All cosmetic companies (Brands) regardless of size, must report Adverse Events to the FDA within 15 days of notification by a consumer and maintain on file an Adverse Event Dossier on each and every Adverse Event for a period of 6 years. This is a significant new requirement in MoCRA affecting all Indie Beauty Brands.

Here’s the language from the FDA MoCRA Draft Guidance For Industry

“Adverse Event Reporting: A responsible person is required to report serious adverse events associated with the use of cosmetic products in the United States to FDA within 15 business days, along with a copy of the label on or within the retail packaging of such cosmetic product, after receiving the report and certain additional information, such as new medical information, within 1 year of the initial report. FDA will also have access to adverse event reports during an inspection.”

What is an Adverse Event?

Adverse Event: any health-related event associated with the use of a cosmetic product that is adverse and/or unexpected whether or not the Adverse Event requires medical attention.

Serious Adverse Event: 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; an infection; or significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended under conditions of use that are customary or usual; or
• (B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in (A) above.

How to handle Adverse Events:

Bloom Cosmetic Test Lab recommends that you set up an Adverse Event Reporting page on your website and a specific e-mail for consumers to report Adverse Events such as adverseevent@company.com

Establish an Adverse Event Standard Operating Procedure/Policy and designate a single individual who will be responsible for intake and reporting of all Adverse Events to the FDA.

Use the MedWatch Forms FDA 3500A to collect AE/SAE information and file with the FDA.

With these records in hand, you will be able to provide a Safety Substantiation Dossier should the FDA request to see your records.

If you need assistance with Safety Substantiation or any other aspect of MoCRA compliance, we can guide you through MoCRA Compliance with our MoCRA Compliance Officer service.