FDA Approves Philip Morris' Heat-Not-Burn IQOS for U.S. Market

RICHMOND, Va. — The Food and Drug Administration (FDA) approved the sale of Philip Morris Products S.A.'s IQOS heated tobacco system in the U.S. market.

The IQOS is an electronic device that heats tobacco-filled sticks wrapped in paper to generate a nicotine-containing aerosol. Under and exclusive licensing agreement with PMI, Philip Morris USA (PM USA) will commercialize IQOS in the U.S. with three HeatStick variants: Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks and Marlboro Fresh Menthol Heatsticks.

Following a rigorous science-based review of the premarket tobacco product application (PMTA), the FDA determined that IQOS products protect public health because they produce fewer or lower levels of some toxins than combustible cigarettes.

To secure market authorization under a PMTA, U.S. federal law obligates an applicant to demonstrate that marketing of a new tobacco product is appropriate for the protection of public health and requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products.

Permission to sell IQOS products, however, does not mean they are safe or "FDA approved," the administration noted.

"Ensuring new tobacco products undergo a robust premarket evaluation by the FDA is a critical part of our mission to protect the public, particularly youth, and to reduce tobacco-related disease and death," stated Mitch Zeller, director of the FDA's Center for Tobacco Products.

"While the authorization of new tobacco products doesn't mean they are safe, the review process makes certain that the marketing of the products is appropriate for the protection of the public health, taking into account the risks and benefits to the population as a whole. This includes how the products may impact youth use of nicotine and tobacco, and the potential for the products to completely move adult smokers away from use of combustible cigarettes," he added.

According to PMI, there are approximately 40 million adult smokers in the U.S., and IQOS offers an innovative alternative to cigarettes. IQOS delivers nicotine in levels close to combustible cigarettes, suggesting a likelihood that users may be able to completely transition away from combustible cigarettes and use IQOS exclusively.

PMI reports that currently more than 7 million people around the world have fully switched to IQOS.

PM USA is adding IQOS to the Altria companies' portfolio of products for adult smokers looking for an alternative to cigarettes. PM USA's goal is to convert U.S. adult smokers interested in non-combustible alternatives to IQOS, according to the company.

To support the introduction of IQOS, PM USA plans to have a number of retail touchpoints in Atlanta, including an IQOS store at Lenox Square, numerous mobile retail units and HeatStick distribution in approximately 500 retail trade partner stores including Circle K, Murphy USA, QuikTrip, RaceTrac, Speedway and select additional retail partners.

"PM USA will act on market insights and expects to scale IQOS quickly and efficiently," said Howard Willard, chairman and CEO of Altria. "With FDA authorization, PM USA will introduce IQOS in the U.S. for adult smokers in Atlanta to learn as much as possible, as quickly as possible, and intends to make the most of the company's first-mover advantage in heated tobacco.

"IQOS has had terrific success internationally. We're very excited to bring this platform to adult smokers in the U.S.," he added.

PM USA will test a range of marketing, sales and consumer engagement approaches to raise adult smokers' awareness of IQOS, facilitate guided trial of the product and provide post-purchase support — all while taking steps to minimize reach to unintended audiences.

The company will also remain consistent with the FDA's order and marketing requirements, in which all package labels and advertisements for these products include a warning about the addictiveness of nicotine, in addition to other warnings required for cigarettes, to prevent consumer misperceptions about the relative addiction risk of using IQOS compared to combusted cigarettes.

On Dec. 5, 2016, PMI submitted a Modified Risk Tobacco Product (MRTP) application for IQOS to the FDA to allow the marketing of the product with modified risk claims. Scientific review of the MRTP application is ongoing and is independent of the PMTA marketing order authorization form the FDA.

Richmond-based Altria’s wholly-owned subsidiaries include Philip Morris USA Inc., U.S. Smokeless Tobacco Company LLC, John Middleton Co., Sherman Group Holdings LLC and its subsidiaries Nat Sherman, Michelle Wine Estates Ltd. and Philip Morris Capital Corp. Altria holds equity investments in Anheuser-Busch InBev SA/NV, Juul Labs Inc. and Cronos Group Inc.