MoCRA Cosmetovigilance: Adverse Event Reporting for Responsible Persons

By Alok Naik, R.Ph., M.S. Regulatory Affairs — Managing Partner, Axentra Global Pharma Compliance LLC

What cosmetovigilance means under MoCRA

Axentra runs the post-market safety process for cosmetic brands: adverse-event intake, serious-event assessment, FDA Form 3500A preparation, and communications for the Responsible Person. Work is quoted per project. This is not FDA approval of the cosmetic.

Day 0 of the statutory clock is the date the Responsible Person receives the information — not the date Axentra is engaged. Foreign brands whose name appears on the U.S. label as the Responsible Person are fully subject to this obligation.

What MoCRA requires

The Responsible Person must report serious adverse events to FDA within 15 business days of becoming aware; submit material new information received within one year as a follow-up; keep records of all adverse events — serious and non-serious — for six years; and produce those records on FDA request during inspection.

Seriousness is assessed against the statutory limbs, including hospitalization, infection, and significant disfigurement. Which limb applies matters — it is not enough to mark a case “serious” without documenting why.

How Axentra works

1. Intake — Capture reports from consumer contact channels into one case record. 2. Seriousness assessment — Evaluate each report against MoCRA’s limbs and document the rationale while the facts are fresh. 3. Causality and recommendation — Assess relatedness, record written reasoning, and recommend whether the case is reportable. 4. FDA reporting — Prepare Form 3500A and supporting materials for the Responsible Person’s filing within the 15-business-day window. 5. Recordkeeping — Maintain audit-ready files for the six-year retention duty. Cases and attachments are never deleted.

Frequently asked questions

Who must report serious adverse events for cosmetics?

The Responsible Person — the manufacturer, packer, or distributor named on the product label. Foreign brands that appear on the label as the Responsible Person are fully subject to this obligation.

How quickly must a serious adverse event be reported?

Within 15 business days of the Responsible Person receiving information about the event.

Must non-serious adverse events be kept on file?

Yes. MoCRA requires records of all adverse events — serious and non-serious — to be retained for six years and made available to FDA on request.

Set up your SAE process

See Axentra’s Cosmetovigilance services page for project-based support, or email info@axentracompliance.com / call +1 505-358-4858. Related: MoCRA cosmetics compliance and U.S. Agent services.

Related service: our Cosmetovigilance services page covers adverse event intake, seriousness assessment, MedWatch Form 3500A filing support and six-year record retention for Responsible Persons.