In 2019 the Food and Drug Administration (FDA) announced the authorisation of the Iqos device through its premarket tobacco application (PMTA) pathway. After its PMTA was approved, Philip Morris International (PMI) and then-US partner Altria launched the product in several US test markets that year.
Although the FDA allowed Iqos into the US market, the device has not been available for sale since patent disputes with British American Tobacco (BAT) led to a 2021 International Trade Commission (ITC) ruling forcing imported Iqos devices and consumables off the US market.