FDA Issues IQOS 3 a Modified Risk Granted Order

Action does not override ITC’s ruling on infringements, agency says
Photograph courtesy of PMI

SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) issued a modified risk granted order authorizing Philip Morris Products S.A. (PMPSA) to market its latest version of heat-not-burn tobacco product IQOS.

PMPSA can market the IQOS 3 System Holder and Charger with the following reduced exposure information, according to the FDA:

  • The IQOS system heats tobacco but does not burn it.
  • This significantly reduces the production of harmful and potentially harmful chemicals.
  • Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.

While IQOS and its accompanying compressed-tobacco HeatSticks are banned for sale and import in the United States by the U.S. International Trade Commission, the FDA’s modified risk granted order does not override that ruling, which claims the heated tobacco product infringes on two patents from competitor R.J. Reynolds Tobacco Co., Winston-Salem, N.C. It allows PMPSA to consider the authorized reduced exposure claim in the potential future marketing of IQOS 3, the FDA said.

PMI did not immediately respond to CSP’s request for comment.

The reduced exposure information is the same as the information previously authorized by the FDA in July 2020 for an earlier version of the device. And the modified risk tobacco product (MRTP) application primarily cross-referenced the supplemental premarket tobacco product application (PMTA) for this device, which was authorized for legal sale and distribution in the United States in December 2020.

The IQOS 3 is similar in design to the previous version, with mainly aesthetic changes, according to the FDA. Philip Morris International (PMI), New York, has said IQOS 3 contains several technological advancements compared to the previous devices, including longer battery life and quicker recharge between usage.

This designation does not mean IQOS 3 is safe or “FDA-approved,” the agency noted, adding there are no safe tobacco products and those who do not use tobacco products should not start. The modified risk granted order for IQOS 3 is effective through July 7, 2021, barring any finding that the order is no longer expected to benefit the health of the population, the FDA said.

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