FDA Authorizes Three New Heated Tobacco Products
Products Are Modified Versions and Line Extensions of Previously Authorized Tobacco-Flavored Product
January 26, 2023
On January 26, FDA 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, an electronic device that heats tobacco-filled sticks wrapped in paper to generate a nicotine-containing aerosol. 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.
While FDA is authorizing the marketing of these products, it does not mean these products are safe nor “FDA approved.” All tobacco products are harmful; however, different tobacco products pose varying levels of health risk to users, with combustible tobacco products being the most harmful. There are no safe tobacco products, so those who do not currently use tobacco products, especially young people, should not start.
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. Like the previously authorized products, FDA has placed stringent marketing restrictions on the new products in an effort to prevent youth access and exposure.
FDA remains committed to upholding the vital public health standards under the law and using all the tools at the agency’s disposal to ensure the efficient and appropriate oversight of tobacco products. Toward that end, FDA may withdraw the marketing orders if the agency determines that, among other things, the benefits no longer outweigh the risks at the population level, such as if there is a notable increase in use of the products among youth or former smokers, or a decrease in the number of current smokers who completely switch to the products.
FDA’s order letters authorizing the marketing of the products covered by today’s announcement and summaries explaining the agency’s decisions are posted online.