Recent draft guidance from the US Food and Drug
Administration (FDA) outlines data the agency needs, to
determine whether a proposed active ingredient for over-thecounter
(OTC) sunscreen products is “generally recognised
as safe and effective” (GRASE), and not misbranded, when
used under certain conditions. Active ingredients deemed
GRASE may be added by the FDA to the OTC sunscreen drug
monograph, becoming eligible for wide use in non-prescription
sunscreen products. In this article, Meg Egan Auderset of
Thomson Reuters deals with FDA issues.