The US Food and Drug Administration issued a premarket tobacco product authorization for IQOS 3, the new version of Philip Morris International’s electrically-heated tobacco system, confirming that the device is “appropriate for the protection of public health” and authorizing it for sale in the United States.
The IQOS 3 device, which is already available in many countries outside the US including the Philippines, contains a number of technological advancements, compared to a previously authorized IQOS device, including longer battery life and quicker recharge between uses.
IQOS is a smoke-free alternative to cigarettes for adult smokers 21 years old and above. The IQOS HeatControl Technology heats tobacco instead of burning it. Unlike cigarettes, IQOS does not burn tobacco and therefore produces no smoke and no ash.
The US FDA first issued PMTA marketing orders for IQOS 2.4 and three HeatStick variants on April 30, 2019. This month’s marketing order for IQOS 3 is generally subject to the same commercialization requirements set in the April 2019 PMTA marketing orders.
The PMTA process is separate from the modified risk tobacco product process, which is the path for authorizing the commercialization of a tobacco product with modified risk claims. PMI received MRTP marketing authorizations for the IQOS 2.4 device and three HeatStick variants on July 7, 2020, with a modified exposure claim.
The US FDA, in its latest decision, said that based on the international survey data it reviewed, the agency found no evidence of increased uptake of IQOS by youth or young adults, while use patterns available for a previously authorized version of IQOS within the US have not raised new concerns regarding product use in youth and young adults.
PMI chief executive André Calantzopoulos welcomed the US FDA’s decision to authorize IQOS 3 for sale in the US and described it as another important step forward for the tens of millions of American men and women who currently smoke.
“In just five years, approximately 11.7 million people around the world have stopped smoking and switched to IQOS, and we believe bringing a more modern version of IQOS to the US will only accelerate switching by adults who smoke,” Calantzopoulos said.
He said the U.S. FDA order is subject to the same comprehensive commercialization requirements set in the April 2019 PMTA marketing orders for IQOS 2.4, which aim to maximize the opportunity for adults to switch from cigarettes while minimizing unintended use.
“We, along with our licensee Altria, are committed to guarding against unintended use and fully support FDA’s focus on protecting youth,” he said.
The FDA authorization to market IQOS 3 through the PMTA is independent of the MRTP authorization for the IQOS 2.4 device. PMI said it intends to submit an MRTP application for the IQOS 3 device in the future.
IQOS devices use a patented heat-control technology that heats tobacco-filled sticks wrapped in paper under the brand HEETS, without burning them, to release water-based aerosol, instead of smoke. When using IQOS, the aerosol dissipates more quickly than cigarette smoke.
IQOS is specifically aimed at adult smokers who would otherwise continue to smoke. To prevent the youth from having access to IQOS, PMFTC said it is implementing age verification and access restriction to ensure that only legal age consumers 21 years old and above will have access to the stores, the e-commerce website and the IQOS products.
PMI has invested more than $7 billion on research, development and production capabilities to develop smoke-free products such as IQOS.
This year, PMFTC Inc., an affiliate of PMI, opened IQOS stores in Metro Manila carrying PMI’s line of smoke-free products, devices, heat sticks and a full range of accessories, to provide better alternatives to the 16 million adult Filipino smokers who would otherwise continue to smoke or use nicotine-containing products.