Federal Oversight

U. S. Department of Health and Human Services (HHS)

Government oversight of tobacco products takes many different forms. Following are some of the major regulatory and oversight roles within the federal government.


Food and Drug Administration (FDA)

In June 2009, Congress gave the Food and Drug Administration (FDA) broad authority to regulate tobacco products through passage of the Family Smoking Prevention and Tobacco Control Act (FSPTCA).

Under the legislation, FDA regulation will include:

  • Setting national performance standards for tobacco products;
  • Restricting the sale and marketing of tobacco products;
  • Requiring manufacturers to obtain FDA clearance or approval for cigarette and smokeless tobacco products commercially launched, or to be launched, after February 15, 2007;
  • New and bigger warning labels on tobacco products, including warnings that take up 50 percent of the front and back of every pack of cigarettes;
  • Requiring the testing and reporting of tobacco ingredients and constituents as well as the submission of certain categories of company documents;
  • Specifying standards for manufacturing facilities and monitoring compliance through facility inspections; and;
  • Prohibiting the use of terms such as “light” or “low tar.”

A new office, the Center for Tobacco Products, to oversee regulation of the tobacco industry will be set up in the FDA. The regulatory regime will be funded by “user fees” of some $5.4 billion in the first 10 years.

Click Here to see the full text of the FDA regulatory oversight of the tobacco industry.

On Aug. 31, 2009, R.J. Reynolds Tobacco Company joined other tobacco manufacturers and a tobacco retailer in filing suit in federal court in Bowling Green, Ky., challenging certain provisions of the FDA Tobacco Act that severely restrict the few remaining channels available to communicate with adult tobacco consumers. In his decision, Judge Joseph H. McKinley ruled that certain provisions of the Act were unconstitutional, including the use of color and imagery in product advertising. The suit did not challenge Congress’ decision to give the FDA regulatory authority over tobacco products, nor did it challenge the vast majority of the provisions of the new law.


Centers for Disease Control and Prevention (CDC)

Through its Office on Smoking and Health (OSH) which was established in 1965, the CDC is the lead federal agency for comprehensive tobacco prevention and control. The OSH works “To develop, conduct, and support strategic efforts to protect the public’s health from the harmful effects of tobacco use.”

The ingredients used in cigarettes are monitored by the Office on Smoking and Health in HHS. Tobacco manufacturers are required to submit to HHS on an annual basis a complete list of all ingredients added to tobacco in the manufacture of both cigarettes and smokeless tobacco products, and with respect to smokeless tobacco products only, information as to the quantity of nicotine for each product commercially sold. HHS is required, in turn, to submit reports advising Congress of any information pertaining to any such ingredient “which in the judgment of the Secretary poses a health risk to cigarettes smokers” and/or users of smokeless tobacco.


Substance Abuse and Mental Health Services Administration (SAMHSA)

SAMHSA works to improve substance abuse prevention, alcohol and drug addiction treatment, and mental health services. The Agency also oversees implementation of the Synar Amendment, which requires States to have laws in place prohibiting the sale and distribution of tobacco products to minors, and the enforcement of those laws.

SAMHSA requires states’ laws to:

  • Prohibit selling or distributing tobacco products to anyone under the age of 18.
  • Enforce the laws in a way that can reasonably be expected to reduce the availability of tobacco products to those underage.
  • Conduct annual random, unannounced inspections to ensure retail compliance.
  • Achieve an inspection failure rate of less than 20% of outlets accessible to youth.
  • Submit an annual report detailing the State’s activities.

The national weighted average rate of tobacco sales to minors as reported by States and the District of Columbia in their Federal Fiscal Year 2010 Annual Synar Reports is now 9.3 percent – the lowest rate in Synar’s 14-year history.


U.S. Department of Treasury


Alcohol and Tobacco Tax and Trade Bureau (TTB)

The TTB oversees industry compliance with laws and regulations relating to tobacco taxes. Responsibilities of the TTB include:

  • Verification of the proper payment of tobacco taxes
  • Ensuring only qualified applicants are granted permits to engage in the production and distribution of tobacco products
  • Ensuring compliance with tax laws relating to tobacco
  • Investigation of alleged trade practice violations in the marketplace


Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF)

A specialized federal law enforcement agency within the U.S. Department of Justice, the ATF oversees the investigation of illegal trafficking of tobacco products. The ATF works in conjunction with many state and local law enforcement agencies in the handling of investigations.


Department of Justice (DOJ)/Federal Communications Commission (FCC)/Federal Trade Commission (FTC)

The Federal Cigarette Labeling and Advertising Act (FCLAA) and the Comprehensive Smokeless Tobacco Health Education Act (CSTHEA), as amended by the FSPTCA, will continue to ban cigarette and smokeless advertising on television and radio, and other electronic media. In the past, the DOJ, in consultation with the FCC, ensured compliance with the ban on advertising in the electronic media. Now, with the passage of the FSPTCA, coordination of these efforts will include the FDA as well.

FCLAA also directs the FTC to submit annually to Congress a report concerning cigarette advertising and promotion, along with any agency recommendations for legislation. To meet those obligations, the FTC has, for many years, required the cigarette manufacturers to submit detailed information concerning cigarette advertising and promotional expenditures on an annual basis. The FTC has authority to address unfair or deceptive cigarette advertising under the Federal Trade Commission Act, and the agency has exercised that authority.


Environmental Protection Agency (EPA)

The EPA approves the types and application rates for pesticides used on tobacco.

Before selling or distributing any pesticide in the U.S., companies must register the pesticide with the EPA and include on the pesticide labeling directions for use and other information necessary to protect human health and the environment. Federal law requires that agricultural employers comply with these labeling directions during pesticide applications to protect their workers from occupational exposure.

Beginning in June 2011, the FDA will prohibit tobacco manufacturers from using tobacco that contains a pesticide residue that is at a level greater than is specified by any tolerance applicable under federal law for domestically grown tobacco.


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