Tobacco Products

Marketing a New Tobacco Product

Newly-regulated tobacco products are subject to the premarket review requirements of the FD&C Act. For such newly-regulated products that were on the market as of August 8, 2016, FDA is providing two compliance periods:

  • One for submission and FDA receipt of applications and
  • One for obtaining premarket authorization.

The FDA expects such products currently on the market to remain available for up to three years from the effective date of the rule while manufacturers seek authorization under the staggered compliance periods.

You must submit an application and obtain FDA authorization before marketing a "new tobacco product." You must determine a pathway to market and follow our regulations on sale, use, and distribution.

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 newly-regulated "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" non-combustible 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: 10/17/2017
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