Authorisations

Fda renews Iqos and Heets status as modified risk tobacco products

Approvals for two Iqos devices and three Heets variants have been renewed in the US. For the FDA the measure is appropriate for the promotion of public health. Philip Morris International: decision based on scientific evidence

by Reddazione Roma

18 April 2026

2' min read

Translated by AI

Versione italiana

2' min read

Translated by AI

Versione italiana

The US Food and Drug Administration (FDA) has renewed marketing orders already granted for two versions of the Iqos device and three variants of Heets tobacco sticks as Modified Risk Tobacco Products (Mrtp).

The renewal allows Philip Morris International (Pmi) to continue to disseminate exposure reduction information to US adults aged 21 years or older who use traditional tobacco products, such as cigarettes.

According to the FDA, the renewal of Mrtp authorisations for Iqos and Heets is appropriate to promote public health and should produce benefits for the population as a whole, considering both users of tobacco products and non-users.

"As the only company to have successfully obtained and maintained Mrtp clearances for heated tobacco products in the US, we are confident that our science-based alternatives can help adult smokers quit cigarettes," said Stacey Kennedy, CEO of Pmi Us. "This FDA decision reflects both the rigorous scientific rationale supporting Iqos and our continued commitment to responsibly offer combustion-free alternatives to adult consumers."

In the ruling, the FDA reiterated that the available scientific evidence, even in the absence of long-term epidemiological studies, shows that a measurable and substantial reduction in morbidity or mortality among individual users of tobacco products is reasonably likely.

Iqos 2.4 had been the first heated tobacco product cleared through the FDA's Mrtp process in 2020, after being cleared through the Premarket Tobacco Product Application route in 2019. Iqos 3, on the other hand, received Mrtp clearance in 2022, following the premarket clearance received in 2020.

In the meantime, the FDA continues to review Pmta concerning Iqos Iluma. Pmi believes that the strength of demand and demonstrated ability to convert legal-age smokers to a better alternative may allow for swift action by the agency.

The renewal covers the Iqos 2.4 system with holder and charger, the Iqos 3.0 system with holder and charger and the Heets Amber, Green Menthol and Blue Menthol variants.

Finally, Pmie points out that since 2008, it has invested more than USD 16 billion globally in the development and commercialisation of combustion-free products for adults who would otherwise continue to smoke.