FDA expected to decide if smokeless cigarette can be sold in U.S., delays ruling on health claims

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Philip Morris International says it has created a heat-not-burn smoking device that will have 90 to 95 percent less toxic compounds than cigarettes, “an innovation it claims could save lives and eliminate smoking in America,” William Wan reports for The Washington Post.

The process gently heats sticks of tobacco in a special battery-operated device and is sold in 25 countries under the brand HeatStick. The Food and Drug Administration is expected to decide in the next two months if it can be sold in the U.S., but won’t rule on the company’s health claims until the beginning of next year, Wan reports.

If the FDA approves the claims, HeatStick “would be the first tobacco product to carry the U.S. government’s stamp as a less harmful alternative to cigarettes — a marketing coup for Philip Morris.”

The company’s request to the FDA has caused “heated debate and worries” among health experts about “whether the new device will lower tobacco-related deaths, or if it is just substituting one harmful product for another” and “fueling such doubts is that many of America’s leading health organizations and experts remain deeply suspicious of Philip Morris,” the leading U.S. cigarette manufacturer, Wan writes.

“They are masterful liars. That’s not an exaggeration — that’s a fact proven by decades of evidence,” Matthew L. Myers, longtime president of the Campaign for Tobacco-Free Kids, told Wan. “So the question we’re all asking ourselves is: What’s their ultimate game plan with this thing?”

The process or device is called IQOS, for “I quit ordinary smoking,” according to the only independent study, of it, published this year in the journal JAMA Internal Medicine. The study found that the process produced “higher levels of several toxic compounds” than Philip Morris has claimed since it announced IQOS in 2014. Wan reports that the company’s forceful response to the study has made the researchers’ unwilling to talk publicly about their work.

Some health advocates say that even if the the company’s health claims are true, they are concerned that the product will hook a new generation of Americans on nicotine, halting the reduction of smoking rates in America, now at an all-time low. Others are concerned about the health issues associated with nicotine and ultrafine particles.

“It probably isn’t as bad as a cigarette, but that’s like saying jumping out of a 10-story building isn’t as bad as jumping out a 50-story building,” Stanton Glantz, a tobacco researcher at the University of California at San Franscisco, told Wan.

But other health researchers support the move to a safer product: “If you have a company willing to shift to a less harmful product, is that something we should be getting in the way of?” Jonathan Foulds, a smoking cessation expert at Penn State, told Wan.

“The skepticism is not surprising for us,” Philip Morris’s chief scientist, Moira Gilchrist, told Wan. “You don’t have to trust or believe us. You don’t have to take our word for it. But what we ask is that people have an open mind. Look at the science we’ve done on this and base your decision on that.”

Philip Morris CEO André Calantzopoulos predicts smokeless products will eventually replace the production of regular cigarettes in his company.

IQOS is a big success in Japan, where Wan reports it has “grabbed 10 percent of Japan’s tobacco market — a feat that has investors salivating over its U.S. prospects,” Wan reports.

The demand in Japan is so large that Philip Morris has had to limit its sales there. The company has plans to “more than triple its manufacturing capacity, from 15 billion HeatSticks to 50 billion. By the end of 2018, it plans to produce 100 billion,” Wan writes.

From Kentucky Health News

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