United States: Organizations ask FDA to refuse marketing of new IQOS models

Six tobacco control and health organizations, including the Campaign for Tobacco-Free Kids, Truth Initiative, the American Academy of Pediatrics, the American Heart Association, the American Cancer Society and the American Lung Association, have writing to the U.S. Food and Drug Administration (FDA) to oppose applications to market new models of Philip Morris' IQOS heated tobacco device in the United States.

The organizations allege that Philip Morris misrepresented FDA statements by suggesting that the IQOS device posed fewer health risks than traditional cigarettes when the FDA had simply stated that there were modified risks. The organizations therefore wrote a joint letter to ensure that the FDA takes into account the various developments that have occurred since the IQOS was first approved for sale in 2019. The authors of the letter remind the agency that recent independent studies of IQOS in other countries have not demonstrated any benefits for public health. They also point out that Philip Morris used and misrepresented the FDA's initial approval to promote its IQOS product as a reduced-risk product.

“Modified risk product” status for IQOS

On July 7, 2020, Philip Morris International (PMI) was granted “modified risk product” status for its flagship product IQOS by the U.S. Food and Drug Administration (FDA). The FDA had rejected the claim that use of the device reduced the risk of tobacco-related diseases, pointing to the lack of evidence of any long-term harm.

Philip Morris recently applied for a renewal of its “modified risk product” status for its IQOS 3, as well as premarket approval for its next-generation product, IQOS ILUMA. The manufacturer also hopes to obtain modified risk product status for ILUMA. The FDA has not yet ruled on these applications.

Philip Morris said it plans a national rollout of ILUMA once it receives regulatory approval, hoping to have the device on the market in 10 states within the first year.

Distortion of FDA decision to promote IQOS as reduced risk product and weaken regulation

After the FDA granted this designation, PMI officials repeatedly made misleading and deceptive public statements implying that the FDA had determined that IQOS was less harmful or posed less of a health risk than other tobacco products.[1].

In France, Philip Morris immediately communicated and quickly "welcomed the FDA's decision" in a press release affirming the existence of a "independent international scientific consensus" on the reduced danger of IQOS. The managers also mentioned in this same communication that "The FDA has concluded that IQOS is intended to benefit the health of the general population, both those who currently use tobacco products and those who do not currently use tobacco products." ".

PMI’s statements thus convey the message that switching from conventional cigarettes to IQOS is a “better choice” because IQOS would reduce the risk of adverse health effects. This is precisely the type of “risk reduction” claim that the FDA has asked PMI not to use in its marketing of IQOS because the scientific data do not support such a claim.

Yet PMI has continued to repeatedly make similar “reduced risk” statements to promote IQOS globally and, in particular, to lobby foreign governments to create a favorable legislative and regulatory environment for IQOS.

In fact, the World Health Organization points out that there is no evidence to show that heated tobacco is less harmful than traditional tobacco products.

The majority of IQOS users also consume manufactured cigarettes

Philip Morris estimates that more than seven in ten IQOS users worldwide have quit smoking conventional cigarettes. In a 2023 submission to the FDA, the tobacco company noted that the majority of IQOS users used the product exclusively.

Analysis of data from the International Tobacco Control Policy Evaluation Project (ITC Project), presented at a session of the Society for Research on Nicotine and Tobacco’s 2023 Annual Conference, showed not only that PMI’s claims about full-switch rates in Japan are inaccurate, but also that most smokers become dual users and actually increase their overall tobacco consumption as a result. They found that only 17% of IQOS users became exclusive IQOS users in 2020.[2], while PMI claimed in its report to shareholders that 73 % of them had switched to IQOS in this country.

Another Japanese study from 2023[3] showed a greater likelihood of switching from exclusive smoking to long-term dual use of cigarettes and heated tobacco products than switching to exclusive use of heated tobacco. The researchers did not find an association between long-term use of heated tobacco and a greater likelihood of quitting. Finally, they found that smokers who had ever used heated tobacco products were less likely to quit than those who had never used heated tobacco products.

ITC Project Results for South Korea[4], presented at the Society for Research on Nicotine and Tobacco 2024 Annual Conference, are similar to those in Japan. The analysis found that the rate of smokers quitting conventional cigarettes to switch exclusively to heated tobacco is significantly lower than the manufacturer's claims: only 30% of IQOS users used the product exclusively.

Heated menthol tobacco not included in upcoming US menthol ban

The FDA’s marketing authorizations for IQOS include the “Smooth Menthol” and “Fresh Menthol” heated tobacco sticks (which have been renamed “Green Menthol” and “Blue Menthol,” respectively). The marketing and risk modification applications for ILUMA also include the TEREA BLUE and TEREA GREEN tobacco brands, which are believed to be menthol-flavored. Since FDA issued the marketing authorizations and risk modification authorizations for IQOS products, including menthol-flavored products, the agency has proposed a rule prohibiting menthol as a characteristic flavor in tobacco. This proposed rule has been forwarded to the Office of Management and Budget’s Office of Information and Regulatory Affairs for review to become the rule.[5].

In the preamble to the proposed rule, FDA requested comments on possible exceptions to the menthol rule for certain products that meet the definition of “cigarette” in the rule, including “smokeless” products. In their comments on the proposed rule, more than 100 public health, medical education, civil rights, and community organizations argued that such an exception for IQOS or other heat-to-use products would not be appropriate to protect public health. Thus, the organizations argued that continued or future authorization of menthol-flavored IQOS would directly contradict FDA’s conclusions in favor of banning menthol cigarettes.

The authors of this mobilization of health stakeholders urge the FDA, when examining PMI applications for new versions of its IQOS device, to take into account all of the aforementioned elements before any marketing authorization for new versions of IQOS and the renewal of its status as a "modified risk" product.

©Generation Without Tobacco

AE

[1] Tobacco-free generation, IQOS marketing strategies before and after the granting of “modified risk product” status by the US FDA, published October 28, 2021, accessed July 17, 2024

[2] Gravely, S, et al. An Examination of Philip Morris International's Estimate of IQOS Consumers Who Have “Completely Transitioned” From Cigarettes: Findings From the 2018/19 and 2020 ITC Japan Surveys. Presentation at 2023 Society for Research on Nicotine and Tobacco Annual Meeting. March 3, 2023

[3] Fong, GT, et al. Transitions of Tobacco Product Use Among Adults Who Smoke Cigarettes and Adults Who Use Heated Tobacco Products (HTPs) in Japan: Initial Findings from Three Waves of the ITC Japan Cohort Survey (2018-20). Presentation at 2023 Society for Research on Nicotine and Tobacco Annual Meeting. March 3, 2023

[4] Gravely, S, et al. An Examination of Philip Morris International's Estimate of Korean Adults Who Have “Completely Transitioned” from Cigarettes to IQOS: Findings from the 2020 and 2021 ITC Korea Surveys. Presentation at 2024 Society for Research on Nicotine and Tobacco Annual Meeting. March 23, 2024

[5] Tobacco-free generation, Biden administration again delays proposed menthol cigarette ban, published on May 2, 2024, accessed on July 17, 2024