The cosmetics industry is undergoing a major shift that will impact manufacturers, retailers and consumers. Signed into law in December 2022, the Modernization of Cosmetics Regulation Act (MoCRA) aims to enhance consumer safety by introducing stricter regulations for the manufacturing, distribution and safety assessment of cosmetic products, according to the FDA.
“MoCRA is the biggest U.S. cosmetics regulation change in 85 years and sets tough new standards for brands, manufacturers, co-manufacturers, testing labs and fillers,” explains Jaclyn Bellomo, senior director of cosmetic science and regulatory affairs at Registrar Corp. “The FDA has new enforcement authority for ensuring MoCRA compliance that is similar to FDA’s food, drug and medical device oversight. MoCRA impacts the entire cosmetic industry, not only brands, and companies need to understand their responsibilities to ensure their organization is compliant.”
Regulatory Changes Long Overdue
Eighty-five years is a very long time to go without updating cosmetic regulatory requirements. So much has changed in that amount of time, such as new formulas and manufacturing techniques, so these changes are long overdue for the industry.
“On average, American consumers are using 6 to 13 cosmetic products a day, which include personal care items like shampoos and body washes to colored cosmetics such as nail polishes and lipsticks,” says Bellomo. “This new law will help ensure the safety of cosmetic products many consumers use daily and provide transparency into who is responsible for the products being distributed in the U.S.”
The new adverse event regulation will require brands to receive, record and if needed, report serious adverse events to the FDA, according to Bellomo. “For the first time, the labeling regulations will require brands to provide contact information for consumers to report any health-related event associated with the use of a cosmetic product,” she says.
FDA Requirements to Meet MoCRA Compliance
As stated in Quality Smart Solutions, here is a breakdown of the FDA’s new requirements:
- Compliance Policy for Facility Registration and Cosmetic Product Listing Requirements. The cosmetic labeling requirements that the FDA guideline outlines are the procedures for facility registration and product listing, including deadlines, submission methods and data requirements.
- Good Manufacturing Practices for Cosmetic Products. The FDA cosmetics labeling guide also outlines the organization’s expectations for GMPs in cosmetic manufacturing, covering topics such as sanitation, quality control and labeling.
- Mandatory Adverse Event Reporting for Cosmetic Products. The cosmetic labeling regulations explain the mandatory adverse event reporting requirements under MoCRA, including reporting criteria, timelines and submission procedures.
How to Prepare For MoCRA Compliance
Registrar Corp, which works with retailers and cosmetic brands, is unveiling a new technology to help tackle the FDA’s requirements. According to Bellomo, the software provides brand owners with the following features:
- Branded URL Domain, which allows the collection of important information needed to properly review and investigate adverse events reported by customers.
- Real Time Data Collection, which helps brands gain immediate access to serious adverse reports, allowing for quicker response to potential safety concerns.
- An All-in-one Platform that allows brands to manage new adverse events, store and evaluate documents for an investigation when needed, and archive reports.
- ISO 27001 Certified. The software ensures the highest level of protection for consumers’ personal and medical information.
“Using other contact information, such as a domestic address or domestic phone number, can severely delay reports to a brand from a consumer’s adverse event,” explains Bellomo. “These methods do not guarantee to receive all the necessary information to properly record or report to the FDA. Additionally, current staff might not have the expertise to properly handle adverse events given the personal and medical information that is provided.”
