The cosmetics industry in the United States is undergoing significant regulatory changes following the implementation of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). One of the most important updates is the mandatory reporting of serious adverse events associated with cosmetic products. If your company manufactures, distributes, or markets cosmetics in the U.S., understanding these reporting obligations is essential for regulatory compliance and consumer safety.

What Is a Serious Adverse Event?

Under FDA regulations, a serious adverse event related to a cosmetic product includes any event that results in:

  • 1Death, a life-threatening experience, inpatient hospitalization, persistent or significant disability or incapacity, congenital anomalies or birth defects, infection, or significant disfigurement, including:
  • Serious or persistent rash
  • Second- or third-degree burns
  • Significant hair loss
  • Persistent alteration of appearance
  • 2Medical or surgical intervention required to prevent any of the above outcomes is also considered a serious adverse event.
Who Is Responsible for Reporting?

The "responsible person" must submit the report to the FDA. This generally refers to the manufacturer, packer, or distributor — the company whose name appears on the product label.

Companies must ensure they have systems in place to identify, evaluate, document, and report qualifying incidents promptly.

Important

Failure to comply with FDA reporting requirements may result in enforcement actions from the FDA. Compliance systems must be in place before an event occurs — not after.

What Is the Timeline for Reporting?
15-Business-Day Rule

The FDA requires responsible persons to submit reports within 15 business days after receiving the adverse event information. Any new or updated medical information received within one year of the original report must also be submitted within 15 business days of receipt.

Why Serious Adverse Event Reporting Matters

Adverse event reporting helps:

  • Protect consumer health and safety
  • Improve product quality monitoring
  • Identify emerging safety concerns
  • Strengthen regulatory compliance
  • Build consumer trust and brand credibility
Need Regulatory Support?

If your business needs assistance with cosmetic adverse event reporting, working with experienced regulatory professionals can help streamline compliance and minimize risk.

At Liberty Management Group, our experts will provide updated guidance on regulations and optimize data collection for easy report submissions.

Contact LMG Our Cosmetics Services