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 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:

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.


Grandfathered Tobacco Products

What is a "grandfathered" tobacco product? Find out here.

Premarket Tobacco Applications (PMTA)

Get an overview of the Premarket Tobacco Application process.

Substantial Equivalence (SE)

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.

Issued Marketing Orders and Final Actions

Summary of Premarket Tobacco Application, Substantial Equivalence, and Exemption from Substantial Equivalence decisions

Denying a New Tobacco Product Application

FDA will not permit a new tobacco product to be marketed if the applicant does not demonstrate that permitting marketing of the product would be appropriate for the protection of the public health. In reviewing a new tobacco product application, we will take into account, among other things:

  • The risks and benefits to the population as a whole, including users and nonusers of tobacco products
  • Increased or decreased likelihood that existing users of tobacco products will stop using such products
  • Increased or decreased likelihood that those who do not use tobacco products will start using such products

Tobacco Product Master Files

Learn how Tobacco Product Master Files (TPMFs) can help manufacturers, component or ingredient suppliers, and researchers with tobacco product submissions to the FDA.

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.

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: 12/10/2018
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