IQOS 3 Modified Risk Tobacco Product Application Moves Forward

FDA is accepting public comments on submission
Photograph courtesy of Altria

SILVER SPRING, Md. — Philip Morris Products S.A.’s modified risk tobacco product (MRTP) application for its IQOS 3 System holder and charger will move on to the substantive review phase.

The U.S. Food and Drug Administration (FDA) made the announcement May 13 and said application materials would be made public on the Center for Tobacco Products’ website after they are redacted. Public comments on the application may be submitted at any time.

The FDA already authorized the updated version of the electronically heated tobacco system for sale in the United States. IQOS 3 contains several technological advancements compared to the previous devices, including longer battery life and quicker recharge between usage, the New York-based tobacco company PMI said.

The IQOS 3 PMTA authorization, however, is independent of the MRTP authorization for the product and of the MRTP issued for an earlier version of IQOS in July 2020.

An MRTP application must demonstrate the product will or is expected to benefit the health of the population, according to the FDA.

For the earlier IQOS version, the FDA said switching completely from conventional cigarettes to the IQOS system significantly reduces exposure to harmful or potentially harmful chemicals, citing scientific studies; however, this does not mean the products are safe or FDA approved, the agency said.

At this time, there is no deadline for public comments for the IQOS 3 MRTP application, the FDA said. Once all materials for the MRTP application have been made publicly available, the FDA will announce a closing date for the comment period, which will be both at least 45 days from the date of the Federal Register notice and at least 30 days from the date the last application materials are posted.

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