1 00:00:01,143 --> 00:00:02,801 I'm going to tell you a story. 2 00:00:04,048 --> 00:00:05,439 I'm going to tell you a story 3 00:00:05,463 --> 00:00:08,642 about how the deadliest consumer product imaginable 4 00:00:08,666 --> 00:00:09,816 came to be. 5 00:00:10,413 --> 00:00:11,679 It's the cigarette. 6 00:00:12,572 --> 00:00:15,104 The cigarette is the only consumer product 7 00:00:15,128 --> 00:00:17,667 that, when used as intended, 8 00:00:17,691 --> 00:00:21,500 will kill half of all long-term users prematurely, later in life. 9 00:00:22,347 --> 00:00:23,572 But this is also a story 10 00:00:23,596 --> 00:00:27,022 about the work that we're doing at the Food and Drug Administration, 11 00:00:27,046 --> 00:00:29,450 and specifically, the work that we're doing 12 00:00:29,474 --> 00:00:32,625 to create the cigarette of the future, 13 00:00:32,649 --> 00:00:37,069 that is no longer capable of creating or sustaining addiction. 14 00:00:37,823 --> 00:00:41,522 A lot of people think that the tobacco problem or the smoking problem 15 00:00:41,546 --> 00:00:43,284 has been solved in the United States 16 00:00:43,308 --> 00:00:45,474 because of the great progress that's been made 17 00:00:45,498 --> 00:00:47,387 over the last 40, 50 years, 18 00:00:47,411 --> 00:00:50,254 when it comes to both consumption and prevalence. 19 00:00:50,278 --> 00:00:51,436 And it's true; 20 00:00:52,205 --> 00:00:55,236 smoking rates are at historic lows. 21 00:00:55,673 --> 00:00:58,474 It's true for both adults and for kids. 22 00:00:59,339 --> 00:01:02,125 And it's true that those who continue to smoke 23 00:01:02,149 --> 00:01:04,783 are smoking far fewer cigarettes per day 24 00:01:04,807 --> 00:01:06,674 than at any time in history. 25 00:01:08,035 --> 00:01:11,936 But what if I told you that tobacco use, 26 00:01:11,960 --> 00:01:15,268 primarily because of firsthand and secondhand exposure 27 00:01:15,292 --> 00:01:18,006 to the smoke in cigarettes, 28 00:01:18,030 --> 00:01:21,788 remains the leading cause of completely preventable disease and death 29 00:01:21,812 --> 00:01:22,962 in this country? 30 00:01:24,196 --> 00:01:25,396 Well, that's true. 31 00:01:26,988 --> 00:01:30,948 And what if I told you that it's actually killing more people 32 00:01:30,972 --> 00:01:33,480 than we thought to be the case ever before? 33 00:01:33,956 --> 00:01:35,234 That's true, too. 34 00:01:36,903 --> 00:01:40,990 Smoking kills more people each year than alcohol, AIDS, car accidents, 35 00:01:41,014 --> 00:01:44,196 illegal drugs, murders and suicides combined. 36 00:01:45,154 --> 00:01:46,554 Year in and year out. 37 00:01:47,979 --> 00:01:49,874 In 2014, 38 00:01:51,177 --> 00:01:52,871 Dr. Adams's predecessor released 39 00:01:52,895 --> 00:01:55,315 the 50th anniversary Surgeon General's report 40 00:01:55,339 --> 00:01:56,806 on smoking and health. 41 00:01:58,133 --> 00:02:01,863 And that report upped the annual death toll from smoking, 42 00:02:01,887 --> 00:02:04,537 because the list of smoking-related illnesses 43 00:02:04,561 --> 00:02:06,042 got bigger. 44 00:02:06,066 --> 00:02:08,260 And so it is now conservatively estimated 45 00:02:08,284 --> 00:02:12,937 that smoking kills 480,000 Americans every year. 46 00:02:13,414 --> 00:02:16,318 These are completely preventable deaths. 47 00:02:16,811 --> 00:02:20,033 How do we wrap our heads around a statistic like this? 48 00:02:20,057 --> 00:02:22,701 So much of what we've heard at this conference 49 00:02:22,725 --> 00:02:27,090 is about individual experiences and personal experiences. 50 00:02:27,114 --> 00:02:29,788 How do we deal with this at a population level, 51 00:02:29,812 --> 00:02:32,783 when there are 480,000 moms, 52 00:02:32,807 --> 00:02:37,347 dads, sisters, brothers, aunts and uncles 53 00:02:37,371 --> 00:02:40,746 dying unnecessary deaths every year from tobacco? 54 00:02:42,329 --> 00:02:45,424 And then what happens when you think about this trajectory 55 00:02:45,448 --> 00:02:46,706 for the future? 56 00:02:47,274 --> 00:02:49,140 And just do the simple math: 57 00:02:49,831 --> 00:02:54,498 from the time of the 50th anniversary Surgeon General's report five years ago, 58 00:02:54,522 --> 00:02:57,220 when this horrible statistic was raised, 59 00:02:57,244 --> 00:02:58,991 just through mid-century -- 60 00:02:59,857 --> 00:03:05,347 that's more than 17 million avoidable deaths in the United States 61 00:03:05,371 --> 00:03:07,142 from tobacco use, 62 00:03:07,166 --> 00:03:09,158 primarily because of cigarettes. 63 00:03:09,855 --> 00:03:12,306 The Surgeon General concluded 64 00:03:12,330 --> 00:03:19,285 that 5.6 million children alive in the United States in 2014 65 00:03:19,309 --> 00:03:23,737 will die prematurely later in life because of cigarettes. 66 00:03:24,301 --> 00:03:26,459 Five point six million children. 67 00:03:27,783 --> 00:03:32,387 So this is an enormous public health problem for all of us 68 00:03:32,411 --> 00:03:34,708 but especially for us as regulators 69 00:03:34,732 --> 00:03:38,387 at the Food and Drug Administration and the Center for Tobacco Products. 70 00:03:38,411 --> 00:03:40,011 What can we do about it? 71 00:03:40,752 --> 00:03:45,363 What can we do to reverse this trajectory of disease and death? 72 00:03:46,942 --> 00:03:52,717 Well, we have an interesting guide to help unravel issues 73 00:03:52,741 --> 00:03:56,561 like: How did the cigarette as we know it come to be? 74 00:03:56,942 --> 00:04:01,023 What is the true nature of the tobacco and cigarette business? 75 00:04:01,650 --> 00:04:02,960 How did the industry behave 76 00:04:02,984 --> 00:04:05,984 in the historically unregulated marketplace? 77 00:04:06,325 --> 00:04:08,047 And our guide 78 00:04:08,071 --> 00:04:12,522 is previously secret internal documents from the tobacco industry. 79 00:04:13,015 --> 00:04:14,872 Come with me 80 00:04:14,896 --> 00:04:17,697 in a tobacco industry document time machine. 81 00:04:19,150 --> 00:04:20,595 Nineteen sixty-three 82 00:04:21,612 --> 00:04:27,265 was 25 years before the Surgeon General was finally able to conclude 83 00:04:27,289 --> 00:04:30,043 that the nicotine and cigarettes was addictive. 84 00:04:30,067 --> 00:04:34,173 That did not happen until the Surgeon General's report in 1998. 85 00:04:35,062 --> 00:04:37,427 Nineteen sixty-three 86 00:04:37,451 --> 00:04:42,792 was one year before the first-ever Surgeon General's report in 1964. 87 00:04:44,688 --> 00:04:46,783 I remember 1964. 88 00:04:46,807 --> 00:04:48,966 I don't remember the Surgeon General's report, 89 00:04:48,990 --> 00:04:50,323 but I remember 1964. 90 00:04:50,625 --> 00:04:53,043 I was a kid growing up in Brooklyn, New York. 91 00:04:53,532 --> 00:04:55,222 This was at a time 92 00:04:55,246 --> 00:04:59,287 when almost one in two adults in the United States smoked. 93 00:05:00,094 --> 00:05:03,257 Both of my parents were heavy smokers at the time. 94 00:05:04,177 --> 00:05:07,366 Tobacco use was so incredibly normalized 95 00:05:07,390 --> 00:05:10,320 that -- and this wasn't North Carolina, Virginia or Kentucky, 96 00:05:10,344 --> 00:05:11,973 this was Brooklyn -- 97 00:05:12,828 --> 00:05:16,379 we made ashtrays for our parents in arts and crafts class. 98 00:05:16,403 --> 00:05:18,680 (Laughter) 99 00:05:19,970 --> 00:05:22,883 The ashtrays I made were pretty awful, but they were ashtrays. 100 00:05:22,907 --> 00:05:24,573 (Laughter) 101 00:05:24,597 --> 00:05:30,492 So normalized that I remember seeing a bowl of loose cigarettes in the foyer 102 00:05:30,516 --> 00:05:32,770 of our house and other houses 103 00:05:32,794 --> 00:05:36,762 as a welcoming gesture when friends came over for a visit. 104 00:05:37,609 --> 00:05:40,702 OK, we're back in 1963. 105 00:05:41,204 --> 00:05:43,172 The top lawyer for Brown and Williamson, 106 00:05:43,196 --> 00:05:46,580 which was then the third-largest cigarette company in the United States, 107 00:05:46,580 --> 00:05:47,787 wrote the following: 108 00:05:47,811 --> 00:05:49,001 "Nicotine is addictive. 109 00:05:49,025 --> 00:05:52,548 We are, then, in the business of selling nicotine -- an addictive drug." 110 00:05:53,184 --> 00:05:54,524 It's a remarkable statement, 111 00:05:54,548 --> 00:05:57,171 as much for what it doesn't say as for what it does say. 112 00:05:57,195 --> 00:05:59,560 He didn't say they were in the cigarette business. 113 00:05:59,584 --> 00:06:01,877 He didn't say they were in the tobacco business. 114 00:06:01,901 --> 00:06:04,543 He said they were in the business of selling nicotine. 115 00:06:05,267 --> 00:06:07,125 Philip Morris in 1972: 116 00:06:07,149 --> 00:06:08,870 "The cigarette isn't a product, 117 00:06:08,894 --> 00:06:10,346 it's a package. 118 00:06:10,712 --> 00:06:12,312 The product is nicotine. 119 00:06:12,768 --> 00:06:16,856 The pack is a storage container for a day's supply of nicotine. 120 00:06:16,880 --> 00:06:21,385 The cigarette, a dispenser for a dose unit of nicotine." 121 00:06:22,055 --> 00:06:24,891 We'll come back to this dose unit notion later. 122 00:06:25,906 --> 00:06:27,787 And R.J. Reynolds in 1972: 123 00:06:27,811 --> 00:06:31,350 "In a sense, the tobacco industry may be thought of as being a specialized, 124 00:06:31,374 --> 00:06:35,120 highly ritualized and stylized segment of the pharmaceutical industry. 125 00:06:35,144 --> 00:06:38,002 Tobacco products uniquely contain and deliver nicotine, 126 00:06:38,026 --> 00:06:41,325 a potent drug with a variety of physiological effects." 127 00:06:41,764 --> 00:06:44,867 At the time, and for many decades, publicly, 128 00:06:44,891 --> 00:06:47,522 the industry completely denied addiction 129 00:06:47,546 --> 00:06:49,679 and completely denied causality. 130 00:06:50,163 --> 00:06:52,744 But they knew the true nature of their business. 131 00:06:52,768 --> 00:06:54,276 And from time to time, 132 00:06:54,300 --> 00:06:57,941 there have been health scares made public about cigarettes, 133 00:06:57,965 --> 00:06:59,565 going back many decades. 134 00:06:59,989 --> 00:07:01,923 How did the industry respond? 135 00:07:02,330 --> 00:07:03,529 And how did they respond 136 00:07:03,553 --> 00:07:06,633 in this historically unregulated marketplace? 137 00:07:06,657 --> 00:07:08,887 Going back to the 1930s, 138 00:07:08,911 --> 00:07:13,990 it was with advertising that heavily featured imagery of doctors 139 00:07:14,014 --> 00:07:15,926 and other health care professionals 140 00:07:15,950 --> 00:07:18,084 sending messages of reassurance. 141 00:07:18,617 --> 00:07:20,252 This is an ad for Lucky Strikes, 142 00:07:20,276 --> 00:07:22,688 the popular cigarette of the time in the '30s: 143 00:07:22,712 --> 00:07:27,010 [20,679 physicians say "Luckies are less irritating." 144 00:07:27,322 --> 00:07:31,524 Your throat protection against irritation, against cough.] 145 00:07:31,548 --> 00:07:33,990 (Laughter) 146 00:07:34,014 --> 00:07:35,871 We laugh, 147 00:07:35,895 --> 00:07:37,641 but this was the kind of advertising 148 00:07:37,665 --> 00:07:40,656 that was there to send a health message of reassurance. 149 00:07:40,680 --> 00:07:44,196 Fast-forward to 1950s, '60s and '70s. 150 00:07:44,220 --> 00:07:47,172 And here, again, in the absence of regulation, 151 00:07:47,196 --> 00:07:49,973 what we're going to see is modifications to the product 152 00:07:49,997 --> 00:07:51,695 and product design 153 00:07:51,719 --> 00:07:54,404 to respond to the health concerns of the day. 154 00:07:55,664 --> 00:07:59,093 This is the Kent Micronite filter. 155 00:07:59,117 --> 00:08:03,655 And here, the innovation, if you will, was the filtered cigarette. 156 00:08:04,395 --> 00:08:06,077 [Full smoking pleasure ... 157 00:08:06,101 --> 00:08:09,013 plus proof of the greatest health protection ever.] 158 00:08:10,244 --> 00:08:13,172 What the smoker of this product didn't know, 159 00:08:13,196 --> 00:08:15,117 what their doctor didn't know, 160 00:08:15,141 --> 00:08:17,300 what the government didn't know, 161 00:08:17,324 --> 00:08:20,820 is that this was a filter that was lined with asbestos -- 162 00:08:20,844 --> 00:08:21,900 (Gasps) 163 00:08:21,924 --> 00:08:24,638 so that when smokers were smoking this filtered cigarette 164 00:08:24,662 --> 00:08:27,178 and still inhaling the chemicals and smoke 165 00:08:27,202 --> 00:08:30,408 that we know are associated with cancer and lung disease 166 00:08:30,432 --> 00:08:31,641 and heart disease, 167 00:08:31,665 --> 00:08:34,098 they were also sucking down asbestos fibers. 168 00:08:34,112 --> 00:08:35,112 (Gasps) 169 00:08:36,236 --> 00:08:38,791 In the 1960s and the 1970s, 170 00:08:38,815 --> 00:08:42,339 the so-called innovation was the light cigarette. 171 00:08:43,490 --> 00:08:46,969 This is a typical brand of the day called True. 172 00:08:47,477 --> 00:08:50,914 And this is after the Surgeon General's reports have started coming out. 173 00:08:50,938 --> 00:08:53,247 And you see the look of concern on her face. 174 00:08:53,271 --> 00:08:54,583 [Considering all I'd heard, 175 00:08:54,607 --> 00:08:57,403 I decided to either quit or smoke True. 176 00:08:57,427 --> 00:08:58,833 I smoke True.] 177 00:08:58,857 --> 00:09:00,395 (Laughter) 178 00:09:00,419 --> 00:09:03,361 [The low tar, low nicotine cigarette.] 179 00:09:03,385 --> 00:09:05,301 And then it says, "Think about it." 180 00:09:05,325 --> 00:09:08,603 And then even below that in the small print 181 00:09:08,627 --> 00:09:11,507 are tar numbers and nicotine numbers. 182 00:09:12,333 --> 00:09:14,452 What was a light cigarette? 183 00:09:15,474 --> 00:09:16,942 How did it work? 184 00:09:18,474 --> 00:09:21,172 This is an illustration of the product modification 185 00:09:21,196 --> 00:09:23,730 known as "filter ventilation." 186 00:09:24,128 --> 00:09:25,787 That's not a real filter blown up. 187 00:09:25,811 --> 00:09:27,001 That's just a picture 188 00:09:27,025 --> 00:09:30,231 so that you could see the rows of laser-perforated ventilation holes 189 00:09:30,255 --> 00:09:31,611 that were put on the filter. 190 00:09:31,635 --> 00:09:33,267 When you look at a real cigarette, 191 00:09:33,291 --> 00:09:34,807 it's harder to see. 192 00:09:34,831 --> 00:09:36,945 Every patent for this product shows 193 00:09:36,969 --> 00:09:40,371 that the ventilation holes should be 12 millimeters 194 00:09:40,395 --> 00:09:42,164 from the lip end of the filter. 195 00:09:42,188 --> 00:09:43,496 How did it work? 196 00:09:44,458 --> 00:09:46,696 The cigarette got stuck into a machine. 197 00:09:47,950 --> 00:09:50,291 The machine started puffing away on the cigarette 198 00:09:50,315 --> 00:09:52,752 and recording tar and nicotine levels. 199 00:09:53,061 --> 00:09:54,791 As the machine smoked, 200 00:09:54,815 --> 00:09:58,260 outside air came through those ventilation holes 201 00:09:58,284 --> 00:10:02,196 and diluted the amount of smoke that was coming through the cigarette. 202 00:10:02,220 --> 00:10:04,307 So as the machine smoked, 203 00:10:04,331 --> 00:10:06,874 there really was less tar and nicotine being delivered 204 00:10:06,898 --> 00:10:08,745 compared to a regular cigarette. 205 00:10:09,975 --> 00:10:11,760 What the tobacco industry knew 206 00:10:11,784 --> 00:10:14,848 was that human beings don't smoke like machines. 207 00:10:15,713 --> 00:10:17,779 How do human beings smoke this? 208 00:10:18,816 --> 00:10:20,416 Where do the fingers go? 209 00:10:20,440 --> 00:10:21,680 (Murmurs) 210 00:10:21,704 --> 00:10:23,104 Where do the lips go? 211 00:10:23,474 --> 00:10:24,966 I told you that the patent said 212 00:10:24,990 --> 00:10:28,014 that the holes are 12 millimeters from the lip end. 213 00:10:28,038 --> 00:10:30,276 The smoker didn't even know they were there, 214 00:10:30,300 --> 00:10:34,099 but between fingers and lips, the holes get blocked. 215 00:10:34,505 --> 00:10:38,219 And when the holes get blocked, it's no longer a light cigarette. 216 00:10:38,807 --> 00:10:40,339 Turns out that there's actually 217 00:10:40,363 --> 00:10:43,069 basically as much nicotine inside a light cigarette 218 00:10:43,093 --> 00:10:44,299 as a regular cigarette. 219 00:10:44,323 --> 00:10:46,289 The difference was what's on the outside. 220 00:10:46,313 --> 00:10:49,559 But once you block what's on the outside, 221 00:10:49,583 --> 00:10:51,130 it's a regular cigarette. 222 00:10:52,821 --> 00:10:55,832 Congress put FDA in the business of regulating tobacco products 223 00:10:55,856 --> 00:10:57,331 10 years ago this June. 224 00:10:57,355 --> 00:10:59,680 So you heard the statistics at the beginning 225 00:10:59,704 --> 00:11:04,364 about the extraordinary contribution to disease and death that cigarettes make. 226 00:11:04,754 --> 00:11:06,782 We've also been paying a lot of attention 227 00:11:06,806 --> 00:11:10,666 to how the cigarette works as a drug-delivery device 228 00:11:10,690 --> 00:11:14,248 and the remarkable efficiency with which it delivers nicotine. 229 00:11:14,272 --> 00:11:15,672 So let's take a look. 230 00:11:16,844 --> 00:11:19,605 When the smoker puffs on the cigarette, 231 00:11:19,629 --> 00:11:22,836 the nicotine from that puff gets up into the brain 232 00:11:22,860 --> 00:11:24,669 in less than 10 seconds. 233 00:11:25,252 --> 00:11:26,728 Less than 10 seconds. 234 00:11:27,300 --> 00:11:29,029 Up in the brain, 235 00:11:29,053 --> 00:11:31,918 there are these things called "nicotinic receptors." 236 00:11:32,929 --> 00:11:34,404 They're there ... 237 00:11:34,428 --> 00:11:35,592 waiting. 238 00:11:35,945 --> 00:11:39,207 They're waiting for, in the words of that Philip Morris document, 239 00:11:39,231 --> 00:11:41,297 the next "dose unit of nicotine." 240 00:11:43,252 --> 00:11:45,918 The smoker that you see outside, 241 00:11:45,942 --> 00:11:47,831 huddled with other smokers, 242 00:11:47,855 --> 00:11:49,339 in the cold, 243 00:11:49,363 --> 00:11:50,625 in the wind, 244 00:11:50,649 --> 00:11:52,342 in the rain, 245 00:11:52,366 --> 00:11:54,620 is experiencing craving 246 00:11:54,644 --> 00:11:57,342 and may be experiencing the symptoms of withdrawal. 247 00:11:58,564 --> 00:12:02,125 Those symptoms of withdrawal are a chemical message 248 00:12:02,149 --> 00:12:04,289 that these receptors are sending to the body, 249 00:12:04,313 --> 00:12:05,869 saying, "Feed me!" 250 00:12:08,490 --> 00:12:14,338 And a product that can deliver the drug in less than 10 seconds 251 00:12:15,230 --> 00:12:19,960 turns out to be an incredibly efficient and incredibly addictive product. 252 00:12:21,379 --> 00:12:24,466 We've spoken to so many addiction treatment experts 253 00:12:24,490 --> 00:12:25,640 over the years. 254 00:12:26,053 --> 00:12:29,359 And the story I hear is the same over and over again: 255 00:12:29,383 --> 00:12:31,867 "Long after I was able to get somebody off of heroin 256 00:12:31,891 --> 00:12:34,605 or cocaine or crack cocaine, 257 00:12:34,629 --> 00:12:36,677 I can't get them to quit cigarettes." 258 00:12:37,145 --> 00:12:40,332 A large part of the explanation is the 10-second thing. 259 00:12:42,081 --> 00:12:45,835 FDA has it within its regulatory reach 260 00:12:45,859 --> 00:12:48,233 to use the tools of product regulation 261 00:12:48,257 --> 00:12:52,627 to render cigarettes as we know them minimally or nonaddictive. 262 00:12:54,030 --> 00:12:55,496 We're working on this. 263 00:12:56,046 --> 00:13:00,092 And this could have a profound impact at a population level 264 00:13:00,116 --> 00:13:01,577 from this one policy. 265 00:13:02,124 --> 00:13:04,587 We did dynamic population-level modeling a year ago, 266 00:13:04,611 --> 00:13:07,345 and we published the results in "The New England Journal." 267 00:13:07,369 --> 00:13:09,922 And because of the generational effect of this policy, 268 00:13:09,946 --> 00:13:11,437 which I'll explain in a minute, 269 00:13:11,461 --> 00:13:14,268 here's what we project out through the end of the century: 270 00:13:14,292 --> 00:13:15,974 more than 33 million people 271 00:13:15,998 --> 00:13:19,680 who would otherwise have gone on to become regular smokers won't, 272 00:13:19,704 --> 00:13:22,345 because the cigarette that they'll be experimenting with 273 00:13:22,369 --> 00:13:24,109 can't create or sustain addiction. 274 00:13:24,569 --> 00:13:28,482 This would drive the adult smoking rate down to less than one and a half percent. 275 00:13:29,450 --> 00:13:31,333 And these two things combined 276 00:13:32,107 --> 00:13:37,591 would result in the saving of more than eight million cigarette-related deaths 277 00:13:37,615 --> 00:13:39,844 that would otherwise have occurred 278 00:13:39,868 --> 00:13:41,891 from the generational impact of this. 279 00:13:41,915 --> 00:13:44,182 Now, why am I saying "generational"? 280 00:13:45,367 --> 00:13:46,756 It's about kids. 281 00:13:48,090 --> 00:13:51,408 Ninety percent of adult smokers started smoking when they were kids. 282 00:13:52,121 --> 00:13:54,224 Half of them became regular smokers 283 00:13:54,248 --> 00:13:57,657 before they were legally old enough to buy a pack of cigarettes. 284 00:13:58,287 --> 00:14:01,466 Half of them became regular smokers before they were 18 years old. 285 00:14:01,490 --> 00:14:02,640 Experimentation. 286 00:14:03,212 --> 00:14:04,362 Regular smoking. 287 00:14:04,728 --> 00:14:05,878 Addiction. 288 00:14:06,522 --> 00:14:07,863 Decades of smoking. 289 00:14:07,887 --> 00:14:09,490 And then the illness, 290 00:14:09,514 --> 00:14:11,661 and that's why we're talking about a product 291 00:14:11,685 --> 00:14:15,654 that will kill half of all long-term users prematurely later in life. 292 00:14:16,880 --> 00:14:20,186 The generational impact of this nicotine-reduction policy 293 00:14:20,210 --> 00:14:21,534 is profound. 294 00:14:22,817 --> 00:14:25,742 Those old industry documents had a word for young people. 295 00:14:26,323 --> 00:14:29,276 They were described as "the replacement smokers." 296 00:14:30,577 --> 00:14:32,942 The replacement smokers for addicted adult smokers 297 00:14:32,966 --> 00:14:34,116 who died or quit. 298 00:14:34,533 --> 00:14:38,303 Future generations of kids, especially teens, 299 00:14:38,327 --> 00:14:40,295 are going to engage in risky behavior. 300 00:14:40,319 --> 00:14:41,586 We can't stop that. 301 00:14:42,010 --> 00:14:46,011 But what if the only cigarette that they could get their hands on 302 00:14:46,035 --> 00:14:48,324 could no longer create or sustain addiction? 303 00:14:48,839 --> 00:14:51,450 That's the public health return on investment 304 00:14:51,474 --> 00:14:53,886 at a population level over time. 305 00:14:55,132 --> 00:14:57,196 Haven't said anything about e-cigarettes. 306 00:14:57,521 --> 00:14:59,727 But I have to say something about e-cigarettes. 307 00:14:59,751 --> 00:15:00,768 (Laughter) 308 00:15:00,792 --> 00:15:03,664 We are dealing with an epidemic of kids' use of e-cigarettes. 309 00:15:03,688 --> 00:15:05,847 And what troubles us the most, 310 00:15:05,871 --> 00:15:10,252 in combination with the rising numbers when it comes to prevalence, 311 00:15:10,276 --> 00:15:11,680 is frequency. 312 00:15:11,704 --> 00:15:14,033 Not only are more kids using e-cigarettes, 313 00:15:14,057 --> 00:15:18,137 but more kids are using e-cigarettes 20 or more days in the past 30 days 314 00:15:18,161 --> 00:15:20,938 than at any time since e-cigarettes came onto the market. 315 00:15:20,962 --> 00:15:23,184 And at FDA, we're doing everything that we can 316 00:15:23,208 --> 00:15:24,466 using program and policy, 317 00:15:24,490 --> 00:15:26,109 first to get the word out to kids 318 00:15:26,133 --> 00:15:28,204 that this is not a harmless product 319 00:15:28,228 --> 00:15:31,163 and to make sure that kids aren't initiating and experimenting 320 00:15:31,187 --> 00:15:32,347 on any tobacco product, 321 00:15:32,371 --> 00:15:34,251 whether combustion is present or not. 322 00:15:34,569 --> 00:15:37,690 But think about e-cigarettes in a properly regulated marketplace 323 00:15:37,714 --> 00:15:39,637 as something that could be of benefit 324 00:15:39,661 --> 00:15:41,781 to addicted adult cigarette smokers 325 00:15:41,805 --> 00:15:44,161 who are trying to transition away from cigarettes. 326 00:15:44,185 --> 00:15:47,716 So, I'll leave you with this vision: 327 00:15:49,748 --> 00:15:51,399 imagine a world 328 00:15:52,077 --> 00:15:54,749 where the only cigarette that future generations of kids 329 00:15:54,773 --> 00:15:55,934 could experiment with 330 00:15:55,958 --> 00:15:58,196 could no longer create or sustain addiction 331 00:15:58,220 --> 00:15:59,957 because of a single policy. 332 00:16:00,585 --> 00:16:01,763 Imagine a world 333 00:16:02,534 --> 00:16:05,220 where health-concerned cigarette smokers, 334 00:16:05,244 --> 00:16:08,140 especially if a policy goes into effect 335 00:16:08,164 --> 00:16:11,768 that takes the nicotine levels down to minimally or nonaddictive levels, 336 00:16:11,792 --> 00:16:14,334 could transition to alternative and less harmful forms 337 00:16:14,358 --> 00:16:15,673 of nicotine delivery, 338 00:16:15,697 --> 00:16:17,950 starting with FDA-approved nicotine medications, 339 00:16:17,974 --> 00:16:19,911 like the gum, patch and lozenge. 340 00:16:20,704 --> 00:16:21,895 And finally, 341 00:16:21,919 --> 00:16:24,768 imagine a world and a properly regulated marketplace, 342 00:16:24,792 --> 00:16:28,006 whether it's e-cigarettes or whatever the technology of the day, 343 00:16:28,030 --> 00:16:30,331 it's not the product developers and the marketers 344 00:16:30,355 --> 00:16:32,300 who decide which products come to market 345 00:16:32,324 --> 00:16:34,133 and what claims get made for them, 346 00:16:34,157 --> 00:16:37,029 it's review scientists at FDA, 347 00:16:37,053 --> 00:16:38,633 who look at applications 348 00:16:38,657 --> 00:16:42,331 and decide, using the standard that Congress has entrusted us 349 00:16:42,355 --> 00:16:44,410 to implement and enforce, 350 00:16:44,434 --> 00:16:47,267 whether a particular product should come to market, 351 00:16:47,291 --> 00:16:50,529 because the marketing of that product and the words of our law 352 00:16:50,553 --> 00:16:53,725 would be appropriate for the protection of the public health. 353 00:16:54,297 --> 00:16:56,602 These are the kinds of powerful regulatory tools 354 00:16:56,626 --> 00:16:59,614 that are within our reach 355 00:16:59,638 --> 00:17:01,014 to deal with what remains 356 00:17:01,038 --> 00:17:04,291 the leading cause of completely preventable disease and death 357 00:17:04,315 --> 00:17:05,474 in the country. 358 00:17:05,498 --> 00:17:06,765 If we get this right, 359 00:17:07,657 --> 00:17:12,246 that trajectory, those 5.6 million kids, 360 00:17:12,270 --> 00:17:13,611 is breakable. 361 00:17:13,635 --> 00:17:14,786 Thank you. 362 00:17:14,810 --> 00:17:17,523 (Applause)