Philip Morris International Inc. wants to shift to a "smoke-free future," but U.S. regulators are concerned that they will need more data to fully assess potential health risks from the company's new electronic cigarettes.
While the company's IQOS (I Quit Ordinary Smoking) product reduced exposure to some harmful chemicals compared with smoking, users could still develop certain precancerous lesions similar to those that can be caused by traditional cigarettes, Food and Drug Administration staff said in a report Monday.
A complete study of IQOS' cancer-causing potential is necessary before it can be marketed as a safer alternative to cigarettes, the report said. Philip Morris is expected to release results from such a study later this year, according to the report.
The findings come as tobacco companies face declining cigarette sales in the United States and an effort by the FDA to cut nicotine in cigarettes to nonaddictive levels.
IQOS includes an electronic heater and a heat stick that resembles a short cigarette. Users insert the stick into the heater and draw on the stick, which has been warmed to almost 600 degrees Fahrenheit. A cigarette burns at more than 1,000 degrees Fahrenheit, according to Philip Morris.
The FDA report questioned whether the company's studies on the noncancerous toxicological effects of IQOS were adequate to measure the effects of chronic use, and raised concern over any potential benefit, given that testing showed users tended to use both IQOS and cigarettes, rather than switch completely to IQOS.
The FDA staff's comments come ahead of a meeting Wednesday and Thursday of outside agency advisers to discuss Philip Morris' application to designate IQOS as less risky than cigarettes. The tobacco giant's application was more than 3 million pages long, the company previously said.
The FDA will ask the outside experts to recommend whether Philip Morris has shown that switching completely from cigarettes to IQOS reduces the risk of developing tobacco-related diseases. The FDA doesn't have to follow the advisory panel's recommendation but it will help the agency determine whether to designate IQOS as a "modified risk tobacco product," meaning it will benefit the health of the population as a whole.
Philip Morris says that the lack of fire, smoke or ash eliminates an average of 90 percent to 95 percent of the harmful chemicals in cigarettes. FDA staff determined that the aerosol released by IQOS produces much lower levels of cancer-causing agents than in the smoke from cigarettes, though in varying degrees.
"We look forward to the opportunity to discuss the scientific evidence" at the hearing, Philip Morris spokesman Corey Henry said in a statement.
Altria Group Inc. will sell IQOS in the U.S. under a licensing agreement if the FDA clears it for sale, which is a separate application from the one Philip Morris submitted to make claims that it is less risky than smoking. The FDA is expected to act on the marketing application early this year; it doesn't have a timeline for making a decision on the relative risk of IQOS.
Business on 01/23/2018