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U.S. Department of Health and Human Services

Tobacco Products

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Modified Risk Tobacco Products

What is a modified risk tobacco product?

A modified risk tobacco product (MRTP) is a tobacco product that is sold or distributed for use to reduce harm and the risk of tobacco-related disease associated with commercially marketed tobacco products. You can legally market a modified risk tobacco product only after FDA issues an order permitting its marketing (Section 911(g)).

 

Must I submit a modified risk tobacco product application to legally market a “new tobacco product?”

No, a modified risk tobacco product application is required only if you are seeking to market a modified risk tobacco product. If your modified risk tobacco product is also a new tobacco product, then to legally market your new tobacco product you must submit one of the following, in addition to your MRTP application:

    1. A Substantial Equivalence Report
    2. An Exemption from Substantial Equivalence Request
    3. A Premarket Tobacco Application  

 

What are the ways in which FDA may grant an order permitting marketing of modified risk tobacco products?

There are two bases for issuing an order permitting the marketing of a modified risk tobacco product:

  1. You must demonstrate that the tobacco product, as actually used by consumers, will significantly reduce the harm and risk of tobacco-related disease. You must also demonstrate that the product, as actually used by consumers, will benefit the health of the population as a whole, including users and non-users of the product. (Section 911(g)(1))

    -OR- 
     
  2. This option is available where a tobacco product:
    • cannot meet the standards of the first order described above without conducting long-term epidemiological studies, and
    • the reduced risk claims for the product are limited to an explicit or implicit representation that the product or its smoke contains a reduced level of a substance or is free of a substance.

      In this option, you must demonstrate (among other things) that the overall reductions in exposure to harmful substances are substantial. You must also demonstrate that it is reasonably likely the tobacco product will be shown to reduce death or disease among individual users in future studies. In addition, you must demonstrate that if a marketing order were issued by FDA, the product is expected to benefit the health of the population as a whole, including users and non-users of the product. (Section 911(g)(2)).

 

Draft Guidance

FDA issued Draft Guidance for Industry to provide information on submitting Modified Risk Tobacco Product Applications. The draft guidance provides recommendations about the types of scientific studies and analyses that should be contained in an application. FDA will use the studies and analyses in the application to determine whether the criteria for issuing an order have been satisfied. The guidance also provides information about how to organize an application for submission to FDA. You can submit comments to this guidance. When this guidance is finalized it will represent FDA’s thinking on this topic.

 

 

 

 

 

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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