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With strong, bipartisan support, Congress in 2009 enacted the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), which gave the U.S. Food and Drug Administration the authority to regulate the manufacturing, marketing and sale of tobacco products.

This landmark law ended the special protection from regulation the tobacco industry enjoyed for decades and represents a milestone in protecting America’s children and health from the devastating consequences of tobacco use.


The Tobacco Control Act:

  • Bans candy and fruit-flavored cigarettes that appeal to kids.

  • Cracks down on cigarette marketing and sales to kids by prohibiting sales to anyone under 18, banning free samples and self-service displays, prohibiting brand sponsorships of athletic and musical events, and strengthening enforcement and penalties to prevent sales to kids.

  • Prohibits deceptive cigarette labels like “light” and “low-tar” used by the cigarette companies to promote the falsehood that some cigarette brands are less harmful than others.

  • Requires tobacco companies seeking to market less harmful products to provide scientific support for these claims and show a public health benefit from making them.

  • Requires tobacco companies to disclose to FDA information about their products, including harmful ingredients.

  • Requires premarket review of new tobacco products to prevent introduction of products that are more harmful, addictive or appealing.

  • Allows FDA to order reduction or elimination of harmful ingredients and additives in tobacco products to protect public health.

  • Requires bigger, bolder health warnings, including graphic warnings on cigarettes.


The Tobacco Control Act gave the FDA immediate regulatory authority over cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco and authorized the agency to extend its jurisdiction to all other tobacco products. In May 2016, the FDA issued a final “deeming rule” extending its authority to other tobacco products, including electronic cigarettes, cigars and hookah.

This rule established a minimum sale age of 18 for those products, with required age verification in face-to-face transactions; required registration and ingredient reporting to provide FDA with information necessary to develop science-based regulations; subjected products already on the market and new products to agency review; provided for premarket review of reduced risk claims for the deemed products; restricted vending machine sales; banned free samples; and required health warnings. This rule is a critical first step toward a comprehensive regulatory structure for e-cigarettes, cigars and other tobacco products.


In several significant ways, the FDA has not exercised the full scope of its authority to regulate tobacco products.

FDA Should Promptly Issue a New Set of Graphic Health Warnings for Cigarettes

The Tobacco Control Act required FDA to issue a regulation mandating large, graphic health warnings for cigarettes.

In June 2011, FDA unveiled nine graphic warnings, which the law specified must be placed on all cigarette packs and ads in the United States starting in September 2012. However, the cigarette companies successfully challenged the specific proposed warnings as a violation of their First Amendment rights. Following the August 2012 decision of the U.S. Court of Appeals for the D.C. Circuit, which struck down the specific proposed warnings, FDA said it would develop new proposed graphic warnings that could survive constitutional challenge. Years later, FDA still has not issued a new set of graphic health warnings, even though research shows them to be far more effective than text warnings alone.

In October 2016, the Campaign for Tobacco-Free Kids and seven other health organizations filed suit to force the FDA to issue a final rule requiring graphic cigarette warnings, as required by the Tobacco Control Act.

FDA Should Require Tobacco Products to be Less Lethal, Addictive and Appealing

The Tobacco Control Act authorized the FDA to set product standards governing the design and contents of tobacco product s in order to make them less lethal, addictive and appealing. The FDA should exercise this authority in several specific ways:

  • The FDA should require the reduction of nicotine in cigarettes to non-addictive levels in order to prevent kids from becoming addicted and help current smokers quit. FDA Commissioner Scott Gottlieb proposed such a plan in July 2017 and should move quickly to implement it.

  • The FDA should prohibit all flavorings in tobacco products, including in e-cigarettes and cigars, given the evidence that flavors play a key role in youth initiation and continued use of tobacco products. The agency should also ban menthol cigarettes in light of the extensive evidence that menthol cigarettes lead to increased smoking initiation among youth and young adults, greater addiction and decreased success in quitting.

FDA Should Protect Against New Tobacco Products that Are More Hazardous, Addictive and Appealing

Given the tobacco industry’s long history of introducing products that are more toxic, addictive and appealing, the FDA must rigorously review new tobacco products to ensure compliance with the public health standard, including e-cigarette products already on the market when the deeming rule was issued.

Last updated March 15, 2018