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MoCRA Adverse Event Reporting: What Cosmetic Brands Need to Know

Updated: 6 days ago


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The cosmetics industry is officially under the FDA’s microscope — and if you’re a brand owner, manufacturer, or distributor, the time to get serious about adverse event reporting is now.


Thanks to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), cosmetic products are no longer flying under the regulatory radar. As of December 29, 2023, serious adverse event reporting is mandatory — and the consequences for non-compliance are real.


What Counts as a “Serious Adverse Event”?

Let’s break it down. According to MoCRA, a serious adverse event includes any health-related issue linked to a cosmetic product that results in:

  • Death or a life-threatening experience

  • Inpatient hospitalization

  • Persistent or significant disability or incapacity

  • Congenital anomaly or birth defect

  • Infection

  • Significant disfigurement (e.g., second- or third-degree burns, serious rashes, hair loss, or unintended changes in appearance)

  • Or requires medical or surgical intervention to prevent any of the above


This goes far beyond a mild skin irritation or a bad reaction to a new moisturizer. If it’s serious, it must be reported.


Who’s Responsible?

The Responsible Person — defined as the manufacturer, packer, or distributor whose name appears on the product label — is legally obligated to report serious adverse events to the FDA.


Reporting Timeline and Requirements

  • Deadline: Reports must be submitted within 15 business days of receiving the information.

  • What to Include:

    • Patient details

    • Description of the event and outcome

    • Suspect product information

    • A copy of the product label

  • Follow-Up: If new material information surfaces within one year, it must be submitted within 15 days of discovery.


How to Submit

Until the FDA’s electronic portal is finalized, reports should be submitted via email using MedWatch Form 3500A to:📧 CosmeticAERS@fda.hhs.gov


Why This Matters

MoCRA gives the FDA mandatory recall authority, records access, and the ability to suspend facility registrations if products pose serious health risks. In other words, this isn’t optional anymore.


What Cosmetic Brands Should Do Now

  1. Create Internal SOPs

    Build a clear process for identifying, documenting, and reporting adverse events.

  2. Train Your Teams

    Everyone from customer service to regulatory affairs should know what qualifies as a serious adverse event and how to escalate it.

  3. Monitor the FDA Dashboard

    The new FAERS Public Dashboard lets you track adverse events across the industry — a great tool for benchmarking and risk management.

  4. Keep Records

    Maintain documentation for at least 6 years (or 3 years for small businesses).


Final Thoughts

MoCRA’s adverse event reporting requirements mark a turning point for the cosmetics industry. It’s about accountability, transparency, and — most importantly — consumer safety. Brands that embrace these changes will not only stay compliant but also build trust in an increasingly scrutinized market.


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