Tobacco Products

Premarket Tobacco Products

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Before a new tobacco product can be legally marketed, the FDA must evaluate it 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.

 


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When Should I Use the Premarket Tobacco Application Process?

Before legally marketing a new tobacco product, you must submit one of the following and receive appropriate authorization from FDA:

*Use the Premarket Tobacco Application for new tobacco products that do not meet the criteria for substantial equivalence or exemption from substantial equivalence. You may submit a Premarket Tobacco Application under Section 910(b)(1) of the  Food, Drug & Cosmetic Act (FD&C Act)


How do I demonstrate that the new tobacco product is appropriate for the protection of public health?

Premarket Tobacco Applications must demonstrate that the new tobacco product is appropriate for the protection of public health. This is determined by assessing its impact on the population as a whole--including users and non-users of tobacco products--and considering the increased or decreased likelihood that:

  • existing tobacco users will stop using such products
  • those who do not use tobacco products will start using them

What Information Is Needed in My Premarket Tobacco Application?

Your Premarket Tobacco 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 which 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 for Industry about Premarket Applications (2011)


When Should I Submit My Premarket Tobacco Application?

When a manufacturer creates a new tobacco product or modifies an existing tobacco product, the manufacturer 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.

The FD&C Act provides FDA with 180 days after receipt of the application for review of a Premarket Tobacco Application. After completing its review, FDA will issue an order that the new product may or may not be introduced or delivered for introduction to consumers.


How Do I Submit My Premarket Tobacco Application?

  • Prominently identify the application with the applicant’s name
  • Label it clearly as a “Premarket Tobacco Application (PMTA)”
  • Submit your application electronically via the Electronic Secure Gateway or if you are unable to submit electronically, by mail to FDA’s Center for Tobacco Products (CTP).

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


Is there guidance available to help me apply for premarket review of new tobacco products?

WebinarFDA published Draft Guidance for Industry: Applications for Premarket Review of New Tobacco Products (2011). When this guidance is finalized, it will represent FDA’s current thinking on this topic.

FDA presented a webinar discussing the draft guidance “Applications for Premarket Review of New Tobacco Products.”


How Do I Request a Meeting with FDA?

If you are planning to conduct the scientific studies necessary to support a Premarket Tobacco Application, submit a meeting request via the Electronic Secure Gateway or by mail.

For more information, please see FDA’s guidance: Meetings with Industry and Investigators on the Research and Development of Tobacco Products.

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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Page Last Updated: 03/26/2015
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