FDA Authorizes Three New Heated Tobacco Products

The U.S. Food and Drug Administration today authorized the marketing of three new tobacco-flavored heated tobacco products included in Philip Morris Products S.A.’s supplemental premarket tobacco product applications (PMTAs).

The products receiving marketing granted orders are Marlboro Sienna HeatSticks, Marlboro Bronze HeatSticks, and Marlboro Amber HeatSticks. 

The three HeatSticks products are “heated tobacco products” (HTPs) used with the IQOS device.

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. 

In 2019, 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.

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 they have already received a marketing granted order.  

“Following FDA’s rigorous scientific evaluation of the applications, the agency determined that Marlboro Sienna HeatSticks, Marlboro Bronze HeatSticks, and Marlboro Amber HeatSticks are comparable to the previously authorized tobacco-flavored product,” according to FDA. “Like the previously authorized products, FDA has placed stringent marketing restrictions on the new products in an effort to prevent youth access and exposure.”