Health advocates have reached out to U.S. regulators, accusing Philip Morris International (PMI) of misrepresenting regulatory decisions as the company seeks approval to launch its heated tobacco product, IQOS, in the United States.
PMI, the largest tobacco firm globally by market value, has invested heavily in IQOS, viewing it as crucial for future growth. However, the company requires authorization from the U.S. Food and Drug Administration (FDA) to market it in this significant tobacco market.
A coalition of six anti-tobacco organizations, including the Campaign for Tobacco-Free Kids and the American Academy of Pediatrics, submitted a letter to the FDA opposing PMI’s applications related to IQOS. The letter, dated June 27, alleges that PMI has made misleading claims suggesting the FDA found IQOS to reduce disease risk.
The health groups assert that PMI has breached FDA regulations by implying that IQOS is less harmful than traditional cigarettes. They referenced statements made by PMI in the U.S., the Philippines, Mexico, and Kazakhstan as part of their argument.
Additionally, the groups highlighted new independent studies that contradict PMI’s claims about the proportion of IQOS users who switch completely from cigarettes. Research from the International Tobacco Control Project (ITC) at Canada’s University of Waterloo indicates that the actual rates of quitting smoking with IQOS are significantly lower than PMI reports.
The letter states that these issues directly influence whether PMI should be permitted to market IQOS in the U.S.
In response to the concerns raised, a PMI spokesperson expressed pride in the FDA’s conclusions regarding IQOS but did not address the specific allegations. The spokesperson insisted that all communications about the product adhere to applicable laws.
The FDA has acknowledged receipt of the letter but has not commented on its potential impact on the decision-making process regarding IQOS.
IQOS operates by heating tobacco rather than burning it, aiming to reduce the harmful chemicals associated with combustion. The FDA first approved a prior version of IQOS in 2019 and later allowed PMI to market it under an “exposure modification order,” which indicates reduced exposure to harmful substances for those who completely switch.
However, the agency has previously rejected PMI’s claims regarding reduced health risks, citing insufficient evidence.
PMI has submitted applications in 2023 to renew existing exposure modification orders and to introduce a new version of IQOS, with the FDA yet to make a decision.
The marketing of IQOS as a safer alternative to traditional cigarettes could facilitate consumer transitions and potentially offer tax benefits in some states.
In addition to the aforementioned studies, the ITC’s findings showed that in 2021, only 15% of IQOS users in Japan and 30% in Korea had completely quit smoking, contrary to PMI’s assertions of a higher switch rate.
Furthermore, users often engaged in “dual use,” combining IQOS with traditional cigarettes, which may lead to an overall increase in tobacco consumption. PMI cited a 2019 Japanese government survey indicating that 75% of heated tobacco users did not smoke, although subsequent research from Georgetown University pointed out flaws in that survey’s methodology.
