FDA clears Philip Morris’s heat-not-burn IQOS tobacco device for sale

Originally published on Washington Post
By Laurie McGinley and William Wan
April 30, 2019

The Food and Drug Administration cleared Philip Morris International’s IQOS — a heat-not-burn tobacco device designed as an alternative to conventional cigarettes — for sale in the United States.

The product consists of a tube that gently heats up sticks of tobacco instead of burning them, making what’s inhaled less harmful than conventional cigarette smoke. Philip Morris has made the device a key part of its plans for growth. The device is already sold in dozens of other countries with varying success, but it has triggered debate among U.S. health experts over whether IQOS would help or hurt overall public health.

The FDA, in announcing the decision, said the marketing of the devices is “appropriate” for public health because “the products produce fewer or lower levels of some toxins than combustible cigarettes.” The agency also said it has placed stringent marketing restrictions on the products in an effort to prevent minors from using the device.

Health experts worry the device could attract minors and people who did not previously smoke, or that current smokers may adopt the device without giving up their smoking, exacerbating their health risks from tobacco rather than improving them.

On Tuesday, the FDA pointed out that while IQOS has been cleared for sale, it has not been officially “approved” by the agency. That’s because all tobacco products are potentially harmful and addictive, and people who do not use them should not start, the agency said.

The agency has not made a decision yet on a separate application by the company to market the product by claiming that it is less harmful than other tobacco products or that it would reduce the risk of disease.

Philip Morris chief executive André Calantzopoulos called Tuesday’s announcement “an important step,” especially for those who have struggled to quit smoking. “For them IQOS offers a smoke-free alternative to continued smoking,” he said.

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