Tobacco Products

Products, Guidance & Regulations

FDA's approach to regulating tobacco products is grounded in science and uses the full power of the law to protect public health.

Tobacco Product Review & Evaluation

Determine which pathway is appropriate to legally market your new tobacco product.

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.


Marketing, Advertising, & Promotion Requirements

Get the latest guidance on new marketing rules and restrictions, especially efforts aimed to appeal to youth.

Labeling Requirements

From health warnings to product descriptors, find out what FDA’s labeling authority includes. 

Extending Authorities to Additional Tobacco Products

Learn more about FDA's final rule to bring more tobacco products under its regulatory authority, including electronic cigarettes, cigars, and pipe tobacco. 

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.
Not Sure? Let us help you.
Substantial Equivalence
Exemption from Substantial Equivalence.
Premarket Tobacco Applications.
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.


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

Page Last Updated: 01/06/2017
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