Blog
The US Food and Drug Administration (FDA) recently published finalized guidance for regulatory approval in the Cosmetics industry. This latest agency publication introduces new methodologies for good manufacturing practices that can increase both patient safety and product quality.
What is MoCRA?
The term MoCRA was first introduced as an acronym for FDA’s Modernization of Cosmetics Regulation Act (2022). The updated FDA guidance is based originally from the existing, previous legislation (e.g. the Consolidated Appropriates Act) which served as the regulatory framework for FDA approval. MoCRA now includes additional provisions for facility registration, adverse events and product labeling that are designed to improve patient safety.
How does MoCRA impact cosmetic manufacturers?
An FDA inspector can access certain types of records and information during a facility inspection. Additionally, one specific inspection request from FDA auditors appears to be more common than others. Cosmetic industry employees have reported that FDA pre approval inspection teams are proactively asking for documentation about known cosmetic ingredients the FDA believes could be a consumer safety threat.
How does MoCRA impact cosmetic vigilance?
The updated regulatory process now requires cosmetic manufacturers to report consumer adverse events to the FDA within 15 days (via Form 3500A). An adverse report would then trigger an FDA inspection where both manufacturing and supplier documentation is inspected very carefully.
Specific documentation used in adverse reporting must be stored in a quality management system. Ideally, the manufacturer and agency should collaborate to clearly define the consumer problem (e.g. dermatitis, pigmentation, etc.) and be able to connect the batch record information from the product manufacturing team.
How does MoCRA impact FDA inspections?
Data documentation from the manufacturing process an FDA inspector may want to review should be shared quickly upon request. Specifically, common areas of FDA interest often include data on retail packaging, a copy of the product’s label, and regulatory compliance documentation. Finally, a cosmetic manufacturer must submit a corrective action and preventive action (CAPA) plan based on FDA inspection findings for how they will prevent adverse effects in the future and return to FDA compliance.
