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Authorize FDA Regulation of Tobacco
Policy: Give the United States Food and Drug Administration (FDA) authority to regulate tobacco products and tobacco advertising.

Intended Outcome: The purpose of this policy is to decrease tobacco use and tobacco-attributable mortality and morbidity by reducing the harmful effects of tobacco products, preventing the sale of tobacco products to minors, and ensuring that consumers are fully informed of the contents of tobacco products.

Burden Addressed: Tobacco use is the leading preventable cause of death in the United States. It accounts for approximately 440,000 deaths per year from diseases including lung cancer, coronary heart diseases, and stroke. CDC estimates that if current smoking patterns continue 5 million people who are currently younger than 18 will die from a tobacco-related illness.1

Background: The number of youth, ages 12-17, using any tobacco product has decreased from 15.5% in 2003 to 13.1% in 2005 with females slightly more likely to report having used a tobacco product in the past month than males.2 Despite this recent decline, 23% of high school students consider themselves cigarette smokers3 and every day, approximately 3,900 youth ages 12-17 initiate cigarette smoking in the United States.4

FDA regulation of tobacco products has three main aims:
  1. Regulation of the ingredients of tobacco and of additives found in tobacco products;
  2. Restriction of youth access to tobacco products; and
  3. Regulation of the marketing and labeling of tobacco products.
The FDA regulates the sale of drugs and medical devices, prohibits the sale of unsafe products, and has the authority to recall items that are found to be unsafe after initial approval.5 Under the statutory definitions of drugs and medical devices, products regulated by the FDA must either be used in the diagnosis or treatment of a disease, or intended by a manufacturer to affect the structure or function of the body. In accordance with the statutes governing FDA review of drugs and medical devices, the FDA has determined that nicotine is a drug, that tobacco products are designed to introduce measured doses of nicotine into the body, and that they are therefore drug delivery devices. However, the FDA does not have jurisdiction over tobacco products. Therefore currently, tobacco products are subject to minimal oversight by the federal government, and their producers are not required to disclose to consumers the ingredients in tobacco products.6

Evidence/Effectiveness: While tobacco products cannot be made to be completely safe, steps can be taken to ensure that they are no more dangerous than those sold in other countries. Tobacco products sold in the United States have been found to be more poisonous than necessary: amounts of nitrosamines, which are carcinogens, are significantly higher in American brands of cigarettes than in comparable brands sold in Germany and Japan.7

In 2000, the U.S. Surgeon General issued a report, “Reducing Tobacco Use: A Report of the Surgeon General.” The report reviews and offers numerous strategies for reducing tobacco use. Though the report does not specifically mention FDA, one of its main findings is that there is a need for more regulation of the sale and promotion of tobacco products, particularly to youth and young adults, to reduce the usage (and to prevent the initiation of usage) of tobacco products. It also finds that product labels should be stronger and more informative. Both recommendations have proven effective in reducing tobacco use.8

Legislative Context: In 1994, the FDA began to assert its jurisdiction over tobacco products and on April 25, 1997, Judge William Osteen of the U.S. District Court for the Middle District in Greensboro, NC, ruled that FDA has the authority to regulate tobacco products as drug delivery devices. Unfortunately, in August 1998, the U.S. Court of Appeals for the Fourth Circuit in Richmond, VA reversed Osteen’s decision. In March 2000, the U.S. Supreme Court upheld the Court of Appeals’ decision. The two higher courts found that neither current federal law nor precedence gives FDA such authority.9

Based on these rulings, federal law is necessary for FDA to regulate tobacco products. There have been two attempts to amend the FDA governing statute with the Family Smoking Prevention and Tobacco Control Act both in the 108th (S.2974 and S.2461/H.R.4433) and 109th Congresses (S.666/H.R.1376). The Act would authorize FDA to: restrict tobacco advertising and promotions, especially to children; develop standards that require changes in tobacco product composition and design, such as the reduction or elimination of toxic chemicals; and require manufacturers to obtain agency approval in order to make reduced-risk and reduced-exposure claims for their products. S.666/H.R.1376 are currently in subcommittee. It is worth noting that S.2974 was passed in the Senate without amendment by Unanimous Consent.


  1. Centers for Disease Control and Prevention. Targeting Tobacco Use: The Nation’s Leading Cause of Death. At-a-Glance 2006.
  2. Substance Abuse and Mental health Services Administration, USDHHS. National Survey on Drug Use and Health: National Findings 2005.
  3. Centers for Disease Control and Prevention. Cigarette use among high school students — United States, 1991–2005. MMWR. 2006: 55(26);724–726.
  4. Substance Abuse and Mental Health Services Administration. (2005). Results from the 2004 National Survey on Drug Use and Health: (Office of Applied Studies, NSDUH Series H-27, DHHS Publication No. SMA 05–4061). Rockville, MD.
  5. Center for Drug Evaluation and Research, Food and Drug Administration. CDER 1997 Report to the Nation. Washington, DC June 1998.
  6. U.S. Department of Health and Human Services. Food and Drug Administration. Regulations Restricting the Sale of Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents: Final Rule. Federal Register: August 28, 1996 (Volume 61, Number 168) Rules and Regulations, Page 44395-44445. Docket No. 95N-0253. RIN 0910-AA48.
  7. Saild J. The Role of the Food and Drug Administration in Regulating Tobacco Products. Policy Analysis No. 11. Health Science Analysis Project, The Advocacy Institute, Washington, DC, May 1998.
  8. Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health U.S. Department of Health and Human Services. Reducing Tobacco Use: A Report of the Surgeon General—Executive Summary, 2000.
  9. Benjamin, Georges C. The Supreme Court rules: The FDA and tobacco regulation – Health Policy Update, July-August 2000.