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FDA authorises marketing of IQOS as a modified risk tobacco product

The U.S. Food and Drug Administration (FDA) has authorised the marketing of IQOS as a modified risk tobacco product (MRTP). 

The agency found that an IQOS exposure modification order is appropriate to promote the public health.

The decision demonstrates that IQOS is a fundamentally different tobacco product. 

IQOS is also the first and only electronic nicotine product to be granted marketing orders through the FDA’s MRTP process

The FDA authorised the marketing of IQOS based on the following information:

  • The IQOS System heats tobacco but does not burn it
  • This reduces the production of harmful and potentially harmful chemicals
  • According to scientific studies, switching completely from conventional cigarettes to the IQOS system reduces your body’s exposure to harmful or potentially harmful chemicals.


 This decision comes after a review of the extensive scientific evidence package PMI submitted to the FDA in December 2016 to support its MRTP applications.

Commenting on the FDA’s announcement, André Calantzopoulos, PMI’s Chief Executive Officer, said:

“The FDA’s decision is a historic public health milestone. Many of the tens of millions of American men and women who smoke today will quit—but many won’t. Today’s decision makes it possible to inform these adults that switching completely to IQOS is a better choice than continuing to smoke. FDA determined that scientific studies show that switching completely from conventional cigarettes to IQOS reduces exposure to harmful or potentially harmful chemicals," said Philip Morris International.

 "The FDA decision confirms that IQOS is distinctly different to cigarettes because it has been demonstrated to reduce exposure to harmful chemicals and that this information should be communicated to consumers to help guide their choices.

The company also encouraged the South African government to follow a science-based approach in their policy-making. 


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