Health risk assessment of an e-cigarette composition change


An e-cigarette manufacturer


A change to an e-cigarette stick configuration had led to an increase in the total weight of components based on a particular polymer. In the absence of a leachables study on the modified stick, bibra was asked if the safety of the new device could be substantiated from existing data.

Project goals

To provide the client with a high-quality assessment of the possible implications of the compositional change on consumer health.


Extractables studies had previously been carried out on e-cigarette components made of a specific Trade name polymer. Based on those analytical results, the extractables profile of the modified device (containing a slightly higher amount of the identical polymer) was predicted. Worst-case assumptions were made regarding the leaching propensity of the additional components, consumer exposures were estimated, and a health risk assessment was carried out on the modified device. As a health-precautionary approach, it was assumed that the extractables profile could reflect actual leaching. This allowed bibra to conclude that the revised configuration did not lead to significant increases in consumer health risk.

Bibra project leader

Pete Watts

E-cigarette safety evaluations

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