Scientific Standards for Studies on Modified Risk Tobacco Products


Report at a Glance

Tobacco use is the leading cause of preventable death and disease in the U.S. Smoking leads to approximately 443,000 premature deaths each year, and smoking-related diseases kill more Americans than alcohol, illegal drugs, murder, and suicide combined. The passage of the Family Smoking Prevention and Tobacco Control Act of 2009 (FSPTCA) granted the FDA broad authority to regulate the manufacturing, distribution, and marketing of tobacco products. It also gave the FDA authority to regulate “modified risk tobacco products” (MRTPs), tobacco products that are either designed or advertised to reduce harm or the risk of tobacco-related disease. In order to market an MRTP, manufacturers must submit to the FDA scientific evidence to demonstrate the product has the potential to reduce tobacco related harms as compared to conventional tobacco products.

At the request of the FDA, the IOM formed a committee to identify minimum standards for scientific studies that an applicant would need to complete to obtain an order to market the product from the FDA. It concludes that the public health standard in the FSPTCA will require a wide range of scientific evidence including the composition and performance of the MRTP, perceptions about the risks and benefits of the MRTP, the addictive potential of the MRTP, and its human health effects. The FDA will need to issue guidance and regulation on the types, design, conduct, analysis, reporting, and governance of studies about MRTPs. The IOM’s recommendations are designed to help the FDA ensure that its evaluation of MRTPs is systematic and founded on evidence, resulting in products that not only reduce risk compared with conventional tobacco products, but also reduce the rates of tobacco-related harm across the country.