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Philip Morris Products S.A. Modified Risk Tobacco Product (MRTP) Applications

On March 11, 2022, FDA issued a modified risk granted order authorizing Philip Morris Product S.A. to market the IQOS 3 System Holder and Charger with the following reduced exposure information:


  • 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.”

As of November 2021, IQOS and Heatsticks are currently subject to a limited exclusion order and cease-and-desist order issued by the U.S. International Trade Commission which restricts the sales, distribution and marketing of the products in the United States.

See the Modified Risk Granted Orders webpage for the order letter and decision summary relevant to this MRTP application.

Please sign up to receive email alerts when any MRTP application materials have been posted or check this webpage regularly. The latest set of application materials from Philip Morris Products S.A. were added on November 10, 2021.

Previously Reviewed Application(s)

Temporary Compliance Waiver: The linked files may not be fully accessible to readers using assistive technology. We regret any inconvenience that this may cause. In the event you are unable to read these documents or portions thereof, please email [email protected] or call 1-877-287-1373.

IQOS 2.4 Tobacco Heating System

Note: FDA is required by section 911(e) of the Federal Food Drug & Cosmetic Act, as amended by the Tobacco Control Act, to make MRTP applications available to the public (except for matters in the application that are trade secrets or otherwise confidential commercial information) and to request comments on the information contained in the applications and on the label, labeling, and advertising accompanying the applications.

Additional Resources

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