IQOS’ US launch, which was scheduled to take place in Q2, is now delayed to Q4. Photo credit: Aphis Marta, CC4.0.
Philip Morris International (PMI) is pushing the launch of its IQOS device in the US market from the second quarter in Austin, TX to the fourth quarter, according to a Reuters report. PMI did not disclose the reason for the delay.
Health campaigners are opposing IQOS’ US launch. An exclusive Reuters report in mid-July revealed these campaigners, which include the Campaign for Tobacco-Free Kids, the American Academy of Pediatrics, and the American Lung Association, have written to the US Food and Drug Administration (FDA) to oppose IQOS-related applications PMI submitted to the agency, as well as accusing the company of misrepresenting past regulatory decisions. The campaign groups allege that PMI violated FDA orders by suggesting that IQOS offers lower risks than cigarettes.
FDA first authorized PMI to sell an older version of IQOS in 2019. The agency later allowed the company to market the device as offering reduced exposure to harmful chemicals compared to cigarettes for smokers who completely switch, under an "exposure modification order." PMI also awaits market authorization from FDA for its IQOS ILUMA device, which it expects by the second half of 2025.
This year, a ban on flavored heated tobacco in the European Union has already impacted shipments more than expected. As a result, PMI revised its volume growth expectations for the heated tobacco category to around 13% for the full year, down from the previous forecast of 14% to 16%.