SafetyCall International, LLC
3600 American Boulevard W, Suite 725
Bloomington, MN 55431
Blog
FDA updates 3500A instructions to provide direction for mandatory cosmetics reporting
December 19, 2023

FDA released an updated guidance for industry to include instructions on mandatory adverse event reporting for cosmetics. Mandatory reporting was included in the sweeping legislative update for cosmetics last year, passed as part of the appropriations package that was signed into law on December 29th, 2022. These are the most significant changes for the industry since cosmetics initially came into FDA’s purview with the FD&C Act passing in 1938. The changes are comprehensive and include: facility registration and product listing, safety substantiation, mandatory recall authority and records access for the FDA, as well as compliance requirements the FDA has yet to establish on GMP, fragrance allergen labeling, and talc and asbestos testing. A number of these changes, including mandatory adverse event reporting, are set to come into effect December 29th, 2023.

Key updates include where to send reports and supplemental information such as label scans and adverse event images. Not included in the guidance were more detailed definitions for significant disfigurement, hair loss, or infections. Of note, while there are also instructions in the form to submit electronic reports through the Safety Reporting Portal for cosmetics, FDA clarified in their announcement that they are continuing to work on updates to the portal which when ready will allow for cosmetics reports to be submitted.

SafetyCall is closely monitoring for updates from the agency on cosmetic reporting and will continue to send out news on the topic.

YOU MAY ALSO LIKE
EPA and FDA CVM Hold Joint Public Meeting to Hear Comments on Modernization Plan
Last Wednesday, March 22nd, several members of SafetyCall’s regulatory team sat in on EPA and FDA’s Center for Veterinary Medicine (CVM) first joint public meeting in which they presented a…
FDA Food Safety Compliance Initiatives
Presently, although there is no requirement for submitting individual adverse event human case reports involving food products to the FDA the Agency does have the expectation that manufacturers have a…
What We Know About MoCRA
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the first major change to FDA’s cosmetics authorities since the passage of the Food, Drug, and Cosmetic Act in 1938.…