FDA Premarket Review of Tobacco Products
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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). More information about the problems with the FDA’s approach is available in our factsheet The FDA’s Premarket Review of Tobacco Products is Not Maximizing the Protection of Public Health.
Unfortunately, not only is the FDA failing to act boldly to protect health in the premarket review process, but the tobacco industry is trying to make things even worse, petitioning the FDA to make changes that 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.
More recently, the FDA has made important changes to its premarket review process, changes that further erode the public health benefits of this process. You can find more information on those changes and what you can do here: FDA Policy Puts Industry Interests Before Public Health.
- The FDA’s Misplaced Priorities: Premarket Review Under the Family Smoking Prevention and Tobacco Control Act (published in Tobacco Control)
- The FDA’s Premarket Review of Tobacco Products Fails to Fully Protect Public Health (2016)
- FDA Policy Puts Industry Interests Before Public Health (2015)
- Comments on Petition of Lorillard for Enforcement Discretion with Respect to Premarket Approval Requirements for New Tobacco Products (2014)