MoCRA 2023

The long-anticipated update to the FDA Cosmetics Regulation Act 2022 has finally been released, introducing a range of compulsory compliance measures, some of which will take effect by the end of this year.

Time sensitivity is crucial, and Delphic's expert regulatory specialists are ready to assist with the following provisions mandated in MoCRA:

1. Domestic Responsible Person (RP):

The product label must include contact details for a domestic Responsible Person, who could be the manufacturer, packer, or distributor. The RP must have a domestic address, phone number, or electronic contact (such as a website) to receive adverse event reports. It is recommended that the RP be based in the US. Additionally, listing allergens on the label will be mandatory.

2. Facility Registration:

Companies need to register their manufacturing or processing facilities with the FDA within 60 days of MoCRA taking effect (by 29th December 2023). These registrations must be renewed annually.

3. Product Registration:

Existing cosmetic products must be registered by 29th December 2023. Initially, registration can be done through the Voluntary Cosmetics Registration Program. Product registrations must be updated annually, and new products must be registered within 120 days of being introduced to the market.

4. Good Manufacturing Practices (GMP):

By 2025, GMP must be implemented, and products should be manufactured in accordance with these practices. While the FDA will publish the final regulation by 29th December 2025, compliance with ISO 22716 in the interim is advisable.

5. Product Labeling:

Cosmetic product labels must include fragrance allergens, with the final list to be determined by the labeling update deadline of 29th December 2025.

6. Adverse Events:

Records of adverse effects must be kept and recorded. Serious Adverse Events must be reported to the FDA within 15 business days after the Responsible Person is informed.

7. Safety Substantiation:

Thorough documentation demonstrating product safety must be maintained, akin to the requirements of a UK/EU Cosmetic Product Safety Report (CPSR). These safety records must be submitted to the FDA upon request.

8. Mandatory Recall:

Under MoCRA, the FDA can issue a mandatory product recall in case of non-compliance and safety issues resulting in misbranding or adulteration of the product. In severe cases of health effects attributed to a cosmetic product, the FDA can suspend a facility's registration. The facility cannot sell any cosmetic products until its registration has been reinstated.

In addition to the above, the FDA is also tasked with publishing a test protocol for asbestos in talc by mid-2024. Moreover, the use of PFAS in cosmetics will be assessed by the FDA, and the results must be published by 29th December 2025.

Lastly, there is a phased-out approach to animal testing, with the exception of "appropriate allowances."