MRTP Renewal Application Filed

The U.S. Food and Drug Administration on May 9 filed for scientific review modified risk tobacco product (MRTP) renewal applications submitted by Philip Morris Products for the following IQOS products: 

• 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)

In 2020 and 2022, the FDA issued modified risk granted orders for products. These orders are valid for a fixed time period. To continue marketing the MRTPs after the authorized term, the company submitted MRTP renewal applications to FDA.

Starting May 10, 2024, people may 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 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, FDA 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.