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REMARKS OF SENATOR EDWARD M. KENNEDY IN SUPPORT OF FDA REGULATION OF TOBACCO PRODUCTS Senate Health, Education, Labor and Pensions Committee Executive Meeting (As Prepared for Delivery)

(As Prepared for Delivery) Today, the Senate is taking the first step toward passage of legislation that should have beenenacted years ago – authority for the FDA to regulate tobacco products, the most lethal of allconsumer products. Used as intended by the companies that manufacture and market them,cigarettes will kill one out of every three smokers. Yet, the federal agency most responsible forprotecting the public health is currently powerless to deal with the enormous risks of tobaccouse. Public health experts overwhelmingly believe that passage of S. 625 is the mostimportant action Congress can take to protect children from this deadly addiction. If Congressfails to act and smoking continues at its current rate, more than six million of today’s childrenwill ultimately die from tobacco-induced disease. Smoking is the number one preventable cause of death in America. Nationally, cigarettes killwell over four hundred thousand people each year. That is more lives lost than fromautomobile accidents, alcohol abuse, illegal drugs, AIDS, murder, and suicide combined.Congress cannot continue to ignore a public health problem of this magnitude.And Congress will not ignore it. This legislation has broad bipartisan support. Fifty-twoSenators have co-sponsored it, including 12 Republicans. They recognize that giving FDAauthority over tobacco products is essential to effectively addressing the tobacco health crisis.The American Cancer Society, the American Heart Association, the American Lung Association,the American Medical Association, the Campaign for Tobacco-Free Kids and dozens of othermajor public health organizations speak with one voice on this issue. They are all supportingS. 625 because they know it will give FDA the tools it needs to reduce youth smoking and helpaddicted smokers quit. A landmark report by the Institute of Medicine, released less than two months ago, stronglyurged Congress to “confer upon the FDA broad regulatory authority over the manufacture,distribution, marketing and use of tobacco products.” Opponents of this legislation argue that FDA should not be regulating such a dangerousproduct. I could not disagree more. It is precisely because tobacco products are so deadlythat we must empower America’s premier public health protector – the FDA – to combattobacco use. For decades the federal government has stayed on the sidelines and done nextto nothing to deal with this enormous health problem. The tobacco industry has been allowedto mislead consumers, to make false health claims, to conceal the lethal contents of theirproducts, to make their products even more addictive, and worst of all – to seducegenerations of children into a lifetime of addiction and early death. The alternative to FDAregulation is more of the same. Allowing this abusive conduct by the tobacco industry to gounchecked would be terribly wrong. Under this legislation, FDA will for the first time have the needed power and resources to takeon this challenge. The cost will be funded entirely by a new user fee paid by the tobaccocompanies in proportion to their market share. Not a single dollar will be diverted from FDA’sexisting responsibilities. Giving FDA authority over tobacco products will not make the tragic toll of tobacco usedisappear overnight. More than forty million people are hooked on this highly addictiveproduct and many of them have been unable to quit despite repeated attempts. However, FDAaction can play a major role in breaking the gruesome cycle that seduces millions of teenagersinto a lifetime of addiction and premature death. What can FDA regulation accomplish?• It can reduce youth smoking by preventing tobacco advertising which targets children.• It can help prevent the sale of tobacco products to minors.• It can stop the tobacco industry from continuing to mislead the public about the dangersof smoking.• It can help smokers overcome their addiction.• It can make tobacco products less toxic and less addictive for those who continue to usethem.• And it can prohibit unsubstantiated health claims about supposedly “reduced risk”products, and encourage the development of genuinely less harmful alternative products.Regulating the conduct of the tobacco companies is as necessary today as it has beenin years past. The facts presented in the federal government’s landmark lawsuit against thetobacco industry conclusively demonstrate that the misconduct is substantial and ongoing. Thedecision of the Court states: “The evidence in this case clearly establishes that Defendantshave not ceased engaging in unlawful activity…Defendants continue to engage in conduct thatis materially indistinguishable from their previous actions, activity that continues to this day.”Only strong FDA regulation can force the necessary change in their corporate behavior. We must deal firmly with tobacco company marketing practices that target childrenand mislead the public. The Food and Drug Administration needs broad authority to regulatethe sale, distribution, and advertising of cigarettes and smokeless tobacco.The tobacco industry currently spends over thirteen billion dollars each year topromote its products. Much of that money is spent in ways designed to tempt children to startsmoking, before they are mature enough to appreciate the enormity of the health risk. Fourthousand children have their first cigarette every day, and one thousand of them become dailysmokers. The industry knows that nearly 90% of smokers begin as children and are addictedby the time they reach adulthood. Documents obtained from tobacco companies prove, in the companies' own words, themagnitude of the industry's efforts to trap children into dependency on their deadly product.Studies by the Institute of Medicine and the Centers for Disease Control show the substantialrole of industry advertising in decisions by young people to use tobacco products.If we are serious about reducing youth smoking, FDA must have the power to prevent industryadvertising designed to appeal to children wherever it will be seen by children. This legislationwill give FDA the authority to stop tobacco advertising that glamorizes smoking to kids. Itgrants FDA full authority to regulate tobacco advertising “consistent with and to the full extentpermitted by the First Amendment.” FDA authority must also extend to the sale of tobacco products. Nearly every statemakes it illegal to sell cigarettes to children under 18, but surveys show that those laws arerarely enforced and frequently violated. FDA must have the power to limit the sale ofcigarettes to face-to-face transactions in which the age of the purchaser can be verified byidentification. This means an end to self-service displays and vending machine sales. Theremust also be serious enforcement efforts with real penalties for those caught selling tobaccoproducts to children. This is the only way to ensure that children under 18 are not able to buycigarettes. The FDA conducted the longest rulemaking proceeding in its history, studying whichregulations would most effectively reduce the number of children who smoke. Seven hundredthousand public comments were received in the course of that rulemaking. At the conclusionof its proceeding, the Agency promulgated rules on the manner in which cigarettes areadvertised and sold. Due to litigation, most of those regulations were never implemented. Ifwe are serious about curbing youth smoking as much as possible, as soon as possible; itmakes no sense to require FDA to reinvent the wheel by conducting a new multi-yearrulemaking process on the same issues. This legislation will give the youth access andadvertising restrictions already developed by FDA the force of law, as if they had been issuedunder the new statute. Once they are in place, FDA will have the authority to modify theserules as changing circumstances warrant. The legislation also provides for stronger warnings on all cigarette and smokelesstobacco packages, and in all print advertisements. These warnings will be more explicit in theirdescription of the medical problems which can result from tobacco use. The FDA is given theauthority to change the text of these warning labels periodically, to keep their impact strong.The nicotine in cigarettes is highly addictive. Medical experts say that it is as addictiveas heroin or cocaine. Yet for decades, tobacco companies vehemently denied the addictivenessof their products. No one can forget the parade of tobacco executives who testified under oathbefore Congress that smoking cigarettes is not addictive. Overwhelming evidence in industrydocuments obtained through the discovery process proves that the companies not only knewof this addictiveness for decades, but actually relied on it as the basis for their marketingstrategy. As we now know, cigarette manufacturers chemically manipulated the nicotine intheir products to make it even more addictive. A newly released analysis by the Harvard School of Public Health demonstrates thatcigarette manufacturers are still manipulating nicotine levels. Between 1998 and 2005, theysignificantly increased the nicotine yield from major brand name cigarettes. The averageincrease in nicotine yield over the period was 11%. The tobacco industry has a long, dishonorable history of providing misleadinginformation about the health consequences of smoking. These companies have repeatedlysought to characterize their products as far less hazardous than they are. They made minorinnovations in product design seem far more significant for the health of the user than theyactually were. It is essential that FDA have clear and unambiguous authority to prevent suchmisrepresentations in the future. The largest disinformation campaign in the history of thecorporate world must end. Given the addictiveness of tobacco products, it is essential that the FDA regulate themfor the protection of the public. Over forty million Americans are currently addicted tocigarettes. No responsible public health official believes that cigarettes should be banned. Aban would leave forty million people without a way to satisfy their drug dependency. FDAshould be able to take the necessary steps to help addicted smokers overcome their addiction,and to make the product less toxic for smokers who are unable or unwilling to stop. To do so,FDA must have the authority to reduce or remove hazardous ingredients from cigarettes, tothe extent that it becomes scientifically feasible. The inherent risk in smoking should not beunnecessarily compounded. Recent statements by several tobacco companies make clear that they planto develop what they characterize as "reduced risk" cigarettes. Some are already on themarket making unsubstantiated claims. This legislation will require manufacturers to submitsuch "reduced risk" products to the FDA for analysis before they can be marketed. No healthrelatedclaims will be permitted until they have been verified to the FDA's satisfaction. Thesesafeguards are essential to prevent deceptive industry marketing campaigns, which could lullthe public into a false sense of health safety. This legislation will vest FDA not only with the responsibility for regulating tobaccoproducts, but with full authority to do the job effectively. It is long overdue.Enacting this bill this year is the right thing to do for America’s children. They aredepending on us. By passing this legislation, we can help them live longer, healthier lives.