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

The U.S. Food and Drug Administration (FDA) has authorized the marketing of our flagship electronically heated tobacco system, IQOS, as a modified risk tobacco product (MRTP), which represents a historic opportunity for public health. 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. To get more news about HNB, you can visit hitaste.net official website.

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. 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.

Now, the FDA has concluded issuing an IQOS exposure modification order is appropriate to promote the public health, and is expected to benefit the health of the population as a whole, taking into account both users and nonusers of tobacco products. Notably, the FDA’s issuance of an exposure modification MRTP order does not mean IQOS is FDA-approved. FDA does not ‘approve’ tobacco products. Further, the FDA’s decision does not mean IQOS is risk-free.

The FDA’s decision is consistent with earlier conclusions of other leading regulatory and scientific bodies, including in the U.K., Germany, and the Netherlands, which have found that the product emits lower levels of harmful toxicants. Furthermore, the FDA’s MRTP authorization shows that IQOS is a fundamentally different product than combustible cigarettes, and must be regulated differently, as the FDA has recognized.

PMI’s CEO André Calantzopoulos 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.

“The FDA determined that scientific studies have shown that switching completely from conventional cigarettes to IQOS reduces exposure to harmful or potentially harmful chemicals.

“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.