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WHY THE FDA SHOULD REGULATE TOBACCO PRODUCTS

WHAT IF a product consumed by nearly 45 million Americans every day killed one-third of those who became regular users and one-half of those who use it for a lifetime? nearly 90 percent of those using the product for the first time were 18 years of age or younger? the product was not only deadly but also as addictive as cocaine or heroin? the manufacturers of the product knew of its harmful and addictive properties and lied to the American public and to the United States Congress about what they knew? the manufacturers knowingly developed more addictive versions of their products? the manufacturers spent billions of dollars every year to market the product, particularly to children? Would there be outrage among the public? The declaration of a public health crisis? Calls for product regulation and restrictions and to make it as safe as possible? In the case of tobacco, the answer is there is no special regulation, only special protection. THE DEADLY FACTS ABOUT TOBACCO Tobacco is the only legal product sold in the United States that, when used according to the manufacturers instructions, is highly addictive and kills a high percentage of its regular users. Tobacco causes nearly one out of every three deaths from cancer1, nearly one out of every five deaths from heart disease2, and 87 percent of all lung cancer deaths.3 Every day approximately 4,000 children will try a cigarette for the first time, and another 2,000 kids will become new regular, daily smokers. One-third of these kids will eventually die of a tobacco-related illness.4 Since Congress attempt to pass legislation granting authority to the FDA to regulate tobacco in 1998,5 nearly 5 million children have become regular smokers, of whom about 1.5 million will die prematurely of tobacco-related illnesses.6 Tobacco kills more than 400,000 people each year in the United States. More than AIDS, car accidents, alcohol, homicides, illegal drugs, suicides, and fires combined. Thats one out of every five deaths.7

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Since Congress 1998 attempt to give FDA the authority to regulate tobacco products, more than 2.8 million Americans have died prematurely from tobacco-related illnesses. Thats the equivalent of the combined populations of Jackson, Mississippi, Casper, Wyoming, Abilene, Texas, Billings, Montana, Burlington, Vermont, Dubuque, Iowa, Anchorage, Alaska, Manchester, New Hampshire, Gainesville, Florida, and Savannah, Georgia all dying of a tobacco-related illness.8 The Centers for Disease Control and Prevention estimates that tobacco causes over $89 billion in annual health care expenditures. This includes over $28 billion in total annual Medicaid costs (state and federal), with the federal share exceeding $16 billion.9 Another study estimates the smoking-caused Medicare expenditures exceed $20 billion annually.10 Evidence strongly suggests that if individuals do not begin smoking before age 19 they will never start.11 The tobacco industry spends billions of dollars on marketing and promotion every year (more than $12.5 billion a year or $34 million a day12), much of which appeals directly to the 18 and under population. Industry marketing practices create a situation in which smoking by children and adolescents is not a matter of informed choice. Then, once a choice to start smoking is made, many children quickly become addicted to nicotine,13 making quitting very difficult. AN ANSWER While tragic and mind numbing in its enormity, the death and disease caused by the use of tobacco products is preventable. And while there are no magic bullets in the fight against tobacco, a critical element in this fight is the effective regulation of the sales, marketing and manufacturing of tobacco products. The U.S. Food and Drug Administration regulates food, drugs and medical devices that range from macaroni and cheese to nicotine gum, to break-through prescription drugs to artificial heart valves but not tobacco products. Other products manufactured by tobacco companies (e.g., Kraft Macaroni and Cheese), and every other product containing nicotine (e.g., Nicorette, Nicoderm), are regulated by the FDA but not tobacco products. The FDA is clearly the most appropriate agency to regulate tobacco products. They have the scientific knowledge and expertise, they are unbiased and objective, and they have years of experience in effectively regulating consumer products. Below is a short summary of how the DeWine-Kennedy and Davis-Waxman bills deal with the issues that have been considered critical in any FDA bill. Youth Access and Marketing. These bills would grant FDA the same broad authority regarding the sale and distribution of tobacco products, including access, advertising and promotion that FDA asserted in 1996. This would allow FDA to restrict advertising and promotion, including advertising that impacts children or misleads consumers, beyond the restrictions of the 1996 FDA Regulations, to the extent permitted under the First Amendment. The FDA could also take further action to ensure that tobacco products are not illegally sold to children. Youth Access and Marketing Restrictions of the 1996 Rule to Help Reduce Youth Tobacco Use Reinstated. These bills require that one month after enactment, FDA republish

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the 1996 regulations, which restrict marketing that targets children and youth access to tobacco products, and require that these regulations shall become effective one year after enactment. These regulations include bans on outdoor advertising within one thousand feet of schools and limiting all remaining outdoor and point-of-sale tobacco advertising to black-and-white text only. The regulations, which will be identical to the regulations promulgated by the FDA in 1996, would become effective one year after enactment After the regulations have gone into effect, the bills give the Secretary of the Department of Health and Human Services (HHS) the authority to amend these regulations through a standard rulemaking process, which will provide for public discussion about the necessity of any changes to the regulations. Health Information Disclosure. These bills require the tobacco companies to submit within six months of the date of the bills enactment a listing of all tobacco ingredients and additives to tobacco, paper and filters by brand and by quantity in each brand, a description of the content, delivery and form of nicotine in each product, as well as all documents developed after enactment that relate to health, toxicological, behavioral, or physiological effects of current or future tobacco products. The Secretary of HHS may also require the tobacco companies to submit information on all research related to health, behavioral or physiologic effects of these products and their marketing, as well as information about whether technology exists to reduce the harm caused by their products. Public Health Standard. The existing FDA standard for approving drugs and devices is whether there is a reasonable assurance that a product is safe and effective. A different standard is necessary with tobacco products because there is no such thing as a safe cigarette. As the public health community has requested, under these bills the FDA would seek to determine whether an action regarding a tobacco product will protect the public health. This standard would require consideration of whether a product change would reduce the overall harm caused by tobacco use, including the harm caused to individual tobacco users and the impact on the population as a whole. Health Warnings. These bills would revise the health warning on both cigarettes and smokeless tobacco products and grant FDA the authority to further revise and add health warnings and to alter their format, including, but not limited to, changing their size, location and color. The bill would result in an immediate change in health warning to require them to cover at least 30% of the front and back of cigarette packs and strengthen the warnings content. Authority to Establish Performance Standards. These bills provide FDA with the authority to require changes to tobacco products to protect the public health, such as the reduction or elimination of ingredients, additives, constituents, including smoke constituents or reduction in nicotine yields through the issuance of performance standards. A performance standard would be the primary way in which FDA would require tobacco products to be made less harmful. While the bill allows FDA to require changes to the product, the bill reserves to Congress the narrow and specifically tailored authority to ban all cigarettes, or all smokeless tobacco products, or all little cigars, or all cigars other than little cigars. While FDA can require the reduction of nicotine on its own, even to very low levels, the bill also reserves to Congress the right to require the reduction of nicotine yields of a tobacco product to zero. The language related to the ban is straightforward language that ensures that only Congress can ban

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cigarettes but it does not prevent the FDA from requiring meaningful changes to tobacco products. Modified Risk Products. FDA authority over new products that the tobacco industry wants to portray as less harmful is increasingly important as new products are marketed with such slogans as, All of the tasteLess of the toxins and Reduced Carcinogens. Premium Taste. Under these bills, FDA would be able to prohibit these claims unless it had first determined that the manufacturer had proven that these claims have been scientifically proven. The bill prohibits any person from labeling, advertising or taking any other action directed to consumers that states or implies that the product is less hazardous or risky than other tobacco products or reduces ones exposure to substances in tobacco products without first having sought and obtained FDA approval according to the standards set forth in the bill. The bill would also prohibit the use of descriptors, such as light, mild and low to characterize the level of a substance in a product. Any product for which such a claim is sought to be made would have to meet the standards for a modified risk product under the bill. Under the bills, the Secretary shall approve an application for a modified tobacco product only if the applicant demonstrates that the product, as actually used by consumers, will significantly reduce harm, and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products. The bill also sets out criteria for certain products where the manufacturer does not seek to make a claim for reduced risk, but seeks to assert that the product contains a reduced level of a substance, or presents a reduced exposure to a substance. The Secretary may only approve an application for a product for which the manufacturer wants to make this type of claim when a number of criteria have been met. They include a requirement that the manufacturer has demonstrated and the Secretary has found, that scientific evidence is not available, and using the best available scientific evidence, it cannot be demonstrated without conducting long term epidemiological studies to meet the strict standards to make a modified risk claim, but that the Secretary concludes that the evidence that is available demonstrates that a substantial reduction in morbidity or mortality among individual tobacco users is anticipated. Under this provision, a product can be approved for no more than five years at a time and the manufacturer must conduct and submit to the Secretary of HHS post-market surveillance and studies annually. This type of application may also be approved only if the Secretary also determines that the manufacturer has demonstrated that the product would be appropriate to promote the public health, is expected to benefit the public as a whole, and will not mislead customers into believing that the product is less harmful than other products. State and Local Authority. The bills expand state authority over tobacco marketing. Today states have no right to regulate tobacco marketing. Under the bills, states and localities could impose bans or restrictions on the time, place and manner, but not content of the advertising or promotion of any cigarettes. Under these bills, state and local governments would be free to adopt measures related to the sale, distribution, possession, exposure to, access to, use of tobacco products, or fire safety standards for tobacco products. FDA would maintain exclusive authority in such areas as tobacco product standards, pre-market approval, adulteration, misbranding, labeling, registration, good manufacturing standards, or modified risk products. States could not establish requirements in these areas.

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Adequate Funding. These bills include adequate funding for FDA to effectively carry out the requirements outlined. The funding is provided through a user fee on tobacco manufacturers. FDA Authority over Tobacco Farms or Tobacco Growers. These bills do not give FDA authority over the growing of tobacco.
American Cancer Society. Cancer Facts and Figures 2005. Atlanta: American Cancer Society, 2005. http://our.cancer.org/downloads/STT/CAFF2005f4PWSecured.pdf 2 U.S. Department of Health and Human Services. The Health Consequences of Smoking: A Report of the Surgeon General., U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Office on Smoking and Health, 2004. http://www.cdc.gov/tobacco/sgr/sgr_2004/index.htm 3 American Cancer Society. Cancer Facts and Figures 2005. Atlanta: American Cancer Society, 2005. http://our.cancer.org/downloads/STT/CAFF2005f4PWSecured.pdf. 4 Substance Abuse and Mental Health Services Administration, U.S. Dept of Health and Human Services (HHS), Results from the 2001 National Household Survey on Drug Abuse (2002), http://www.samhsa.gov/oas/nhsda.htm. 5 On June 17, 1998 the Senate defeated the Universal Tobacco Settlement Act (S. 1415) sponsored by Senator John McCain of Arizona (the McCain bill). 6 Substance Abuse and Mental Health Services Administration, U.S. Dept of Health and Human Services (HHS), Summary Findings from the 2000 National Household Survey on Drug Abuse, 2001, www.samhsa.gov/oas/nhsda.htm [estimates assume that youth initiation both trying first cigarette & becoming regular smokers) declines by 5% per year after 2000, the last year with actual data]. Youth deaths: Approximately one-third of regular youth smokers will ultimately dying prematurely from smoking. U.S. Centers for Disease Control (CDC), State Highlights 2002: Impact and Opportunity, April 2002, [updating CDC, "Projected Smoking Deaths Among Youth United States," Morbidity and Mortality Weekly Report (MMWR) 45(44): 971-9740, November 8, 1996, http://www2.cdc.gov/mmwr/], www.cdc.gov/tobacco/StateHighlights.htm. 7 Lynch, B.S., and R.J. Bonnie, editors, Growing Up Tobacco Free Preventing Nicotine Addiction In Children and Youths, Committee on Preventing Nicotine Addiction in Children and Youths, Division of Biobehavioral Sciences and Mental Disorders, Institute of Medicine, National Academy of Sciences, Washington, D.C., p.3, 1994. See also, American Cancer Society. Cancer Facts and Figures 2005. Atlanta: American Cancer Society, 2005. http://our.cancer.org/downloads/STT/CAFF2005f4PWSecured.pdf 8 Based on 1999 U.S. Census Bureau population estimates for metropolitan statistical areas, http://www.census.gov/population/estimates/metro-city/ma99-02.txt. 9 CDC, Sustaining State Programs for Tobacco Control: Data Highlights 2004 [and underlying CDC data and estimates], http://www.cdc.gov/tobacco/datahighlights/index.htm; Centers for Disease Control and Prevention, "Annual Smoking-Attributable Mortality, Years of Potential Life Lose, and Economic Costs -- United States 1995-1999," MMWR, April 11, 2002, http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5114a2.htm; L. Miller et al, State Estimates of Total Medical Expenditures Attributable to Cigarette Smoking, 1993 Public Health Reports 113. 10 Zhang, X., et al., Cost of Smoking to the Medicare Program, 1993, Health Care Financing Review 20(4): 1-19 (Summer 1999). 11 Federal Register, Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents; Final Rule, page 44399, August 28, 1996. 12 U.S. Federal Trade Commission (FTC), Cigarette Report for 2002, October 22, 2004 [data for top six manufacturers only], http://www.ftc.gov/reports/cigarette/041022cigaretterpt.pdf; FTC, Federal Trade Commission Smokeless Tobacco Report for the Years 2000 and 2001, August 2003 [top five companies], http://www.ftc.gov/os/2003/08/2k2k1smokeless.pdf. 13 DiFranza, Joseph R et al, Initial Symptoms of Nicotine Dependence in Adolescents, National Cancer Institute grant CA7706703.
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