FDA Adds 18 Constituents to the List of Harmful and Potentially Harmful Constituents, Seeks Comment on Three Additional Constituents

https://www.fda.gov/tobacco-products/ctp-newsroom/fda-adds-18-constituents-list-harmful-and-potentially-harmful-constituents-seeks-comment-three?utm_campaign=ctp-hphc&utm_content=statement&utm_medium=email&utm_source=govdelivery&utm_term=stratcomms FDA Adds 18 Constituents to the List of Harmful and Potentially Harmful Constituents, Seeks Comment on Three Additional Constituents On April 22, FDA published a Federal Register notice finalizing the addition of 18 constituents to the established list of Harmful and Potentially Harmful Constituents (HPHCs) in tobacco products. The HPHC list identifies chemicals and chemical compounds found in tobacco products or tobacco smoke and/or aerosol that cause or could cause harm to users or non-users of tobacco products. FDA’s updated HPHC list delivers transparency to the public and clarity for industry. For the public, the list highlights certain toxic chemicals in tobacco products for which there is extensive evidence of harm, or potential harm, to human health. For industry, the updated list lets them know areas of focus for FDA’s review of applications for new tobacco products. The HPHC list is not a ban; rather, the Food, Drug and Cosmetic Act (FD&C) requires industry to report a full statement of the product’s constituents, including HPHCs, to FDA. With the 18 additional constituents, the list currently contains 111 HPHCs. The chemicals on this updated list may be found in tobacco products—including e-cigarettes, hookah tobacco, and cigars—as well as in their smoke and/or aerosol. FDA is proposing to add three additional constituents to the established list and requests public comments. Comments must be submitted to the docket by 11:59 p.m. ET on May 26, 2026, to ensure they are considered by FDA. Additionally, FDA finalized a previously tentative conclusion that constituents identified by the National Institute for Occupational Safety and Health (NIOSH) as respiratory toxicants will be an additional criterion that will be applied for determining inclusion on the HPHC list.