Due to the commitment of Senate Democrats and more than ten years of hard work, legislation granting the Food and Drug Administration (FDA) the authority to regulate the manufacture, marketing, and sale of tobacco is on its way to the President’s desk. For far too long, tobacco manufacturers have preyed upon our children, viewing them merely as “replacement smokers,” taking the place of the hundreds of thousands of Americans who die from tobacco use or secondhand smoke each year. 

The legislation, supported by more than 1,000 public health, faith, and other organizations across the country, gives the FDA the legal authority necessary to reduce youth smoking, prevent the sale of tobacco to minors, help current smokers quit, reduce the toxicity of tobacco products, and stop the tobacco industry from misleading the public with their misleading claims about the dangers of using tobacco products.

Need for FDA Regulation

Tobacco use in the United States is killing our citizens, costing us billions of dollars in health care costs, and reducing our economic productivity.

Hazardous to Americans’ Health

Nearly 20 percent of American adults, or more than 43 million people, are addicted to cigarettes._[1]Tobacco use kills more than 400,000 Americans each year, and an additional 50,000 non-smokers die prematurely each year due to exposure to secondhand smoke._[2]Americans’ health suffers from tobacco use, with 8.6 million Americans currently suffering from a smoking-caused illness._[3]

High Health Care Costs

Health care costs for these individuals are staggering, with $96 billion in total annual public and private health care expenditures attributable to smoking._[4]Estimates indicate that American taxpayers shoulder $68 billion of those costs due to expenditures made by Medicare, Medicaid, and other federal health programs._[5]

Lost Economic Productivity

Our national economy experiences approximately $98.6 billion each year in productivity losses due to cigarette smoking and exposure to tobacco smoke, making the total economic burden of smoking approximately $192 billion per year._[6]In contrast, in Fiscal Year 2007, the nation invested a mere $595 million in comprehensive, state-based tobacco prevention and control programs, 325-times less than the total economic burden of smoking._[7]

Too Many Children Use Tobacco

One of the keys to reducing the staggering toll of tobacco on our nation is to protect our children from exposure to tobacco products and marketing. Nearly 90 percent of smokers begin as children and are addicted by the time they become adults. Sadly, the pattern of tobacco use by children mirrors that of adults, with 20 percent of high school students classified as current smokers, or 3.5 million children._[8]The tobacco industry refers to our children as “replacement smokers,” and each day, more than 3,500 children try smoking for the first time, and more than 1,000 children become regular, daily smokers._[9]The tobacco industry has no economic incentive to reduce smoking by children, because youth smoking generates approximately $2 billion in revenue for tobacco manufacturers annually, and these child smokers replace the adult smokers who are dying as a result of their addiction._[10]Flavors, like fruit or candy, make cigarettes more attractive to children and easier to smoke.

No Current Oversight of Tobacco Products

Tobacco, one of the most dangerous products sold in the United States, is currently exempt from oversight by the very agency that regulates nearly every other product consumed by Americans. FDA does regulate nicotine-replacement therapies that help smokers quit, and it has the necessary scientific expertise, regulatory experience, and public health mission to appropriately regulate tobacco products. Finally, a 2007 report by the Institute of Medicine entitled, “Ending the Tobacco Problem: A Blueprint for the Nation,” stated, “The committee concludes that product regulation by the FDA will advance tobacco control efforts in the United States and around the world. The proposed tobacco control legislation embodies the principles that should govern the regulation of tobacco products in the coming years.”_[11]

New FDA Authority

When President Obama signs the Family Smoking Prevention and Tobacco Control Act into law, the FDA will be granted the authority to: 

• Regulate tobacco productsthrough a new chapter in the Federal Food, Drug, and Cosmetic Act (FFDCA).
   
• Restrict tobacco advertisingto stop marketing practices that target children and mislead the public, and to regulate the sale, distribution, and advertising of cigarettes and smokeless tobacco “consistent with and to the full extent permitted by the First Amendment.”
   
• Prevent the sale of tobacco products to youth by limiting tobacco sales to face-to-face transactions, in which the age of the purchaser is verifiable, eliminating self-service displays and vending machine sales of tobacco, except in adult-only facilities.
   
• Codify 1996 FDA rule to reduce youth tobacco use by giving a rule already developed by FDA the force of law. In 1996, FDA conducted an extensive rulemaking process to determine effective methods to reduce youth smoking. The rulemaking process included 700,000 public comments, resulting in a rule regarding the sale and advertisement of cigarettes. Due to litigation, the rule was never implemented. Rather than engaging in yet another lengthy rulemaking process and delaying the protection of our children from the dangers of tobacco use, the rule will be given the force of law.
   
• Require stronger warning labels for all tobacco packages and advertising, with regular updates to ensure a strong impact, and an unambiguous description of the health problems that may result from tobacco use.
   
• Prevent misrepresentation by tobacco manufacturers of the addictiveness of nicotine in their products. Industry documents overwhelmingly demonstrate that tobacco manufacturers knew their products were addictive, and relied on this addictive nature in their marketing strategies and chemically manipulated the nicotine in their products to make them even more addictive.
   
• Remove hazardous ingredientsto ensure that the inherent risk of using tobacco products is not unnecessarily increased, to help those who are addicted overcome their addiction, and to make tobacco products less toxic to those who are unable or unwilling to quit.
   
• Set standards for so-called “reduced risk” products by requiring manufacturers to submit the products for FDA analysis before making such a marketing claim.
   
• Ensure tobacco companies, not American taxpayers, bear the cost of regulation through a new user fee on tobacco manufacturers and importers, based on their market share.

Anticipated Results of FDA Regulation of Tobacco

In its cost estimate of the Family Smoking Prevention and Tobacco Control Act, the Congressional Budget Office (CBO) noted that the effect of FDA regulation of tobacco products on tobacco use is uncertain._[12]Using information from academic and other sources, CBO estimated that the legislation would reduce the number of underage tobacco users by 11 percent over ten years, and would reduce the number of adult tobacco users by two percent over the same period. 

Some have used this CBO analysis to criticize the legislation, minimizing the impact of these reductions as “only” two percent for adults and 11 percent for children. It is important to remember that even just a two percent reduction in adult smoking would reduce the number of adult smokers in the United States by 900,000. And, an 11 percent reduction in underage use of tobacco would mean that two million children will never become addicted adult smokers, and at least 700,000 children alive today will not experience a premature death due to tobacco use. 

In addition, CBO estimates that FDA regulation of tobacco will lead to a reduction in smoking among pregnant women. This will lead to a decline in health care spending on pregnancy, because women who do not smoke during pregnancy are less likely to give birth to children with low birth weights, avoiding high costs at birth and afterwards of caring for these children. CBO estimates this will save Medicaid $100 million over ten years. 

Furthermore, not only is it difficult for CBO to estimate the effects of FDA regulation of tobacco, the estimates it did provide are conservative, because they are based on only the provisions that automatically take effect when the bill becomes law. However, the legislation provides FDA with the authority to take further action with regard to restricting tobacco marketing and advertising, making tobacco products less harmful, and taking other action to prevent and reduce the terrible results of tobacco use. The extent to which FDA utilizes this new authority will result in further declines in youth and adult tobacco use and further savings in health care costs.

Keeping American Children and Their Families Healthier

Senate Democrats persisted through more than ten years for hard work to ensure that tobacco, one of the most dangerous products available in the United States, is subject to the same regulation as all other consumer products. The legislation on its way to the President’s desk will reduce tobacco use among children and adults, ensure that claims made by tobacco manufacturers are not misleading, and limit children’s exposure to tobacco marketing and advertising. This long overdue legislation will also improve our health and our economy, by reducing health care costs and productivity losses due to tobacco use.