FDA renews modified risk authorization for Philip Morris IQOS, HEETS in US

Philip Morris International Inc.

Philip Morris International Inc.

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  • FDA renewed Modified Risk Tobacco Product orders for Philip Morris International’s IQOS heated tobacco devices, allowing continued reduced-exposure marketing claims in US.
  • Renewal covers two IQOS systems plus three HEETS consumable variants.
  • FDA concluded renewal is appropriate for public health, citing evidence supporting a reasonably likely reduction in morbidity or mortality without long-term epidemiological studies.
  • PMI said FDA continues to review premarket tobacco product applications for IQOS ILUMA.


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