The U.S. Food and Drug Administration (FDA) has reaffirmed its previous Modified Risk Tobacco Product (MRTP) orders for two versions of the IQOS device owned by Philip Morris International (PMI) and three variants of HEETS tobacco sticks marketed under the HEETS brand.
This reauthorization allows PMI to continue communicating information about reduced harm to U.S. adults aged 21 and over who currently use traditional combustible tobacco products such as cigarettes.
According to the agency, renewing the MRTP authorizations for IQOS and HEETS is appropriate from the standpoint of promoting public health. This confirmation is expected to provide a benefit to overall public health, taking into account both tobacco users and non‑users.
In its decision, the FDA stated that, based on scientific research, completely switching from conventional cigarettes to the IQOS system significantly reduces users’ exposure to harmful or potentially harmful chemicals. The regulator once again confirmed that, even in the absence of long‑term epidemiological studies, the existing scientific evidence indicates the possibility of a meaningful reduction in disease and mortality among individual tobacco users.
According to statements by Stacy Kennedy, Chief Executive Officer of PMI U.S., PMI is the only company in the United States that has successfully obtained and retained MRTP authorizations for heated tobacco products:
“We believe our science‑based alternatives can help adult smokers move away from combustible cigarettes. The FDA’s decision reflects both the robust scientific foundation supporting IQOS and our commitment to responsibly offering smoke‑free options for adults.”
It should be recalled that the IQOS 2.4 system became the first heated tobacco product authorized by the FDA in 2020 as “appropriate for the promotion of the public health” under the MRTP pathway, following authorization for market entry through the Premarket Tobacco Product Application (PMTA) process in 2019.
The IQOS 3.0 system, after receiving initial market authorization in 2020, was granted MRTP status in 2022.
