Tobacco Products

Tobacco Product Review & Evaluation

FDA’s oversight of the pathways to legally market and distribute tobacco products is designed to create a healthier future for all Americans. New tobacco products are evaluated based on a public health standard that considers the product’s risks on the population as a whole.


Introducing a New Tobacco Product

According to the Federal Food, Drug, & Cosmetic Act (FD&C Act), a new tobacco product is any product that was not commercially marketed in the United States as of Feb. 15, 2007. This includes tobacco products that were modified and the modified product was marketed after Feb. 15, 2007 [(see Section 910(a)(1) of the FD&C Act.]

New tobacco products may not be legally marketed in the United States unless FDA has issued an order permitting their marketing. However, if a new tobacco product was:

  1. Commercially marketed after Feb. 15, 2007 but before March 22, 2011; AND
  2. A Substantial Equivalence Report was submitted by March 22, 2011;

THEN: This new tobacco product may continue to be marketed unless FDA issues an order that the new product is not substantially equivalent to an appropriate predicate 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.


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Premarket Tobacco Products

Get an overview of the Premarket Tobacco Application process.


Substantial Equivalence

Learn how FDA determines if a new tobacco product is substantially equivalent to a predicate product.


Exemption from Substantial Equivalence

Find out what determines if a tobacco product may be considered for an exemption from substantial equivalence.


Misbranded and Adulterated NSE Tobacco Products

When a tobacco product is misbranded or adulterated, it is illegal to sell or distribute the product in interstate commerce or import the product into the United States. Learn what causes FDA to issue a “Not Substantially Equivalent” Order.


Modified Risk Tobacco Products

Understand the ways in which FDA may grant an order permitting marketing of modified risk tobacco products.


Questions & Answers

FAQs about the tobacco product pathways to market.  

This web content highlights provisions of the Food, Drug, and Cosmetic Act. It is not intended to be comprehensive or reflect FDA's interpretation of the Act. For complete information, you must read the entire law. For your convenience, the section number of the FD&C Act is referenced and relevant sections are linked to throughout the web content. 


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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 Products.
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.

Page Last Updated: 02/27/2015
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