With several provisions going into effect on December 29, 2023, it’s important to start preparing for MoCRA now. As the industry waits for the FDA to finalize instructions and guidance, there are many undertakings to note and do to assure you do not find yourself out of compliance when December 29th arrives.
Facilities and Product Registration
MoCRA requires that all cosmetic manufacturers and processors register their facilities in advance of the December 2023 deadline, and likewise for the responsible persons to register all their cosmetic products by the same date. Failing to register a facility or a product risks the FDA determining that a marketed cosmetic product is tainted or misbranded. This can lead to a mandatory recall; criminal action against a company or facility; rejection or suspension of a facility registration, resulting in a shutdown of the facility and/or a fine or other penalty associated with noncompliance.
Registration will need to include the following information:
- The facility’s name, physical address, email address, and telephone number.
- The contact (including electronic contact information) for the United States Agent for any foreign facility.
- The facility registration number assigned by the Secretary of HHS (if any).
- All brand names under which cosmetic products manufactured or processed in the facility are sold.
- The product category or categories and responsible person for each cosmetic product manufactured or processed at the facility.
- The facility registration number of each facility where the cosmetic product is manufactured or processed.
- The name and contact of the responsible person and the name for the cosmetic product as such name appears on the label.
- The applicable cosmetic category or categories for the product.
- A list of ingredients in the cosmetic product, including any fragrances, flavors, or colors, with each ingredient identified by name set forth in the Code of Federal Regulations or by the common or usual name of the ingredient.
- The product listing number assigned by the Secretary of HHS (if any).
The FDA has yet to release an electronic system for filing these registrations and has promised to have a system ready in time for December 2023 MoCRA deadline. It is expected the FDA will provide guidance on its new registration system in the next 2-3 months.
It’s important to be prepared now and not wait for the registration system to be finalized as it can open risks of significant delays that could place it out of compliance in December 2023. To lessen potential risks, “responsible persons” should be working diligently to assemble all the information required above. Additionally, that “responsible person” must ensure and maintain records supporting there is adequate substantiation of safety for each cosmetic product for which it is responsible by the December 2023 deadline. These records include determining the safety of a cosmetic product and its ingredients under customary and usual use, and potential effects from cumulative or other relevant exposures. FDA will expect these records to sit with contract manufacturers and any listed “responsible persons.”
MoCRA also requires all “responsible persons” to maintain records of any adverse event reported for a cosmetic product they have manufactured, processed, or distributed for six years or three years for qualifying small businesses. Furthermore, MoCRA requires responsible person must report any serious adverse event to FDA within 15 days and provide FDA with any updates concerning “new or material medical information” associated with such serious adverse events within 15 days for a period of one year.
FDA is developing a process for submitting mandatory adverse event reports for cosmetics. Currently, they encourage electronic reporting through the Safety Reporting Portal (SRP). To access the portal, request an SRP account by emailing email@example.com.
MoCRA places significant responsibilities on companies in the cosmetics industry that come with substantial risks if a company or product fails to comply by December 29, 2023. These risks include withdrawal of a product from the market or complete shutdown of a manufacturing facility. It is obligatory upon “responsible persons” and other manufacturers and processors to take the necessary steps to ensure no product or facility gets left behind.