U.S. FDA okays premarket tobacco product authorization for IQOS 3

Published December 15, 2020, 4:50 PM

by Manila Bulletin

The U.S. Food and Drug Administration (FDA) recently confirmed that IQOS 3, Philip Morris International’s electrically heated tobacco system, is “appropriate for the protection of public health” and has authorized it for sale in the United States following an assessment of a premarket tobacco product application (PMTA) filed with the agency in March 2020.

IQOS from PMI is the most popular heated tobacco product in the world today. The system heats instead of burning the tobacco thus eliminating toxic smoke.

The IQOS 3 device, which features a number of technological advancements, such as longer battery life and quicker recharge between uses compared to a previously authorized IQOS device, is already available in many countries outside the U.S. including the Philippines.

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 U.S. 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 (MRTP) 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 U.S. 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 U.S. have not raised new concerns regarding product use in youth and young adults.

PMI CEO André Calantzopoulos described the U.S. FDA’s decision to authorize IQOS 3 for sale in the U.S. 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 U.S. 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.

This year, PMFTC Inc., an affiliate of PMI, opened IQOS stores in the Philippines 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.  

PMFTC said it is committed to ensuring that access to the device and heat sticks is limited to adult consumers 21 years old and above who wish to continue tobacco products or other nicotine-containing products.  The IQOS stores practice age verification and adhere to the Good Conversion Practices which is a global standard observed across PMI.

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 US$7 billion on research, development and production capabilities to develop smoke-free products such as IQOS.