FDA Statement on the Institute of Medicine Report: Scientific Standards for Studies on Modified Risk

On December 14, 2011, the Institute of Medicine released a report on the design and conduct of studies which the FDA will take into consideration in the assessment and ongoing review of modified risk tobacco products. A modified risk tobacco product is any tobacco product sold or distributed for use to lower the harm or risk of tobacco-related disease associated with other tobacco products. Experts within the FDA’s Center for Tobacco Products will take these recommendations into consideration in developing its guidance and/or regulation on the scientific evidence required for the assessment and ongoing review of modified risk tobacco products.

The 2009 Family Smoking Prevention and Tobacco Control Act requires the FDA to consult with the IOM on the design and conduct of studies and surveillance required for the assessment and ongoing review of modified risk tobacco products. The FDA must publish regulations and/or guidance on the scientific evidence required for assessment and ongoing review of modified risk tobacco products by April 2012.

For more information:

• FDA Public Workshop on Modified Risk Tobacco Products
• IOM Report: Scientific Standards for Studies on Modified Risk Tobacco Products