FDA Oversight of Tobacco Products

Tobacco use remains the leading cause of preventable death in the U.S. killing close to half a million people each year. The American Lung Association believes it is critical that the federal government has strong oversight authority over the manufacturing, sales and marketing of all tobacco products to help reduce this deadly toll and protect public health.

The Lung Association was a leader in passing the Family Smoking Prevention and Tobacco Control Act in 2009, which established the Center for Tobacco Products. The 2009 law gave FDA immediate authority over cigarettes and smokeless tobacco products and in 2016, FDA asserted its authority over all other tobacco products, including cigars, e-cigarettes, little cigars, hookah and pipe tobacco.

After years of delay and due to a successful lawsuit from the Lung Association and our public health partners against FDA, e-cigarettes and other tobacco products introduced to the market after February 15, 2007 were finally required to submit their products to FDA for review to remain on the market. The deadline for submission of these pre-market tobacco authorizations was September 9, and FDA has up to one year to respond to the applications.

FDA has the authority to remove products from the marketplace that are not "appropriate for the protection of the public health." FDA can also require product standards, or changes to existing tobacco products on the marketplace.  

For more information about FDA authority over tobacco products:

  1. A court decision that has been appealed has overturned FDA’s authority over certain large cigars.

Page last updated: November 17, 2022

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