The Food and Drug Administration authorized three new tobacco-flavored heated tobacco products from Philip Morris Products S.A.’s supplemental premarket tobacco product applications (PMTAs).
Marlboro Sienna HeatSticks, Marlboro Bronze HeatSticks and Marlboro Amber HeatSticks, all of which are used with the Iqos device, received marketing granted orders (MGOs).
Iqos is an electronic device that heats tobacco-filled sticks wrapped in paper to generate a nicotine-containing aerosol. The FDA determined that the marketing of these products should be allowed to be sold in the United States because the benefits to adult smokers outweigh the risks to youth. Authorization by the FDA does not mean the products are safe nor “FDA approved,” the agency noted, adding that there are no safe tobacco products.
The FDA authorized the sale of Iqos in 2019 and several other Marlboro HeatSticks through the PMTA process. Philip Morris pursued authorization for these new HeatSticks by submitting supplemental PMTAs for modified versions and line extensions of the tobacco-flavored product, which had previously received an MGO.
Like the previously authorized products, the FDA placed stringent marketing restrictions on the new products to prevent youth access and exposure. The FDA can withdraw marketing orders if the agency determines, among other things, the benefits no longer outweigh the risks, like a notable increase in use of the products among youth or former smokers, the agency said.
Iqos has not been sold in the United States for more than a year due to a U.S. International Trade Commission (ITC) ruling that said the device infringes on two patents held by rival R.J. Reynolds, Winston-Salem, North Carolina.
Altria Group, Richmond, Virginia, is under an exclusive licensing agreement with PMI, New York, to sell Iqos in the United States; however, the companies announced in October 2022 they would be ending their agreement for Altria’s subsidiary Philip Morris USA to sell Iqos in the country. PMI will pay a total of $2.7 billion to Altria and have the full rights to commercialize Iqos in the United States as of April 30, 2024.
This marks the first round of MGOs issued in 2023—the last FDA authorization was in June for Njoy’s tobacco-flavored e-cigarettes. A full list of products with MGOs can be found on the FDA’s website.
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