Federal Oversight

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

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

Food and Drug Administration (FDA)

In June, 2009, Congress gave the Food and Drug Administration (FDA) broad authority to regulate tobacco products.

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 for cigarette and smokeless tobacco products commercially launched, or to be launched, after February 15, 2007;
• New and bigger warning labels on tobacco products;
• Require the testing and reporting of tobacco ingredients and constituents as well as the submission of certain categories of company documents;
• Specify standards for manufacturing facilities and monitor 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 ten years.

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

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. Cigarette manufacturers are required to submit a complete list of all ingredients added to tobacco in the manufacture of cigarettes to HHS on an annual basis. Cigarette manufacturers have also submitted additional ingredient information at the request of HHS. Congress considered this reporting system to be adequate to “permit the federal government to initiate the toxicologic research necessary to measure any health risk posed by the addition of additives and other ingredients to cigarettes during the manufacturing process.” 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 cigarette smokers.”

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.

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) bans cigarette advertising on television and radio, and other electronic media. The DOJ, in consultation with the FCC, ensures compliance with the ban on advertising in the electronic media.

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)/U.S. Department of Agriculture (USDA)

The EPA approves the types and application rates for pesticides used on tobacco and the USDA enforces these rules.

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.

Domestic farmers are required to certify to the USDA that they are in compliance with the use of proper pesticides and application rates.