Tobacco Products

Marketing a New Tobacco Product

In order to allow the FDA to encourage innovation that has the potential to make a notable public health difference—and to inform future policies and efforts that will protect kids and help smokers quit cigarettes—the agency extended timelines to submit tobacco product review applications for deemed products that were on the market as of August 8, 2016. Under the revised timelines:

  • Applications to market deemed combustible products, such as cigars, pipe tobacco, and hookah tobacco, must be submitted by August 8, 2021.
  • Applications to market deemed non-combustible products, such as electronic nicotine delivery systems (ENDS) or e-cigarettes, must be submitted by August 8, 2022

All other compliance deadlines for manufacturers will remain the same. Importantly, the new enforcement policy does not affect any current requirements from the deeming rule that have already passed. For example, mandatory age and photo-ID checks to prevent illegal sales to minors remain in effect and subject to enforcement by the FDA.

Which path is right for your new tobacco product?

Use our interactive tool to learn about the three pathways to legally marketing a new tobacco product.


Which path is right for your new tobacco product?

 

NOTE: "Grandfathered tobacco products” are not considered new tobacco products and thus are not subject to the premarket requirements of the FD&C Act.  Tobacco products that were commercially marketed (other than exclusively in test markets) in the U.S. as of February 15, 2007, and have not been modified since then are known as grandfathered tobacco products.

In August 2017, FDA published extended timelines to submit tobacco product review applications for deemed "finished tobacco products" that were on the market as of August 8, 2016. As such, you must comply by these deadlines*:

  • For "new" combustible tobacco products by August 8, 2021.
  • For "new" noncombustible tobacco products by August 8, 2022.

*Revised deadlines are based on whether or not the product is combustible—regardless of the pathway chosen (SE, Exemption from SE, or PMTA).

 

Page Last Updated: 04/11/2018
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