Companies have concerns about how the FDA will respond if struggles to obtain data, or hiccups in the cosmetic product facility registration or listing process, lead to errors or deadline misses under the Modernization of Cosmetics Regulations Act. Attorneys from Duane Morris and Covington & Burling provide views on FDA’s related draft guidance, key challenges facing industry, and how the agency may proceed.

Cosmetic manufacturers may need to retain a medical professional to determine if adverse events they receive are minor or serious given the looming deadline for maintaining records and reporting serious adverse events to the US FDA, says Locke Lord partner David Abramowitz.

Companies that have struggled to secure quality agreements with suppliers have additional leverage and a new starting point for those discussions, namely the Modernization of Cosmetic Regulations Act. Anand Natarajan, associate counsel at The Estee Lauder Companies, provided his view in a recent FDLI webinar.