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U.S. Department of Health and Human Services

Tobacco Products

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Premarket Tobacco Products

When should I use the Premarket Tobacco Application process?

The Premarket Tobacco Application process is available for new tobacco products that do not meet the criteria for either substantial equivalence or exemption from substantial equivalence. If you want to market a new tobacco product, you may submit a Premarket Tobacco Application under Section 910 of the FD&C Act. Before marketing your product in the United States, you must receive written notification from FDA permitting the marketing of your new tobacco product. 

New Tobacco Product Review & Evaluation Sections:


 

  

Will you be making a modified risk claim for your new tobacco product?

Learn the process at the Modified Risk Tobacco Product Application page. 

 

  

Which path is right for your new tobacco product? Go to the page with our new interactive tool to help you answer the questions.

 

Which path is right for your new tobacco product?

 

 

 

 

 

 

 

 

 

 

Premarket Tobacco Products and the Public Health

Premarket Tobacco Applications must demonstrate that the new tobacco product is appropriate for the protection of the public health, which will be determined with respect to the risks and benefits to the population as a whole, including users and non-users of tobacco products, and taking into account:

  • The increased or decreased likelihood that existing users of tobacco products will stop using such products; and
  • The increased or decreased likelihood that those who do not use tobacco products will start using such products.

 

What information is needed in my Premarket Tobacco Application?

Your Premarket Tobacco Application must include the information required by section Section 910(b)(1) of the FD&C Act. FDA has published Draft Guidance for Industry about Premarket Applications (see Draft Guidance section below). You may provide comments on this guidance. When this guidance is finalized, it will represent FDA’s thinking on this topic.

 

When should I submit my Premarket Tobacco Application?

Before marketing your product in the United States, you must receive a written order from FDA permitting the marketing of your new tobacco product. The Tobacco Control Act provides 180 days for FDA review of a Premarket Tobacco Application. After completing the review, FDA will issue an order that the new product may or may not be introduced or delivered for introduction into interstate commerce.

 

How do I submit my Premarket Tobacco Application?

FDA requests that you:

  1. Prominently identify the application with the applicant’s name and label it clearly as a “Premarket Tobacco Application (PMTA).”
  2. Submit your application electronically via the Electronic Secure Gateway or in paper format to CTP's address.

As part of FDA’s review, we may refer the application to the Tobacco Products Scientific Advisory Committee (TPSAC). You may also request that FDA refer the application to TPSAC.

Before marketing your product in the United States, you must receive a written order from FDA permitting the marketing of your new tobacco product.

 

Draft Guidance 

FDA published Draft Guidance for Industry related to Premarket Tobacco Applications. When this guidance is finalized, it will represent FDA’s thinking on this topic.
 

 

Webinar

In November  2011, CTP presented a webinar discussing the draft guidance “Applications for Premarket Review of New Tobacco Products.” This draft guidance assists those who submit applications for new tobacco products under section 910 of the FD&C Act. This draft guidance, when finalized, will represent  FDA's current thinking on this topic.

 

Request a Meeting with FDA

If you are planning to conduct the scientific studies necessary to support a Premarket Tobacco Application, we encourage you to submit a meeting request via the Electronic Secure Gateway or in paper format to CTP's address. 

 

 

 

 

  

This web content highlights provisions of the Food, Drug and Cosmetic Act (FD&C 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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