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UNITED STATES

FDA permits sale of IQOS

30 Apr 2019. The U.S. Food and Drug Administration (FDA) has announced it has authorised Philip Morris International (PMI) to sell its heated tobacco device IQOS in the United States, according to a press release.

The IQOS device, Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks and Marlboro Fresh Menthol Heatsticks have all been approved for sale in the US, according to the press release. The agency said, however, that it still will be making a separate decision about marketing the products as reduced exposure or reduced risk products. The FDA said that it is currently reviewing PMI’s modified risk tobacco product (MRTP) applications, which, when approved, would allow the company to market the tobacco products as less harmful or as reduced-risk tobacco products. According to the statement, the FDA found “that the aerosol produced by the IQOS Tobacco Heating System contains fewer toxic chemicals than cigarette smoke, and many of the toxins identified are present at lower levels than in cigarette smoke.

“For example, the carbon monoxide exposure from IQOS aerosol is comparable to environmental exposure, and levels of acrolein and formaldehyde are 89 per cent to 95 per cent and 66 per cent to 91 per cent lower than from combustible cigarettes, respectively,” the agency wrote.

The products will have to adhere to the same regulatory restrictions as cigarettes, the agency warned. All package labels and advertisements for these products will be required to have warnings about the addictiveness of nicotine, in addition to other warnings required for cigarettes.

Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products commented on the decision, saying, “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. While the authorization of new tobacco products doesn’t mean they are safe, the review process makes certain that the marketing of the products is appropriate for the protection of the public health, taking into account the risks and benefits to the population as a whole. This includes how the products may impact youth use of nicotine and tobacco, and the potential for the products to completely move adult smokers away from use of combustible cigarettes.”