US regulator renews IQOS modified risk orders

The US Food and Drug Administration (FDA) has renewed modified risk tobacco product (MRTP) orders for IQOS devices and associated tobacco sticks, allowing continued communication of reduced-exposure claims to adult smokers in the US market.

The decision covers the IQOS 2.4 and IQOS 3.0 systems, alongside three HEETS variants (Amber, Green Menthol and Blue Menthol). Following a fresh scientific review, the agency concluded that the available evidence remains consistent with earlier findings and supports the original determination that the products are “appropriate for the protection of public health,” when considering both users and non-users of tobacco products.

Under the renewed orders, Philip Morris International (PMI) can continue to market IQOS in the US with specific exposure modification claims, including that the device heats rather than burns tobacco and that switching completely from cigarettes significantly reduces exposure to harmful chemicals. However, the FDA reiterated that no tobacco product is safe and strictly limits how reduced-risk messaging can be communicated, prohibiting any suggestion of endorsement or safety.

The regulator also emphasised that the authorisations are conditional. It retains the power to withdraw them if population-level health benefits are no longer demonstrated. As part of the renewal, PMI must continue post-market surveillance, including monitoring user behaviour and consumer understanding of the claims.

PMI welcomed the decision, positioning it as validation of its reduced-harm strategy and long-term investment in smoke-free alternatives.

“As the only company to have successfully secured and maintained MRTP authorisations for heated tobacco products in the US, we are confident that our science-based alternatives can help adult smokers transition away from combustible cigarettes,” said Stacey Kennedy, CEO, PMI US.

The company highlighted that IQOS aerosol contains lower levels of harmful constituents compared with cigarette smoke and pointed to real-world data from markets such as Japan, where heated tobacco uptake has coincided with declines in cigarette consumption.

The IQOS 2.4 system was the first heated tobacco product authorised via the FDA’s MRTP process in 2020, following its authorisation through the premarket tobacco product application (PMTA) process in 2019. The IQOS 3 system secured MRTP authorisation in 2022, following premarket authorisation in 2020.

The FDA continues to review PMTAs for IQOS ILUMA and given its strong application and demonstrated track record converting legal age smokers to a better alternative, PMI said it believes the application warrants expeditious FDA action.