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 recognizes that it is critical that the federal government uses its authority over the manufacturing, sales and marketing of all tobacco products to help reduce this deadly toll and protect public health.

What Is FDA's Role in Tobacco Product Oversight?

Manufacturers are required to submit applications if they wish to bring new tobacco products onto the market; these applications must demonstrate that the product is "appropriate for the protection of the public health." FDA can also require product standards, or changes to existing tobacco products on the marketplace, such as the currently proposed product standards that would remove menthol as a characterizing flavor in cigarettes and all flavors in cigars.

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, 2020 and FDA was given until September 9, 2021 to respond to the applications. Two and a half years later they have completed review of most, but not all of the applications from millions of products.