profound difference and positive impact on public health.
How are we going to do it? We've spent more than 2 years researching and doing our homework and thinking about how you break through to these 10 million of the 25 million 12- to 17-year olds that are out there. Ten million of them are at risk for either taking that first puff or progressing to becoming regular smokers. The insight that we developed from the research is they know smoking is harmful, and they know all about cancer and heart disease and lung disease. But those health consequences are so far down the road that they dismiss them.
What we learned from our research is there are other health consequences that can be much more meaningful and impactful, and those are health consequences related to appearance. The Real Cost Campaign focuses on such health consequences as skin wrinkling, gum disease, and tooth loss, and this is where we think we have the opportunity to break through.
We've tested these ads and the messages which are going to appear in multiple media on about 1600 of the teens that we are targeting nationally with this effort. The results of the testing were that these messages were extremely positive, memorable, impactful, and something that they wanted to talk to their friends about. We are very optimistic that over time with the right dose -- and we have the funding to provide the dose -- that this campaign is going to build awareness; change knowledge, attitudes, and beliefs; and ultimately, over time, alter both behavioral intent and behavior.
The evaluation of our campaign that we are funding is going to follow 8000 kids for 2 years. It's a longitudinal study. They've been interviewed at baseline, so we know their baseline attitudes. Over the next 2 years, they will be exposed to this and other complementary campaigns. Two years from now, we will have a very good handle on the degree to which we've moved the needle changing attitudes and beliefs, and then ultimately behavior.
Medscape: Has there been outreach to manufacturers to try and protect youth from marketing that continues to target them? Is that part of this campaign?
Mr. Zeller: No. The tobacco manufacturers have been in the business of doing their own youth prevention efforts, and I'm not going to comment on them. We developed this completely independently of the tobacco industry, talking to experts and doing extensive message testing. When we had the messages that we thought had the best chance of working, we conducted qualitative focus group testing and then very extensive quantitative copy testing on the ads that we had produced.
Medscape: Was the recent decision on the part of CVS Caremark a happy coincidence? Or do other strategies of this new campaign include limiting access through steps such as that taken by CVS?
Mr. Zeller: We were very happy to hear of the CVS decision to no longer sell tobacco products, and we applaud that decision. But it was completely fortuitous that their announcement followed within 24 hours of our unveiling The Real Cost Campaign earlier this week. We applaud CVS for taking this action, and it's a real sign of the degree to which tobacco use continues to be denormalized in the United States.
Medscape: The AAP released a press statement praising the FDA for this effort but also urging increased federal regulation of all tobacco products, including electronic nicotine delivery devices (e-cigarettes). Can you discuss the current regulatory parameters under which the FDA operates? With the example of CVS, does the FDA have the authority to regulate tobacco at the point of sale?
Mr. Zeller: Let me start with the products that we do and don't regulate, and then talk about enforcement. In 2009, Congress passed, and the President signed into law, the Family Smoking Prevention and Tobacco Control Act. It gave the FDA broad authorities to regulate the manufacture, sale, and distribution of tobacco products within the agency's jurisdiction. The initial grant of authority by Congress in the Tobacco Control Act was limited to cigarettes, roll-your-own tobacco, and smokeless tobacco.
There is a provision in the law that we call the deeming clause. That means we can do a rulemaking to expand our authority and deem other products that meet the statutory definition of a tobacco product to be within our regulatory and jurisdictional reach. The FDA has been on record as saying that it intends to issue such a regulation.
Basically, all smokeless tobacco products were part of the original jurisdictional grant of authority from Congress in 2009. There are other tobacco products out there that we do not currently regulate, such as large cigars and small cigars. When we get this deeming regulation published, everybody will be able to see how we are proposing to expand our authority to cover all products that meet the statutory definition of a tobacco product. And specifically for e-cigarettes, the FDA intends to create a regulatory framework for e-cigarettes.
The deeming document was formally submitted to the Office of Management and Budget this past October, where it remains under review.
Although we do not currently regulate e-cigarettes, we are concerned that initiation of any nicotine-containing product by kids is harmful to public health, and we are concerned about kids initiating that use with e-cigarettes.
We absolutely have the authority to make sure, for the products that we regulate, that tobacco products are not sold to kids. We have enforcement contracts with 45 jurisdictions, and we have conducted well over 200,000 compliance checks where trained and commissioned adults and minors walk in together and the minor attempts to purchase one of the products that we regulate, whether it's cigarettes or smokeless tobacco.
Medscape: Can you speak a little more about electronic cigarettes? E-cig use by students in grades 6-12 has essentially doubled[1] in the past few years, and there are many unanswered questions regarding their safety. Can you speak specifically about concerns regarding the use of e-cigs by teens and, for that matter, adults? Are there specific plans to address their use?
Mr. Zeller: The reality is that the marketplace for e-cigarettes today is what I would call the Wild, Wild West. We do not regulate them, but we have announced our intention to create that regulatory framework. Until we do, we need to monitor the behaviors that are going on in the marketplace and better understand the products, and we are funding a lot of research to get a better handle on the safety and the toxicity profile of these cigarettes. We want to answer 2 fundamental questions about behavior: Who is using e-cigarettes, and how are they being used?
What is going on with currently addicted adult smokers of conventional cigarettes? Are they completely switching to e-cigarettes, or are they engaging in what we call "dual use" -- continuing to smoke some combusting cigarettes while also using e-cigarettes? If that dual-use behavior is going on, does that mean that addicted adult smokers who might otherwise have been more motivated to quit are losing that motivation, because now they can use e-cigarettes as a bridge to get from their last burning cigarette to their next burning cigarette?
We have a lot of questions about the products and behavior at the population level. We're funding the research to try to get those answers. The bottom line is that we do not currently regulate e-cigarettes, but as I mentioned, we have submitted proposed regulations. This is all as a result of a court decision, so let me provide a little more historical context and then put it in terms of the statutory definition.
In 2009, the FDA took an enforcement action against e-cigarettes and tried to prohibit the import of e-cigarettes from abroad on the grounds that they were unapproved drugs and devices -- unapproved nicotine delivery products. One of the importers sued the FDA and actually won in both the Federal District Court and the Federal Court of Appeals.
Here is what the court ruled. It sounds a little counterintuitive, but when you understand the definition of a tobacco product, hopefully it will make some sense. The court ruled that as long as an e-cigarette product is not making a therapeutic or cessation claim, which would put it squarely under the drug and device laws of our statute, the only way that that FDA can regulate e-cigarettes is under the Family Smoking Prevention and Tobacco Control Act. Here's the counterintuitive part: E-cigarettes do not contain any tobacco, so how could 2 courts rule that that is the only way that the FDA could regulate them?
They ruled that way because of the definition of a tobacco product under the law. The definition is, basically, anything that is made of or -- and here are the key words -- derived from tobacco. And it turns out that all of the nicotine in e-cigarettes is derived from the tobacco plant. The companies are not manufacturing or synthesizing nicotine. They are deriving nicotine in the same way that nicotine-replacement therapy products come up with nicotine.
It's on that basis that the courts ruled. And the FDA has announced the intention to create the regulatory framework under the tobacco authorities to regulate the manufacture, sale, and distribution of e-cigarettes.
Medscape: What about cigars, blunts, and other sources of tobacco that are not FDA-regulated? Will the campaign include efforts to address these delivery devices? What about smokeless tobacco use?
Mr. Zeller: Here is the plan. The first campaign that we launched, The Real Cost Campaign that we've been discussing, is a general-market effort aimed at cigarette use by kids. There are 25 million 12- to 17-year olds in the country. Roughly 40%, or 10 million, of those 25 million are at risk of taking the first puff or continuing to smoke and becoming regular smokers. This general-market campaign is aimed at all at-risk 12- to 17-year olds.
Over the next year or two, there will to be complementary campaigns. One is going to be focused exclusively on rural use, and especially those boys who are at greatest risk of using smokeless tobacco products. There's going to be a separate campaign aimed at multicultural use, a campaign aimed at Native American/Alaskan Native youth, and a separate campaign aimed at LGBT (lesbian, gay, bisexual, and transgender) youth.
We can only do campaigns on products that we currently regulate. For now, the campaign that we unveiled this week is aimed at cigarettes, which remain far and away the single greatest cause of tobacco-related death and disease in the United States. But as I said, at least one of the other campaigns that we plan to launch down the road will focus on other products, starting with smokeless tobacco.
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Cite this: Preventing Teen Tobacco Use: An Interview With the FDA - Medscape - Feb 10, 2014.
