On this page:
- What are MRTPs?
- Who can submit an MRTP application?
- When should an MRTP application be submitted?
- What happens after an MRTP application is submitted?
- What happens after an order under Section 911(g) of the FD&C Act is issued?
Modified risk tobacco products (MRTPs) are tobacco products that are sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.
Any person may submit an application seeking an order under section 911(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The requirements of this section apply to any tobacco product subject to regulation under Chapter IX of the FD&C Act that meets the definition of an MRTP.
Before a product may be introduced or delivered for introduction into interstate commerce as an MRTP, an order under section 911(g) of the FD&C Act must be in effect for that product. FDA encourages applicants to meet with FDA early in their process of developing an MRTP to discuss MRTP application submission and investigational requirements and recommendations.
Upon receipt of an application, FDA will first determine if the application can be accepted and filed for substantive review. For example, if the application has a deficiency, we will refuse to accept it. FDA has refuse to accept procedures for premarket tobacco product submissions, including MRTP.
If the application is accepted, the FDA then will conduct a filing review to determine whether the application contains all the items required under Section 911(d) of the FD&C Act. If not, the application is incomplete, and we will refuse to file it.
If the application is complete, we will file the application and begin substantive review.
FDA will issue an order authorizing the marketing of a modified risk tobacco product if the evidence submitted in the application meets certain requirements in section 911, including, if applicable, showing that the product will benefit the health of the population as a whole.
FDA’s goal is to review and act upon each MRTP application within 360 days of receipt, if it contains the information required by section 911 of the FD&C Act.
An applicant granted an order under section 911(g) of the FD&C Act may market the tobacco product as described in the order issued by FDA.
An FDA order permitting marketing of an MRTP is not permanent; it is for a fixed period of time that will be specified in the order. To continue to market a modified risk tobacco product after the set term, a company would need to seek renewal of the order and FDA would need to determine that the findings continue to be satisfied.
In addition, companies will be required to conduct post-market surveillance and studies and submit the results to FDA annually. FDA will review these results and collect further information about the product’s use and health risks.
If, at any time, FDA determines that it can no longer make the determinations required under section 911(g) of the FD&C Act, FDA is required to withdraw the order. Before FDA withdraws an MRTP order, it will provide an opportunity for an informal hearing as required under the law.