Tobacco

FDA Files for Philip Morris’ MRTP Renewal Applications

Submitted by Philip Morris Products S.A., products include IQOS devices
IQOS
Photograph: Shutterstock

The Food and Drug Administration on Thursday filed for scientific review modified risk tobacco product (MRTP) renewal applications submitted by Philip Morris Products S.A., a subsidiary of Philip Morris International (PMI).

MRTPs help reduce exposure to, and consumption of, nicotine for smokers who use them. The renewal applications include the following:

  • Iqos 2.4 System Holder and Charger
  • Iqos 3.0 System Holder and Charger
  • Marlboro Amber HeatSticks (formerly named Marlboro HeatSticks)
  • Marlboro Green Menthol HeatSticks (formerly named Marlboro Smooth Menthol HeatSticks)
  • Marlboro Blue Menthol HeatSticks (formerly named Marlboro Fresh Menthol HeatSticks)

Iqos is an electronic device that heats tobacco-filled sticks wrapped in paper to generate a nicotine-containing aerosol.

In 2020 and 2022, the FDA issued modified risk granted orders for these five Iqos heated tobacco products made by Philip Morris Products S.A. These orders are valid for a fixed time period, as specified in the orders, the agency said. To continue marketing the MRTPs after the authorized term, the company submitted MRTP renewal applications to the FDA on May 9.

People may now submit public comments on these applications on regulations.gov to docket FDA-2021-N-0408 for the IQOS 3.0 device and docket FDA-2017-D-3001 for the IQOS 2.4 device and the Marlboro HeatSticks products.

The FDA said it will post application documents, including amendments; given that the documents will need to be redacted for any confidential information, they will be posted on the Center for Tobacco Products website on a rolling basis.

Once all materials for these MRTP applications, including amendments, have been made publicly available, the FDA said it will announce a closing date for the comment period.

The closing date will be no earlier than 180 days from the date of the Federal Register notice and at least 30 days from the date FDA posts the last application materials.

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