FDA Authorizes Sale of Updated IQOS

Heat-not-burn device did not raise new concerns related to safety, health effects, agency says
Photograph courtesy of Altria Group

SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) authorized the sale of Philip Morris Products SA’s IQOS 3 System Holder and Charger.

This marketing order is different from the one issued in April, the FDA said. The newly authorized version has minor design differences, including how the holder inserts into the charger, changes to the charging connectors and LED indicators, a new touch feedback feature and an option to reduce the perceived heat from the tobacco aerosol inhaled by users.

Data from product use in international markets shows no differences among user population from the previous version and no new concerns regarding product initiation or use among youth and young adults, the FDA said.

“Following FDA’s scientific review of the application, the agency found, among other things, that the modifications to the device do not raise new concerns related to safety, health effects, product quality, or product misuse,” the FDA said, adding that this does not mean the product is safe or FDA-approved.

After more than two years of anticipation, Altria Group Inc. in April announced the FDA authorized the sale of the heat-not-burn IQOS tobacco device in the U.S. market, with about 500 convenience stores in the Atlanta area ready to market the product. Under an exclusive licensing agreement with PMI, Philip Morris USA (PM USA), which is a subsidiary of Richmond, Va.-based Altria, commercialized IQOS nationally, along with three varieties of the insertable tobacco “sticks” called HeatSticks that the device requires.

The U.S. rollout of IQOS was hampered by the COVID-19 pandemic, Goldman Sachs Managing Director Bonnie Herzog previously said, partially due to the company waiting on the FDA’s approval of the updated product.

This marks the first supplemental premarket tobacco product application (PMTA) received by the FDA, the agency said. 

“Such applications seek authorization to modify a tobacco product that previously received a marketing order via the PMTA pathway,” the FDA said.

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