FDA Authorizes 3 Marlboro HeatSticks Products

The new products are comparable to HeatSticks authorized in 2019.

January 27, 2023

WASHINGTON—The U.S. Food and Drug Administration (FDA) has authorized the marketing of three tobacco-flavored heated tobacco products by Philip Morris International. The products receiving marketing granted orders are Marlboro Sienna HeatSticks, Marlboro Bronze HeatSticks and Marlboro Amber HeatSticks.

“Based on FDA’s review of the supplemental PMTAs, the agency determined that the marketing of these products should be authorized because, among other things, the net population-level benefits to adult smokers outweigh the risks to youth,” wrote the FDA in a statement.

The three HeatSticks products are used with the IQOS device, an electronic device that heats tobacco-filled sticks wrapped in paper to generate a nicotine-containing aerosol.

In 2019, the FDA authorized the marketing of IQOS and several other Marlboro HeatSticks products through the PMTA pathway. Philip Morris pursued marketing authorization for these new Marlboro HeatSticks by submitting supplemental PMTAs for modified versions and line extensions of the tobacco-flavored product for which the company had previously received a marketing granted order.

According to the FDA, a supplemental PMTA can be submitted in situations where an applicant is seeking authorization for a new tobacco product that is a modified version of a tobacco product for which the applicant has already received a marketing granted order.

The FDA stated that these three Marlboro products were comparable to the previously authorized tobacco-flavored product.

Earlier this week, the FDA issued marketing denial orders for two menthol e-cigarette products marketed by R.J. Reynolds Vapor Company. The products are the Vuse Vibe Tank Menthol 3.0% and the Vuse Ciro Cartridge Menthol 1.5%. R.J. Reynolds plans to immediately seek a stay of enforcement, as well as pursue other appropriate avenues that would allow Vuse to be available to adult nicotine consumers.