MoCRA Adverse Event Contact | U.S. Cosmetics Compliance Explained (Fast Guide)

Описание: #MoCRA #FDA #USCosmetics #AdverseEventContact #Cosmereg #CosmeticCompliance #USAgent #CosmeticLabeling #RegulatoryAffairs #CosmeticRegulations #MoCRA2022 #CosmeticsLaw

📌 MoCRA Adverse Event Contact for U.S. Cosmetics | What You MUST Include on Your Label

If you're selling cosmetics in the United States, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) requires a major update to your labeling and one of the most overlooked (but critical) elements is the Adverse Event Contact.

In this short but essential video, we’ll explain exactly what the MoCRA Adverse Event Contact is, who must provide it, and how failing to comply could put your cosmetic brand at risk. Whether you manufacture in the U.S. or export to the U.S. market from abroad, this regulation applies to you.

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🎯 In This Video You’ll Learn:
What an “Adverse Event Contact” is under MoCRA
Why it must be listed on every cosmetic product label sold in the U.S.
Who qualifies to be listed as the contact (including foreign brands)
The role of the U.S. Agent or Responsible Person in reporting adverse events
What happens if you don’t comply — including FDA action, warning letters, or delisting
How Cosmereg can act as your U.S. Adverse Event Contact and ensure you meet MoCRA obligations

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⚠️ What Is an Adverse Event Contact?

Under MoCRA, every cosmetic product marketed in the United States must include a domestic address, phone number, or electronic contact on the label where adverse events (like allergic reactions, rashes, or injuries) can be reported.

This contact information must reach a “Responsible Person” — typically the manufacturer, packer, or distributor listed on the label — and that entity must be located in the U.S.

If your company is based outside the United States, you must appoint a U.S.-based contact, like a U.S. Agent, to fulfill this requirement. The U.S. contact must be available to receive consumer complaints and submit serious adverse event reports to the FDA within 15 business days.

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MoCRA Labeling Requirements (Adverse Event Clause)

✅ The Adverse Event Contact must be clearly visible on the outer packaging.
✅ It can be a U.S. phone number, mailing address, or website/email.
✅ The label must include a way for consumers to contact the Responsible Person directly.
✅ If using a website or email, it must be functional and monitored.
✅ Failure to provide this information may result in enforcement action by the FDA, including recalls, seizures, or refusal to market.

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👤 Who Can Serve as the MoCRA Adverse Event Contact?

✔️ A U.S.-based affiliate of your company
✔️ A contract manufacturer or distributor based in the U.S.
✔️ A U.S. Agent or third-party regulatory representative — like Cosmereg

If you're a foreign brand, you cannot list a non-U.S. address or contact. You must designate a U.S. point of contact, or your product will be considered non-compliant.

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🛡️ What Happens If You Don’t Comply?

Non-compliant labels may result in:
FDA-issued warning letters
Cosmetic products being refused at port of entry
Risk of product recalls
Long-term reputational and legal damage
Disqualification from retail platforms or retailers demanding FDA-compliant labeling



✅ How Cosmereg Helps Global Brands Stay MoCRA-Compliant

Cosmereg offers turnkey regulatory services for cosmetic brands entering or already selling in the U.S. market. We help you comply with MoCRA and all FDA cosmetic regulations, including:

🔹 Acting as your U.S. Adverse Event Contact
🔹 Offering U.S. Agent services
🔹 Reviewing your cosmetic labels for MoCRA compliance
🔹 Submitting serious adverse event reports to the FDA
🔹 Supporting Facility Registration and Product Listing under MoCRA
🔹 Providing ongoing regulatory support and monitoring

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📞 Ready to stay compliant with MoCRA?
Visit [www.cosmereg.com](https://www.cosmereg.com) or contact our team for support in navigating U.S. cosmetics compliance.

We help brands in Europe, Asia, the Middle East, and beyond access the U.S. market with confidence.

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⏱️ CHAPTERS
00:00 Introduction
00:15 What is an Adverse Event Contact?
00:45 MoCRA Labeling Requirements
01:20 Who Can Be the Contact Person?
01:55 Risks of Non-Compliance
02:30 What Must Be Reported
03:10 Role of the U.S. Agent
03:40 How Cosmereg Can Help
04:15 Final Reminder & Call to Action