Tobacco Products

Overview of the Family Smoking Prevention and Tobacco Control Act: Consumer Fact Sheet

To protect the public and create a healthier future for all Americans, the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) gives FDA authority to regulate the manufacture, distribution, and marketing of tobacco products.

Mother and daughter smiling

Consider the staggering facts:

  • Each year, tobacco use kills more than 480,000 people in the United States, making it the leading cause of preventable death.1
  • Each day, more than 3,200 youth under age 18 smoke their first cigarette; more than 700 of them will go on to become daily smokers.2
  • An estimated 42.1 million Americans – nearly one in five adults – currently smoke cigarettes.3

This law, among other things, ended the tobacco industry’s ability to introduce new products without oversight, ushering in a new era where tobacco products are subject to public health-based regulation. 

What the Tobacco Control Act does:

Restricts Tobacco Marketing and Sales to Youth

The Tobacco Control Act puts in place specific restrictions on marketing tobacco products to children and gives FDA authority to take further action in the future to protect public health. These provisions:

  • Require retailers to confirm proof of age for all face-to-face sales
  • Restrict vending machine sales, with exceptions in adult-only facilities
  • Ban the sale of packages of fewer than 20 cigarettes
  • Ban tobacco-brand sponsorships of sports and entertainment events or other social or cultural events
  • Ban free giveaways of sample cigarettes and brand-name non-tobacco promotional items

Requires Larger Warning Labels on Tobacco Products

The Tobacco Control Act requires FDA to include new warning labels on cigarette packages and in cigarette advertisements.  On June 22, 2011, FDA published a final rule requiring color graphics depicting the negative health consequences of smoking to accompany the nine new textual warning labels.  However, the final rule was challenged in court by several tobacco companies, and on August 24, 2012, the United States Court of Appeals for the District of Columbia Circuit vacated the rule and remanded the matter to the Agency.[1]  On December 5, 2012, the Court denied the government’s petition for panel rehearing and rehearing en banc.  The government decided not to seek further review of the Court’s ruling.  Therefore, information listed on this page became outdated and was archived. 

FDA will move forward to implement the Tobacco Control Act and is committed to building a healthier future for all Americans by using accurate, evidence-based science in regulating the manufacturing, marketing and distribution of tobacco products.

[1] R.J. Reynolds Tobacco Co., et al., v. Food & Drug Administration, et al., 696 F.3d 1205 (D.C. Cir. 2012)

Smokeless Tobacco Product Warning Labels

The Tobacco Control Act requires that smokeless tobacco packages and advertisements have larger and more visible warnings. Smokeless tobacco includes tobacco products such as moist snuff, chewing tobacco, and snus.
Every smokeless tobacco package and advertisement will include one of the following warning label statements:

  • WARNING: This product can cause mouth cancer.
  • WARNING: This product can cause gum disease and tooth loss.
  • WARNING: This product is not a safe alternative to cigarettes.
  • WARNING: Smokeless tobacco is addictive.

For smokeless tobacco packaging, the warning label statement must be located on the two principal sides of the package and cover at least 30 percent of each side.

For advertisements, the warning label statements must cover at least 20 percent of the area of the ad.

These changes aim to increase awareness of the health risks associated with smokeless tobacco use and improve the public health.

Modified Risk Tobacco Products

The landmark law prohibits tobacco companies from making reduced harm claims like “light,” “low,” or “mild,” without filing an application for a modified risk tobacco product and obtaining an order to market as such. 

Requires Disclosure of Ingredients in Tobacco Products

Tobacco companies are now required to provide FDA with detailed information about the ingredients in their products and report any changes. This information allows FDA to evaluate the public health impact of the products, take steps to reduce the harm, and educate the public about the toxic substances in tobacco products so that public health can be improved.

Preserves State and Local Authority

The Tobacco Control Act preserves the authority of state, local, and tribal governments to regulate tobacco products in certain specific respects. It also prohibits, with certain exceptions, state and local requirements that are different from, or in addition to, requirements under the provisions of the FDCA relating to specified areas.

Other Powers

The TCA gives FDA additional power to help protect the public and create a healthier future for all Americans by:

  • Requiring tobacco company owners and operators to register annually and open their manufacturing and processing facilities to be subject to inspection every two years by FDA. 
  • Allowing FDA to implement standards for tobacco products to protect public health. For example, FDA has the authority to regulate nicotine and ingredient levels.
  • Banning cigarettes with characterizing flavors, except menthol and tobacco.
  • Funding FDA regulation of tobacco products through a user fee on the manufacturers of certain tobacco products sold in the United States, based on their U.S. market share.

Limits on FDA’s Powers

The law makes clear that FDA’s role is to regulate and protect the public health, but it places a few restrictions on FDA’s powers. FDA cannot:

  • Require prescriptions to purchase tobacco products.
  • Require the reduction of nicotine yields to zero.
  • Ban face-to-face sales in a particular category of retail outlets.
  • Ban certain classes of tobacco products.

NOTE: This overview highlights some of the provisions of the Tobacco Control Act and is not intended to be a comprehensive guide or to reflect FDA’s interpretation of the Tobacco Control Act.  For complete information, you must read the entire law.

1. U.S. Department of Health and Human Services. The Health Consequences of Smoking: 50 Years of Progress. A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2014.
2. Substance Abuse and Mental Health Services Administration (SAMHSA). Results from the 2012 National Survey on Drug Use and Health, NSDUH: Table 4.10A Past Year Initiation of Substance Use among Persons Aged 12 or Older Who Initiated Use Prior to the Age of 18, by Gender: Numbers in Thousands, 2011 and 2012. Rockville (MD): U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Center for Behavioral Health Statistics and Quality, 2013.
3. Centers for Disease Control and Prevention. Current Cigarette Smoking Among Adults - United States, 2005-2012. Morbidity and Mortality Weekly Report 2014;63: 29-34.

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Page Last Updated: 03/06/2015
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