STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS -- (Senate - February 15, 2007)
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By Mr. KENNEDY (for himself, Mr. Cornyn, Mr. Harkin, Mr. McCain, Mr. Durbin, Mr. Lugar, Mr. Dodd, Mr. Smith, Mr. Reed, Ms. Snowe, Mr. Lautenberg, Ms. Murkowski, Mr. Bingaman, Ms. Collins, Ms. Mikulski, Mr. Stevens, Mrs. Murray, Mr. Domenici, Mrs. Clinton, Mr. Cochran, Mrs. Feinstein, Mr. Leahy, Mr. Obama, Mr. Sanders, Mr. Brown, Mr. Schumer, Mr. Akaka, Mr. Kohl, Ms. Cantwell, Mr. Carper, and Mr. Nelson of Florida):
S. 625. A bill to protect the public health by providing the Food and Drug Administration with certain authority to regulate tobacco products; to the Committee on Health, Education, Labor, and Pensions.
Mr. KENNEDY. Mr. President, today, we are introducing legislation to give the Food and Drug Administration broad authority to regulate tobacco products. Congress cannot in good conscience allow the Federal agency most responsible for protecting the public health to remain powerless to deal with the enormous risks of tobacco, the most deadly of all consumer products. Health experts believe this legislation is the most important action Congress could take to protect children from this deadly addiction.
This is a bipartisan, bicameral initiative. The bill that Senator Cornyn and I are introducing already has over 25 cosponsors. Congressman Waxman and Davis will introduce identical legislation in the House. Our bill has the support of a broad coalition of public health organizations led by the Campaign for Tobacco-Free Kids, the American Cancer Society, the American Heart Association and the American Lung Association. They all recognize the importance of enacting this bill this year.
The legislation we are introducing today is well known. It is the same bill that passed the Senate in 2004, and that we introduced in the last Congress. However, in this new Congress, the likelihood of passage is greatly enhanced. Last November's election swept away many of the barriers to passage from prior years. We believe 2007 is the year that legislation empowering the FDA to regulate tobacco products will finally become law.
We intend to move forward on the legislation quickly. I have already scheduled a hearing in the HELP Committee for February 27, and a markup is planned soon thereafter.
The stakes are vast. Four thousand children have their first cigarette every day, and one thousand become daily smokers. More than one-third of them will die prematurely from tobacco-induced diseases. Cigarettes kill well over 400,000 Americans each year. That is more lives lost than from automobile accidents, alcohol abuse, illegal drugs, AIDS, murder, and suicide combined. Congress's response to a public health problem of this magnitude is long overdue.
Regulating the conduct of tobacco companies is as necessary today as it has been in years past. The facts presented in the Federal Government's landmark lawsuit against the tobacco industry demonstrate that the misconduct is substantial and ongoing. The decision of the court states: ``The evidence in this case clearly establishes that Defendants have not ceased engaging in unlawful activity ..... Defendants continue to engage in conduct that is materially indistinguishable from their previous actions, activity that continues to this day.'
We must deal firmly with tobacco company marketing practices that target children and mislead the public. The Food and Drug Administration needs broad authority to regulate the sale, distribution, and advertising of cigarettes and smokeless tobacco.
The tobacco industry currently spends over $15 billion a year to promote its products. Much of that money is spent in ways designed to tempt children to start smoking, before they are mature enough to appreciate the enormity of the health risk. The industry knows that nearly 90 percent of smokers begin as children and are addicted by the time they reach adulthood.
Documents obtained from tobacco companies prove, in the companies' own words, the magnitude 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 substantial role 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 industry advertising designed to appeal to children wherever it will be seen by children. This legislation will give FDA the authority to stop tobacco advertising that glamorizes smoking to kids. It grants FDA full authority to regulate tobacco advertising ``consistent with and to the full extent permitted by the First Amendment.'
FDA authority must also extend to the sale of tobacco products. Nearly every State makes it illegal to sell cigarettes to children under 18, but surveys show that those laws are rarely enforced and frequently violated. FDA must have the power to limit the sale of cigarettes to face-to-face transactions in which the age of
the purchaser can be verified by identification. This means an end to self-service displays and vending machine sales. There must also be serious enforcement efforts with real penalties for those caught selling tobacco products to children. This is the only way to ensure that children under 18 are not able to buy cigarettes.
The FDA conducted the longest rulemaking proceeding in its history, studying which regulations would most effectively reduce the number of children who smoke. Seven hundred thousand public comments were received in the course of that rulemaking. At the conclusion of its proceeding, the agency promulgated rules on the manner in which cigarettes are advertised and sold. Due to litigation, most of those regulations were never implemented. If we are serious about curbing youth smoking as much as possible, as soon as possible; it makes no sense to require FDA to reinvent the wheel by conducting a new multi-year rulemaking process on the same issues. This legislation will give the youth access and advertising restrictions already developed by FDA the immediate force of law, as if they had been issued under the new statute.
The legislation also provides for stronger warnings on all cigarette and smokeless tobacco packages, and in all print advertisements. These warnings will be more explicit in their description of the medical problems which can result from tobacco use. The FDA is given the authority 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 addictive as heroin or cocaine. Yet for decades, tobacco companies vehemently denied the addictiveness of their products. No one can forget the parade of tobacco executives who testified under oath before Congress that smoking cigarettes is not addictive. Overwhelming evidence in industry documents obtained through the discovery process proves that the companies not only knew of this addictiveness for decades, but actually relied on it as the basis for their marketing strategy. As we now know, cigarette manufacturers chemically manipulated the nicotine in their products to make it even more addictive.
A newly released analysis by the Harvard School of Public Health demonstrates that cigarette manufacturers are still manipulating nicotine levels. Between 1998 and 2005, they significantly increased the nicotine yield from major brand name cigarettes. The average increase in nicotine yield over the period was 11 percent.
The tobacco industry has a long, dishonorable history of providing misleading information about the health consequences of smoking. These companies have repeatedly sought to characterize their products as far less hazardous than they are. They made minor innovations in product design seem far more significant for the health of the user than they actually were. It is essential that FDA have clear and unambiguous authority to prevent such misrepresentations in the future. The largest disinformation campaign in the history of the corporate world must end.
Given the addictiveness of tobacco products, it is essential that the FDA regulate them for the protection of the public. Over 40 million Americans are currently addicted to cigarettes. No responsible public health official believes that cigarettes should be banned. A ban would leave 40 million people without a way to satisfy their drug dependency. FDA should 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, to the extent that it becomes scientifically feasible. The inherent risk in smoking should not be unnecessarily compounded.
Recent statements by several tobacco companies make clear that they plan to develop what they characterize as ``reduced risk' cigarettes. Some are already on the market making unsubstantiated claims. This legislation will require manufacturers to submit such ``reduced risk' products to the FDA for analysis before they can be marketed. No health-related claims will be permitted until they have been verified to the FDA's satisfaction. These safeguards are essential to prevent deceptive industry marketing campaigns, which could lull the public into a false sense of health safety.
Smoking is the number one preventable cause of death in America. Congress must vest FDA not only with the responsibility for regulating tobacco products, but with full authority to do the job effectively.
This legislation will give the FDA the legal authority it needs to reduce youth smoking by preventing tobacco advertising which targets children, to prevent the sale of tobacco products to minors, to help smokers overcome their addiction, to make tobacco products less toxic for those who continue to use them, and to prevent the tobacco industry from misleading the public about the dangers of smoking.
Enacting this bill this year is the right thing to do for America's children. They are depending on us. By passing this legislation, we can help them live longer, healthier lives.
Mr. President, I ask unanimous consent that the text of the bill be printed in the RECORD.
There being no objection, the text of the bill was ordered to be printed in the RECORD
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By Mr. KENNEDY (for himself, Mr. Bond, Mr. akaka, Mr. Leahy, Mr. Menendez, Mr. Craig, and Mr. Shelby):
S. 626 A bill to amend the Public Health Service Act to provide for arthritis research and public health, and for other purposes; to the Committee on Health, Education, Labor, and Pensions.
Mr. KENNEDY. Mr. President, it is a privilege to join Senator Bond in introducing ``The Arthritis Prevention, Control and Cure Act.'
Our goal in this important initiative is to provide a strong federal response to arthritis. Early diagnosis, treatment, and appropriate management of arthritis can control its symptoms, improve the quality of life of patients, and Federal action will improve the lives of the family members and caregivers of those affected by the disease.
Arthritis exits in more than a hundred different forms. It's one of the most devastating diseases impairing the health of the American people. It's second only to heart disease as a cause of work disability. It undermines everyday activities such as walking, dressing and bathing for more than seven million Americans.
One out of very five adults in the United States suffers from some form of arthritis. The number of patients in the U.S. with arthritis will keep growing as the number of older Americans continues to increase dramatically in the next few decades. Today, 8.7 million adults, ages 18 through 44, have arthritis and millions of others are at risk of developing the disease.
In fact, arthritis is one of the most prevalent chronic illnesses and the leading cause of disability among Americans over age 15. More than 40 percent of adults with arthritis are limited in their activities because of their arthritis. By 2030, nearly 25 percent of the projected United States adult population will have arthritis and these numbers don't account for the current trends in obesity, which may contribute to future cases of the disease.
It is an illness that affects all types of people in the U.S., not just older Americans. Arthritis knows no boundaries. Men, women and children are all afflicted with the disease. According to the Arthritis Foundation, 24 million women and 17 million men have been diagnosed with arthritis by their doctors. Women are still disproportionately affected by the disease.
Nearly 3 out of every 1,000 American children are affected by arthritis. The devastating effects of pediatric arthritis justifies greater investment by the federal government in research and to identify more effective treatments.
Special concerns are raised by juvenile arthritis because of its impact on family relationships, school life, dating, sports and other aspects active, growing youths. Teens and young adults entering the workforce face even greater challenges.
Arthritis an other rheumatic diseases cost our economy $128 billion annually, according to the Centers for Disease Control and Prevention. In 2003, the cost was
equivalent to 1.2 percent of the nation's gross domestic product. $80 million of that amount were direct costs for medical care and $47 million were indirect costs for lost earnings. National medical costs attributed to arthritis grew by 24 percent between 1997 and 2003, with an increase attributed to the growing number of people affected with the disease.
In 1975, Congress enacted the National Arthritis Act to encourage basic and clinical research, establish Multipurpose Arthritis Centers and expand clinical knowledge of the illness. The act was successful in implementing and continued funding of research and has led to important advances in the control, treatment and prevention of the illness.
Early diagnosis, treatment and management can control symptoms and improve the quality of life. Weight control and exercise can help lower risks. Patient education, training and self-management also contribute to greater control of these diseases. Innovative and increasingly effective drug therapies, joint replacements, and other therapeutic alternatives are being developed.
Despite much research identifying effective interventions, many of them are not being used well enough and the inevitable result is unnecessary loss of life, poorer health and poorer quality of life.
Our legislation will expand the effort to find new ways to prevent, treat and care for patients with arthritis and related rheumatic diseases.
It will enhance the National Arthritis Action Plan by providing additional support to federal, state and private efforts to prevent and manage arthritis. It will establish a National Arthritis Education and Outreach Campaign to inform the health care profession and the public about the most successful self-management strategies for controlling the illness.
With greater coordination and intensification of federal research, this bill will organize a National Arthritis and Rheumatic Diseases Summit to look at the challenges and opportunities related to these efforts.
In addition, the bill will provide greater attention to juvenile arthritis research by offering planning grants for research specific to juveniles and by prioritizing the activities that create better understanding of the incidence and outcomes associated with juvenile arthritis.
Finally the bill contains incentives to encourage health professionals to enter the field of pediatric rheumatology by education loan repayment and career development awards.
I urge my colleagues to support this public health initiative to reduce the pain and disability of arthritis. Early diagnosis, effective treatment and greater investment in research and prevention can help us wage a stronger battle against one of the most widespread and devastating conditions affecting our Nation.
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