FDA says, “Not Yet”
The Tobacco Products Scientific Advisory Committee recently wrapped up a two-day panel concerning two separate FDA applications submitted by Philip Morris in regard to its IQOS device. The first submittal was a request to sell the IQOS in the U.S. and the second application was in hopes of being able to market the “heat-not-burn” device as a safer alternative to analog cigarettes.
The TPSAC, which included scientists advising U.S. regulators ended discussions in unanimous agreement against PMI’s IQOS device stating a lack of evidence supporting the hand-held device as an alternative to traditional cigarettes.
As stated in The Wall Street Journal, several committee members expressed concern that young people who don’t currently smoke could be lured by IQOS marketing. “We have to use the e-cigarette experience,” said Deborah Ossip, professor in the department of public health sciences at the University of Rochester Medical Center.
What is the IQOS?
According to Philip Morris International, “at the heart of IQOS are sophisticated electronics that heat specially designed heated tobacco units. IQOS heats the tobacco just enough to release a flavorful nicotine-containing vapor but without burning the tobacco.” PMI says the tobacco in a cigarette burns at temperatures in excess of 600 degrees Celsius, generating smoke that contains harmful chemicals. What distinguishes the IQOS device is that it heats tobacco to much lower temperatures, up to 350 degrees Celsius, without combustion, fire, ash, or smoke, “thus” eliminating much if not all of the carcinogens.
According to the WSJ, the Marlboro maker (PMI) has invested over $3 billion to develop the IQOS and other cigarette alternatives. Since 2008, Philip Morris has hired over 400 scientists and experts to conduct research and development, housing the team in a glass building in Neuchâtel, Switzerland, nicknamed “the cube.”
The overarching feeling during the two-day session was that Philip Morris’s evidence suggesting that using IQOS exclusively exposes the body to fewer toxic chemicals than smoking cigarettes, while compelling, lacked clear wording and evidence in claiming that the device could reduce disease risk.
“I don’t think I’d be able in good conscience to say this has been really demonstrated to reduce harm,” said Dr. Michael Weitzman, professor of pediatrics at New York University.
Long before PMI’s New Year’s resolution which called for “an end to cigarettes,” the company has focused on getting as many American smokers as possible away from cigarettes.
Read the full WSJ article here.
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