The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) has sparked a shift in the regulatory landscape of the beauty industry. This groundbreaking legislation amplifies the U.S. Food and Drug Administration’s (FDA) authority in overseeing cosmetics and personal care products, introducing safety testing requirements and mandatory compliance protocols. This translates into a significant ramp-up in safety testing and quality control operations for skincare product manufacturers.
The Genesis of MoCRA: A Brief Overview
MoCRA, enacted on December 29, 2022, as part of the 2023 omnibus bill, symbolizes the first significant overhaul of the FDA’s regulatory framework for cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938. The law gives the FDA increased authority to regulate cosmetics, introducing new obligations for the cosmetics industry. This piece will dive into what this means for skincare product manufacturers and how they can navigate this new regulatory landscape.
The Constructs of MoCRA: Key Provisions and their Implications
In a nutshell, MoCRA introduces provisions that revamp the existing regulatory structure in several critical areas. Here’s a breakdown:
- Facility Registration and Product Listing
Under MoCRA, all facilities involved in the manufacturing or processing of cosmetic products must register with the FDA and renew their registration biennially. Additionally, manufacturers, packers, or distributors of cosmetic products, referred to as “responsible persons,” are obligated to list each cosmetic product, including its ingredients, with the FDA.
- Mandatory Adverse Event Reporting
MoCRA mandates “responsible persons” to submit reports of serious adverse events to the FDA within 15 days of receiving the report. These adverse events encompass any health-related event associated with using a cosmetic product that results in detrimental outcomes such as death, a life-threatening experience, or inpatient hospitalization, among others.
- Safety Substantiation
“Responsible persons” are also required to maintain records that support “adequate substantiation” of the safety of their cosmetic products. This includes tests, studies, research, analyses, or other evidence or information deemed sufficient by experts to support a reasonable certainty that a cosmetic product is safe.
- Good Manufacturing Practice (GMP) Regulations
For the first time, the FDA is mandated to issue obligatory GMP regulations for cosmetics that align with national and international standards. This marks a significant shift in the manufacturing landscape for skincare products and other cosmetics.
- Mandatory Recall Authority
MoCRA equips the FDA with the power to order a mandatory recall of a cosmetic product if it determines that it is likely to cause serious adverse health consequences or death.
We’re Ready for the New Regulatory Landscape in Skincare Product Manufacturing
As we embark on this new era, defined by the implementation of MoCRA and its increased regulatory oversight, Bell International Laboratories stands ready to aid beauty brands in successfully navigating this complex regulatory landscape. We bring to the table advanced testing equipment and robust quality management systems. Beyond meeting challenges, this shift offers an opportunity to underscore our dedication to safety, quality, and consumer protection. As the industry adapts to these changes, partnering with Bell International Laboratories can serve as a testament and commitment to consumer trust and confidence.