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:
- When should I use the premarket tobacco application process?
- How do I demonstrate that the new tobacco product is appropriate for the protection of public health?
- What information is needed in my premarket tobacco application?
- When should I submit my premarket tobacco application?
- How do I submit my premarket tobacco application?
- What happens after I submit my premarket tobacco application?
- Is there Information Available to Help Me in the Premarket Tobacco Application Process?
- How do I request a meeting with FDA?
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.
A premarket tobacco 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 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.
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
- 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)
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 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.
Upon receipt of an application, FDA will determine if the application can be accepted and then filed for substantive review. For example, if that application is for a product that is not a “tobacco product,” or is for a tobacco product that is not currently regulated by FDA, or FDA is unable to review and process the application, FDA may refuse to accept it. If the application is accepted, FDA will conduct a filing review to determine whether the application is complete, i.e., whether it contains all the items required under Section 910(b)(1) of the FD&C Act. If the application is incomplete, FDA may 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). The applicant 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 Application that the new product may or may not be introduced or delivered for introduction to consumers
FDA 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.”
Meetings are another mechanism which may be useful to obtain guidance and information on specific questions regarding the Premarket Tobacco Application process.
FDA encourages applicants to request meetings prior to submitting a Premarket Tobacco Application.
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.