FDA Scorches Sunscreen Wipe Marketers With October Warning Letters
This article was originally published in The Rose Sheet
Inspections conducted over the past year may have contributed to a wider FDA crackdown on unapproved sunscreen drug products – specifically those in dosage forms deemed ineligible under OTC drug review for inclusion in the sunscreen monograph – with five marketers targeted so far this month with warning letters.
You may also be interested in...
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.
FDA warned Clientele Inc. about drug good manufacturing practices violations and about claims that render its “Age Blocker” and “Estro-Lift Day Therapy” cosmetic products as misbranded drugs.
Industry and the FDA agree that the OTC drug monograph system is direly in need of reform, but innovating with noncompliant dosage forms and indications, without approved new drug applications, is a risk companies need to weigh seriously, says Arnall Golden Gregory partner Alan Minsk. The FDA offers perspective on its OTC monographs for acne and antiperspirant products.