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Selected Actions of the U.S.
Government Regarding the Regulation of Tobacco Sales,
Marketing, and Use
(excluding laws pertaining to agriculture or excise
tax)
Legislation | Regulation
| Additional Reading
Food and Drugs Act of 1906
- 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.
Federal Food, Drug, and Cosmetic Act (FFDCA) of 1938
- Superseded 1906 Act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
Federal Trade Commission (FTC) Act of 1914 (amended in 1938)
- 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.
Federal Hazardous Substances Labeling Act (FHSA) of
1960
- 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.
Federal Cigarette Labeling and Advertising Act of 1965
- 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
Public Health Cigarette Smoking Act of 1969
- 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
Controlled Substances Act of 1970
- To prevent the abuse of drugs,
narcotics, and other addictive substances
- Specifically excludes tobacco from the definition of a "controlled substance"
Consumer Product Safety Act of 1972
- 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
Little Cigar Act of 1973
- Bans little cigar advertisements
from television and radio (authority to DOJ)
1976 amendment to the Federal Hazardous Substances
Labeling Act of 1960
- 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)
Toxic Substances Control Act of 1976
- 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
Comprehensive Smoking Education Act of 1984
- Institutes 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)
Cigarette Safety Act of 1984
- To determine the technical and
commercial feasibility of developing cigarettes and little cigars that would be less
likely to ignite upholstered furniture and mattresses
Comprehensive Smokeless Tobacco Health Education Act
of 1986
- 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
Public Law 100-202 (1987)
- Banned smoking on domestic airline
flights scheduled for two hours or less
Public Law 101-164 (1989)
- Bans smoking on domestic airline
flights scheduled for six hours or less
Synar Amendment to the Alcohol, Drug Abuse, and Mental
Health Administration (ADAMHA) Reorganization Act of 1992
- Requires all states to adopt and
enforce restrictions on tobacco sales and distribution to minors.
Pro-Children Act of 1994
- 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.
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(in addition to some of the actions listed previously)
1967
Federal Communications Commission rules that the Fairness Doctrine applies to cigarette
advertising. Stations broadcasting cigarette commercials must donate air time to
antismoking messages.
1971
Fairness Doctrine antismoking messages end when cigarette advertising is
prohibited on radio and
television.
1973
Civil Aeronautics Board requires no-smoking sections on all commercial airline flights.
1975
Cigarettes are discontinued in K-rations and C-rations given to soldiers and sailors.
1987
Department of Health and Human Services establishes a smokefree environment in its
facilities.
1992
Federal Trade Commission takes first enforcement action under the Comprehensive Smokeless
Tobacco Health Education Act, alleging that Pinkerton Tobacco Company's Red Man brand name
appeared illegally during a televised event.
1993
Environmental Protection Agency releases final risk assessment on environmental tobacco
smoke (ETS) and classifies ETS as a "Group A" (known human) carcinogen.
1994
Occupational Safety and Health Administration announces proposed regulation to prohibit
smoking in the workplace, except in separately ventilated smoking rooms.
1994
Department of Defense (DOD) bans smoking in DOD workplaces.
1995
Department of Justice reaches a settlement with Philip Morris to remove tobacco
advertisements from the line of sight of television cameras in sports stadiums.
1995
President Clinton announces the publication of the Food and Drug Administration's proposed
regulations that would restrict the sale, distribution, and marketing of cigarettes and
smokeless tobacco products to protect children and adolescents.
1996
On August 23, 1996, President Clinton announces the nation's first comprehensive program
to prevent children and adolescents from smoking cigarettes or using smokeless tobacco and
beginning a lifetime of nicotine addiction. With the August 1996 publication of a final
rule on tobacco in the Federal Register, the Food and Drug Administration (FDA) will
regulate the sale and distribution of cigarettes and smokeless tobacco to children and
adolescents. The provisions of the FDA rule are aimed at reducing youth access to tobacco
products and the appeal of tobacco advertising to young people. Additionally, the FDA will
propose to require the major tobacco companies to educate young people about the real
health dangers associated with tobacco use through a multimedia campaign.
1997
President Clinton announces an Executive Order to make all federal
workplaces smoke-free.
2000
The Supreme Court rules against the Food and Drug Administration finding
that the agency lacks the authority to regulate tobacco.
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Giovino GA, Henningfield JE, Tomar SL, Escobedo LG, Slade
J. Epidemiology of Tobacco Use and Dependence. Epidemiologic Reviews
1995;17(1):48–65.
Kessler DA. Nicotine Addiction in Young People. New
England Journal of Medicine. 1995;333:186–189.
Kessler DA. Statement on Nicotine-Containing Cigarettes. Tobacco
Control. 1994;3:148–158.
Kessler DA. The Control and Manipulation of Nicotine in
Cigarettes. Tobacco Control. 1994;3:362–369.
Lynch BS, Bonnie RJ eds. Growing Up Tobacco Free:
Preventing Nicotine Addiction in Children and Youths. Washington, D.C.: National
Academy Press, Institute of Medicine, 1994.
Orleans CT, Slade J, eds. Nicotine Addiction:
Principles and Management. New York, NY: Oxford University Press, 1993.
Slade J. A Bold Move to Regulate Tobacco Products. Tobacco
Control. 1994;3:99–100.
Slade J, Ballin S. Who's Minding the Tobacco Store? It's
Time to Level the Regulatory Playing Field. In, Houston TP ed. Tobacco Use: An American
Crisis. Final Report of the Conference; January 9–12, 1993; Washington, D.C. Chicago,
Illinois: American Medical Association, 1993.
Slade J, Bero LA, Hanauer P, Barnes DE, Glantz SA.
Nicotine and Addiction: The Brown and Williamson Documents. Journal of the American
Medical Association. 1995;274:225–233.
U.S Department of Health and Human Services. Preventing
Tobacco Use Among Young People. A Report of the Surgeon General. Atlanta, Georgia:
U.S. Department of Health and Human Services, Public Health Service, Centers for Disease
Control and Prevention, National Center for Chronic Disease Prevention and Health
Promotion, Office on Smoking and Health, 1994.
U.S. Department of Health and Human Services. Reducing
the Health Consequences of Smoking: 25 Years of Progress. A Report of the Surgeon General.
Rockville, Maryland: U.S. Department of Health and Human Services, Public Health Service,
Centers for Disease Control, Center for Chronic Disease Prevention and Health Promotion,
Office on Smoking and Health. DHHS Publication No. (CDC) 89-8411, 1989 (especially pages
608–618).
U.S. Department of Health and Human Services, Food and
Drug Administration. Regulations Restricting the Sale and Distribution of Cigarettes and
Smokeless Tobacco Products to Protect Children and Adolescents; Proposed Rule Regarding
FDA's Jurisdiction Over Nicotine-Containing Cigarettes and Smokeless Tobacco Products;
Notice. Federal Register. 21 CFR Parts 801, 803, 804, and 897. [Docket No.
95N-0253] Vol. 60, No. 155;41314–41787, Friday, August 11, 1995.
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