Tobacco Products

Market and Distribute a Tobacco Product

FDA oversees all pathways to legally market and distribute tobacco products in the U.S. Determine an appropriate pathway to market for your tobacco product and learn more about how the FDA reviews and evaluates marketing order applications.


Substantial Equivalance Interactive Tool Icon

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.


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Common questions and additional help

Read more questions about pathways to market.

Which path is right for your
new tobacco product?

Answer a few questions using our interactive tool to help determine which pathway may be appropriate for your new tobacco product.
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Substantial Equivalence
Exemption from Substantial Equivalence.
Premarket Tobacco Applications.
Question
Yes
No
 
 
 
Characteristics is defined as "the materials, ingredients, design, composition, heating source, or other features of a tobacco product." Section 910(a)(3)(B) of the FD&C Act.
A predicate tobacco product is one that was commercially marketed (other than in a test market) as of February 15, 2007.

OR

A product previously found to be substantially equivalent by the Secretary and in compliance with Section 910(a)(3) of the FD&C Act.

Introduce a new tobacco product to market

A “new tobacco product” is any product not commercially marketed in the United States as of February 15, 2007, or the modification of a tobacco product where the modified product was commercially marketed in the U.S. after February 15, 2007.

Products on the market as of or on February 15, 2007 are considered grandfathered tobacco products.

New tobacco products may not be legally marketed in the United States without a tobacco product marketing order from the FDA.* These products are evaluated based on the product's risks to the population as a whole. There are three pathways to market for new tobacco products:

  • Premarket Tobacco Product Applications
    A premarket tobacco product application may be submitted when seeking marketing authorization for any new tobacco product. However, for some products, other pathways may be more applicable.

  • Substantial Equivalence
    A new tobacco product may be found “substantially equivalent,” to a “predicate” product by demonstrating the product has the same characteristics as that predicate product, or if the product has different characteristics, by demonstrating that the new product does not raise different questions of public health than the predicate product. 

  • Request Exemption from Demonstrating Substantial Equivalence
    A tobacco product that is modified by adding or deleting a tobacco additive, or by increasing or decreasing the quantity of an existing tobacco additive may be considered for an exemption from demonstrating substantial equivalence.
     

*New tobacco products commercially marketed after February 15, 2007 but before March 22, 2011 with an SE Report submitted by March 22, 2011 are known as provisional SE tobacco products— these may continue to be marketed unless FDA issues an order that the new product is not substantially equivalent.

Page Last Updated: 04/11/2019
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