FDA Premarket Review of Tobacco Products

The Family Smoking Prevention and Tobacco Control Act gives the U.S. Food and Drug Administration unprecedented authority to regulate tobacco products.  One of the most powerful tools available to the FDA is the ability to decide whether or not a new tobacco product can be introduced to the market.  In theory, this gatekeeping role for the FDA should allow it to prevent those products with the most potential to harm public health from ever making it to retail store shelves. However, the FDA’s implementation of this authority has not maximized the potential to protect public health.

We have identified concrete steps the FDA should take to improve the premarket review process to better promote public health. These suggestions are outlined in The FDA’s Misplaced Priorities: Premarket Review Under the Family Smoking Prevention and Tobacco Control Act (published in Tobacco Control). 

Unfortunately, not only is the FDA failing to act boldly to protect health in the premarket review process, but the tobacco industry is petitioning the FDA to make changes that further undermine the public health benefits of the premarket review process. You can read the Consortium’s comment on the industry’s petition and submit a comment telling the FDA to reject this petition.

In 2015, the FDA has made important changes to its premarket review process, changes that further erode the public health benefits of this process. Even as the FDA weakened its premarket review oversight, the tobacco industry used litigation to further erode this authority.

The most important recent development in premarket review is the FDA’s shifting policy on how it will implement its authority for products that come under its authority via the deeming regulation. How premarket review is implemented for e-cigarettes, cigars, and other newly-regulated products will have significant consequences for public health in the future.


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The FDA’s Misplaced Priorities: Premarket Review Under the Family Smoking Prevention and Tobacco Control Act

This peer-reviewed article, published in Tobacco Control in May 2016, concludes that the FDA has not implemented the premarket review process in a manner that prioritizes the protection of public health.

Tobacco Display

The FDA’s Premarket Review of Tobacco Products Fails to Fully Protect Public Health (2016)

This fact sheet will explain FDA processes for authorizing the marketing of new tobacco products and provide information on FDA’s actions to date.

Video on FDA Policy

FDA Policy Puts Industry Interests Before Public Health (2015)

Video that addresses a 2015 FDA guidance document that allows the tobacco industry to circumvent the Tobacco Control Act by introducing new or modified products with little or no review.