FDA Renews Authorization for Five IQOS Products to be Marketed with Exposure Modification Claims

Following the U.S. Food and Drug Administration's (FDA) rigorous scientific review, the agency has issued a renewal of modified risk granted orders to Philip Morris Products S.A. (PMP S.A.) for two IQOS system holders and chargers and three flavors of HeatSticks products. With this renewal, these five products may be marketed with the following exposure modification claim:

The products receiving modified risk granted orders are:

  • IQOS 2.4 System Holder and Charger (PM0000479)
  • IQOS 3.0 System Holder and Charger (PM0000634)
  • Marlboro Amber HeatSticks (previously Marlboro HeatSticks) (PM0000424)
  • Marlboro Green Menthol HeatSticks (previously Marlboro Smooth Menthol HeatSticks) (PM0000425)
  • Marlboro Blue Menthol HeatSticks (previously Marlboro Fresh Menthol HeatSticks) (PM0000426)

View the announcement here.