November 8, 2023, FDA announced that the enforcement date for cosmetic facility registration and product listing will be delayed until July 1, 2024. The announcement stated that this was “to provide regulated industry additional time to comply with these requirements.” However, the guidance document itself states, “FDA anticipates that electronic submission, technical assistance documents, and paper submission forms will be available in early December 2023.” It’s not surprising that FDA would need more time to prepare for the mandates in MoCRA, which was apparently written by interest groups with no real understanding of FDA’s capacity. In complete disclosure, the guidance also said that, “FDA will be ready to accept registration and listing information by the statutory deadline of December 29, 2023, and we encourage companies to meet that deadline if they are able to do so.” Time will tell whether the submission portal will actually be ready. Meanwhile, see the draft paper submission forms for facility registration and cosmetic product listing to be aware of the data you will need to collect. You can also find a brief summary of the registration and listing requirements here.
Other requirements are still effective December 29, 2023
The delay for cosmetic registration and listing will be welcome news to many cosmetic companies around the world. However, it is important to note that this delay does not affect other MoCRA requirements with effective dates of December 29. 2023:
| Regulatory Requirement | Comments | Effective Date |
| Safety Substantiation | Companies must have safety dossiers for their products that include tests, studies, or other evidence sufficient to support a conclusion that a cosmetic product is safe under the conditions of use indicated on the labels or in other labeling. | December 29, 2023 |
| Serious Adverse Event Reporting | Companies must have a system for receiving, responding to, and reporting serious adverse events. | December 29, 2023 |
| Mandatory Recall Authority | FDA will be able to require market removal of cosmetics that have a reasonable probability of causing serious adverse health consequences or death. |
December 29, 2023 |
As always, we hope you will find this information helpful. Contact us with your questions about safety substantiation, adverse event reporting, or other aspects of cosmetic regulations.
