Finally the committee on health, education, labor, and pensions will come to order. I think everyone for their patience. We have a lot of votes on the senate floor. Reconvene this hearing. Of the extraordinary publichealth efforts that have driven down tobacco use and the enormous challenges that remain. The nation has made remarkable progress in the 50 years as the first Surgeon Generals report on smoking and health. That time does not carry has been cut by more than half. We have learned what works from smoke free workplace is to access to free Cessation Services from meaningful tobacco taxes to robust regulations to Media Campaigns led a wildly successful tips from a former smoker to commonsense marketing restrictions. We know what works. Yes, despite all these efforts and successes tobacco use remains the leading preventable cause of death and the u. S. Let me repeat that. Tobacco use remains the number one preventable cause of death in the u. S. Right now 16 million americans are suffering from smoking caused illness, and over five and a half million kids alive today will ultimately die from smoking. Today nearly one in four Highschool Seniors smoke. Sadly, most young smokers become adult smokers. The problem is not just cigarettes. Last fall the centers for Disease Control and prevention reported that the use of Electronic Cigarettes were ecigarette and i will have more to say about those after a bit because i have an array of them appeared. The cdc reports the use of these Electronic Cigarettes are run to of among middle and i School Students more than doubled in one year. This is because of statistics like these that the Public Health efforts to combat tobacco have been among my top priority since i came here. In responding to the hundreds of thousands who die every year, in 1998 and introduced the First Comprehensive bipartisan bill to give the fda authority to regulate tobacco. Well, it took awhile but that finally became a reality five years ago with passage of the family smoking prevention and Tobacco Control act. Today we want to examine some of that, the implementation of that long. More recently in light of the fact that some 3500 children try smoking for the first time each state aisle for provisions in the Affordable Care act assures every american has access to tobacco Cessation Services without copays of deductibles. Also in the provisions i put in on the prevention of Public Health, investing more than 300 million in communitybased Public Health efforts to curb tobacco use. Last month confronted with the big prospect of a whole new generation becoming addicted to nicotine by way of ecigarette had joined with ten of my colleagues to release an Investigative Reporter feeling that manufacturers are devoting massive resources to the marketing of ecigarette and the Marketing Strategies are requested designed to appeal to kids. I urge everyone to read the report. I will share one example of the many graphics that contains. This chart you see a pair is an animated cartoon video game, video game through which players earn ecigarette coupons to redeem on facebook. Kids play these games. Then they get on facebook and they can redeem coupons. Cartoons, video games, social media, can the fivers. The ones i got here. Lets see. Ive got come ibert. That is one. That appeals to adults, right . Of a bear. And here is one. Any popsicle front of it. Cotton candy. Concentrated nicotine. Ive got another one here, crandall. Hello, ive got a strawberry. I did not want to leave out strawberry. Again, it is the same thing we used to see with clever cigarettes. The same thing. Again, they are pulling out all the stops to target children. It is absolutely shameful. A disgusting throwback to big tobacco playbook to promote traditional cigarettes to kids before restrictions were in place. I know that some believe that ecigarette era promising alternative to cigarettes. But hopefully we can all agree these products dont belong in the hands of kids. Keep in mind, this is a Drug Delivery device. Delivers nicotine. Nicotine is an addictive drug. And so i look forward to hearing more today from the fda about their new proposal to regulate these ecigarette and other Tobacco Products of the authority of the familys blocking prevention and control act. Well, that is what is this one called . Oh, jerry crash. That is not mentally that out. That is for the refills. You can refill it. Anyway, the ecigarette phenomenon has created a regulatory black hole that has gone on too long. Todays hearing is congresss first examination of a proposal which has extraordinary consequences for publichealth. So we are pleased today to have dr. Tim mcafee of the cdc office on smoking and health, mr. Mrs. Heller of the fdas center for tobacco parts to talk about the ongoing Public Health challenge posed by both. They will also report on the board communitybased and regulatory work in those agencies that are engaged in this. And now i will turn to senator alexander for his Opening Statement. Thank you, mr. Chairman. Welcome to the witnesses. Congress passed the law to which senator harkin referred, the family smoking prevention and Tobacco Control act almost five years ago. It clearly was taking a position to discourage the use of Tobacco Products. What has happened since then, run 18 percent of adults still smokes cigarettes, that is down from 20 in 2010. Smoking among youth continues to decline. Electronic cigarettes have grown rapidly. The number of adult smokers who tried ecigarette doubled between 2010 and 11. I am going to focus mostly on the socalled teaming regulation proposed two weeks ago by the fda, but i did want to first read some statistics about the center for Tobacco Products. The fda spin nearly 80 of the user fees collected. More than half of the spending to make under 68 million occur during fiscal year 2013. The fda has received only four premarket tobacco product applications which would have to be filed for any normal product put on the market after february 2,007 if deeming is finalized as it is. All four were rejected as a complete. There are over 4,000 such as liquid applications pending for Tobacco Products. The fda has decided on 34 of the over 4500 that the agency received. I believe the statistics reflect the poor performance, and i think it is important to college your attention. Now, appreciate being informed about the proposed regulation. I want to articulate my strong support for the alternative exempting premium cigars from fda regulation. I have some concerns about that, but i will followup with questions on how the works. The fda regulation should fit the product proposed by the product. And throughout the proposed regulation the fta talks about a somewhat controversial idea of farm reaction. For the 42 million americans currently smoke the fda should enable companies to find creative ways to reduce the negative Health Effects of nicotine addiction, not regulate that innovation out of existence. Most of the discussion around the deeming regulation and tobacco seems to be about ecigarette. I am here to listen. I understand there are competing points of view. Some Public Health experts such as david adams, american legacy foundation, the largest nonprofit public of charity in the nation devoted specifically to Tobacco Control has said this could be the single biggest opportunity that has come along in a century to make of the cigarette obsolete. That is one view. On the other hand, the cdc director has been quoted as stating that many kids are starting out with the cigarettes and then going on to smoke conventional cigarettes. So what are would like to understand is what research have we done to answer those questions. There are reports from countries overseas that some of these new products do not seem to be a gateway to traditional cigarette use, but we dont know that. We dont know that yet. So the purpose of a hearing such as this and a thank the chairman for calling it, is not to presuppose an answer but to find from experts in our government with their opinion is and what i would like to know is which of those points of view is prescribed to. Here is where i think we have agreement on. Regulations should be based in data and sound science. S. Sales to anyone under 18. Any child beginning to use a tobacco or nicotine product is bad for Public Health. Number three toy manufacturers should register at least approach to make ingredients to use with the fda. After that i think what we need to focus on is what is the research and what does it tell us . Of the torch to the testimony. Thank you. I know that Center White House has to leave shortly. If you want to make a short statement. I appreciate the chair recognizing me for one minute. We have two wonderful witnesses, one from the fda and one from the cdc. Wanted to make the point as a senator from rhode island that there has been important corporate in this area of reducing access to the number one cause of preventable death which is tobacco. And that comes from a company headquartered in rhode island. A very significant pharmacy chain across the country. And the ceo and his Management Team had made the decision to phase out the sales of tobacco product by october 1st of this year. That is an important commendable step. I just wanted that to be a part of the record of this hearing. Thank you very much. Mr. Chairman, i never miss some of which ended this is something when given the of the kennedy. Since i feel like and have lived with this issue as long as anybody in congress, and thank you for the job your doing of it eric when newly created agency. Very tough to get up and running mr. Chairman, i can remember when opportunities for Harm Reduction were the goal. Could not be achieved because technology did not allow us to get there. I remember when r. J. Reynolds expand several decades and came out with the product that to my desk was a precursor to some degree of the electronics cigarette even though it operated differently. You might remember that and there became a real opportunity for individuals to use the product that tell what they were looking for without a combustible. And how quickly we have moved to a point where no Harm Reduction is no longer gold we can work out these things about flavors. Americans. Look at the pool that was available. The cycle of combustible tobacco. Residents than careless befall we know we got in the right with the children attempting to do that. Another job the above the statutory requirements. Lets let him do it, but was not condemned where the technology has gone before we ever had an opportunity to see. In fact what effect this can have on pulling people off of combustible Tobacco Products. The committee, nova i hope the fda puts as much stock in Harm Reduction and now we get people off of something that is not as safe to a product is safer. This is, for some people, not eliminating access but a product category. Has been for 20 years, and nothing changed. That is fine. But as far as long as i am a member of the committee will fight for the American People to have a right to make a choice. And for mr. Mitch zeller to determine what those choices will be within reason. And i encourage you to continue the job is youre doing. Arrow that our policies reflect an opportunity for the American People to make a decision based upon what technology is available to choose a reduced farm product which i think many of the categories we see today are beginning to move toward. A think the chairman. Thank you. We will start to with our first witness, dr. Kim tim mcafee. The National Center for chronic disease prevention and health promotion. All science policy in programming and Tobacco Control and prevention. A family physician who practiced for more than a decade and served as a clinical faculty member at the university of washington Family Medicine and school of Public Health. Also offering the World Health Organization tobacco manual for low and middle income countries. Thank you for being here. And then after we will recognize mr. Sellars who is the director of the center for Tobacco Products wary the leaves the fda efforts to reduce disease, tobacco use and to develop regulations for the authority of a variety of products. Working on f. D. A. Issues for more than 30 years. He served as assistant commissioner director of the fda first office of tobacco programs prior to rejoining the fda in 2013 he worked on Tobacco Control as executive Vice President of the american legacy foundation. The taft. Thank you very much. And members of the committee for their statements previously. It is an honor to provide this statement. I wanted thank the chairman for his lead and also recognize this committees bipartisan history of support on Tobacco Control. As noted, i serve as the director of the office on smoking and health at the centers for Disease Controland prevention, and i am also a physician. Today and will discuss briefly the past, present, and future Tobacco Control trying on findings and recommendations primarily from the 50th anniversary Surgeon Generals report on tobacco and health. Fifty years ago half man and a third of the women in this country smokes cigarettes. Tobacco companies could advertise everywhere, including tv. And School Children carry lunch boxes with cigarette logos paris market was common in public places. Today the landscape is already dramatically different to me at all cigarette smoking has fallen from 42 in 1965 and 18 percent today and tobacco prevention and control measures save 8 million lives platinum over the last 50 years. Today half of our states prohibit smoking in work sites, restaurants, and bars and we now see the real consequences of smoking. Have these have had so real people fighting serious disease and disability. In the first year the ads hall lead over onehalf million to make a quick attempt. Despite enormous progress every day over 3,000 children to appear for Cigarette Companies smokingrelated deaths approach half a million a year and another 16 million americans suffer from serious smokingrelated disease. The 2014 Surgeon Generals report concluded that was initiated in sustained by the aggressive strategies of the Tobacco Industry was deliberately misled the public. In addition to making their products powerfully addictive the Tobacco Industry spends nearly a Million Dollars now are on promotions to developing products such as fruit and canned beef liver cigars and electronics cigarettes. The o. C. Are similar in size and shape to cigarettes appeal even more to you if than adults because of the flavors and lower prices. Responses to a large survey to five survey shows serious is nearly double the rate. And among 12th graders and surge to levels that we have not seen in over a decade. And ecigarette are heavily marketed on tv and radio some including Unproven Health claims that are proven to appeal to youth. As a result since reporter trying cigarettes. There are now hundreds of products ranging from disposables to tanked devices that are refillable, adjustable, and allow for use of other jurors the seismic in. Could propose an important regulatory requirements and allow for a comprehensive protection as we move forward. However, fda regulation alone is insufficient for this process. That is why states and cities across the country are falling these cigarettes enacting bans. Now, when the fact that they exist and there being marketed as the same as cigarettes but safer is a dramatic shift. According to the Surgeon General report a ecigarette could be beneficial if completely substituted for burns tobacco and could assist in a rapid transition to a society with little or no use of burns Tobacco Products. As we consider these issues we must not forget that burns Tobacco Products are overwhelmingly responsible for tobacco related death and disease. The appeal to children, half of longtime users and are addicted by design. If current rates continue or five and half million children under the age of 18 will tire of it because of smoking. The good news is we know a great deal of words and have a Regulatory Framework to its own rita progress. The bad news is in not doing enough of what works. Higher prices, access to cessation treatments, hardhitting media and state based Tobacco Control programs. The progress made is due to efforts from across soci