WEBVTT 00:00:01.143 --> 00:00:02.801 I'm going to tell you a story. 00:00:04.048 --> 00:00:05.439 I'm going to tell you a story 00:00:05.463 --> 00:00:08.642 about how the deadliest consumer product imaginable 00:00:08.666 --> 00:00:09.816 came to be. 00:00:10.413 --> 00:00:11.679 It's the cigarette. 00:00:12.572 --> 00:00:15.104 The cigarette is the only consumer product 00:00:15.128 --> 00:00:17.667 that, when used as intended, 00:00:17.691 --> 00:00:21.500 will kill half of all long-term users prematurely, later in life. 00:00:22.347 --> 00:00:23.572 But this is also a story 00:00:23.596 --> 00:00:27.022 about the work that we're doing at the Food and Drug Administration, 00:00:27.046 --> 00:00:29.450 and specifically, the work that we're doing 00:00:29.474 --> 00:00:32.625 to create the cigarette of the future, 00:00:32.649 --> 00:00:37.069 that is no longer capable of creating or sustaining addiction. NOTE Paragraph 00:00:37.823 --> 00:00:41.522 A lot of people think that the tobacco problem or the smoking problem 00:00:41.546 --> 00:00:43.284 has been solved in the United States 00:00:43.308 --> 00:00:45.474 because of the great progress that's been made 00:00:45.498 --> 00:00:47.387 over the last 40, 50 years, 00:00:47.411 --> 00:00:50.254 when it comes to both consumption and prevalence. 00:00:50.278 --> 00:00:51.436 And it's true; 00:00:52.205 --> 00:00:55.236 smoking rates are at historic lows. 00:00:55.673 --> 00:00:58.474 It's true for both adults and for kids. 00:00:59.339 --> 00:01:02.125 And it's true that those who continue to smoke 00:01:02.149 --> 00:01:04.783 are smoking far fewer cigarettes per day 00:01:04.807 --> 00:01:06.674 than at any time in history. NOTE Paragraph 00:01:08.035 --> 00:01:11.936 But what if I told you that tobacco use, 00:01:11.960 --> 00:01:15.268 primarily because of firsthand and secondhand exposure 00:01:15.292 --> 00:01:18.006 to the smoke in cigarettes, 00:01:18.030 --> 00:01:21.788 remains the leading cause of completely preventable disease and death 00:01:21.812 --> 00:01:22.962 in this country? 00:01:24.196 --> 00:01:25.396 Well, that's true. 00:01:26.988 --> 00:01:30.948 And what if I told you that it's actually killing more people 00:01:30.972 --> 00:01:33.480 than we thought to be the case ever before? 00:01:33.956 --> 00:01:35.234 That's true, too. 00:01:36.903 --> 00:01:40.990 Smoking kills more people each year than alcohol, AIDS, car accidents, 00:01:41.014 --> 00:01:44.196 illegal drugs, murders and suicides combined. 00:01:45.154 --> 00:01:46.554 Year in and year out. NOTE Paragraph 00:01:47.979 --> 00:01:49.874 In 2014, 00:01:51.177 --> 00:01:52.871 Dr. Adams's predecessor released 00:01:52.895 --> 00:01:55.315 the 50th anniversary Surgeon General's report 00:01:55.339 --> 00:01:56.806 on smoking and health. 00:01:58.133 --> 00:02:01.863 And that report upped the annual death toll from smoking, 00:02:01.887 --> 00:02:04.537 because the list of smoking-related illnesses 00:02:04.561 --> 00:02:06.042 got bigger. 00:02:06.066 --> 00:02:08.260 And so it is now conservatively estimated 00:02:08.284 --> 00:02:12.937 that smoking kills 480,000 Americans every year. 00:02:13.414 --> 00:02:16.318 These are completely preventable deaths. NOTE Paragraph 00:02:16.811 --> 00:02:20.033 How do we wrap our heads around a statistic like this? 00:02:20.057 --> 00:02:22.701 So much of what we've heard at this conference 00:02:22.725 --> 00:02:27.090 is about individual experiences and personal experiences. 00:02:27.114 --> 00:02:29.788 How do we deal with this at a population level, 00:02:29.812 --> 00:02:32.783 when there are 480,000 moms, 00:02:32.807 --> 00:02:37.347 dads, sisters, brothers, aunts and uncles 00:02:37.371 --> 00:02:40.746 dying unnecessary deaths every year from tobacco? NOTE Paragraph 00:02:42.329 --> 00:02:45.424 And then what happens when you think about this trajectory 00:02:45.448 --> 00:02:46.706 for the future? 00:02:47.274 --> 00:02:49.140 And just do the simple math: 00:02:49.831 --> 00:02:54.498 from the time of the 50th anniversary Surgeon General's report five years ago, 00:02:54.522 --> 00:02:57.220 when this horrible statistic was raised, 00:02:57.244 --> 00:02:58.991 just through mid-century -- 00:02:59.857 --> 00:03:05.347 that's more than 17 million avoidable deaths in the United States 00:03:05.371 --> 00:03:07.142 from tobacco use, 00:03:07.166 --> 00:03:09.158 primarily because of cigarettes. 00:03:09.855 --> 00:03:12.306 The Surgeon General concluded 00:03:12.330 --> 00:03:19.285 that 5.6 million children alive in the United States in 2014 00:03:19.309 --> 00:03:23.737 will die prematurely later in life because of cigarettes. 00:03:24.301 --> 00:03:26.459 Five point six million children. NOTE Paragraph 00:03:27.783 --> 00:03:32.387 So this is an enormous public health problem for all of us 00:03:32.411 --> 00:03:34.708 but especially for us as regulators 00:03:34.732 --> 00:03:38.387 at the Food and Drug Administration and the Center for Tobacco Products. 00:03:38.411 --> 00:03:40.011 What can we do about it? 00:03:40.752 --> 00:03:45.363 What can we do to reverse this trajectory of disease and death? NOTE Paragraph 00:03:46.942 --> 00:03:52.717 Well, we have an interesting guide to help unravel issues 00:03:52.741 --> 00:03:56.561 like: How did the cigarette as we know it come to be? 00:03:56.942 --> 00:04:01.023 What is the true nature of the tobacco and cigarette business? 00:04:01.650 --> 00:04:02.960 How did the industry behave 00:04:02.984 --> 00:04:05.984 in the historically unregulated marketplace? 00:04:06.325 --> 00:04:08.047 And our guide 00:04:08.071 --> 00:04:12.522 is previously secret internal documents from the tobacco industry. 00:04:13.015 --> 00:04:14.872 Come with me 00:04:14.896 --> 00:04:17.697 in a tobacco industry document time machine. NOTE Paragraph 00:04:19.150 --> 00:04:20.595 Nineteen sixty-three 00:04:21.612 --> 00:04:27.265 was 25 years before the Surgeon General was finally able to conclude 00:04:27.289 --> 00:04:30.043 that the nicotine and cigarettes was addictive. 00:04:30.067 --> 00:04:34.173 That did not happen until the Surgeon General's report in 1998. 00:04:35.062 --> 00:04:37.427 Nineteen sixty-three 00:04:37.451 --> 00:04:42.792 was one year before the first-ever Surgeon General's report in 1964. NOTE Paragraph 00:04:44.688 --> 00:04:46.783 I remember 1964. 00:04:46.807 --> 00:04:48.966 I don't remember the Surgeon General's report, 00:04:48.990 --> 00:04:50.323 but I remember 1964. 00:04:50.625 --> 00:04:53.043 I was a kid growing up in Brooklyn, New York. 00:04:53.532 --> 00:04:55.222 This was at a time 00:04:55.246 --> 00:04:59.287 when almost one in two adults in the United States smoked. 00:05:00.094 --> 00:05:03.257 Both of my parents were heavy smokers at the time. 00:05:04.177 --> 00:05:07.366 Tobacco use was so incredibly normalized 00:05:07.390 --> 00:05:10.320 that -- and this wasn't North Carolina, Virginia or Kentucky, 00:05:10.344 --> 00:05:11.973 this was Brooklyn -- 00:05:12.828 --> 00:05:16.379 we made ashtrays for our parents in arts and crafts class. NOTE Paragraph 00:05:16.403 --> 00:05:18.680 (Laughter) NOTE Paragraph 00:05:19.970 --> 00:05:22.883 The ashtrays I made were pretty awful, but they were ashtrays. NOTE Paragraph 00:05:22.907 --> 00:05:24.573 (Laughter) NOTE Paragraph 00:05:24.597 --> 00:05:30.492 So normalized that I remember seeing a bowl of loose cigarettes in the foyer 00:05:30.516 --> 00:05:32.770 of our house and other houses 00:05:32.794 --> 00:05:36.762 as a welcoming gesture when friends came over for a visit. NOTE Paragraph 00:05:37.609 --> 00:05:40.702 OK, we're back in 1963. 00:05:41.204 --> 00:05:43.172 The top lawyer for Brown and Williamson, 00:05:43.196 --> 00:05:46.580 which was then the third-largest cigarette company in the United States, 00:05:46.580 --> 00:05:47.787 wrote the following: 00:05:47.811 --> 00:05:49.001 "Nicotine is addictive. 00:05:49.025 --> 00:05:52.548 We are, then, in the business of selling nicotine -- an addictive drug." 00:05:53.184 --> 00:05:54.524 It's a remarkable statement, 00:05:54.548 --> 00:05:57.171 as much for what it doesn't say as for what it does say. 00:05:57.195 --> 00:05:59.560 He didn't say they were in the cigarette business. 00:05:59.584 --> 00:06:01.877 He didn't say they were in the tobacco business. 00:06:01.901 --> 00:06:04.543 He said they were in the business of selling nicotine. NOTE Paragraph 00:06:05.267 --> 00:06:07.125 Philip Morris in 1972: 00:06:07.149 --> 00:06:08.870 "The cigarette isn't a product, 00:06:08.894 --> 00:06:10.346 it's a package. 00:06:10.712 --> 00:06:12.312 The product is nicotine. 00:06:12.768 --> 00:06:16.856 The pack is a storage container for a day's supply of nicotine. 00:06:16.880 --> 00:06:21.385 The cigarette, a dispenser for a dose unit of nicotine." 00:06:22.055 --> 00:06:24.891 We'll come back to this dose unit notion later. NOTE Paragraph 00:06:25.906 --> 00:06:27.787 And R.J. Reynolds in 1972: 00:06:27.811 --> 00:06:31.350 "In a sense, the tobacco industry may be thought of as being a specialized, 00:06:31.374 --> 00:06:35.120 highly ritualized and stylized segment of the pharmaceutical industry. 00:06:35.144 --> 00:06:38.002 Tobacco products uniquely contain and deliver nicotine, 00:06:38.026 --> 00:06:41.325 a potent drug with a variety of physiological effects." NOTE Paragraph 00:06:41.764 --> 00:06:44.867 At the time, and for many decades, publicly, 00:06:44.891 --> 00:06:47.522 the industry completely denied addiction 00:06:47.546 --> 00:06:49.679 and completely denied causality. 00:06:50.163 --> 00:06:52.744 But they knew the true nature of their business. 00:06:52.768 --> 00:06:54.276 And from time to time, 00:06:54.300 --> 00:06:57.941 there have been health scares made public about cigarettes, 00:06:57.965 --> 00:06:59.565 going back many decades. 00:06:59.989 --> 00:07:01.923 How did the industry respond? 00:07:02.330 --> 00:07:03.529 And how did they respond 00:07:03.553 --> 00:07:06.633 in this historically unregulated marketplace? NOTE Paragraph 00:07:06.657 --> 00:07:08.887 Going back to the 1930s, 00:07:08.911 --> 00:07:13.990 it was with advertising that heavily featured imagery of doctors 00:07:14.014 --> 00:07:15.926 and other health care professionals 00:07:15.950 --> 00:07:18.084 sending messages of reassurance. 00:07:18.617 --> 00:07:20.252 This is an ad for Lucky Strikes, 00:07:20.276 --> 00:07:22.688 the popular cigarette of the time in the '30s: NOTE Paragraph 00:07:22.712 --> 00:07:27.010 [20,679 physicians say "Luckies are less irritating." 00:07:27.322 --> 00:07:31.524 Your throat protection against irritation, against cough.] NOTE Paragraph 00:07:31.548 --> 00:07:33.990 (Laughter) NOTE Paragraph 00:07:34.014 --> 00:07:35.871 We laugh, 00:07:35.895 --> 00:07:37.641 but this was the kind of advertising 00:07:37.665 --> 00:07:40.656 that was there to send a health message of reassurance. NOTE Paragraph 00:07:40.680 --> 00:07:44.196 Fast-forward to 1950s, '60s and '70s. 00:07:44.220 --> 00:07:47.172 And here, again, in the absence of regulation, 00:07:47.196 --> 00:07:49.973 what we're going to see is modifications to the product 00:07:49.997 --> 00:07:51.695 and product design 00:07:51.719 --> 00:07:54.404 to respond to the health concerns of the day. NOTE Paragraph 00:07:55.664 --> 00:07:59.093 This is the Kent Micronite filter. 00:07:59.117 --> 00:08:03.655 And here, the innovation, if you will, was the filtered cigarette. NOTE Paragraph 00:08:04.395 --> 00:08:06.077 [Full smoking pleasure ... 00:08:06.101 --> 00:08:09.013 plus proof of the greatest health protection ever.] NOTE Paragraph 00:08:10.244 --> 00:08:13.172 What the smoker of this product didn't know, 00:08:13.196 --> 00:08:15.117 what their doctor didn't know, 00:08:15.141 --> 00:08:17.300 what the government didn't know, 00:08:17.324 --> 00:08:20.820 is that this was a filter that was lined with asbestos -- NOTE Paragraph 00:08:20.844 --> 00:08:21.900 (Gasps) 00:08:21.924 --> 00:08:24.638 so that when smokers were smoking this filtered cigarette 00:08:24.662 --> 00:08:27.178 and still inhaling the chemicals and smoke 00:08:27.202 --> 00:08:30.408 that we know are associated with cancer and lung disease 00:08:30.432 --> 00:08:31.641 and heart disease, 00:08:31.665 --> 00:08:34.098 they were also sucking down asbestos fibers. 00:08:34.112 --> 00:08:35.112 (Gasps) NOTE Paragraph 00:08:36.236 --> 00:08:38.791 In the 1960s and the 1970s, 00:08:38.815 --> 00:08:42.339 the so-called innovation was the light cigarette. 00:08:43.490 --> 00:08:46.969 This is a typical brand of the day called True. 00:08:47.477 --> 00:08:50.914 And this is after the Surgeon General's reports have started coming out. 00:08:50.938 --> 00:08:53.247 And you see the look of concern on her face. NOTE Paragraph 00:08:53.271 --> 00:08:54.583 [Considering all I'd heard, 00:08:54.607 --> 00:08:57.403 I decided to either quit or smoke True. 00:08:57.427 --> 00:08:58.833 I smoke True.] NOTE Paragraph 00:08:58.857 --> 00:09:00.395 (Laughter) NOTE Paragraph 00:09:00.419 --> 00:09:03.361 [The low tar, low nicotine cigarette.] 00:09:03.385 --> 00:09:05.301 And then it says, "Think about it." 00:09:05.325 --> 00:09:08.603 And then even below that in the small print 00:09:08.627 --> 00:09:11.507 are tar numbers and nicotine numbers. 00:09:12.333 --> 00:09:14.452 What was a light cigarette? 00:09:15.474 --> 00:09:16.942 How did it work? NOTE Paragraph 00:09:18.474 --> 00:09:21.172 This is an illustration of the product modification 00:09:21.196 --> 00:09:23.730 known as "filter ventilation." 00:09:24.128 --> 00:09:25.787 That's not a real filter blown up. 00:09:25.811 --> 00:09:27.001 That's just a picture 00:09:27.025 --> 00:09:30.231 so that you could see the rows of laser-perforated ventilation holes 00:09:30.255 --> 00:09:31.611 that were put on the filter. 00:09:31.635 --> 00:09:33.267 When you look at a real cigarette, 00:09:33.291 --> 00:09:34.807 it's harder to see. 00:09:34.831 --> 00:09:36.945 Every patent for this product shows 00:09:36.969 --> 00:09:40.371 that the ventilation holes should be 12 millimeters 00:09:40.395 --> 00:09:42.164 from the lip end of the filter. 00:09:42.188 --> 00:09:43.496 How did it work? NOTE Paragraph 00:09:44.458 --> 00:09:46.696 The cigarette got stuck into a machine. 00:09:47.950 --> 00:09:50.291 The machine started puffing away on the cigarette 00:09:50.315 --> 00:09:52.752 and recording tar and nicotine levels. 00:09:53.061 --> 00:09:54.791 As the machine smoked, 00:09:54.815 --> 00:09:58.260 outside air came through those ventilation holes 00:09:58.284 --> 00:10:02.196 and diluted the amount of smoke that was coming through the cigarette. 00:10:02.220 --> 00:10:04.307 So as the machine smoked, 00:10:04.331 --> 00:10:06.874 there really was less tar and nicotine being delivered 00:10:06.898 --> 00:10:08.745 compared to a regular cigarette. 00:10:09.975 --> 00:10:11.760 What the tobacco industry knew 00:10:11.784 --> 00:10:14.848 was that human beings don't smoke like machines. 00:10:15.713 --> 00:10:17.779 How do human beings smoke this? 00:10:18.816 --> 00:10:20.416 Where do the fingers go? NOTE Paragraph 00:10:20.440 --> 00:10:21.680 (Murmurs) NOTE Paragraph 00:10:21.704 --> 00:10:23.104 Where do the lips go? 00:10:23.474 --> 00:10:24.966 I told you that the patent said 00:10:24.990 --> 00:10:28.014 that the holes are 12 millimeters from the lip end. 00:10:28.038 --> 00:10:30.276 The smoker didn't even know they were there, 00:10:30.300 --> 00:10:34.099 but between fingers and lips, the holes get blocked. 00:10:34.505 --> 00:10:38.219 And when the holes get blocked, it's no longer a light cigarette. 00:10:38.807 --> 00:10:40.339 Turns out that there's actually 00:10:40.363 --> 00:10:43.069 basically as much nicotine inside a light cigarette 00:10:43.093 --> 00:10:44.299 as a regular cigarette. 00:10:44.323 --> 00:10:46.289 The difference was what's on the outside. 00:10:46.313 --> 00:10:49.559 But once you block what's on the outside, 00:10:49.583 --> 00:10:51.130 it's a regular cigarette. NOTE Paragraph 00:10:52.821 --> 00:10:55.832 Congress put FDA in the business of regulating tobacco products 00:10:55.856 --> 00:10:57.331 10 years ago this June. 00:10:57.355 --> 00:10:59.680 So you heard the statistics at the beginning 00:10:59.704 --> 00:11:04.364 about the extraordinary contribution to disease and death that cigarettes make. 00:11:04.754 --> 00:11:06.782 We've also been paying a lot of attention 00:11:06.806 --> 00:11:10.666 to how the cigarette works as a drug-delivery device 00:11:10.690 --> 00:11:14.248 and the remarkable efficiency with which it delivers nicotine. 00:11:14.272 --> 00:11:15.672 So let's take a look. 00:11:16.844 --> 00:11:19.605 When the smoker puffs on the cigarette, 00:11:19.629 --> 00:11:22.836 the nicotine from that puff gets up into the brain 00:11:22.860 --> 00:11:24.669 in less than 10 seconds. 00:11:25.252 --> 00:11:26.728 Less than 10 seconds. 00:11:27.300 --> 00:11:29.029 Up in the brain, 00:11:29.053 --> 00:11:31.918 there are these things called "nicotinic receptors." 00:11:32.929 --> 00:11:34.404 They're there ... 00:11:34.428 --> 00:11:35.592 waiting. 00:11:35.945 --> 00:11:39.207 They're waiting for, in the words of that Philip Morris document, 00:11:39.231 --> 00:11:41.297 the next "dose unit of nicotine." NOTE Paragraph 00:11:43.252 --> 00:11:45.918 The smoker that you see outside, 00:11:45.942 --> 00:11:47.831 huddled with other smokers, 00:11:47.855 --> 00:11:49.339 in the cold, 00:11:49.363 --> 00:11:50.625 in the wind, 00:11:50.649 --> 00:11:52.342 in the rain, 00:11:52.366 --> 00:11:54.620 is experiencing craving 00:11:54.644 --> 00:11:57.342 and may be experiencing the symptoms of withdrawal. 00:11:58.564 --> 00:12:02.125 Those symptoms of withdrawal are a chemical message 00:12:02.149 --> 00:12:04.289 that these receptors are sending to the body, 00:12:04.313 --> 00:12:05.869 saying, "Feed me!" 00:12:08.490 --> 00:12:14.338 And a product that can deliver the drug in less than 10 seconds 00:12:15.230 --> 00:12:19.960 turns out to be an incredibly efficient and incredibly addictive product. 00:12:21.379 --> 00:12:24.466 We've spoken to so many addiction treatment experts 00:12:24.490 --> 00:12:25.640 over the years. 00:12:26.053 --> 00:12:29.359 And the story I hear is the same over and over again: 00:12:29.383 --> 00:12:31.867 "Long after I was able to get somebody off of heroin 00:12:31.891 --> 00:12:34.605 or cocaine or crack cocaine, 00:12:34.629 --> 00:12:36.677 I can't get them to quit cigarettes." 00:12:37.145 --> 00:12:40.332 A large part of the explanation is the 10-second thing. NOTE Paragraph 00:12:42.081 --> 00:12:45.835 FDA has it within its regulatory reach 00:12:45.859 --> 00:12:48.233 to use the tools of product regulation 00:12:48.257 --> 00:12:52.627 to render cigarettes as we know them minimally or nonaddictive. 00:12:54.030 --> 00:12:55.496 We're working on this. 00:12:56.046 --> 00:13:00.092 And this could have a profound impact at a population level 00:13:00.116 --> 00:13:01.577 from this one policy. 00:13:02.124 --> 00:13:04.587 We did dynamic population-level modeling a year ago, 00:13:04.611 --> 00:13:07.345 and we published the results in "The New England Journal." 00:13:07.369 --> 00:13:09.922 And because of the generational effect of this policy, 00:13:09.946 --> 00:13:11.437 which I'll explain in a minute, 00:13:11.461 --> 00:13:14.268 here's what we project out through the end of the century: 00:13:14.292 --> 00:13:15.974 more than 33 million people 00:13:15.998 --> 00:13:19.680 who would otherwise have gone on to become regular smokers won't, 00:13:19.704 --> 00:13:22.345 because the cigarette that they'll be experimenting with 00:13:22.369 --> 00:13:24.109 can't create or sustain addiction. 00:13:24.569 --> 00:13:28.482 This would drive the adult smoking rate down to less than one and a half percent. 00:13:29.450 --> 00:13:31.333 And these two things combined 00:13:32.107 --> 00:13:37.591 would result in the saving of more than eight million cigarette-related deaths 00:13:37.615 --> 00:13:39.844 that would otherwise have occurred 00:13:39.868 --> 00:13:41.891 from the generational impact of this. NOTE Paragraph 00:13:41.915 --> 00:13:44.182 Now, why am I saying "generational"? 00:13:45.367 --> 00:13:46.756 It's about kids. 00:13:48.090 --> 00:13:51.408 Ninety percent of adult smokers started smoking when they were kids. 00:13:52.121 --> 00:13:54.224 Half of them became regular smokers 00:13:54.248 --> 00:13:57.657 before they were legally old enough to buy a pack of cigarettes. 00:13:58.287 --> 00:14:01.466 Half of them became regular smokers before they were 18 years old. 00:14:01.490 --> 00:14:02.640 Experimentation. 00:14:03.212 --> 00:14:04.362 Regular smoking. 00:14:04.728 --> 00:14:05.878 Addiction. 00:14:06.522 --> 00:14:07.863 Decades of smoking. 00:14:07.887 --> 00:14:09.490 And then the illness, 00:14:09.514 --> 00:14:11.661 and that's why we're talking about a product 00:14:11.685 --> 00:14:15.654 that will kill half of all long-term users prematurely later in life. 00:14:16.880 --> 00:14:20.186 The generational impact of this nicotine-reduction policy 00:14:20.210 --> 00:14:21.534 is profound. 00:14:22.817 --> 00:14:25.742 Those old industry documents had a word for young people. 00:14:26.323 --> 00:14:29.276 They were described as "the replacement smokers." 00:14:30.577 --> 00:14:32.942 The replacement smokers for addicted adult smokers 00:14:32.966 --> 00:14:34.116 who died or quit. NOTE Paragraph 00:14:34.533 --> 00:14:38.303 Future generations of kids, especially teens, 00:14:38.327 --> 00:14:40.295 are going to engage in risky behavior. 00:14:40.319 --> 00:14:41.586 We can't stop that. 00:14:42.010 --> 00:14:46.011 But what if the only cigarette that they could get their hands on 00:14:46.035 --> 00:14:48.324 could no longer create or sustain addiction? 00:14:48.839 --> 00:14:51.450 That's the public health return on investment 00:14:51.474 --> 00:14:53.886 at a population level over time. NOTE Paragraph 00:14:55.132 --> 00:14:57.196 Haven't said anything about e-cigarettes. 00:14:57.521 --> 00:14:59.727 But I have to say something about e-cigarettes. NOTE Paragraph 00:14:59.751 --> 00:15:00.768 (Laughter) NOTE Paragraph 00:15:00.792 --> 00:15:03.664 We are dealing with an epidemic of kids' use of e-cigarettes. 00:15:03.688 --> 00:15:05.847 And what troubles us the most, 00:15:05.871 --> 00:15:10.252 in combination with the rising numbers when it comes to prevalence, 00:15:10.276 --> 00:15:11.680 is frequency. 00:15:11.704 --> 00:15:14.033 Not only are more kids using e-cigarettes, 00:15:14.057 --> 00:15:18.137 but more kids are using e-cigarettes 20 or more days in the past 30 days 00:15:18.161 --> 00:15:20.938 than at any time since e-cigarettes came onto the market. 00:15:20.962 --> 00:15:23.184 And at FDA, we're doing everything that we can 00:15:23.208 --> 00:15:24.466 using program and policy, 00:15:24.490 --> 00:15:26.109 first to get the word out to kids 00:15:26.133 --> 00:15:28.204 that this is not a harmless product 00:15:28.228 --> 00:15:31.163 and to make sure that kids aren't initiating and experimenting 00:15:31.187 --> 00:15:32.347 on any tobacco product, 00:15:32.371 --> 00:15:34.251 whether combustion is present or not. 00:15:34.569 --> 00:15:37.690 But think about e-cigarettes in a properly regulated marketplace 00:15:37.714 --> 00:15:39.637 as something that could be of benefit 00:15:39.661 --> 00:15:41.781 to addicted adult cigarette smokers 00:15:41.805 --> 00:15:44.161 who are trying to transition away from cigarettes. NOTE Paragraph 00:15:44.185 --> 00:15:47.716 So, I'll leave you with this vision: 00:15:49.748 --> 00:15:51.399 imagine a world 00:15:52.077 --> 00:15:54.749 where the only cigarette that future generations of kids 00:15:54.773 --> 00:15:55.934 could experiment with 00:15:55.958 --> 00:15:58.196 could no longer create or sustain addiction 00:15:58.220 --> 00:15:59.957 because of a single policy. 00:16:00.585 --> 00:16:01.763 Imagine a world 00:16:02.534 --> 00:16:05.220 where health-concerned cigarette smokers, 00:16:05.244 --> 00:16:08.140 especially if a policy goes into effect 00:16:08.164 --> 00:16:11.768 that takes the nicotine levels down to minimally or nonaddictive levels, 00:16:11.792 --> 00:16:14.334 could transition to alternative and less harmful forms 00:16:14.358 --> 00:16:15.673 of nicotine delivery, 00:16:15.697 --> 00:16:17.950 starting with FDA-approved nicotine medications, 00:16:17.974 --> 00:16:19.911 like the gum, patch and lozenge. NOTE Paragraph 00:16:20.704 --> 00:16:21.895 And finally, 00:16:21.919 --> 00:16:24.768 imagine a world and a properly regulated marketplace, 00:16:24.792 --> 00:16:28.006 whether it's e-cigarettes or whatever the technology of the day, 00:16:28.030 --> 00:16:30.331 it's not the product developers and the marketers 00:16:30.355 --> 00:16:32.300 who decide which products come to market 00:16:32.324 --> 00:16:34.133 and what claims get made for them, 00:16:34.157 --> 00:16:37.029 it's review scientists at FDA, 00:16:37.053 --> 00:16:38.633 who look at applications 00:16:38.657 --> 00:16:42.331 and decide, using the standard that Congress has entrusted us 00:16:42.355 --> 00:16:44.410 to implement and enforce, 00:16:44.434 --> 00:16:47.267 whether a particular product should come to market, 00:16:47.291 --> 00:16:50.529 because the marketing of that product and the words of our law 00:16:50.553 --> 00:16:53.725 would be appropriate for the protection of the public health. 00:16:54.297 --> 00:16:56.602 These are the kinds of powerful regulatory tools 00:16:56.626 --> 00:16:59.614 that are within our reach 00:16:59.638 --> 00:17:01.014 to deal with what remains 00:17:01.038 --> 00:17:04.291 the leading cause of completely preventable disease and death 00:17:04.315 --> 00:17:05.474 in the country. 00:17:05.498 --> 00:17:06.765 If we get this right, 00:17:07.657 --> 00:17:12.246 that trajectory, those 5.6 million kids, 00:17:12.270 --> 00:17:13.611 is breakable. NOTE Paragraph 00:17:13.635 --> 00:17:14.786 Thank you. NOTE Paragraph 00:17:14.810 --> 00:17:17.523 (Applause)