Key Takeaways
- FDA published a Federal Register notice on April 22, 2026, finalizing the addition of 18 constituents to the established HPHC list.
- The updated HPHC list now contains 111 constituents.
- FDA said the listed chemicals may be found in tobacco products including e-cigarettes, hookah tobacco and cigars, as well as in their smoke and/or aerosol.
- FDA also proposed adding three more constituents: pulegone, furfuryl alcohol and methyl eugenol.
- Public comments on the three proposed additions must be submitted by 11:59 p.m. ET on May 26, 2026.
2Firsts, April 24, 2026
The U.S. Food and Drug Administration published a Federal Register notice finalizing the addition of 18 constituents to the established list of Harmful and Potentially Harmful Constituents in tobacco products. With this update, the list now contains 111 constituents.
FDA added 18 constituents to the HPHC list
FDA said the HPHC list identifies chemicals and chemical compounds found in tobacco products or in tobacco smoke and/or aerosol that cause or could cause harm to users or non-users of tobacco products.
The agency said the updated list improves transparency for the public and provides greater 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 identifies areas of focus for FDA’s review of new tobacco product applications.
FDA also said the HPHC list is not a ban. Under the Food, Drug and Cosmetic Act, industry is required to report a full statement of a product’s constituents, including HPHCs, to FDA.
The total number of listed constituents rose to 111
FDA said that with the 18 additional constituents, the established list now contains 111 HPHCs. The agency said the chemicals on the 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 published the names of the 18 newly added constituents
FDA said it had published a request for public comments in August 2019 on HPHCs proposed for inclusion on the established list. After considering public comments and other scientific information, the agency finalized the following 18 additions:
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
FDA proposed three additional constituents for inclusion
FDA also said that, based on public comments suggesting constituents beyond those in the 2019 notice, it is proposing to add three additional constituents to the established list and is requesting public comment. Those three proposed additions are pulegone, furfuryl alcohol and methyl eugenol.
The agency said 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. FDA said comments must be submitted by 11:59 p.m. ET on May 26, 2026, to ensure they are considered.
Respiratory toxicants were confirmed as an added criterion
In addition, FDA finalized its tentative conclusion from the 2019 notice that constituents identified by the National Institute for Occupational Safety and Health as respiratory toxicants will be an additional criterion for determining whether a constituent should be included on the HPHC list.
FDA said it will continue to revise the list
FDA said it intends to continue revising the established HPHC list as additional criteria are defined and more scientific information becomes available. The agency said this action is part of its ongoing commitment to protecting public health through comprehensive oversight of tobacco products.
Image Source: FDA
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