Quick Guide to MoCRA Compliance for Cosmetics in the United States

He Modernization of Cosmetics Regulation Act (MoCRA) represents one of the most significant regulatory reforms in the US cosmetic sector. With new provisions regarding registration, labeling, adverse event reporting and inspections, the MoCRA imposes stricter compliance standards for companies operating in the US market. This guide offers a detailed in-depth look at the main requirements and their respective deadlines.

📅 Key Dates and Main Obligations

• July 1, 2024Deadline for registration of cosmetic facilities and product listing with the FDA.
• December 29, 2024Requirement to update labels with contact information for reporting adverse events.
• December 29, 2025FDA publication of the safety report on PFAS in cosmetics.

🏭 Facility Registration and Product Listing

Companies that manufacture or process cosmetics destined for the United States must:

• Get a Facility Establishment Identifier (FEI) from the FDA.
• Register the plant every two years.
• Submit an updated list of marketed cosmetic products to the FDA, specifying the ingredients contained.

⚠️ Adverse Events and FDA Reporting

Starting December 29, 2023, companies must report to the FDA any serious adverse event within 15 working days using the form MedWatch 3500. The definition of “serious adverse event” includes:

• Death, life-threatening danger, or hospital admission.
• Persistent disability or congenital anomalies.
• Severe persistent skin rashes and significant hair loss.

🏷️ New Labeling Requirements

From December 29, 2024, cosmetic labels must include:

• Electronic contact information (URL or QR code) for reporting adverse events.
• Declaration of identity of the product and net quantity of the contents.
• List of ingredients in descending order of weight (INCI names and colorants without CI code).
• Warnings and instructions for safe use.
• Specific wording for professional use products.

🏛️ New FDA Authorities

MoCRA has expanded the FDA's authority, which can now:

• Conduct inspections on the facilities and access company records.
• Mandatory recalls of non-conforming products.
• Issue Warning Letters and Import Alerts, blocking the distribution and importation of unregulated products.

🌍 Role of the US Agent for Non-US Companies

Foreign companies exporting cosmetics to the United States must appoint a US Agent, which will act as an intermediary with the FDA for communications and inspections.

🏢 Small Business Exemptions

Companies with a turnover of less than $1 million annually they can benefit from certain exemptions, but they must still ensure the safety and compliance of the products.

📖 Frequently Asked Questions (FAQ)

🔹 Which companies must register with the FDA?
All companies that manufacture, package, or distribute cosmetics intended for the US market.

🔹 How is the registration of a cosmetic facility carried out?
Companies must obtain an FEI Number and complete registration on the FDA platform.

🔹 What is the difference between an adverse event and a serious adverse event?
A serious adverse event includes permanent damage, hospitalization, or life-threatening conditions, while a minor adverse event might be temporary irritation.

🔹 What information must be included on the label of a cosmetic product?
Product name, net quantity, ingredient list, manufacturer, warnings and claims.

🔹 Can cosmetic products contain pharmaceutical ingredients?
No, if a product contains active ingredients that modify the biological function of the skin, it could be classified as an OTC drug.

🔹 What happens if a product does not comply with MoCRA?
It may be subject to recalls, customs holds, and FDA penalties.

🔹 Is there a transition period to comply with MoCRA?
Companies must comply by the established dates, without grace periods.

📚 Glossary of Terms (in alphabetical order)

• AdulterationContamination or presence of unsafe ingredients in a product.
• ClaimClaim about a cosmetic product property.
• Facility Establishment Identifier (FEI)Unique facility identifier assigned by the FDA.
• FDA (Food and Drug Administration)US regulatory agency for drugs, cosmetics, and other products.
• Good Manufacturing Practices (GMP)Good manufacturing practices to ensure the quality of cosmetics.
• Import AlertFDA notification blocking the import of non-compliant products.
• INCI (International Nomenclature of Cosmetic Ingredients)Cosmetic ingredient naming system.
• Labeling ComplianceCompliance of labels with FDA regulations.
• MedWatch 3500Serious adverse event reporting form.
• MisbrandingMislabeling or misleading labeling of a product.
• MoCRA (Modernization of Cosmetics Regulation Act)US regulations governing the cosmetic industry.
• Product ListingCosmetic product registration with the FDA.
• Responsible PersonLegal entity responsible for product compliance.
• Small Business ExemptionExemptions for companies with revenues of less than 1 million dollars.
• US AgentIntermediary between non-US companies and the FDA.

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