WASHINGTON — The Food and Drug Administration on Tuesday said that it would permit the sale of IQOS, a “heat-not-burn” tobacco device made by Philip Morris International, in the United States.
IQOS is a penlike electronic device that comes with a sleek battery pack resembling a cigarette case. An electronically controlled heating blade in the apparatus warms a tobacco stick, which releases a vapor with the taste of tobacco but fewer harmful chemicals than cigarette smoke.
The agency said the decision did not mean that it was pronouncing the products “safe,” and that they still met the definition of cigarettes even though they released fewer toxins than traditional cigarettes.
But the devices, the agency said, deliver “nicotine in levels close to combustible cigarettes suggesting a likelihood that IQOS users may be able to completely transition away from combustible cigarettes and use IQOS exclusively.” The agency said data provided by Philip Morris indicated that it appeared unlikely that non-tobacco users, including youths, would take up an IQOS device.
It also said it would require the company to attach additional labeling stressing the addictiveness of nicotine.
The F.D.A. has been reviewing IQOS since December 2016. Initially, IQOS seemed to be a sure bet — an example of the kind of innovative alternative to combustible cigarettes that the agency wanted to promote. But the public backlash that followed Juul’s unexpected popularity among teenagers made the F.D.A. more cautious about letting another electronic nicotine delivery system onto the market.
Philip Morris International launched IQOS in test cities in late 2014. It became nationally available in Japan in the spring of 2016 and quickly became popular. It is now sold in 44 countries. The company touts IQOS as a more natural smoking experience than e-cigarettes like Juul, its main rival for those seeking alternatives to traditional cigarettes. Altria will distribute IQOS in the United States.
Philip Morris International had hoped to become the first company in the United States permitted to claim that it was selling a new tobacco product that would be considered less harmful than other products, like traditional cigarettes. But the agency is still reviewing its application to sell the device under such a label.
IQOS will be sold with Marlboro regular and menthol flavored heat sticks. The agency wants adult smokers to be able to choose from a range of reduced risk alternatives to cigarettes. Although smoking rates have declined, cigarettes still kill about 480,000 people every year.
Philip Morris International, like most of the tobacco industry, hid evidence for decades that cigarettes cause cancer and mistrust of the industry lingers today. In January 2018, a federal advisory panel raised questions about the quality of the company’s safety studies, and its claim that IQOS would not appeal to youths.
At one time, the approval of IQOS would have been a clear win for Altria. But IQOS is a competitor to Juul, the vaping giant in which Altria now has a 35 percent stake. So any customers IQOS steals from Juul may hurt Altria more than help it, depending on the precise terms of the distribution deal.
Altria officials say that IQOS and Juul will appeal to different consumers. But the Philip Morris team had chafed at being kept off the market while Juul gobbled up market share, and were not pleased with Altria’s $12.8 billion investment.