In the first three parts of this series (Part I, Part II and Part III), we provided an overview of the new US Food and Drug Administration (FDA) regulatory requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the good manufacturing practices (GMPs) regulations FDA plans to establish, as well as the FDA draft guidance on the facility registrations and products listings. In this Part IV, we are providing an important update of FDA’s compliance policy – enforcement discretion for MoCRA facility registration and product listing until July 1, 2024, as well as the existing FDA resources to help industry prepare for MoCRA implementation.
For quick background, under MoCRA, every person that, on December 29, 2022, owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States must register each facility no later than December 29, 2023. Further, the responsible person of a cosmetic product that is marketed on December 29, 2022, must submit a cosmetic product listing not later than December 29, 2023. As of today, the FDA is not currently accepting facility registration or product listing submissions. This has led to widespread speculation that the compliance timeline may experience delays. On November 8, 2023, FDA issued a new guidance titled “Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing,” which informs the industry the agency’s intent to delay enforcement of the facility registration and product listing requirements under MoCRA for six months to help ensure the industry has sufficient time to submit such facility registration and product listing information.
Further, according to the new guidance, FDA is in the process of developing an electronic submission portal known as Cosmetics Direct. This portal aims to streamline the submission process and receipt of facility registration and product listing information. While FDA strongly encourages the use of electronic submissions, the agency is also working on the creation of paper forms, specifically FDA Form 5066 and 5067, as an alternative means of submission. To ensure the functionality and usability of the new electronic submission portal, FDA also intends to conduct a pilot program. FDA anticipates that the electronic submission, technical assistance documents, and paper submission forms will be available in early December 2023.
Below, we further discuss the new MoCRA compliance timeline with FDA enforcement discretion as well as the existing FDA resources for MoCRA implementation.
In more detail
New MoCRA Compliance Timeline with FDA Enforcement Discretion
In the new guidance, FDA notes it does not intend to enforce the MoCRA requirements related to cosmetic product facility registration and product listing for an additional six months after the December 29, 2023, statutory deadline, or until July 1, 2024, to provide the industry additional time to comply with these requirements. Similarly, FDA does not intend to enforce the facility registration and product listing requirements for businesses that first engage in manufacturing, processing, or marketing after December 29, 2022 until July 1, 2024.
However, importantly, the FDA enforcement discretion only applies to the facility registration and product listing, and there are other legal obligations including adverse events reporting and safety substantiation under MoCRA that would also take effect on December 29, 2023. It is unclear how the FDA enforcement discretion would impact these obligations under MoCRA. For easy reference, we have summarized these requirements in the chart below.
|Action items for cosmetic companies under MoCRA
|FDA Enforcement Discretion
|Facility registration and product listingManufacturers and processors must register their facilities with the FDA and renew their registration every two years. Companies must list each marketed cosmetic product with the FDA, including product ingredients, and provide any updates annually.
|December 29, 2023
|July 1, 2024
|Adverse events reportingCompanies are required to report serious adverse events associated with the use of cosmetic products in the US to the FDA within 15 business days after receiving the report.
|December 29, 2023
|Mandatory recall authorityIf the agency determines that there is a reasonable probability that a cosmetic is adulterated or misbranded and the use of or exposure to the cosmetic will cause serious adverse health consequences or death, the FDA has the authority to order a mandatory recall if the responsible person refuses to do so voluntarily.
|December 29, 2023
|Safety substantiationEnsure and maintain records supporting adequate safety substantiation for their products.
December 29, 2023
FDA’s Existing Resources for Facility Registration and Product Listing
FDA intends to use the FDA Establishment Identifier (FEI) as the mandatory facility registration number. In order to streamline the facility registration process, facility owners or operators must obtain an FEI number before submitting the facility registration. To ascertain whether an entity already possesses an FEI number, please refer to the FEI Search Portal.
Additionally, registrations for cosmetic product facilities and product listings have been integrated into the Structured Product Labeling (SPL) framework. In the future, once FDA begins accepting data, users may transmit SPL-formatted submissions through FDA’s Electronic Submissions Gateway (ESG), or SPL authoring software for cosmetic product facility registrations and product listings. FDA also intends to make the Cosmetics Direct electronic submission portal available in the future here. Cosmetics Direct will be an FDA-provided SPL authoring tool that contains user-friendly data entry forms, performs initial validations, creates and saves the SPL submission.
The draft paper forms for facility registration and product listing are also available on FDA’s website:
- FDA will exercise enforcement discretion for facility registration and product listing requirements under MoCRA until July 1, 2024. However, no such enforcement discretion is explicitly provided for other obligations that would take effect on December 29, 2023, including adverse event reporting and safety substantiation.
- FDA intends to make the new electronic submission portal available for submitting registration and product listing information in December 2023. As the agency has provided additional details on the electronic submission and paper forms, cosmetic companies should start collecting information needed for facility registration and product listing.
For further information and to discuss what this development might mean for you, please get in touch with the Baker McKenzie contacts provided above.