FDA updates 3500A instructions to provide direction for mandatory cosmetics reporting

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.

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