Following a review of about two years, the FDA determined that authorizing the device for sale in the U.S. market was “appropriate for the protection of public health”. The device is not an e-cigarette or vape but a noncombustible device that heats, without burning, “tobacco-filled sticks wrapped in paper to generate a nicotine-containing aerosol.” The device contains “fewer toxic chemicals than cigarette smoke, and many of the toxins identified are present at lower levels than in cigarette smoke,” the FDA said. “Ensuring new tobacco products undergo a robust premarket evaluation by the FDA is a critical part of our mission to protect the public, particularly youth, and to reduce tobacco-related disease and death,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, declared in a statement Tuesday.
The product was previously sold in other countries. Harold Wimmer, president and CEO of the American Lung Association, said in a statement that he’s “deeply concerned” about the product’s potential health impacts. The agency warned that is possible to reverse its decision if any uptake among youth will occur. The tobacco company can’t market the devices “with claims of reduced exposure or reduced risk,” the FDA said. The FDA also placed restrictions on how the products can be marketed on the internet and through social media. Altria Group Inc, which sells Marlboro cigarettes in the United States, will market IQOS devices as part of a licensing agreement with Philip Morris International.