22 July 2020

The U.S. FDA authorizes PMI’s IQOS as a modified risk tobacco product

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The U.S. Food and Drug Administration (FDA) has authorized the marketing of electronically heated tobacco system, IQOS, as a modified risk tobacco product (MRTP). In doing so, the agency found that issuing an exposure modification order for the IQOS Tobacco Heating System (THS) is appropriate to promote the public health, and is expected to benefit the health of the population as a whole. 

This decision demonstrates that IQOS is fundamentally different from combustible cigarettes, and a better choice for adults who would otherwise continue smoking.

IQOS becomes the first and only electronic nicotine product to receive such authorization from the Food and Drug Administration.

The FDA’s action authorizes the marketing of IQOS in the USA with the following 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.

“Data submitted by the company shows that marketing these particular products with the authorized information could help addicted adult smokers transition away from combusted cigarettes and reduce their exposure to harmful chemicals, but only if they completely switch. The FDA will closely monitor how IQOS is used by consumers to determine if these products meet this potential and do not cause increased use among youth”, said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products.

This decision demonstrates that IQOS is fundamentally different from combustible cigarettes, and a better choice for adults who would otherwise continue smoking. It follows a review of the extensive scientific evidence package PMI submitted to the FDA in December 2016 to support its MRTP applications. 

“IQOS is a fundamentally different product than combustible cigarettes and must be regulated differently, as the FDA has recognized. Now, more than ever, there is an urgent need for a fundamentally different conversation on a cooperative approach to achieve a smoke-free future. The FDA’s decision provides an important example of how governments and public health organizations can regulate smoke-free alternatives to differentiate them from cigarettes in order to promote the public health”, mentioned PMI’s CEO André Calantzopoulos.

In April 2019, the agency authorized IQOS for sale in the U.S. through issuance of premarket tobacco product application marketing orders, that deemed marketing the product to be appropriate for the protection of the public health. 

 

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