For decades, cosmetic products legally carried a disclaimer: their safety had not been determined. Now, under the Modernization of Cosmetics Regulation Act (MoCRA) of 2022, manufacturers must actively prove it. This profound shift elevates consumer protection, fundamentally reshaping cosmetic product development and safety by 2026.
Historically, the industry largely self-regulated cosmetic product safety, with minimal federal intervention. MoCRA now grants the Food and Drug Administration (FDA) expansive authority to mandate and enforce safety standards, fundamentally altering this long-standing practice.
Consequently, the cosmetics industry will likely see consolidation, increased investment in safety substantiation and compliance infrastructure, and potentially higher product costs as companies adapt to these rigorous new federal mandates.
MoCRA: A New Era of Cosmetic Safety Regulation
Signed into law on December 29, 2022, as part of the Consolidated Appropriations Act 2023, MoCRA fundamentally redefines cosmetic industry oversight, according to the Personal Care Products Council. This legislation expands the FDA's regulatory authority, imposing new obligations on manufacturers, packers, and distributors, as detailed by The Regulatory Review. The most significant change: MoCRA eliminates the long-standing disclaimer option, forcing companies to prove product safety. Initial cosmetic product facility registrations and product listings were due by July 1, 2024, a deadline that has now passed, according to Clarkston Consulting.
This shift mandates that cosmetic companies adequately substantiate product safety and maintain supporting records, as noted by Product Law Perspective. The burden of proof now rests squarely on manufacturers, establishing a new baseline for industry responsibility and consumer trust. Compliance with cGMPs for cosmetics will also be phased in, with final guidance expected in the coming years, signaling a continuous evolution of regulatory demands.
