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WASHINGTON – The Food and Drug Administration announced Tuesday that it would allow the sale of IQOS, a "burn-free heat" tobacco device manufactured by Philip Morris International, in the United States.
IQOS is an electronic device similar to a pen, delivered with an elegant battery resembling a cigarette case. An electronically controlled heating blade in the appliance warms a tobacco stick that releases a vapor that tastes like tobacco but contains fewer harmful chemicals than cigarette smoke.
The agency said the decision did not mean that she was declaring the products "safe" and that they still met the definition of cigarettes although they released fewer toxins than the traditional cigarettes.
But the devices, says the agency, provide "nicotine levels close to combustible cigarettes, suggesting that IQOS users may be able to move away completely from fuel cigarettes and use only 'IQOS ". It seemed unlikely that non-smokers, including young people, would opt for an IQOS device.
He also said that the company should put additional labels highlighting the addictive nature of nicotine.
The F.D.A. IQOS has been studying since December 2016. Initially, IQOS seemed to be a safe bet – an example of the kind of innovative alternative that agencies wanted to promote for combustible cigarettes. But the public reaction that followed the unexpected popularity of Juul among teens pushed the F.D.A. more cautious to leave another electronic nicotine delivery system on the market.
Philip Morris International launched IQOS in test cities at the end of 2014. It became available in Japan in the spring of 2016 and quickly became popular. It is now sold in 44 countries. The company touted IQOS as a more natural smoking experience than electronic cigarettes like Juul, its main rival for those looking for 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 to be able to sell a new tobacco product that would be considered less harmful than other products, such as traditional cigarettes. But the agency is still reviewing its application to sell the device under such a label.
The IQOS will be sold with ordinary Marlboro and Menthol flavored thermal sticks. The agency wants adult smokers to choose from a range of low-risk alternatives for smoking. Although smoking rates have decreased, smoking still kills an estimated 480,000 people each year.
Philip Morris International, like most tobacco companies, has for decades been hiding the evidence that smoking was the cause of cancer and that mistrust of the industry continues today. In January 2018, a federal advisory committee raised questions about the quality of the company's safety studies and claimed that IQOS would not appeal to young people.
At one point, the approval of IQOS would have been a clear victory for Altria. But IQOS is a competitor of Juul, the vaping giant in which Altria now holds 35% of the capital. Thus, any flight of Juul by a customer that IQOS flies can do more harm to Altria than to help, depending on the specific conditions of the distribution contract.
Altria officials say that IQOS and Juul will appeal to different consumers. However, the Philip Morris team was ashamed to be excluded from the market as Juul gained market share and was not satisfied with Altria's $ 12.8 billion investment.
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