IQOS: FDA renews controversial "modified risk tobacco product" status

The US Food and Drug Administration (FDA) has renewed the authorization allowing several Philip Morris IQOS products to be marketed with claims of reduced exposure to certain toxic substances.[1]. While strictly regulated and not constituting an acknowledgment of reduced health risks, this decision nonetheless raises major public health issues. It comes in a context marked by the increasing influence of tobacco industry repositioning strategies, which leverage these regulatory frameworks to support the promotion of new products, maintain confusion about their harmfulness, and exert pressure on public policy, including at the European and international levels.

A re-authorization strictly limited to reducing exposure

On April 17, 2026, the FDA renewed the authorizations granted to five IQOS products from Philip Morris Products SA under the "Modified Risk Tobacco Product" (MRTP) designation, following a scientific review described as rigorous. This decision concerns two IQOS devices (2.4 and 3.0) as well as three variants of heated tobacco refills, which can continue to be marketed with claims/statements strictly limited to reducing exposure to certain harmful substances.

The FDA has authorized the dissemination of messages stating that the system heats tobacco without burning it, that this process significantly reduces the production of certain toxic substances, and that switching completely from cigarettes to these products decreases the body's exposure to these specific compounds. The agency considers that the available scientific data supports this reduction in exposure.

However, this framework remains strictly regulated. The FDA explicitly states that this authorization does not constitute product validation or recognition of its safety, and reiterates that no tobacco product is risk-free. It prohibits any communication suggesting that these products are safe or approved as such. Furthermore, the manufacturer is required to conduct post-marketing studies to assess usage, consumer understanding of the messaging, and the overall impact on public health. The agency reserves the right to withdraw authorization in the event of adverse effects.

Thus, this re-authorisation is based exclusively on the notion of reduced exposure, without demonstration of an effective reduction of health risks in the medium or long term.

A regulatory status used as a tool in commercial valuation strategies

The renewal of the MRTP (Medical Risk Prevention Program) status highlights how the tobacco industry appropriates regulatory mechanisms to support its repositioning and marketing strategies. Designed to strictly regulate claims related to tobacco products, this mechanism tends, in practice, to be used by tobacco companies as a lever for commercial enhancement, allowing them to promote an image of reduced harm.

The authorization to communicate about reduced exposure, while legally regulated, is part of broader marketing strategies that rely on visual and discursive codes that emphasize innovation, technology, and a break from traditional cigarettes. IQOS products are thus frequently presented as "modern" or "improved" alternatives, through campaigns highlighting cleanliness, technological sophistication, and the idea of health progress.

These strategies are accompanied by specific marketing approaches, such as dedicated retail spaces or brand experiences inspired by consumer electronics, contributing to the normalization of these products and altering their social perception. They perpetuate historical practices of the tobacco industry, which consist of maintaining the ambiguity between reducing exposure and overall reducing harm.

In this context, MRTP status provides a structuring framework for these strategies. By authorizing certain claims, it effectively confers institutional endorsement that can be incorporated into marketing materials, potentially confusing consumers about the actual health effects of these products.[2]-[3].

A precedent that can be used in the ongoing revisions of European texts

Beyond the US framework alone, the manufacturers' objective is to use the FDA's decision to influence other regulatory spaces, particularly in the current context of reviewing European directives relating to tobacco and nicotine products, notably the Tobacco Products Directive (TPD) and the Tobacco Advertising Directive (TAD).

By relying on an authorization issued by a recognized health authority, industry players seek to legitimize demands for regulatory differentiation between products, particularly in favor of heated tobacco products and new nicotine products.

However, such an approach appears to be out of step with public health objectives, provisions adopted at the international level and with the principles of the WHO Framework Convention on Tobacco Control, in particular its article 5.3 relating to the protection of public policies against the interests of the tobacco industry.

©Generation Without Tobacco

AE

[1] Press release, FDA Renews Authorization for Five IQOS Products to be Marketed with Exposure Modification Claims, FDA, published April 17, 2026, accessed April 20, 2026

[2] Press release, WHO statement on heated tobacco products and the decision of the United States Food and Drug Administration (FDA) regarding IQOS, WHO published on 27 July 2020, accessed on 20 April 2026

[3] IQOS Marketing Strategies Before and After US FDA Granting Modified Risk Product Status, Tobacco-Free Generation, published on October 28, 2021, accessed on April 20, 2026