The U.S. Food and Drug Administration (FDA) is currently reviewing a tobacco product application (TPA/PMTA) submitted for IQOS ILUMA, a product owned by Philip Morris International (PMI).
According to FED.AZ, PMI believes that the comprehensive application package submitted, together with its proven experience in helping adult smokers switch to better alternatives, makes this application worthy of an expedited review by the FDA.
It is reported that there are currently 45 million adult nicotine users in the United States, approximately 25 million of whom continue to smoke cigarettes, the most harmful form of nicotine consumption.
Taking this into account, PMI’s application to the FDA focuses primarily on offering better alternatives to traditional tobacco products. The company’s Modified Risk Tobacco Product (MRTP) application includes an extensive body of scientific evidence demonstrating that the IQOS system generates an aerosol with significantly lower levels of harmful and potentially harmful constituents compared to cigarette smoke.
It should be noted that since 2008, PMI has invested more than USD 16 billion globally in the development, scientific substantiation, and commercialization of innovative smoke‑free products for adult consumers who would otherwise continue smoking. The primary objective of these investments is to completely eliminate cigarette sales.
Naturally, no tobacco product is risk‑free. However, PMI points to the Japanese experience, which shows that the availability of heated tobacco products is associated with a marked decline in the use of combustible cigarettes.
It should also be noted that heated tobacco products such as IQOS heat tobacco rather than burn it, which significantly reduces the formation of harmful chemicals produced by combustion, while still delivering real tobacco taste and nicotine satisfaction.
PMI’s ambition is that all adults who would otherwise continue smoking either quit entirely or fully switch to scientifically substantiated smoke‑free products as quickly as possible. Regulatory policies and decisions can significantly increase both the speed and scale of this historic transformation.
