Tobacco Products

Premarket Tobacco Product Applications

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Before a new tobacco product can be legally marketed, FDA must issue an order permitting marketing of that product.  To issue an order, FDA must evaluate that product based on a public health standard that considers the risks and benefits of the product on the population as a whole, including tobacco product users as well as non-users.


Commonly Asked Questions:

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.

Which path is right for your new tobacco product?


When Should I Use the Premarket Tobacco Product Application Process?

A premarket tobacco product application may be submitted when seeking authorization for any new tobacco product. There are other pathways for marketing authorizations. If you are not sure what pathway is appropriate for your product, use the interactive tool.

How Do I Demonstrate that the New Tobacco Product Is Appropriate for the Protection of Public Health?

Premarket Tobacco Product Applications must provide scientific data to demonstrate that the new tobacco product is beneficial to the population as a whole including users and non-users. This demonstration shall take into account the increased or decreased likelihood that existing tobacco users will stop using such products, and the increased or decreased likelihood that those who do not use tobacco products will start using them.

What Information Is Needed in My Premarket Tobacco Product Application?

Your Premarket Tobacco Product Application must include the information, as required by Section 910(b)(1) of the FD&C Act:

  • full reports of all information, published or known to, or which should reasonably be known to, the applicant, concerning investigations that have been made to show the health risks of such tobacco product and whether such tobacco product presents less risk than other tobacco products;
  • a full statement of the tobacco product's
    • components
    • ingredients
    • additives
    • properties
    • principle(s) of operation
  • a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of such tobacco product;
  • an identifying reference to any tobacco product standard, under section 907, which would be applicable to any aspect of such tobacco product, and either adequate information to show that such aspect of such tobacco product fully meets such tobacco product standard or adequate information to justify any deviation from such standard;
  • such samples of such tobacco product and of components thereof as the Secretary may reasonably require;
  • specimens of the labeling proposed to be used for such tobacco product; and such other information relevant to the subject matter of the application as the Secretary may require.

For more information, see Draft Guidance: Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS) (2016) and Draft Guidance: Applications for Premarket Review of New Tobacco Products (2011). Some applicants may be able to request the use of Tobacco Product Master Files to complete this information.

When Should I Submit My Premarket Tobacco Product Application?

The applicant must obtain an order from FDA authorizing marketing of the new product before it can be introduced or delivered for introduction into interstate commerce as per Section 910(a)(2) of the FD&C Act.  To receive a marketing order, a premarket tobacco product application must be submitted by the applicant, reviewed by FDA, and determined to be appropriate for the protection of public health. 

A new tobacco product is either a product commercially marketed in the United States after February 15, 2007, or any modification to a tobacco product commercially marketed after February 15, 2007.

How Do I Submit My Premarket Tobacco Product Application?

Submit online through the CTP Portal, an alternative to the existing FDA Electronic Submissions Gateway (ESG) WebTrader tool. The CTP Portal provides a convenient, secure online system for electronically submitting documents.

If you are unable to submit online, you can mail your submission to CTP's Document Control Center.

What Happens After I Submit My Premarket Tobacco Product Application?

Upon receipt of an application, the FDA will determine if the application can be accepted and then filed for substantive review. FDA has refuse to accept procedures for premarket tobacco product submissions.

If the application is accepted, the FDA then will conduct a filing review to determine whether the application is complete, i.e., whether it contains all the items under Section 910(b)(1) of the FD&C Act. If not, the application is incomplete, and we will refuse to file it.

If the application is complete, FDA will file the application and begin substantive review.

As part of its review, FDA may refer the applications to the Tobacco Product Scientific Advisory Committee (TPSAC). You may also request that FDA refer the application to TPSAC.

After completing its review, FDA intends to issue an order within 180 days after receipt of the Premarket Tobacco Product Application that the new product may or may not be introduced or delivered for introduction to consumers.

Is There Information Available to Help Me in the Premarket Tobacco Product Application Process?

FDA has published guidances for industry that represent FDA's current thinking on this topic:

FDA has also presented webinars discussing the draft guidances:

  • Watch the 2016 webinar discussing the draft guidance "Premarket Tobacco Product Applications (PMTA) for Electronic Nicotine Delivery System (ENDS)."

Meetings are another mechanism that may be useful to obtain guidance and information on specific questions regarding the Premarket Tobacco Product Application process. See below for more information on meeting requests.

How Do I Request a Meeting with FDA?

FDA encourages applicants to request meetings prior to submitting a Premarket Tobacco Product Application. 

For more information, please see FDA's Guidance: Meetings with Industry and Investigators on the Research and Development of Tobacco Products (2016).

You may submit a meeting request via the CTP Portal or by mail.

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.

Page Last Updated: 03/14/2019
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