A Food and Drug Administration advisory committee is expected to vote Thursday on whether Philip Morris International Inc. has made a convincing case that it should be allowed to market its IQOS tobacco heating device in the U.S. as less harmful than cigarettes.
The findings, which are to be released at the end of a two-day meeting, could help chart a new course for tobacco regulation in the U.S. and have enormous implications for U.S. public health. The stakes are also high for the Marlboro maker, which has invested more than $3 billion to develop IQOS and other cigarette alternatives.
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The safety and role of these alternatives are a matter of intense debate in the U.S., and Philip Morris hopes its U.S. partner Altria Group Inc. will be allowed to market IQOS to adult smokers who want to quit. IQOS heats but doesn't burn tobacco; Philip Morris says the device eliminates most of the health harms of cigarettes while mimicking smoking more closely than e-cigarettes, which use nicotine liquid concoctions.
Of the 36.5 million adult smokers in the U.S., 67% of men and 69% of women want to quit, according to the Centers for Disease Control and Prevention.
The committee is debating whether Philip Morris has proven that switching from cigarettes to IQOS -- which the company already sells in 29 countries -- cuts the risk of tobacco-related diseases such as cancer and benefits public health. The FDA doesn't have to follow the findings of its advisers, but frequently does.
The vote by the Tobacco Products Scientific Advisory Committee will set a precedent regardless of which way it goes. Philip Morris is the first major tobacco company to seek FDA approval in the U.S. for a true cigarette alternative -- a noncombustible tobacco product that contains nicotine and, like a cigarette, is inhalable.
The FDA, under Commissioner Scott Gottlieb, laid out a plan last year to identify products that are less harmful than cigarettes and steer smokers toward them. At the same time, the agency aims to cut nicotine in cigarettes to make them less addictive. The idea is to put a regulatory system in place that offers cigarette alternatives with scientifically-verified risks, said Michael Eriksen, dean of Georgia State University's School of Public Health and principal investigator of the university's Tobacco Center of Regulatory Science.
"This is one important step in ending smoking as we know it," he said.
While tobacco companies have published research showing their e-cigarettes, which produce vapor, are safer than conventional ones, they have struggled to get smokers to switch.
On Wednesday, officials from Philip Morris International and Altria -- once part of the same company -- presented the results of scientific studies as well as plans for marketing IQOS in the U.S. If the FDA gives the go-ahead, Altria will market and sell the device here according to a licensing agreement with Philip Morris.
IQOS produces fewer toxic chemicals than conventional cigarettes, reducing molecular changes in cells and tissue that could lead to disease, Philip Morris said during a live webcast of the meeting. The company projected that six million smokers would switch to IQOS in 10 years and that use of the product could save more than 90,000 lives over 20 years.
In Japan -- where e-cigarette sales are heavily restricted -- IQOS has lured enough smokers since launching nationwide in the summer of 2016 to account for about 12% of the overall cigarette market, according to Philip Morris.
"Our evidence shows that IQOS is a much better choice than continuing to smoke," said Moira Gilchrist, Philip Morris International's vice president of scientific and public communications.
FDA committee members quizzed the companies' officials on teenagers' potential use of IQOS, which is meant for adult smokers. Sarah Knakmuhs, vice president of heated tobacco products for Altria unit Philip Morris USA, said the company would implement safeguards "to minimize reach to unintended audiences" such as youth, including verifying the age of people who want to enter the Apple Inc. style stores IQOS is sold at in some countries.
The FDA noted some concerns in its presentations Wednesday. Studies Philip Morris conducted of exposure to toxicants may have been too short to understand potential long-term effects, Karen Konkel, an FDA medical officer, told the committee.
The deliberations over IQOS are one part of an intense debate over cigarette alternatives. In a report on the public-health consequences of e-cigarettes by the National Academies of Sciences, Engineering and Medicine released Tuesday, a panel of experts concluded that e-cigarettes are likely less harmful than conventional cigarettes and may help adult smokers quit. But their long-term health effects aren't clear, and vaping may put teenagers -- who use e-cigarettes at higher rates than adults -- at greater risk of taking up smoking conventional cigarettes, the panel found.
The panel didn't assess heat-not-burn products like IQOS or British American Tobacco PLC's Glo.
Critics say more long-term studies and independent research are needed before IQOS should be approved by regulators.
"It is too early for anyone to assert it is a safe product," said Vinayak Mohan Prasad, program manager for the WHO's Tobacco Free Initiative. The WHO says there is no evidence that heat-not-burn products are less harmful than conventional cigarettes.
Following the committee's recommendation, the FDA could take many months to come to its own conclusions. Morgan Stanley analyst Matthew Grainger expects the agency to approve Philip Morris's application to sell IQOS in the U.S. in the next 12 to 18 months but says it could take "several years" to offer approval on the reduced risk claim.
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(END) Dow Jones Newswires
January 25, 2018 08:01 ET (13:01 GMT)
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