Legislation

Selected Laws Enacted by the U.S. Government Regarding the Regulation of Tobacco Sales, Marketing, and Use
(excluding laws pertaining to agriculture or excise tax)

• First federal food and drug law
• No express reference to tobacco products
• Definition of a drug includes medicines and preparations listed in U.S. Pharmacoepia or National Formulary.
• 1914 interpretation advised that tobacco be included only when used to cure, mitigate, or prevent disease.

• Required package warning label—”Caution: Cigarette Smoking May Be Hazardous to Your Health” (other health warnings prohibited)
• Required no labels on cigarette advertisements (in fact, implemented a three-year prohibition of any such labels)
• Required FTC to report to Congress annually on the effectiveness of cigarette labeling, current cigarette advertising and promotion practices, and to make recommendations for legislation
• Required Department of Health, Education, and Welfare (DHEW) to report annually to Congress on the health consequences of smoking
• More on the Federal Cigarette Labeling and Advertising Act of 1965
• Banned smoking on domestic airline flights scheduled for two hours or less

• Superseded 1906 Act
• Definition of a “drug” includes “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals”
• FDA has asserted jurisdiction in cases where the manufacturer or vendor has made medical claims.
  • 1953—Fairfax cigarettes (manufacturer claimed these prevented respiratory and other diseases)
  • 1959—Trim Reducing-Aid Cigarettes (contained the additive tartaric acid, which was claimed to aid in weight reduction)
• FDA has asserted jurisdiction over alternative nicotine-delivery products
  • 1984—Nicotine Polacrilex gum
  • 1985—Favor Smokeless Cigarette (nicotine-delivery device; ruled a “new drug,” intended to treat nicotine dependence and to affect the structure and function of the body; removed from market)
  • 1989—Masterpiece Tobacs tobacco chewing gum; ruled an adulterated food and removed from the market)
  • 1991—Nicotine patches

• Empowers the FTC to “prevent persons, partnerships, or corporations … from using unfair or deceptive acts or practices in commerce”
• Between 1945 and 1960, FTC completed seven formal cease-and-desist order proceedings for medical or health claims (e.g., a 1942 complaint countering claims that Kool cigarettes provide extra protection against or cure colds)
• In January 1964, FTC proposed a rule to strictly regulate the imagery and copy of cigarette ads to prohibit explicit or implicit health claims
• 1983—FTC determines that its testing procedures may have “significantly underestimated the level of tar, nicotine, and carbon monoxide that smokers received from smoking” certain low-tar cigarettes. Prohibits Brown and Williamson Tobacco Company from using the tar rating for Barclay cigarettes in advertising, packaging or promotions because of problems with the testing methodology and consumers’ possible reliance on that information. FTC authorized revised labeling in 1986.
• 1985—FTC acts to remove the RJ Reynolds advertisements, “Of Cigarettes and Science,” in which the multiple risk factor intervention trail (MRFIT) results were misinterpreted
• 1999—FTC requires RJ Reynolds to add a label to packages and ads explaining that “no additives” does not make Winston cigarettes safer.

• Authorized FDA to regulate substances that are hazardous (either toxic, corrosive, irritant, strong sensitizers, flammable, or pressure-generating). Such substances may cause substantial personal injury or illness during or as a result of customary use.
• 1963—FDA expressed its interpretation that tobacco did not fit the “hazardous” criteria stated previously and withheld recommendations pending the release of the report of the Surgeon General’s Advisory Committee on Smoking and Health.

• Required package warning label— Warning: The Surgeon General Has Determined that Cigarette Smoking Is Dangerous to Your Health” (other health warnings prohibited)
• Temporarily preempted FTC requirement of health labels on advertisements
• Prohibited cigarette advertising on television and radio (authority to Department of Justice [DOJ])
• Prevents states or localities from regulating or prohibiting cigarette advertising or promotion for health-related reasons

• To prevent the abuse of drugs, narcotics, and other addictive substances
• Specifically excludes tobacco from the definition of a “controlled substance”

• Transferred authority from the FDA to regulate hazardous substances as designated by the Federal Hazardous Substances Labeling Act (FHSA) to the Consumer Product Safety Commission (CPSC)
• The term “consumer product” does not include tobacco and tobacco products

• Bans little cigar advertisements from television and radio (authority to DOJ)

• The term “hazardous substance” shall not apply to tobacco and tobacco products (passed when the American Public Health Association petitioned CPSC to set a maximum level of 21 mg. of tar in cigarettes)

• To “regulate chemical substances and mixtures which present an unreasonable risk of injury to health or the environment”
• The term “chemical substance” does not include tobacco or any tobacco products

• Requires four rotating health warning labels (all listed as Surgeon General’s Warnings) on cigarette packages and advertisements (smoking causes lung cancer, heart disease and may complicate pregnancy; quitting smoking now greatly reduces serious risks to your health; smoking by pregnant women may result in fetal injury, premature birth, and low birth weight; cigarette smoke contains carbon monoxide) (preempted other package warnings)
• Requires Department of Health and Human Services (DHHS) to publish a biennial status report to Congress on smoking and health
• Creates a Federal Interagency Committee on Smoking and Health
• Requires cigarette industry to provide a confidential list of ingredients added to cigarettes manufactured in or imported into the United States (brand-specific ingredients and quantities not required)

• To determine the technical and commercial feasibility of developing cigarettes and little cigars that would be less likely to ignite upholstered furniture and mattresses

• Institutes three rotating health warning labels on smokeless tobacco packages and advertisements (this product may cause mouth cancer; this product may cause gum disease and tooth loss; this product is not a safe alternative to cigarettes) (preempts other health warnings on packages or advertisements [except billboards])
• Prohibits smokeless tobacco advertising on television and radio
• Requires DHHS to publish a biennial status report to Congress on smokeless tobacco
• Requires FTC to report to Congress on smokeless tobacco sales, advertising, and marketing
• Requires smokeless tobacco companies to provide a confidential list of additives and a specification of nicotine content in smokeless tobacco products
• Requires DHHS to conduct public information campaign on the health hazards of smokeless tobacco
• More on the Comprehensive Smokeless Tobacco Health Education Act of 1986

• Bans smoking on domestic airline flights scheduled for six hours or less

• Banned smoking on domestic airline flights scheduled for two hours or less

• Requires all states to adopt and enforce restrictions on tobacco sales and distribution to minors to be eligible to receive block grant funding to address substance abuse

• Requires all federally funded children’s services to become smoke-free. Expands upon 1993 law that banned smoking in Women, Infants, and Children (WIC) clinics

• Grants the Food and Drug Administration (FDA) the authority to regulate tobacco products
• More on FDA’s regulations to implement the Tobacco Control Act

• Prohibits the sale of tobacco products to any person under the age of 21, and requires FDA to adopt regulations to implement this change
• Requires states to assess whether sales are being made to persons under the age of 20, to be eligible for substance abuse block grant funds through the Synar program.