Food and Drug Administration | December 13, 2019
Read the PublicationAs a coalition of researchers concerned about the impacts of tobacco regulations on vulnerable populations, we urge FDA to evaluate the potential for new tobacco products to harm or put vulnerable populations at risk as part of its Premarket Tobacco Product Application (PMTA) reviews. Beyond youth, the proposed rule does not describe explicitly how PMTAs will be evaluated with respect to vulnerable or disadvantaged subpopulations. The Tobacco Control Act’s (TCA) Appropriate for the Protection of Public Health (AFPPH) standard requires FDA to evaluate the risks and benefits to the population “as a whole” when determining whether to issue a PMTA order.