LONDON, July 16 – Several health advocacy groups have lodged a formal complaint with U.S. regulators against Philip Morris International (PM.N), accusing the tobacco giant of misrepresenting past regulatory decisions in a bid to launch its flagship heated tobacco device IQOS in the United States.
PMI, the world’s largest tobacco company by market value, has invested heavily in developing IQOS, viewed by investors as pivotal for future growth. However, its entry into the world’s second-largest tobacco market by revenue hinges on approval from the U.S. Food and Drug Administration (FDA).
Six prominent anti-tobacco and health organizations, including the Campaign for Tobacco-Free Kids, the American Academy of Pediatrics, and the American Lung Association, jointly penned a letter to the FDA opposing PMI’s applications related to IQOS.
The letter, dated June 27 and reviewed by Reuters, accuses PMI of making misleading statements suggesting that the FDA has endorsed IQOS as reducing the risk of disease.
The campaign groups cited instances in the United States, the Philippines, Mexico, and Kazakhstan where PMI allegedly violated FDA directives by implying that IQOS carries lower health risks compared to cigarettes.
They also referenced upcoming independent studies from Canada’s University of Waterloo’s International Tobacco Control Project (ITC), which reportedly challenge PMI’s claims about the number of IQOS users who completely switch from cigarettes.
In response to Reuters’ inquiry about the letter, a spokesperson for PMI stated that the company stands by its compliance with FDA guidelines, though they did not initially address specific examples cited by the campaigners. Later, the spokesperson reiterated that PMI’s communications align with regulatory requirements.
The FDA confirmed receipt of the letter and indicated it would respond directly to the senders without further elaboration.
IQOS devices heat tobacco sticks without burning them, aiming to reduce the harmful chemicals released through combustion, which traditional cigarette smoking entails.
The FDA initially authorized PMI to market an earlier version of IQOS in 2019, granting it an “exposure modification order” indicating reduced exposure to harmful chemicals for smokers who completely switch to IQOS. However, obtaining a “risk modification order,” which permits claims of reduced health risks, requires more rigorous evidence, including long-term epidemiological studies.
PMI’s application to renew existing exposure modification orders for IQOS, submitted in 2023, and its subsequent application to market a newer version are pending FDA decisions.
The company plans to introduce the older IQOS device in four U.S. cities but has deferred a full-scale launch pending FDA approval of the newer model.
Regarding user behavior, the campaigners referenced preliminary ITC data suggesting lower than claimed rates of complete cessation of smoking among IQOS users in Japan and Korea, highlighting a significant prevalence of “dual use,” where individuals use both IQOS and cigarettes concurrently.
While PMI asserts that a majority of its registered IQOS customers globally have quit smoking, the ITC’s findings challenge these claims, indicating much lower cessation rates among IQOS users in certain markets.
PMI’s reliance on a 2019 Japanese government survey indicating high quit rates among heated tobacco users was countered by recent academic research questioning the survey’s methodology and suggesting under-reporting of smoking prevalence.
The outcome of the FDA’s review of PMI’s applications and the implications for IQOS marketing in the United States remain uncertain amid ongoing scrutiny from health advocates and regulatory authorities.
Related topics:
- Oral Health Providers Rally Behind Canadian Dental Care Plan Amid Controversy
- Care Health Insurance Expands Coverage for Pre-Existing Conditions Through New Partnership
- Urgent Call for Action on UK Men’s Health as Report Highlights Alarming Mortality Rates
