The U.S. Food and Drug Administration announced that it finalized the addition of 18 chemicals to its list of Harmful and Potentially Harmful Constituents (HPHCs), bringing the total to 111 substances identified in tobacco products, smoke, or aerosol. The list is intended to highlight compounds that pose known or potential risks to human health and applies across cigarette, e-cigarette, cigar, and hookah tobacco product categories.
The newly added constituents include a range of flavoring agents, solvents, and byproducts, many of which are commonly associated with e-liquid formulations. FDA said the update provides greater transparency for the public while also signaling to manufacturers which chemicals may receive increased scrutiny during the review of new product applications. The agency emphasized that inclusion on the HPHC list does not constitute a ban, but triggers reporting requirements under the Federal Food, Drug, and Cosmetic Act.
The agency also opened a new consultation on three additional compounds—pulegone, furfuryl alcohol, and methyl eugenol—frequently used as flavoring ingredients, with public comments due by May 26. In addition, FDA confirmed that respiratory toxicants identified by the National Institute for Occupational Safety and Health (NIOSH) will now be considered as a criterion for future additions to the list. The agency said it expects to continue updating the HPHC list as new scientific evidence emerges.
The constituents added to the Register are: Acetic Acid, Acetoin (also known as 3-hydroxy-2-butanone), Acetyl Propionyl (also known as 2,3-pentanedione), Benzyl Acetate, Butyraldehyde, Diacetyl, Diethylene Glycol, Ethyl Acetate, Ethylene Glycol, Furfural, Glycerol, Glycidol, Isoamyl Acetate, Isobutyl Acetate, Methyl Acetate, n-Butanol, Propionic Acid, and Propylene Glycol.