April 22, 2026

Today, 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.

In August 2019, FDA published a request for public commentsExternal Link Disclaimer on HPHCs proposed for inclusion on the established list. After considering public comments and other scientific information, FDA finalized the following 18 additions to the HPHC list:

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

Propylene Glycol

As a result of public comments suggesting constituents beyond those included in the 2019 notice, FDA is proposing to add three additional constituents to the established list. FDA requests comments on the three proposed additions: pulegone, furfuryl alcohol, and methyl eugenol. These constituents are often added to e-liquid formulations as flavoring ingredients, but may also be present in other tobacco products, such as cigarettes and smokeless tobacco. Public 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 its tentative conclusion from the 2019 notice 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.

FDA intends to continue to revise the established HPHC list as additional criteria are defined and additional scientific information becomes available. This action contributes to FDA’s ongoing commitment to protecting public health through comprehensive oversight of tobacco products.