As the December 29, 2023 deadline for certain aspects of the Modernization of Cosmetics Regulation Act (“MoCRA”) approaches, FDA has finalized its guidance document governing the registration of cosmetic manufacturing facilities and listing of products with FDA and updated its instructions for industry connected with the reporting of serious adverse events.
Facilities Registration and Product Listing
On December 18, 2024, FDA announced that the portal for electronic submission of facility registrations and product listings under MoCRA is now online and can be accessed by industry. Alternative forms for paper submission are still being prepared and will be issued soon.
At that same time, FDA issued a final guidance document titled Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products. The final guidance adopts the recommendations set forth in FDA’s earlier draft guidance issued in August 2023 that are discussed in Locke Lord Quick Study: FDA Issues Draft Guidance on Facilities and Product Registration and Listing Under MoCRA without any significant changes and confirms that FDA does not intend to enforce the requirements for facilities registration or product listing until July 1, 2024.
Importantly, the final guidance document reiterates FDA’s request that facilities registrations and product listings include: (1) additional corporate and product identifying information beyond that required in the MoCRA statute; and (2) an attestation as to the accuracy and veracity of the information being submitted to be made by the individuals responsible for the submission, though it confirms those requests remain optional and not mandatory.
We recommend that any facility registration or product listing be reviewed by legal counsel to ensure compliance with MoCRA and the final guidance document, as well as maintain the confidentiality of you company’s proprietary information.
Serious Adverse Event Reporting
FDA has confirmed that it will not have an electronic portal for mandatory submission of serious adverse event reports from cosmetic products online by December 29, 2023, the date the serious adverse event section of MoCRA becomes operational. As of that date, all responsible persons learning of a serious adverse event associated with a cosmetic product must report that event to FDA within fifteen days of first receiving notice. For a review of the MoCRA’s requirements with respect to reporting serious adverse events please see Locke Lord QuickStudy: Prepare for MoCRA’s New Adverse Event Requirements Now.
Instead, on December 14, 2023, FDA announced that it has updated the instructions for FDA’s MedWatch Adverse Event Reporting Form (Form 3500A) to include specific instructions for reporting serious adverse events associated with cosmetics products. Until the electronic submission portal is ready, FDA has asked responsible persons under MoCRA to fill out the MedWatch Form in .pdf form then send the form along with any supporting information such as labels, pictures, and health care records digitally by email to CosmeticAERS@fda.hhs.gove or in paper by mail to:
FDA CDER Mail Center
Attn: Cosmetics MedWatch reports
White Oak Campus, Building 22, G0207
10903 New Hampshire Ave.
Silver Spring, MD 20993
Should the responsible person choose to submit the serious adverse event report in paper, any mandatory follow-up reports may be submitted digitally, or vice versa.
We recommend that any serious adverse event report is reviewed by a medical professional and your legal counsel to ensure that it properly sets forth that your product(s) have “adequate substantiation of safety” and that the product(s) “is not injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual.”
