Worldover’s Comprehensive Guide to Serious Adverse Event Reporting in Cosmetics
With the introduction of the Modernization of Cosmetics Regulation Act (MoCRA), cosmetics companies selling in the U.S. must navigate a significant regulatory change: the requirement for serious adverse event reporting. Previously reserved for industries like pharmaceuticals and medical devices, this new regulation places the onus on cosmetics companies to report certain adverse events to the FDA, starting December 29, 2023. This responsibility is handled by the designated “Responsible Person” (RP), a role central to MoCRA compliance.
This guide by Worldover breaks down the essentials of serious adverse event reporting and outlines the broader RP obligations to help your business confidently comply with MoCRA regulations.
Under MoCRA, all companies selling cosmetics in the U.S. market are now required to report serious adverse events to the FDA. This mandate applies to the designated Responsible Person (RP) and encompasses any major health-related incident associated with a cosmetic product in the market. The FDA has specific criteria for “serious” adverse events, defining them as instances that result in:
An event may also be classified as serious if it requires medical intervention or surgery to prevent these outcomes.
MoCRA mandates that RPs file a report for serious adverse events within 15 business days of becoming aware of the incident. Each report must contain detailed information, including:
If new, relevant information arises within a year of the initial filing, companies have another 15-day window to submit an updated report. Critically, submitting a report doesn’t indicate an admission of liability; companies can include statements denying any connection to the adverse event if applicable.
To simplify the reporting process, the FDA recommends using the MedWatch Form 3500A. This downloadable form requires detailed documentation about the adverse event, including patient and product information. Companies can submit completed reports by email or mail to the FDA’s Center for Drug Evaluation and Research (CDER) within the designated 15-day period.
Although the FDA’s Cosmetics Direct portal currently supports facility registration and product listing, it doesn’t yet allow for adverse event report submissions. However, the FDA is developing a system for mandatory electronic reporting, expected to streamline the process for companies in the near future.
Beyond the requirements for serious adverse events, MoCRA assigns additional duties to RPs, which include receiving, recording, and labelling adverse events. RPs must maintain records of all adverse events (both minor and serious) for up to six years, or three years for small businesses. These records may be subject to FDA inspection, requiring companies to have organised, accessible documentation.
Furthermore, product labels must now include the RP’s contact information—such as a U.S.-based address, phone number, or electronic contact—so consumers have a straightforward way to report any adverse events directly.
You have three options: build something in-house, outsource or use Worldover. We’ve developed an automated adverse events reporting system that takes 1 minute to set up and is designed to be affordable for every single brand.
Fill in a form on our website for a free demo.
