Philip Morris International Announces U.S. Food and Drug Administration Authorization of IQOS 3 for Sale in the United States

NEW YORK--(BUSINESS WIRE)--The U.S. Food and Drug Administration (FDA) today 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. FDA’s decision follows an assessment of a premarket tobacco product application (PMTA) filed with the agency in March 2020.

The IQOS 3 device contains a number of technological advancements, compared to a previously authorized IQOS device, including longer battery life and quicker recharge between uses.

In its decision the FDA noted that:

• International survey data reviewed by 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.

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

“The agency’s decision to authorize IQOS 3 for sale in the U.S. is 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.”

He added, “The 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.”

Editor’s Note:

On July 7, 2020, the FDA authorized IQOS 2.4 as a modified risk tobacco product (MRTP), finding that an IQOS exposure modification order is appropriate to promote the public health.

The IQOS 3 PMTA authorization is independent of the MRTP authorization for the IQOS 2.4 device. PMI expects to file an application seeking a modified exposure marketing order for the IQOS 3 device.

On April 30, 2019, the FDA authorized IQOS 2.4 for sale in the U.S. through issuance of premarket tobacco authorization marketing orders.

IQOS is available in the U.S. market through an exclusive license with Altria Group, Inc.

Philip Morris International: Delivering a Smoke-Free Future

Philip Morris International (PMI) is leading a transformation in the tobacco industry to create a smoke-free future and ultimately replace cigarettes with smoke-free products to the benefit of adults who would otherwise continue to smoke, society, the company, and its shareholders. PMI is a leading international tobacco company engaged in the manufacture and sale of cigarettes, as well as smoke-free products and associated electronic devices and accessories, and other nicotine-containing products in markets outside the U.S. In addition, PMI ships a version of its IQOS Platform 1 device and its consumables to Altria Group, Inc. for sale under license in the U.S., where the U.S. Food and Drug Administration (FDA) has authorized their marketing as a modified risk tobacco product (MRTP), finding that an exposure modification order for these products is appropriate to promote the public health. PMI is building a future on a new category of smoke-free products that, while not risk-free, are a much better choice than continuing to smoke. Through multidisciplinary capabilities in product development, state-of-the-art facilities, and scientific substantiation, PMI aims to ensure that its smoke-free products meet adult consumer preferences and rigorous regulatory requirements. PMI’s smoke-free product portfolio includes heat-not-burn and nicotine-containing vapor products. As of September 30, 2020, PMI estimates that approximately 11.7 million adult smokers around the world have already stopped smoking and switched to PMI’s heat-not-burn product, available for sale in 61 markets in key cities or nationwide under the IQOS brand. For more information, please visit www.pmi.com and www.pmiscience.com.