Several prominent health advocacy organizations, including the Campaign for Tobacco-Free Kids, the American Academy of Pediatrics, and the American Lung Association, have submitted a letter to the FDA opposing applications related to the IQOS heated tobacco device. The letter, dated June 27, alleges that Philip Morris International has made misleading statements suggesting the FDA has found IQOS reduces disease risk.
Philip Morris International (PMI) has invested substantially in the development of IQOS, which heats tobacco sticks without combustion to avoid harmful chemicals released during burning. The company seeks FDA authorization to market the device in the US, the world's second-largest tobacco market by revenue.
The health groups' letter cites four instances of alleged misrepresentation by PMI in the US, Philippines, Mexico, and Kazakhstan. They argue that PMI violated FDA orders by implying IQOS offers lower risks than cigarettes. The letter also references upcoming independent studies from the International Tobacco Control Project at the University of Waterloo, which reportedly contradict PMI's findings on the proportion of IQOS users who completely switch from cigarettes.
In response to the allegations, a PMI spokesperson stated the company is proud to discuss the FDA's conclusions on IQOS and believes the cited language aligns with FDA orders. The spokesperson added that PMI discusses its science and products in accordance with applicable laws.
The FDA previously authorized an older version of IQOS for sale in 2019 and granted an "exposure modification order," allowing PMI to market it as offering reduced exposure to harmful chemicals for smokers who completely switch. However, the agency rejected PMI's application for a "risk modification order," which would permit claims of reduced tobacco-related harm and disease risk, citing insufficient evidence.
PMI applied in 2023 to renew its exposure modification orders and to sell and market a newer IQOS version. The FDA has yet to decide on these applications. Marketing IQOS as having health benefits compared to cigarettes could help PMI persuade consumers to switch and potentially afford tax benefits in some US states.
The ITC studies, presented at academic conferences but not yet peer-reviewed, found lower rates of complete switching among IQOS users in Japan (15%) and Korea (30%) compared to PMI's estimates. The most common pattern was dual use of IQOS and cigarettes, often leading to increased overall tobacco consumption.
PMI cited a 2019 Japanese government health survey in which 75% of heated tobacco users reported not smoking. However, a recent paper led by Georgetown University researchers highlighted flaws in the survey methodology that may have led to underreporting of smoking.
The FDA's response to the health groups' letter and its decisions on PMI's pending applications will have significant implications for the marketing and adoption of heated tobacco products in the US.
