FDA’s Proposed Order For Sunscreens, A First Under OTC Reforms, Reprises 2019 Proposed Rule

24 Sep 2021

As anticipated, the US FDA’s proposed order for sunscreens released on 24 September creates a bridge to the agency’s 2019 proposed rule before the CARES Act overhauled OTC drug review in March 2020.

The US Food and Drug Administration’s 24 September proposed order to amend the OTC sunscreen drug monograph provides a first look at the new administrative – versus rulemaking – process for OTC drug review under reforms achieved through COVID relief legislation last year.

Acting FDA commissioner Janet Woodcock states in a same-day release, “Today's activities represent a key milestone in our implementation of...