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Getting A Jump On MoCRA Compliance; Due Diligence Now Will Lighten Load, Risks Later

Executive Summary

Cosmetics companies should not sit idly waiting for FDA to clarify new requirements under the Modernization of Cosmetic Regulations Act, speakers agreed at the Independent Beauty Association’s 2023 Technical/Regulatory Forum. Companies should be reviewing products, people and processes, including those of contract manufacturers, to get ahead of the curve.

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Doc On Call? Cosmetic Manufacturers May Need M.D. On Retainer Under MoCRA

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.

Lauder In-House Counsel: Start Planning For Supply Chain Quality Agreements Under MoCRA

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.

MoCRA Check-In: FDA Guidance Urgently Needed As Year-End Compliance Deadlines Loom

John Bailey, independent advisor for colors and cosmetics at EAS Consulting Group, is checking in with HBW Insight periodically in 2023 to offer his views on developments under the US Modernization of Cosmetic Regulations Act of 2022. Here he discusses the urgent need for FDA guidance as deadlines creep closer for registration, product listing, safety substantiation, and adverse event reporting.

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