Activity

Scientific Standards for Studies on Modified Risk Tobacco Products


Type: Consensus Study
Topics: Public Health
Board: Board on Population Health and Public Health Practice

Activity Description

The IOM will advise the Food and Drug Administration on the minimum standards for scientific studies to allow the marketing of modified risk tobacco products, and for post-market studies of marketed products, as described in Section 911 of the Family Smoking Prevention and Tobacco Control Act of 2009. The Food and Drug Administration was advised in the Act to consult with the IOM in developing guidance or regulation on this topic. Specifically, the IOM will provide advice on:

  • the minimum scientific standards for scientific studies needed to show that issuing an order for the sale of a modified risk tobacco product will result in substantial reduction in morbidity or mortality among individual tobacco users, or is reasonably likely to occur, and
  • the minimum standards for post-market studies that will include regular and long-term assessments of health outcomes and mortality, intermediate clinical endpoints, consumer perception, and the impact on quitting behavior and the new use of tobacco products.

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