Important Deadlines to Meet New FDA Regulations for Cosmetic Adverse Events
December 29, 2023
- A Responsible Person (RP) MUST submit any report received of a serious adverse event to FDA no later than 15 business days after RP receives it
- RP must keep records related to each adverse event report for their cosmetic product for 6 years
(3 years for small businesses)
December 29, 2024
- Cosmetic product label must include contact information that consumer can use to report adverse events to company
Consumer Disclosures and FDA Reporting Done Right
Cosmetic companies are required to collect, maintain, and submit adverse event reports to FDA. Registrar Corp’s Adverse Event Reporting Software enables you to manage the entire process in a single integrated system.
- Create branded URL or QR codes to add to your cosmetic labels
- Provide consumers a simple way to disclose adverse events
- Manage adverse event consumer disclosures for unlimited products
- Quickly collect the information your company needs
- Receive organized adverse event reports for review
Deepen Your Understanding of MoCRA
Frequently Asked Questions
Under the Modernization of Cosmetics Regulation Act (MoCRA), U.S. Food & Drug Administration (FDA) requires cosmetics labels to include either a:
- U.S. address
- U.S. telephone number
- Electronic contact information
This information is needed on each of your product labels for receiving and documenting consumer reports of adverse, and serious adverse, events. Products that don’t meet this requirement will be considered “misbranded” by FDA and subject to detention and refusal.
Under the new guidelines, cosmetic companies are now required to maintain records of, and report, adverse events. FDA requires these records to be available should any of your products pose a potential threat to public health. Upon identification of a threat, FDA now reserves the right to enforce detentions, refusals, and mandatory recalls of these products.
Cosmetic adverse event reporting must be conducted and submitted to FDA within 15 business days — including any updates that follow within a year of the original submission.
Adverse events are also required to be accepted through a U.S. address, telephone number, or electronic contact information supplied on each of your product labels.
This section of MoCRA also expanded FDA’s definition of a serious adverse event to better cover cosmetics as a whole. The definition now includes:
- Significant disfigurement, including serious and persistent rashes
- Second or third-degree burns
- Significant hair loss
- Persistent or significant alteration of appearance
A serious adverse event under MoCRA is an adverse event that results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, and infection.
To account for considerations relevant to the cosmetics sector, significant disfigurement other than as intended under conditions that are customary or usual include serious persistent rashes or infections, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance.
FDA announced that a responsible person should submit reports of serious adverse events online via MedWatch, FDA is developing a process for submitting mandatory adverse event reports for cosmetics.
FDA’s enforcement provisions for adverse events go into effect on December 29th, 2023 and once the requirement is effective, a responsible person must submit a report of serious adverse event to FDA within 15 business days after receipt by the responsible person.
Yes. All adverse events are required to be accepted through a U.S. address, telephone number, or electronic contact information supplied on each of your product labels.
Under MoCRA, all label or labeling statements required by law or regulation must be in the English language and must contain:
- Statement of identity
- Net Quantity of contents
- Directions for safe use
- Any necessary or mandatory warning statements
- Ingredients
- Corporate name and address of the manufacturer, packer, or distributor
- Country of origin
Warning Labels must also be added to cosmetic products that are:
- Self-pressurized containers
- Feminine deodorant sprays
- All-over body sprays
- Foaming detergent bath products
- Coal tar hair dyes
- Sunless tanners and sun tanning preparations