Page History

...

The Food and Drug Administration in the premarket tobacco product applications (PMTAs) defines “adverse experience” as any unfavorable physical or psychological effect in a person that is temporally associated with the use of or exposure to a tobacco product, whether or not the person uses the tobacco product, and whether or not the effect is considered to be related to the use of or exposure to the tobacco product.. For the purposes of this section, the terminology "adverse event" is used.

Adverse event terms may be captured either as free text or via a prespecified list of terms.

...