FDA
26th January 2018

FDA Panel Rejects Philip Morris’ Claim that iQOS Device is Safer than Continuing to Smoke Cigarettes

The Tobacco Products Scientific Advisory Committee met on January 24th and 25th, 2018 to discuss the modified risk tobacco product (MRTP).

FDA Panel Rejects Philip Morris’ Claim that iQOS Device is Safer than Continuing to Smoke Cigarettes

The Tobacco Products Scientific Advisory Committee met on January 24th and 25th, 2018 to discuss the modified risk tobacco product (MRTP) applications submitted by Philip Morris Products S.A. for iQOS system with Marlboro Heatsticks, IQOS system with Marlboro Smooth Menthol Heatsticks, and IQOS system with Marlboro Fresh Menthol Heatsticks. These modified-risk applications are different from the company’s concurrent application to market and sell iQOS in the United States, also known as a premarket tobacco product (PMTP) application.

MRTPs are tobacco products that are sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products. The iQOS system consists of a pen-shaped heating device and recharger. The device vaporizes mini tobacco sticks by heating them, rather than burning them. The applicant claims iQOS reduces exposure to the carcinogens created when tobacco is burned, and thus, provides a health benefit over conventional cigarettes and other combustible tobacco products.

Over the two-day meeting, the panelists were challenged with a series of questions in order to test these claims. Specifically, when asked whether the applicant demonstrated evidence showing that switching completely from cigarettes to the iQOS system can reduce the risks of tobacco-related diseases, the panel voted against the reduced-risk claim (0 Yes, 8 No, 1 Abstention). The panel also expressed mixed views that iQOS is less risky than continuing to smoke cigarettes (in a 4 Yes, 5 No vote). However, the committee did agree (8 Yes, 1 No), that the iQOS system significantly reduces the body’s exposure to harmful or potentially harmful chemicals.

The panel’s decisions arose from doubts that the scientific studies, which were primarily animals and laboratory conducted experiments, could predict lower rates of diseases and death in humans. The panel also expressed concerns that the device would more likely attract a younger population, increasing youth nicotine use and smoking rates, rather than declining cigarette use in long-term smokers.

The agency is not obligated to follow its panel’s recommendation, but normally does so. If approved, iQOS would be the first “reduced harm” marketed product, and would set the standard for MRTP applications moving forward. A decision on the general PMTP application is expected in February of 2018.

ISS has almost two decades of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net

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