Close up of person's hands applying lotion on white background for Registrar Corp serious adverse events for cosmetics guide.
Author

Jaclyn Bellomo

Senior Director of Cosmetic Science and Regulatory Affairs

A Guide to Serious Adverse Event Reporting for Cosmetics

Apr 3, 2024

Cosmetics companies selling to the U.S. market face a new layer of regulation under the Modernization of Cosmetics Regulation Act (MoCRA): serious adverse event reporting.  

 Previously limited to drug products and medical devices, this cosmetics requirement is enforceable by FDA as of December 29, 2023. Cosmetics serious adverse event reporting is also one of the duties of the newly designated “Responsible Person” (RP) under MoCRA.  

 A Responsible Person is defined by FDA as the “manufacturer, packer, or distributor of a cosmetics product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.” 

Other RP duties include cosmetic product listings, professional use labeling, fragrance allergen disclosure, and safety substantiation. 

 In this short guide, we offer an overview of serious adverse event reporting for cosmetics companies and other adverse event RP requirements to help you successfully comply with MoCRA regulations. 

 

What Is a Serious Adverse Event? 

FDA requires that RPs submit reports of all serious adverse events associated with the use of marketed cosmetics products in the U.S. 

The Federal Food, Drug, & Cosmetic Act (FD&C) defines an adverse event as “any health-related event associated with the use of a cosmetic product that is adverse”. In December 2023, FDA issued updated instructions for serious adverse event reporting to reflect adverse events that may occur in the cosmetics sector. 

 A “serious adverse event” is any adverse event that results in:  

  • Death or a life-threatening experience 
  • Inpatient hospitalization or an infection 
  • A persistent or significant disability or incapacity 
  • A congenital anomaly or birth defect 
  • Significant disfigurement (serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance not intended under conditions of use) 

 An adverse event may also be considered serious if it requires “reasonable medical judgment, a medical or surgical intervention” to prevent the outcomes described above. 

 

Serious Adverse Event Reporting for Responsible Persons 

Serious adverse event reports must be submitted no more than 15 business days after receiving information about the event. They should include: 

  • Patient information 
  • Details of serious adverse events and outcome 
  • Suspect product(s) information 
  • Copy of label found on or within cosmetics product(s) retail packaging 

If you receive additional “new and material” information about the serious adverse event within one year of the initial report, you must submit this new information within 15 days to FDA.  

These reports will not be considered an admission that your product has caused or contributed to an adverse event. You may include a statement denying that your product contributed to the adverse event in your report. 

 

How To Submit Adverse Event Reports 

FDA recommends that Responsible Persons use the current downloadable and fillable MedWatch Form 3500A to submit serious adverse event reports.  

This 7-page form requires detailed information about the patient, event, and suspect product and can be challenging for companies new to adverse event reporting. It should be completed and submitted with additional supporting information, such as copies of product labels and images of the serious adverse event. 

Reports can be submitted via email or by mail to FDA’s Center for Drug Evaluation and Research (CDER). Keep in mind that you will have 15 business days, or 3 weeks, to collect, organize, fill out, and submit each report from the day you receive information of a serious adverse event.  

FDA’s Cosmetics Direct portal for facility registration and product listing does not currently allow users to submit adverse event reports. However, FDA is in the process of developing a system for mandatory electronic report submission. 

The statutory deadline for serious adverse event reports and additional information submissions was December 29, 2023, and is currently being enforced by FDA.

 

Other Adverse Event MoCRA Requirements 

Aside from reporting serious adverse events, RPs are also responsible for adverse event receiving, recordkeeping, and product labeling. 

Under MoCRA, Responsible Persons are required to receive and record all adverse and serious adverse event reports for up to 6 years, or 3 years for small business distributors. In the event of an inspection, FDA can request all adverse event records. 

All cosmetic products must also include the Responsible Person’s contact information on the product label so consumers can submit information about adverse events. This can be a domestic address, phone number, or electronic contact information.

 

3 Ways To Manage Your Cosmetics Adverse Event Receiving, Record Keeping, and Reporting 

Information on adverse events comes from consumers and may be reported via phone, mail, email, or website. The contact information you share on product labels, and your customers’ preferred channels of communication, may result in a variety of reports from different courses.  

It is important to have an established Adverse Event Record-Keeping process in place. Under the new regulation, FDA can request access to all adverse event records, so companies need to be organized and contain all necessary information.  

Proper record keeping can detect issues, trends, and patterns of a product to protect against a public health concern or mandatory recall. And when it comes to serious adverse events, companies with a proper intake and record-keeping system can expedite serious adverse event reports to FDA.  

Lastly, companies can normalize incidence rates and predictable events with the use of a specific product and determine acceptable ranges and actionable variations.  

To help you comply, there are several ways you can collect and maintain documentation. 

Collect Your Own Adverse Event Reports 

Your company can develop its own software or manually manage the collection and reporting of adverse events.  

This could involve assigning staff member(s) to collecting and organizing adverse event reports for you to categorize and submit. It could also mean directing consumers to an online form or other single data collection point to streamline the process. 

In-house solutions for adverse event report data collection may be preferable. However, keep in mind that some adverse events may require additional or ongoing medical treatment. It will be crucial to train your staff in responding to potential media emergencies or directing them to a medical professional. 

Hire A Call Center 

If you don’t have the staff or resources to create your own adverse event reporting solution, some call centers offer adverse event collection.

Be aware that different call centers will provide different levels of service. Some concentrate on data collection and reporting while others offer adverse event triage and case management. Using a call center can be a lengthy process and prone to human error, potentially endangering your 15-day reporting deadline.  

Work With a Regulatory Professional Service or SaaS Solution 

In-house and outsourced solutions may help streamline adverse event data collection. But they often can’t provide the same level of expertise as a professional service or software platform. 

Regulatory industry professionals have in-depth knowledge of MoCRA and serious adverse event reporting requirements. Software solutions created by regulatory specialists will include updated guidance and regulations, optimizing data collection for easy report submissions. 

Built on in-depth industry experience, these solutions work quickly and efficiently with minimal human error. 

 

Quick, Efficient Adverse Event Reporting With Registrar Corp 

Registrar Corp has helped thousands of cosmetic companies maintain compliance and bring safe products to market. We’re committed to supporting our clients as they navigate new MoCRA regulations for adverse event reporting. 

Manage adverse event disclosure for unlimited products from start to finish with Adverse Event Management. Our turnkey software solution provides a branded electronic contact for consumers to report adverse events. It also offers intuitive data collection and report creation tools. 

With Registrar Corp’s solution, you can: 

  • Create branded URLs and QR codes for easy reporting on websites, social sites, and product labels 
  • Access an easy-to-use platform for consumers to report adverse events 
  • Manage adverse event disclosure for unlimited products 
  • Quickly collect all adverse and serious adverse event information in real-time and store and manage it in a secure database
  • Easily access and log into your AER database via myFDA 
  • Receive organized adverse and serious adverse event reports for review 

Adverse Event Management gives you the tools to manage and record all adverse events. Let us help you stay compliant as you prepare to update your cosmetic product labels in compliance with MoCRA.  

Learn more about our adverse event management solution.

Looking for additional support for Responsible Persons? Registrar Corp makes the process of submitting cosmetic product listings quick and easy. Work with our experienced product listing specialists to submit and update your annual product listings today. 

Author


Jaclyn Bellomo

Senior Director of Cosmetic Science and Regulatory Affairs

A seasoned expert on the cosmetic industry, Jaclyn's deep understanding and insights on cosmetic regulations brought on with the passage of the Modernization of Cosmetics Regulation Act (MoCRA) are unmatched. Her experience and reputation throughout the global cosmetic industry helps companies worldwide meet the newly enacted FDA regulations under MoCRA.

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