March 10, 2025
Common Mistakes to Avoid Under MoCRA
The Modernization of Cosmetics Regulation Act (MoCRA) has introduced significant changes to FDA oversight of cosmetic products. As businesses adapt to these new regulations, it’s essential to avoid common compliance mistakes that could lead to FDA enforcement actions, penalties, or product recalls. Below, we highlight the most frequent mistakes and how to prevent them.
1. Failing to Register Facilities with the FDA
Mistake: Some companies assume that because they previously complied with the Voluntary Cosmetic Registration Program (VCRP), they do not need to take further action. However, VCRP has been replaced with MoCRA’s mandatory facility registration requirement.
Solution: Ensure that your manufacturing and processing facilities are registered with the FDA. Update registrations as required every two years.
2. Incomplete or Inaccurate Product Listings
Mistake: Submitting incomplete or incorrect product ingredient lists can lead to compliance issues, especially if the FDA audits your records.
Solution: Provide accurate product formulations, brand names, and ingredient disclosures in your product listing submissions. Any changes to formulations must be updated promptly with the FDA.
3. Not Complying with Good Manufacturing Practices (GMPs)
Mistake: Overlooking Good Manufacturing Practices (GMPs) can lead to contamination, mislabeling, or other safety risks that violate MoCRA.
Solution: Implement and document compliance with FDA’s forthcoming mandatory GMP regulations for cosmetic products to ensure product safety and avoid costly recalls.
4. Failing to Maintain and Report Adverse Event Records
Mistake: MoCRA mandates that companies track and report serious adverse events associated with their products, yet many brands fail to establish proper record-keeping systems.
Solution: Maintain records of consumer complaints and adverse events for six years. Report any serious adverse events (e.g., hospitalizations, infections) to the FDA within 15 business days.
5. Mislabeling Products with Unverified Claims
Mistake: Using drug-like claims (e.g., “treats acne” or “heals eczema”) on cosmetic products can result in FDA reclassification of the product as a drug, leading to compliance violations.
Solution: Ensure all marketing and labeling remain compliant with MoCRA’s cosmetic definition. Avoid unapproved drug claims and ensure ingredient lists and warnings align with FDA standards.
6. Not Having a Responsible Person for Compliance
Mistake: Every cosmetic product must have a designated Responsible Person who ensures MoCRA compliance, yet many brands overlook this requirement.
Solution: Assign a Responsible Person (manufacturer, packer, or distributor) to handle labeling compliance, safety substantiation, and FDA communication.
Stay MoCRA-Compliant with Expert Guidance
Avoiding these common mistakes is crucial for ensuring smooth compliance under MoCRA. Provision Consulting Group specializes in helping cosmetic brands navigate MoCRA’s complex requirements and stay ahead of FDA regulations.
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