An FDA advisory panel on Thursday rejected claims by Philip Morris International that a new smokeless cigarette for which it is seeking regulatory approval to sell in the United States reduces the risks and harm of smoking.
About the new device
The new device, called IQOS, consists of a reusable tube that gently heats up sticks of compressed tobacco, but without igniting and burning them. The device shuts off automatically after six minutes or 14 puffs, whichever comes first. According to Philip Morris, the tobacco is heated to a temperature only capable of producing an aerosol that contains nicotine. As a result, the company says the device contains 90% to 95% lower levels of toxic chemicals found in cigarette smoke, when compared with traditional cigarettes.
The company spent $3 billion developing IQOS and other smokeless tobacco products, amid declining sales of combustible cigarettes. IQOS currently is available in 30 markets outside the United States.
Philip Morris is seeking regulatory approval to market IQOS as a less harmful alternative to cigarettes. FDA is not required to follow a panel's recommendation, but experts say the agency typically does. If approved in the United States, Philip Morris said IQOS would be exclusively marketed to smokers and estimated the device could save 90,000 lives over 20 years.
The panel in an 8-1 vote agreed with Philip Morris' claim that its smokeless cigarette reduces smokers' exposure to harmful chemicals. However, the panel in separate votes said the company had not proved conclusively that the device would result in a measurable reduction in disease or death.
The panel in a narrow 4-5 vote also rejected the company's claim that "switching completely to IQOS presents less risk of harm than continuing to smoke cigarettes."
Philip Morris in a statement called the two-day hearing an "open, positive dialogue." Corey Henry, a Philip Morris spokesperson, said, "We are confident in our ability to address the valid questions raised by the committee with the FDA as the review process for our application continues."
According to the Washington Post's "To Your Health," Phillip Morris can submit amendments to its application to address some of the panel's concerns (Wan, "To Your Health," Washington Post, 1/25; Clarke, Reuters, 1/25; Stein, "Shots," NPR, 1/25).
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