WASHINGTON >> The Food and Drug Administration said it will permit the sale of IQOS, a “heat not burn” tobacco device made by Philip Morris International, in the United States.
While the agency stopped short of declaring that the device was safer than traditional cigarettes, the FDA did say the heated tobacco-stick system could help people to quit smoking.
Philip Morris has waited two years for the agency to clear IQOS (pronounced EYE-kose), a penlike device that comes with a sleek battery pack resembling a cigarette case. The product includes an electronically controlled heating blade that warms a tobacco stick and releases a vapor with the taste of tobacco but fewer harmful chemicals than cigarette smoke.
It differs from e-cigarettes already on the market because it contains tobacco rather than liquid nicotine. But IQOS still delivers an amount of nicotine that is similar to traditional cigarettes.
“The FDA’s decision to authorize IQOS in the U.S. is an important step forward for the approximately 40 million American men and women who smoke,” said André Calantzopoulos, the chief executive of Philip Morris International. “Some will quit. Most won’t, and for them IQOS offers a smoke-free alternative to continued smoking.”
Howard A. Willard III, chief executive of Altria, which will distribute the product in this country, said the company planned to begin sales of IQOS in Atlanta.
A few years ago, the FDA’s decision would have been a clear win for both Philip Morris and Altria. But IQOS products will now have to compete with the extremely popular devices sold by the vaping giant Juul Labs, in which Altria has a 35% stake.
Altria officials say the products will appeal to different consumers. But the Philip Morris team had chafed at their product’s being kept off the shelves while Juul gobbled up market share, and was unhappy with Altria’s $12.8 billion investment in the San Francisco startup. Juul now commands over 70% of the e-cigarette market in this country.
The FDA said it did not appear that the IQOS devices, which will be sold with Marlboro-branded regular and menthol sticks, would appeal to younger people. In Japan and Italy, the devices have not attracted use among teenagers, and the product is not sold in flavors except for menthol, the FDA noted in its report. But in an effort to prevent sales of IQOS to minors, the agency said the company would have to submit advertising and marketing plans for review.
The FDA said it still considered IQOS to be a type of cigarette, even though it releases fewer toxic chemicals. That designation means that IQOS must adhere to the same advertising and other federal restrictions. In addition, Philip Morris must include a label warning that nicotine is addictive.