U.S. Federal Issues

FDA Authority Over Tobacco


Overview of FDA Authority Over Tobacco

In a historic victory of America's children and health, on June 22, 2009, President Obama signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) giving the U.S. Food and Drug Administration authority to regulate the manufacturing, marketing and sale of tobacco products.  Because of this law, the most deadly products sold in America are now regulated to protect public health.


Key Provisions

Key Provisions of the Tobacco Control Act:


Extending FDA Authority to All Tobacco Products

In addition to giving FDA immediate authority to regulate cigarettes and smokeless tobacco, the Tobacco Control Act also gave FDA authority to issue a rule “deeming” other tobacco products subject to FDA regulation.   In May, 2016 FDA issued a final “deeming rule” extending its authority to other tobacco products, including electronic cigarettes, cigars and hookah.  The final 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 on the deemed products.  The “deeming rule” is a critical first step toward a comprehensive regulatory structure for cigars, e-cigarettes and other tobacco products. 


FDA’s Unfinished Tobacco Business

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

FDA Should 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 final 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 the companies’ First Amendment rights.  Following the August 2012 decision of a federal appeals court in the District of Columbia striking down the specific proposed warnings, FDA said it would develop new proposed graphic warnings that would 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.

FDA Should Require Tobacco Products to be Less Lethal, Addictive and Appealing, Including Prohibiting Flavorings in Tobacco Products

FDA should use its power to order companies to reduce or eliminate harmful ingredients and additives, including prohibiting kid-friendly flavorings in cigars, electronic cigarettes and other nicotine vapor products.  The agency should prohibit menthol in cigarettes and other tobacco products because it masks the harshness of smoke, making it easier for young people to begin smoking.

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, 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.

FDA Should Apply All Current Cigarette Marketing Provisions to Electronic Cigarettes and Cigars

Although FDA has applied some of the current cigarette marketing restrictions on sellers of cigars and e-cigarettes, it needs to apply them all, including requiring effective age verification for internet sales, restricting vending machine sales and prohibiting self-service displays.