On November 8, 2023, the United States Food and Drug Administration (FDA or agency) announced it does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) for six months after the December 29, 2023 statutory deadline. In other words, the agency has delayed the deadline for the registration and listing requirements until July 1, 2024. The delayed deadline will help ensure that industry has sufficient time to gather and verify the relevant information required for facility registration and product listing, including obtaining facility registration numbers to associate with cosmetic product listings, and obtaining access to the electronic submission database (electronic registration is strongly encouraged).
The table below reflects the updated key MoCRA deadlines.
MoCRA Requirement |
Original Deadline |
Current Deadline |
|
Register covered cosmetic manufacturing or processing facilities |
December 29, 2023 |
July 1, 2024 |
|
List covered cosmetic products and their ingredients |
December 29, 2023 |
July 1, 2024 |
|
Safety substantiation documentation and recordkeeping |
December 29, 2023 |
December 29, 2023 |
|
Submit serious adverse event reports to FDA no later than 15 business days of receipt and maintain records of adverse events |
December 29, 2023 |
December 29, 2023 |
|
Professional use labeling – The label must state that the product must be administered or used only by licensed professionals |
December 29, 2023 |
December 29, 2023 |
|
Contact information labeling – Certain contact information for the responsible person must be on the label |
December 29, 2024 |
December 29, 2024 |
The compliance deadlines for other key MoCRA requirements are currently unknown because agency rulemaking is required. The statutory deadlines for the rulemakings are:
Required Rulemaking |
Publication Deadline for Proposed Rule |
Publication Deadline for Final Rule |
|
Good Manufacturing Practice (GMP) regulations |
December 29, 2024 |
December 29, 2025 |
|
Establishing and requiring standardized testing methods for detecting asbestos in talc-containing cosmetic products |
December 29, 2023 |
180 days after the proposed rulemaking's public comment period closes |
|
The identification of fragrance allergens to be listed on cosmetic products labels |
June 29, 2024 |
180 days after the proposed rulemaking's public comment period closes |
In addition to the above rulemakings, FDA also must assess the use and safety of per- and polyfluoroalkyl substances (PFAS) in cosmetic products and, by December 29, 2025, must publish a report summarizing its findings.
Despite the delayed deadline, FDA has advised that it will be ready to accept registration and listing information by December 29 and encourages companies to meet that deadline if they are able to do so. We note that the agency has released some information related to the registration and listing process that will help companies comply with these new requirements. For example, in August, the agency issued draft guidance, which, when finalized, will provide recommendations and instructions to assist with facility registration and product listing requirements.
If you would like to learn more about MoCRA, please refer to the article "Prepare Now for the New FDA Requirements for Cosmetics Companies" on our blog. Contact the authors if you would like to discuss your current regulatory compliance obligations and considerations.