FDA Authorizes IQOS Marketing as Modified Risk



On July 7, 2020, the FDA authorized Philip Morris to market its IQOS Tobacco Heating System as ‘modified risk tobacco products’, making the IQOS device and its accompanying HeatSticks only the second set of products to be authorized as modified risk tobacco products and the first tobacco products to receive “exposure modification” orders.

As background, the IQOS Tobacco Heating System and the accompanying HeatSticks are heated tobacco products, also called non-combusted cigarettes by the public health field and heat-not-burn products by the industry. According to the FDA, heated tobacco products are classified as cigarettes and are federally regulated as such. These specific Philip Morris products, which are newer in the US market but have been on the international market for multiple years now, consist of the rechargeable IQOS device and the Marlboro-branded HeatSticks. Unlike traditional, combustible cigarettes which ignite and burn, the IQOS device heats tobacco to a much lower temperate and generates an inhalable aerosol, that Philip Morris claims delivers less toxicity and fewer chemicals than traditional, combusted tobacco. In design, the product aims to simulate a traditional smoking experience; tactilely, IQOS provides a similar look and feel to cigarettes and the HeatSticks, similar to cigarettes, are sold in packs of 20 and in both menthol and non-menthol flavors.

IQOS debuted in test markets in Atlanta, Georgia and Richmond, Virginia in late 2019. The devices are currently sold at flagship stores in malls, mobile units and kiosks, and sometimes in parking lots of convenience stores. For now, the sale of HeatSticks is a bit more expansive, as they can be found in traditional tobacco retailers in these cities. With the FDA’s recently determined authorization, Philip Morris can now market the claims that the IQOS system “heats tobacco but does not burn it” and “significantly reduces the production of harmful and potentially harmful chemicals”; they can also advertise that “scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful products”.

Whether these products are truly safer than cigarettes remains questionable. Even with authorization of the modified risk claim, the FDA maintains that the products are neither safe nor FDA-approved. The nicotine in the product is highly addictive, and independent, peer-reviewed research assessing the short- and long-term effects of these products is severely lacking. As well, a significant portion of the current research has been led, funded by, or in some way associated with the tobacco industry. As a result, the authorization requires both the FDA and Philip Morris to continue to monitor the appropriateness of the modified risk order and its impact on youth use.

In response to the FDA authorization, multiple organizations, including the Campaign for Tobacco-Free Kids, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association and Truth Initiative, issued a joint counterstatement, arguing the authorization puts youth and the public’s health at risk. Their concerns center on Philip Morris marketing IQOS as a safe, sleek, and stylish product, in a similar way e-cigarettes were marketed, leading to non-smokers and youth, in particular, falling for the advertising and initiating tobacco use. We entirely agree with their position. We have significant concerns regarding the safety of these products and the influence of the marketing and modified risk claim on perceptions and behaviors, particularly among youth and young adults. We believe it is imperative that the FDA and other independent researchers not only continue to assess the risk of harm of these products but also routinely assess how these products are being marketed and sold; as this new modified risk claim will likely impact perceptions of harm, there is a critical need to keep a finger on the pulse of how the marketing of this product affects use, especially among youth and young adults.

Additionally, we would like to highlight that, while youth appeal is of critical concern, we should also maintain a critical eye on whether the marketing of the mentholated versions of HeatSticks is being targeted at Black and Brown individuals and communities. The industry is notorious for targeted marketing towards these communities, and it is yet to be seen whether they will follow down the same path for IQOS and the mentholated HeatSticks.

The FDA’s decision in this matter is monumental, and, as such, those in the field of tobacco control must remain vigilant on the impact this decision has on current and future marketing and use of not only heated tobacco products but all tobacco products.

Learn more about heated tobacco products and how they are currently regulated across the country:

CounterTobacco.org is a project of Counter Tools. Counter Tools (logo)
#pf-body #pf-header-img { margin: 0 0 0.5rem; height: 62px; }