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

Six tobacco control and health organizations, including 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 US 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 the FDA's statements by suggesting that the IQOS device posed fewer health risks than traditional cigarettes when the FDA had simply stated the existence of altered risks. Therefore, the structures wrote a joint letter to ensure that the FDA takes into account the various developments that have occurred since the first marketing authorization for IQOS was granted in 2019. The authors of the letter remind the agency that recent independent studies of IQOS in other countries have not demonstrated public health benefits. They also point out that Philip Morris used and distorted the first FDA authorization to promote its IQOS product as a reduced risk product.

The status of “modified risk product” for IQOS

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

Recently, Philip Morris requested the renewal of its “modified risk product” status for its IQOS 3, as well as pre-market authorization for the IQOS ILUMA, its new generation product. The manufacturer also hopes to obtain modified risk product status for ILUMA. The FDA has not yet ruled on these requests.

Philip Morris said it plans a national rollout of ILUMA once it receives marketing approval, hoping to bring the device to 10 states within the first year.

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

After the FDA granted this status, 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 alternatives. 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 less dangerous nature of the IQOS. The leaders also mentioned in this same communication that “the FDA has concluded that IQOS is intended to benefit the health of the population as a whole, both for users of tobacco products and for individuals 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 legislative and regulatory environment favorable to IQOS .

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

The majority of IQOS consumers 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 at the 2023 annual conference of the Society for Research on Nicotine and Tobacco, showed not only that the claims PMI estimates regarding full transition 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 had become exclusive IQOS consumers 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. Researchers did not find an association between long-term heated tobacco use and a greater likelihood of quitting smoking. Finally, they established that smokers who had ever used heated tobacco products were less likely to quit smoking than those who had never used heated tobacco products.

Results of the ITC project concerning South Korea[4], presented at the 2024 annual conference of the Society for Research on Nicotine and Tobacco, are similar to those in Japan. The analysis revealed the rate of smokers stopping smoking traditional cigarettes to switch exclusively to heated tobacco is significantly lower than the manufacturer's claims: only 30% of IQOS consumers consumed this product exclusively.

Menthol heated tobacco not included in upcoming ban on menthol products in the United States

The marketing authorizations granted by the FDA for IQOS include the heated tobacco sticks “Smooth Menthol” and “Fresh Menthol” (which have been renamed “Green Menthol” and “Blue Menthol” respectively). The marketing and risk modification applications for ILUMA also include the tobacco brands TEREA BLUE and TEREA GREEN, which are presumably flavored with menthol. Since the FDA issued marketing authorizations and risk modification authorizations for IQOS products, including menthol-flavored products, the agency has proposed a rule banning menthol as a signature flavor in tobacco. This has been forwarded for review by the Office of Information and Regulatory Affairs of the Office of Management and Budget 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 “non-combustion” 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 heated products would not be appropriate for protection of public health. Thus, for organizations, continued or future authorization of menthol-flavored IQOS would directly contradict the FDA's findings in favor of banning menthol cigarettes.

The authors of this mobilization of health stakeholders urge the FDA, when examining PMI requests for new versions of its IQOS device, to take into account all of the above-mentioned elements before any authorization for release. on the market for new versions of the IQOS and the renewal of its status as a “modified risk” product.

©Tobacco Free Generation

AE

[1] Tobacco-free generation, IQOS commercialization strategies before and after being granted “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] Generation without tobacco, Biden administration once again delays proposed ban on menthol cigarettes, published on May 2, 2024, consulted on July 17, 2024