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Confusion over IQOS as modified risk tobacco product


Last month, the United States Food and Drug Administration (FDA) published the outcome of Philip Morris International’s (PMI) application to market IQOS, its heated tobacco product, as a “modified risk tobacco product.”

PMI hailed the FDA’s decision as a “milestone for public health,” encouraging other countries to follow the FDA’s lead—effectively ignoring the fact that the FDA ruled that IQOS may reduce exposure to harmful substances, but PMI did not demonstrate that IQOS reduces risk of tobacco-related disease and death. In short, there is currently no evidence that IQOS is safer than cigarettes. Further, this decision was made largely on the basis of research produced or funded by PMI, which the company supplied to the FDA.

Last week, the World Health Organisation (WHO) issued a statement, reiterating the fact that reducing exposure to harmful chemicals in Heated Tobacco Products (HTPs) does not render them harmless, nor does it translate to reduced risk to human health. Yet, PMI is already portraying the FDA’s decision as a win for public health.


However, a tobacco control expert from STOP, a global tobacco industry watchdog, laid out the facts surrounding the FDA’s decision and the concerns the FDA expressed about youth and non-smoker uptake, as well as gaps in PMI’s research.

The expert, Director of the Tobacco Tactics Team at the University of Bath, and Partner in STOP, Andy Rowell, pointed to trends in PMI’s behaviour that suggest how it will use this decision to lobby other governments to permit the sale of IQOS and afford it a preferential regulatory environment.

STOP insisted among other things:
*The FDA has not ruled that IQOS is safer than cigarettes.
*In its own words, PMI acknowledges, “It has not been demonstrated that switching to the IQOS system reduces the risk of developing tobacco-related diseases compared to smoking cigarettes.”
*Analyses by independent researchers and by other governments have not found that IQOS reduces disease or death.
*Based on available evidence, several countries have banned the product or restricted its sales.
*There is no level of tobacco exposure that has been found to be safe.
*Governments should be alert to PMI’s spin on the FDA ruling—it is not an endorsement of IQOS.
*Governments and civil society should monitor PMI’s Public Relation (PR) and marketing to ensure that consumers are not being misled on the FDA decision or the safety of IQOS.
*There is currently no evidence that IQOS helps smokers quit. Smokers wishing to quit should use products shown to be safe and effective in line with national and international guidance.

According to the WHO statement on heated tobacco products and the US FDA decision regarding IQOS, …reducing exposure to harmful chemicals in HTPs does not render them harmless, nor does it translate to reduced risk to human health. Indeed, some toxins are present at higher levels in HTP aerosols than in conventional cigarette smoke, and there are some additional toxins present in HTP aerosols that are not present in conventional cigarette smoke. The health implications of exposure to these are unknown.

On July 7, 2020, the US FDA authorized the marketing of a heated tobacco product, the IQOS Tobacco Heating System, under the Federal Food, Drug and Cosmetic Act. This Act requires pre-market authorisation of new tobacco products before they can be placed on the US market.

The US FDA statement noted that, “Even with this action, these products are not safe nor “FDA approved“. The exposure modification orders also do not permit the company to make any other modified risk claims or any express or implied statements that convey or could mislead consumers into believing that the products are endorsed or approved by the FDA, or that the FDA deems the products to be safe for use by consumers.”


The US FDA authorisation rejected claims that the use of the product is less harmful than another tobacco product or reduces risks to health. The FDA orders also require the company to monitor youth awareness and use of the products to help ensure that the marketing of the MRTPs does not have unintended consequences for youth use. The company must also keep the FDA apprised of efforts to prevent youth access and exposure.

Given that health may be affected by exposure to additional toxins when using HTPs, claims that HTPS reduce exposure to harmful chemicals relative to conventional cigarettes may be misleading.

Moreover, the relevant orders grant a temporary market authorization within the US and are based on factors specific to the US, which is not a Party to the WHO Framework Convention on Tobacco Control (WHO FCTC).

WHO insists that all tobacco products pose risks to health and urges full implementation of the WHO FCTC. Rigorous implementation will support quit attempts and reduce initiation by non-users of tobacco products, especially the young. WHO recommends cessation of all tobacco use with interventions, such as brief advice from health professionals, national toll-free quit lines, nicotine replacement therapies and cessation interventions delivered via mobile text messaging.


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