Modified Risk Tobacco Products (MRTPs)
Modified risk tobacco products are tobacco products that are sold, distributed, or marketed with a claim to reduce harm or the risk of tobacco-related disease.
The Tobacco Control Act establishes rigorous scientific criteria an applicant’s tobacco product must meet before FDA can allow the applicant to sell that product with a claim to reduce harm.
- The draft guidance for MRTPs provides details for those who seek to market a tobacco product as modified or lower risk including how to organize and submit an MRTP application, what scientific studies and analyses should be submitted, and what information should be collected through post-market surveillance and studies.
Before issuing the final guidance, FDA will consider the public comments submitted on the draft guidance document, a December 2011 report from the Institute of Medicine , and feedback from an FDA public workshop held in August 2011.