Adverse Event Reporting for Cosmetics | MOCRA Compliance with Cosmereg

What is Adverse Event Reporting for Cosmetic Products? | MOCRA Compliance with Cosmereg

With the Modernization of Cosmetics Regulation Act of 2022 (MOCRA), the U.S. FDA has strengthened regulatory requirements for cosmetic products, bringing them closer to the standards seen in food and drug industries. One of the most significant changes is the mandatory reporting of adverse events by the Responsible Person. MOCRA adverse effect reporting ensures that any serious health-related reactions linked to cosmetic products are properly documented and addressed, enhancing consumer safety.

For brands selling cosmetics in the U.S., understanding serious adverse event reporting (SAER) is crucial to maintaining compliance and avoiding regulatory penalties. In this article, we’ll explain what adverse event reporting entails, who is responsible, and how Cosmereg can assist in ensuring compliance with FDA requirements.

What is an Adverse Event for Cosmetic Products?

An adverse event refers to any health-related reaction or complaint associated with the use of a cosmetic product. These reactions can range from minor irritations to serious adverse events, which are defined by MOCRA as incidents that result in:

Hospitalization
Permanent disfigurement or disability
Serious infections
Birth defects
Death

Unlike before, where reporting was voluntary, MOCRA now mandates the Responsible Person to report serious adverse events to the FDA within 15 business days of receiving the complaint.

Who is the Responsible Person for Adverse Event Reporting?

Under MOCRA, the Responsible Person (RP) is:

The manufacturer, packer, or distributor whose name appears on the product label.
The entity responsible for ensuring regulatory compliance, including maintaining safety records and adverse event documentation.

If a consumer or healthcare professional reports an adverse event, the RP must:

Collect detailed information about the incident.
Determine if the event qualifies as “serious” under MOCRA.
Submit a Serious Adverse Event Report (SAER) to the FDA within 15 business days.
Maintain records of all adverse events for a minimum of 6 years (for small businesses, 3 years).

Failure to comply could result in FDA enforcement actions, including recalls, warning letters, and potential legal liability.

How Can Cosmereg Assist the Responsible Person?

Navigating FDA compliance under MOCRA can be challenging, but Cosmereg simplifies the process by offering comprehensive regulatory support for cosmetic brands.

1. Adverse Event Management & Reporting

Cosmereg helps brands identify, document, and report serious adverse events in line with FDA requirements. Our team:

Reviews all adverse event complaints to determine reportability.
Prepares and submits Serious Adverse Event Reports (SAERs) to the FDA within the required timeframe.
Maintains detailed adverse event records for compliance audits.

2. Compliance Guidance & Risk Mitigation

Our regulatory experts provide guidance on best practices for adverse event tracking, helping brands implement internal reporting systems to capture consumer complaints efficiently.

We also assist in:

Developing adverse event response protocols.
Conducting post-market safety surveillance.
Advising on corrective actions to mitigate regulatory risks.

3. FDA Communication & Audit Support

Cosmereg acts as an intermediary between your company and the FDA, ensuring all regulatory communications are handled promptly and professionally. In case of an FDA inquiry or audit, we provide:

Support in responding to FDA requests.
Guidance in preparing for FDA inspections related to MOCRA compliance.
Documentation and reporting assistance to avoid penalties.

4. MOCRA Compliance Training for Brands

We offer training sessions and consultations to educate cosmetic companies on their responsibilities under MOCRA, including:

How to identify and classify adverse events.
Proper documentation and record-keeping practices.
FDA submission procedures to avoid compliance errors.

Why Choose Cosmereg for MOCRA Compliance?

With years of expertise in U.S. FDA regulatory affairs, Cosmereg is a trusted partner for cosmetic brands seeking MOCRA compliance. By appointing us, you ensure:

Fast and accurate adverse event reporting to the FDA.
Seamless compliance with new MOCRA requirements.
Reduced regulatory risks and brand protection in the U.S. market.

💡 Don’t leave FDA compliance to chance! Let Cosmereg handle your adverse event reporting and MOCRA compliance while you focus on growing your brand.

📞 Contact us today to learn how we can assist your business with FDA compliance and Responsible Person duties.